CHAPTER 6 —THE CHILDREN'S BUREAU
Chapter Referred to in Other Sections
This chapter is referred to in title 22 section 2102.
§191. Bureau established
There shall be established in the Department of Health and Human Services a bureau to be known as the Children's Bureau.
(Apr. 9, 1912, ch. 73, §1,
Codification
Section was formerly classified to
Transfer of Functions
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
"Federal Security Agency" substituted for "Department of Labor" pursuant to Reorg. Plan No. 2 of 1946, set out in the Appendix to Title 5, Government Organization and Employees, which transferred Children's Bureau, exclusive of its Industrial Division, from Department of Labor to Federal Security Agency. Functions of Bureau, its Chief, and of Secretary of Labor relating to such functions transferred to Federal Security Administrator.
Functions authorized by
Functions of Children's Bureau under
For transfer of personnel, property, records and funds, see section 12 of Reorg. Plan No. 2 of 1946.
Act Apr. 9, 1912, established Children's Bureau in Department of Commerce and Labor. Act Mar. 4, 1913, transferred Children's Bureau to Department of Labor, which was created by that act, and was authority for substitution of "Department of Labor" for "Department of Commerce and Labor".
Cross References
Health research and research training resources in participating foreign countries, use by Secretary in exercise of functions under this chapter, see
§192. Chief of bureau; investigations and reports
The Children's Bureau shall be under the direction of a chief, to be appointed by the President, by and with the advice and consent of the Senate. The said bureau shall investigate and report to the Secretary of Health and Human Services, upon all matters pertaining to the welfare of children and child life among all classes of our people, and shall especially investigate the questions of infant mortality, the birth rate, orphanage, juvenile courts, desertion, dangerous occupations, accidents and diseases of children, employment, legislation affecting children in the several States and Territories. But no official, or agent, or representative of said bureau shall, over the objection of the head of the family, enter any house used exclusively as a family residence. The chief of said bureau may from time to time publish the results of these investigations in such manner and to such extent as may be prescribed by the Secretary.
(Apr. 9, 1912, ch. 73, §2,
Codification
In the first sentence of this section, provisions which specified an annual compensation of $5,000 for the chief of the Childrens Bureau have been omitted superseded. Following enactment of the Classification Act of 1923, the compensation was fixed in accordance with that Act. See act Feb. 27, 1925, title IV,
Section was formerly classified to
Transfer of Functions
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
"Federal Security Administrator" substituted for "said department" and for "Secretary of Labor" pursuant to Reorg. Plan No. 2 of 1946. See note set out under
"Secretary of Labor" substituted for "Secretary of Commerce and Labor" pursuant to act Mar. 4, 1913. See note set out under
§193. Assistant chief
There shall be in the Children's Bureau, until otherwise provided for by law, an assistant chief, to be appointed by the Secretary of Health and Human Services.
(Apr. 9, 1912, ch. 73, §3,
Codification
Section 3 of act Apr. 9, 1912, also provided for compensation of assistant chief and for appointment and compensation of other employees of the bureau.
Section was formerly classified to
Transfer of Functions
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out in as a note under
"Federal Security Administrator" substituted for "Secretary of Labor" pursuant to Reorg. Plan No. 2 of 1946. See note set out under
"Secretary of Labor" substituted for "Secretary of Commerce and Labor" pursuant to act Mar. 4, 1913. See note set out under
§194. Quarters for bureau
The Secretary of Health and Human Services is directed to furnish sufficient quarters for the work of this bureau at an annual rental not to exceed $2,000.
(Apr. 9, 1912, ch. 73, §4,
Codification
Section was formerly classified to
Transfer of Functions
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
"Federal Security Administrator" substituted for "Secretary of Labor" pursuant to Reorg. Plan No. 2 of 1946. See note set out under
"Secretary of Labor" substituted for "Secretary of Commerce and Labor" pursuant to act Mar. 4, 1913. See note set out under
10
CHAPTER 6A —PUBLIC HEALTH SERVICE
SUBCHAPTER I—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
Part A—Administration
(a)
Deputy Surgeon General.
(b)
Assistant Surgeons General.
(c)
Creation of temporary positions as Assistant Surgeons General.
(d)
Designation of Assistant Surgeon General with respect to absence, disability, or vacancy in offices of Surgeon General and Deputy Surgeon General.
(a)
Grades of commissioned officers.
(b)
Titles of medical officers.
(c)
Repealed.
(d)
Maximum number in grade for each fiscal year.
(e)
Exception to grade limitations for officers assigned to Department of Defense.
(a)
Original appointments to Regular and Reserve Corps; limitation on appointment and call to active duty.
(b)
Grade and number of original appointments.
(c)
Issuance of commissions.
(d)
Date of appointment; credit for service.
(e)
Reappointment; credit for service.
(f)
Special consultants.
(g)
Designation for fellowships; duties; pay.
(h)
Aliens.
(i)
Civil service appointments by Secretary.
(a)
Commissioned officers of Regular and Reserve Corps; special pay for active duty; incentive special pay for Public Health Service nurses.
(b)
Purchase of supplies.
(c)
Members of national advisory or review councils or committees.
(d)
Field employees.
(e)
Additional pay for service at Gillis W. Long Hansen's Disease Center.
(f)
Allowances included in fellowships.
(g)
Positions in professional, scientific and executive service; compensation; appointment.
(a)
Regulations.
(b),
(c) Repealed.
(d)
Definitions.
(a)
Division of corps; basis of categories.
(b)
Assignment of officers.
(c)
Maximum number of officers in each category.
(d)
Vacancies in grade for purposes of promotion.
(e)
Absence of vacancy in grade as affecting promotion.
(f)
Vacancy in grade as affecting maximum number for each category.
(a)
Permanent or temporary promotions; examination.
(b)
Promotion to certain grades only to fill vacancies; regulations; "restricted grade" defined.
(c)
Examinations.
(d)
Permanent promotions to qualified officers on length of service.
(e)
Promotion of professional category officers to fill certain vacancies.
(f)
Reexamination upon failure of promotion; effective date of promotion.
(g)
Separation from service upon failure of promotion.
(h)
Separation from service upon refusal to stand examination.
(i)
Review of record; separation from service.
(j)
Determination of order of seniority.
(k)
Temporary promotions; fill vacancy in higher grade; war or national emergency; selection of officers; termination of appointment.
(l)
Determination of requirements of Service by Secretary; assignment of Reserve Officers to professional categories; temporary promotions; termination of temporary promotions.
(m)
Acceptance of promotion; oath and affidavit.
(a)
Age; voluntariness; length of service; computation of retired pay.
(b)
Basic pay of highest temporary grade.
(c)
Recall to active duty.
(d)
"Active service" defined.
(e)
Crediting of part of year.
(f)
Retirement or separation for physical disability.
(a)
Rights, privileges, immunities, and benefits accorded to commissioned officers or their survivors.
(b)
Award of decorations.
(c)
Authority of Surgeon General.
(d)
Active service deemed active military service with respect to laws administered by Secretary of Veterans Affairs.
(e)
Active service deemed active military service with respect to Soldiers' and Sailors' Civil Relief Act of 1940.
(a)
Other Government departments.
(b)
State health or mental health authorities.
(c)
Congressional committees and nonprofit educational, research, or other institutions engaged in health activities for special studies and dissemination of information.
(d)
Availability of funds; reimbursement by State; detailed services deemed service for computation of pay, promotion, etc.
(a)
Prescription by President: appointments, retirement, etc.
(b)
Promulgation by Surgeon General; administration of Service.
(c)
Preference to school of medicine.
(a)
Appointment; purpose.
(b)
Compensation and allowances of members not full-time employees of United States.
(c)
Delegation of functions.
(a)
Appointment; duties.
(b)
Membership.
(c)
Terms of office.
(d)
Applicability of section 14(a) of Federal Advisory Committee Act.
(a)
Exclusiveness of remedy.
(b)
Attorney General to defend action or proceeding; delivery of process to designated official; furnishing of copies of pleading and process to United States attorney, Attorney General, and Secretary.
(c)
Removal to United States district court; procedure; proceeding upon removal deemed a tort action against United States; hearing on motion to remand to determine availability of remedy against United States; remand to State court or dismissal.
(d)
Compromise or settlement of claim by Attorney General.
(e)
Assault or battery.
(f)
Authority of Secretary or designee to hold harmless or provide liability insurance for assigned or detailed employees.
(g)
Exclusivity of remedy against United States for entities deemed Public Health Service employees; subrogation of medical malpractice claims; applicable period; entity and contractor defined.
(h)
Qualifications for designation as Public Health Service employee.
(i)
Authority of Attorney General to exclude health care professionals from coverage.
(j)
Remedy for denial of hospital admitting privileges to certain health care providers.
(k)
Estimate of annual claims by Attorney General; criteria; establishment of fund; transfer of funds to Treasury accounts.
(a)
Establishment; composition; chairman.
(b)
Function.
(c)
Duties with respect to drugs for rare diseases or conditions.
(d)
Consultation.
(e)
Annual report; contents.
(a)
Creation; number of members.
(b)
Appointments; qualifications; provisions inapplicable to members.
(c)
Performance appraisal system.
(d)
Pay of members.
(e)
Contribution to retirement system of institutions of higher education.
(f)
Career and noncareer appointment of certain individuals.
(g)
Rules and regulations.
Part B—Miscellaneous Provisions
(a)
Acceptance by Secretary.
(b)
Depository of funds; availability for expenditure.
(c)
Evidences of unconditional gifts of intangible property.
(d)
Real property or tangible personal property.
(a)
In general.
(b)
Report on evaluations.
(a)
Right of United States to recover base amount plus interest.
(b)
Notice of sale, transfer, or change.
(c)
Base amount; interest.
(d)
Waiver of recovery rights.
(e)
Pre-judgment lien.
(a)
Contracting authority.
(b)
Contracting prerequisites.
(c)
Advances under contracts.
(d)
Applicable statutory provisions.
(e)
"Fiscal agent" defined.
SUBCHAPTER II—GENERAL POWERS AND DUTIES
Part A—Research and Investigations
(a)
Authority of Secretary.
(b)
Testing for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects; consultation.
(c)
Diseases not significantly occurring in United States.
(d)
Protection of privacy of individuals who are research subjects.
(a)
Clinical training and instruction and clinical traineeships; stipends and allowances; research projects.
(b)
Effect of treaties and other international agreements on confidentiality.
(c)
Grants to public and other nonprofit institutions.
(d)
Obligatory service for traineeships.
(a)
Scope of activities.
(b)
Additional authority; scope of activities.
(c)
Coordination of activities through units of Department.
(a)
Establishment; appointment of Director; statistical and epidemiological activities.
(b)
Duties.
(c)
Statistical and epidemiological compilations and surveys.
(d)
Technical aid to States and localities.
(e)
Cooperative Health Statistics System.
(f)
Federal-State cooperation.
(g)
Collection of health data; data collection forms.
(h)
Registration area records.
(i)
Technical assistance in effective use of statistics.
(j)
Coordination of health statistical and epidemiological activities.
(k)
National Committee on Vital and Health Statistics; establishment; membership; term of office; compensation; functions; consultations of Secretary with Committee and professional advisory groups.
(l)
Data specific to particular ethnic and racial populations.
(m)
Grants for assembly and analysis of data on ethnic and racial populations.
(n)
Authorization of appropriations.
(a)
Cooperative endeavors; statement of purpose.
(b)
Authority of Secretary; building construction prohibition.
(c)
Benefits for overseas assignees.
(a)
Reports to Congress and President; preparation; review by Office of Management and Budget.
(b)
Grants or contracts; applications, submittal; application peer review group, findings and recommendations; necessity of favorable recommendation; appointments.
(c)
Development and dissemination of statistics.
(d)
Information; publication restrictions.
(e)
Payment procedures; advances or reimbursement; installments; conditions; reductions.
(f)
Contracts without regard to
(a)
Establishment.
(b)
Duties.
(c)
Provision of information to public.
(a)
Composition.
(b)
Chair.
(c)
Quorum.
(d)
Meetings.
(e)
Compensation and expenses.
(a)
In general.
(b)
Availability to public.
Part B—Federal-State Cooperation
(a)
Enforcement of quarantine regulations; prevention of communicable diseases.
(b)
Comprehensive and continuing planning; training of personnel for State and local health work; fees.
(c)
Development of plan to control epidemics and meet emergencies or problems resulting from disasters; cooperative planning; temporary assistance; reimbursement of United States.
(a)
Comprehensive health planning and services.
(b)
Project grants for areawide health planning; authorization of appropriations; prerequisites for grants; application; contents.
(c)
Project grants for training, studies, and demonstrations; authorization of appropriations.
(a)
Establishment; priorities.
(b)
National network to coordinate groups.
(a)
Grant authority.
(b)
Application.
(c)
Approval; annual project review.
(d)
Amount of grant; payment.
(e)
Reduction.
(f)
Recordkeeping; audit authority.
(g)
Use of grant funds; mandatory treatment prohibited.
(h)
Reports.
(i)
Technical assistance.
(j)
Authorization of appropriations.
(k)
Additional grants to States, political subdivisions, and other public and nonprofit private entities.
(a)
Authority for grants.
(b)
Status as medicaid provider.
(c)
Priority in making grants.
(d)
Grant application.
(e)
Relationship to services and activities under other programs.
(f)
Method and amount of payment.
(g)
Supplies, equipment, and employee detail.
(h)
Records.
(i)
Audit and examination of records.
(j)
Annual report.
(k)
Indian tribes.
(l)
Funding.
(a)
Prevention.
(b)
Technology assessment and epidemiology.
(a)
State programs.
(b)
National Clearinghouse.
(c)
Report.
(d)
Authorization of appropriations.
(a)
In general.
(b)
Requirement of matching funds.
(c)
Education on significance of early detection.
(d)
Requirement of provision of all services by date certain.
(e)
Additional required agreements.
(f)
Reports to Secretary.
(g)
Description of intended uses of grant.
(h)
Requirement of submission of application.
(i)
Method and amount of payment.
(j)
Technical assistance and provision of supplies and services in lieu of grant funds.
(k)
"Units of local government" defined.
(l)
Authorization of appropriations.
(a)
In general.
(b)
Research, demonstration projects, education, and training.
(c)
Cooperation with providers of primary health services.
(d)
Application for grant.
(e)
Supplies and services in lieu of grant funds.
(f)
Advisory Council.
(g)
Funding.
(a)
In general.
(b)
Applicability of certain provisions.
(c)
Authorization of appropriations.
(a)
Technical assistance to public and nonprofit private entities and scientific institutions.
(b)
Research, demonstration, and public information and education projects.
(c)
Project grants to States.
(d)
Grants for innovative, interdisciplinary approaches.
(e)
Authorization of appropriations; terms and conditions; payments; recordkeeping; audit; grant reduction; information disclosure.
(e)
Consent of individuals.
(a)
In general.
(b)
Authority regarding individual diseases.
(c)
Authorized activities.
(d)
Requirement of availability of all services through each grantee.
(e)
Required providers regarding certain services.
(f)
Quality assurance regarding screening for diseases.
(g)
Confidentiality.
(h)
Limitation on imposition of fees for services.
(i)
Limitations on certain expenditures.
(j)
Reports to Secretary.
(k)
Maintenance of effort.
(l)
Requirement of application.
(m)
Duration of grant.
(n)
Technical assistance, and supplies and services in lieu of grant funds.
(o)
Evaluations and reports by Secretary.
(p)
Coordination of Federal programs.
(q)
Authorization of appropriations.
(r)
Separate grants for research on delivery of services.
(a)
Determination of existence of emergency; authorization to act.
(b)
Public Health Emergency Fund; authorization of appropriations; annual report to Congress.
Part C—Hospitals, Medical Examinations, and Medical Care
(a)
Care and treatment.
(b)
Payments to Board of Health of Hawaii.
(a)
Deadline for closure, transfer, or financial self-sufficiency.
(b)
Proposals for transfer or financial self-sufficiency.
(c)
Evaluation of proposals.
(d)
Rejection or approval of proposal.
(e)
Establishment of identifiable administrative unit.
(f)
Finding of financial self-sufficiency.
(a)
Facilities providing medical or dental care to members and former members of uniformed services and dependents.
(b)
Termination of approved status.
(c)
Reimbursement of approved facilities for medical and dental care provided to members and former members of uniformed services and dependents.
(a)
Demonstration projects; comparisons with care furnished by contract providers.
(b)
Alternative payment mechanisms.
(c)
Designation of additional civilian medical facilities.
(d)
Reports to Congress on study and project results.
(e)
Termination of status.
(f)
Limitation on expenditures.
(a)
Persons entitled to treatment.
(b)
Temporary treatment in emergency cases.
(c)
Authorization for outside treatment.
(a)
Persons entitled to medical services.
(b)
Health care for involuntarily separated officers and dependents.
(c)
Examination of personnel of Service assigned to Coast Guard or National Oceanic and Atmospheric Administration.
(a)
Eligibility.
(b)
Treatment of dependents of personnel.
(c)
Identification.
(a)
Definitions.
(b)
Statement of purpose; agreements or arrangements; reciprocity; reimbursement; credits.
Part D—Primary Health Care
subpart i—primary health centers
(a)
Definitions.
(b)
Priority areas for project and program assistance; assignment and determination of priorities; approval of application for grant to area without migratory agricultural workers.
(c)
Grants pursuant to assigned priorities to public and nonprofit private entities for projects to plan and develop centers; costs includable and criteria for grants; grants or contracts with public and nonprofit private entities for projects to plan and develop programs in areas without centers and specified migratory population; scope of programs for grants or contracts; number of grants or contracts; determination of amount of grants.
(d)
Grants for centers in high impact areas; programs in areas in which no migrant health center exists; health services provided on a prepaid basis; two-grant maximum; maximum amount of grant; payments.
(e)
Contracts with public and private entities for implementation and enforcement of environmental health standards and projects and studies related to environmental health hazard problems.
(f)
Approval of application as prerequisite for grant or contract; form and manner of submission and contents of application; determination of entity as center as prerequisite for approval of application; criteria for determination; priorities for applications; improvements of private property; nonapplicability of statutory provisions to contracts; new building grant conditions.
(g)
Technical and other nonfinancial assistance for centers or public or private nonprofit entities operating as centers without determination of status; resources list.
(h)
Authorization of appropriations; reduction in infant mortality and health management for infants and pregnant women; obligation for grants and contracts.
(i)
Delegation of authority to administer programs; exception.
(a)
Definitions.
(b)
Additional definitions; criteria to determine specific shortages of personal health services; designation of medically underserved population or termination of such designation.
(c)
Grants to public and nonprofit private entities for projects to plan and develop centers; costs includable and criteria for grants; number of grants; determination of amount of grants.
(d)
Grants to public and nonprofit private centers and related entities functioning without center determination for costs of operation; prepayment; costs includable for grants; number of grants; determination of amount of grants; payments.
(e)
Approval of application as prerequisite for grant; form and manner of submission and contents of application; determination of entity as center as prerequisite for approval of application; "public center" defined; improvement of private property; new building grant conditions.
(f)
Technical and other nonfinancial assistance; resources list.
(g)
Authorization of appropriations; establishment of general policies by governing boards; reduction in infant mortality and health management for infants and pregnant women.
(h)
Memorandum of agreement.
(i)
Audit of grants; reports; records; waiver of audit.
(j)
Delegation of authority to administer programs; exception.
(k)
Special consideration of needs of frontier areas.
(a)
Grants.
(b)
Use of grants or contracts.
(c)
Advisory Council.
(d)
Advisory Council functions.
(e)
Report.
(f)
Authorization of appropriation.
subpart ii—national health service corps program
(a)
Establishment; composition; purpose; definitions.
(b)
Recruitment and fellowship programs.
(c)
Travel expenses; persons entitled; reimbursement; limitation.
(d)
Monthly pay adjustments of members directly engaged in delivery of health services in health professional shortage area; "monthly pay" defined; monthly pay adjustment of member with service obligation incurred under Scholarship Program or Loan Repayment Program; personnel system applicable.
(e)
Employment ceiling of Department not affected by Corps members.
(f)
Assignment of personnel provisions inapplicable to members whose service obligation incurred under Scholarship Program or Loan Repayment Program.
(g)
Conversion from Corps member to commissioned officer; retirement credits.
(h)
Effective administration of program.
(i)
Definitions.
(a)
Designation by Secretary; removal from areas designated; "medical facility" defined.
(b)
Criteria for designation of health professional shortage areas; promulgation of regulations.
(c)
Considerations in determination of designation.
(d)
Designation; publication of descriptive lists.
(e)
Notice of proposed designation of areas and facilities; time for comment.
(f)
Notice of designation.
(g)
Recommendations to Secretary.
(h)
Public information programs in designated areas.
(a)
Conditions necessary for assignment of Corps personnel to area; contents of application for assignment; assignment to particular facility; approval of applications.
(b)
Corps member income assurances; grants respecting sufficiency of financial resources.
(c)
Assignment of members without regard to ability of area to pay for services.
(d)
Entities entitled to aid; forms of assistance; coordination of efforts; agreements for assignment of Corps members; qualified entity.
(e)
Practice within State by Corps member.
(a)
In general.
(b)
Exclusive factors for determining greatest shortages.
(c)
Establishment of criteria for determining priorities.
(d)
Notifications regarding priorities.
(e)
Limitation on number of entities offered as assignment choices in Scholarship Program.
(f)
Applicable period regarding priorities.
(a)
Charges for services; collection of payments; payment to United States; calculation of payments; annual report.
(b)
Waiver of payment; use of funds.
(c)
Excess funds.
(d)
Charge for services; reduced rate; no charge.
(e)
Deposit of funds in Treasury as miscellaneous receipts; appropriations unaffected.
(f)
Small health centers.
(a)
Means of delivery of services; cooperation with other health care providers.
(b)
Utilization of existing health facilities; lease, acquisition, and use of equipment and supplies; permanent and temporary professional services.
(c)
Loan; purposes; limitations.
(d)
Property and equipment disposal; fair market value; sale at less than full market value.
(e)
Admitting privileges denied to Corps member by hospital; notice and hearing; denial of Federal funds for violation; "hospital" defined.
(a)
Consideration of individual characteristics of members in making assignments.
(b)
Counseling on service in Corps.
(c)
Grants regarding preparation of students for practice.
(d)
Assistance in establishing local professional relationships.
(e)
Temporary relief from Corps duties.
(f)
Determinations regarding effective service.
(a)
Establishment; appointment of members.
(b)
Term of members; compensation; expenses.
(c)
Termination.
subpart iii—scholarship program and loan repayment program
(a)
Establishment.
(b)
Eligibility; application; written contract.
(c)
Review and evaluation of information and forms by prospective applicant.
(d)
Factors considered in providing contracts; priorities.
(e)
Commencement of participation in Scholarship Program; notice.
(f)
Written contract; contents.
(g)
Scholarship provisions; contract with educational institution; increase in monthly stipend.
(h)
Employment ceiling of Department unaffected.
(i)
Annual report to Congress; contents.
(a)
Establishment.
(b)
Eligibility.
(c)
Information to be included with application and contract forms; understandability; availability.
(d)
Factors considered in providing contracts; priorities.
(e)
Approval required for participation.
(f)
Contents of contracts.
(g)
Payments.
(h)
Employment ceiling.
(i)
Reports.
(a)
Service in full-time clinical practice.
(b)
Notice to individual; information for informed decision; eligibility; notice to Secretary; qualification and appointment as commissioned officer; appointment as civilian member; designation of non-United States employee as member; deferment of obligated service.
(c)
Obligated service period; commencement.
(d)
Assignment of personnel.
(e)
Service under National Research Service Award program; credits against obligated service time.
(a)
Application for release of obligations; conditions.
(b)
Written agreement; fee rates; ability to pay; health insurance; regulations; actions to ensure compliance.
(c)
Breach of service contract.
(d)
Travel expenses.
(e)
Sale of equipment and supplies.
(f)
Malpractice insurance.
(g)
Technical assistance.
(a)
Failure to maintain academic standing; dismissal from institution; voluntary termination; liability; failure to accept payment.
(b)
Failure to commence or complete service obligations; formula to determine liability; payment to United States; recovery of delinquent damages; disclosure to credit reporting agencies.
(c)
Failure to commence or complete service obligations for other reasons; determination of liability; payment to United States; waiver of recovery for extreme hardship or good cause shown.
(d)
Cancellation of obligation upon death of individual; waiver or suspension of obligation for impossibility, hardship, or unconscionability; release of debt by discharge in bankruptcy, time limitations.
(a)
Establishment of Fund.
(b)
Authorization of appropriations to Fund.
(c)
Use of Fund.
(d)
Investment.
(a)
Persons entitled; conditions.
(b)
Amount of loan; maximum interest rate.
(c)
Application for loan; submission and approval; interest rates and repayment terms.
(d)
Breach of agreement; notice; determination of liability.
(a)
Report.
(b)
Funding.
(a)
In general.
(b)
Requirement of matching funds.
(c)
Coordination with Federal program.
(d)
Restrictions on use of funds.
(e)
Reports.
(f)
Requirement of application.
(g)
Noncompliance.
(h)
"State" defined.
(i)
Authorization of appropriations.
(a)
In general.
(b)
Requirement of matching funds.
(c)
Certain required activities.
(d)
Requirement regarding annual budget for office.
(e)
Certain uses of funds.
(f)
Reports.
(g)
Requirement of application.
(h)
Noncompliance.
(i)
"State" defined.
(j)
Authorization of appropriations.
(k)
Termination of program.
(a)
Eligibility.
(b)
Terms and conditions.
(c)
"Native Hawaiian" defined.
(d)
Authorization of appropriations.
(a)
In general.
(b)
Certain requirements for States.
(c)
Grants by States to community organizations for provision of scholarship contracts.
(d)
Requirement of State and local matching funds.
(e)
Specifications regarding scholarship contract.
(f)
Reports to Secretary.
(g)
Estimates regarding allocations between urban and rural areas.
(h)
Requirement of application.
(i)
Noncompliance.
(j)
Reports to Congress.
(k)
Definitions.
(l)
Funding.
subpart iv—home health services
(a)
Purpose; authorization of grants and loans; considerations; conditions on loans; appropriations.
(b)
Grants and contracts for training programs for paraprofessionals; considerations; applications; appropriations.
(c)
Report to Congress with respect to grants and loans and training of personnel.
(d)
"Home health services" defined.
subpart v—health services for the homeless
(a)
Establishment.
(b)
Minimum qualifications of grantees.
(c)
Preferences in making grants.
(d)
Requirement of submission of application containing certain agreements.
(e)
Requirement of provision of matching funds.
(f)
Requirement of provision of certain health services.
(g)
Optional provision of certain services.
(h)
Temporary continued provision of services to certain former homeless individuals.
(i)
Restrictions on use of grant funds.
(j)
Limitation on charges for services.
(k)
Requirements with respect to administration.
(l)
Limitation on administrative expenses of grantee.
(m)
Use of grant funds for referrals to certain advocacy systems.
(n)
Use of self-help organizations.
(o)
Technical assistance.
(p)
Annual reports by Secretary.
(q)
Funding.
(r)
Definitions.
(s)
Grants regarding outreach and primary health services for homeless children.
(t)
Infant mortality and morbidity.
subpart vi—health services for residents of public housing
(a)
Establishment.
(b)
Minimum qualifications of grantees.
(c)
Preferences in making grants.
(d)
Requirement of matching funds from public grantees.
(e)
Requirements regarding services.
(f)
Optional provision of certain services.
(g)
Consultation with residents.
(h)
Restrictions on use of grant funds.
(i)
Limitation on charges for services.
(j)
Requirements regarding administration.
(k)
Limitation on administrative expenses of grantee.
(l)
Requirement of application.
(m)
Technical assistance.
(n)
Annual reports by Secretary.
(o)
Definitions.
(p)
Funding.
(q)
Infant mortality and morbidity.
subpart vii—drug pricing agreements
(a)
Requirements for agreement with Secretary.
(b)
Other definitions.
(c)
References to Social Security Act.
(d)
Compliance with requirements.
subpart viii—bulk purchases of vaccines for certain programs
(a)
Agreements for purchases.
(b)
Negotiation of prices.
(c)
Authority of Secretary.
(d)
Rule of construction.
(a)
In general.
(b)
Certain authorities.
(c)
Relevant entities.
Part E—Narcotic Addicts and Other Drug Abusers
(a)
Surgeon General authorized to provide programs.
(b)
Furnishing of information relating to persons voluntarily undergoing care to Mayor of District of Columbia.
(c)
Agreements with other departments and agencies.
(a)
Transfers to and from hospitals; duty of prosecuting officers to report convicted persons believed to be addicts.
(b)
Repealed.
(c)
Discharge; further treatment.
(d)
Gratuities and transportation furnished upon discharge or release on parole or supervised release.
(e)
Admission of probationers to hospitals for treatment.
(a)
Application for admission.
(b)
Determination of addiction; conditions of admission; payment of subsistence, care, and treatment.
(c)
Period of confinement.
(d)
Other rights unaffected.
(a)
Conditions.
(b)
Discharge from hospitals; notice; delivery to court.
(c)
Authority of Surgeon General and other officers.
(d)
Payment of costs; determination; disposition of moneys; availability of appropriations.
Part F—Licensing of Biological Products and Clinical Laboratories
subpart 1—biological products
(a)
Intrastate and interstate traffic; suspension or revocation of license as affecting prior sales.
(b)
Falsely labeling or marking package or container; altering label or mark.
(c)
Inspection of establishment for propagation and preparation.
(d)
Regulations governing licenses; recall of product presenting imminent hazard; violations.
(e)
Interference with officers.
(f)
Penalties for offenses.
(g)
Construction with other laws.
(h)
Exportation of partially processed biological products.
subpart 2—clinical laboratories
(a)
"Laboratory" or "clinical laboratory" defined.
(b)
Certificate requirement.
(c)
Issuance and renewal of certificates.
(d)
Requirements for certificates.
(e)
Accreditation.
(f)
Standards.
(g)
Inspections.
(h)
Intermediate sanctions.
(i)
Suspension, revocation, and limitation.
(j)
Injunctions.
(k)
Judicial review.
(l)
Sanctions.
(m)
Fees.
(n)
Information.
(o)
Delegation.
(p)
State laws.
(q)
Consultations.
(a)
In general.
(b)
Pregnancy success rates.
(c)
Consultation.
(a)
In general.
(b)
Distribution.
(c)
Requirements.
(d)
Standards.
(e)
Certification under State programs.
(f)
Use of accreditation organizations.
(g)
Inspections.
(h)
Validation inspections.
(i)
Limitation.
(j)
Term.
(a)
Approval of accreditation organizations.
(b)
Criteria and procedures.
(c)
Evaluations.
(d)
Transition.
(a)
In general.
(b)
Effect.
subpart 3—mammography facilities
(a)
Definitions.
(b)
Certificate requirement.
(c)
Issuance and renewal of certificates.
(d)
Application for certificate.
(e)
Accreditation.
(f)
Quality standards.
(g)
Inspections.
(h)
Sanctions.
(i)
Suspension and revocation.
(j)
Injunctions.
(k)
Judicial review.
(l)
Information.
(m)
State laws.
(n)
National Advisory Committee.
(o)
Consultations.
(p)
Breast cancer screening surveillance research grants.
(q)
State program.
(r)
Funding.
Part G—Quarantine and Inspection
(a)
Promulgation and enforcement by Surgeon General.
(b)
Apprehension, detention, or conditional release of individuals.
(c)
Application of regulations to persons entering from foreign countries.
(d)
Apprehension and examination of persons reasonably believed to be infected.
(a)
Control and management.
(b)
Hours of inspection.
(c)
Overtime pay for employees of Service.
(d)
Payment of extra compensation to United States; bond or deposit to assure payment; deposit of moneys to credit of appropriation.
(a)
Detail of medical officer; conditions precedent to issuance; consular officer to receive fees.
(b)
Collectors of customs to receive originals; duplicate copies as part of ship's papers.
(c)
Regulations to secure sanitary conditions of vessels.
(d)
Vessels from ports near frontier.
(e)
Compliance with regulations.
(a)
Penalties for persons violating quarantine laws.
(b)
Penalties for vessels violating quarantine laws.
(c)
Remittance or mitigation of forfeitures.
Part H—Organ Transplants
(a)
Grant authority of Secretary.
(b)
Qualified organizations.
(a)
Contract authority of Secretary; limitation; available appropriations.
(b)
Functions.
(c)
Consideration of critical comments.
(a)
Application requirement.
(b)
Special considerations and priority; planning and establishment grants.
(c)
Determination of grant amount; terms of payment; recordkeeping; access for purposes of audits and examination of records.
(d)
"Transplant center" and "organ" defined.
(a)
Prohibition.
(b)
Penalties.
(c)
Definitions.
(a)
In general.
(b)
Report.
Part I—National Bone Marrow Donor Registry
(a)
Establishment.
(b)
Functions.
(c)
Criteria, standards, and procedures.
(d)
Comment procedures.
(e)
Consultation.
(f)
Application.
(g)
Eligibility.
(h)
Records.
(i)
Penalties for disclosure.
(j)
Authorization of appropriations.
(a)
In general.
(b)
Report.
Part J—Prevention and Control of Injuries
(a)
Advisory committee.
(b)
Technical assistance.
(c)
Biennial report.
Part K—Health Care Services in the Home
subpart i—grants for demonstration projects
(a)
In general.
(b)
Requirement with respect to age of recipients of services.
(c)
Relationship to items and services under other programs.
(a)
Limitation on duration of grant.
(b)
Requirement of matching funds.
(c)
Determination of amount of non-Federal contribution.
(a)
Limitation on administrative expenses.
(b)
Description of intended use of grant.
(c)
Requirement of application.
(d)
Evaluations and report by Secretary.
(e)
Authorizations of appropriations.
subpart ii—grants for demonstration projects with respect to alzheimer's disease
(a)
In general.
(b)
Requirement with respect to certain expenditures.
(c)
Relationship to items and services under other programs.
(a)
Limitation on duration of grant.
(b)
Requirement of matching funds.
(c)
Determination of amount of non-Federal contribution.
(a)
Limitation on administrative expenses.
(b)
Description of intended use of grant.
(c)
Requirement of application.
(d)
Evaluations and report by Secretary.
(e)
Authorizations of appropriations.
subpart iii—grants for home visiting services for at-risk families
(a)
In general.
(b)
Home visiting services for eligible families.
(c)
Considerations in making grants.
(d)
Federal share.
(e)
Rule of construction regarding at-risk births.
(f)
Delivery of services and case management.
(g)
Outreach.
(h)
Confidentiality.
(i)
Certain assurances.
(j)
Submission to Secretary of certain information.
(k)
Limitation regarding administrative expenses.
(l)
Restrictions on use of grant.
(m)
Reports to Secretary.
(n)
Requirement of application.
(o)
Peer review.
(p)
Evaluations.
(q)
Definitions.
(r)
Authorization of appropriations.
Part L—Services for Children of Substance Abusers
(a)
Establishment.
(b)
Services for children of substance abusers.
(c)
Services for affected families.
(d)
Considerations in making grants.
(e)
Federal share.
(f)
Coordination with other providers.
(g)
Restrictions on use of grant.
(h)
Submission to Secretary of certain information.
(i)
Reports to Secretary.
(j)
Requirement of application.
(k)
Peer review.
(l)
Evaluations.
(m)
Report to Congress.
(n)
Data collection.
(o)
Definitions.
(p)
Funding.
Part N—National Foundation for the Centers for Disease Control and Prevention
(a)
In general.
(b)
Purpose of Foundation.
(c)
Endowment fund.
(d)
Certain activities of Foundation.
(e)
General structure of Foundation; nonprofit status.
(f)
Board of directors.
(g)
Certain responsibilities of executive director.
(h)
General provisions.
(i)
Federal funding.
(j)
Committee for establishment of Foundation.
Part M—National Program of Cancer Registries
(a)
In general.
(b)
Matching funds.
(c)
Eligibility for grants.
(d)
Relationship to certain programs.
(e)
Requirement regarding certain study on breast cancer.
(a)
In general.
(b)
Application.
(a)
In general.
(b)
Relevant States.
(c)
Cooperation of State.
(d)
Planning, commencement, and duration.
(e)
Report.
(a)
Registries.
(b)
Breast cancer study.
SUBCHAPTER III—NATIONAL RESEARCH INSTITUTES
Part A—National Institutes of Health
(a)
Agency of Public Health Service.
(b)
Agencies within.
(c)
Establishment of additional national research institutes; reorganization or abolition of institutes.
(d)
"National research institute" defined.
(a)
Appointment.
(b)
Duties and authority.
(c)
Availability of substances and organisms for research.
(d)
Services of experts or consultants; number; payment of expenses, conditions, recovery.
(e)
Dissemination of research information.
(f)
Associate Director for Prevention; functions; report to Director.
(g)
Enhancing competitiveness of certain entities in obtaining research funds.
(h)
Increased participation of women and disadvantaged individuals in biomedical and behavioral research.
(i)
Discretionary fund; uses; report to Congressional committees; authorization of appropriations.
(j)
Day care for children of employees.
(k)
Interagency research on trauma.
(a)
In general.
(b)
Education programs.
(c)
Longitudinal studies.
(d)
Exposure to DES in utero.
(e)
Authorization of appropriations.
(a)
Establishment.
(b)
Purpose.
(a)
Development of new vaccines.
(b)
Report.
(c)
Authorization of appropriations.
(a)
Preparation.
(b)
Submission to Congressional committees.
(c)
Periodic review and revision.
(d)
Dissemination of information.
(e)
Interagency Coordinating Committee on the Use of Animals in Research.
(a)
Establishment.
(b)
Purpose.
(c)
Advisory council.
(d)
Duties.
Part B—General Provisions Respecting National Research Institutes
(a)
Appointment.
(b)
Duties and authority; grants, contracts, and cooperative agreements.
(c)
Coordination with other public and private entities; cooperation with other national research institutes; appointment of additional peer review groups.
(a)
Establishment; acceptance of conditional gifts; functions.
(b)
Membership; compensation.
(c)
Term of office; reappointment; vacancy.
(d)
Chairman; term of office.
(e)
Meetings.
(f)
Appointment of executive secretary; training and orientation for new members.
(g)
Comments and recommendations for inclusion in biennial report; additional reports.
(h)
Advisory councils in existence; application of section to National Cancer Advisory Board and advisory council to National Heart, Lung, and Blood Institute.
(a)
Establishment.
(b)
Coordination.
(c)
Information clearinghouse.
(d)
Authorization of appropriations.
Part C—Specific Provisions Respecting National Research Institutes
subpart 1—national cancer institute
(a)
Cooperative agreements and grants for establishing and supporting.
(b)
Uses for Federal payments under cooperative agreements or grants.
(c)
Period of support; additional periods.
(a)
Expansion and coordination of activities.
(b)
Coordination with other institutes.
(c)
Programs for breast cancer.
(d)
Other cancers.
(e)
Report.
(a)
Expansion and coordination of activities.
(b)
Coordination with other institutes.
(c)
Programs.
(a)
Activities generally.
(b)
Breast cancer and gynecological cancers.
(c)
Prostate cancer.
(d)
Allocation regarding cancer control.
subpart 2—national heart, lung, and blood institute
(a)
Heart, blood vessel, lung, blood diseases, and blood resources; utilization of centers for prevention programs.
(b)
Sickle cell anemia.
(c)
Cooperative agreements and grants for establishing and supporting; uses for Federal payments; period of support, additional periods.
(a)
Establishment.
(b)
Purpose.
(c)
Sleep Disorders Research Advisory Board.
(d)
Development of comprehensive research plan; revision.
(e)
Collection and dissemination of information.
subpart 3—national institute of diabetes and digestive and kidney diseases
(a)
National Diabetes Data System and National Diabetes Clearinghouse.
(b)
National Digestive Diseases Data System and National Digestive Diseases Information Clearinghouse.
(c)
National Kidney and Urologic Diseases Data System and National Kidney and Urologic Diseases Information Clearinghouse.
(a)
Establishment and purpose.
(b)
Membership; chairman; meetings.
(c)
Annual report.
(a)
Establishment.
(b)
Membership; ex officio members.
(c)
Compensation.
(d)
Term of office; vacancy.
(e)
Chairman.
(f)
Executive director; professional and clerical staff; administrative support services and facilities.
(g)
Meetings.
(h)
Functions of National Diabetes Advisory Board and National Digestive Diseases Advisory Board.
(i)
Subcommittees; establishment and membership.
(j)
Annual report.
(k)
Termination of predecessor boards; time within which to appoint members.
(a)
Diabetes mellitus and related endocrine and metabolic diseases.
(b)
Digestive diseases and related functional, congenital, metabolic disorders, and normal development of digestive tract.
(c)
Kidney and urologic diseases.
(d)
Nutritional disorders.
(e)
Geographic distribution; period of support, additional periods.
(a)
Establishment.
(b)
Support of activities.
(c)
Dissemination of information.
subpart 4—national institute of arthritis and musculoskeletal and skin diseases
(a)
Plan to expand, intensify, and coordinate activities; submission; periodic review and revision.
(b)
Coordination of activities with other national research institutes; minimum activities under program.
(c)
Program to be carried out in accordance with plan.
(a)
Establishment and purpose.
(b)
Membership; chairman; meetings.
(c)
Annual report.
(a)
Grants for establishment and support.
(b)
Programs included.
(c)
Standardization of patient data and recordkeeping.
(a)
Development, modernization, and operation.
(b)
Duties and functions.
(c)
Optional programs.
(d)
Geographical distribution.
(e)
Period of support; additional periods.
(f)
Treatment and rehabilitation of children.
(a)
Establishment.
(b)
Membership; ex officio members.
(c)
Compensation.
(d)
Term of office; vacancy.
(e)
Chairman.
(f)
Executive director, professional and clerical staff; administrative support services and facilities.
(g)
Meetings.
(h)
Duties and functions.
(i)
Subcommittees; establishment and membership.
(j)
Annual report.
(k)
Termination of predecessor board; time within which to appoint members.
subpart 5—national institute on aging
(a)
Education and training of adequate numbers of personnel.
(b)
Scientific studies.
(c)
Public information and education programs.
(d)
Grants for research relating to Alzheimer's Disease.
(a)
Cooperative agreements and grants for establishing and supporting.
(b)
Use of Federal payments under cooperative agreement or grant.
(c)
Support period; additional periods.
(a)
Development and expansion of centers.
(b)
Functions of centers.
(c)
Geographic distribution of centers.
(d)
"Independence" defined.
(a)
Senior researchers in biomedical research.
(b)
Eligible centers.
(c)
Required recommendation.
(d)
Selection procedures.
(e)
Term of award; renewal.
(a)
Grants for research.
(b)
Preparation of plan; contents; revision.
(c)
Consultation for preparation and revision of plan.
(d)
Grants for promoting independence and preventing secondary disabilities.
(e)
"Council on Alzheimer's Disease" defined.
(a)
Establishment; purpose; duties; publication of summary.
(b)
Fee for information.
(c)
Summaries of research findings from other agencies.
(a)
Grant or contract for establishment.
(b)
Project activities.
(c)
Fees for information; exception.
(d)
Application for grant or contract; contents.
(a)
In general.
(b)
Qualifications.
subpart 6—national institute of allergy and infectious diseases
subpart 7—national institute of child health and human development
(a)
Establishment of Center.
(b)
Purpose.
(c)
Authority of Director.
(d)
Research Plan.
(e)
Medical Rehabilitation Coordinating Committee.
(f)
National Advisory Board on Medical Rehabilitation Research.
(a)
Grants and contracts.
(b)
Number of centers.
(c)
Duties.
(d)
Coordination of information.
(e)
Facilities.
(f)
Period of support.
(g)
Authorization of appropriations.
(a)
In general.
(b)
Design of study.
(c)
Coordination with Women's Health Initiative.
subpart 8—national institute of dental research
subpart 9—national eye institute
(a)
Program of grants.
(b)
Use of funds.
(c)
Authorized expenditures.
subpart 10—national institute of neurological disorders and stroke
subpart 11—national institute of general medical sciences
subpart 12—national institute of environmental health sciences
subpart 13—national institute on deafness and other communication disorders
(a)
Development, modernization and operation; "modernization" defined.
(b)
Use of facilities; qualifications.
(c)
Requisite programs.
(d)
Stipends.
(e)
Discretionary programs.
(f)
Equitable geographical distribution; needs of elderly and children.
(g)
Period of support; recommended extensions of peer review group.
(a)
Establishment.
(b)
Composition; qualifications; appointed and ex officio members.
(c)
Compensation.
(d)
Term of office; vacancies.
(e)
Chairman.
(f)
Personnel; executive director; professional and clerical staff members; consultants; information and administrative support services and facilities.
(g)
Meetings.
(h)
Functions.
(i)
Subcommittee activities; workshops and conferences; collection of data.
(j)
Annual report.
(k)
Commencement of existence.
(a)
Establishment.
(b)
Functions.
(c)
Composition.
(d)
Chairman; meetings.
(e)
Annual report; recipients of report.
subpart 14—national institute on alcohol abuse and alcoholism
(a)
In general.
(b)
Research program.
(c)
Collaboration.
(d)
Funding.
(a)
In general.
(b)
Biennial report.
(a)
Designation; procedures applicable for approval of applications.
(b)
Annual grants; amount; limitation on uses.
subpart 15—national institute on drug abuse
(a)
In general.
(b)
Research program.
(c)
Collaboration.
(d)
Funding.
(a)
In general.
(b)
Report.
(a)
Authority.
(b)
Grants.
(a)
Establishment.
(b)
Duties.
(c)
Report.
(d)
"Pharmacotherapeutics" defined.
(e)
Authorization of appropriations.
subpart 16—national institute of mental health
(a)
In general.
(b)
Research program.
(c)
Collaboration.
(d)
Information with respect to suicide.
(e)
Associate Director for Special Populations.
(f)
Funding.
(a)
In general.
(b)
Report.
(a)
In general.
(b)
Coordination of activities.
(c)
Research, demonstrations, evaluations, and dissemination.
(d)
Authority regarding grants and contracts.
(e)
Report to Congress.
subpart 17—national institute of nursing research
(a)
Appointment; functions and duties; acceptance of conditional gifts; subcommittees.
(b)
Membership; ex officio members; compensation.
(c)
Term of office; vacancy; reappointment.
(d)
Chairman; selection; term of office.
(e)
Meetings.
(f)
Executive secretary; staff; orientation and training for new members.
(g)
Material for inclusion in biennial report; additional reports.
Part D—National Library of Medicine
subpart 1—general provisions
(a)
Purpose and establishment.
(b)
Functions.
(c)
Exchange, destruction, or disposal of materials not needed.
(d)
Availability of publications, materials, facilities, or services; prescription of rules.
(e)
Regional medical libraries; establishment.
(f)
Acceptance and administration of gifts; memorials.
(g)
"Medicine" and "medical" defined.
(a)
Membership; ex officio members.
(b)
Recommendations on matters of policy; recommendations included in annual report; use of services of members by Secretary.
(c)
Term of office; vacancy; reappointment.
subpart 2—financial assistance
(a)
Board of Regents of National Library of Medicine to serve as.
(b)
Functions.
(c)
Use of services of members by Secretary.
(d)
Compensation.
(a)
Compilation of existing and original writings on health.
(b)
Medical library science and related activities.
(c)
Development of education technologies.
(a)
Existing public or private nonprofit medical libraries.
(b)
Uses for grants and contracts.
(c)
Conditions.
(d)
Basic resources materials; limitation on grant or contract.
subpart 3—national center for biotechnology information
(a)
Establishment.
(b)
Functions.
subpart 4—national information center on health services research and health care technology
(a)
Establishment.
(b)
Purpose.
(c)
Electronic, convenient format; criteria for inclusion.
(d)
Coordination with Administrator for Health Care Policy and Research.
Part E—Other Agencies of NIH
subpart 1—national center for research resources
(a)
Appointment; functions and duties; acceptance of conditional gifts; subcommittees.
(b)
Membership; ex officio members; compensation.
(c)
Term of office; vacancy; reappointment.
(d)
Chairman; selection; term of office.
(e)
Meetings.
(f)
Executive secretary; staff; orientation and training for new members.
(g)
Material for inclusion in biennial report; additional reports.
(h)
Advisory council in existence on November 20, 1985.
(a)
Modernization and construction of facilities.
(b)
Scientific and technical review boards for merit-based review of proposals.
(c)
Requirements for grants.
(d)
Requirement of application.
(e)
Amount of grant; payments.
(f)
Recapture of payments.
(g)
Guidelines.
(h)
Authorization of appropriations.
subpart 2—john e. fogarty international center for advanced study in health sciences
subpart 3—national center for human genome research
(a)
General purpose.
(b)
Research training.
(c)
Amount available for ethical and legal issues.
subpart 4—office of dietary supplements
(a)
Establishment.
(b)
Purpose.
(c)
Duties.
(d)
"Dietary supplement" defined.
(e)
Authorization of appropriations.
Part F—Research on Women's Health
(a)
Establishment.
(b)
Purpose.
(c)
Coordinating Committee.
(d)
Advisory Committee.
(e)
Representation of women among researchers.
(f)
Definitions.
(a)
Data system.
(b)
Clearinghouse.
(a)
In general.
(b)
Inclusion in biennial report of Director of NIH.
Part G—Awards and Training
(a)
Biomedical and behavioral research and research training; programs and institutions included; restriction; special consideration.
(b)
Prerequisites for Award; review and approval by appropriate advisory councils; Award period; uses for Award; payments to non-Federal public or nonprofit private institutions.
(c)
Health research or teaching; service period; recovery upon noncompliance with service requirement, formula; cancellation or waiver of obligation.
(d)
Authorization of appropriations; apportionment.
(a)
In general.
(b)
Applicability of certain provisions.
(c)
Authorization of appropriations.
(a)
Establishment.
(b)
Contracts, obligated service, breach of contract.
(c)
Availability of funds.
(a)
In general.
(b)
Applicability of certain provisions.
(a)
Establishment of program.
(b)
Facilitation of interest of students in careers at National Institutes of Health.
(c)
Period of obligated service.
(d)
Provisions regarding scholarship.
(e)
Penalties for breach of scholarship contract.
(f)
Requirement of application.
(g)
Availability of authorization of appropriations.
(a)
Implementation of program.
(b)
Availability of authorization of appropriations.
(a)
Scope of undertaking.
(b)
Arrangement with National Academy of Sciences or other nonprofit private groups or associations.
(c)
Report to Congressional committees.
Part H—General Provisions
(a)
Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations.
(b)
Periodic review of research at National Institutes of Health.
(c)
Compliance with requirements for inclusion of women and minorities in clinical research.
(a)
Review as precondition to research.
(b)
Ethical review of research.
(a)
Requirement of inclusion.
(b)
Inapplicability of requirement.
(c)
Design of clinical trials.
(d)
Guidelines.
(e)
Date certain for guidelines; applicability.
(f)
Reports by advisory councils.
(g)
Definitions.
(a)
In general.
(b)
Existence of administrative processes as condition of funding for research.
(c)
Process for response of Director.
(d)
Monitoring by Director.
(e)
Protection of whistleblowers.
(a)
Issuance of regulations.
(b)
Relevant projects.
(c)
Identifying and reporting to Secretary.
(d)
Monitoring of process.
(e)
Response.
(f)
Definitions.
(a)
In general.
(b)
Report.
(a)
Establishment of guidelines.
(b)
Animal care committees; establishment; membership; functions.
(c)
Assurances required in application or contract proposal; reasons for use of animals; notice and comment requirements for promulgation of regulations.
(d)
Failure to meet guidelines; suspension or revocation of grant or contract.
(e)
Disclosure of trade secrets or privileged or confidential information.
(a)
Conduct or support by Secretary; restrictions.
(b)
Risk standard for fetuses intended to be aborted and fetuses intended to be carried to term to be same.
(a)
Establishment of program.
(b)
Informed consent of donor.
(c)
Informed consent of researcher and donee.
(d)
Availability of statements for audit.
(e)
Applicability of State and local law.
(f)
Report.
(g)
"Human fetal tissue" defined.
(a)
Purchase of tissue.
(b)
Solicitation or acceptance of tissue as directed donation for use in transplantation.
(c)
Criminal penalties for violations.
(d)
Definitions.
(a)
Research on burns, burn injuries, and rehabilitation.
(b)
Authorization of appropriations.
Part I—National Foundation for Biomedical Research
(a)
In general.
(b)
Purpose of Foundation.
(c)
Certain activities of Foundation.
(d)
Board of Directors.
(e)
Redesignated (g).
(f)
Incorporation.
(g)
Nonprofit status.
(h)
Executive Director.
(i)
Powers.
(j)
Administrative control.
(k)
General provisions.
(l)
Duties of Director.
(m)
Funding.
(n)
Report on adequacy of compliance.
SUBCHAPTER III–A—SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
Part A—Organization and General Authorities
(a)
Establishment.
(b)
Agencies.
(c)
Administrator and Deputy Administrator.
(d)
Authorities.
(e)
Associate Administrator for Alcohol Prevention and Treatment Policy.
(f)
Associate Administrator for Women's Services.
(g)
Services of experts.
(h)
Peer review groups.
(i)
Voluntary services.
(j)
Administration.
(k)
Report concerning activities and progress.
(l)
Applications for grants and contracts.
(m)
Authorization of appropriations.
(a)
Appointment.
(b)
Membership.
(c)
Terms of office.
(d)
Chair.
(e)
Meetings.
(f)
Executive Secretary and staff.
(a)
Alcoholism and alcohol abuse.
(b)
Drug abuse.
(a)
In general.
(b)
Members.
(c)
Requirements.
(d)
Recommendations.
(a)
Requirement of annual collection of data on mental illness and substance abuse.
(b)
Requisite areas of data collection on mental health.
(c)
Requisite areas of data collection on substance abuse.
(d)
Development of uniform criteria for data collection.
(a)
Grants for benefit of homeless individuals.
(b)
Preference.
(c)
Services for certain individuals.
(d)
Term of grant.
(e)
Authorization of appropriations.
Part B—Centers and Programs
subpart 1—center for substance abuse treatment
(a)
Establishment.
(b)
Duties.
(c)
Grants and contracts.
(a)
In general.
(b)
Availability of services for each participant.
(c)
Individualized plan of services.
(d)
Required supplemental services.
(e)
Minimum qualifications for receipt of award.
(f)
Requirement of matching funds.
(g)
Outreach.
(h)
Accessibility of program; cultural context of services.
(i)
Continuing education.
(j)
Imposition of charges.
(k)
Reports to Director.
(l)
Requirement of application.
(m)
Equitable allocation of awards.
(n)
Duration of award.
(o)
Evaluations; dissemination of findings.
(p)
Reports to Congress.
(q)
Definitions.
(r)
Authorization of appropriations.
(a)
Grants.
(b)
Prevention.
(c)
Evaluation.
(a)
Grants for treatment improvement.
(b)
Nature of projects.
(c)
Preferences in making grants.
(d)
Duration of grants.
(e)
Authorization of appropriations.
(a)
In general.
(b)
Eligibility.
(c)
Priority.
(d)
Authorization of appropriations.
(a)
In general.
(b)
Priority.
(c)
Health professions education.
(d)
Authorization of appropriations.
(a)
Center for Substance Abuse Treatment.
(b)
States.
(c)
Reservation of space.
subpart 2—center for substance abuse prevention
(a)
Establishment; Director.
(b)
Duties of Director.
(c)
Grants, contracts and cooperative agreements.
(d)
National data base.
(a)
In general.
(b)
Strategies for reducing use.
(c)
Authorization of appropriations.
(a)
Grants to public and nonprofit private entities.
(b)
Priority of projects.
(c)
Strategies for reducing use.
(d)
Regionally equal distribution of grants.
(e)
Application for grants.
(f)
Evaluation of projects.
(g)
"High risk youth" defined.
(h)
Authorization of appropriations.
(a)
In general.
(b)
Certain requirements.
(c)
Special consideration for certain small businesses.
(d)
Consultation and technical assistance.
(e)
Authorization of appropriations.
subpart 3—center for mental health services
(a)
Establishment.
(b)
Duties.
(c)
Grants and contracts.
(a)
Seriously mentally ill individuals, and children and adolescents with serious emotional and mental disturbances.
(b)
Individuals at risk of mental illness.
(c)
Limitation on duration of grant.
(d)
Limitation on administrative expenses.
(e)
Authorizations of appropriations.
(a)
In general.
(b)
Preferences in making grants.
(c)
Requirement of provision of information on prevention.
(d)
Authority for training.
(e)
Requirement of identification of needs and objectives.
(f)
Requirement of application.
(g)
Requirement of minimum number of grants for fiscal year 1989.
(h)
Technical assistance and administrative support.
(i)
"Mental health treatment" defined.
(j)
Authorization of appropriations.
Part C—Projects for Assistance in Transition From Homelessness
(a)
In general.
(b)
Specification of services.
(c)
Coordination.
(d)
Special consideration regarding veterans.
(e)
Special rules.
(f)
Administrative expenses.
(g)
Maintenance of effort.
(h)
Restrictions on use of funds.
(a)
In general.
(b)
Determination of amount.
(c)
Limitation regarding grants by States.
(a)
Minimum allotment.
(b)
Determination under formula.
(a)
In general.
(b)
Specification of funds.
(c)
Requirement of provision of services in State involved.
(a)
In general.
(b)
Opportunity for public comment.
(c)
Relationship to State comprehensive mental health services plan.
(a)
In general.
(b)
Availability to public of reports.
(c)
Evaluations by comptroller general.
(a)
Repayment of payments.
(b)
Withholding of payments.
(c)
Opportunity for hearing.
(d)
Rule of construction.
(a)
In general.
(b)
Criminal penalty for violation of prohibition.
(a)
In general.
(b)
Enforcement.
(a)
Authorization of appropriations.
(b)
Effect of insufficient appropriations for minimum allotments.
Part D—Miscellaneous Provisions Relating to Substance Abuse and Mental Health
(a)
Programs and services.
(b)
Deprivation of employment.
(c)
Construction.
(a)
Nondiscrimination.
(b)
Regulations.
(a)
Requirement.
(b)
Permitted disclosure.
(c)
Use of records in criminal proceedings.
(d)
Application.
(e)
Nonapplicability.
(f)
Penalties.
(g)
Regulations.
(h)
Application to Department of Veterans Affairs.
Part E—Children With Serious Emotional Disturbances
(a)
Grants to certain public entities.
(b)
Considerations in making grants.
(c)
Matching funds.
(a)
Systems of comprehensive care.
(b)
Limitation on age of children provided access to system.
(c)
Required mental health services of system.
(d)
Required arrangements regarding other appropriate services.
(e)
General provisions regarding services of system.
(f)
Restrictions on use of grant.
(a)
In general.
(b)
Multidisciplinary team.
(c)
Coordination with services under Individuals with Disabilities Education Act.
(d)
Contents of plan.
(a)
Optional services.
(b)
Comprehensive plan.
(c)
Limitation on imposition of fees for services.
(d)
Relationship to items and services under other programs.
(e)
Limitation on administrative expenses.
(f)
Reports to Secretary.
(g)
Description of intended uses of grant.
(h)
Requirement of application.
(a)
Duration of support.
(b)
Technical assistance.
(c)
Evaluations and reports by Secretary.
(d)
Definitions.
(e)
Rule of construction.
(f)
Funding.
Part F—Model Comprehensive Program for Treatment of Substance Abuse
(a)
In general.
(b)
Purposes.
(c)
Certain requirements.
(d)
Requirement of non-Federal contributions.
(e)
Evaluations.
(f)
Reports.
(g)
"National capital area" defined.
(h)
Obligation of funds.
SUBCHAPTER IV—CONSTRUCTION AND MODERNIZATION OF HOSPITALS AND OTHER MEDICAL FACILITIES
Part A—Grants and Loans for Construction and Modernization of Hospitals and Other Medical Facilities
(a)
Computation for individual States; formulas for both new construction and modernization.
(b)
Minimum allotments.
(c)
Allotment percentages; definitions; determination.
(d)
Availability of allotments in subsequent years.
(e)
Transfer of allotments.
(f)
Request by State to transfer portion of allotment.
(a)
Priority of projects; determination.
(b)
Standards of construction and equipment.
(c)
Criteria for determining needs for beds, hospitals and other facilities; plans for distribution of beds and facilities.
(d)
Criteria for determining need for modernization.
(e)
State plan requirements; assurances necessary for approval of application.
(a)
Submission; requirements.
(b)
Approval by Surgeon General; hearing after disapproval.
(a)
Application; contents.
(b)
Approval by Surgeon General; requisites; additional approval by Secretary of Health and Human Services.
(c)
Opportunity for hearing required prior to disapproval.
(d)
Amendments subject to same approval as original applications.
(e)
Outpatient facilities; requirements of applicants.
(a)
Certification of work by Surgeon General; conditions affecting payments.
(b)
Additional payments in cases of amended applications.
(c)
Administration expenses; use of portion of allotments to defray; manner of payment.
(a)
Refusal to approve application; procedure; jurisdiction of court of appeals.
(b)
Conclusiveness of Surgeon General's findings; remand; new or modified findings.
(c)
Review by Supreme Court; stay of Surgeon General's action.
(a)
Persons liable.
(b)
Notice to Secretary.
(c)
Amount of recovery; interest; interest period.
(d)
Waiver.
(e)
Lien.
(a)
Authorization; conditions.
(b)
Approval; payments to applicants.
(c)
Terms.
(d)
Funds; miscellaneous receipts.
Part B—Loan Guarantees and Loans for Modernization and Construction of Hospitals and Other Medical Facilities
(a)
Authority of Secretary.
(b)
Cost limitations.
(c)
Administrative assistance.
(a)
Allotment regulations.
(b)
Reallotment.
(c)
Time of availability of amounts for subsequent allotment.
(d)
Modernization or construction commenced on or after January 1, 1968.
(a)
Contents of applications.
(b)
Conditions for approval.
(c)
Hearing.
(d)
Amendment of approved applications.
(e)
Recovery rights; terms and conditions.
(f)
Incontestable guarantee.
(a)
Interest rates; security; equitable geographical distribution.
(b)
Sale.
(c)
Agreements.
(d)
Right of recovery; waiver.
(e)
Interest and interest subsidies as gross income under Internal Revenue Code.
(f)
Sales proceeds; deposit and use.
(g)
Authorization of appropriations.
Part C—Construction or Modernization of Emergency Rooms
Part D—General Provisions
(a)
Membership; qualifications.
(b)
Term of membership.
(c)
Meetings; annual or by call of Surgeon General.
(d)
Advisory or technical committees.
(a)
Other public or private sources unavailable for alleviation of hardship due to increased construction costs.
(b)
Application; form; information.
(c)
Interest; repayment period.
(d)
Authorization of appropriation.
SUBCHAPTER V—HEALTH PROFESSIONS EDUCATION
Part A—Student Loans
subpart i–insured health education assistance loans to graduate students
(a)
In general.
(b)
Certain limitations and priorities.
(c)
Authority of Student Loan Marketing Association.
(a)
In general.
(b)
Extent of insurance liability.
(a)
In general.
(b)
Limitation on rate of interest.
(c)
Minimum annual payment by borrower.
(d)
Applicability of certain laws on rate or amount of interest.
(e)
Determination regarding forbearance.
(f)
Loan repayment schedule.
(g)
Rule of construction regarding determination of need of students.
(h)
Definitions.
(a)
In general.
(b)
Authority regarding comprehensive insurance coverage.
(c)
Assignment of insurance rights.
(d)
Effect of consolidation of obligations.
(e)
Rule of construction regarding consolidation of debts.
(a)
Conditions for payment to beneficiary.
(b)
Subrogation.
(c)
Forbearance.
(d)
Reasonable care and diligence regarding loans.
(e)
Definitions.
(f)
Reductions in Federal reimbursements or payments for defaulting borrowers.
(g)
Conditions for discharge of debt in bankruptcy.
(h)
Requirement regarding actions for default.
(i)
Inapplicability of Federal and State statute of limitations on actions for loan collection.
(j)
School collection assistance.
(a)
Authority.
(b)
Assessment of premium.
(c)
Reduction of risk-based premium.
(d)
Administrative waivers.
(e)
Payoff to reduce risk category.
(a)
Establishment.
(b)
Purpose and functions.
(c)
Additional duties.
(d)
Allocation of funds for Office.
(a)
In general.
(b)
Contingent authority for issuance of notes or other obligations.
(a)
In general.
(b)
Annual budget; accounts.
(a)
In general.
(b)
Recording by institution of information on students.
(c)
Workshop for student borrowers.
(a)
In general.
(b)
Availability of sums.
subpart ii—federally-supported student loan funds
(a)
Fund agreements.
(b)
Requirements.
(c)
Failure of school to collect loans.
(a)
Amount of loan.
(b)
Terms and conditions.
(c)
Repayment; exclusions from ten-year period.
(d)
Cancellation of liability.
(e)
Rate of interest.
(f)
Security or endorsement.
(g)
Transferring and assigning loans.
(h)
Charge with respect to insurance for certain cancellations.
(i)
Charge with respect to late payments.
(j)
Authority of schools regarding rate of payment.
(k)
Authority regarding repayments by Secretary.
(l)
Collection efforts by Secretary.
(a)
Requirements for students.
(b)
Requirements for schools.
(c)
Reports by Secretary.
(d)
Definitions.
(a)
Fund agreements regarding certain amounts.
(b)
Minimum qualifications for schools.
(c)
Certain agreements regarding education of students; date certain for compliance.
(d)
Availability of other amounts.
(e)
"Disadvantaged" defined.
(f)
Authorization of appropriations.
(a)
In general.
(b)
Statement regarding loan.
(a)
Distribution after termination of fund.
(b)
Payment of proportionate share to Secretary.
(a)
Date certain for applications.
(b)
Contingent reduction in allotments.
(c)
Allotment of excess funds.
(d)
Payment of installments to schools.
(e)
Disposition of funds returned to Secretary.
(f)
Funding for certain medical schools.
Part B—Students From Disadvantaged Backgrounds
(a)
In general.
(b)
Requirements regarding scholarships.
(c)
Authorization of appropriations.
(a)
Establishment of program.
(b)
Minimum qualifications of grantees.
(c)
Preferences in providing scholarships.
(d)
Use of scholarship.
(e)
Provisions regarding purposes other than scholarships.
(f)
Requirement of application.
(g)
"School of nursing" defined.
(h)
Funding.
(a)
Loan repayments.
(b)
Fellowships.
(c)
Authorization of appropriations.
(a)
In general.
(b)
Required use of funds.
(c)
Centers of excellence.
(d)
Designation as Center of Excellence.
(e)
Authority regarding Native American Centers of Excellence.
(f)
Duration and amount of grant.
(g)
Maintenance of effort.
(h)
Definitions.
(i)
Funding.
(a)
In general.
(b)
Requirements regarding enrollment; priority in making grants.
(c)
Equitable allocation of financial assistance.
(d)
Funding.
Part C—Training in Primary Health Care
(a)
Authority for provision of financial assistance.
(b)
Structure of programs.
(c)
Requirements for schools.
(d)
Requirements for centers.
(e)
Certain provisions regarding funding.
(f)
Health education and training centers.
(g)
Definitions.
(h)
Criteria and standards.
(i)
Authorization of appropriations.
(a)
Training generally.
(b)
Academic administrative units.
(c)
Duration of award.
(d)
Funding.
(a)
In general.
(b)
Duration of award.
(c)
Authorization of appropriations.
(a)
In general.
(b)
Authorization of appropriations.
(a)
In general.
(b)
Regulations.
(c)
Placement of graduates.
(d)
Funding.
(a)
In general.
(b)
Preference in making grants.
(c)
Authorization of appropriations.
(a)
Traineeships and fellowships.
(b)
Amount of grant.
Part D—Training in Certain Health Professions
subpart i—public health and preventive medicine
(a)
In general.
(b)
Certain requirements.
(a)
In general.
(b)
Preferences in making awards.
(c)
Participation and training of students.
(d)
Application for award.
(e)
Establishment of goals; related reports.
(a)
In general.
(b)
Administration.
(a)
In general.
(b)
Limitation regarding certain program.
subpart ii—allied health professions
(a)
In general.
(b)
Preference.
(c)
Limitation.
(d)
Eligible entities.
(e)
Authorization of appropriations.
(a)
Projects related to strengthening training and increasing enrollment in allied health professions.
(b)
Application.
(c)
Eligible entities.
(d)
Authorization of appropriations.
subpart iii—health administration
(a)
In general.
(b)
Relevant programs.
(c)
Preference in making grants.
(d)
Certain provisions regarding traineeships.
(e)
Application for grant.
(f)
Funding.
Part E—Special Training Projects
(a)
Schools; centers.
(b)
Dental schools.
(c)
Definitions.
(d)
Authorization of appropriations.
(a)
Geriatric education centers.
(b)
Geriatric training regarding physicians and dentists.
(c)
Geriatric training regarding optometrists.
(d)
Authorization of appropriations.
(a)
Grants.
(b)
Use of amounts.
(c)
Eligible applicants.
(d)
Applications.
(e)
"Rural" defined.
(f)
Authorization of appropriations.
Part F—Miscellaneous Programs
(a)
Educational indebtedness.
(b)
Effect of programs for minority and disadvantaged individuals.
(c)
Extent of investigations and disciplinary actions by State licensing authorities.
(d)
Primary health care.
(e)
Authorization of appropriations.
(a)
In general.
(b)
Participation of medical schools.
(c)
Peer review.
(d)
Report to Congress.
(e)
Authorization of appropriations.
Part G—General Provisions
(a)
Preferences in making awards.
(b)
Required submission of information.
(c)
"Graduate" defined.
(a)
In general.
(b)
Certain authorities and requirements.
(d)
Reports to Congress.
(e)
Requirements regarding personal data.
(g)
Technical assistance.
(h)
Grants and contracts regarding nonprofit entities.
(a)
Statistics and other information.
(b)
Requirements regarding personal data.
(c)
Report.
(d)
"Public and community health personnel" defined.
(a)
In general.
(b)
Breach of agreements.
(a)
Peer review.
(b)
Delegation of authority of Secretary.
(c)
Differential tuition and fees.
(d)
Applicability of certain provisions on contracts.
(e)
Records and audits.
(f)
Miscellaneous provisions.
SUBCHAPTER VI—NURSE EDUCATION
Part A—Special Projects
subpart i—special projects in general
(a)
Expansion of enrollment in professional nursing programs.
(b)
Primary health care in noninstitutional settings.
(c)
Continuing education for nurses in medically underserved communities.
(d)
Long-term care fellowships for certain paraprofessionals.
(e)
Authorization of appropriations.
(a)
In general.
(b)
Authorized programs.
(c)
Funding.
(a)
In general.
(b)
Authorized programs.
(c)
Certain considerations in making awards.
(d)
Authorization of appropriations.
subpart ii—nursing education opportunities for individuals from disadvantaged backgrounds
(a)
Covered costs.
(b)
Application; contents.
(c)
Authorization of appropriations.
Part B—Assistance to Nursing Students
subpart i—traineeships
(a)
In general.
(b)
Special consideration in making grants.
(c)
Preference in provision of traineeships.
(d)
Eligibility of individuals in master's degree programs.
(e)
Use of grant.
(f)
Funding.
(a)
Authority of Secretary; program eligibility; payments; limitations.
(b)
Additional granting authorities.
(c)
Authorization of appropriations; limitations.
subpart ii—student loans
(a)
Agreements to establish and operate fund authorized.
(b)
Provisions of agreements.
(c)
Regulatory standards applicable to collection of loans.
(a)
Maximum amount per individual per year; preference to first year students.
(b)
Terms and conditions.
(c)
Cancellation.
(d)
Installments.
(e)
Availability to eligible students in need.
(f)
Penalty for late payment.
(g)
Minimum monthly repayment.
(h)
Loan cancellation.
(i)
Loan repayment.
(j)
Collection by Secretary of loan in default; preconditions and procedures applicable.
(a)
Application for allotment; reduction or adjustment of amount requested in application; reallotment; continued availability of funds.
(b)
Installment payment of allotments.
(c)
Manner of payment.
(a)
Capital distribution of balance of loan fund.
(b)
Payment of principal or interest on loans.
(c)
Payment of balance of loan fund.
subpart iii—loan repayment program
(a)
In general.
(b)
Manner of payments.
(c)
Payment by due date.
(d)
Breach of agreement.
(e)
Preferences regarding participants.
(f)
Definitions.
(g)
Authorization of appropriations.
Part C—General
(a)
Conditions for recovery by United States of base amount and interest.
(b)
Notice by owner of cessation or change of use of facility.
(c)
Computation of base amount and interest.
(d)
Waiver of recovery rights of United States.
(e)
Nature of prejudgment right of recovery.
(a)
Evaluations directly or through contractual arrangement; dissemination of information.
(b)
Reports to Congress.
(c)
Amounts available from appropriated funds.
(a)
Application for grants, cooperative agreements, or contracts.
(b)
Duration of assistance.
(c)
Breach of agreements for obligated service.
(d)
Peer review regarding certain programs.
(e)
Preferences and required information in certain programs.
Part D—Scholarship Grants to Schools of Nursing
SUBCHAPTER VII—AGENCY FOR HEALTH CARE POLICY AND RESEARCH
Part A—Establishment and General Duties
(a)
In general.
(b)
Purpose.
(c)
Appointment of Administrator.
(a)
In general.
(b)
Requirements with respect to rural areas and underserved populations.
(c)
Health services training grants.
(d)
Multidisciplinary centers.
(e)
Relation to certain authorities regarding social security.
(a)
In general.
(b)
Prohibition against restrictions.
(c)
Limitation on use of certain information.
(d)
Certain interagency agreement.
(e)
Required interagency agreement.
(a)
In general.
(b)
Specific assessments.
(c)
Agenda and priorities.
(d)
Conduct of assessments.
(e)
Description of process.
(f)
Program of innovative assessments.
Part B—Forum for Quality and Effectiveness in Health Care
(a)
Establishment of forum program.
(b)
Certain requirements.
(c)
Authority for contracts.
(d)
Date certain for initial guidelines and standards.
(e)
Relationship with medicare program.
(f)
Development of certain guidelines and standards.
(a)
Development through contracts and panels.
(b)
Authority for additional panels.
(c)
Selection of panel members.
(a)
Program agenda.
(b)
Standards and criteria.
(c)
Dissemination.
(d)
Pilot testing.
(e)
Evaluations.
(f)
Recommendations to Administrator.
Part C—General Provisions
(a)
Establishment.
(b)
Duties.
(c)
Membership.
(d)
Terms.
(e)
Vacancies.
(f)
Chair.
(g)
Meetings.
(h)
Compensation and reimbursement of expenses.
(i)
Staff.
(j)
Duration.
(a)
Requirement of review.
(b)
Approval as precondition of awards.
(c)
Establishment of peer review groups.
(d)
Categories of review.
(e)
Regulations.
(a)
Standards with respect to utility of data.
(b)
Statistics.
(c)
Authority regarding certain requests.
(a)
Financial conflicts of interest.
(b)
Requirement of application.
(c)
Provision of supplies and services in lieu of funds.
(d)
Applicability of certain provisions with respect to contracts.
(a)
Deputy Administrator and other officers and employees.
(b)
Facilities.
(c)
Provision of financial assistance.
(d)
Utilization of certain personnel and resources.
(e)
Consultants.
(f)
Experts.
(g)
Voluntary and uncompensated services.
(a)
Authorization of appropriations.
(b)
Evaluations.
(c)
Information center.
(d)
Health care technology assessment.
(e)
Program of innovative assessments.
SUBCHAPTER VIII—POPULATION RESEARCH AND VOLUNTARY FAMILY PLANNING PROGRAMS
(a)
Authority of Secretary.
(b)
Factors determining awards; establishment and preservation of rights of local and regional entities.
(c)
Reduction of grant amount.
(d)
Authorization of appropriations.
(a)
Authority of Secretary; prerequisites.
(b)
Factors determining amount of State allotments.
(c)
"State" defined.
(d)
Authorization of appropriations.
(a)
Promulgation of regulations governing execution; amount of grants.
(b)
Payment of grants.
(c)
Prerequisites; "low-income family" defined.
(d)
Suitability of informational or educational materials.
(a)
Submission of report to Congress; purposes of plan.
(b)
Minimum requirements for plan.
(c)
Contents of report.
(a)
Omitted.
(b)
Prohibition of public officials and public authorities from imposition of certain requirements contrary to religious beliefs or moral convictions.
(c)
Discrimination prohibition.
(d)
Individual rights respecting certain requirements contrary to religious beliefs or moral convictions.
(e)
Prohibition on entities receiving Federal grant, etc., from discriminating against applicants for training or study because of refusal of applicant to participate on religious or moral grounds.
SUBCHAPTER VIII–A—ADOLESCENT PREGNANCIES
Part A—Grant Program
Part B—Improving Coordination of Federal and State Programs
SUBCHAPTER IX—GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT DEATH SYNDROME
Part A—Genetic Diseases
(a)
Manner of submission; contents.
(b)
Considerations for grants and contracts under
Part B—Sudden Infant Death Syndrome
(a)
Adequate amounts for identification and prevention progress.
(b)
Reports to Congressional committees; contents: data as to applications and funds for specific and general research, summary of findings and plan for taking advantage of research leads and findings.
(c)
Reports to Congressional committees; current and past estimates for research.
Part C—Hemophilia Programs
(a)
Grants and contracts with public and nonprofit private entities for projects to develop and expand existing facilities; definitions.
(b)
Grants for alleviation of insufficient supplies of blood fractions.
(c)
Approval of application as prerequisite for grant or contract; form, manner of submission, and contents of application.
(d)
Nonapplicability of statutory provisions to contracts.
(e)
Authorization of appropriations.
SUBCHAPTER X—TRAUMA CARE
Part A—General Authority and Duties of Secretary
(a)
In general.
(b)
Grants, cooperative agreements, and contracts.
(c)
Administration.
(a)
Establishment.
(b)
Duties.
(c)
Fees and assessments.
(a)
In general.
(b)
Special consideration for certain rural areas.
(c)
Requirement of application.
Part B—Formula Grants With Respect to Modifications of State Plans
(a)
Requirement of allotments for States.
(b)
Purpose.
(a)
Non-Federal contributions.
(b)
Determination of amount of non-Federal contribution.
(a)
Trauma care modifications to State plan for emergency medical services.
(b)
Certain standards with respect to trauma care centers and systems.
(c)
Model trauma care plan.
(d)
Rule of construction with respect to number of designated trauma centers.
(a)
Trauma plan.
(b)
Information received by State reporting and analysis system.
(c)
Availability of emergency medical services in rural areas.
(a)
In general.
(b)
Exception.
(a)
In general.
(b)
Availability to public of reports.
(c)
Evaluations by Comptroller General.
(a)
Minimum allotment.
(b)
Determination under formula.
(c)
Disposition of certain funds appropriated for allotments.
(a)
Repayment of payments.
(b)
Opportunity for hearing.
(a)
In general.
(b)
Criminal penalty for violation of prohibition.
(a)
Technical assistance.
(b)
Provision by Secretary of supplies and services in lieu of grant funds.
Part C—General Provisions Regarding Parts A and B
(a)
Authorization of appropriations.
(b)
Allocation of funds by Secretary.
(c)
Effect of insufficient appropriations for minimum allotments.
Part D—Trauma Centers Operating in Areas Severely Affected by Drug-Related Violence
(a)
In general.
(b)
Minimum qualifications of centers.
(a)
In general.
(b)
Further preference for certain applications.
(a)
Commitment regarding continued participation in trauma care system.
(b)
Maintenance of financial support.
(c)
Trauma care registry.
(a)
Application.
(b)
Limitation on duration of support.
(c)
Limitation on amount of grant.
Part E—Miscellaneous Programs
(a)
In general.
(b)
Identification and referral of domestic violence.
(c)
Authorization of appropriations.
Part F—Interagency Program for Trauma Research
(a)
In general.
(b)
Plan for Program.
(c)
Participating agencies; coordination and collaboration.
(d)
Certain activities of Program.
(e)
Mechanisms of support.
(f)
Resources.
(g)
Coordinating Committee.
(h)
Definitions.
SUBCHAPTER XI—HEALTH MAINTENANCE ORGANIZATIONS
(a)
"Health maintenance organization" defined.
(b)
Manner of supplying basic and supplemental health services to members.
(c)
Organizational requirements.
(a)
Authority.
(b)
Limitations.
(c)
Source of loan funds.
(d)
Time limit on loans and loan guarantees.
(e)
Repealed.
(f)
Medically underserved populations.
(a)
Submission to and approval by Secretary required for making loans and loan guarantees.
(b)
Application contents.
(c)
Regulations.
(a)
Recordkeeping; audit and examination.
(b)
Report upon expiration of period.
(c)
Repealed.
(d)
Other entities considered health maintenance organizations.
(a)
Conditions.
(b)
Application requirements.
(c)
Sale of loans.
(d)
Loan guarantee fund.
(e)
Loan fund.
(f)
Actions to protect interest of United States in event of default.
(a)
Regulations; membership option; acceptance of offer.
(b)
Basic health service requirement.
(c)
Effect on costs; payroll deductions; nondiscriminatory contributions for services.
(d)
"Qualified health maintenance organization" defined.
(e)
Civil penalty; notice and presentation of views; review.
(f)
"Employer" defined.
(g)
Termination of payment for failure to comply.
(a)
Entities operating as health maintenance organizations.
(b)
Advertising.
(c)
Digest of State laws, regulations, and practices; legal consultative assistance.
(a)
Determination of deficiency.
(b)
Action by Secretary upon determination.
(a)
National Health Maintenance Organization Intern Program.
(b)
Technical assistance.
(c)
Amounts provided in advance in appropriation acts.
(a)
Financial information reported to Secretary.
(b)
"Party in interest" defined.
(c)
Information availability.
(d)
Evaluation of transactions.
(e)
Repealed.
(f)
Rates.
(g)
Annual financial statement.
(h)
Penalties.
SUBCHAPTER XII—SAFETY OF PUBLIC WATER SYSTEMS
Part A—Definitions
Part B—Public Water Systems
(a)
National primary drinking water regulations; maximum contaminant level goals; simultaneous publication of regulations and goals.
(b)
Standard setting schedules and deadlines; substitution of contaminants; additional contaminants; adequate safety margin in levels; "feasible" defined; technology, techniques, or other means to meet contaminant level; alternative treatment techniques; filtration and disinfection as required treatment techniques; amendment, review, effective date, and supersedure of regulations; addition of substances unrelated to contamination.
(c)
Secondary regulations; publication of proposed regulations; promulgation; amendments.
(d)
Regulations; public hearings; administrative consultations.
(e)
Science Advisory Board comments.
(a)
Notice to State and public water system; issuance of administrative order; civil action.
(b)
Judicial determinations in appropriate Federal district courts; civil penalties; separate violations.
(c)
Notice of owner or operator of public water system to persons served; regulations for form, manner, and frequency of notice; amendment of regulations to provide different types and frequencies of notice; penalties.
(d)
Notice of noncompliance with secondary drinking water regulations.
(e)
State authority to adopt or enforce laws or regulations respecting drinking water regulations or public water systems unaffected.
(f)
Notice and public hearing; availability of recommendations transmitted to State and public water system.
(g)
Administrative order requiring compliance; notice and hearing; civil penalty; civil actions.
(a)
Characteristics of raw water sources; specific treatment technique; notice to Administrator, reasons for variance; compliance, enforcement; approval or revision of schedules and revocation of variances; review of variances and schedules; publication in Federal Register, notice and results of review; notice to State; considerations respecting abuse of discretion in granting variances or failing to prescribe schedules; State corrective action; authority of Administrator in a State without primary enforcement responsibility; alternative treatment techniques.
(b)
Enforcement of schedule or other requirement.
(c)
Applications for variances; regulations: reasonable time for acting.
(d)
"Treatment technique requirement" defined.
(a)
Requisite findings.
(b)
Compliance schedule and implementation of control measures; notice and hearing; dates for compliance with schedule; extension of final date for compliance; compliance, enforcement; approval or revision of schedules and revocation of exemptions.
(c)
Notice to Administrator; reasons for exemption.
(d)
Review of exemptions and schedules; publication in Federal Register, notice and results of review; notice to State; considerations respecting abuse of discretion in granting exemptions or failing to prescribe schedules; State corrective action.
(e)
"Treatment technique requirement" defined.
(f)
Authority of Administrator in a State without primary enforcement responsibility.
(g)
Applications for exemptions; regulations; reasonable time for acting.
(a)
In general.
(b)
State enforcement.
(c)
Penalties.
(d)
"Lead free" defined.
Part C—Protection of Underground Sources of Drinking Water
(a)
Publication of proposed regulations; promulgation; amendments; public hearings; administrative consultations.
(b)
Minimum requirements; restrictions.
(c)
Temporary permits; notice and hearing.
(d)
"Underground injection" defined; underground injection endangerment of drinking water sources.
(a)
List of States in need of a control program; amendment of list.
(b)
State applications; notice to Administrator of compliance with revised or added requirements; approval or disapproval by Administrator; duration of State primary enforcement responsibility; public hearing.
(c)
Program by Administrator for State without primary enforcement responsibility; restrictions.
(d)
"Applicable underground injection control program" defined.
(e)
Primary enforcement responsibility by Indian Tribe.
(a)
Notice to State and violator; issuance of administrative order; civil action.
(b)
Civil and criminal actions.
(c)
Administrative orders.
(d)
State authority to adopt or enforce laws or regulations respecting underground injection unaffected.
(a)
Necessity for well operation permit; designation of one aquifer areas.
(b)
Well operation permits; publication in Federal Register; notice and hearing; issuance or denial; conditions for issuance.
(c)
Civil penalties; separate violations; penalties for willful violations; temporary restraining order or injunction.
(d)
"New underground injection well" defined.
(e)
Areas with one aquifer; publication in Federal Register; commitments for Federal financial assistance.
(a)
Approval of State underground injection control program; alternative showing of effectiveness of program by State.
(b)
Revision or amendment of requirements of regulation; showing of effectiveness of program by State.
(c)
Primary enforcement responsibility of State; voiding by Administrator under duly promulgated rule.
(a)
Monitoring methods.
(b)
Report.
(a)
Purpose.
(b)
"Critical aquifer protection area" defined.
(c)
Application.
(d)
Criteria.
(e)
Contents of application.
(f)
Comprehensive plan.
(g)
Plans under section 208 of Clean Water Act.
(h)
Consultation and hearings.
(i)
Approval or disapproval.
(j)
Grants and reimbursement.
(k)
Activities funded under other law.
(l)
Report.
(m)
Savings provision.
(n)
Authorization of appropriations.
(a)
State programs.
(b)
Public participation.
(c)
Disapproval.
(d)
Federal assistance.
(e)
"Wellhead protection area" defined.
(f)
Prohibitions.
(g)
Implementation.
(h)
Federal agencies.
(i)
Additional requirement.
(j)
Coordination with other laws.
(k)
Authorization of appropriations.
Part D—Emergency Powers
(a)
Actions authorized against imminent and substantial endangerment to health.
(b)
Penalties for violations; separate offenses.
(a)
Tampering.
(b)
Attempt or threat.
(c)
Civil penalty.
(d)
"Tamper" defined.
Part E—General Provisions
(a)
Certification of need application.
(b)
Application requirements; publication in Federal Register; waiver; certification, issuance or denial.
(c)
Certification of need; issuance; executive orders; implementation of orders; equitable apportionment of orders; factors considered.
(d)
Breach of contracts; defense.
(e)
Penalties for noncompliance with orders; temporary restraining orders and preliminary or permanent injunctions.
(f)
Termination date.
(a)
Specific powers and duties of Administrator.
(b)
Other powers and duties of Administrator.
(c)
Report to Congress on present and projected future availability of safe drinking water; additional contents; utilization of information and data.
(d)
Establishment of training programs and grants for training; training fees.
(e)
Repealed.
(f)
Authorization of appropriations.
(g)
Technical assistance for small systems; authorization of appropriations; amount to be utilized for public water systems owned or operated by Indian tribes.
(a)
Public water systems supervision programs; applications for grants; allotment of sums; waiver of grant restrictions; notice of approval or disapproval of application; authorization of appropriations.
(b)
Underground water source protection programs; applications for grants; allotment of sums; authorization of appropriations.
(c)
Definitions.
(a)
Special study and demonstration project grants.
(b)
Limitations.
(c)
Authorization of appropriations.
(d)
Loan guarantees to public water systems; conditions; indebtedness limitation; regulations.
(a)
Assistance for development and demonstration projects.
(b)
Limitations.
(c)
Authorization of appropriations.
(a)
Persons subject to requirements; size of system and likely contaminants as considerations for monitoring; monitoring for unregulated contaminants; notification of availability of results; waiver of monitoring requirement; authorization of appropriations.
(b)
Entry of establishments, facilities, or other property; inspections; conduct of certain tests; audit and examination of records; entry restrictions; prohibition against informing of a proposed entry.
(c)
Penalty.
(d)
Confidential information; trade secrets and secret processes; information disclosure; "information required under this section" defined.
(e)
"Grantee" and "person" defined.
(f)
Information regarding drinking water coolers.
(a)
Establishment; membership; representation of interests; term of office, vacancies; reappointment.
(b)
Functions.
(c)
Compensation and allowances; travel expenses.
(d)
Advisory committee termination provision inapplicable.
(a)
Compliance with Federal, State, and local requirements, etc.; scope of applicability of compliance requirements, etc.; liability for civil penalties.
(b)
Waiver; national security; records available in judicial proceedings; publication in Federal Register; notice to Congressional committees.
(c)
Indian rights and sovereignty as unaffected; "Federal agency" defined.
(a)
Courts of appeals; petition for review: actions respecting regulations; filing period; grounds arising after expiration of filing period; exclusiveness of remedy.
(b)
District courts; petition for review: actions respecting variances or exemptions; filing period; grounds arising after expiration of filing period; exclusiveness of remedy.
(c)
Judicial order for additional evidence before Administrator; modified or new findings; recommendation for modification or setting aside of original determination.
(a)
Persons subject to civil action; jurisdiction of enforcement proceedings.
(b)
Conditions for commencement of civil action; notice.
(c)
Intervention of right.
(d)
Costs; attorney fees; expert witness fees; filing of bond.
(e)
Availability of other relief.
(a)
Regulations; delegation of functions.
(b)
Utilization of officers and employees of Federal agencies.
(c)
Assignment of Agency personnel to State or interstate agencies.
(d)
Payments of grants; adjustments; advances; reimbursement; installments; conditions; eligibility for grants; "nonprofit agency or institution" defined.
(e)
Labor standards.
(f)
Appearance and representation of Administrator through Attorney General or attorney appointees.
(g)
Authority of Administrator under other provisions unaffected.
(h)
Reports to Congressional committees; review by Office of Management and Budget: submittal of comments to Congressional committees.
(i)
Discrimination prohibition; filing of complaint; investigation; orders of Secretary; notice and hearing; settlements; attorneys' fees; judicial review; filing of petition; procedural requirements; stay of orders; exclusiveness of remedy; civil actions for enforcement of orders; appropriate relief; mandamus proceedings; prohibition inapplicable to undirected but deliberate violations.
(a)
In general.
(b)
EPA regulations.
Part F—Additional Requirements To Regulate Safety of Drinking Water
(a)
Publication of lists.
(b)
Prohibition.
(c)
Criminal penalty.
(d)
Civil penalty.
(a)
Distribution of drinking water cooler list.
(b)
Guidance document and testing protocol.
(c)
Dissemination to schools, etc.
(d)
Remedial action program.
(a)
School drinking water programs.
(b)
Limits.
(c)
Authorization of appropriations.
SUBCHAPTER XIII—PREVENTIVE HEALTH MEASURES WITH RESPECT TO BREAST AND CERVICAL CANCERS
(a)
In general.
(b)
Grant and contract authority of States.
(c)
Special consideration for certain States.
(c)
Coordinating committee regarding year 2000 health objectives.
(a)
In general.
(b)
Determination of amount of non-Federal contribution.
(a)
Requirement of provision of all services by date certain.
(b)
Use of improved screening procedures.
(c)
Quality assurance regarding screening procedures.
(a)
Priority for low-income women.
(b)
Limitation on imposition of fees for services.
(c)
Statewide provision of services.
(d)
Relationship to items and services under other programs.
(e)
Coordination with other breast and cervical cancer programs.
(f)
Limitation on administrative expenses.
(g)
Restrictions on use of grant.
(h)
Records and audits.
(i)
Reports to Secretary.
(a)
Technical assistance.
(b)
Provision of supplies and services in lieu of grant funds.
(a)
Evaluations.
(b)
Report to Congress.
(a)
Demonstration projects.
(b)
Status as participant in program regarding breast and cervical cancer.
(c)
Applicability of provisions of general program.
(d)
Funding.
(a)
Authorization of appropriations.
(b)
Set-aside for technical assistance and provision of supplies and services.
SUBCHAPTER XIV—HEALTH RESOURCES DEVELOPMENT
Part A—Loans and Loan Guarantees
(a)
Covered projects: duration; payment of principal and interest on loans for covered projects: duration; payments for reduction of interest rate.
(b)
Amount of loans for medical facilities projects and such projects in urban or rural poverty areas.
(c)
Limitation on cumulative total of principal of outstanding loans.
(d)
Administrative assistance of Department of Housing and Urban Development.
(a)
Loan guarantees; criteria for approval; recovery of payments by United States; modification, etc., of terms and conditions; incontestability.
(b)
Loans; criteria for approval; terms and conditions; waiver of recovery of payments by United States.
(c)
Sale of loans; authority; amount; agreements with purchasers; deposit of proceeds.
(d)
Loan and loan guarantee fund; establishment; amounts authorized to be appropriated; issuance, purchase, and sale of notes, obligations, etc.; interest rates; public debt transactions.
(e)
Transfers to and additional capitalization of loan and loan guarantee fund.
(f)
Default prevention measures; terms and conditions; implementation of reforms; foreclosures; protection of Federal interest on default.
Part B—Project Grants
(a)
Authority; objectives; eligible grantees; maximum amounts; authorization of appropriations; availability of unobligated funds.
(b)
Projects for medically underserved populations; eligible grantees; maximum amounts; authorization of appropriations.
Part C—General Provisions
(a)
Submissions.
(b)
Form; required provisions; waiver; projects subject to requirements.
(a)
Persons liable.
(b)
Notice to Secretary.
(c)
Amount of recovery; interest; interest period.
(d)
Waiver.
(e)
Lien.
(a)
Filing of financial statement with appropriate State Agency; form and contents.
(b)
Maintenance of records; access to books, etc., for audit and examination.
(c)
Filing of financial statement with Secretary; form and contents.
Part D—Area Health Services Development Funds
(a)
Eligible recipients; purpose of grants.
(b)
Determination of amounts; maximum amounts.
(c)
Applications; submission and approval as prerequisite; form and contents.
(d)
Authorization of appropriations.
Part E—Program To Assist and Encourage Voluntary Discontinuance of Unneeded Hospital Services and Conversion of Unneeded Hospital Services to Other Health Services Needed by Community
(a)
Terms and conditions; determination of amount; authorized uses.
(b)
Application; submission and approval; form; required provisions; review by health systems agency; basis of State Agency's recommendations; urban or rural poverty population considerations; approval by Secretary: restrictions and special considerations.
(c)
Certification of protective arrangements for employment benefits and interests; guidelines; satisfactory arrangement determinations.
(d)
Records and audits requirements.
(e)
"Hospital" defined.
(a)
"Excess hospital capacity" defined; particular activities.
(b)
Terms and conditions.
SUBCHAPTER XV—HEALTH INFORMATION AND HEALTH PROMOTION
(a)
Development, support, and implementation of programs, activities, etc.
(b)
Authorization of appropriations.
(c)
Application; submission and approval as prerequisite; form and content.
(a)
Authority of Secretary; particular activities.
(b)
Grants to States and other public and nonprofit private entities; costs of demonstrating and evaluating programs; development of models.
(c)
Private nonprofit entities; limitation on amount of grant or contract.
(a)
Establishment; grants; contracts; research and demonstration projects.
(b)
Location; types of research and projects.
(c)
Equitable geographic distribution of centers; procedures.
(d)
"Academic health center" defined.
(e)
Authorization of appropriations.
(a)
In general.
(b)
Duties.
(c)
Certain requirements regarding duties.
(d)
Grants and contracts regarding duties.
(e)
Reports.
(f)
Funding.
(a)
In general.
(b)
Duties.
(c)
Certain demonstration projects.
(d)
Information clearinghouse.
(e)
National plan.
(f)
Adolescent health.
(a)
Biennial report.
(b)
Submission to Congress.
SUBCHAPTER XVI—PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH
(a)
Establishment; composition; appointment of members; vacancies.
(b)
Terms of members.
(c)
Chairman.
(d)
Meetings.
(e)
Compensation; travel expenses, etc.
(a)
Studies and investigations; priority and order; report to President and Congress.
(b)
Recommendations to agencies; subsequent administrative requirements.
(c)
Report on protection of human subjects; scope; submission to President, etc.
(d)
Annual report; scope; submission to President, etc.
(e)
Publication and dissemination of reports.
(f)
Definitions.
(a)
Hearings.
(b)
Appointment and compensation of staff personnel; procurement and compensation of temporary and intermittent services; detail of personnel from other Federal agencies.
(c)
Contracting authority.
(d)
Informational requirements and prohibitions.
(e)
Support services from Administrator of General Services.
SUBCHAPTER XVII—BLOCK GRANTS
Part A—Preventive Health and Health Services Block Grants
(a)
Availability based upon prior year distributions.
(b)
Population.
(c)
Distribution of appropriated funds not allotted.
(d)
Distributions to Indian tribes.
(e)
Report on equitable distribution of available funds.
(a)
Preventive health services, comprehensive public health services, emergency medical services, etc.
(b)
Prohibited uses.
(c)
Transfer of funds.
(d)
Limitation on administrative costs.
(a)
In general.
(b)
State plan.
(c)
State certification.
(d)
State Advisory Committee.
(a)
Annual reports; contents; data collection; copies.
(b)
Fiscal control; accounting procedures; annual audits; repayments and offsets; public inspection; Comptroller General evaluations; report to Congress.
(c)
Inapplicability of title XVII of Omnibus Budget Reconciliation Act of 1981.
(a)
Prerequisites.
(b)
Investigations.
(c)
Availability of books, documents, papers, and records.
(d)
Information not readily available.
(a)
Programs and activities receiving Federal financial assistance.
(b)
Failure to comply.
(c)
Civil actions by Attorney General.
(a)
Grant authority.
(b)
Renewals.
(c)
Definitions.
(d)
Authorization of appropriations.
(a)
Permitted use.
(b)
Targeting of education programs.
(c)
Authorization of appropriations.
(d)
Limitation.
(e)
"Rape prevention and education" defined.
(f)
Terms.
Part B—Block Grants Regarding Mental Health and Substance Abuse
subpart i—block grants for community mental health services
(a)
In general.
(b)
Purpose of grants.
(a)
In general.
(b)
Criteria for plan.
(c)
Definitions regarding mental illness and emotional disturbance; methods for estimate of incidence and prevalence.
(d)
Requirement of implementation of plan.
(a)
Allocation for systems of integrated services for children.
(b)
Providers of services.
(c)
Criteria for mental health centers.
(a)
In general.
(b)
Duties.
(c)
Membership.
(d)
"Council" defined.
(a)
Review of State plan by mental health planning council.
(b)
Maintenance of effort regarding State expenditures for mental health.
(a)
In general.
(b)
Limitation on administrative expenses.
(a)
In general.
(b)
Waivers regarding certain territories.
(a)
States.
(b)
Minimum allotments for States.
(c)
Territories.
(a)
Authorization of appropriations.
(b)
Allocations for technical assistance, data collection, and program evaluation.
subpart ii—block grants for prevention and treatment of substance abuse
(a)
In general.
(b)
Authorized activities.
(a)
Allocations regarding alcohol and other drugs.
(b)
Allocation regarding primary prevention programs.
(c)
Allocations regarding women.
(a)
Capacity of treatment programs.
(b)
Outreach regarding intravenous substance abuse.
(a)
Tuberculosis.
(b)
Human immunodeficiency virus.
(c)
Expenditure of grant for compliance with agreements.
(d)
Maintenance of effort.
(e)
Applicability of certain provision.
(a)
State revolving funds for establishment of homes.
(b)
Issuance by Secretary of guidelines.
(c)
Applicability to territories.
(a)
Relevant law.
(b)
Enforcement.
(c)
Noncompliance of State.
(d)
"First applicable fiscal year" defined.
(a)
In general.
(b)
Referrals regarding States.
(a)
Improvement of process for appropriate referrals for treatment.
(b)
Continuing education.
(c)
Coordination of various activities and services.
(d)
Waiver of requirement.
(a)
In general.
(b)
Waiver.
(c)
Noncompliance by State.
(a)
In general.
(b)
Exception regarding inpatient hospital services.
(c)
Waiver regarding construction of facilities.
(a)
In general.
(b)
State plan.
(c)
Waivers regarding certain territories.
(d)
Issuance of regulations; precondition to making grants.
(a)
States.
(b)
Minimum allotments for States.
(c)
Territories.
(d)
Indian tribes and tribal organizations.
(a)
Authorization of appropriations.
(b)
Allocations for technical assistance, national data base, data collection, and program evaluations.
subpart iii—general provisions
(a)
Report.
(b)
Audits.
(c)
Availability to public.
(a)
In general.
(b)
Patient records.
(a)
In general.
(b)
Specification of amounts.
(a)
Suspension or termination of payments.
(b)
Repayment of payments.
(c)
Withholding of payments.
(d)
Applicability of remedies to certain violations.
(e)
Opportunity for hearing.
(f)
Requirement of hearing in certain circumstances.
(g)
Certain investigations.
(a)
Establishment.
(b)
Criminal penalty for violation of prohibition.
(a)
In general.
(b)
Enforcement.
(a)
Technical assistance.
(b)
Provision of supplies and services in lieu of grant funds.
(a)
In general.
(b)
Exception regarding noncompliance of subgrantees.
(a)
In general.
(b)
Expenditure of amounts.
(c)
Definitions.
(a)
Definitions for this subpart.
(b)
Definitions for this part.
Part C—Certain Programs Regarding Substance Abuse
subpart i—expansion of capacity for providing treatment
(a)
Grants for States with insufficient capacity.
(b)
Priority in making grants.
(c)
Requirement of matching funds.
(d)
Limitation regarding direct treatment services.
(e)
Requirement of application.
(f)
Duration of grant.
(g)
Maintenance of effort.
(h)
Restrictions on use of grant.
(i)
Definitions.
(j)
Authorization of appropriations.
subpart ii—interim maintenance treatment of narcotics dependence
(a)
Requirement regarding Secretary.
(b)
Inapplicability of requirement in certain circumstances.
(c)
Conditions for obtaining authorization from Secretary.
(d)
Definitions.
SUBCHAPTER XVIII—ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS
(a)
Covered projects.
(b)
Family planning services; availability in community.
(c)
Fees for services: criteria.
(a)
Priorities.
(b)
Factors to be considered in making grants; special needs of rural areas.
(c)
Duration; Federal share.
(a)
Form, content, and assurances.
(b)
Evaluations: amount, conduct, and technical assistance.
(c)
Reports.
(d)
Notification of parents; "adult" defined.
(e)
Submission of applications to Governor; comments by Governor.
(f)
Availability of core services.
(a)
Grants and contracts; duration; renewal; amount.
(b)
Scope of permissible activities.
(c)
Applications.
(d)
Coordination with National Institutes of Health.
(e)
Review of applications for grants and contracts; establishment of review panel.
(f)
Reports.
SUBCHAPTER XIX—VACCINES
Part 1—National Vaccine Program
Part 2—National Vaccine Injury Compensation Program
subpart a—program requirements
(a)
Program established.
(b)
Attorney's obligation.
(c)
Publicity.
(a)
General rule.
(b)
Petitioners.
(c)
Petition content.
(d)
Additional information.
(e)
Schedule.
(a)
General rule.
(b)
Parties.
(c)
United States Court of Federal Claims special masters.
(d)
Special masters.
(e)
Action by United States Court of Federal Claims.
(f)
Appeals.
(g)
Notice.
(a)
General rule.
(b)
Matters to be considered.
(c)
"Record" defined.
(a)
Initial table.
(b)
Qualifications and aids to interpretation.
(c)
Administrative revision of table.
(d)
Role of Commission.
(e)
Additional vaccines.
(a)
General rule.
(b)
Vaccines administered before effective date.
(c)
Residential and custodial care and service.
(d)
Types of compensation prohibited.
(e)
Attorneys' fees.
(f)
Payment of compensation.
(g)
Program not primarily liable.
(h)
Liability of health insurance carriers, prepaid health plans, and benefit providers.
(i)
Source of compensation.
(j)
Authorization.
(a)
General rule.
(b)
Effect of revised table.
(c)
State limitations of actions.
(a)
General rule.
(b)
Disposition of amounts recovered.
(a)
Establishment.
(b)
Term of office.
(c)
Meetings.
(d)
Compensation.
(e)
Staff.
(f)
Functions.
subpart b—additional remedies
(a)
Election.
(b)
Continuance or withdrawal of petition.
(c)
Limitations of actions.
(a)
General rule.
(b)
Unavoidable adverse side effects; warnings.
(c)
Direct warnings.
(d)
Construction.
(e)
Preemption.
(a)
General rule.
(b)
Liability.
(c)
General damages.
(d)
Punitive damages.
(e)
Evidence.
subpart c—assuring a safer childhood vaccination program in united states
(a)
General rule.
(b)
Reporting.
(c)
Release of information.
(a)
General rule.
(b)
Development and revision of materials.
(c)
Information requirements.
(d)
Health care provider duties.
(a)
General rule.
(b)
Task force.
(c)
Report.
(a)
General rule.
(b)
Sanction.
subpart d—general provisions
(a)
General rule.
(b)
Notice.
(c)
Costs of litigation.
(a)
Reviews.
(b)
Report.
SUBCHAPTER XX—REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR CERTAIN STATE AND LOCAL EMPLOYEES
(a)
In general.
(b)
Exception for certain plans.
SUBCHAPTER XXI—RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME
Part A—Administration of Research Programs
(a)
In general.
(b)
Inclusion of certain information.
(a)
In general.
(b)
Time limitations with respect to certain applications.
(c)
Requirements with respect to adjustments in time limitations.
(d)
Annual reports to Congress.
(e)
Quarterly reports for fiscal year 1989.
(a)
In general.
(b)
Notice to Secretary and to Assistant Secretary for Health.
(c)
"Priority request" defined.
(a)
In general.
(b)
Composition.
(c)
Duties.
Part B—Research Authority
(a)
In general.
(b)
Personnel and administrative support.
(c)
Authorization of appropriations.
(a)
Encouragement of applications with respect to clinical trials.
(b)
Encouragement of applications with respect to treatment use in circumstances other than clinical trials.
(c)
Technical assistance with respect to treatment use.
(d)
"New drug" defined.
(a)
In general.
(b)
Requirement of certain projects.
(c)
Participation of private industry, schools of medicine and primary providers.
(d)
Requirement of application.
(e)
Authorization of appropriations.
(a)
Establishment of program.
(b)
Authority with respect to grants and contracts.
(c)
Scientific and ethical guidelines.
(d)
Authorization of appropriations.
(a)
Grants and contracts for research.
(b)
Grants and contracts for additional purposes.
(c)
Special Programme of World Health Organization.
(d)
Preferences.
(e)
Requirement of application.
(f)
Authorization of appropriations.
(a)
In general.
(b)
Use of financial assistance.
(c)
Duration of support.
(d)
Authorization of appropriations.
(a)
Establishment of program.
(b)
Toll-free telephone communications for health care entities.
(c)
Data bank on research information.
(d)
Data bank on clinical trials and treatments.
(e)
Requirements with respect to data bank on clinical trials and treatments.
(a)
In general.
(b)
Requirement of provision of certain services.
(c)
Limitation on imposition of charges for services.
(d)
Evaluation and reports.
(e)
Authorization of appropriations.
(a)
Data collection with respect to national prevalence.
(b)
Epidemiological and demographic data.
(c)
Long-term research.
(d)
Social sciences research.
(e)
Authorization of appropriations.
Part C—Research Training
(a)
In general.
(b)
Programs conducted by National Institute of Mental Health.
(c)
Relationship to limitation on number of employees.
(d)
Authorization of appropriations.
Part D—Office of AIDS Research
subpart i—interagency coordination of activities
(a)
In general.
(b)
Duties.
(a)
Advisory Council.
(b)
Individual coordinating committees regarding research disciplines.
(a)
In general.
(b)
Certain components of plan.
(c)
Budget estimates.
(d)
Funding.
(a)
In general.
(b)
Report to Secretary.
(c)
Projects for cooperation among public and private health entities.
subpart ii—emergency discretionary fund
(a)
In general.
(b)
Peer review.
(c)
Limitations on use of Fund.
(d)
Applicability of limitation regarding number of employees.
(e)
Report to Congress.
(f)
Definitions.
(g)
Funding.
subpart iii—general provisions
(a)
Administrative support for Office.
(b)
Evaluation and report.
(c)
Definitions.
Part E—General Provisions
SUBCHAPTER XXII—HEALTH SERVICES WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY SYNDROME
Part A—Formula Grants to States for Home and Community-Based Health Services
Part B—Subacute Care
(a)
Definitions.
(b)
Authorization to conduct three projects.
(c)
Services.
(d)
Time and place.
(e)
Evaluation and report.
(f)
Other research.
(g)
Authorization of appropriations.
(h)
Services to veterans.
Part C—Other Health Services
(a)
Counseling before testing.
(b)
Counseling of individuals with negative test results.
(c)
Counseling of individuals with positive test results.
(d)
Rule of construction with respect to counseling without testing.
(e)
Use of funds.
SUBCHAPTER XXIII—PREVENTION OF ACQUIRED IMMUNE DEFICIENCY SYNDROME
(a)
In general.
(b)
Contents of programs.
(c)
Limitation.
(d)
Construction.
(a)
Development and dissemination of guidelines.
(b)
Use in occupational standards.
(c)
Development and dissemination of model curriculum for emergency response employees.
(a)
In general.
(b)
Limitation.
(c)
Requirement of matching funds.
(d)
Requirement of application.
(e)
Authorization of appropriations.
Part A—Formula Grants to States
(a)
Allotments for States.
(b)
Purpose of grants.
(a)
In general.
(b)
Opportunity for public comment.
(a)
In general.
(b)
Limitation on administrative expenses.
(a)
Reports.
(b)
Audits.
(c)
Availability to public.
(d)
Evaluations by Comptroller General.
(a)
In general.
(b)
"Significant percentage" defined.
(a)
Minimum allotment.
(b)
Determination of minimum allotment.
(c)
Determination under formula.
(d)
Disposition of certain funds appropriated for allotments.
(a)
Repayment of payments.
(b)
Withholding of payments.
(c)
Opportunity for hearing.
(d)
Prompt response to serious allegations.
(e)
Investigations.
(a)
In general.
(b)
Criminal penalty for violation of prohibition.
(a)
Technical assistance.
(b)
Provision by Secretary of supplies and services in lieu of grant funds.
(a)
Authorization of appropriations.
(b)
Availability to States.
Part B—National Information Programs
(a)
Comprehensive information plan.
(b)
Clearinghouse.
(c)
Toll-free telephone communications.
(a)
In general.
(b)
Requirement of application.
(a)
In general.
(b)
Preferences in making grants.
(a)
In general.
(b)
Allocations.
SUBCHAPTER XXIV—HIV HEALTH CARE SERVICES PROGRAM
Part A—Emergency Relief for Areas With Substantial Need for Services
(a)
Eligible areas.
(b)
Requirement regarding confirmation of cases.
(a)
Administration.
(b)
HIV health services planning council.
(a)
Grants based on relative need of area.
(b)
Supplemental grants.
(a)
Requirements.
(b)
Primary purposes.
(c)
Limited expenditures for personnel needs.
(d)
Requirement of status as medicaid provider.
(e)
Administration and planning.
(f)
Construction.
(a)
In general.
(b)
Additional application.
(c)
Date certain for submission.
(d)
Requirements regarding imposition of charges for services.
Part B—Care Grant Program
(a)
In general.
(b)
Infants and women, etc.
(a)
Consortia.
(b)
Assurances.
(c)
Application.
(d)
"Family centered care" defined.
(e)
Priority.
(a)
Uses.
(b)
Priority.
(c)
"Home- and community-based health services" defined.
(a)
In general.
(b)
Limitations.
(a)
In general.
(b)
Eligible individual.
(c)
State duties.
(a)
In general.
(b)
Description of intended uses and agreements.
(c)
Requirements regarding imposition of charges for services.
(d)
Requirement of matching funds regarding State allotments.
(a)
Special projects of national significance.
(b)
Amount of grant to State.
(c)
Allocation of assistance by States.
(d)
Expedited distribution.
(e)
Reallocation.
Part C—Early Intervention Services
subpart i—formula grants for states
(a)
Allotments for States.
(b)
Purposes of grants.
(a)
In general.
(b)
Waiver regarding certain secondary agreements.
(a)
In general.
(b)
Determination of amount of non-Federal contribution.
(c)
Applicability of matching requirement.
(d)
Diminished State contribution.
(a)
In general.
(b)
Sufficiency of amount of grant.
(c)
Criteria for offering and encouraging.
(a)
In general.
(b)
Rule of construction.
(a)
Reporting.
(b)
Partner notification.
(c)
Rules of construction.
(a)
In general.
(b)
Consent to risk of transmission.
(c)
State certification with respect to required laws.
(d)
Time limitations with respect to required laws.
(a)
In general.
(b)
Requirement of matching funds.
(c)
Testing.
(d)
Determination of prisons subject to requirement.
(e)
Applicability of provisions regarding informed consent, counseling, and other matters.
(f)
Requirement of application.
(g)
Rule of construction.
(g)
Authorization of appropriations.
(a)
Minimum allotment.
(b)
Determination under formula.
(c)
Certain allocations by Secretary.
(d)
Disposition of certain funds appropriated for allotments.
(e)
Transition rules.
subpart ii—categorical grants.
(a)
In general.
(b)
Purposes of grants.
(c)
Participation in certain consortium.
(a)
In general.
(b)
Status as medicaid provider.
(a)
In general.
(b)
Specification of factors.
(c)
Equitable allocations.
(a)
Services for individuals with hemophilia.
(b)
Technical assistance.
subpart iii—general provisions
(a)
Confidentiality.
(b)
Informed consent.
(a)
Counseling before testing.
(b)
Counseling of individuals with negative test results.
(c)
Counseling of individuals with positive test results.
(d)
Additional requirements regarding appropriate counseling.
(e)
Counseling of emergency response employees.
(f)
Rule of construction regarding counseling without testing.
(a)
Reports to Secretary.
(b)
Provision of opportunities for anonymous counseling and testing.
(c)
Prohibition against requiring testing as condition of receiving other health services.
(d)
Maintenance of support.
(e)
Requirements regarding imposition of charges for services.
(f)
Relationship to items and services under other programs.
(g)
Administration of grant.
(h)
Construction.
(a)
In general.
(b)
Limitation.
Part D—General Provisions
(a)
In general.
(b)
Minimum qualifications of grantees.
(c)
Cooperation with biomedical institutions.
(d)
Case management.
(e)
Referrals for additional services.
(f)
Incidental services.
(g)
Application.
(h)
Evaluations.
(i)
"Community health center" defined.
(j)
Authorization of appropriations.
(a)
Informational and training programs.
(b)
Updates.
(c)
Authorization of appropriations.
(a)
Establishment.
(b)
Report.
(c)
Authorization of appropriations.
(a)
Evaluations.
(b)
Report to Congress.
(c)
Authorization of appropriations.
(a)
Requirement.
(b)
Integration by State.
(c)
Integration by local or private entities.
Part E—Emergency Response Employees
subpart i—guidelines and model curriculum
(a)
In general.
(b)
Requirement of application.
(c)
Authorization of appropriations.
subpart ii—notifications of possible exposure to infectious diseases
(a)
In general.
(b)
Specification of airborne infectious diseases.
(c)
Dissemination.
(a)
Routine notification of designated officer.
(b)
Requirement of prompt notification.
(a)
Initiation of process by employee.
(b)
Initial determination by designated officer.
(c)
Submission of request to medical facility.
(d)
Evaluation and response regarding request to medical facility.
(e)
Time for making response.
(f)
Death of victim of emergency.
(g)
Assistance of public health officer.
(a)
Contents of notification to officer.
(b)
Manner of notification.
(a)
In general.
(b)
Certain contents of notification to employee.
(c)
Responses other than notification of exposure.
(a)
In general.
(b)
Preference in making designations.
(a)
Liability of medical facilities and designated officers.
(b)
Testing.
(c)
Confidentiality.
(d)
Failure to provide emergency services.
(a)
In general.
(b)
Facilitation of information on violations.
SUBCHAPTER XXV—MISCELLANEOUS
Chapter Referred to in Other Sections
This chapter is referred to in
SUBCHAPTER I—ADMINISTRATION AND MISCELLANEOUS PROVISIONS
Subchapter Referred to in Other Sections
This subchapter is referred to in title 5 section 5948.
§201. Definitions
When used in this chapter—
(a) The term "Service" means the Public Health Service;
(b) The term "Surgeon General" means the Surgeon General of the Public Health Service;
(c) Unless the context otherwise requires, the term "Secretary" means the Secretary of Health and Human Services.
(d) The term "regulations", except when otherwise specified, means rules and regulations made by the Surgeon General with the approval of the Secretary;
(e) The term "executive department" means any executive department, agency, or independent establishment of the United States or any corporation wholly owned by the United States;
(f) Except as provided in sections 246(g)(4)(B),1 247c(c)(1),1 254d(h)(3),1 263(5), 264(d), 292a(9),1 300a(c), 300f(13), and 300n(1) 1 of this title, the term "State" includes, in addition to the several States, only the District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, American Samoa, and the Trust Territory of the Pacific Islands.
(g) The term "possession" includes, among other possessions, Puerto Rico and the Virgin Islands;
(h) Repealed.
(i) The term "vessel" includes every description of watercraft or other artificial contrivance used, or capable of being used, as a means of transportation on water, exclusive of aircraft and amphibious contrivances;
(j) The term "habit-forming narcotic drug" or "narcotic" means opium and coca leaves and the several alkaloids derived therefrom, the best known of these alkaloids being morphia, heroin, and codeine, obtained from opium, and cocaine derived from the coca plant; all compounds, salts, preparations, or other derivatives obtained either from the raw material or from the various alkaloids; Indian hemp and its various derivatives, compounds, and preparations, and peyote in its various forms; isonipecaine and its derivatives, compounds, salts, and preparations; opiates (as defined in section 4731(g) 1 of title 26);
(k) The term "addict" means any person who habitually uses any habit-forming narcotic drugs so as to endanger the public morals, health, safety, or welfare, or who is or has been so far addicted to the use of such habit-forming narcotic drugs as to have lost the power of self-control with reference to his addiction;
(l) The term "psychiatric disorders" includes diseases of the nervous system which affect mental health;
(m) The term "State mental health authority" means the State health authority, except that, in the case of any State in which there is a single State agency, other than the State health authority, charged with responsibility for administering the mental health program of the State, it means such other State agency;
(n) The term "heart diseases" means diseases of the heart and circulation;
(o) The term "dental diseases and conditions" means diseases and conditions affecting teeth and their supporting structures, and other related diseases of the mouth; and
(p) The term "uniformed service" means the Army, Navy, Air Force, Marine Corps, Coast Guard, Public Health Service, or National Oceanic and Atmospheric Administration.
(q) The term "drug dependent person" means a person who is using a controlled substance (as defined in
(July 1, 1944, ch. 373, title I, §2,
References in Text
Amendments
1993—Subsec. (c).
1981—Subsec. (f).
Subsec. (h).
1979—Subsec. (f).
1977—Subsec. (f).
1976—Subsec. (f).
1974—Subsec. (f).
1970—Subsec. (c).
Subsec. (q).
1960—Subsec. (f).
Subsec. (p).
1959—Subsec. (f).
1948—Subsec. (j). Act Feb. 28, 1948, inserted "isonipecaine and its derivatives, compounds, salts, and preparations; opiates (as defined in
Subsec. (n). Act June 16, 1948, added subsec. (n).
Subsec. (o). Act June 24, 1948, added subsec. (o).
1946—Subsecs. (l), (m). Act July 3, 1946, added subsecs. (l) and (m).
Change of Name
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services Administration, and commissioned officers of Survey transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff. July 13, 1965, 30 F.R. 8819,
Effective Date of 1993 Amendment
Section 2101 of
Effective Date of 1981 Amendment
Amendment by section 902(d)(5) of
Amendment by section 986(a) of
Effective Date of 1979 Amendment
Amendment by
Effective Date of 1970 Amendment
Section 12(b) of
Effective Date of 1960 Amendment
Section 47(f) of
Effective Date of 1959 Amendment
Amendment by
Short Title of 1993 Amendments
Section 1(a) of
Short Title of 1992 Amendments
Short Title of 1991 Amendments
Short Title of 1990 Amendments
Short Title of 1989 Amendment
Short Title of 1988 Amendments
Short Title of 1987 Amendments
Short Title of 1986 Amendments
Short Title of 1985 Amendments
Short Title of 1984 Amendments
Short Title of 1983 Amendments
Short Title of 1981 Amendment
Section 940(a) of
Short Title of 1980 Amendment
Short Title of 1979 Amendments
Section 1(a) of
Short Title of 1978 Amendments
Short Title of 1977 Amendments
Section 101 of title I of
Section 201 of title II of
Section 301 of title III of
Short Title of 1976 Amendments
Section 1(a) of
Section 101 of title I of
Section 201 of title II of
Short Title of 1975 Amendments
Short Title of 1974 Amendments
Short Title of 1973 Amendments
Short Title of 1972 Amendments
Short Title of 1971 Amendments
Short Title of 1970 Amendments
Section 1 of
Short Title of 1968 Amendments
Short Title of 1967 Amendments
Short Title of 1966 Amendments
Short Title of 1965 Amendments
Section 1 of
Short Title of 1964 Amendments
Short Title of 1963 Amendment
Short Title of 1962 Amendments
Section 319 of act July 1, 1944, formerly §310, as added by
Short Title of 1961 Amendment
Short Title of 1960 Amendment
Section 1 of
Short Title of 1956 Amendments
Section 2 of act Aug. 3, 1956, ch. 907,
Act July 3, 1956, ch. 510, §1,
Short Title of 1955 Amendment
Joint Res. July 28, 1955, ch. 417, §1,
Short Title of 1948 Amendments
Section 1 of act June 24, 1948, provided that: "This Act [enacting part C of subchapter III of this chapter and amending this section and
Section 1 of act June 16, 1948, provided that: "This Act [enacting
Short Title of 1946 Amendment
Section 1 of act July 3, 1946, provided: "That this Act [enacting
Short Title
Section 1 of act July 1, 1944, as amended by acts Aug. 13, 1946, ch. 958, §4,
Renumbering and Repeal of Repealing Act
Section 1313, formerly §611, of act July 1, 1944, renumbered §711 by act Aug. 13, 1946, ch. 958, §5,
Savings Provision
Section 1314, formerly §612, of act July 1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, §5,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3, of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Congressional Declaration of Purpose for Comprehensive Alcohol Abuse, Drug Abuse, and Mental Health Amendments Act of 1988
"(1) to prevent the transmission of the etiologic agent for acquired immune deficiency syndrome by ensuring that treatment services for intravenous drug abuse are available to intravenous drug abusers;
"(2) to continue the Federal Government's partnership with the States in the development, maintenance, and improvement of community-based alcohol and drug abuse programs;
"(3) to provide financial and technical assistance to the States and communities in their efforts to develop and maintain a core of prevention services for the purpose of reducing the incidence of substance abuse and the demand for alcohol and drug abuse treatment;
"(4) to assist and encourage States in the initiation and expansion of prevention and treatment services to underserved populations;
"(5) to increase, to the greatest extent possible, the availability and quality of treatment services so that treatment on request may be provided to all individuals desiring to rid themselves of their substance abuse problem; and
"(6) to increase understanding about the extent of alcohol abuse and other forms of drug abuse by expanding data collection activities and supporting research on the comparative cost and efficacy of substance abuse prevention and treatment services."
Purpose of Act July 3, 1946
Section 2 of act July 3, 1946, provided: "The purpose of this Act [see Short Title of 1946 Amendment note above] is the improvement of the mental health of the people of the United States through the conducting of researches, investigations, experiments, and demonstrations relating to the cause, diagnosis, and treatment of psychiatric disorders; assisting and fostering such research activities by public and private agencies, and promoting the coordination of all such researches and activities and the useful application of their results; training personnel in matters relating to mental health; and developing, and assisting States in the use of, the most effective methods of prevention, diagnosis, and treatment of psychiatric disorders."
Existing Positions, Procedures, Regulations, Funds, Appropriations, and Property
Sections 1301 to 1303, formerly §§601 to 603, of act July 1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, §5,
Appropriations for Emergency Health and Sanitation Activities
Section 1304, formerly §604, of act July 1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, §5,
Availability of Appropriations
Federal Accountability
Hazardous Substances
Federal Hazardous Substances Act as not modifying this chapter, see
Definition of "Secretary"
Section Referred to in Other Sections
This section is referred to in title 18 section 3672.
1 See References in Text note below.
Part A—Administration
§202. Administration and supervision of Service
The Public Health Service in the Department of Health and Human Services shall be administered by the Assistant Secretary for Health under the supervision and direction of the Secretary.
(July 1, 1944, ch. 373, title II, §201,
Amendments
1993—
Transfer of Functions
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
International Health Administration
Ex. Ord. No. 10399, Sept. 27, 1952, 17 F.R. 8648, designated Surgeon General to perform certain duties under International Sanitary Regulations of World Health Organization.
REORGANIZATION PLAN NO. 3 OF 1966
Eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610
Prepared by the President and transmitted to the Senate and the House of Representatives in Congress assembled, April 25, 1966, pursuant to the provisions of the Reorganization Act of 1949,
PUBLIC HEALTH SERVICE
Section 1. Transfer of Functions
(a) Except as otherwise provided in subsection (b) of this section, there are hereby transferred to the Secretary of Health, Education, and Welfare (hereinafter referred to as the Secretary) all functions of the Public Health Service, of the Surgeon General of the Public Health Service, and of all other officers and employees of the Public Health Service, and all functions of all agencies of or in the Public Health Service.
(b) This section shall not apply to the functions vested by law in any advisory council, board, or committee of or in the Public Health Service which is established by law or is required by law to be established.
Sec. 2. Performance of Transferred Functions
The Secretary may from time to time make such provisions as he shall deem appropriate authorizing the performance of any of the functions transferred to him by the provisions of this reorganization plan by any officer, employee, or agency of the Public Health Service or of the Department of Health, Education, and Welfare.
Sec. 3. Abolitions
(a) The following agencies of the Public Health Service are hereby abolished:
(1) The Bureau of Medical Services, including the office of Chief of the Bureau of Medical Services.
(2) The Bureau of State Services, including the office of Chief of the Bureau of State Services.
(3) The agency designated as the National Institutes of Health (
(4) The agency designated as the Office of the Surgeon General (
(b) The Secretary shall make such provisions as he shall deem necessary respecting the winding up of any outstanding affairs of the agencies abolished by the provisions of this section.
Sec. 4. Incidental Transfers
As he may deem necessary in order to carry out the provisions of this reorganization plan, the Secretary may from time to time effect transfers within the Department of Health, Education, and Welfare of any of the records, property, personnel and unexpended balances (available or to be made available) of appropriations, allocations, and other funds of the Department which relate to functions affected by this reorganization plan.
[The Secretary and Department of Health, Education, and Welfare were redesignated the Secretary and Department of Health and Human Services, respectively, by
Message of the President
To the Congress of the United States:
I transmit herewith Reorganization Plan No. 3 of 1966, prepared in accordance with the Reorganization Act of 1949, as amended, and providing for reorganization of health functions of the Department of Health, Education, and Welfare.
I
Today we face new challenges and unparalleled opportunities in the field of health. Building on the progress of the past several years, we have truly begun to match the achievements of our medicine to the needs of our people.
The task ahead is immense. As a nation, we will unceasingly pursue our research and learning, our training and building, our testing and treatment. But now our concern must also turn to the organization of our Federal health programs.
As citizens we are entitled to the very best health services our resources can provide.
As taxpayers, we demand the most efficient and economic health organizations that can be devised.
I ask the Congress to approve a reorganization plan to bring new strength to the administration of Federal health programs.
I propose a series of changes in the organization of the Public Health Service that will bring to all Americans a structure modern in design, more efficient in operation and better prepared to meet the great and growing needs of the future. Through such improvements we can achieve the full promise of the landmark health legislation enacted by the 89th Congress.
I do not propose these changes lightly. They follow a period of careful deliberation. For many months the Secretary of Health, Education, and Welfare, and the Surgeon General have consulted leading experts in the Nation—physicians, administrators, scientists, and public health specialists. They have confirmed my belief that modernization and reorganization of the Public Health Service are urgently required and long overdue.
II
The Public Health Service is an operating agency of the Department of Health, Education, and Welfare. It is the principal arm of the Federal Government in the field of health. Its programs are among those most vital to our well-being.
Since 1953 more than 50 new programs have been placed in the Public Health Service. Its budget over the past 12 years has increased tenfold—from $250 million to $2.4 billion.
Today the organization of the Public Health Service is clearly obsolete. The requirement that new and expanding programs be administered through an organizational structure established by law more than two decades ago stands as a major obstacle to the fulfillment of our Nation's health goals.
As presently constituted, the Public Health Service is composed of four major components:
National Institutes of Health.
Bureau of State Services.
Bureau of Medical Services.
Office of the Surgeon General.
Under present law, Public Health Service functions must be assigned only to these four components.
This structure was designed to provide separate administrative arrangements for health research, programs of State and local aid, health services, and executive staff resources. At a time when these functions could be neatly compartmentalized, the structure was adequate. But today the situation is different.
Under recent legislation many new programs provide for an integrated attack on specific disease problems or health hazards in the environment by combining health services, State and local aid, and research. Each new program of this type necessarily is assigned to one of the three operating components of the Public Health Service. Yet none of these components is intended to administer programs involving such a variety of approaches.
Our health problems are difficult enough without having them complicated by outmoded organizational arrangements.
But if we merely take the step of integrating the four agencies within the Public Health Service we will not go far enough. More is required.
III
The Department of Health, Education, and Welfare performs major health or health-related functions which are not carried out through the Public Health Service, although they are closely related to its functions. Among these are:
Health insurance for the aged, administered through the Social Security Administration;
Medical assistance for the needy, administered through the Welfare Administration;
Regulation of the manufacture, labeling, and distribution of drugs, carried out through the Food and Drug Administration; and
Grants-in-aid to States for vocational rehabilitation of the handicapped, administered by the Vocational Rehabilitation Administration.
Expenditures for health and health-related programs of the Department administered outside the Public Health Service have increased from $44 million in 1953 to an estimated $5.4 billion in 1967.
As the head of the Department, the Secretary of Health, Education, and Welfare is responsible for the Administration and coordination of all the Department's health functions. He has clear authority over the programs I have just mentioned.
But today he lacks this essential authority over the Public Health Service. The functions of that agency are vested in the Surgeon General and not in the Secretary.
This diffusion of responsibility is unsound and unwise.
To secure the highest possible level of health services for the American people the Secretary of Health, Education, and Welfare must be given the authority to establish—and modify as necessary—the organizational structure for Public Health Service programs.
He must also have the authority to coordinate health functions throughout the Department. The reorganization plan I propose will accomplish these purposes. It will provide the Secretary with the flexibility to create new and responsive organizational arrangements to keep pace with the changing and dynamic nature of our health programs.
My views in this respect follow a basic principle of good government set by the Hoover Commission in 1949 when it recommended that "the Department head should be given authority to determine the organization within his Department."
IV
In summary, the reorganization plan would:
Transfer to the Secretary of Health, Education, and Welfare the functions now vested in the Surgeon General of the Public Health Service and in its various subordinate units (this transfer will not affect certain statutory advisory bodies such as the National Advisory Cancer and Heart Councils);
Abolish the four principal statutory components of the Public Health Service, including the offices held by their heads (the Bureau of Medical Services, the Bureau of State Services, the National Institutes of Health exclusive of its several research institutes such as the National Cancer and Heart Institutes, and the Office of the Surgeon General); and
Authorize the Secretary to assign the functions transferred to him by the plan to officials and entities of the Public Health Service and to other agencies of the Department as he deems appropriate.
Thus, the Secretary would be—
Enabled to assure that all health functions of the Department are carried out as effectively and economically as possible;
Given authority commensurate with his responsibility; and
Made responsible in fact for matters for which he is now, in any case, held accountable by the President, the Congress, and the people.
V
I have found, after investigation, that each reorganization included in the accompanying reorganization plan is necessary to accomplish one or more of the purposes set forth in section 2(a) of the Reorganization Act of 1949, as amended.
Should the reorganizations in the accompanying reorganization plan take effect, they will make possible more effective and efficient administration of the affected health programs. It is, however, not practicable at this time to itemize the reductions in expenditures which may result.
I strongly recommend that the Congress allow the reorganization plan to become effective.
Lyndon B. Johnson.
Executive Order No. 10506
Ex. Ord. No. 10506, Dec. 10, 1953, 18 F.R. 8219, which delegated certain functions of the President relating to the Public Health Service, was superseded by Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, set out below.
Ex. Ord. No. 11140. Delegation of Functions
Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended by Ex. Ord. No. 12608, Sept. 9, 1987, 52 F.R. 34617, provided:
By virtue of the authority vested in me by
(a) The authority under Section 203 (
(b) The authority under Section 206(b) (
(c) The authority under Section 207(a)(2) (
(d) The authority under Section 210(a), (k), and (l) (
(e) The authority under Section 211(a)(5) (
(f) The authority to prescribe regulations under the following-designated Sections: 207(a), 207(b), 208(e), 210(a), 210(b), 210(d)(1), 210(h), 210(i), 210(j)(1), 210(k), 215(a), 218(a), 219(a), and 510 (
(g) The authority under Sections 321(a) and 364(a) (
(b) Executive Orders Nos. 9993 of August 31, 1948, 10031 of January 26, 1949, 10280 of August 16, 1951, 10354 of May 26, 1952, and 10497 of October 27, 1953, which prescribed regulations relating to commissioned officers and employees of the Public Health Service, are hereby revoked. Nothing in this subsection shall be deemed to alter or otherwise affect the regulations prescribed by the Surgeon General (42 CFR Parts 21 and 22) to replace the regulations prescribed by the orders described in the preceding sentence.
§203. Organization of Service
The Service shall consist of (1) the Office of the Surgeon General, (2) the National Institutes of Health, (3) the Bureau of Medical Services, and 1 (4) the Bureau of State Services, and 2 the Agency for Health Care Policy and Research. The Secretary is authorized and directed to assign to the Office of the Surgeon General,3 to the National Institutes of Health, to the Bureau of Medical Services, and to the Bureau of State Services, respectively, the several functions of the Service, and to establish within them such divisions, sections, and other units as he may find necessary; and from time to time abolish, transfer, and consolidate divisions, sections, and other units and assign their functions and personnel in such manner as he may find necessary for efficient operation of the Service. No division shall be established, abolished, or transferred, and no divisions shall be consolidated, except with the approval of the Secretary. The National Institutes of Health shall be administered as a part of the field service. The Secretary may delegate to any officer or employee of the Service such of his powers and duties under this chapter, except the making of regulations, as he may deem necessary or expedient.
(July 1, 1944, ch. 373, title II, §202,
Amendments
1993—
1948—Act June 16, 1948, substituted "National Institutes of Health" for "National Institute of Health" in cl. (2).
Transfer of Functions
Bureau of Medical Services, Bureau of State Services, National Institutes of Health, excluding several research Institutes in agency, and Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare, and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Section Referred to in Other Sections
This section is referred to in
1 So in original. The "and" probably should not appear.
2 So in original. Probably should be followed by "(5)".
3 See 1993 Amendment note below.
§204. Commissioned corps; composition; appointment of Regular and Reserve officers; appointment and status of warrant officers
There shall be in the Service a commissioned Regular Corps and, for the purpose of securing a reserve for duty in the Service in time of national emergency, a Reserve Corps. All commissioned officers shall be citizens and shall be appointed without regard to the civil-service laws and compensated without regard to
(July 1, 1944, ch. 373, title II, §203,
References in Text
The civil-service laws, referred to in text, are set forth in Title 5, Government Organization and Employees. See, particularly,
Codification
"
Amendments
1979—
1949—Act Oct. 28, 1949, substituted "Classification Act of 1949" for "Classification Act of 1923".
1948—Act Feb. 28, 1948, struck out provision that all active service in Reserve Corps, as well as service in Regular Corps, shall be credited for purpose of promotion in Regular Corps.
Repeals
Act Oct. 28, 1949, cited as a credit to this section, was repealed (subject to a savings clause) by
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services and Surgeon General, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Osteopaths as Reserve Officers
Section 709 of act July 1, 1944, formerly §609, renumbered §709 by act Aug. 13, 1946, ch. 958, §5,
Cross References
Pay and allowances of commissioned officers, see
§205. Appointment and tenure of office of Surgeon General; reversion in rank
The Surgeon General shall be appointed from the Regular Corps for a four-year term by the President by and with the advice and consent of the Senate. The Surgeon General shall be appointed from individuals who (1) are members of the Regular Corps, and (2) have specialized training or significant experience in public health programs. Upon the expiration of such term the Surgeon General, unless reappointed, shall revert to the grade and number in the Regular or Reserve Corps that he would have occupied had he not served as Surgeon General.
(July 1, 1944, ch. 373, title II, §204,
Amendments
1981—
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Section Referred to in Other Sections
This section is referred to in
§206. Assignment of officers
(a) Deputy Surgeon General
The Surgeon General shall assign one commissioned officer from the Regular Corps to administer the Office of the Surgeon General, to act as Surgeon General during the absence or disability of the Surgeon General or in the event of a vacancy in that office, and to perform such other duties as the Surgeon General may prescribe, and while so assigned he shall have the title of Deputy Surgeon General.
(b) Assistant Surgeons General
The Surgeon General shall assign eight commissioned officers from the Regular Corps to be, respectively, the Director of the National Institutes of Health, the Chief of the Bureau of State Services, the Chief of the Bureau of Medical Services, the Chief Medical Officer of the United States Coast Guard, the Chief Dental Officer of the Service, the Chief Nurse Officer of the Service, the Chief Pharmacist Officer of the Service, and the Chief Sanitary Engineering Officer of the Service, and while so serving they shall each have the title of Assistant Surgeon General.
(c) Creation of temporary positions as Assistant Surgeons General
(1) The Surgeon General, with the approval of the Secretary, is authorized to create special temporary positions in the grade of Assistant Surgeons General when necessary for the proper staffing of the Service. The Surgeon General may assign officers of either the Regular Corps or the Reserve Corps to any such temporary position, and while so serving they shall each have the title of Assistant Surgeon General.
(2) Except as provided in this paragraph, the number of special temporary positions created by the Surgeon General under paragraph (1) shall not on any day exceed 1 per centum of the highest number, during the ninety days preceding such day, of officers of the Regular Corps on active duty and officers of the Reserve Corps on active duty for more than thirty days. If on any day the number of such special temporary positions exceeds such 1 per centum limitation, for a period of not more than one year after such day, the number of such special temporary positions shall be reduced for purposes of complying with such 1 per centum limitation only by the resignation, retirement, death, or transfer to a position of a lower grade, of any officer holding any such temporary position.
(d) Designation of Assistant Surgeon General with respect to absence, disability, or vacancy in offices of Surgeon General and Deputy Surgeon General
The Surgeon General shall designate the Assistant Surgeon General who shall serve as Surgeon General in case of absence or disability, or vacancy in the offices, of both the Surgeon General and the Deputy Surgeon General.
(July 1, 1944, ch. 373, title II, §205,
Amendments
1979—Subsec. (b).
Subsec. (c).
1948—Subsec. (b). Act June 16, 1948, substituted "National Institutes of Health" for "National Institute of Health".
Subsecs. (c), (d). Act Feb. 28, 1948, added subsec. (c) and redesignated former subsec. (c) as (d).
Effective Date of 1979 Amendment
Section 314 of
Transfer of Functions
Office of Surgeon General, together with office held by Deputy Surgeon General, Bureau of Medical Services, including office of Chief of Bureau of Medical Services, Bureau of State Services, including office of Chief of Bureau of State Services, and National Institutes of Health, including office of Director of National Institutes of Health, abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare, by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§207. Grades, ranks, and titles of commissioned corps
(a) Grades of commissioned officers
The Surgeon General, during the period of his appointment as such, shall be of the same grade as the Surgeon General of the Army; the Deputy Surgeon General and the Chief Medical Officer of the United States Coast Guard, while assigned as such, shall have the grade corresponding with the grade of major general; and the Chief Dental Officer, while assigned as such, shall have the grade as is prescribed by law for the officer of the Dental Corps selected and appointed as Assistant Surgeon General of the Army. During the period of appointment to the position of Assistant Secretary for Health, a commissioned officer of the Public Health Service shall have the grade corresponding to the grade of General of the Army. Assistant Surgeons General, while assigned as such, shall have the grade corresponding with either the grade of brigadier general or the grade of major general, as may be determined by the Secretary after considering the importance of the duties to be performed: Provided, That the number of Assistant Surgeons General having a grade higher than that corresponding to the grade of brigadier general shall at no time exceed one-half of the number of positions created by subsection (b) of
(1) Officers of the director grade—colonel;
(2) Officers of the senior grade—lieutenant colonel;
(3) Officers of the full grade—major;
(4) Officers of the senior assistant grade—captain;
(5) Officers of the assistant grade—first lieutenant;
(6) Officers of the junior assistant grade—second lieutenant;
(7) Chief warrant officers of (W–4) grade—chief warrant officer (W–4);
(8) Chief warrant officers of (W–3) grade—chief warrant officer (W–3);
(9) Chief warrant officers of (W–2) grade—chief warrant officer (W–2); and
(10) Warrant officers of (W–1) grade—warrant officer (W–1).
(b) Titles of medical officers
The titles of medical officers of the foregoing grades shall be respectively (1) medical director, (2) senior surgeon, (3) surgeon, (4) senior assistant surgeon, (5) assistant surgeon, and (6) junior assistant surgeon. The President is authorized to prescribe titles, appropriate to the several grades, for commissioned officers of the Service other than medical officers. All titles of the officers of the Reserve Corps shall have the suffix "Reserve."
(c) Repealed. Pub. L. 96–76, title III, §304(b), Sept. 29, 1979, 93 Stat. 584
(d) Maximum number in grade for each fiscal year
Within the total number of officers of the Regular Corps authorized by the appropriation Act or Acts for each fiscal year to be on active duty, the Secretary shall by regulation prescribe the maximum number of officers authorized to be in each of the grades from the warrant officer (W–1) grade to the director grade, inclusive. Such numbers shall be determined after considering the anticipated needs of the Service during the fiscal year, the funds available, the number of officers in each grade at the beginning of the fiscal year, and the anticipated appointments, the anticipated promotions based on years of service, and the anticipated retirements during the fiscal year. The number so determined for any grade for a fiscal year may not exceed the number limitation (if any) contained in the appropriation Act or Acts for such year. Such regulations for each fiscal year shall be prescribed as promptly as possible after the appropriation Act fixing the authorized strength of the corps for that year, and shall be subject to amendment only if such authorized strength or such number limitation is thereafter changed. The maxima established by such regulations shall not require (apart from action pursuant to other provisions of this chapter) any officer to be separated from the Service or reduced in grade.
(e) Exception to grade limitations for officers assigned to Department of Defense
In computing the maximum number of commissioned officers of the Public Health Service authorized by law to hold a grade which corresponds to the grade of brigadier general or major general, there may be excluded from such computation not more than three officers who hold such a grade so long as such officers are assigned to duty and are serving in a policymaking position in the Department of Defense.
(July 1, 1944, ch. 373, title II, §206,
Amendments
1990—Subsec. (a).
1989—Subsec. (e).
1985—Subsec. (e).
1979—Subsec. (a).
Subsec. (c).
Subsec. (d).
1977—Subsec. (b)(6).
1962—Subsec. (a).
1952—Subsec. (a). Act July 17, 1952, provided that the Chief Medical Officer of the Coast Guard should have the grade, pay, and allowances of a major general.
1951—Subsec. (a). Act Oct. 31, 1951, provided equality of grade, pay, and allowances between the Chief Dental Officer and the comparable officer in the Army.
1948—Subsec. (a). Act Feb. 28, 1948, increased grade of Deputy Surgeon General from brigadier general to major general and increased grade of certain Assistant Surgeons General from brigadier general to major general as the Federal Security Administrator might determine.
Subsecs. (c), (d). Act Feb. 28, 1948, added subsecs. (c) and (d).
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1979 Amendment
Amendment by
Effective Date of 1962 Amendment
Amendment by
Transfer of Functions
Office of Surgeon General, together with office held by Deputy Surgeon General, abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§208. Repealed. Feb. 28, 1948, ch. 83, §5(a), 62 Stat. 40
Section, act July 1, 1944, ch. 373, title II, §207,
§209. Appointment of personnel
(a) Original appointments to Regular and Reserve Corps; limitation on appointment and call to active duty
(1) Except as provided in subsections (b) and (e) of this section, original appointments to the Regular Corps may be made only in the warrant officer (W–1), chief warrant officer (W–2), chief warrant officer (W–3), chief warrant officer (W–4), junior assistant, assistant, and senior assistant grades and original appointments to a grade above junior assistant shall be made only after passage of an examination, given in accordance with regulations of the President, in one or more of the several branches of medicine, dentistry, hygiene, sanitary engineering, pharmacy, psychology, nursing, or related scientific specialties in the field of public health.
(2) Original appointments to the Reserve Corps may be made to any grade up to and including the director grade but only after passage of an examination given in accordance with regulations of the President. Reserve commissions shall be for an indefinite period and may be terminated at any time, as the President may direct.
(3) No individual who has attained the age of forty-four shall be appointed to the Regular Corps, or called to active duty in the Reserve Corps for a period in excess of one year, unless (A) he has had a number of years of active service (as defined in
(b) Grade and number of original appointments
(1) Not more than 10 per centum of the original appointments to the Regular Corps authorized to be made during any fiscal year may be made to grades above that of senior assistant, but no such appointment (other than an appointment under
(2) In addition to the number of original appointments to the Regular Corps authorized by paragraph (1) to be made to grades above that of senior assistant, original appointments authorized to be made to the Regular Corps in any year may be made to grades above that of senior assistant, but not above that of director, in the case of any individual who—
(A)(i) was on active duty in the Reserve Corps on July 1, 1960, (ii) was on such active duty continuously for not less than one year immediately prior to such date, and (iii) applies for appointment to the Regular Corps prior to July 1, 1962; or
(B) does not come within clause (A)(i) and (ii) but was on active duty in the Reserve Corps continuously for not less than one year immediately prior to his appointment to the Regular Corps and has not served on active duty continuously for a period, occurring after June 30, 1960, of more than three and one-half years prior to applying for such appointment.
(3) No person shall be appointed pursuant to this subsection unless he meets standards established in accordance with regulations of the President.
(c) Issuance of commissions
Commissions evidencing the appointment by the President of officers of the Regular or Reserve Corps shall be issued by the Secretary under the seal of the Department of Health and Human Services.
(d) Date of appointment; credit for service
(1) For purposes of basic pay and for purposes of promotion, any person appointed under subsection (a) of this section to the grade of senior assistant in the Regular Corps, and any person appointed under subsection (b) of this section, shall, except as provided in paragraphs (2) and (3) of this subsection, be considered as having had on the date of appointment the following length of service: Three years if appointed to the senior assistant grade, ten years if appointed to the full grade, seventeen years if appointed to the senior grade, and eighteen years if appointed to the director grade.
(2) For purposes of basic pay, any person appointed under subsection (a) of this section to the grade of senior assistant in the Regular Corps, and any person appointed under subsection (b) of this section, shall, in lieu of the credit provided in paragraph (1) of this subsection, be credited with the service for which he is entitled to credit under any other provision of law if such service exceeds that to which he would be entitled under such paragraph.
(3) For purposes of promotion, any person originally appointed in the Regular Corps to the senior assistant grade or above who has had active service in the Reserve Corps shall be considered as having had on the date of appointment the length of service provided for in paragraph (1) of this subsection, plus whichever of the following is greater: (A) The excess of his total active service in the Reserve Corps (above the grade of junior assistant) over the length of service provided in such paragraph, to the extent that such excess is on account of service in the Reserve Corps in or above the grade to which he is appointed in the Regular Corps or (B) his active service in the same or any higher grade in the Reserve Corps after the first day on which, under regulations in effect on the date of his appointment to the Regular Corps, he would have had the training and experience necessary for such appointment.
(4) For purposes of promotion, any person whose original appointment is to the assistant grade in the Regular Corps shall be considered as having had on the date of appointment service equal to his total active service in the Reserve Corps in and above the assistant grade.
(e) Reappointment; credit for service
(1) A former officer of the Regular Corps may, if application for appointment is made within two years after the date of the termination of his prior commission in the Regular Corps, be reappointed to the Regular Corps without examination, except as the Surgeon General may otherwise prescribe, and without regard to the numerical limitations of subsection (b) of this section.
(2) Reappointments pursuant to this subsection may be made to the permanent grade held by the former officer at the time of the termination of his prior commission, or to the next higher grade if such officer meets the eligibility requirements prescribed by regulation for original appointment to such higher grade. For purposes of pay, promotion, and seniority in grade, such reappointed officer shall receive the credits for service to which he would be entitled if such appointment were an original appointment, but in no event less than the credits he held at the time his prior commission was terminated, except that if such officer is reappointed to the next higher grade he shall receive no credit for seniority in grade.
(3) No former officer shall be reappointed pursuant to this subsection unless he shall meet such standards as the Secretary may prescribe.
(f) Special consultants
In accordance with regulations, special consultants may be employed to assist and advise in the operations of the Service. Such consultants may be appointed without regard to the civil-service laws.
(g) Designation for fellowships; duties; pay
In accordance with regulations, individual scientists, other than commissioned officers of the Service, may be designated by the Surgeon General to receive fellowships, appointed for duty with the Service without regard to the civil-service laws, may hold their fellowships under conditions prescribed therein, and may be assigned for studies or investigations either in this country or abroad during the terms of their fellowships.
(h) Aliens
Persons who are not citizens may be employed as consultants pursuant to subsection (f) of this section and may be appointed to fellowships pursuant to subsection (g) of this section. Unless otherwise specifically provided, any prohibition in any other Act against the employment of aliens, or against the payment of compensation to them, shall not be applicable in the case of persons employed or appointed pursuant to such subsections.
(i) Civil service appointments by Secretary
The appointment of any officer or employee of the Service made in accordance with the civil-service laws shall be made by the Secretary, and may be made effective as of the date on which such officer or employee enters upon duty.
(July 1, 1944, ch. 373, title II, §207, formerly §208,
References in Text
The civil-service laws, referred to in subsecs. (f), (g), and (i), are set out in Title 5, Government Organization and Employees. See, particularly,
Codification
In subsec. (f), the words "and their compensation may be fixed without regard to the Classification Act of 1923, as amended", and in subsec. (g), the words "and compensated without regard to the Classification Act of 1923, as amended" were omitted as obsolete. Sections 1202 and 1204 of the Classification Act of 1949,
In subsec. (h), the references to subsections (f) and (g) of this section were, in the original, references to subsections (e) and (f) and were changed to reflect the probable intent of Congress.
Prior Provisions
A prior section 207 of act July 1, 1944, was classified to
Amendments
1983—Subsec. (a)(1).
1981—Subsec. (b)(1).
1979—Subsec. (a)(1).
1960—Subsec. (a)(3).
Subsec. (b).
1956—Subsec. (a)(1). Act Apr. 27, 1956, §3(a), inserted reference to subsection (e) of this section.
Subsec. (a)(2). Act Apr. 27, 1956, §3(c)(1), substituted "an indefinite period" for "a period of not more than five years".
Subsecs. (e) to (i). Act Apr. 27, 1956, §3(b), added subsec. (e) and redesignated former subsecs. (e) to (h) as (f) to (i), respectively.
1949—Subsec. (d). Act Oct. 12, 1949, substituted "base pay" for "pay and pay period" wherever appearing.
1948—Subsec. (a)(1). Act Feb. 28, 1948, struck out "surgery" after "several branches of medicine".
Subsec. (a)(2). Act Feb. 28, 1948, struck out "any such commission" before "may be terminated", and "in his discretion" after "at any time".
Subsec. (b). Act Feb. 28, 1948, provided for grade and number of original appointments.
Subsecs. (c) to (f). Act Feb. 28, 1948, added subsecs. (c) and (d) and redesignated former subsecs. (c) and (d) as (e) and (f), respectively. Former subsecs. (e) and (f) redesignated (g) and (h).
Subsec. (g). Act Feb. 28, 1948, redesignated former subsec. (e) as (g) and changed reference in text from "subsection (c) of this section" to "subsection (e) of this section", and "subsection (d) of this section" to "subsection (g) of this section".
Subsec. (h). Act Feb. 28, 1948, redesignated former subsec. (f) as (h).
1946—Subsec. (b). Act July 3, 1946, authorized appointment of additional officers to grades above that of senior assistant but not above that of director, and limits the number so appointed to 20.
Subsec. (b)(2). Act Aug. 13, 1946, inserted "(A)" before "to assist", substituted "clause" for "paragraphs", and inserted cl. (B).
Effective Date of 1979 Amendment
Amendment by
Effective Date of 1960 Amendment
Section 8(a) of
Effective Date of 1949 Amendment
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949, see section 533(a) of act Oct. 12, 1949.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services and Surgeon General, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Term of Reserve Commissions in Effect on April 27, 1956
Section 3(c)(2) of act Apr. 27, 1956, provided that: "The enactment of paragraph (1) of this subsection [amending subsec. (a)(2) of this section] shall not affect the term of the commission of any officer in the Reserve Corps in effect on the date of such enactment [Apr. 27, 1956] unless such officer consents in writing to the extension of his commission for an indefinite period, in which event his commission shall be so extended without the necessity of a new appointment."
Section Referred to in Other Sections
This section is referred to in
§§209a, 209b. Omitted
Codification
Section 209a, act Dec. 22, 1944, ch. 660, title I,
Section 209b, act Dec. 22, 1944, ch. 660, title I,
§209c. Repealed. Pub. L. 87–649, §14b, Sept. 7, 1962, 76 Stat. 499
Section, act July 3, 1945, ch. 263, title II,
§209d. Appointment of osteopaths as commissioned officers
Graduates of colleges of osteopathy whose graduates are eligible for licensure to practice medicine or osteopathy in a majority of the States of the United States, or approved by a body or bodies acceptable to the Secretary, shall be eligible, subject to the other provisions of this Act, for appointment as commissioned medical officers in the Public Health Service.
(Feb. 28, 1948, ch. 83, §5(b),
References in Text
This Act, referred to in text, is act Feb. 28, 1948, ch. 83,
Codification
Section was not enacted as a part of the Public Health Service Act which comprises this chapter.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§210. Pay and allowances
(a) Commissioned officers of Regular and Reserve Corps; special pay for active duty; incentive special pay for Public Health Service nurses
(1) Commissioned officers of the Regular and Reserve Corps shall be entitled to receive such pay and allowances as are now or may hereafter be authorized by law.
(2)(A) Except as provided in subparagraph (B), commissioned medical and dental officers in the Regular and Reserve Corps shall while on active duty be paid special pay in the same amounts as, and under the same terms and conditions which apply to, the special pay now or hereafter paid to commissioned medical and dental officers of the Armed Forces under
(B) A commissioned medical officer in the Regular or Reserve Corps (other than an officer serving in the Indian Health Service) may not receive additional special pay under
(3) Commissioned nurse officers in the Regular and Reserve Corps shall, while in active duty, be paid incentive special pay in the same amounts as, and under the same terms and conditions which apply to, the incentive special pay now or hereafter paid to commissioned nurse officers of the Armed Forces under
(b) Purchase of supplies
Commissioned officers on active duty and retired officers entitled to retired pay pursuant to
(c) Members of national advisory or review councils or committees
Members of the National Advisory Health Council and members of other national advisory or review councils or committees established under this chapter, including members of the Technical Electronic Product Radiation Safety Standards Committee and the Board of Regents of the National Library of Medicine, but excluding ex officio members, while attending conferences or meetings of their respective councils or committees or while otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, but at rates not exceeding the daily equivalent of the rate specified at the time of such service for grade GS–18 of the General Schedule, including traveltime; and while away from their homes or regular places of business they may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by
(d) Field employees
Field employees of the Service, except those employed on a per diem or fee basis, who render part-time duty and are also subject to call at any time for services not contemplated in their regular part-time employment, may be paid annual compensation for such part-time duty and, in addition, such fees for such other services as the Surgeon General may determine; but in no case shall the total paid to any such employee for any fiscal year exceed the amount of the minimum annual salary rate of the classification grade of the employee.
(e) Additional pay for service at Gillis W. Long Hansen's Disease Center
Any civilian employee of the Service who is employed at the Gillis W. Long Hansen's Disease Center on April 7, 1986, shall be entitled to receive, in addition to any compensation to which the employee may otherwise be entitled and for so long as the employee remains employed at the Center, an amount equal to one-fourth of such compensation.
(f) Allowances included in fellowships
Individuals appointed under
(g) Positions in professional, scientific and executive service; compensation; appointment
The Secretary is authorized to establish and fix the compensation for, within the Public Health Service, not more than one hundred and seventy-nine positions, of which not less than one hundred and fifteen shall be for the National Institutes of Health, not less than five shall be for the National Institute on Alcohol Abuse and Alcoholism for individuals engaged in research on alcohol abuse and alcoholism, not less than ten shall be for the National Center for Health Services Research, not less than twelve shall be for the National Center for Health Statistics, and not less than seven shall be for the National Center for Health Care Technology, in the professional, scientific, and executive service, each position being established to effectuate those research and development activities of the Public Health Service which require the services of specially qualified scientific, professional and administrative personnel: Provided, That the rates of compensation for positions established pursuant to the provisions of this subsection shall not be less than the minimum rate of grade 16 of the General Schedule nor more than (1) the highest rate of grade 18 of the General Schedule, or (2) in the case of two such positions, the rate specified, at the time the service in the position is performed, for level II of the Executive Schedule (
(July 1, 1944, ch. 373, title II, §208, formerly §209,
References in Text
Classified civil service, referred to in subsec. (g), as meaning "competitive service", see
Prior Provisions
A prior section 208 of act July 1, 1944, was renumbered section 207 and is classified to
Amendments
1988—Subsec. (a)(3).
1986—Subsec. (a)(2)(B).
Subsec. (e).
1985—Subsec. (a)(2).
1980—Subsec. (a).
1979—Subsec. (c).
1978—Subsec. (g).
1977—Subsec. (g).
1971—Subsec. (f).
1970—Subsec. (c).
1968—Subsec. (g).
1962—Subsec. (b).
Subsec. (g).
1960—Subsec. (b).
Subsec. (g).
1958—Subsec. (g).
1956—Subsec. (g). Act June 29, 1956, substituted "$20,000" for "$15,000".
1955—Subsec. (g). Act Aug. 1, 1955, increased from thirty to sixty the number of positions which the Administrator may establish in the professional and scientific service.
1950—Subsec. (b). Act Aug. 9, 1950, struck out "and may be granted leaves of absence without any deduction from their pay" after "allotments from their pay" in first sentence.
Subsec. (c). Act Aug. 15, 1950, §3(e), made provisions applicable to members of all national advisory councils.
Subsec. (g). Act Aug. 15, 1950, §4(b), added subsec. (g).
1949—Subsec. (a). Act Oct. 12, 1949, made section applicable to Reserve officers.
Subsec. (b). Act Oct. 12, 1949, redesignated subsec. (c) as (b) and repealed former subsec. (b) relating to Reserve officers.
Subsec. (c). Act Oct. 12, 1949, redesignated subsec. (e) as (c). Former subsec. (c) redesignated (b).
Subsec. (d). Act Oct. 12, 1949, redesignated subsec. (f) as (d) and repealed former subsec. (d) relating to female commissioned officers and defining "dependent".
Subsec. (e). Act Oct. 12, 1949, redesignated subsec. (g) as (e) and struck out references to allowances. Former subsec. (e) redesignated (c).
Subsec. (f). Act Oct. 12, 1949, redesignated subsec. (h) as (f). Former subsec. (f) redesignated (d).
Subsecs. (g), (h). Act Oct. 12, 1949, redesignated subsecs. (g) and (h) as (e) and (f), respectively.
1948—Subsec. (b). Act Feb. 28, 1948, inserted "except as otherwise provided by law".
Subsec. (e). Acts June 16, 1948, §4(d), and June 24, 1948, §4(d), made section applicable to the National Advisory Heart Council and increased the per diem of all members from $25 to $50, and made section applicable to the National Advisory Dental Research Council, respectively.
Subsec. (h). Act Feb. 28, 1948, substituted "
1946—Subsec. (e). Act July 3, 1946, inserted "members of the National Advisory Mental Health Council".
Effective Date of 1986 Amendment
Section 17002(a)(2) of
Effective Date of 1985 Amendment
Section 3(b) of
Effective Date of 1962 Amendments
Amendment by
Amendment by
Effective Date of 1960 Amendment
Amendment by
Effective Date of 1958 Amendments
Amendment by
Amendment by
Effective Date of 1956 Amendment
Amendment by act July 31, 1956, effective at beginning of first pay period commencing after June 30, 1956, see section 120 of act July 31, 1956.
Effective Date of 1950 Amendment
Section 3(a) of act Aug. 9, 1950, provided that: "Sections 1 and 2 of this Act [amending this section and enacting
Effective Date of 1949 Amendment
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949, see section 533(a) of act Oct. 12, 1949.
Repeals
Act July 31, 1956, ch. 804, title I, §117(b),
Transfer of Functions
"Director of the Office of Personnel Management" substituted for "Civil Service Commission" in subsec. (g) pursuant to Reorg. Plan No. 2 of 1978, §102, 43 F.R. 36037,
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, eff. Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Termination of Advisory Committees
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Maximum Pay and Allowances for Specific Fiscal Years
Similar provisions were contained in the following prior appropriation acts:
Nurses and Allied Health Professionals
Cross References
Allotments by commissioned officers of the Public Health Service, see
National advisory councils, see
Pay and allowances of officers of Public Health Service, see Title 37, Pay and Allowances of the Uniformed Services.
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§210–1. Annual and sick leave
(a) Regulations
In accordance with regulations of the President, commissioned officers of the Regular Corps and officers of the Reserve Corps on active duty may be granted annual leave and sick leave without any deductions from their pay and allowances: Provided, That such regulations shall not authorize annual leave to be accumulated in excess of sixty days.
(b) Repealed. Pub. L. 87–649, §14b, Sept. 7, 1962, 76 Stat. 499
(c) Repealed. Pub. L. 96–76, title III, §311, Sept. 29, 1979, 93 Stat. 586
(d) Definitions
For purposes of this section the term "accumulated annual leave" means unused accrued annual leave carried forward from one leave year into a succeeding leave year, and the term "accrued annual leave" means the annual leave accruing to an officer during one leave year.
(July 1, 1944, ch. 373, title II, §219, as added Aug. 9, 1950, ch. 654, §2,
Partial Repeal of Subsection (d)
Subsection (d) of this section was repealed by
Amendments
1979—Subsec. (c).
1962—Subsec. (b).
Subsec. (c).
Effective Date of 1962 Amendment
Amendment by
Effective Date
Section effective July 1, 1950, see section 3(a) of act Aug. 9, 1950, set out as an Effective Date of 1950 Amendment note under
Transfer of Functions
Functions of Public Health Service, of Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Compensation for Prior Accumulated and Accrued Leave; Limitation; Inapplicable to Officers on Terminal Leave Prior to July 1, 1950
Section 3(b), (c) of act Aug. 9, 1950, provided that any officer credited with more than sixty days of accumulated and accrued leave on June 30, 1949, be compensated for so much of such leave as exceeds sixty days, that such compensation be due and payable on July 1, 1950, and that the provisions of this Act not apply to any officer on terminal leave preceding separation, retirement, or release from active duty.
Availability of Funds
Section 4 of act Aug. 9, 1950, provided for the availability of funds for payment of compensation for prior accumulated and accrued leave for any officer under section 3 of this Act.
Leave Regulations
Section 5 of act Aug. 9, 1950, provided that: "Except insofar as the provisions of this Act [enacting this section, amending
§210a. Repealed. Pub. L. 87–649, §14b, Sept. 7, 1962, 76 Stat. 499
Section, act Feb. 28, 1948, ch. 83, §5(e), (f),
§210b. Professional categories
(a) Division of corps; basis of categories
For the purpose of establishing eligibility of officers of the Regular Corps for promotions, the Surgeon General shall by regulation divide the corps into professional categories. Each category shall, as far as practicable, be based upon one of the subjects of examination set forth in
(b) Assignment of officers
Each officer of the Regular Corps on active duty shall, on the basis of his training and experience, be assigned by the Surgeon General to one of the categories established by regulations under subsection (a) of this section. Except upon amendment of such regulations, no assignment so made shall be changed unless the Surgeon General finds (1) that the original assignment was erroneous, or (2) that the officer is equally well qualified to serve in another category to which he has requested to be transferred, and that such transfer is in the interests of the Service.
(c) Maximum number of officers in each category
Within the limits fixed by the Secretary in regulations under
(d) Vacancies in grade for purposes of promotion
The excess of the number so fixed for any grade in any category over the number of officers of the Regular Corps on active duty in such grade in such category (including in the case of the director grade, officers holding such grade in accordance with
(e) Absence of vacancy in grade as affecting promotion
The absence of a vacancy in a grade in a category shall not prevent an appointment to such grade pursuant to
(f) Vacancy in grade as affecting maximum number for each category
Whenever a vacancy exists in any grade in a category the Surgeon General may increase by one the number fixed by him under subsection (c) of this section for the next lower grade in the same category, without regard to the numbers fixed in regulations under
(July 1, 1944, ch. 373, title II, §209, as added Feb. 28, 1948, ch. 83, §5(i),
Prior Provisions
A prior section 209 of act July 1, 1944, was renumbered section 208 and is classified to
Amendments
1979—Subsec. (c).
Effective Date of 1979 Amendment
Amendment by
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§211. Promotion of commissioned officers
(a) Permanent or temporary promotions; examination
Promotions of officers of the Regular Corps to any grade up to and including the director grade shall be either permanent promotions based on length of service, other permanent promotions to fill vacancies, or temporary promotions. Permanent promotions shall be made by the President, by and with the advice and consent of the Senate, and temporary promotions shall be made by the President. Each permanent promotion shall be to the next higher grade, and shall be made only after examination given in accordance with regulations of the President.
(b) Promotion to certain grades only to fill vacancies; regulations; "restricted grade" defined
The President may by regulation provide that in a specified professional category permanent promotions to the senior grade, or to both the full grade and the senior grade, shall be made only if there are vacancies in such grade. A grade in any category with respect to which such regulations have been issued is referred to in this section as a "restricted grade".
(c) Examinations
Examinations to determine qualification for permanent promotions may be either noncompetitive or competitive, as the Surgeon General shall in each case determine; except that examinations for promotions to the assistant or senior assistant grade shall in all cases be noncompetitive. The officers to be examined shall be selected by the Surgeon General from the professional category, and in the order of seniority in the grade, from which promotion is to be recommended. In the case of a competitive examination the Surgeon General shall determine in advance of the examination the number (which may be one or more) of officers who, after passing the examination, will be recommended to the President for promotion; but if the examination is one for promotions based on length of service, or is one for promotions to fill vacancies other than vacancies in the director grade or in a restricted grade, such number shall not be less than 80 per centum of the number of officers to be examined.
(d) Permanent promotions to qualified officers on length of service
Officers of the Regular Corps, found pursuant to subsection (c) of this section to be qualified, shall be given permanent promotions based on length of service, as follows:
(1) Officers in the warrant officer (W–1) grade, chief warrant officer (W–2) grade, chief warrant officer (W–3) grade, chief warrant officer (W–4) grade, and junior assistant grade shall be promoted at such times as may be prescribed in regulations of the President.
(2) Officers with permanent rank in the assistant grade, the senior assistant grade, and the full grade shall (except as provided in regulations under subsection (b) of this section) be promoted after completion of three, ten, and seventeen years, respectively, of service in grades above the junior assistant grade; and such promotions, when made, shall be effective, for purposes of pay and seniority in grade, as of the day following the completion of such years of service. An officer with permanent rank in the assistant, senior assistant, or full grade who has not completed such years of service shall be promoted at the same time, and his promotion shall be effective as of the same day, as any officer junior to him in the same grade in the same professional category who is promoted under this paragraph.
(e) Promotion of professional category officers to fill certain vacancies
Officers in a professional category of the Regular Corps, found pursuant to subsection (c) of this section to be qualified, may be given permanent promotions to fill any or all vacancies in such category in the senior assistant grade, the full grade, the senior grade, or the director grade; but no officer who has not had one year of service with permanent or temporary rank in the next lower grade shall be promoted to any restricted grade or to the director grade.
(f) Reexamination upon failure of promotion; effective date of promotion
If an officer who has completed the years of service required for promotion to a grade under paragraph (2) of subsection (d) of this section fails to receive such promotion, he shall (unless he has already been twice examined for promotion to such grade) be once reexamined for promotion to such grade. If he is thereupon promoted (otherwise than under subsection (e) of this section), the effective date of such promotion shall be one year later than it would have been but for such failure. Upon the effective date of any permanent promotion of such officer to such grade, he shall be considered as having had only the length of service required for such promotion which he previously failed to receive.
(g) Separation from service upon failure of promotion
If, for reasons other than physical disability, an officer of the Regular Corps in the warrant officer (W–1) grade or junior assistant grade is found pursuant to subsection (c) of this section not to be qualified for promotion he shall be separated from the Service. If, for reasons other than physical disability, an officer of the Regular Corps in the chief warrant officer (W–2), chief warrant officer (W–3), assistant, senior assistant, or full grade, after having been twice examined for promotion (other than promotion to a restricted grade), fails to be promoted—
(1) if in the chief warrant officer (W–2) or assistant grade he shall be separated from the Service and paid six months' basic pay and allowances;
(2) if in the chief warrant officer (W–3) or senior assistant grade he shall be separated from the Service and paid one year's basic pay and allowances;
(3) if in the full grade he shall be considered as not in line for promotion and shall, at such time thereafter as the Surgeon General may determine, be retired from the Service with retired pay (unless he is entitled to a greater amount by reason of another provision of law)—
(A) in the case of an officer who first became a member of a uniformed service before September 8, 1980, at the rate of 2½ percent of the retired pay base determined under
(B) in the case of an officer who first became a member of a uniformed service on or after September 8, 1980, at the rate determined by multiplying—
(i) the retired pay base determined under
(ii) the retired pay multiplier determined under section 1409 of such title for the number of years of his active commissioned service in the Service.
(h) Separation from service upon refusal to stand examination
If an officer of the Regular Corps, eligible to take an examination for promotion, refuses to take such examination, he may be separated from the Service in accordance with regulations of the President.
(i) Review of record; separation from service
At the end of his first three years of service, the record of each officer of the Regular Corps originally appointed to the senior assistant grade or above, shall be reviewed in accordance with regulations of the President and, if found not qualified for further service, he shall be separated from the Service and paid six months' pay and allowances.
(j) Determination of order of seniority
(1) The order of seniority of officers in a grade in the Regular Corps shall be determined, subject to the provisions of paragraph (2) of this subsection, by the relative length of time spent in active service after the effective date of each such officer's original appointment or permanent promotion to that grade. When permanent promotions of two or more officers to the same grade are effective on the same day, their relative seniority shall be the same as it was in the grade from which promoted. In all other cases of original appointments or permanent promotions (or both) to the same grade effective on the same day, relative seniority shall be determined in accordance with regulations of the President.
(2) In the case of an officer originally appointed in the Regular Corps to the grade of assistant or above, his seniority in the grade to which appointed shall be determined after inclusion, as service in such grade, of any active service in such grade or in any higher grade in the Reserve Corps, but (if the appointment is to the grade of senior assistant or above) only to the extent of whichever of the following is greater: (A) His active service in such grade or any higher grade in the Reserve Corps after the first day on which, under regulations in effect on the date of his appointment to the Regular Corps, he had the training and experience necessary for such appointment, or (B) the excess of his total active service in the Reserve Corps (above the grade of junior assistant) over three years if his appointment in the Regular Corps is to the senior assistant grade, over ten years if the appointment is to the full grade, or over seventeen years if the appointment is to the senior grade.
(k) Temporary promotions; fill vacancy in higher grade; war or national emergency; selection of officers; termination of appointment
Any commissioned officer of the Regular Corps in any grade in any professional category may be recommended to the President for temporary promotion to fill a vacancy in any higher grade in such category, up to and including the director grade. In time of war, or of national emergency proclaimed by the President, any commissioned officer of the Regular Corps in any grade in any professional category may be recommended to the President for promotion to any higher grade in such category, up to and including the director grade, whether or not a vacancy exists in such grade. The selection of officers to be recommended for temporary promotions shall be made in accordance with regulations of the President. Promotion of an officer recommended pursuant to this subsection may be made without regard to length of service, without examination, and without vacating his permanent appointment, and shall carry with it the pay and allowances of the grade to which promoted. Such promotions may be terminated at any time, as may be directed by the President.
(l) Determination of requirements of Service by Secretary; assignment of Reserve Officers to professional categories; temporary promotions; termination of temporary promotions
Whenever the number of officers of the Regular Corps on active duty, plus the number of officers of the Reserve Corps who have been on active duty for thirty days or more, exceeds the authorized strength of the Regular Corps, the Secretary shall determine the requirements of the Service in each grade in each category, based upon the total number of officers so serving on active duty and the tasks being performed by the Service; and the Surgeon General shall thereupon assign each officer of the Reserve Corps on active duty to a professional category. If the Secretary finds that the number of officers fixed under
(m) Acceptance of promotion; oath and affidavit
Any officer of the Regular Corps, or any officer of the Reserve Corps on active duty, who is promoted to a higher grade shall, unless he expressly declines such promotion, be deemed for all purposes to have accepted such promotion; and shall not be required to renew his oath of office, or to execute a new affidavit as required by
(July 1, 1944, ch. 373, title II, §210,
Codification
In subsec. (m), "
Amendments
1986—Subsec. (g)(3).
"(A) in the case of an officer who first became a member of a uniformed service before September 8, 1980, at the rate of 2½ per centum of basic pay of the permanent grade held by him at the time of retirement for each year, not in excess of thirty, of his active commissioned service in the Service; or
"(B) in the case of an officer who first became a member of a uniformed service on or after September 8, 1980, 2½ per centum of the monthly retired pay base computed under
1980—Subsec. (g)(3).
1979—Subsec. (d)(1).
Subsec. (g).
1962—Subsec. (g).
1960—Subsec. (g).
1956—Subsec. (d)(2). Act Apr. 27, 1956, struck out "pay period and for purposes of" before "seniority in grade".
1949—Subsec. (g). Act Oct. 12, 1949, struck out "incurred in line of duty" wherever appearing.
1948—Act Feb. 28, 1948, amended subsecs. (a) to (c) generally and added subsecs. (d) to (m).
Effective Date of 1979 Amendment
Amendment by
Effective Date of 1962 Amendment
Amendment by
Effective Date of 1949 Amendment
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949, see section 533(a) of act Oct. 12, 1949.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under section 3501 this title. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953. Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by section 509(b) of
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§211a. Repealed. Pub. L. 93–222, §7(b), Dec. 29, 1973, 87 Stat. 936
Section, act July 1, 1944, ch. 373, title XIII, §1311, formerly title VII, §711, as added Feb. 28, 1948, ch. 83, §9(b),
§211b. Repealed. Pub. L. 94–412, title V, §501(f), Sept. 14, 1976, 90 Stat. 1258
Section, act Feb. 28, 1948, ch. 83, §6(b)–(f),
Savings Provision
Repeal not to affect any action taken or proceeding pending at the time of repeal, see section 501(h) of
§211c. Promotion credit for medical officers in assistant grade
Any medical officer of the Regular Corps of the Public Health Service who—
(1)(A) was appointed to the assistant grade in the Regular Corps and whose service in such Corps has been continuous from the date of appointment or (B) may hereafter be appointed to the assistant grade in the Regular Corps, and
(2) had or will have completed a medical internship on the date of such appointment,
shall be credited with one year for purposes of promotion and seniority in grade, except that no such credit shall be authorized if the officer has received or will receive similar credit for his internship under other provisions of law. In the case of an officer on active duty on the effective date of this section who is entitled to the credit authorized herein, the one year shall be added to the promotion and seniority-in-grade credits with which he is credited on such date.
(July 1, 1944, ch. 373, title II, §220, as added Apr. 30, 1956, ch. 223, §3,
References in Text
For "the effective date of this section", referred to in text, see section 7 of act Apr. 30, 1956, which provided in part that this section shall become effective the first day of the month following the day of enactment, Apr. 30, 1956.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
§212. Retirement of commissioned officers
(a) Age; voluntariness; length of service; computation of retired pay
(1) A commissioned officer of the Service shall, if he applies for retirement, be retired on or after the first day of the month following the month in which he attains the age of sixty-four years. This paragraph does not permit or require the involuntary retirement of any individual because of the age of the individual.
(2) A commissioned officer of the Service may be retired by the Secretary, and shall be retired if he applies for retirement, on the first day of any month after completion of thirty years of active service.
(3) Any commissioned officer of the Service who has had less than thirty years of active service may be retired by the Secretary, with or without application by the officer, on the first day of any month after completion of twenty or more years of active service of which not less than ten are years of active commissioned service in any of the uniformed services.
(4) Except as provided in paragraph (6), a commissioned officer retired pursuant to paragraph (1), (2), or (3) who was (in the case of an officer in the Reserve Corps) on active duty with the Service on the day preceding such retirement shall be entitled to receive retired pay at the rate of 2½ per centum of the basic pay of the highest grade held by him as such officer and in which, in the case of a temporary promotion to such grade, he has performed active duty for not less than six months, (A) for each year of active service, or (B) if it results in higher retired pay, for each of the following years:
(i) his years of active service (determined without regard to subsection (d) of this section) as a member of a uniformed service; plus
(ii) in the case of a medical or dental officer, four years and, in the case of a medical officer, who has completed one year of medical internship or the equivalent thereof, one additional year, the four years and the one year to be reduced by the period of active service performed during such officer's attendance at medical school or dental school or during his medical internship; plus
(iii) the number of years of service with which he was entitled to be credited for purposes of basic pay on May 31, 1958, or (if higher) on any date prior thereto, reduced by any such year included under clause (i) and further reduced by any such year with which he was entitled to be credited under paragraphs (7) and (8) of
except that (C) in the case of any officer whose retired pay, so computed, is less than 50 per centum of such basic pay, who retires pursuant to paragraph (1) of this subsection, who has not less than twelve whole years of active service (computed without the application of subsection (e) of this section), and who does not use, for purposes of a retirement annuity under subchapter III of
(5) With the approval of the President, a commissioned officer whose service as Surgeon General, Deputy Surgeon General, or Assistant Surgeon General has totaled four years or more and who has had not less than twenty-five years of active service in the Service may retire voluntarily at any time; and except as provided in paragraph (6), his retired pay shall be at the rate of 75 per centum of the basic pay of the highest grade held by him as such officer.
(6) The retired pay of a commissioned officer retired under this subsection who first became a member of a uniformed service after September 7, 1980, is determined by multiplying—
(A) the retired pay base determined under
(B) the retired pay multiplier determined under section 1409 of such title for the number of years of service credited to the officer under paragraph (4).
(7) Retired pay computed under
(b) Basic pay of highest temporary grade
For purposes of subsection (a) of this section, the basic pay of the highest grade to which a commissioned officer has received a temporary promotion means the basic pay to which he would be entitled if serving on active duty in such grade on the date of his retirement.
(c) Recall to active duty
A commissioned officer, retired for reasons other than for failure of promotion to the senior grade, may (1) if an officer of the Regular Corps or an officer of the Reserve Corps entitled to retired pay under subsection (a) of this section, be involuntarily recalled to active duty during such times as the Commissioned Corps constitutes a branch of the land or naval forces of the United States, and (2) if an officer of either the Regular or Reserve Corps, be recalled to active duty at any time with his consent.
(d) "Active service" defined
The term "active service", as used in subsection (a) of this section, includes:
(1) all active service in any of the uniformed services;
(2) active service with the Public Health Service, other than as a commissioned officer, which the Surgeon General determines is comparable to service performed by commissioned officers of the Service, except that, if there are more than five years of such service only the last five years thereof may be included;
(3) all active service (other than service included under the preceding provisions of this subsection) which is creditable for retirement purposes under laws governing the retirement of members of any of the uniformed services; and
(4) service performed as a member of the Senior Biomedical Research Service established by
(e) Crediting of part of year
For the purpose of determining the number of years by which a percentage of the basic pay of an officer is to be multiplied in computing the amount of his retired pay pursuant to
(f) Retirement or separation for physical disability
For purposes of retirement or separation for physical disability under
(July 1, 1944, ch. 373, title II, §211,
Codification
In subsec. (a)(4), "subchapter III of
Amendments
1990—Subsec. (d)(4).
1986—Subsec. (a)(6).
1983—Subsec. (a)(7).
Subsec. (e).
1981—Subsec. (a)(1).
1980—Subsec. (a)(4).
Subsec. (a)(5).
Subsec. (a)(6).
1979—Subsec. (e).
1970—Subsec. (a)(4).
1960—
1956—Subsec. (a). Act Apr. 27, 1956, §5(a), authorized crediting of noncommissioned service for purposes of retirement.
Subsec. (b)(1). Act Apr. 27, 1956, §5(b), authorized crediting of noncommissioned service in the Service for purposes of retirement.
Subsec. (c). Act Apr. 27, 1956, §5(c), permitted recall of retired officers of the Regular Corps without their consent whenever the Regular Corps has military status, and authorized recall of retired officers of the Regular or Reserve Corps with their consent at any time.
Subsec. (g). Act Aug. 10, 1956, provided for crediting of service for purposes of retirement or separation for physical disability under
1949—Subsec. (a). Act Oct. 12, 1949, redesignated subsec. (b) as (a), substituted "subsection (b)" for "subsection (c)" and repealed former subsec. (a) relating to retirement for disability or disease.
Subsec. (b). Act Oct. 12, 1949, redesignated subsec. (c) as (b) and struck out reference to retirement for disability or disease. Former subsec. (b) redesignated (a).
Subsec. (c). Act Oct. 12, 1949, redesignated subsec. (d) as (c) and struck out reference to recovery from a disability. Former subsec. (c) redesignated (b).
Subsecs. (d) to (f). Act Oct. 12, 1949, redesignated subsecs. (e) to (g) as (d) to (f), respectively. Former subsec. (d) redesignated (c).
Subsecs. (g), (h). Act Oct. 12, 1949, redesignated subsec. (h) as (g) and amended subsection generally to relate to retirement or separation for physical disability. Former subsec. (g) redesignated (f).
1948—Subsec. (b). Act Feb. 28, 1948, inserted length of service for retirement purposes.
Subsec. (c)(2). Act Feb. 28, 1948, made subdivision applicable to grade of Assistant Surgeon General.
Subsec. (d). Act Feb. 28, 1948, substituted "under the provisions of subsection (b) of this section" for "for age".
Subsecs. (g), (h). Act Feb. 28, 1948, added subsecs. (g) and (h).
Change of Name
Senior Biomedical Research Service changed to Silvio O. Conte Senior Biomedical Research Service by
Effective Date of 1990 Amendment
Section 529 [title III, §304(c)] of
Effective Date of 1983 Amendment
Amendment by section 922(d) of
Amendment by section 923(f) of
Effective Date of 1970 Amendment
Section 2 of
Effective Date of 1960 Amendment
Section 8(b) of
Effective Date of 1949 Amendment
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949, see section 533(a) of act Oct. 12, 1949.
Savings Provision
Section 8(c), (d) of
"(c) An officer in the Regular Corps on active duty on the date of enactment of this Act [Apr. 8, 1960] may be retired and have his retired pay computed under section 211 of the Public Health Service Act, as amended by this Act [this section], or, if he so elects, under such section as in effect prior to the date of enactment of this Act [Apr. 8, 1960].
"(d) The limitation under subsection (f) of section 211 of the Public Health Service Act, as amended by this Act [subsec. (f) of this section], on the amount of active service with the Public Health Service, other than as a commissioned officer, which may be counted for purposes of retirement or separation for physical disability, shall not apply in the case of any officer of the Reserve Corps of the Public Health Service on active duty on June 30, 1960."
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, eff. Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Coverage Under Civil Service Retirement Act
Creditable service for purposes of the Civil Service Retirement Act for certain commissioned officers of the Regular or Reserve Corps of the Public Health Service, see section 6(a), (b) of
Section Referred to in Other Sections
This section is referred to in
§212a. Repealed. Pub. L. 93–222, §7(b), Dec. 29, 1973, 87 Stat. 936
Section, act July 1, 1944, ch. 373, title XIII, §1312, formerly title VII, §712, as added Feb. 28, 1948, ch. 83, §9(b),
§212b. Repealed. Apr. 27, 1956, ch. 211, §5(d), 70 Stat. 117
Section, act July 31, 1953, ch. 296, title II, §201,
§213. Military benefits
(a) Rights, privileges, immunities, and benefits accorded to commissioned officers or their survivors
Except as provided in subsection (b) of this section, commissioned officers of the Service and their surviving beneficiaries shall, with respect to active service performed by such officers—
(1) in time of war;
(2) on detail for duty with the Army, Navy, Air Force, Marine Corps, or Coast Guard; or
(3) while the Service is part of the military forces of the United States pursuant to Executive order of the President;
be entitled to all rights, privileges, immunities, and benefits now or hereafter provided under any law of the United States in the case of commissioned officers of the Army or their surviving beneficiaries on account of active military service, except retired pay and uniform allowances.
(b) Award of decorations
The President may prescribe the conditions under which commissioned officers of the Service may be awarded military ribbons, medals, and decorations.
(c) Authority of Surgeon General
The authority vested by law in the Department of the Army, the Secretary of the Army, or other officers of the Department of the Army with respect to rights, privileges, immunities, and benefits referred to in subsection (a) of this section shall be exercised, with respect to commissioned officers of the Service, by the Surgeon General.
(d) Active service deemed active military service with respect to laws administered by Secretary of Veterans Affairs
Active service of commissioned officers of the Service shall be deemed to be active military service in the Armed Forces of the United States for the purposes of all laws administered by the Secretary of Veterans Affairs (except the Servicemen's Indemnity Act of 1951) and
(e) Active service deemed active military service with respect to Soldiers' and Sailors' Civil Relief Act of 1940
Active service of commissioned officers of the Service shall be deemed to be active military service in the Armed Forces of the United States for the purposes of all rights, privileges, immunities, and benefits now or hereafter provided under the Soldiers' and Sailors' Civil Relief Act of 1940 (50 App. U.S.C. 501 et seq.).
(July 1, 1944, ch. 373, title II, §212,
References in Text
The Servicemen's Indemnity Act of 1951, referred to in subsec. (d), is act Apr. 25, 1951, ch. 39, pt. I,
The Soldiers' and Sailors' Civil Relief Act of 1940, referred to in subsec. (e), is act Oct. 17, 1940, ch. 888,
Amendments
1991—Subsec. (d).
1976—Subsec. (e).
1956—Act Aug. 1, 1956, amended section generally to extend all rights, privileges, immunities, and benefits provided for commissioned officers of the Army or their surviving beneficiaries to commissioned officers of the Service, with the exception of retired pay and uniform allowances, when performing duty under certain circumstances, and to provide that active service of commissioned officers shall be deemed to be active military service in the Armed Forces for the purposes of all laws administered by the Veterans' Administration (except the Servicemen's Indemnity Act of 1951) and
1954—Subsec. (a)(1). Act July 15, 1954, struck out "burial payments in the event of death," after "limited to,".
Effective Date of 1956 Amendment; Applicability
Section 501(b)(2) of act Aug. 1, 1956, provided that: "The amendment made by this subsection [amending this section] (A) shall apply only with respect to service performed on or after July 4, 1952, (B) shall not be construed to affect the entitlement of any person to benefits under the Veterans' Readjustment Assistance Act of 1952 [act July 16, 1952, ch. 875,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Recomputation of Social Security Benefits for Officers Entitled to Old-Age Insurance Benefits Prior to January 1, 1957, or for Survivors of Officers Who Died Prior to January 1, 1957
Section 501(b)(3) of act Aug. 1, 1956, provided that: "In the case of any individual—
"(A) who performed active service (i) as a commissioned officer of the Public Health Service at any time during the period beginning July 4, 1952, and ending December 31, 1956, or (ii) as a commissioned officer of the Coast and Geodetic Survey at any time during the period beginning July 29, 1945, and ending December 31, 1956; and
"(B)(i) who became entitled to old-age insurance benefits under section 202(a) of the Social Security Act [
"(ii) who died prior to January 1, 1957, and whose widow, child, or parent is entitled for the month of January 1957, on the basis of his wages and self-employment income, to a monthly survivor's benefit under section 202 of such act [
"(C) any part of whose service described in subparagraph (A) was not included in the computation of his primary insurance amount under section 215 of such act [
the Secretary of Health, Education, and Welfare [now Health and Human Services] shall, notwithstanding the provisions of section 215(f)(1) of the Social Security Act [
Disposition of Remains of Deceased Personnel
Recovery, care, and disposition of the remains of deceased members of the uniformed services and other deceased personnel, see
Burial of Certain Commissioned Officers
Act Apr. 30, 1956, ch. 227,
Delegation of Authority
Memorandum of President of the United States, Dec. 30, 1992, 58 F.R. 3485, provided:
Memorandum for the Secretary of Defense, the Secretary of Health and Human Services
The authority of the President under section 212(b) of the Public Health Service Act (
The Secretary of Defense shall ensure the publication of this memorandum in the Federal Register.
George Bush.
Section Referred to in Other Sections
This section is referred to in
§213a. Rights, benefits, privileges, and immunities for commissioned officers or beneficiaries; exercise of authority by Secretary or designee
(a) Commissioned officers of the Service or their surviving beneficiaries are entitled to all the rights, benefits, privileges, and immunities now or hereafter provided for commissioned officers of the Army or their surviving beneficiaries under the following provisions of title 10:
(1) Section 1036, Escorts for dependents of members: transportation and travel allowances.
(2)
(3)
(4)
(5)
(6)
(7) Section 2771, Final settlement of accounts: deceased members.
(8)
(9) Section 2603, Acceptance of fellowships, scholarships, or grants.
(10) Section 2634, Motor vehicles: for members on permanent change of station.
(11) Section 1035, Deposits of Savings.
(12) Section 1552, Correction of military records: claims incident thereto.
(13) Section 1553, Review of discharge or dismissal.
(14) Section 1554, Review of retirement or separation without pay for physical disability.
(15) Section 1124, Cash awards for suggestions, inventions, or scientific achievements.
(b) The authority vested by title 10 in the "military departments", "the Secretary concerned", or "the Secretary of Defense" with respect to the rights, privileges, immunities, and benefits referred to in subsection (a) of this section shall be exercised, with respect to commissioned officers of the Service, by the Secretary of Health and Human Services or his designee.
(July 1, 1944, ch. 373, title II, §221, as added Aug. 10, 1956, ch. 1041, §4,
References in Text
Codification
Section was formerly classified to
Amendments
1985—Subsec. (a)(15).
1980—Subsec. (a)(3).
1979—Subsec. (a)(12) to (14).
1972—Subsec. (a)(5).
1966—Subsec. (a)(11).
1964—Subsec. (a)(10).
1963—Subsec. (b).
1962—Subsec. (a).
1959—Subsec. (a).
1958—Subsec. (a).
Effective Date of 1980 Amendment
Amendment by
Effective Date of 1963 Amendment
Amendment by
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Rules and Regulations; Savings Deposit Benefits
Regulations prescribed by the Secretary of Health, Education, and Welfare [now Health and Human Services] concerning savings deposit benefits for Public Health Service personnel to be prescribed jointly with regulations prescribed by the Secretaries concerned under
Back Payments: Validation; Application; Limitations; Accountability of Disbursing Officers; Regulations
Transportation and travel allowances to escorts for dependents of members, see sections 4 to 7 of
Designation of Beneficiary Made Before January 1, 1956
Designation of beneficiary made before Jan. 1, 1956, considered as the designation of a beneficiary for the purposes of section 4 of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§214. Repealed. Pub. L. 87–649, §14b, Sept. 7, 1962, 76 Stat. 499
Section, acts July 1, 1944, ch. 373, title II, §213,
§214a. Repealed. Sept. 1, 1954, ch. 1211, §5, 68 Stat. 1130
Section, act July 31, 1953, ch. 296, title II, §204,
§215. Detail of Service personnel
(a) Other Government departments
The Secretary is authorized, upon the request of the head of an executive department, to detail officers or employees of the Service to such department for duty as agreed upon by the Secretary and the head of such department in order to cooperate in, or conduct work related to, the functions of such department or of the Service. When officers or employees are so detailed their salaries and allowances may be paid from working funds established as provided by law or may be paid by the Service from applicable appropriations and reimbursement may be made as agreed upon by the Secretary and the head of the executive department concerned. Officers detailed for duty with the Army, Air Force, Navy, or Coast Guard shall be subject to the laws for the government of the service to which detailed.
(b) State health or mental health authorities
Upon the request of any State health authority or, in the case of work relating to mental health, any State mental health authority, personnel of the Service may be detailed by the Surgeon General for the purpose of assisting such State or a political subdivision thereof in work related to the functions of the Service.
(c) Congressional committees and nonprofit educational, research, or other institutions engaged in health activities for special studies and dissemination of information
The Surgeon General may detail personnel of the Service to any appropriate committee of the Congress or to nonprofit educational, research 1 or other institutions engaged in health activities for special studies of scientific problems and for the dissemination of information relating to public health.
(d) Availability of funds; reimbursement by State; detailed services deemed service for computation of pay, promotion, etc.
Personnel detailed under subsections (b) and (c) of this section shall be paid from applicable appropriations of the Service, except that, in accordance with regulations such personnel may be placed on leave without pay and paid by the State, subdivision, or institution to which they are detailed. In the case of detail of personnel under subsections (b) or (c) of this section to be paid from applicable Service appropriations, the Secretary may condition such detail on an agreement by the State, subdivision, or institution concerned that such State, subdivision, or institution concerned shall reimburse the United States for the amount of such payments made by the Service. The services of personnel while detailed pursuant to this section shall be considered as having been performed in the Service for purposes of the computation of basic pay, promotion, retirement, compensation for injury or death, and the benefits provided by
(July 1, 1944, ch. 373, title II, §214,
Codification
In subsec. (a), Air Force was inserted on the authority of section 207(a), (f) of act July 26, 1947, ch. 343, title II,
Amendments
1979—Subsec. (c).
Subsec. (d).
1949—Subsec. (d). Act Oct. 12, 1949, substituted "the computation of basic pay" for "longevity pay".
1946—Subsec. (b). Act July 3, 1946, provided for detail of personnel on request from a State mental health authority.
Effective Date of 1949 Amendment
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949, see section 533(a) of act Oct. 12, 1949.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Transfers of Personnel Occasioned by Creation of the Environmental Protection Agency
"(1) Subject to such requirements as the Civil Service Commission may prescribe, any commissioned officer of the Public Health Service (other than an officer who retires under section 211 of the Public Health Service Act [
"(2) An election pursuant to paragraph (1) shall be effective only if made in accordance with such procedures as may be prescribed by the Civil Service Commission (A) before the close of the 24th month after the effective date of the plan [Dec. 2, 1970], or (B) in the case of a commissioned officer who would be liable for training and service under the Military Selective Service Act of 1967 [
"(3)(A) Except as provided in subparagraph (B), any commissioned officer of the Public Health Service who, pursuant to paragraphs (1) and (2), elects to transfer to a position in the Agency which is subject to
"(i) the basic pay, the special pay, the continuation pay, and the subsistence and quarters allowances, to which he is annually entitled as a commissioned officer of the Public Health Service pursuant to
"(ii) the amount of Federal income tax, as determined by estimate of the Secretary, which the transferring officer, had he remained a commissioned officer, would have been required to pay on his subsistence and quarters allowances for the taxable year then current if they had not been tax free;
"(iii) an amount equal to the biweekly average cost of the coverages designated 'high option, self and family' under the Government-wide Federal employee health benefits programs plans, multiplied by twenty-six; and
"(iv) an amount equal to 7 per centum of the sum of the amounts determined under clauses (i) through (iii), inclusive.
"(B) A transferring officer shall in no event receive, pursuant to subparagraph (A), a pay rate in excess of the maximum rate applicable under the General Schedule to the class of position, as established under
"(4)(A) A transferring officer shall be credited, on the day of his transfer pursuant to his election under paragraphs (1) and (2), with one hour of sick leave for each week of active service, as defined by section 211(d) of the Public Health Service Act [
"(B) The annual leave to the credit of a transferring officer on the day before the day of his transfer, shall, on such day of transfer, be transferred to his credit in the Agency on an adjusted basis under regulations prescribed by the Civil Service Commission. The portion of such leave, if any, that is in excess of the sum of (i) 240 hours, and (ii) the number of hours that have accrued to the credit of the transferring officer during the calendar year then current and which remain unused, shall thereafter remain to his credit until used, and shall be reduced in the manner described by subsection (c) of
"(5) A transferring officer who is required to change his official station as a result of his transfer under this subsection shall be paid such travel, transportation, and related expenses and allowances, as would be provided pursuant to subchapter II of
"(6) Each transferring officer who prior to January 1, 1958, was insured pursuant to the Federal Employees' Group Life Insurance Act of 1954, and who subsequently waived such insurance, shall be entitled to become insured under
"(7)(A) Effective as of the date a transferring officer acquires competitive status as an employee of the Agency, there shall be considered as the civilian service of such officer for all purposes of
"(B) A transferring officer on whose behalf a deposit is required to be made by subparagraph (C) and who, after transfer to a competitive position in the Agency under paragraphs (1) and (2), is separated from Federal service or transfers to a position not covered by subchapter III of
"(C) The Secretary shall deposit in the Treasury of the United States to the credit of the Civil Service Retirement and Disability Fund, on behalf of and to the credit of such transferring officer, an amount equal to that which such individual would be required to deposit in such fund to cover the years of service credited to him for purposes of his retirement under subparagraph (A), had such service been service as an employee as defined in
"(8)(A) A commissioned officer of the Public Health Service, who, upon the day before the effective date of the plan, is on active service therewith primarily assigned to the performance of functions described in paragraph (1)(A), shall, while he remains in active service, as defined by section 211(d) of the Public Health Service Act [
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be followed by a comma.
§216. Regulations
(a) Prescription by President: appointments, retirement, etc.
The President shall from time to time prescribe regulations with respect to the appointment, promotion, retirement, termination of commission, titles, pay, uniforms, allowances (including increased allowances for foreign service), and discipline of the commissioned corps of the Service.
(b) Promulgation by Surgeon General; administration of Service
The Surgeon General, with the approval of the Secretary, unless specifically otherwise provided, shall promulgate all other regulations necessary to the administration of the Service, including regulations with respect to uniforms for employees, and regulations with respect to the custody, use, and preservation of the records, papers, and property of the Service.
(c) Preference to school of medicine
No regulation relating to qualifications for appointment of medical officers or employees shall give preference to any school of medicine.
(July 1, 1944, ch. 373, title II, §215,
Amendments
1949—Subsec. (b). Act Oct. 12, 1949, struck out references to travel and transportation of household goods and effects.
Effective Date of 1949 Amendment
Amendment by act Oct. 12, 1949, effective Oct. 1, 1949, see section 533(a) of act Oct. 12, 1949.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, January 30, 1964, 29 F.R. 1637, as amended, set out as a note under
§217. Use of Service in time of war or emergency
In time of war, or of emergency proclaimed by the President, he may utilize the Service to such extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency involving the national defense proclaimed by the President, he may by Executive order declare the commissioned corps of the Service to be a military service. Upon such declaration, and during the period of such war or such emergency or such part thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President, be subject to the Uniform Code of Military Justice [
(July 1, 1944, ch. 373, title II, §216,
References in Text
The Uniform Code of Military Justice, referred to in text, is classified to
Amendments
1956—Act Apr. 27, 1956, empowered President to declare commissioned corps of the Service to be a military service in time of emergency involving national defense, and substituted "the Uniform Code of Military Justice" for "the Articles of War and to the Articles for the Government of the Navy".
Repeal of Prior Acts Continuing Section
Section 6 of Joint Res. July 3, 1952, ch. 570,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Executive Order No. 9575
Ex. Ord. No. 9575, eff. June 28, 1945, 10 F.R. 7895, which declared the Commissioned Corps of the Public Health Service to be a military service subject to the Articles for the Government of the Navy as therein prescribed, was superseded by Ex. Ord. No. 10349, eff. Apr. 28, 1952, 17 F.R. 3769.
Executive Order No. 10349
Ex. Ord. No. 10349, eff. Apr. 28, 1952, 17 F.R. 3769, superseded Ex. Ord. No. 9575, and subjected the Commissioned Corps of the Public Health Service to the provisions of the Uniform Code of Military Justice until June 1, 1952.
Executive Order No. 10356
Ex. Ord. No. 10356, eff. June 2, 1952, 17 F.R. 4967, amended Ex. Ord. No. 10349, and extended from June 1, 1952, to June 15, 1952 the period during which the Commissioned Corps of the Public Health Service was subject to the provisions of the Uniform Code of Military justice.
Executive Order No. 10362
Ex. Ord. No. 10362, eff. June 14, 1952, 17 F.R. 5413, amended Ex. Ord. No. 10356, and extended from June 15, 1952 to June 30, 1952 the period during which the Commissioned Corps of the Public Health Service was subject to the Uniform Code of Military Justice.
Executive Order No. 10367
Ex. Ord. No. 10367, eff. June 30, 1952, 17 F.R. 5929, amended Ex. Ord. No. 10362, and extended from June 30, 1952 to July 3, 1952, the period during which the Commissioned Corps of the Public Health Service was subject to the Uniform Code of Military Justice.
Cross References
Personnel of Public Health Service serving with armed forces as subject to Uniform Code of Military Justice, see
Section Referred to in Other Sections
This section is referred to in
§217a. Advisory councils or committees
(a) Appointment; purpose
The Secretary may, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of
(b) Compensation and allowances of members not full-time employees of United States
Members of any advisory council or committee appointed under this section who are not regular full-time employees of the United States shall, while attending meetings or conferences of such council or committee or otherwise engaged on business of such council or committee receive compensation and allowances as provided in
(c) Delegation of functions
Upon appointment of any such council or committee, the Secretary may delegate to such council or committee such advisory functions relating to grants-in-aid for research or training projects or programs, in the areas or fields with which such council or committee is concerned, as the Secretary determines to be appropriate.
(July 1, 1944, ch. 373, title II, §222, as added Oct. 17, 1962,
References in Text
The provisions of title 5 governing appointments in the competitive service, referred to in subsec. (a), are classified to
The General Schedule, referred to in subsec. (a), is set out under
Amendments
1985—Subsec. (c).
1970—Subsec. (a).
Subsec. (b).
Subsec. (c).
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Termination of Advisory Committees; Report by Secretary to Congressional Committees Relating to Termination
"(a) An advisory committee established by or pursuant to the Public Health Service Act [
"(b) The Secretary of Health, Education, and Welfare shall report, within one year after the date of the enactment of the Act [Jan. 4, 1975], to the Committee on Labor and Public Welfare of the Senate and the Committee on Interstate and Foreign Commerce of the House of Representatives (1) the purpose and use of each advisory committee established by or pursuant to the Public Health Service Act, the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963, or the Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 and (2) his recommendations respecting the termination of each such advisory committee."
Section Referred to in Other Sections
This section is referred to in
§217a–1. Advisory committees; prohibition of consideration of political affiliations
All appointments to advisory committees established to assist in implementing the Public Health Service Act [
(
References in Text
The Public Health Service Act, referred to in text, is act July 1, 1944, ch. 373,
The Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963, referred to in text, is
The Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970, referred to in text, is
Codification
Section was not enacted as a part of the Public Health Service Act which comprises this chapter.
§217b. Volunteer services
Subject to regulations, volunteer and uncompensated services may be accepted by the Secretary, or by any other officer or employee of the Department of Health and Human Services designated by him, for use in the operation of any health care facility or in the provision of health care.
(July 1, 1944, ch. 373, title II, §223, as added Dec. 5, 1967,
Amendments
1993—
§218. National Advisory Councils on Migrant Health
(a) Appointment; duties
Within 120 days of July 29, 1975, the Secretary shall appoint and organize a National Advisory Council on Migrant Health (hereinafter in this subsection referred to as the "Council") which shall advise, consult with, and make recommendations to, the Secretary on matters concerning the organization, operation, selection, and funding of migrant health centers and other entities under grants and contracts under
(b) Membership
The Council shall consist of fifteen members, at least twelve of whom shall be members of the governing boards of migrant health centers or other entities assisted under
(c) Terms of office
Each member of the Council shall hold office for a term of four years, except that (1) any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed for the remainder of such term; and (2) the terms of the members first taking office after July 29, 1975, shall expire as follows: four shall expire four years after such date, four shall expire three years after such date, four shall expire two years after such date, and three shall expire one year after such date, as designated by the Secretary at the time of appointment.
(d) Applicability of section 14(a) of Federal Advisory Committee Act
Section 14(a) of the Federal Advisory Committee Act shall not apply to the Council.
(July 1, 1944, ch. 373, title II, §217,
References in Text
Section 14(a) of the Federal Advisory Committee Act, referred to in subsec. (d), is section 14(a) of
Amendments
1986—
Subsec. (c).
1985—Subsec. (a).
Subsec. (b).
Subsecs. (c) to (e), (g).
1984—Subsec. (a).
1983—Subsecs. (c), (d).
1980—Subsec. (a).
Subsec. (e)(1).
1978—Subsec. (f).
Subsec. (g)(1), (2).
1976—Subsec. (d).
1975—Subsec. (g).
1974—Subsec. (f).
1972—Subsec. (a).
Subsec. (b).
Subsec. (e).
1971—Subsec. (a).
Subsec. (b).
1970—Subsec. (a).
Subsec. (b).
Subsec. (d).
1950—Act Aug. 15, 1950, §3(d), amended section catchline to reflect addition of new advisory councils.
Subsec. (a). Act Aug. 15, 1950, §3(a), applied provisions to all of the advisory councils with regard to composition, qualifications, and appointment and tenure of members.
Subsec. (b). Act Aug. 15, 1950, §3(b), made subsection also applicable to new advisory councils.
Subsec. (c). Act Aug. 15, 1950, §3(c), redesignated subsec. (e) as (c) and repealed former subsec. (c).
Subsecs. (d), (f), (g). Act. Aug. 15, 1950, §3(c), repealed subsecs. (d), (f), and (g).
1948—Acts June 16, 1948, §4(c), and June 24, 1948, §4(c), included in section catchline the National Advisory Heart and Dental Research Councils, respectively.
Subsec. (a). Act June 16, 1948, §6(b), substituted "National Institutes of Health" for "National Institute of Health" in second sentence.
Subsec. (b). Acts June 16, 1948, §4(b), and June 24, 1948, §4(b), made subsection applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
Subsec. (f). Act June 16, 1948, §4(a), added subsec. (f) which established the National Advisory Heart Council.
Subsec. (g). Act June 24, 1948, §4(a), added subsec. (g) which established the National Advisory Dental Research Council.
1946—Act July 3, 1946, inserted "Mental Health" in section catchline.
Subsec. (b). Act July 3, 1946, inserted "or of the National Advisory Mental Health Council".
Subsecs. (d), (e). Act July 3, 1946, added subsecs. (d) and (e).
Effective Date of 1978 Amendment
Section 302(b) of
Effective Date of 1975 Amendment
Amendment by
Effective Date of 1974 Amendment
Section 211(b) of
Effective Date of 1972 Amendment
Section 9 of
Effective Date of 1971 Amendment
Section 7 of
"(a) This Act and the amendments made by this Act [enacting
"(b) The first sentence of section 454 of the Public Health Service Act [
"(c) Notwithstanding the provisions of subsection (a), members of the National Cancer Advisory Board (authorized under section 410B of the Public Health Service Act, as added by this Act) [
Effective Date of 1950 Amendment
Section 3(a), (c) of act Aug. 15, 1950, provided that the amendments and repeals made by that section are effective Oct. 1, 1950.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
For transfer of certain membership functions, insofar as they pertain to the Air Force, which functions were not previously transferred from Secretary of the Army to Secretary of the Air Force and from Department of the Army to Department of the Air Force, see Secretary of Defense Transfer Order No. 40 [App. C(7)], July 22, 1949.
Expiration of Terms of Office on September 30, 1950
Section 3(c) of act Aug. 15, 1950, provided in part that terms of office as members of national advisory councils pursuant to this section subsisting on Sept. 30, 1950, shall expire at the close of business on such day.
Termination of National Advisory Health Council
Section 3(a)(1) of
Termination of Advisory Committees
§218a. Training of officers; availability of appropriations for pay and allowances, tuition, fees, and expenses; payment by officer upon voluntary separation
(a) Appropriations available for the pay and allowances of commissioned officers of the Service shall also be available for the pay and allowances of any such officer on active duty while attending any Federal or non-Federal educational institution or training program and, subject to regulations of the President and to the limitation prescribed in such appropriations, for payment of his tuition, fees, and other necessary expenses incident to such attendance.
(b) Any officer whose tuition, fees, and other necessary expenses are paid pursuant to subsection (a) of this section while attending an educational institution or training program for a period in excess of thirty days shall be obligated to pay to the Service an amount equal to two times the total amount of such tuition, fees, and other necessary expenses received by such officer during such period, and two times the total amount of any compensation received by, and any allowance paid to, such officer during such period, if after return to active service such officer voluntarily leaves the Service within (1) six months, or (2) twice the period of such attendance, whichever is greater. Such subsequent period of service shall commence upon the cessation of such attendance and of any further continuous period of training duty for which no tuition and fees are paid by the Service and which is part of the officer's prescribed formal training program, whether such further training is at a Service facility or otherwise. The Surgeon General may waive, in whole or in part, any payment which may be required by this subsection upon a determination that such payment would be inequitable or would not be in the public interest.
(July 1, 1944, ch. 373, title II, §218, as added Feb. 28, 1948, ch. 83, §8,
Amendments
1979—Subsec. (b).
1956—Subsec. (a). Act Apr. 27, 1956, §6(a), authorized training of all officers of the Service, and substituted "any Federal or non-Federal educational institution or training program" for "any educational institution".
Subsec. (b). Act Apr. 27, 1956, §6(b), required reimbursement of tuition and fees by officers who receive training in excess of 30 days and who voluntarily leave the Service within a period of time which is equal to twice the period of such training, with a minimum period of six months of service, and a maximum period of two years, and permitted the Surgeon General to waive any reimbursement.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
§§219 to 224. Transferred
Codification
Section 219, acts July 1, 1944, ch. 373, title V, §501,
Section 220, act July 1, 1944, ch. 373, title V, §502,
Section 221, act July 1, 1944, ch. 373, title V, §503,
Section 222, acts July 1, 1944, ch. 373, title V, §504,
Section 223, act July 1, 1944, ch. 373, title V, §505,
Section 224, acts July 1, 1944, ch. 373, title V, §506,
A new title V (§501 et seq.) of the Public Health Service Act was added by
§225. Repealed. July 12, 1955, ch. 328, §5(4), 69 Stat. 296
Section, acts July 1, 1944, ch. 373, title V, §507,
Effective Date of Repeal
Repeal effective as of effective date of payment provisions of sections 361 to 365 of former Title 37, Pay and Allowances, except with respect to the deaths of members, see section 5 of act July 12, 1955.
§§225a to 227. Transferred
Codification
Section 225a, act July 1, 1944, ch. 373, title V, §507, as added June 24, 1967,
A prior section 507 of act July 1, 1944, ch. 373, title V, providing for settlement of accounts of deceased officers, was classified to
Section 226, act July 1, 1944, ch. 373, title V, §508,
Section 227, acts July 1, 1944, ch. 373, title V, §509
§227a. Omitted
Codification
Section,
Similar provisions were contained in the following prior appropriation acts:
§§228 to 229d. Transferred
Codification
Section 228, acts July 1, 1944, ch. 373, title V, §510,
Section 229, act July 1, 1944, ch. 373, title V, §511,
Section 229a, act July 1, 1944, ch. 373, title V, §512, as added Oct. 15, 1968,
Section 229b, act July 1, 1944, ch. 373, title V, §513, as added June 30, 1970,
Section 229c, act July 1, 1944, ch. 373, title V, §514, as added Nov. 9, 1978,
Section 229d, act July 1, 1944, ch. 373, title V, §515, formerly
§230. Repealed. Apr. 27, 1956, ch. 211, §5(e), 70 Stat. 117
Section, act July 1, 1944, ch. 373, title VII, §706, formerly title VI, §606,
§231. Service and supply fund; uses; reimbursement
A service and supply fund of $250,000 is established, without fiscal year limitation, for the payment of salaries, travel, and other expenses necessary to the maintenance and operation of (1) a supply service for the purchase, storage, handling, issuance, packing, or shipping of stationery, supplies, materials, equipment, and blank forms, for which stocks may be maintained to meet, in whole or in part, requirements of the Public Health Service and requisitions of other Government Offices, and (2) such other services as the Surgeon General, with the approval of the Secretary of Health and Human Services, determines may be performed more advantageously as central services; said fund to be reimbursed from applicable appropriations or funds available when services are performed or stock furnished, or in advance, on a basis of rates which shall include estimated or actual charges for personal services, materials, equipment (including maintenance, repairs, and depreciation), and other expenses.
(July 3, 1945, ch. 263, title II,
Codification
Section is from the Federal Security Appropriation Act, 1946, act July 3, 1945, and was not enacted as part of the Public Health Service Act which comprises this chapter.
Amendments
1983—
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§232. National Institute of Mental Health; authorization of appropriation; construction; location
There is authorized to be appropriated a sum not to exceed $7,500,000 for the erection and equipment, for the use of the Public Health Service in carrying out the provisions of this Act, of suitable and adequate hospital buildings and facilities, including necessary living quarters for personnel, and of suitable and adequate laboratory buildings and facilities, and such buildings and facilities shall be known as the National Institute of Mental Health. The Administrator of General Services is authorized to acquire, by purchase, condemnation, donation, or otherwise, a suitable and adequate site or sites, selected on the advice of the Surgeon General of the Public Health Service, in or near the District of Columbia for such buildings and facilities, and to erect thereon, furnish, and equip such buildings and facilities. The amount authorized to be appropriated in this section shall include the cost of preparation of drawings and specifications, supervision of construction, and other administrative expenses incident to the work: Provided, That the Administrator of General Services shall prepare the plans and specifications, make all necessary contracts, and supervise construction.
(July 3, 1946, ch. 538, §11,
References in Text
This Act, referred to in text, is act July 3, 1946, ch. 538,
Codification
Section was enacted as a part of the National Mental Health Act, and not as a part of the Public Health Service Act which comprises this chapter.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Works Agency and of all agencies thereof, together with functions of Federal Works Administrator transferred to Administrator of General Services by section 103(a) of act June 30, 1949, which is classified to
Effective Date of Transfer of Functions
Transfer of functions by act June 30, 1949, effective July 1, 1949, see section 605 of act June 30, 1949, set out as an Effective Date note under
§233. Civil actions or proceedings against commissioned officers or employees
(a) Exclusiveness of remedy
The remedy against the United States provided by
(b) Attorney General to defend action or proceeding; delivery of process to designated official; furnishing of copies of pleading and process to United States attorney, Attorney General, and Secretary
The Attorney General shall defend any civil action or proceeding brought in any court against any person referred to in subsection (a) of this section (or his estate) for any such damage or injury. Any such person against whom such civil action or proceeding is brought shall deliver within such time after date of service or knowledge of service as determined by the Attorney General, all process served upon him or an attested true copy thereof to his immediate superior or to whomever was designated by the Secretary to receive such papers and such person shall promptly furnish copies of the pleading and process therein to the United States attorney for the district embracing the place wherein the proceeding is brought, to the Attorney General, and to the Secretary.
(c) Removal to United States district court; procedure; proceeding upon removal deemed a tort action against United States; hearing on motion to remand to determine availability of remedy against United States; remand to State court or dismissal
Upon a certification by the Attorney General that the defendant was acting in the scope of his employment at the time of the incident out of which the suit arose, any such civil action or proceeding commenced in a State court shall be removed without bond at any time before trial by the Attorney General to the district court of the United States of the district and division embracing the place wherein it is pending and the proceeding deemed a tort action brought against the United States under the provisions of title 28 and all references thereto. Should a United States district court determine on a hearing on a motion to remand held before a trial on the merit that the case so removed is one in which a remedy by suit within the meaning of subsection (a) of this section is not available against the United States, the case shall be remanded to the State Court: Provided, That where such a remedy is precluded because of the availability of a remedy through proceedings for compensation or other benefits from the United States as provided by any other law, the case shall be dismissed, but in the event the running of any limitation of time for commencing, or filing an application or claim in, such proceedings for compensation or other benefits shall be deemed to have been suspended during the pendency of the civil action or proceeding under this section.
(d) Compromise or settlement of claim by Attorney General
The Attorney General may compromise or settle any claim asserted in such civil action or proceeding in the manner provided in
(e) Assault or battery
For purposes of this section, the provisions of
(f) Authority of Secretary or designee to hold harmless or provide liability insurance for assigned or detailed employees
The Secretary or his designee may, to the extent that he deems appropriate, hold harmless or provide liability insurance for any officer or employee of the Public Health Service for damage for personal injury, including death, negligently caused by such officer or employee while acting within the scope of his office or employment and as a result of the performance of medical, surgical, dental, or related functions, including the conduct of clinical studies or investigations, if such employee is assigned to a foreign country or detailed to a State or political subdivision thereof or to a non-profit institution, and if the circumstances are such as are likely to preclude the remedies of third persons against the United States described in
(g) Exclusivity of remedy against United States for entities deemed Public Health Service employees; subrogation of medical malpractice claims; applicable period; entity and contractor defined
(1) For purposes of this section, an entity described in paragraph (4) and any officer, employee, or contractor (subject to paragraph (5)) of such an entity who is a physician or other licensed or certified health care practitioner shall be deemed to be an employee of the Public Health Service for a calendar year that begins during a fiscal year for which a transfer of the full amount estimated under subsection (k)(1)(A) of this section was made under subsection (k)(3) of this section (subject to paragraph (3)). The remedy against the United States for an entity described in paragraph (4) and any officer, employee, or contractor (subject to paragraph (5)) of such an entity who is deemed to be an employee of the Public Health Service pursuant to this paragraph shall be exclusive of any other civil action or proceeding to the same extent as the remedy against the United States is exclusive pursuant to subsection (a) of this section.
(2) If, with respect to an entity or person deemed to be an employee for purposes of paragraph (1), a cause of action is instituted against the United States pursuant to this section, any claim of the entity or person for benefits under an insurance policy with respect to medical malpractice relating to such cause of action shall be subrogated to the United States.
(3) This subsection shall apply with respect to a cause of action arising from an act or omission which occurs on or after January 1, 1993. This subsection shall not apply with respect to a cause of action arising from an act or omission which occurs on or after January 1, 1996.
(4) An entity described in this paragraph is a public or non-profit private entity receiving Federal funds under any of the following grant programs:
(A)
(B)
(C)
(D)
(5) For purposes of paragraph (1), an individual may be considered a contractor of an entity described in paragraph (4) only if—
(A) the individual normally performs on average at least 32½ hours of service per week for the entity for the period of the contract; or
(B) in the case of an individual who normally performs on average less than 32½ hours of services per week for the entity for the period of the contract and is a licensed or certified provider of obstetrical services—
(i) the individual's medical malpractice liability insurance coverage does not extend to services performed by the individual for the entity under the contract, or
(ii) the Secretary finds that patients to whom the entity furnishes services will be deprived of obstetrical services if such individual is not considered a contractor of the entity for purposes of paragraph (1).
(h) Qualifications for designation as Public Health Service employee
Notwithstanding subsection (g)(1) of this section, the Secretary, in consultation with the Attorney General, may not deem an entity described in subsection (g)(4) of this section to be an employee of the Public Health Service Act 1 for purposes of this section unless the entity—
(1) has implemented appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions performed by the entity;
(2) has reviewed and verified the professional credentials, references, claims history, fitness, professional review organization findings, and license status of its physicians and other licensed or certified health care practitioners, and, where necessary, has obtained the permission from these individuals to gain access to this information;
(3) has no history of claims having been filed against the United States as a result of the application of this section to the entity or its officers, employees, or contractors as provided for under this section, or, if such a history exists, has fully cooperated with the Attorney General in defending against any such claims and either has taken, or will take, any necessary corrective steps to assure against such claims in the future; and
(4) has fully cooperated with the Attorney General in providing information relating to an estimate described under subsection (k) of this section.
(i) Authority of Attorney General to exclude health care professionals from coverage
(1) Notwithstanding subsection (g)(1) of this section, the Attorney General, in consultation with the Secretary, may determine, after notice and opportunity for a hearing, that an individual physician or other licensed or certified health care practitioner who is an officer, employee, or contractor of an entity described in subsection (g)(4) of this section shall not be deemed to be an employee of the Public Health Service for purposes of this section, if treating such individual as such an employee would expose the Government to an unreasonably high degree of risk of loss because such individual—
(A) does not comply with the policies and procedures that the entity has implemented pursuant to subsection (h)(1) of this section;
(B) has a history of claims filed against him or her as provided for under this section that is outside the norm for licensed or certified health care practitioners within the same specialty;
(C) refused to reasonably cooperate with the Attorney General in defending against any such claim;
(D) provided false information relevant to the individual's performance of his or her duties to the Secretary, the Attorney General, or an applicant for or recipient of funds under this chapter; or
(E) was the subject of disciplinary action taken by a State medical licensing authority or a State or national professional society.
(2) A final determination by the Attorney General under this subsection that an individual physician or other licensed or certified health care professional shall not be deemed to be an employee of the Public Health Service shall be effective upon receipt by the entity employing such individual of notice of such determination, and shall apply only to acts or omissions occurring after the date such notice is received.
(j) Remedy for denial of hospital admitting privileges to certain health care providers
In the case of a health care provider who is an officer, employee, or contractor of an entity described in subsection (g)(4) of this section,
(k) Estimate of annual claims by Attorney General; criteria; establishment of fund; transfer of funds to Treasury accounts
(1)(A) For each of the fiscal years 1993, 1994, and 1995, the Attorney General, in consultation with the Secretary, shall estimate by the beginning of the year (except that an estimate shall be made for fiscal year 1993 by December 31, 1992, subject to an adjustment within 90 days thereafter) the amount of all claims which are expected to arise under this section (together with related fees and expenses of witnesses) for which payment is expected to be made in accordance with section 1346 and
(B) The estimate under subparagraph (A) shall take into account—
(i) the value and frequency of all claims for damage for personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions by entities described in subsection (g)(4) of this section or by officers, employees, or contractors (subject to subsection (g)(5) of this section) of such entities who are deemed to be employees of the Public Health Service under subsection (g)(1) of this section that, during the preceding 5-year period, are filed under this section or, with respect to years occurring before this subsection takes effect, are filed against persons other than the United States,
(ii) the amounts paid during that 5-year period on all claims described in clause (i), regardless of when such claims were filed, adjusted to reflect payments which would not be permitted under section 1346 and
(iii) amounts in the fund established under paragraph (2) but unspent from prior fiscal years.
(2) Subject to appropriations, for each of the fiscal years 1993, 1994, and 1995, the Secretary shall establish a fund of an amount equal to the amount estimated under paragraph (1) that is attributable to entities receiving funds under each of the grant programs described in paragraph (4) of subsection (g) of this section, but not to exceed a total of $30,000,000 for each such fiscal year. Appropriations for purposes of this paragraph shall be made separate from appropriations made for purposes of
(3) In order for payments to be made for judgments against the United States (together with related fees and expenses of witnesses) pursuant to this section arising from the acts or omissions of entities described in subsection (g)(4) of this section and of officers, employees, or contractors (subject to subsection (g)(5) of this section) of such entities, the total amount contained within the fund established by the Secretary under paragraph (2) for a fiscal year shall be transferred not later than the December 31 that occurs during the fiscal year to the appropriate accounts in the Treasury.
(July 1, 1944, ch. 373, title II, §224, formerly §223, as added Dec. 31, 1970,
Amendments
1993—Subsec. (k)(2).
1992—Subsecs. (g) to (k).
Effective Date of 1992 Amendment
Section 6 of
Report on Risk Exposure of Covered Entities
Section 5 of
"(a)
"(b)
"(1) the Secretary's estimate of the aggregate amounts that such entities (together with the officers, employees, and contractors of such entities who are subject to section 224(g) of such Act) would have directly or indirectly paid to obtain medical malpractice liability insurance coverage had section 224(g) of the Public Health Service Act not been enacted into law, with
"(2) the aggregate amounts by which the grants received by such entities under the Public Health Service Act [this chapter] were reduced as a result of the enactment of section 224(k)(2) of such Act [
Section Referred to in Other Sections
This section is referred to in
1 So in original. The word "Act" probably should not appear.
§234. Repealed. Pub. L. 94–484, title IV, §408(b)(1), Oct. 12, 1976, 90 Stat. 2281 , eff. Oct. 1, 1977
Section, act July 1, 1944, ch. 373, title II, §225, as added Oct. 27, 1972,
§235. Administration of grants in multigrant projects; promulgation of regulations
For the purpose of facilitating the administration of, and expediting the carrying out of the purposes of, the programs established by subchapters V, VI, and VII 1 of this chapter, and sections 242b, 246(a), 246(b), 246(c), 246(d),1 and 246(e) 1 of this title in situations in which grants are sought or made under two or more of such programs with respect to a single project, the Secretary is authorized to promulgate regulations—
(1) under which the administrative functions under such programs with respect to such project will be performed by a single administrative unit which is the administrative unit charged with the administration of any of such programs or is the administrative unit charged with the supervision of two or more of such programs;
(2) designed to reduce the number of applications, reports, and other materials required under such programs to be submitted with respect to such project, and otherwise to simplify, consolidate, and make uniform (to the extent feasible), the data and information required to be contained in such applications, reports, and other materials; and
(3) under which inconsistent or duplicative requirements imposed by such programs will be revised and made uniform with respect to such project;
except that nothing in this section shall be construed to authorize the Secretary to waive or suspend, with respect to any such project, any requirement with respect to any of such programs if such requirement is imposed by law or by any regulation required by law.
(July 1, 1944, ch. 373, title II, §226, formerly title III, §310A, as added Oct. 30, 1970,
References in Text
Subchapters V and VI of this chapter, referred to in text, are classified to sections 292 et seq. and 296 et seq., respectively, of this title.
Subchapter VII of this chapter, referred to in text, which was classified to
Codification
Section was formerly classified to
Amendments
1971—
1 See References in Text note below.
§236. Orphan Products Board
(a) Establishment; composition; chairman
There is established in the Department of Health and Human Services a board for the development of drugs (including biologics) and devices (including diagnostic products) for rare diseases or conditions to be known as the Orphan Products Board. The Board shall be comprised of the Assistant Secretary for Health of the Department of Health and Human Services and representatives, selected by the Secretary, of the Food and Drug Administration, the National Institutes of Health, the Centers for Disease Control and Prevention, and any other Federal department or agency which the Secretary determines has activities relating to drugs and devices for rare diseases or conditions. The Assistant Secretary for Health shall chair the Board.
(b) Function
The function of the Board shall be to promote the development of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies in carrying out their respective functions relating to the development of such articles for such diseases or conditions.
(c) Duties with respect to drugs for rare diseases or conditions
In the case of drugs for rare diseases or conditions the Board shall—
(1) evaluate—
(A) the effect of subchapter B of the Federal Food, Drug, and Cosmetic Act [
(B) the implementation of such subchapter; 1
(2) evaluate the activities of the National Institutes of Health for the development of drugs for such diseases or conditions,
(3) assure appropriate coordination among the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention in the carrying out of their respective functions relating to the development of drugs for such diseases or conditions to assure that the activities of each agency are complementary,
(4) assure appropriate coordination among all interested Federal agencies, manufacturers, and organizations representing patients, in their activities relating to such drugs,
(5) with the consent of the sponsor of a drug for a rare disease or condition exempt under section 505(i) of the Federal Food, Drug, and Cosmetic Act [
(6) seek business entities and others to undertake the sponsorship of drugs for rare diseases or conditions, seek investigators to facilitate the development of such drugs, and seek business entities to participate in the distribution of such drugs, and
(7) recognize the efforts of public and private entities and individuals in seeking the development of drugs for rare diseases or conditions and in developing such drugs.
(d) Consultation
The Board shall consult with interested persons respecting the activities of the Board under this section and as part of such consultation shall provide the opportunity for the submission of oral views.
(e) Annual report; contents
The Board shall submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives an annual report—
(1) identifying the drugs which have been designated under section 526 of the Federal Food, Drug, and Cosmetic Act [
(2) describing the activities of the Board, and
(3) containing the results of the evaluations carried out by the Board.
The Director of the National Institutes of Health shall submit to the Board for inclusion in the annual report a report on the rare disease and condition research activities of the Institutes of the National Institutes of Health; the Secretary of the Treasury shall submit to the Board for inclusion in the annual report a report on the use of the credit against tax provided by section 44H 2 of title 26; and the Secretary of Health and Human Services shall submit to the Board for inclusion in the annual report a report on the program of assistance under
(July 1, 1944, ch. 373, title II, §227, as added Jan. 4, 1983,
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(1)(A), is act June 25, 1938, ch. 675,
Prior Provisions
A prior section 236, act July 1, 1944, ch. 373, title II, §227, formerly title III, §310B, as added Oct. 30, 1970,
Amendments
1992—Subsec. (a).
Subsec. (c)(2).
Subsec. (c)(3).
Subsec. (e).
1986—Subsec. (e).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1992 Amendment
Section 801 of
"(a)
"(b)
"(c)
"(d)
"(1)
"(2)
"(A) Except as provided in subparagraph (B), in the case of any program making awards of grants, cooperative agreements, or contracts, if the program began operation prior to the date of the enactment of this Act [July 10, 1992] and the program is amended by this Act, awards made prior to October 1, 1992, shall continue to be subject to the terms and conditions upon which such awards were made, notwithstanding the amendments made by this Act.
"(B) Subparagraph (A) does not apply with respect to the amendments made by this Act to part B of title XIX of the Public Health Service Act [
Use of "CDC" as Acronym for Centers for Disease Control and Prevention
Section 312(i) of
National Commission on Orphan Diseases
"(a)
"(b)
"(1) basic research conducted on rare diseases;
"(2) the use in research on rare diseases of knowledge developed in other research;
"(3) applied and clinical research on the prevention, diagnosis, and treatment of rare diseases; and
"(4) the dissemination to the public, health care professionals, researchers, and drug and medical device manufacturers of knowledge developed in research on rare diseases and other diseases which can be used in the prevention, diagnosis, and treatment of rare diseases.
"(c)
"(1) the appropriateness of the priorities currently placed on research on rare diseases;
"(2) the relative effectiveness of grants and contracts when used to fund research on rare diseases;
"(3) the appropriateness of specific requirements applicable to applications for funds for research on rare diseases taking into consideration the reasonable capacity of applicants to meet such requirements;
"(4) the adequacy of the scientific basis for such research, including the adequacy of the research facilities and research resources used in such research and the appropriateness of the scientific training of the personnel engaged in such research;
"(5) the effectiveness of activities undertaken to encourage such research;
"(6) the organization of the peer review process applicable to applications for funds for such research to determine if the organization of the peer review process could be revised to improve the effectiveness of the review provided to proposals for research on rare diseases;
"(7) the effectiveness of the coordination between the national research institutes of the National Institutes of Health, the Food and Drug Administration, and private entities in supporting such research; and
"(8) the effectiveness of activities undertaken to assure that knowledge developed in research on nonrare diseases is, when appropriate, used in research on rare diseases.
"(d)
"(1) Ten members shall be appointed from individuals who are not officers or employees of the Government and who by virtue of their training or experience in research on rare diseases or in the treatment of rare diseases are qualified to serve on the Commission.
"(2) Five members shall be appointed from individuals who are not officers or employees of the Government and who have a rare disease or are employed to represent or are members of an organization concerned about rare disease.
"(3) Four nonvoting members shall be appointed for the directors of the national research institutes of the National Institutes of Health which the Secretary determines are involved with rare diseases.
"(4) One nonvoting member shall be appointed from officers or employees of the Food and Drug Administration who the Secretary determines are involved with rare diseases.
A vacancy in the Commission shall be filled in the manner in which the original appointment was made. If any member of the Commission who was appointed to the Commission as a director of a national research institute or as an officer or employee of the Food and Drug Administration leaves that office or position, or if any member of the Commission who was appointed from persons who are not officers or employees of the Government becomes an officer or employee of the Government, such member may continue as a member of the Commission for not longer than the ninety-day period beginning on the date such member leaves that office or position or becomes such an officer or employee, as the case may be.
"(e)
"(f)
"(1) Except as provided in paragraph (2), members of the Commission shall each be entitled to receive compensation at a rate not to exceed the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule for each day (including traveltime) during which they are engaged in the actual performance of duties as members of the Commission.
"(2) Members of the Commission who are full-time officers or employees of the Government shall receive no additional pay by reason of their service on the Commission.
"(g)
"(h)
"(i)
"(j)
"(k)
"(l)
"(m)
"(n)
"(1) a long range plan for the use of public and private resources to improve research into rare diseases and to assist in the prevention, diagnosis, and treatment of rare diseases; and
"(2) such legislation or administrative actions as it considers appropriate.
"(o)
"(p)
1 So in original. The semicolon probably should be a comma.
2 See References in Text note below.
§237. Silvio O. Conte Senior Biomedical Research Service
(a) Creation; number of members
(1) There shall be in the Public Health Service a Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members.
(2) The authority established in paragraph (1) regarding the number of members in the Silvio O. Conte Senior Biomedical Research Service is in addition to any authority established regarding the number of members in the commissioned Regular Corps, in the Reserve Corps, and in the Senior Executive Service. Such paragraph may not be construed to require that the number of members in the commissioned Regular Corps, in the Reserve Corps, or in the Senior Executive Service be reduced to offset the number of members serving in the Silvio O. Conte Senior Biomedical Research Service (in this section referred to as the "Service").
(b) Appointments; qualifications; provisions inapplicable to members
The Service shall be appointed by the Secretary without regard to the provisions of title 5 regarding appointment, and shall consist of individuals outstanding in the field of biomedical research or clinical research evaluation. No individual may be appointed to the Service unless such individual (1) has earned a doctoral level degree in biomedicine or a related field, and (2) meets the qualification standards prescribed by the Office of Personnel Management for appointment to a position at GS–15 of the General Schedule. Notwithstanding any previous applicability to an individual who is a member of the Service, the provisions of subchapter I of
(c) Performance appraisal system
The Secretary shall develop a performance appraisal system designed to—
(1) provide for the systematic appraisal of the performance of members, and
(2) encourage excellence in performance by members.
(d) Pay of members
(1) The Secretary shall determine, subject to the provisions of this subsection, the pay of members of the Service.
(2) The pay of a member of the Service shall not be less than the minimum rate payable for GS–15 of the General Schedule and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under
(e) Contribution to retirement system of institutions of higher education
The Secretary may, upon the request of a member who—
(1) performed service in the employ of an institution of higher education immediately prior to his appointment as a member of the Service, and
(2) retains the right to continue to make contributions to the retirement system of such institution,
contribute an amount not to exceed 10 percent per annum of the member's basic pay to such institution's retirement system on behalf of such member. A member who requests that such contribution be made shall not be covered by, or earn service credit under, any retirement system established for employees of the United States under title 5, but such service shall be creditable for determining years of service under section 6303(a) of such title.
(f) Career and noncareer appointment of certain individuals
Subject to the following sentence, the Secretary may, notwithstanding the provisions of title 5 regarding appointment, appoint an individual who is separated from the Service involuntarily and without cause to a position in the competitive civil service at GS–15 of the General Schedule, and such appointment shall be a career appointment. In the case of such an individual who immediately prior to his appointment to the Service was not a career appointee in the civil service or the Senior Executive Service, such appointment shall be in the excepted civil service and may not exceed a period of 2 years.
(g) Rules and regulations
The Secretary shall promulgate such rules and regulations, not inconsistent with this section, as may be necessary for the efficient administration of the Service.
(July 1, 1944, ch. 373, title II, §228, as added Nov. 5, 1990,
References in Text
The General Schedule, referred to in subsecs. (b), (d)(2), and (f), is set out under
The provisions of title 5 regarding appointments, referred to in subsecs. (b) and (f), are classified to
Level I of the Executive Schedule, referred to in subsec. (d)(2), is set out in
Amendments
1993—
Subsec. (a).
Effective Date
Section effective on the 90th day following Nov. 5, 1990, see section 529 [title III, §304(c)] of
Section Referred to in Other Sections
This section is referred to in
Part B—Miscellaneous Provisions
Codification
This part was classified to subchapter XXV (§300aaa et seq.) of this chapter prior to its renumbering by
§238. Gifts for benefit of Service
(a) Acceptance by Secretary
The Secretary of Health and Human Services is authorized to accept on behalf of the United States gifts made unconditionally by will or otherwise for the benefit of the Service or for the carrying out of any of its functions. Conditional gifts may be so accepted if recommended by the Surgeon General, and the principal of and income from any such conditional gift shall be held, invested, reinvested, and used in accordance with its conditions, but no gift shall be accepted which is conditioned upon any expenditure not to be met therefrom or from the income thereof unless such expenditure has been approved by Act of Congress.
(b) Depository of funds; availability for expenditure
Any unconditional gift of money accepted pursuant to the authority granted in subsection (a) of this section, the net proceeds from the liquidation (pursuant to subsection (c) or subsection (d) of this section) of any other property so accepted, and the proceeds of insurance on any such gift property not used for its restoration, shall be deposited in the Treasury of the United States and are hereby appropriated and shall be held in trust by the Secretary of the Treasury for the benefit of the Service, and he may invest and reinvest such funds in interest-bearing obligations of the United States or in obligations guaranteed as to both principal and interest by the United States. Such gifts and the income from such investments shall be available for expenditure in the operation of the Service and the performance of its functions, subject to the same examination and audit as is provided for appropriations made for the Service by Congress.
(c) Evidences of unconditional gifts of intangible property
The evidences of any unconditional gift of intangible personal property, other than money, accepted pursuant to the authority granted in subsection (a) of this section shall be deposited with the Secretary of the Treasury and he, in his discretion, may hold them, or liquidate them except that they shall be liquidated upon the request of the Secretary of Health and Human Services whenever necessary to meet payments required in the operation of the Service or the performance of its functions. The proceeds and income from any such property held by the Secretary of the Treasury shall be available for expenditure as is provided in subsection (b) of this section.
(d) Real property or tangible personal property
The Secretary of Health and Human Services, shall hold any real property or any tangible personal property accepted unconditionally pursuant to the authority granted in subsection (a) of this section and he shall permit such property to be used for the operation of the Service and the performance of its functions or he may lease or hire such property, and may insure such property, and deposit the income thereof with the Secretary of the Treasury to be available for expenditure as provided in subsection (b) of this section: Provided, That the income from any such real property or tangible personal property shall be available for expenditure in the discretion of the Secretary of Health and Human Services, for the maintenance, preservation, or repair and insurance of such property and that any proceeds from insurance may be used to restore the property insured. Any such property when not required for the operation of the Service or the performance of its functions may be liquidated by the Secretary of Health and Human Services, and the proceeds thereof deposited with the Secretary of the Treasury, whenever in his judgment the purposes of the gifts will be served thereby.
(July 1, 1944, ch. 373, title II, §231, formerly title V, §501,
Codification
Section was formerly classified to
Amendments
1968—Subsec. (e).
1948—Subsec. (e). Act June 16, 1948, substituted "National Institutes of Health" for "National Institute of Health".
1946—Subsec. (e). Act July 3, 1946, inserted reference to National Institute of Mental Health.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Cross References
National Institutes of Health gift fund and conditional gift fund to be classified on books of Treasury as trust funds, see
Section Referred to in Other Sections
This section is referred to in
§238a. Use of immigration station hospitals
The Immigration and Naturalization Service may, by agreement of the heads of the departments concerned, permit the Public Health Service to use hospitals at immigration stations for the care of Public Health Service patients. The Surgeon General shall reimburse the Immigration and Naturalization Service for the actual cost of furnishing fuel, light, water, telephone, and similar supplies and services, which reimbursement shall be covered into the proper Immigration and Naturalization Service appropriation, or such costs may be paid from working funds established as provided by law, but no charge shall be made for the expense of physical upkeep of the hospitals. The Immigration and Naturalization Service shall reimburse the Surgeon General for the care and treatment of persons detained in hospitals of the Public Health Service at the request of the Immigration and Naturalization Service unless such persons are entitled to care and treatment under section 249(a) 1 of this title.
(July 1, 1944, ch. 373, title II, §232, formerly title V, §502,
References in Text
Subsec. (a) of
Codification
Section was formerly classified to
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of all other officers of Department of Justice and functions of all agencies and employees of such Department, with a few exceptions, transferred to Attorney General, with power vested in him to authorize their performance or performance of any of his functions by any of such officers, agencies, and employees, by sections 1 and 2 of Reorg. Plan No. 2 of 1950, eff. May 24, 1950, 15 F.R. 3173,
1 See References in Text note below.
§238b. Disposition of money collected for care of patients
Money collected as provided by law for expenses incurred in the care and treatment of foreign seamen, and money received for the care and treatment of pay patients, including any amounts received from any executive department on account of care and treatment of pay patients, shall be covered into the appropriation from which the expenses of such care and treatment were paid.
(July 1, 1944, ch. 373, title II, §233, formerly title V, §503,
Codification
Section was formerly classified to
§238c. Transportation of remains of officers
Appropriations available for traveling expenses of the Service shall be available for meeting the cost of preparation for burial and of transportation to the place of burial of remains of commissioned officers, and of personnel specified in regulations, who die in line of duty. Appropriations available for carrying out the provisions of this chapter shall also be available for the payment of such expenses relating to the recovery, care and disposition of the remains of personnel or their dependents as may be authorized under other provisions of law.
(July 1, 1944, ch. 373, title II, §234, formerly title V, §506,
Codification
Section was formerly classified to
Amendments
1954—Act July 15, 1954, inserted sentence at end relating to availability of appropriations for paying expenses relating to recovery, care, and disposition of the remains of personnel or their dependents.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Disposition of Remains of Deceased Personnel
Recovery, care and disposition of the remains of deceased members of the uniformed services and other deceased personnel, see
§238d. Availability of appropriations for grants to Federal institutions
Appropriations to the Public Health Service available under this chapter for research, training, or demonstration project grants or for grants to expand existing treatment and research programs and facilities for alcoholism, narcotic addiction, drug abuse, and drug dependence and appropriations under title VI of the Mental Health Systems Act [
(July 1, 1944, ch. 373, title II, §235, formerly title V, §507, as added June 24, 1967,
References in Text
The Mental Health Systems Act, referred to in text, is
Codification
Section was formerly classified to
Amendments
1981—
1980—
1976—
1970—
Effective Date of 1981 Amendment
Amendment by
Effective Date
Section 5 of
§238e. Transfer of funds
For the purpose of any reorganization under
(July 1, 1944, ch. 373, title II, §236, formerly title V, §508,
Codification
Section was formerly classified to
Transfer of Functions
Functions vested by law (including reorganization plan) in Bureau of the Budget or Director of Bureau of the Budget transferred to President of the United States by section 101 of Reorg. Plan No. 2 of 1970, eff. July 1, 1970, 35 F.R. 7959,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§238f. Availability of appropriations
Appropriations for carrying out the purposes of this chapter shall be available for expenditure for personal services and rent at the seat of Government; books of reference, periodicals, and exhibits; printing and binding; transporting in Government-owned automotive equipment, to and from school, children of personnel who have quarters for themselves and their families at stations determined by the Surgeon General to be isolated stations; expenses incurred in pursuing, identifying, and returning prisoners who escape from any hospital, institution, or station of the Service or from the custody of any officer or employee of the Service, including rewards for the capture of such prisoners; furnishing, repairing, and cleaning such wearing apparel as may be prescribed by the Surgeon General for use by employees in the performance of their official duties; reimbursing officers and employees, subject to regulations of the Secretary, for the cost of repairing or replacing their personal belongings damaged or destroyed by patients while such officers or employees are engaged in the performance of their official duties; and maintenance of buildings of the National Institutes of Health.
(July 1, 1944, ch. 373, title II, §237, formerly title V, §509,
Codification
Section was formerly classified to
Amendments
1948—Act June 25, 1948, amended section generally to make it apply to all appropriations to carry out the purposes of the Service instead of merely to appropriations to carry out the research functions of the Service.
Act June 16, 1948, substituted "National Institutes of Health" for "National Institute of Health".
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Buy American Provisions
Section 2004 of
"(a)
"(b)
"(1)
"(2)
Availability of Appropriations for Active Commissioned Officers and Other Expenses
Similar provisions were contained in the following prior appropriation acts:
Crediting of Payments for Room and Board to Appropriation Accounts
Similar provisions were contained in the following prior appropriation acts:
§238g. Wearing of uniforms
Except as may be authorized by regulations of the President, the insignia and uniform of commissioned officers of the Service, or any distinctive part of such insignia or uniform, or any insignia or uniform any part of which is similar to a distinctive part thereof, shall not be worn, after the promulgation of such regulations, by any person other than a commissioned officer of the Service.
(July 1, 1944, ch. 373, title II, §238, formerly title V, §510,
Codification
Section was formerly classified to
Amendments
1948—Act June 25, 1948, struck out penal provisions. See
Effective Date of 1948 Amendment
Amendment effective Sept. 1, 1948, see section 20 of act June 25, 1948.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
§238h. Annual report of Surgeon General
The Surgeon General shall transmit to the Secretary, for submission to the Congress at the beginning of each regular session, a full report of the administration of the functions of the Service under this chapter, including a detailed statement of receipts and disbursements.
(July 1, 1944, ch. 373, title II, §239, formerly title V, §511,
Codification
Section was formerly classified to
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Agency Reporting Requirements; Report by Secretary of Health, Education, and Welfare to Congressional Committees Relating to Requirements, Termination, etc.
§238i. Memorials and other acknowledgments for contributions to health of Nation
The Secretary may provide for suitably acknowledging, within the Department (whether by memorials, designations, or other suitable acknowledgments), (1) efforts of persons who have contributed substantially to the health of the Nation and (2) gifts for use in activities of the Department related to health.
(July 1, 1944, ch. 373, title II, §240, formerly title V, §512, as added Oct. 15, 1968,
Codification
Section was formerly classified to
§238j. Evaluation of programs
(a) In general
Such portion as the Secretary shall determine, but not less than 0.2 percent nor more than 1 percent, of any amounts appropriated for programs authorized under this chapter shall be made available for the evaluation (directly, or by grants of contracts) of the implementation and effectiveness of such programs.
(b) Report on evaluations
Not later than February 1 of each year, the Secretary shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives a report summarizing the findings of the evaluations conducted under subsection (a) of this section.
(July 1, 1944, ch. 373, title II, §241, formerly title V, §513, as added June 30, 1970,
Codification
Section was formerly classified to
Amendments
1993—
1981—
1980—
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1993 Amendment
Section 701 of
Effective Date of 1981 Amendment
Amendment by
Section Referred to in Other Sections
This section is referred to in
§238k. Contract authority
The authority of the Secretary to enter into contracts under this chapter shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance by appropriation Acts.
(July 1, 1944, ch. 373, title II, §242, formerly title V, §514, as added Nov. 9, 1978,
Codification
Section was formerly classified to
§238l. Recovery
(a) Right of United States to recover base amount plus interest
If any facility with respect to which funds have been paid under the Community Mental Health Centers Act [
(1) sold or transferred to any entity (A) which would not have been qualified to file an application under section 222 of such Act [
(2) ceases to be used by a community mental health center in the provision of comprehensive mental health services,
the United States shall be entitled to recover from the transferor, transferee, or owner of the facility, the base amount prescribed by subsection (c)(1) of this section plus the interest (if any) prescribed by subsection (c)(2) of this section.
(b) Notice of sale, transfer, or change
The transferor and transferee of a facility that is sold or transferred as described in subsection (a)(1) of this section, or the owner of a facility the use of which changes as described in subsection (a)(2) of this section, shall provide the Secretary written notice of such sale, transfer, or change within 10 days after the date on which such sale, transfer, or cessation of use occurs or within 30 days after October 22, 1985, whichever is later.
(c) Base amount; interest
(1) The base amount that the United States is entitled to recover under subsection (a) of this section is the amount bearing the same ratio to the then value (as determined by the agreement of the parties or in an action brought in the district court of the United States for the district in which the facility is situated) of so much of the facility as constituted an approved project or projects as the amount of the Federal participation bore to the cost of the remodeling, construction, expansion, or acquisition of the project or projects.
(2)(A) The interest that the United States is entitled to recover under subsection (a) of this section is the interest for the period (if any) described in subparagraph (B) at a rate (determined by the Secretary) based on the average of the bond equivalent rates of ninety-one-day Treasury bills auctioned during that period.
(B) The period referred to in subparagraph (A) is the period beginning—
(i) if notice is provided as prescribed by subsection (b) of this section, 191 days after the date on which such sale, transfer, or cessation of use occurs, or
(ii) if notice is not provided as prescribed by subsection (b) of this section, 11 days after such sale, transfer, or cessation of use occurs,
and ending on the date the amount the United States is entitled to recover is collected.
(d) Waiver of recovery rights
The Secretary may waive the recovery rights of the United States under subsection (a) of this section with respect to a facility (under such conditions as the Secretary may establish by regulation) if the Secretary determines that there is good cause for waiving such rights.
(e) Pre-judgment lien
The right of recovery of the United States under subsection (a) of this section shall not, prior to judgment, constitute a lien on any facility.
(July 1, 1944, ch. 373, title II, §243, formerly title V, §515, formerly
References in Text
The Community Mental Health Centers Act, referred to in subsec. (a), is title II of
Codification
Section was classified to
Amendments
1991—Subsec. (d).
1985—
"(1) sold or transferred to any person or entity (A) which is not qualified to file an application under section 222 of the Community Mental Health Centers Act, or (B) which is not approved as a transferee by the State agency of the State in which such facility is located, or its successor; or
"(2) not used by a community mental health center in the provision of comprehensive mental health services, and the Secretary has not determined that there is good cause for termination of such use,
the United States shall be entitled to recover from either the transferor or the transferee in the case of a sale or transfer or from the owner in the case of termination of use an amount bearing the same ratio to the then value (as determined by the agreement of the parties or by action brought in the United States district court for the district in which the center is situated) of so much of such facility or center as constituted an approved project or projects, as the amount of the Federal participation bore to the acquisition, remodeling, construction, or expansion cost of such project or projects. Such right of recovery shall not constitute a lien upon such facility or center prior to judgment."
1981—
1978—
Effective Date of 1985 Amendment
Section 226(b) of
Effective Date of 1981 Amendment
Section 902(h) of
Effective Date of 1978 Amendment
Section 110(c) of
Effective Date
Section effective July 1, 1975, see section 608 of
Other Legal Rights of United States Not Adversely Affected by 1985 Amendment
Section 226(c) of
§238m. Use of fiscal agents
(a) Contracting authority
The Secretary may enter into contracts with fiscal agents—
(1)(A) to determine the amounts payable to persons who, on behalf of the Indian Health Service, furnish health services to eligible Indians,
(B) to determine the amounts payable to persons who, on behalf of the Public Health Service, furnish health services to individuals pursuant to
(2) to receive, disburse, and account for funds in making payments described in paragraph (1),
(3) to make such audits of records as may be necessary to assure that these payments are proper, and
(4) to perform such additional functions as may be necessary to carry out the functions described in paragraphs (1) through (3).
(b) Contracting prerequisites
(1) Contracts under subsection (a) of this section may be entered into without regard to
(2) No such contract shall be entered into with an entity unless the Secretary finds that the entity will perform its obligations under the contract efficiently and effectively and will meet such requirements as to financial responsibility, legal authority, and other matters as he finds pertinent.
(c) Advances under contracts
A contract under subsection (a) of this section may provide for advances of funds to enable entities to make payments under the contract.
(d) Applicable statutory provisions
Subsections (d) and (e) of
(e) "Fiscal agent" defined
In this section, the term "fiscal agent" means a carrier described in
(July 1, 1944, ch. 373, title II, §244, formerly title XXI, §2116, as added Apr. 7, 1986,
References in Text
The Indian Self-Determination Act, referred to in subsec. (e), is title I of
Codification
Section was classified to
SUBCHAPTER II—GENERAL POWERS AND DUTIES
Part A—Research and Investigations
§241. Research and investigations generally
(a) Authority of Secretary
The Secretary shall conduct in the Service, and encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scientists in the conduct of, and promote the coordination of, research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man, including water purification, sewage treatment, and pollution of lakes and streams. In carrying out the foregoing the Secretary is authorized to—
(1) collect and make available through publications and other appropriate means, information as to, and the practical application of, such research and other activities;
(2) make available research facilities of the Service to appropriate public authorities, and to health officials and scientists engaged in special study;
(3) make grants-in-aid to universities, hospitals, laboratories, and other public or private institutions, and to individuals for such research projects as are recommended by the advisory council to the entity of the Department supporting such projects and make, upon recommendation of the advisory council to the appropriate entity of the Department, grants-in-aid to public or nonprofit universities, hospitals, laboratories, and other institutions for the general support of their research;
(4) secure from time to time and for such periods as he deems advisable, the assistance and advice of experts, scholars, and consultants from the United States or abroad;
(5) for purposes of study, admit and treat at institutions, hospitals, and stations of the Service, persons not otherwise eligible for such treatment;
(6) make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of statistical methods to experiments, studies, and surveys in health and medical fields;
(7) enter into contracts, including contracts for research in accordance with and subject to the provisions of law applicable to contracts entered into by the military departments under
(8) adopt, upon recommendations of the advisory councils to the appropriate entities of the Department or, with respect to mental health, the National Advisory Mental Health Council, such additional means as the Secretary considers necessary or appropriate to carry out the purposes of this section.
The Secretary may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
(b) Testing for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects; consultation
(1) The Secretary shall conduct and may support through grants and contracts studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects. In carrying out this paragraph, the Secretary shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct for such entity studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects.
(2)(A) The Secretary shall establish a comprehensive program of research into the biological effects of low-level ionizing radiation under which program the Secretary shall conduct such research and may support such research by others through grants and contracts.
(B) The Secretary shall conduct a comprehensive review of Federal programs of research on the biological effects of ionizing radiation.
(3) The Secretary shall conduct and may support through grants and contracts research and studies on human nutrition, with particular emphasis on the role of nutrition in the prevention and treatment of disease and on the maintenance and promotion of health, and programs for the dissemination of information respecting human nutrition to health professionals and the public. In carrying out activities under this paragraph, the Secretary shall provide for the coordination of such of these activities as are performed by the different divisions within the Department of Health and Human Services and shall consult with entities of the Federal Government, outside of the Department of Health and Human Services, engaged in comparable activities. The Secretary, upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct and support such activities for such entity.
(4) The Secretary shall publish a biennial report which contains—
(A) a list of all substances (i) which either are known to be carcinogens or may reasonably be anticipated to be carcinogens and (ii) to which a significant number of persons residing in the United States are exposed;
(B) information concerning the nature of such exposure and the estimated number of persons exposed to such substances;
(C) a statement identifying (i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or exposure standard has been established by a Federal agency, and (ii) for each effluent, ambient, or exposure standard established by a Federal agency with respect to a substance contained in the list under subparagraph (A), the extent to which, on the basis of available medical, scientific, or other data, such standard, and the implementation of such standard by the agency, decreases the risk to public health from exposure to the substance; and
(D) a description of (i) each request received during the year involved—
(I) from a Federal agency outside the Department of Health and Human Services for the Secretary, or
(II) from an entity within the Department of Health and Human Services to any other entity within the Department,
to conduct research into, or testing for, the carcinogenicity of substances or to provide information described in clause (ii) of subparagraph (C), and (ii) how the Secretary and each such other entity, respectively, have responded to each such request.
(5) The authority of the Secretary to enter into any contract for the conduct of any study, testing, program, research, or review, or assessment under this subsection shall be effective for any fiscal year only to such extent or in such amounts as are provided in advance in appropriation Acts.
(c) Diseases not significantly occurring in United States
The Secretary may conduct biomedical research, directly or through grants or contracts, for the identification, control, treatment, and prevention of diseases (including tropical diseases) which do not occur to a significant extent in the United States.
(d) Protection of privacy of individuals who are research subjects
The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.
(July 1, 1944, ch. 373, title III, §301,
Amendments
1993—Subsec. (b)(4).
1988—Subsec. (d).
1986—Subsec. (a)(3).
Subsec. (c).
1985—Subsec. (a)(3).
Subsec. (a)(8).
1978—
1976—Subsecs. (c), (h).
1974—Subsec. (c).
Subsec. (d).
Subsecs. (e), (f).
Subsec. (g).
Subsecs. (h), (i).
1972—Subsecs. (d), (i).
1971—Subsecs. (d), (i).
1970—Subsec. (d).
Subsec. (h).
1967—Subsec. (h).
1965—Subsecs. (h), (i).
1962—Subsec. (d).
1960—Subsec. (d).
1956—Subsecs. (g), (h). Act July 3, 1956, added subsec. (g) and redesignated former subsec. (g) as (h).
1948—Subsec. (d). Acts June 16, 1948, §4(e), and June 24, 1948, §4(e), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
Subsec. (d). Act June 25, 1948, continued in basic legislation the authority to purchase penicillin and other antibiotic compounds for use in research projects.
Subsec. (g). Acts June 16, 1948, §4(f), and June 24, 1948, §4(f), made provisions applicable to the National Advisory Heart Council and the National Advisory Dental Research Council, respectively.
1946—Subsec. (d). Act July 3, 1946, made the National Advisory Mental Health Council the body to make recommendations to the Surgeon General on awarding of grants-in-aid for research projects with respect to mental health.
Subsec. (g). Act July 3, 1946, gave National Advisory Health Council the right to make recommendations to carry out purposes of this section.
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (a)(7), and "Department of Health and Human Services" substituted for "Department of Health, Education, and Welfare" in subsec. (b)(1), (3), and (4)(D)(I), (II), pursuant to section 509(b) of
Effective Date of 1978 Amendment
Sections 261 and 262 of
Effective Date of 1974 Amendment
Section 104(b) of
Effective Date of 1972 Amendment
Amendment by
Effective Date of 1971 Amendment
Amendment by
Sentinel Disease Concept Study
Section 1910 of
"(a)
"(b)
"(c)
Study of Thyroid Morbidity for Hanford, Washington
Section 161 of
"(a)
"(b)
"(c)
"(1)
"(2)
"(d)
National Commission on Sleep Disorders Research
Section 162 of
Research With Respect to Health Resources and Services Administration
Section 632 of
Continuing Care for Psychiatric Patients in Former Clinical Research Center at National Institute on Drug Abuse
Analysis of Thyroid Cancer; Creation and Publication of Radioepidemiological Tables
"(a) In carrying out section 301 of the Public Health Service Act [this section], the Secretary of Health and Human Services shall—
"(1) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the risks of thyroid cancer that are associated with thyroid doses of Iodine 131;
"(2) conduct scientific research and prepare analyses necessary to develop valid and credible methods to estimate the thyroid doses of Iodine 131 that are received by individuals from nuclear bomb fallout;
"(3) conduct scientific research and prepare analyses necessary to develop valid and credible assessments of the exposure to Iodine 131 that the American people received from the Nevada atmospheric nuclear bomb tests; and
"(4) prepare and transmit to the Congress within one year after the date of enactment of this Act [Jan. 4, 1983] a report with respect to the activities conducted in carrying out paragraphs (1), (2), and (3).
"(b)(1) Within one year after the date of enactment of this Act [Jan. 4, 1983], the Secretary of Health and Human Services shall devise and publish radioepidemiological tables that estimate the likelihood that persons who have or have had any of the radiation related cancers and who have received specific doses prior to the onset of such disease developed cancer as a result of these doses. These tables shall show a probability of causation of developing each radiation related cancer associated with receipt of doses ranging from 1 millirad to 1,000 rads in terms of sex, age at time of exposure, time from exposure to the onset of the cancer in question, and such other categories as the Secretary, after consulting with appropriate scientific experts, determines to be relevant. Each probability of causation shall be calculated and displayed as a single percentage figure.
"(2) At the time the Secretary of Health and Human Services publishes the tables pursuant to paragraph (1), such Secretary shall also publish—
"(A) for the tables of each radiation related cancer, an evaluation which will assess the credibility, validity, and degree of certainty associated with such tables; and
"(B) a compilation of the formulas that yielded the probabilities of causation listed in such tables. Such formulas shall be published in such a manner and together with information necessary to determine the probability of causation of any individual who has or has had a radiation related cancer and has received any given dose.
"(3) The tables specified in paragraph (1) and the formulas specified in paragraph (2) shall be devised from the best available data that are most applicable to the United States, and shall be devised in accordance with the best available scientific procedures and expertise. The Secretary of Health and Human Services shall update these tables and formulas every four years, or whenever he deems it necessary to insure that they continue to represent the best available scientific data and expertise."
Termination of Advisory Committees
Section Referred to in Other Sections
This section is referred to in
§242. Studies and investigations on use and misuse of narcotic drugs and other drugs; annual report to Attorney General; cooperation with States
(a) In carrying out the purposes of
(b) The Surgeon General shall cooperate with States for the purpose of aiding them to solve their narcotic drug problems and shall give authorized representatives of the States the benefit of his experience in the care, treatment, and rehabilitation of narcotic addicts to the end that each State may be encouraged to provide adequate facilities and methods for the care and treatment of its narcotic addicts.
(July 1, 1944, ch. 373, title III, §302,
References in Text
The Controlled Substances Act, referred to in subsec. (a), is title II of
The Controlled Substances Import and Export Act, referred to in subsec. (a), is title III of
Amendments
1970—Subsec. (a).
Effective Date of 1970 Amendment
Amendment by
Savings Provision
Amendment by
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Marihuana and Health Reporting
§242a. Mental health
(a) Clinical training and instruction and clinical traineeships; stipends and allowances; research projects
In carrying out the purposes of
(1) the Secretary, acting through the Director of the Center for Mental Health Services, is authorized to provide clinical training and instruction and to establish and maintain clinical traineeships (with such stipends and allowances (including travel and subsistence expenses and dependency allowances) for the trainees as the Secretary may deem necessary);
(2) the Surgeon General is authorized to make grants to State or local agencies, laboratories, and other public or nonprofit agencies and institutions, and to individuals for investigations, experiments, demonstrations, studies, and research projects with respect to the development of improved methods of diagnosing mental illness, and of care, treatment, and rehabilitation of the mentally ill, including grants to State agencies responsible for administration of State institutions for care, or care and treatment, of mentally ill persons for developing and establishing improved methods of operation and administration of such institutions.
(b) Effect of treaties and other international agreements on confidentiality
Nothing in the Single Convention on Narcotic Drugs, the Convention on Psychotropic Substances, or other treaties or international agreements shall be construed to limit, modify, or prevent the protection of the confidentiality of patient records or of the names and other identifying characteristics of research subjects as provided by any Federal, State, or local law or regulation.
(c) Grants to public and other nonprofit institutions
The Secretary may provide for training, instruction, and traineeships under subsection (a)(1) of this section through grants to public and other nonprofit institutions. Grants under paragraph (2) of subsection (a) of this section may be made only upon recommendation of the National Advisory Mental Health Council. Such grants may be paid in advance or by way of reimbursement, as may be determined by the Surgeon General; and shall be made on such conditions as the Surgeon General finds necessary.
(d) Obligatory service for traineeships
(1) Any individual who has received a clinical traineeship, in psychology, psychiatry, nursing, marital and family therapy, or social work, under subsection (a)(1) of this section that was not of a limited duration or experimental nature (as determined by the Secretary) is obligated to serve, in service determined by the Secretary to be appropriate in the light of the individual's training and experience, at the rate of one year for each year (or academic year, whichever the Secretary determines to be appropriate) of the traineeship.
(2) The service required under paragraph (1) shall be performed—
(A) for a public inpatient mental institution providing inpatient care or any entity receiving a grant under the Mental Health Systems Act [
(B) in a health professional shortage area (as determined under subpart II of part D of this subchapter),
(C) in any other area or for any other entity designated by the Secretary, or
(D) in a Federal or State correctional facility,
and shall begin within such period after the termination of the traineeship as the Secretary may determine. In developing criteria for determining for which institutions or entities or in which areas, referred to in the preceding sentence, individuals must perform service under paragraph (1), the Secretary shall give preference to institutions, entities, or areas which in his judgment have the greatest need for personnel to perform that service. The Secretary may permit service for or in other institutions, entities, or areas if the Secretary determines that the request for such service is supported by good cause.
(3) Any individual who fails to perform the service required under this subsection within the period prescribed by the Secretary is obligated to repay to the United States an amount equal to three times the cost of the traineeship (including stipends and allowances) plus interest at the maximum legal rate at the time of payment of the traineeship, multiplied, in any case in which the service so required has been performed in part, by the percentage which the length of the service not so performed is of the length of the service so required to be performed.
(4)(A) In the case of any individual any part of whose obligation to perform service under this subsection exists at the same time as any part of the individual's obligation to perform service under
(B) In any case to which subparagraph (A) is applicable and in which one of the obligations is to perform service under
(C) In any case to which subparagraph (A) is applicable, if any part of the obligation to perform service under section 288 1 of this title exists at the same time as any part of the obligation to perform service under this subsection, the manner and time of meeting each obligation shall be prescribed by the Secretary.
(5) In disseminating application forms to individuals desiring traineeships, the Secretary shall include with such forms a fair summary of the liabilities under this subsection of an individual who receives a traineeship.
(July 1, 1944, ch. 373, title III, §303, as added July 3, 1946, ch. 538, §7(c),
References in Text
The Mental Health Systems Act, referred to in subsec. (d)(2)(A), is
Codification
Amendments
1992—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (d)(2)(D).
1990—Subsec. (d)(2)(B).
1988—Subsec. (a).
Subsec. (d)(1).
1987—Subsec. (d)(4).
1980—Subsec. (d).
1978—Subsecs. (b), (c).
1974—Subsec. (a).
Subsec. (a)(1).
Subsec. (b).
1970—Subsec. (a).
1956—Subsec. (a). Act Aug. 2, 1956, substituted provisions of par. (1) relating to traineeships in accordance with
Subsec. (b). Act Aug. 2, 1956, substituted provisions relating to recommendation of grants by Council and payment by Surgeon General for provisions relating to mental health training.
Effective Date of 1992 Amendment
Amendment by
Effective Date of 1990 Amendment
Section 501 of
Effective Date of 1980 Amendment
Section 803(b) of
Effective Date of 1978 Amendment
Amendment by
Effective Date of 1974 Amendment
Amendment by
Effective Date of 1956 Amendment
Amendment by act Aug. 2, 1956, effective July 1, 1956, see section 503 of act Aug. 2, 1956.
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Termination of Advisory Committees
Section Referred to in Other Sections
This section is referred to in
1 See Codification note below.
§242b. General authority respecting research, evaluations, and demonstrations in health statistics, health services, and health care technology
(a) Scope of activities
The Secretary may, through the Agency for Health Care Policy and Research or the National Center for Health Statistics, or using National Research Service Awards or other appropriate authorities, undertake and support training programs to provide for an expanded and continuing supply of individuals qualified to perform the research, evaluation, and demonstration projects set forth in
(b) Additional authority; scope of activities
To implement subsection (a) of this section and
(1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the physical resources of such Department, provide technical assistance and advice, make grants to public and nonprofit private entities and individuals, and, when appropriate, enter into contracts with public and private entities and individuals.
(2) Admit and treat at hospitals and other facilities of the Service persons not otherwise eligible for admission and treatment at such facilities.
(3) Secure, from time to time and for such periods as the Secretary deems advisable but in accordance with
(4) Acquire, construct, improve, repair, operate, and maintain laboratory, research, and other necessary facilities and equipment, and such other real or personal property (including patents) as the Secretary deems necessary; and acquire, without regard to
(c) Coordination of activities through units of Department
(1) The Secretary shall coordinate all health services research, evaluations, and demonstrations, all health statistical and epidemiological activities, and all research, evaluations, and demonstrations respecting the assessment of health care technology undertaken and supported through units of the Department of Health and Human Services. To the maximum extent feasible such coordination shall be carried out through the Agency for Health Care Policy and Research and the National Center for Health Statistics.
(2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health statistical and (where appropriate) epidemiological activities, and the research, evaluations, and demonstrations respecting the assessment of health care technology authorized by this chapter through the Agency for Health Care Policy and Research and the National Center for Health Statistics.
(July 1, 1944, ch. 373, title III, §304, as added July 28, 1955, ch. 417, §3,
References in Text
Amendments
1993—Subsec. (d).
1989—Subsec. (a).
Subsec. (b).
Subsec. (c)(1), (2).
1984—Subsec. (a)(1).
Subsec. (a)(3).
Subsec. (c)(1), (2).
1981—Subsec. (a)(3).
Subsecs. (b)(1), (c)(1).
Subsec. (d)(1).
Subsec. (d)(3).
1979—Subsec. (b)(1), (3).
Subsec. (d).
1978—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b)(1).
Subsec. (b)(3).
Subsec. (c).
Subsec. (d).
1974—
1973—Subsec. (c)(1).
1970—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b).
Subsecs. (c), (d).
1967—
1956—Act Aug. 2, 1956, changed heading of section 304 of act July 1, 1944 from "Grants for special projects in mental health" to "Mental health study grants". Section heading has been changed for purposes of codification.
Effective Date of 1970 Amendments
Section 201(d) of
Section 401(b)(1) of
Effective Date of 1956 Amendment
Amendment of section by act Aug. 2, 1956, effective July 1, 1956, see section 503 of act Aug. 2, 1956.
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Model Standards With Respect to Preventive Health Services in Communities
Transfer of Equipment
Congressional Declaration of Purpose
Section 2 of Joint Res. July 28, 1955, provides a Congressional statement of the critical need for an analysis and reevaluation of the human and economic problems of mental illness and of the resources, methods, and practices utilized in diagnosing, treating, caring for, and rehabilitating the mentally ill, both within and outside of institutions, as might lead to the development of recommendations for such better utilization of those resources or such improvements on and new developments in methods of diagnosis, treatment, care, and rehabilitation as give promise of resulting in a marked reduction in the incidence or duration of mental illness and, in consequence, a lessening of the appalling emotional and financial drain on the families of those afflicted or on the economic resources of the States and of the Nation and a declaration of the policy to promote mental health and to help solve the complex and the interrelated problems posed by mental illness by encouraging the undertaking of nongovernmental, multidisciplinary research into and reevaluation of all aspects of our resources, methods, and practices for diagnosing, treating, caring for, and rehabilitating the mentally ill, including research aimed at the prevention of mental illness.
Children's Emotional Illness Study; Program Grants; Conditions; Definitions; Appropriations; Terms of Grant
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§242c. Repealed. Pub. L. 101–239, title VI, §6103(d)(1)(A), Dec. 19, 1989, 103 Stat. 2205
Section, act July 1, 1944, ch. 373, title III, §305, as added July 3, 1956, ch. 510, §3,
Termination of National Center for Health Services Research and Health Care Technology Assessment
Section 6103(d)(1)(A) of
Transitional and Savings Provisions for Pub. L. 101–239
For provision transferring personnel of Department of Health and Human Services employed on Dec. 19, 1989, in connection with functions vested in Administrator for Health Care Policy and Research pursuant to amendments made by section 6103 of
§242d. Transferred
Codification
Section, act July 1, 1944, ch. 373, title III, §306, as added Aug. 2, 1956, ch. 871, title I, §101,
§242e. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362
Section, act July 1, 1944, ch. 373, title III, §307, as added Aug. 2, 1956, ch. 871, title II, §201,
§§242f to 242j. Transferred
Codification
Section 242f, act July 1, 1944, ch. 373, title III, §308, as added July 12, 1960,
Section 242g, act July 1, 1944, ch. 373, title III, §309, as added Sept. 8, 1960,
Section 242h, act July 1, 1944, ch. 373, title III, §310, as added Sept. 25, 1962,
Section 242i, act July 1, 1944, ch. 373, title III, §310A, as added Oct. 30, 1970,
Section 242j, act July 1, 1944, ch. 373, title III, §310B, as added Oct. 30, 1970,
§242k. National Center for Health Statistics
(a) Establishment; appointment of Director; statistical and epidemiological activities
There is established in the Department of Health and Human Services the National Center for Health Statistics (hereinafter in this section referred to as the "Center") which shall be under the direction of a Director who shall be appointed by the Secretary. The Secretary, acting through the Center, shall conduct and support statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in the United States.
(b) Duties
In carrying out subsection (a) of this section, the Secretary, acting through the Center,
(1) shall collect statistics on—
(A) the extent and nature of illness and disability of the population of the United States (or of any groupings of the people included in the population), including life expectancy, the incidence of various acute and chronic illnesses, and infant and maternal morbidity and mortality,
(B) the impact of illness and disability of the population on the economy of the United States and on other aspects of the well-being of its population (or of such groupings),
(C) environmental, social, and other health hazards,
(D) determinants of health,
(E) health resources, including physicians, dentists, nurses, and other health professionals by specialty and type of practice and the supply of services by hospitals, extended care facilities, home health agencies, and other health institutions,
(F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types of practice of the health professionals providing such services, and (ii) services of hospitals, extended care facilities, home health agencies, and other institutions,
(G) health care costs and financing, including the trends in health care prices and cost, the sources of payments for health care services, and Federal, State, and local governmental expenditures for health care services, and
(H) family formation, growth, and dissolution;
(2) shall undertake and support (by grant or contract) research, demonstrations, and evaluations respecting new or improved methods for obtaining current data on the matters referred to in paragraph (1);
(3) may undertake and support (by grant or contract) epidemiological research, demonstrations, and evaluations on the matters referred to in paragraph (1); and
(4) may collect, furnish, tabulate, and analyze statistics, and prepare studies, on matters referred to in paragraph (1) upon request of public and nonprofit private entities under arrangements under which the entities will pay the cost of the service provided.
Amounts appropriated to the Secretary from payments made under arrangements made under paragraph (4) shall be available to the Secretary for obligation until expended.
(c) Statistical and epidemiological compilations and surveys
The Center shall furnish such special statistical and epidemiological compilations and surveys as the Committee on Labor and Human Resources and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives may request. Such statistical and epidemiological compilations and surveys shall not be made subject to the payment of the actual or estimated cost of the preparation of such compilations and surveys.
(d) Technical aid to States and localities
To insure comparability and reliability of health statistics, the Secretary shall, through the Center, provide adequate technical assistance to assist State and local jurisdictions in the development of model laws dealing with issues of confidentiality and comparability of data.
(e) Cooperative Health Statistics System
For the purpose of producing comparable and uniform health information and statistics, there is established the Cooperative Health Statistics System. The Secretary, acting through the Center, shall—
(1) coordinate the activities of Federal agencies involved in the design and implementation of the System;
(2) undertake and support (by grant or contract) research, development, demonstrations, and evaluations respecting the System;
(3) make grants to and enter into contracts with State and local health agencies to assist them in meeting the costs of data collection and other activities carried out under the System; and
(4) review the statistical activities of the Department of Health and Human Services to assure that they are consistent with the System.
States participating in the System shall designate a State agency to administer or be responsible for the administration of the statistical activities within the State under the System. The Secretary, acting through the Center, shall prescribe guidelines to assure that statistical activities within States participating in the system 1 produce uniform and timely data and assure appropriate access to such data.
(f) Federal-State cooperation
To assist in carrying out this section, the Secretary, acting through the Center, shall cooperate and consult with the Departments of Commerce and Labor and any other interested Federal departments or agencies and with State and local health departments and agencies. For such purpose he shall utilize insofar as possible the services or facilities of any agency of the Federal Government and, without regard to
(g) Collection of health data; data collection forms
To secure uniformity in the registration and collection of mortality, morbidity, and other health data, the Secretary shall prepare and distribute suitable and necessary forms for the collection and compilation of such data.
(h) Registration area records
(1) There shall be an annual collection of data from the records of births, deaths, marriages, and divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data on ethnic and racial populations, including subpopulations of Hispanics, Asian Americans, and Pacific Islanders with significant representation in the State or registration area. Each State or registration area shall be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such data.
(2) There shall be an annual collection of data from a statistically valid sample concerning the general health, illness, and disability status of the civilian noninstitutionalized population. Specific topics to be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations, and the relationship between demographic and socioeconomic characteristics and health characteristics.
(i) Technical assistance in effective use of statistics
The Center may provide to public and nonprofit private entities technical assistance in the effective use in such activities of statistics collected or compiled by the Center.
(j) Coordination of health statistical and epidemiological activities
In carrying out the requirements of
(1) establishing standardized means for the collection of health information and statistics under laws administered by the Secretary;
(2) developing, in consultation with the National Committee on Vital and Health Statistics, and maintaining the minimum sets of data needed on a continuing basis to fulfill the collection requirements of subsection (b)(1) of this section;
(3) after consultation with the National Committee on Vital and Health Statistics, establishing standards to assure the quality of health statistical and epidemiological data collection, processing, and analysis;
(4) in the case of proposed health data collections of the Department which are required to be reviewed by the Director of the Office of Management and Budget under section 3509 2 of title 44, reviewing such proposed collections to determine whether they conform with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3), and if any such proposed collection is found not to be in conformance, by taking such action as may be necessary to assure that it will conform to such sets of data and standards, and
(5) periodically reviewing ongoing health data collections of the Department, subject to review under such section 3509, to determine if the collections are being conducted in accordance with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3) and, if any such collection is found not to be in conformance, by taking such action as may be necessary to assure that the collection will conform to such sets of data and standards not later than the ninetieth day after the date of the completion of the review of the collection.
(k) National Committee on Vital and Health Statistics; establishment; membership; term of office; compensation; functions; consultations of Secretary with Committee and professional advisory groups
(1) There is established in the Office of the Secretary a committee to be known as the National Committee on Vital and Health Statistics (hereinafter in this subsection referred to as the "Committee") which shall consist of 16 members.
(2) The members of the Committee shall be appointed by the Secretary from among persons who have distinguished themselves in the fields of health statistics, health planning, epidemiology, and the provision of health services. Members of the Committee shall be appointed for terms of 4 years.
(3) Members of the Committee shall be compensated in accordance with
(4) It shall be the function of the Committee to assist and advise the Secretary—
(A) to delineate statistical problems bearing on health and health services which are of national or international interest;
(B) to stimulate studies of such problems by other organizations and agencies whenever possible or to make investigations of such problems through subcommittees;
(C) to determine, approve, and revise the terms, definitions, classifications, and guidelines for assessing health status and health services, their distribution and costs, for use (i) within the Department of Health and Human Services, (ii) by all programs administered or funded by the Secretary, including the Federal-State-local cooperative health statistics system referred to in subsection (e) of this section, and (iii) to the extent possible as determined by the head of the agency involved, by the Department of Veterans Affairs, the Department of Defense, and other Federal agencies concerned with health and health services;
(D) with respect to the design of and approval of health statistical and health information systems concerned with the collection, processing, and tabulation of health statistics within the Department of Health and Human Services, with respect to the Cooperative Health Statistics System established under subsection (e) of this section, and with respect to the standardized means for the collection of health information and statistics to be established by the Secretary under subsection (j)(1) of this section;
(E) to review and comment on findings and proposals developed by other organizations and agencies and to make recommendations for their adoption or implementation by local, State, national, or international agencies;
(F) to cooperate with national committees of other countries and with the World Health Organization and other national agencies in the studies of problems of mutual interest; and
(G) to issue an annual report on the state of the Nation's health, its health services, their costs and distributions, and to make proposals for improvement of the Nation's health statistics and health information systems.
(5) In carrying out health statistical activities under this part, the Secretary shall consult with, and seek the advice of, the Committee and other appropriate professional advisory groups.
(l) Data specific to particular ethnic and racial populations
In carrying out this section, the Secretary, acting through the Center, shall collect and analyze adequate health data that is specific to particular ethnic and racial populations, including data collected under national health surveys. Activities carried out under this subsection shall be in addition to any activities carried out under subsection (m) of this section.
(m) Grants for assembly and analysis of data on ethnic and racial populations
(1) The Secretary, acting through the Center, may make grants to public and nonprofit private entities for—
(A) the conduct of special surveys or studies on the health of ethnic and racial populations or subpopulations;
(B) analysis of data on ethnic and racial populations and subpopulations; and
(C) research on improving methods for developing statistics on ethnic and racial populations and subpopulations.
(2) The Secretary, acting through the Center, may provide technical assistance, standards, and methodologies to grantees supported by this subsection in order to maximize the data quality and comparability with other studies.
(3) Provisions of
(n) Authorization of appropriations
(1) For health statistical and epidemiological activities undertaken or supported under subsections (a) through (l) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 1998.
(2) For activities authorized in subsection (m) of this section, there are authorized to be appropriated $5,000,000 for fiscal year 1991, $7,500,000 for fiscal year 1992, $10,000,000 for fiscal year 1993, and $10,000,000 for each of the fiscal years 1994 through 1998. Of such amounts, the Secretary shall use not more than 10 percent for administration and for activities described in subsection (m)(2) of this section.
(July 1, 1944, ch. 373, title III, §306, as added July 23, 1974,
References in Text
Prior Provisions
Provisions similar to those comprising subsec. (g) of this section were contained in section 313 of act July 1, 1944, ch. 373, title III,
Provisions similar to those comprising subsec. (h) of this section were contained in section 312a of act July 1, 1944, ch. 373, title III, as added Aug. 31, 1954, ch. 1158, §2,
Amendments
1993—Subsec. (c).
Subsec. (g).
Subsec. (i).
Subsec. (k)(2).
Subsec. (l).
Subsec. (m).
Subsecs. (n), (o).
1991—Subsec. (k)(4)(C).
1990—Subsec. (h).
Subsecs. (m) to (o).
1989—Subsec. (a).
Subsec. (b).
Subsec. (m).
1987—Subsec. (a).
Subsec. (k)(1).
Subsec. (k)(2)(A).
Subsec. (k)(2)(B).
"(i) five shall be appointed for terms of one year,
"(ii) five shall be appointed for terms of two years, and
"(iii) five shall be appointed for terms of three years,
as designated by the Secretary at the time of appointment. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which his predecessor was appointed shall be appointed only for the remainder of such term. A member may serve after the expiration of his term until his successor has taken office."
1983—Subsec. (l)(2)(D).
Subsec. (l)(2)(E) to (G).
1981—Subsec. (a).
Subsec. (c).
Subsec. (e).
Subsecs. (j), (k)(4)(C), (D).
Subsec. (l)(2).
1978—Subsec. (b).
Subsec. (c).
Subsec. (e).
Subsec. (f).
Subsecs. (i), (j).
Subsec. (k).
Subsec. (l).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1990 Amendment
Section 12 of
Effective Date of 1987 Amendment
Section 105(b) of
Money Received by Center From Reimbursements, Interagency Agreements, and Sale of Data Tapes To Remain Available Until Expended
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be capitalized.
2 See References in Text note below.
§242l. International cooperation
(a) Cooperative endeavors; statement of purpose
For the purpose of advancing the status of the health sciences in the United States (and thereby the health of the American people), the Secretary may participate with other countries in cooperative endeavors in biomedical research, health care technology, and the health services research and statistical activities authorized by
(b) Authority of Secretary; building construction prohibition
In connection with the cooperative endeavors authorized by subsection (a) of this section, the Secretary may—
(1) make such use of resources offered by participating foreign countries as he may find necessary and appropriate;
(2) establish and maintain fellowships in the United States and in participating foreign countries;
(3) make grants to public institutions or agencies and to nonprofit private institutions or agencies in the United States and in participating foreign countries for the purpose of establishing and maintaining the fellowships authorized by paragraph (2);
(4) make grants or loans of equipment and materials, for use by public or nonprofit institutions or agencies, or by individuals, in participating foreign countries;
(5) participate and otherwise cooperate in any international meetings, conferences, or other activities concerned with biomedical research, health services research, health statistics, or health care technology;
(6) facilitate the interchange between the United States and participating foreign countries, and among participating foreign countries, of research scientists and experts who are engaged in experiments or programs of biomedical research, health services research, health statistical activities, or health care technology activities, and in carrying out such purpose may pay per diem compensation, subsistence, and travel for such scientists and experts when away from their places of residence at rates not to exceed those provided in section 5703(b) 1 of title 5 for persons in the Government service employed intermittently;
(7) procure, in accordance with
(8) enter into contracts with individuals for the provision of services (as defined in section 104 of part 37 of title 48, Code of Federal Regulations (48 CFR 37.104)) in participating foreign countries, which individuals may not be deemed employees of the United States for any purpose.
The Secretary may not, in the exercise of his authority under this section, provide financial assistance for the construction of any facility in any foreign country.
(c) Benefits for overseas assignees
The Secretary may provide to personnel appointed or assigned by the Secretary to serve abroad, allowances and benefits similar to those provided under
(July 1, 1944, ch. 373, title III, §307, formerly §308, as added July 12, 1960,
References in Text
The Foreign Service Act of 1990, referred to in subsec. (c), probably means the Foreign Service Act of 1980, which is
Codification
Section was formerly classified to
Prior Provisions
A prior section 307 of act July 1, 1944, was classified to
Amendments
1993—Subsec. (c).
1992—Subsec. (b)(8).
1989—Subsec. (a).
1981—Subsec. (a).
Subsec. (b).
1974—
International Health Study
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§242m. General provisions respecting effectiveness, efficiency, and quality of health services
(a) Reports to Congress and President; preparation; review by Office of Management and Budget
(1) Not later than March 15 of each year, the Secretary shall submit to the President and Congress the following reports:
(A) A report on health care costs and financing. Such report shall include a description and analysis of the statistics collected under
(B) A report on health resources. Such report shall include a description and analysis, by geographical area, of the statistics collected under
(C) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
(D) A report on the health of the Nation's people. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
(2) The reports required in paragraph (1) shall be prepared through the National Center for Health Statistics.
(3) The Office of Management and Budget may review any report required by paragraph (1) of this subsection before its submission to Congress, but the Office may not revise any such report or delay its submission beyond the date prescribed for its submission, and may submit to Congress its comments respecting any such report.
(b) Grants or contracts; applications, submittal; application peer review group, findings and recommendations; necessity of favorable recommendation; appointments
(1) No grant or contract may be made under
(2)(A) Each application submitted for a grant or contract under
(B) A peer review group to which an application is submitted pursuant to subparagraph (A) shall report its finding and recommendations respecting the application to the Secretary, acting through the Director of the National Center for Health Statistics, in such form and manner as the Secretary shall by regulation prescribe. The Secretary may not approve an application described in such subparagraph unless a peer review group has recommended the application for approval.
(C) The Secretary, acting through the Director of the National Center for Health Statistics, shall make appointments to the peer review groups required in subparagraph (A) from among persons who are not officers or employees of the United States and who possess appropriate technical and scientific qualifications, except that peer review groups regarding grants under section 242k(n) 1 of this title may include appropriately qualified such officers and employees.
(c) Development and dissemination of statistics
The Secretary shall take such action as may be necessary to assure that statistics developed under
(d) Information; publication restrictions
No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under
(e) Payment procedures; advances or reimbursement; installments; conditions; reductions
(1) Payments of any grant or under any contract under
(2) The amounts otherwise payable to any person under a grant or contract made under
(A) amounts equal to the fair market value of any equipment or supplies furnished to such person by the Secretary for the purpose of carrying out the project with respect to which such grant or contract is made, and
(B) amounts equal to the pay, allowances, traveling expenses, and related personnel expenses attributable to the performance of services by an officer or employee of the Government in connection with such project, if such officer or employee was assigned or detailed by the Secretary to perform such services,
but only if such person requested the Secretary to furnish such equipment or supplies, or such services, as the case may be.
(f) Contracts without regard to section 3324 of title 31 and section 5 of title 41
Contracts may be entered into under
(July 1, 1944, ch. 373, title III, §308, as added July 23, 1974,
References in Text
Prior Provisions
Provisions similar to those comprising subsec. (e) of this section were contained in subsec. (a)(3) of section 304 of act July 1, 1944, ch. 373, title III, as added July 28, 1955, ch. 417, §3,
Amendments
1993—Subsec. (a)(1).
"(i) the administration of
"(ii) the current state and progress of health services research, health statistics, and health care technology."
Subsec. (a)(2).
Subsec. (c).
Subsec. (f).
Subsec. (g).
"(A) publish, make available and disseminate, promptly in understandable form and on as broad a basis as practicable, the results of health services research, demonstrations, and evaluations undertaken and supported under
"(B) make available to the public data developed in such research, demonstrations, and evaluations; and
"(C) provide indexing, abstracting, translating, publishing, and other services leading to a more effective and timely dissemination of information on health services research, demonstrations, and evaluations in health care delivery to public and private entities and individuals engaged in the improvement of health care delivery and the general public; and undertake programs to develop new or improved methods for making such information available."
Subsec. (h).
"(1) Except where the Secretary determines that unusual circumstances make a larger percentage necessary in order to effectuate the purposes of
"(2) Laborers and mechanics employed by contractors and subcontractors in the construction of such a facility shall be paid wages at rates not less than those prevailing on similar work in the locality, as determined by the Secretary of Labor in accordance with the Act of March 3, 1931 (
"(3) Such grants and contracts shall be subject to such additional requirements as the Secretary may by regulation prescribe."
1990—Subsec. (b)(2)(A).
Subsec. (b)(2)(C).
Subsec. (b)(3).
1989—
Subsec. (a)(1)(A)(i).
Subsec. (a)(2).
Subsec. (b)(1).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (b)(2)(C).
Subsec. (b)(3).
Subsec. (d).
Subsec. (e)(1), (2).
Subsec. (f).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (h)(1).
Subsec. (i).
1988—Subsec. (b)(2)(A).
1987—Subsec. (a)(1), (2).
"(1) Not later than December 1 of each year, the Secretary shall make a report to Congress respecting (A) the administration of sections 242b, 242c, 242k, and 242l and
"(2) The Secretary, acting through the National Center for Health Services Research and the National Center for Health Statistics, shall assemble and submit to the President and the Congress not later than December 1 of each year the following reports:
"(A) A report on health care costs and financing. Such report shall include a description and analysis of the statistics collected under
"(B) A report on health resources. Such report shall include a description and analysis, by geographic area, of the statistics collected under
"(C) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
"(D) A report on the health of the Nation's people. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
Subsec. (a)(3).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (i).
1984—Subsec. (i)(1).
Subsec. (i)(2).
1983—Subsec. (d).
1981—Subsec. (a)(2).
Subsec. (b)(2).
Subsec. (d)(2).
Subsec. (i)(1).
Subsec. (i)(2).
1978—Subsec. (a)(1).
Subsec. (b)(1).
Subsec. (d).
Subsecs. (e), (f), (g)(2), (h)(1).
Subsec. (i)(1).
Subsec. (i)(2).
1977—Subsec. (i)(1).
Subsec. (i)(2).
1976—Subsec. (a).
Effective Date of 1988 Amendment
Section 2600 of
Effective Date of 1987 Amendment
Section 106(c) of
Mine Workers Study; Report Completed and Submitted No Later Than 30 Months After November 9, 1978
Section 10 of
Authorization of Appropriations for Fiscal Year Ending June 30, 1977
Section 107(b) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§242n. Repealed. Pub. L. 101–239, title VI, §6103(d)(1)(B), Dec. 19, 1989, 103 Stat. 2205
Section, act July 1, 1944, ch. 373, title III, §309, as added Nov. 9, 1978,
Termination of Council on Health Care Technology
Section 6103(d)(1)(B) of
Transitional and Savings Provisions for Pub. L. 101–239
For provision transferring personnel of Department of Health and Human Services employed on Dec. 19, 1989, in connection with functions vested in Administrator for Health Care Policy and Research pursuant to amendments made by section 6103 of
§242o. Health conferences; publication of health educational information
(a) A conference of the health authorities in and among the several States shall be called annually by the Secretary. Whenever in his opinion the interests of the public health would be promoted by a conference, the Secretary may invite as many of such health authorities and officials of other State or local public or private agencies, institutions, or organizations to confer as he deems necessary or proper. Upon the application of health authorities of five or more States it shall be the duty of the Secretary to call a conference of all State health authorities joining in the request. Each State represented at any conference shall be entitled to a single vote. Whenever at any such conference matters relating to mental health are to be discussed, the mental health authorities of the respective States shall be invited to attend.
(b) From time to time the Secretary shall issue information related to public health, in the form of publications or otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United States and other countries and other pertinent health information for the use of persons and institutions concerned with health services.
(July 1, 1944, ch. 373, title III, §310, formerly §§309, 310, as added July 23, 1974,
Codification
Subsec. (a) of this section consists of former section 309 of act July 1, 1944, prior to the renumbering of that section as section 310(a) by
Prior Provisions
Provisions similar to those comprising subsec. (a) of this section were contained in section 312 of act July 1, 1944, ch. 373, title III,
Provisions similar to those comprising subsec. (b) of this section were contained in section 315 of act July 1, 1944, ch. 373, title III,
§242p. National disease prevention data profile
(a) The Secretary, acting through the National Center for Health Statistics, shall submit to Congress on March 15, 1990, and on March 15 of every third year thereafter, a national disease prevention data profile in order to provide a data base for the effective implementation of this Act and to increase public awareness of the prevalence, incidence, and any trends in the preventable causes of death and disability in the United States. Such profile shall include at a minimum—
(1) mortality rates for preventable diseases;
(2) morbidity rates associated with preventable diseases;
(3) the physical determinants of health of the population of the United States and the relationship between these determinants of health and the incidence and prevalence of preventable causes of death and disability; and
(4) the behavioral determinants of health of the population of the United States including, but not limited to, smoking, nutritional and dietary habits, exercise, and alcohol consumption, and the relationship between these determinants of health and the incidence and prevalence of preventable causes of death and disability.
(b) In preparing the profile required by subsection (a) of this section, the Secretary, acting through the National Center for Health Statistics, shall comply with all relevant provisions of
(
References in Text
This Act, referred to in subsec. (a), is
Codification
Section was enacted as part of the Health Services and Centers Amendments of 1978, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1987—Subsec. (a).
Effective Date of 1987 Amendment
Amendment by
§242q. Task Force on Aging Research; establishment and duties
(a) Establishment
The Secretary of Health and Human Services shall establish a Task Force on Aging Research.
(b) Duties
With respect to aging research (as defined in
(1) make recommendations to the Secretary specifying the particular projects of research, or the particular categories of research, that should be conducted or supported by the Secretary;
(2) of the projects specified under paragraph (1), make recommendations to the Secretary of the projects that should be given priority in the provision of funds; and
(3) make recommendations to the Secretary of the amount of funds that should be appropriated for such research.
(c) Provision of information to public
The Task Force may make available to health professionals, and to other members of the public, information regarding the research described in subsection (b) of this section.
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§242q–1. Membership
(a) Composition
The Task Force shall be composed of—
(1) the Assistant Secretary for Health;
(2) the Surgeon General of the Public Health Service;
(3) the Assistant Secretary for Planning and Evaluation;
(4) the Director of the National Institute on Aging, and the Directors of such other agencies of the National Institutes of Health as the Secretary determines to be appropriate;
(5) the Commissioner of the Administration on Aging;
(6) the Commissioner of Food and Drugs;
(7) the Under Secretary for Health of the Department of Veterans Affairs;
(8) the Administrator of the the 1 Substance Abuse and Mental Health Services Administration;
(9) the Administrator of the Health Care Financing Administration;
(10) the Commissioner of Social Security;
(11) the Administrator for Health Care Policy and Research;
(12) two Members of the House of Representatives appointed by the Speaker of the House in consultation with the Minority Leader, and two members of the Senate appointed by the Majority Leader in consultation with the Minority Leader, not more than one of whom from each body shall be members of the same political party; and
(13) three members of the general public, to be appointed by the Secretary, that shall include one representative each from—
(A) a nonprofit group representing older Americans;
(B) a private voluntary health organization concerned with the health problems affecting older Americans; and
(C) a nonprofit organization concerned with research related to the health and independence of older Americans.
(b) Chair
The Secretary, acting through either the Assistant Secretary for Health or the Director of the National Institute on Aging, shall serve as the Chair of the Task Force.
(c) Quorum
A majority of the members of the Task Force shall constitute a quorum, and a lesser number may hold hearings.
(d) Meetings
The Task Force shall meet periodically at the call of the Chair, but in no event less than twice each year.
(e) Compensation and expenses
(1) Compensation
Members of the Task Force who are not regular full-time employees of the United States Government shall, while attending meetings and conferences of the Task Force or otherwise engaged in the business of the Task Force (including traveltime), be entitled to receive compensation at a rate fixed by the Secretary, but not exceeding the rate specified at the time of such service under GS–18 of the General Schedules established under
(2) Expenses
While away from their homes or regular places of business on the business of the Task Force, members of such Task Force may be allowed travel expenses, including per diem in lieu of subsistence, as is authorized under
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1992—Subsec. (a)(7).
Subsec. (a)(8).
Effective Date of 1992 Amendment
Amendment by
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Section Referred to in Other Sections
This section is referred to in
§242q–2. Administrative staff and support
The Secretary, acting through either the Assistant Secretary for Health or the Director of the National Institute on Aging, shall appoint an Executive Secretary for the Task Force and shall provide the Task Force with such administrative staff and support as may be necessary to enable the Task Force to carry out subsections (b) and (c) of
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§242q–3. Reports
(a) In general
Not later than 1 year after November 15, 1990, and annually thereafter, the Task Force shall prepare and submit to the Secretary, and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report providing the recommendations required in
(b) Availability to public
The Task Force may make available to the public copies of the reports required in subsection (a) of this section.
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Section Referred to in Other Sections
This section is referred to in
§242q–4. Definitions
For purposes of
(1) Aging research
(A) The term "aging research" means research on the aging process and on the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause. Such research includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders, and complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals.
(B) For purposes of subparagraph (A), the term "independence", with respect to diseases, disorders, and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of daily living without assistance or supervision.
(2) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(3) Task Force
The term "Task Force" means the Task Force on Aging Research established under
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
§242q–5. Authorization of appropriations
For the purpose of carrying out
(
Codification
Section was enacted as part of the Home Health Care and Alzheimer's Disease Amendments of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Section Referred to in Other Sections
This section is referred to in
Part B—Federal-State Cooperation
§243. General grant of authority for cooperation
(a) Enforcement of quarantine regulations; prevention of communicable diseases
The Secretary is authorized to accept from State and local authorities any assistance in the enforcement of quarantine regulations made pursuant to this chapter which such authorities may be able and willing to provide. The Secretary shall also assist States and their political subdivisions in the prevention and suppression of communicable diseases and with respect to other public health matters, shall cooperate with and aid State and local authorities in the enforcement of their quarantine and other health regulations, and shall advise the several States on matters relating to the preservation and improvement of the public health.
(b) Comprehensive and continuing planning; training of personnel for State and local health work; fees
The Secretary shall encourage cooperative activities between the States with respect to comprehensive and continuing planning as to their current and future health needs, the establishment and maintenance of adequate public health services, and otherwise carrying out public health activities. The Secretary is also authorized to train personnel for State and local health work. The Secretary may charge only private entities reasonable fees for the training of their personnel under the preceding sentence.
(c) Development of plan to control epidemics and meet emergencies or problems resulting from disasters; cooperative planning; temporary assistance; reimbursement of United States
(1) The Secretary is authorized to develop (and may take such action as may be necessary to implement) a plan under which personnel, equipment, medical supplies, and other resources of the Service and other agencies under the jurisdiction of the Secretary may be effectively used to control epidemics of any disease or condition and to meet other health emergencies or problems. The Secretary may enter into agreements providing for the cooperative planning between the Service and public and private community health programs and agencies to cope with health problems (including epidemics and health emergencies).
(2) The Secretary may, at the request of the appropriate State or local authority, extend temporary (not in excess of six months) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. The Secretary may require such reimbursement of the United States for assistance provided under this paragraph as he may determine to be reasonable under the circumstances. Any reimbursement so paid shall be credited to the applicable appropriation for the Service for the year in which such reimbursement is received.
(July 1, 1944, ch. 373, title III, §311,
Amendments
1985—Subsec. (c)(1).
1983—Subsec. (c)(2).
1981—Subsec. (a).
Subsec. (b).
1976—Subsec. (b).
Subsec. (c).
1970—Subsecs. (a), (b).
1967—Subsec. (c).
1966—
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1966 Amendment
Section 5(a) of
Section 5(b) of
Training of Private Persons Subject to Reimbursement or Advances to Appropriations
Section Referred to in Other Sections
This section is referred to in
§244. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362
Section, acts July 1, 1944, ch. 373, title III, §312,
§244–1. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, §312, formerly §306, as added Aug. 2, 1956, ch. 871, title I, §101,
Effective Date of Repeal
Section 503(c) of
§§244a, 245. Repealed. Pub. L. 93–353, title I, §102(a), July 23, 1974, 88 Stat. 362
Section 244a, act July 1, 1944, ch. 373, title III, §312a, as added Aug. 31, 1954, ch. 1158, §2,
Section 245, acts July 1, 1944, ch. 373, title III, §313,
§245a. Repealed. Pub. L. 94–484, title V, §503(b), Oct. 12, 1976, 90 Stat. 2300
Section, act July 1, 1944, ch. 373, title III, §313, formerly §309, as added Sept. 8, 1960,
Effective Date of Repeal
Repeal effective Oct. 1, 1977, see section 503(c) of
§246. Grants and services to States
(a) Comprehensive health planning and services
(1) In order to assist the States in comprehensive and continuing planning for their current and future health needs, the Secretary is authorized during the period beginning July 1, 1966, and ending June 30, 1973, to make grants to States which have submitted, and had approved by the Secretary, State plans for comprehensive State health planning. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $2,500,000 for the fiscal year ending June 30, 1967, $7,000,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $15,000,000 for the fiscal year ending June 30, 1971, $17,000,000 for the fiscal year ending June 30, 1972, $20,000,000 for the fiscal year ending June 30, 1973, and $10,000,000 for the fiscal year ending June 30, 1974.
(2) In order to be approved for purposes of this subsection, a State plan for comprehensive State health planning must—
(A) designate, or provide for the establishment of, a single State agency, which may be an interdepartmental agency, as the sole agency for administering or supervising the administration of the State's health planning functions under the plan;
(B) provide for the establishment of a State health planning council, which shall include representatives of Federal, State, and local agencies (including as an ex officio member, if there is located in such State one or more hospitals or other health care facilities of the Department of Veterans Affairs, the individual whom the Secretary of Veterans Affairs shall have designated to serve on such council as the representative of the hospitals or other health care facilities of such Department which are located in such State) and nongovernmental organizations and groups concerned with health (including representation of the regional medical program or programs included in whole or in part within the State), and of consumers of health services, to advise such State agency in carrying out its functions under the plan, and a majority of the membership of such council shall consist of representatives of consumers of health services;
(C) set forth policies and procedures for the expenditure of funds under the plan, which, in the judgment of the Secretary, are designed to provide for comprehensive State planning for health services (both public and private and including home health care), including the facilities and persons required for the provision of such services, to meet the health needs of the people of the State and including environmental considerations as they relate to public health;
(D) provide for encouraging cooperative efforts among governmental or nongovernmental agencies, organizations and groups concerned with health services, facilities, or manpower, and for cooperative efforts between such agencies, organizations, and groups and similar agencies, organizations, and groups in the fields of education, welfare, and rehabilitation;
(E) contain or be supported by assurances satisfactory to the Secretary that the funds paid under this subsection will be used to supplement and, to the extent practicable, to increase the level of funds that would otherwise be made available by the State for the purpose of comprehensive health planning and not to supplant such non-Federal funds;
(F) provide such methods of administration (including methods relating to the establishment and maintenance of personnel standards on a merit basis, except that the Secretary shall exercise no authority with respect to the selection, tenure of office, and compensation of any individual employed in accordance with such methods) as are found by the Secretary to be necessary for the proper and efficient operation of the plan;
(G) provide that the State agency will make such reports, in such form and containing such information, as the Secretary may from time to time reasonably require, and will keep such records and afford such access thereto as the Secretary finds necessary to assure the correctness and verification of such reports;
(H) provide that the State agency will from time to time, but not less often than annually, review its State plan approved under this subsection and submit to the Secretary appropriate modifications thereof;
(I) effective July 1, 1968, (i) provide for assisting each health care facility in the State to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan developed in accordance with criteria established by the Secretary after consultation with the State which will meet the needs of the State for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner, and (ii) provide that the State agency furnishing such assistance will periodically review the program (developed pursuant to clause (i)) of each health care facility in the State and recommend appropriate modification thereof;
(J) provide for such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement of and accounting for funds paid to the State under this subsection; and
(K) contain such additional information and assurances as the Secretary may find necessary to carry out the purposes of this subsection.
(3)(A) From the sums appropriated for such purpose for each fiscal year, the several States shall be entitled to allotments determined, in accordance with regulations, on the basis of the population and the per capita income of the respective States; except that no such allotment to any State for any fiscal year shall be less than 1 per centum of the sum appropriated for such fiscal year pursuant to paragraph (1). Any such allotment to a State for a fiscal year shall remain available for obligation by the State, in accordance with the provisions of this subsection and the State's plan approved thereunder, until the close of the succeeding fiscal year.
(B) The amount of any allotment to a State under subparagraph (A) for any fiscal year which the Secretary determines will not be required by the State, during the period for which it is available, for the purposes for which allotted shall be available for reallotment by the Secretary from time to time, on such date or dates as he may fix, to other States with respect to which such a determination has not been made, in proportion to the original allotments to such States under subparagraph (A) for such fiscal year, but with such proportionate amount for any of such other States being reduced to the extent it exceeds the sum the Secretary estimates such State needs and will be able to use during such period; and the total of such reductions shall be similarly reallotted among the States whose proportionate amounts were not so reduced. Any amount so reallotted to a State from funds appropriated pursuant to this subsection for a fiscal year shall be deemed part of its allotment under subparagraph (A) for such fiscal year.
(4) From each State's allotment for a fiscal year under this subsection, the State shall from time to time be paid the Federal share of the expenditures incurred during that year or the succeeding year pursuant to its State plan approved under this subsection. Such payments shall be made on the basis of estimates by the Secretary of the sums the State will need in order to perform the planning under its approved State plan under this subsection, but with such adjustments as may be necessary to take account of previously made underpayments or overpayments. The "Federal share" for any State for purposes of this subsection shall be all, or such part as the Secretary may determine, of the cost of such planning, except that in the case of the allotments for the fiscal year ending June 30, 1970, it shall not exceed 75 per centum of such cost.
(b) Project grants for areawide health planning; authorization of appropriations; prerequisites for grants; application; contents
(1)(A) The Secretary is authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make, with the approval of the State agency administering or supervising the administration of the State plan approved under subsection (a) of this section, project grants to any other public or nonprofit private agency or organization (but with appropriate representation of the interests of local government where the recipient of the grant is not a local government or combination thereof or an agency of such government or combination) to cover not to exceed 75 per centum of the costs of projects for developing (and from time to time revising) comprehensive regional, metropolitan area, or other local area plans for coordination of existing and planned health services, including the facilities and persons required for provision of such services; and including the provision of such services through home health care; except that in the case of project grants made in any State prior to July 1, 1968, approval of such State agency shall be required only if such State has such a State plan in effect at the time of such grants. No grant may be made under this subsection after June 30, 1970, to any agency or organization to develop or revise health plans for an area unless the Secretary determines that such agency or organization provides means for appropriate representation of the interests of the hospitals, other health care facilities, and practicing physicians serving such area, and the general public. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $5,000,000 for the fiscal year ending June 30, 1967, $7,500,000 for the fiscal year ending June 30, 1968, $10,000,000 for the fiscal year ending June 30, 1969, $15,000,000 for the fiscal year ending June 30, 1970, $20,000,000 for the fiscal year ending June 30, 1971, $30,000,000 for the fiscal year ending June 30, 1972, $40,000,000 for the fiscal year ending June 30, 1973, and $25,100,000 for the fiscal year ending June 30, 1974.
(B) Project grants may be made by the Secretary under subparagraph (A) to the State agency administering or supervising the administration of the State plan approved under subsection (a) of this section with respect to a particular region or area, but only if (i) no application for such a grant with respect to such region or area has been filed by any other agency or organization qualified to receive such a grant, and (ii) such State agency certifies, and the Secretary finds, that ample opportunity has been afforded to qualified agencies and organizations to file application for such a grant with respect to such region or area and that it is improbable that, in the foreseeable future, any agency or organization which is qualified for such a grant will file application therefor.
(2)(A) In order to be approved under this subsection, an application for a grant under this subsection must contain or be supported by reasonable assurances that there has been or will be established, in or for the area with respect to which such grant is sought, an areawide health planning council. The membership of such council shall include representatives of public, voluntary, and nonprofit private agencies, institutions, and organizations concerned with health (including representatives of the interests of local government of the regional medical program for such area, and of consumers of health services). A majority of the members of such council shall consist of representatives of consumers of health services.
(B) In addition, an application for a grant under this subsection must contain or be supported by reasonable assurances that the areawide health planning agency has made provision for assisting health care facilities in its area to develop a program for capital expenditures for replacement, modernization, and expansion which is consistent with an overall State plan which will meet the needs of the State and the area for health care facilities, equipment, and services without duplication and otherwise in the most efficient and economical manner.
(c) Project grants for training, studies, and demonstrations; authorization of appropriations
The Secretary is also authorized, during the period beginning July 1, 1966, and ending June 30, 1974, to make grants to any public or nonprofit private agency, institution, or other organization to cover all or any part of the cost of projects for training, studies, or demonstrations looking toward the development of improved or more effective comprehensive health planning throughout the Nation. For the purposes of carrying out this subsection, there are hereby authorized to be appropriated $1,500,000 for the fiscal year ending June 30, 1967, $2,500,000 for the fiscal year ending June 30, 1968, $5,000,000 for the fiscal year ending June 30, 1969, $7,500,000 for the fiscal year ending June 30, 1970, $8,000,000 for the fiscal year ending June 30, 1971, $10,000,000 for the fiscal year ending June 30, 1972, $12,000,000 for the fiscal year ending June 30, 1973, and $4,700,000 for the fiscal year ending June 30, 1974.
(July 1, 1944, ch. 373, title III, §314,
Amendments
1991—Subsec. (a)(2)(B).
1985—Subsec. (g).
1981—Subsec. (d).
1980—Subsec. (g).
1979—Subsec. (d)(2)(C)(ii).
Subsec. (d)(4)(A).
Subsec. (g)(2)(D)(iv).
1978—Subsec. (d).
Subsec. (d)(7)(A).
Subsec. (d)(7)(B).
Subsec. (f).
Subsec. (g).
1977—Subsec. (d)(7)(A).
Subsec. (d)(7)(B).
1976—Subsec. (g)(4)(B).
1975—Subsec. (d).
Subsec. (e).
1973—Subsec. (a)(1).
Subsec. (b)(1)(A).
Subsec. (c).
Subsec. (d)(1).
Subsec. (e).
1972—Subsec. (d)(2)(K).
1971—Subsec. (f).
1970—
Subsec. (a)(1).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(2)(C).
Subsec. (d)(2)(K).
Subsec. (d)(2)(L).
Subsec. (e).
1967—Subsec. (a)(1).
Subsec. (a)(2)(I) to (K).
Subsec. (a)(4).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(5).
Subsec. (d)(7).
Subsec. (e).
Subsec. (f)(5).
Subsec. (f)(6), (8).
Subsec. (g)(4)(B).
1966—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsecs. (h) to (m).
1965—Subsec. (c).
1962—Subsec. (l).
1961—Subsec. (c).
Subsec. (m).
1958—Subsec. (c).
1956—Subsec. (l). Act Aug. 1, 1956, added subsec. (l).
1948—Subsec. (e). Act June 16, 1948, §5(a), added subsec. (e) to provide for community programs of heart disease control. Former subsec. (e) redesignated (f).
Subsec. (f). Act June 16, 1948, §5(a), (b), redesignated former subsec. (e) as (f) and inserted proviso relating to determination and certification of amounts to be paid under subsec. (e). Former subsec. (f) redesignated (g).
Subsec. (g). Act June 16, 1948, §5(a), (c), redesignated former subsec. (f) as (g) and brought subsecs. (e) and (f)(1) within the provisions of this subsection. Former subsec. (g) redesignated (h).
Subsec. (h). Act June 16, 1948, §5(a), (d), redesignated former subsec. (g) as (h) and made subsection applicable to agencies, institutions or other organizations specified in subsec. (f)(1). Former subsec. (h) redesignated (i).
Subsec. (i). Act June 16, 1948, §5(a), (e), redesignated former subsec. (h) as (i), made subsection applicable to subsec. (e), and made technical changes as a result of the renumbering of subsections. Former subsec. (i) redesignated (j).
Subsecs. (j), (k). Act June 16, 1948, §5(a), redesignated former subsecs. (i) and (j) as (j) and (k), respectively.
1946—Subsec. (c). Act July 3, 1946, increased annual appropriation from $20,000,000 to $30,000,000, and increased annual amount available to provide demonstrations and to train personnel for State and local health work from $2,000,000 to $3,000,000.
Subsec. (d). Act July 3, 1946, provided that Surgeon General shall give special consideration to the extent of the mental health problem as well as other special problems.
Subsecs. (f), (h), (i). Act July 3, 1946, provided that in matters relating to work in field of mental health Surgeon General shall deal with State mental health authorities where they differ from general health authorities.
Effective Date of 1981 Amendment
Amendment by
Effective Date of 1980 Amendment
Section 107(d) of
Effective Date of 1979 Amendment
Amendment by
Effective Date of 1978 Amendments
Section 201(b)(2) of
Section 403(b) of
Effective Date of 1975 Amendment
Section 102 of
Amendment by section 501(b) of
Effective Date of 1971 Amendment
Repeal of subsec. (f) of this section (less applicability to commissioned officers of the Public Health Service) by section 403(a) of
Effective Date of 1970 Amendments
Section 260(c)(2) of
Section 401(b)(1) of
Effective Date of 1967 Amendment
Section 2(d)(2), (f) of
Section 3(b) of
Effective Date of 1966 Amendment
Section 6 of
Effective Date of 1962 Amendment
Section 4(b) of
Effective and Termination Date of 1958 Amendment
Section 2 of
Effective Date of 1956 Amendment
Section 18 of act Aug. 1, 1956, provided that the amendment made by that section is effective July 1, 1956.
Repeals
The directory language of, but not the amendment made by,
Transfer of Functions
Functions, powers, and duties of Secretary of Health and Human Services under subsecs. (a)(2)(F) and (d)(2)(F) of this section, insofar as relates to the prescription of personnel standards on a merit basis, transferred to Office of Personnel Management, see
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Year 2000 Health Objectives Planning
Congressional Findings and Declaration
Section 201(b)(1) of
"(A) individual health status can be effectively and economically improved through an adequate investment in community public health programs and services;
"(B) the Federal Government and the States and their communities share in the financial responsibility for funding public health programs;
"(C) the Federal contribution to funds for public health programs should serve as an incentive to an additional investment by State and local governments;
"(D) existing categorical programs of Federal financial assistance to combat specific public health problems should be supplemented by a national program of stable generic support for such public health activities as the prevention and control of environmental health hazards, prevention and control of diseases, prevention and control of health problems of particularly vulnerable population groups, and development and regulation of health care facilities and health services delivery systems; and
"(E) the States and their communities, not the Federal Government, should have primary responsibility for identifying and measuring the impact of public health problems and the allocation of resources for their amelioration."
Section 2 of
"(a) The Congress declares that fulfillment of our national purpose depends on promoting and assuring the highest level of health attainable for every person, in an environment which contributes positively to healthful individual and family living; that attainment of this goal depends on an effective partnership, involving close intergovernmental collaboration, official and voluntary efforts, and participation of individuals and organizations; that Federal financial assistance must be directed to support the marshaling of all health resources—national, State, and local—to assure comprehensive health services of high quality for every person, but without interference with existing patterns of private professional practice of medicine, dentistry, and related healing arts.
"(b) To carry out such purpose, and recognizing the changing character of health problems, the Congress finds that comprehensive planning for health services, health manpower, and health facilities is essential at every level of government; that desirable administration requires strengthening the leadership and capacities of State health agencies; and that support of health services provided people in their communities should be broadened and made more flexible."
Section 2 of act July 3, 1956, provided that:
"(a) The Congress hereby finds and declares—
"(1) that the latest information on the number and relevant characteristics of persons in the country suffering from heart disease, cancer, diabetes, arthritis and rheumatism, and other diseases, injuries, and handicapping conditions is now seriously out of date; and
"(2) that periodic inventories providing reasonably current information on these matters are urgently needed for purposes such as (A) appraisal of the true state of health of our population (including both adults and children), (B) adequate planning of any programs to improve their health, (C) research in the field of chronic diseases, and (D) measurement of the numbers of persons in the working ages so disabled as to be unable to perform gainful work.
"(b) It is, therefore, the purpose of this Act [see Short Title of 1956 Amendment note set out under
Limitation on Grants-in-Aid to Schools of Public Health
Section 2 of
Grants to States To Provide for Vaccination Against Poliomyelitis
The Poliomyelitis Vaccination Assistance Act of 1955, act Aug. 12, 1955, ch. 863,
Applicability of Reorganization Plan No. 3 of 1966
Section 7 of
Section Referred to in Other Sections
This section is referred to in
§246a. Bureau of State Services management fund; establishment; advancements; availability
For the purpose of facilitating the economical and efficient conduct of operations in the Bureau of State Services which are financed by two or more appropriations where the costs of operation are not readily susceptible of distribution as charges to such appropriations, there is established the Bureau of State Services management fund. Such amounts as the Secretary may determine to represent a reasonable distribution of estimated costs among the various appropriations involved may be advanced each year to this fund and shall be available for expenditure for such costs under such regulations as may be prescribed by the Secretary: Provided, That funds advanced to this fund shall be available only in the fiscal year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected wherever practicable with the appropriations from which such funds are advanced.
(
Codification
Section was not enacted as part of the Public Health Service Act which comprises this chapter.
Amendments
1970—
§247. Omitted
Section, act July 1, 1944, ch. 373, title III, §315, as added Oct. 4, 1988,
Prior Provisions
A prior section 247, act July 1, 1944, ch. 373, title III, §315, as added Nov. 10, 1978,
Another prior section 247, acts July 1, 1944, ch. 373, title III, §315,
§247a. Family support groups for Alzheimer's disease patients
(a) Establishment; priorities
Subject to available appropriations, the Secretary, acting through the National Institute of Mental Health, the National Institutes of Health, and the Administration on Aging, shall promote the establishment of family support groups to provide, without charge, educational, emotional, and practical support to assist individuals with Alzheimer's disease or a related memory disorder and members of the families of such individuals. In promoting the establishment of such groups, the Secretary shall give priority to—
(1) university medical centers and other appropriate health care facilities which receive Federal funds from the Secretary and which conduct research on Alzheimer's disease or provide services to individuals with such disease; and
(2) community-based programs which receive funds from the Secretary, acting through the Administration on Aging.
(b) National network to coordinate groups
The Secretary shall promote the establishment of a national network to coordinate the family support groups described in subsection (a) of this section.
(July 1, 1944, ch. 373, title III, §316, as added May 23, 1986,
Prior Provisions
A prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Nov. 10, 1978,
Another prior section 247a, act July 1, 1944, ch. 373, title III, §316, as added Oct. 30, 1970,
Amendments
1993—Subsec. (c).
§247b. Project grants for preventive health services
(a) Grant authority
The Secretary may make grants to States, and in consultation with State health authorities, to political subdivisions of States and to other public entities to assist them in meeting the costs of establishing and maintaining preventive health service programs.
(b) Application
No grant may be made under subsection (a) of this section unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and be submitted in such manner as the Secretary shall by regulation prescribe and shall provide—
(1) a complete description of the type and extent of the program for which the applicant is seeking a grant under subsection (a) of this section;
(2) with respect to each such program (A) the amount of Federal, State, and other funds obligated by the applicant in its latest annual accounting period for the provision of such program, (B) a description of the services provided by the applicant in such program in such period, (C) the amount of Federal funds needed by the applicant to continue providing such services in such program, and (D) if the applicant proposes changes in the provision of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of Federal funds needed by the applicant to make such changes;
(3) assurances satisfactory to the Secretary that the program which will be provided with funds under a grant under subsection (a) of this section will be provided in a manner consistent with the State health plan in effect under section 300m–3(c) 1 of this title and in those cases where the applicant is a State, that such program will be provided, where appropriate, in a manner consistent with any plans in effect under an application approved under section 247 1 of this title;
(4) assurances satisfactory to the Secretary that the applicant will provide for such fiscal control and fund accounting procedures as the Secretary by regulation prescribes to assure the proper disbursement of and accounting for funds received under grants under subsection (a) of this section;
(5) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or programs;
(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such information as the Secretary may by regulation prescribe) as the Secretary may reasonably require and keep such records and afford such access thereto as the Secretary may find necessary to assure the correctness of, and to verify, such reports;
(7) assurances satisfactory to the Secretary that the applicant will comply with any other conditions imposed by this section with respect to grants; and
(8) such other information as the Secretary may by regulation prescribe.
(c) Approval; annual project review
(1) The Secretary shall not approve an application submitted under subsection (b) of this section for a grant for a program for which a grant was previously made under subsection (a) of this section unless the Secretary determines—
(A) the program for which the application was submitted is operating effectively to achieve its stated purpose,
(B) the applicant complied with the assurances provided the Secretary when applying for such previous grant, and
(C) the applicant will comply with the assurances provided with the application.
(2) The Secretary shall review annually the activities undertaken by each recipient of a grant under subsection (a) of this section to determine if the program assisted by such grant is operating effectively to achieve its stated purposes and if the recipient is in compliance with the assurances provided the Secretary when applying for such grant.
(d) Amount of grant; payment
The amount of a grant under subsection (a) of this section shall be determined by the Secretary. Payments under such grants may be made in advance on the basis of estimates or by the way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(e) Reduction
The Secretary, at the request of a recipient of a grant under subsection (a) of this section, may reduce the amount of such grant by—
(1) the fair market value of any supplies (including vaccines and other preventive agents) or equipment furnished the grant recipient, and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee,
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) of this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(f) Recordkeeping; audit authority
(1) Each recipient of a grant under subsection (a) of this section shall keep such records as the Secretary shall by regulation prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of grants under subsection (a) of this section that are pertinent to such grants.
(g) Use of grant funds; mandatory treatment prohibited
(1) Nothing in this section shall limit or otherwise restrict the use of funds which are granted to a State or to an agency or a political subdivision of a State under provisions of Federal law (other than this section) and which are available for the conduct of preventive health service programs from being used in connection with programs assisted through grants under subsection (a) of this section.
(2) Nothing in this section shall be construed to require any State or any agency or political subdivision of a State to have a preventive health service program which would require any person, who objects to any treatment provided under such a program, to be treated or to have any child or ward treated under such program.
(h) Reports
The Secretary shall include, as part of the report required by
(i) Technical assistance
The Secretary may provide technical assistance to States, State health authorities, and other public entities in connection with the operation of their preventive health service programs.
(j) Authorization of appropriations
(1) Except for grants for immunization programs the authorization of appropriations for which are established in paragraph (2), for grants under subsections (a) and (k)(1) of this section for preventive health service programs to immunize without charge individuals against vaccine-preventable diseases, there are authorized to be appropriated $205,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1995. Not more than 10 percent of the total amount appropriated under the preceding sentence for any fiscal year shall be available for grants under subsection (k)(1) of this section for such fiscal year.
(2) For grants under subsection (a) of this section for preventive health service programs for the provision without charge of immunizations with vaccines approved for use, and recommended for routine use, after October 1, 1990, there are authorized to be appropriated such sums as may be necessary.
(k) Additional grants to States, political subdivisions, and other public and nonprofit private entities
(1) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases that may be prevented through vaccination;
(B) demonstration projects for the prevention and control of such diseases;
(C) public information and education programs for the prevention and control of such diseases; and
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).
(2) The Secretary may make grants to States, political subdivisions of States, and other public and nonprofit private entities for—
(A) research into the prevention and control of diseases and conditions;
(B) demonstration projects for the prevention and control of such diseases and conditions;
(C) public information and education programs for the prevention and control of such diseases and conditions; and
(D) education, training, and clinical skills improvement activities in the prevention and control of such diseases and conditions for health professionals (including allied health personnel).
(3) No grant may be made under this subsection unless an application therefor is submitted to the Secretary in such form, at such time, and containing such information as the Secretary may by regulation prescribe.
(4) Subsections (d), (e), and (f) of this section shall apply to grants under this subsection in the same manner as such subsections apply to grants under subsection (a) of this section.
(July 1, 1944, ch. 373, title III, §317, as added Oct. 23, 1962,
References in Text
Amendments
1993—Subsec. (j).
Subsec. (k)(2).
"(A) research into the prevention, control, and elimination of tuberculosis, especially research concerning strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect certain populations;
"(B) demonstration projects for the prevention, control, and elimination of tuberculosis;
"(C) public information and education programs for prevention, control, and elimination of tuberculosis; and
"(D) education, training, and clinical skills improvement activities in the prevention, control, and elimination of tuberculosis for health professionals, including allied health personnel."
Subsec. (k)(3).
Subsec. (k)(4), (5).
Subsec. (l).
1990—Subsec. (j)(1)(A).
Subsec. (j)(1)(B).
Subsec. (j)(1)(C).
Subsec. (j)(2).
Subsec. (k)(2)(A) to (D).
Subsec. (l).
1987—Subsec. (j).
Subsec. (k).
1985—Subsec. (j).
1984—Subsec. (j)(1).
Subsec. (j)(2).
1981—Subsec. (a).
Subsec. (j).
1979—Subsec. (j)(4), (5).
1978—
Subsec. (g)(2).
1976—
Subsecs. (j) to (l).
1975—Subsec. (d)(3).
Subsec. (h)(1).
1974—Subsec. (a).
Subsec. (b)(2)(C).
Subsecs. (b)(3), (d)(1), (2), (3), (f)(1).
Subsec. (h)(1).
Subsec. (i).
1972—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
1970—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsecs. (f), (g).
1965—Subsec. (a).
Subsec. (b).
Subsec. (c).
Effective Date of 1978 Amendment
Section 202 of
Effective Date of 1976 Amendment
Section 202(a) of
Effective Date of 1975 Amendment
Section 608 of title VI of
Effective Date of 1972 Amendment
Section 102 of
Assistance of Administrator of Veterans' Affairs in Administration of National Swine Flu Immunization Program of 1976; Claims for Damages
Study by Secretary of Scope and Extent of Liability Arising Out of Immunization Program; Alternative Protective Approaches; Report to Congress
Section 3 of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§247b–1. Screenings, referrals, and education regarding lead poisoning
(a) Authority for grants
(1) In general
Subject to paragraph (2), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and political subdivisions of States for the initiation and expansion of community programs designed—
(A) to provide, for infants and children—
(i) screening for elevated blood lead levels;
(ii) referral for treatment of such levels; and
(iii) referral for environmental intervention associated with such levels; and
(B) to provide education about childhood lead poisoning.
(2) Authority regarding certain entities
With respect to a geographic area with a need for activities authorized in paragraph (1), in any case in which neither the State nor the political subdivision in which such area is located has applied for a grant under paragraph (1), the Secretary may make a grant under such paragraph to any grantee under
(3) Provision of all services and activities through each grantee
In making grants under paragraph (1), the Secretary shall ensure that each of the activities described in such paragraph is provided through each grantee under such paragraph. The Secretary may authorize such a grantee to provide the services and activities directly, or through arrangements with other providers.
(b) Status as medicaid provider
(1) In general
Subject to paragraph (2), the Secretary may not make a grant under subsection (a) of this section unless, in the case of any service described in such subsection that is made available pursuant to the State plan approved under title XIX of the Social Security Act [
(A) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(B) the applicant will enter into an agreement with a provider under which the provider will provide the service, and the provider has entered into such a participation agreement and is qualified to receive such payments.
(2) Waiver regarding certain secondary agreements
(A) In the case of a provider making an agreement pursuant to paragraph (1)(B) regarding the provision of services, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the provider does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits plan.
(B) A determination by the Secretary of whether a provider referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the provider accepts voluntary donations regarding the provision of services to the public.
(c) Priority in making grants
In making grants under subsection (a) of this section, the Secretary shall give priority to applications for programs that will serve areas with a high incidence of elevated blood lead levels in infants and children.
(d) Grant application
No grant may be made under subsection (a) of this section, unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be in such form and shall be submitted in such manner as the Secretary shall prescribe and shall include each of the following:
(1) A complete description of the program which is to be provided by or through the applicant.
(2) Assurances satisfactory to the Secretary that the program to be provided under the grant applied for will include educational programs designed to—
(A) communicate to parents, educators, and local health officials the significance and prevalence of lead poisoning in infants and children (including the sources of lead exposure, the importance of screening young children for lead, and the preventive steps that parents can take in reducing the risk of lead poisoning) which the program is designed to detect and prevent; and
(B) communicate to health professionals and paraprofessionals updated knowledge concerning lead poisoning and research (including the health consequences, if any, of low-level lead burden; the prevalence of lead poisoning among all socioeconomic groupings; the benefits of expanded lead screening; and the therapeutic and other interventions available to prevent and combat lead poisoning in affected children and families).
(3) Assurances satisfactory to the Secretary that the applicant will report on a quarterly basis the number of infants and children screened for elevated blood lead levels, the number of infants and children who were found to have elevated blood lead levels, the number and type of medical referrals made for such infants and children, the outcome of such referrals, and other information to measure program effectiveness.
(4) Assurances satisfactory to the Secretary that the applicant will make such reports respecting the program involved as the Secretary may require.
(5) Assurances satisfactory to the Secretary that the applicant will coordinate the activities carried out pursuant to subsection (a) of this section with related activities and services carried out in the State by grantees under title V or XIX of the Social Security Act [
(6) Assurances satisfactory to the Secretary that Federal funds made available under such a grant for any period will be so used as to supplement and, to the extent practical, increase the level of State, local, and other non-Federal funds that would, in the absence of such Federal funds, be made available for the program for which the grant is to be made and will in no event supplant such State, local, and other non-Federal funds.
(7) Such other information as the Secretary may prescribe.
(e) Relationship to services and activities under other programs
(1) In general
A recipient of a grant under subsection (a) of this section may not make payments from the grant for any service or activity to the extent that payment has been made, or can reasonably be expected to be made, with respect to such service or activity—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(2) Applicability to certain secondary agreements for provision of services
Paragraph (1) shall not apply in the case of a provider through which a grantee under subsection (a) of this section provides services under such subsection if the Secretary has provided a waiver under subsection (b)(2) of this section regarding the provider.
(f) Method and amount of payment
The Secretary shall determine the amount of a grant made under subsection (a) of this section. Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants. Not more than 10 percent of any grant may be obligated for administrative costs.
(g) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of a grant under subsection (a) of this section, may reduce the amount of such grant by—
(1) the fair market value of any supplies or equipment furnished the grant recipient; and
(2) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) of this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(h) Records
Each recipient of a grant under subsection (a) of this section shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the undertaking in connection with which such grant was made, and the amount of that portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(i) Audit and examination of records
The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of a grant under subsection (a) of this section, that are pertinent to such grant.
(j) Annual report
(1) In general
Not later than May 1 of each year, the Secretary shall submit to the Congress a report on the effectiveness during the preceding fiscal year of programs carried out with grants under subsection (a) of this section and of any programs that are carried out by the Secretary pursuant to subsection (l)(2) of this section.
(2) Certain requirements
Each report under paragraph (1) shall include, in addition to any other information that the Secretary may require, the following information:
(A) The number of infants and children screened.
(B) Demographic information on the population of infants and children screened, including the age and racial or ethnic status of such population.
(C) The number of screening sites.
(D) A description of the severity of the extent of the blood lead levels of the infants and children screened, expressed in categories of severity.
(E) The sources of payment for the screenings.
(F) A comparison of the data provided pursuant to subparagraphs (A) through (E) with the equivalent data, if any, provided in the report under paragraph (1) preceding the report involved.
(k) Indian tribes
For purposes of this section, the term "political subdivision" includes Indian tribes.
(l) Funding
(1) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998.
(2) Allocation for other programs
Of the amounts appropriated under paragraph (1) for any fiscal year, the Secretary may reserve not more than 20 percent for carrying out programs regarding the activities described in subsection (a) of this section in addition to the program of grants established in such subsection.
(July 1, 1944, ch. 373, title III, §317A, as added Oct. 31, 1988,
References in Text
The Social Security Act, referred to in subsecs. (b)(1) and (d)(5), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 247b–1,
Amendments
1993—Subsec. (l)(1).
1992—
§247b–2. Repealed. Pub. L. 97–35, title IX, §902(a), Aug. 13, 1981, 95 Stat. 559
Section,
Effective Date of Repeal
Repeal effective Oct. 1, 1981, see section 902(h) of
§247b–3. Education, technology assessment, and epidemiology regarding lead poisoning
(a) Prevention
(1) Public education
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out a program to educate health professionals and paraprofessionals and the general public on the prevention of lead poisoning in infants and children. In carrying out the program, the Secretary shall make available information concerning the health effects of low-level lead toxicity, the causes of lead poisoning, and the primary and secondary preventive measures that may be taken to prevent such poisoning.
(2) Interagency Task Force
(A) Not later than 6 months after October 27, 1992, the Secretary shall establish a council to be known as the Interagency Task Force on the Prevention of Lead Poisoning (in this paragraph referred to as the "Task Force"). The Task Force shall coordinate the efforts of Federal agencies to prevent lead poisoning.
(B) The Task Force shall be composed of—
(i) the Secretary, who shall serve as the chair of the Task Force;
(ii) the Secretary of Housing and Urban Development;
(iii) the Administrator of the Environmental Protection Agency; and
(iv) senior staff of each of the officials specified in clauses (i) through (iii), as selected by the officials respectively.
(C) The Task Force shall—
(i) review, evaluate, and coordinate current strategies and plans formulated by the officials serving as members of the Task Force, including—
(I) the plan of the Secretary of Health and Human Services entitled "Strategic Plan for the Elimination of Lead Poisoning", dated February 21, 1991;
(II) the plan of the Secretary of Housing and Urban Development entitled "Comprehensive and Workable Plan for the Abatement of Lead-Based Paint in Privately Owned Housing", dated December 7, 1990; and
(III) the strategy of the Administrator of the Environmental Protection Agency entitled "Strategy for Reducing Lead Exposures", dated February 21, 1991;
(ii) develop a unified implementation plan for programs that receive Federal financial assistance for activities related to the prevention of lead poisoning;
(iii) establish a mechanism for sharing and disseminating information among the agencies represented on the Task Force;
(iv) identify the most promising areas of research and education concerning lead poisoning;
(v) identify the practical and technological constraints to expanding lead poisoning prevention;
(vi) annually carry out a comprehensive review of Federal programs providing assistance to prevent lead poisoning, and not later than May 1 of each year, submit to the Committee on Labor and Human Resources of the Senate and the Committee on the Environment and Public Works of the Senate, and to the Committee on Energy and Commerce of the House of Representatives, a report that summarizes the findings made as a result of such review and that contains the recommendations of the Task Force on the programs and policies with respect to which the Task Force is established, including related budgetary recommendations; and
(vii) annually review and coordinate departmental and agency budgetary requests with respect to all lead poisoning prevention activities of the Federal Government.
(b) Technology assessment and epidemiology
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall, directly or through grants or contracts—
(1) provide for the development of improved, more cost-effective testing measures for detecting lead toxicity in children;
(2) provide for the development of improved methods of assessing the prevalence of lead poisoning, including such methods as may be necessary to conduct individual assessments for each State;
(3) provide for the collection of data on the incidence and prevalence of lead poisoning of infants and children, on the demographic characteristics of infants and children with such poisoning (including racial and ethnic status), and on the source of payment for treatment for such poisoning (including the extent to which insurance has paid for such treatment); and
(4) provide for any applied research necessary to improve the effectiveness of programs for the prevention of lead poisoning in infants and children.
(July 1, 1944, ch. 373, title III, §317B, as added Oct. 27, 1992,
Amendments
1993—
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
§247b–4. Collection of data on birth defects
(a) State programs
(1) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall encourage States to establish or improve programs for the collection and analysis of epidemiological data on birth defects.
(2) Provision of assistance
The Secretary may, directly or through grants, cooperative agreements, or contracts, provide assistance to States regarding the purpose specified in subsection (a).1
(b) National Clearinghouse
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish and maintain a National Information Clearinghouse on Birth Defects to collect and disseminate to health professionals and the general public information on birth defects, including the prevention of such defects.
(c) Report
Not later than July 1, 1993, and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Labor and Human Resources of the Senate, a report describing activities carried out under this section and containing any recommendations of the Secretary regarding this section.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 and 1995.
(July 1, 1944, ch. 373, title III, §317C, as added Oct. 27, 1992,
Amendments
1993—
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
1 So in original. Probably should be "paragraph (1)."
§247b–5. Preventive health measures with respect to prostate cancer
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States and local health departments for the purpose of enabling such States and departments to carry out programs—
(1) to screen men for prostate cancer as a preventive health measure;
(2) to provide appropriate referrals for medical treatment of men screened pursuant to paragraph (1) and to ensure, to the extent practicable, the provision of appropriate follow-up services;
(3) to develop and disseminate public information and education programs for the detection and control of prostate cancer;
(4) to improve the education, training, and skills of health professionals (including appropriate allied health professionals) in the detection and control of prostate cancer;
(5) to establish mechanisms through which the States and such departments can monitor the quality of screening procedures for prostate cancer, including the interpretation of such procedures; and
(6) to evaluate activities conducted under paragraphs (1) through (5) through appropriate surveillance or program monitoring activities.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such section, to make available non-Federal contributions (in cash or in kind under paragraph (2)) toward such costs in an amount equal to not less than $1 for each $3 of Federal funds provided in the grant. Such contributions may be made directly or through donations from public or private entities.
(2) Determination of amount of non-Federal contribution
(A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including equipment or services (and excluding indirect or overhead costs). Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary may include only non-Federal contributions in excess of the average amount of non-Federal contributions made by the applicant involved toward the purpose described in subsection (a) of this section for the 2-year period preceding the fiscal year for which the applicant involved is applying to receive a grant under such subsection.
(C) In making a determination of the amount of non-Federal contributions for purposes of paragraph (1), the Secretary shall, subject to subparagraphs (A) and (B) of this paragraph, include any non-Federal amounts expended pursuant to title XIX of the Social Security Act [
(c) Education on significance of early detection
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that, in carrying out subsection (a)(3) of this section, the applicant will carry out education programs to communicate to men, and to local health officials, the significance of the early detection of prostate cancer.
(d) Requirement of provision of all services by date certain
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees—
(1) to ensure that, initially and throughout the period during which amounts are received pursuant to the grant, not less than 60 percent of the grant is expended to provide each of the services or activities described in paragraphs (1) and (2) of such subsection;
(2) to ensure that, by the end of any second fiscal year of payments pursuant to the grant, each of the services or activities described in such subsection is provided; and
(3) to ensure that not more than 40 percent of the grant is expended to provide the services or activities described in paragraphs (3) through (6) of such section.1
(e) Additional required agreements
(1) Priority for low-income men
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that low-income men, and men at risk of prostate cancer, will be given priority in the provision of services and activities pursuant to paragraphs (1) and (2) of such subsection.
(2) Limitation on imposition of fees for services
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(A) will be made according to a schedule of charges that is made available to the public;
(B) will be adjusted to reflect the income of the man involved; and
(C) will not be imposed on any man with an income of less than 100 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with
(3) Relationship to items and services under other programs
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that the grant will not be expended to make payment for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(A) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(B) by an entity that provides health services on a prepaid basis.
(4) Coordination with other prostate cancer programs
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that the services and activities funded through the grant will be coordinated with other Federal, State, and local prostate cancer programs.
(5) Limitation on administrative expenses
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that not more than 10 percent of the grant will be expended for administrative expenses with respect to the grant.
(6) Restrictions on use of grant
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that the grant will not be expended to provide inpatient hospital services for any individual.
(7) Records and audits
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees that—
(A) the applicant will establish such fiscal control and fund accounting procedures as may be necessary to ensure the proper disbursal of, and accounting for, amounts received by the applicant under such section; 2 and
(B) upon request, the applicant will provide records maintained pursuant to paragraph (1) to the Secretary or the Comptroller of the United States for purposes of auditing the expenditures by the applicant of the grant.
(f) Reports to Secretary
The Secretary may not make a grant under subsection (a) of this section unless the applicant involved agrees to submit to the Secretary such reports as the Secretary may require with respect to the grant.
(g) Description of intended uses of grant
The Secretary may not make a grant under subsection (a) of this section unless—
(1) the applicant involved submits to the Secretary a description of the purposes for which the applicant intends to expend the grant;
(2) the description identifies the populations, areas, and localities in the applicant 3 with a need for the services or activities described in subsection (a) of this section;
(3) the description provides information relating to the services and activities to be provided, including a description of the manner in which the services and activities will be coordinated with any similar services or activities of public or nonprivate entities; and
(4) the description provides assurances that the grant funds will be used in the most cost-effective manner.
(h) Requirement of submission of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary, the application contains the description of intended uses required in subsection (g) of this section, and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(i) Method and amount of payment
The Secretary shall determine the amount of a grant made under subsection (a) of this section. Payments under such grants may be made in advance on the basis of estimates or by way of reimbursement, with necessary adjustments on account of the underpayments or overpayments, and in such installments and on such terms and conditions as the Secretary finds necessary to carry out the purposes of such grants.
(j) Technical assistance and provision of supplies and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and technical assistance with respect to the planning, development, and operation of any program or service carried out pursuant to subsection (a) of this section. The Secretary may provide such technical assistance directly or through grants to, or contracts with, public and private entities.
(2) Provision of supplies and services in lieu of grant funds
(A) Upon the request of an applicant receiving a grant under subsection (a) of this section, the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the applicant in carrying out such section and, for such purpose, may detail to the applicant any officer or employee of the Department of Health and Human Services.
(B) With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the grant under subsection (a) of this section to the applicant involved by an amount equal to the costs of detailing personnel (including pay, allowances, and travel expenses) and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(k) "Units of local government" defined
For purposes of this section, the term "units of local government" includes Indian tribes.
(l) Authorization of appropriations
(1) In general
For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998.
(2) Allocation for technical assistance
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall reserve not more than 20 percent for carrying out subsection (j)(1) of this section.
(July 1, 1944, ch. 373, title III, §317D, as added Oct. 27, 1992,
References in Text
The Social Security Act, referred to in subsec. (b)(2)(C), is act Aug. 14, 1935, ch. 531,
Amendments
1993—
Subsec. (l)(1).
1 So in original. Probably should be "subsection."
2 So in original. Probably should be "subsection;".
3 So in original. Probably should be "application".
§247b–6. Preventive health services regarding tuberculosis
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions, and other public entities for preventive health service programs for the prevention, control, and elimination of tuberculosis.
(b) Research, demonstration projects, education, and training
With respect to the prevention, control, and elimination of tuberculosis, the Secretary may, directly or through grants to public or nonprofit private entities, carry out the following:
(1) Research, with priority given to research concerning strains of tuberculosis resistant to drugs and research concerning cases of tuberculosis that affect certain populations.
(2) Demonstration projects.
(3) Public information and education programs.
(4) Education, training, and clinical skills improvement activities for health professionals, including allied health personnel and emergency response employees.
(5) Support of centers to carry out activities under paragraphs (1) through (4).
(6) Collaboration with international organizations and foreign countries in carrying out such activities.
(c) Cooperation with providers of primary health services
The Secretary may make a grant under subsection (a) or (b) of this section only if the applicant for the grant agrees that, in carrying out activities under the grant, the applicant will cooperate with public and nonprofit private providers of primary health services or substance abuse services, including entities receiving assistance under
(d) Application for grant
(1) In general
The Secretary may make a grant under subsection (a) or (b) of this section only if an application for the grant is submitted to the Secretary and the application, subject to paragraph (2), is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the subsection involved.
(2) Plan for prevention, control, and elimination
The Secretary may make a grant under subsection (a) of this section only if the application under paragraph (1) contains a plan regarding the prevention, control, and elimination of tuberculosis in the geographic area with respect to which the grant is sought.
(e) Supplies and services in lieu of grant funds
(1) In general
Upon the request of a grantee under subsection (a) or (b) of this section, the Secretary may, subject to paragraph (2), provide supplies, equipment, and services for the purpose of aiding the grantee in carrying out the subsection involved and, for such purpose, may detail to the State any officer or employee of the Department of Health and Human Services.
(2) Corresponding reduction in payments
With respect to a request described in paragraph (1), the Secretary shall reduce the amount of payments under the grant involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld.
(f) Advisory Council
(1) In general
The Secretary shall establish an advisory council to be known as the Advisory Council for the Elimination of Tuberculosis (in this subsection referred to as the "Council").
(2) General duties
The Council shall provide advice and recommendations regarding the elimination of tuberculosis to the Secretary, the Assistant Secretary for Health, and the Director of the Centers for Disease Control and Prevention.
(3) Certain activities
With respect to the elimination of tuberculosis, the Council shall—
(A) in making recommendations under paragraph (2), make recommendations regarding policies, strategies, objectives, and priorities;
(B) address the development and application of new technologies; and
(C) review the extent to which progress has been made toward eliminating tuberculosis.
(4) Composition
The Secretary shall determine the size and composition of the Council, and the frequency and scope of official meetings of the Council.
(5) Staff, information, and other assistance
The Secretary shall provide to the Council such staff, information, and other assistance as may be necessary to carry out the duties of the Council.
(g) Funding
(1) In general; allocation for emergency grants
(A) For the purpose of making grants under subsection (a) of this section, there are authorized to be appropriated $200,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.
(B) Of the amounts appropriated under subparagraph (A) for a fiscal year, the Secretary may reserve not more than $50,000,000 for emergency grants under subsection (a) of this section for any geographic area in which there is, relative to other areas, a substantial number of cases of tuberculosis or a substantial rate of increase in such cases.
(2) Research, demonstration projects, education, and training
For the purpose of making grants under subsection (b) of this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1998.
(July 1, 1944, ch. 373, title III, §317E, as added Dec. 14, 1993,
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
Section Referred to in Other Sections
This section is referred to in
§247b–7. Loan repayment program
(a) In general
(1) Authority
Subject to paragraph (2), the Secretary may carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct prevention activities, as employees of the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.
(2) Limitation
The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the Centers for Disease Control and Prevention or the Agency for Toxic Substances and Disease Registry for purposes of paragraph (1) for a period of not less than 3 years.
(b) Applicability of certain provisions
With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of this subchapter, the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $500,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.
(July 1, 1944, ch. 373, title III, §317F, as added Dec. 14, 1993,
§247c. Sexually transmitted diseases; prevention and control projects and programs
(a) Technical assistance to public and nonprofit private entities and scientific institutions
The Secretary may provide technical assistance to appropriate public and nonprofit private entities and to scientific institutions for their research in, and training and public health programs for, the prevention and control of sexually transmitted diseases.
(b) Research, demonstration, and public information and education projects
The Secretary may make grants to States, political subdivisions of States, and any other public and nonprofit private entity for—
(1) research into the prevention and control of sexually transmitted diseases;
(2) demonstration projects for the prevention and control of sexually transmitted diseases;
(3) public information and education programs for the prevention and control of such diseases; and
(4) education, training, and clinical skills improvement activities in the prevention and control of such diseases for health professionals (including allied health personnel).
(c) Project grants to States
The Secretary is also authorized to make project grants to States and, in consultation with the State health authority, to political subdivisions of States, for—
(1) sexually transmitted diseases surveillance activities, including the reporting, screening, and followup of diagnostic tests for, and diagnosed cases of, sexually transmitted diseases;
(2) casefinding and case followup activities respecting sexually transmitted diseases, including contact tracing of infectious cases of sexually transmitted diseases and routine testing, including laboratory tests and followup systems;
(3) interstate epidemiologic referral and followup activities respecting sexually transmitted diseases; and
(4) such special studies or demonstrations to evaluate or test sexually transmitted diseases prevention and control strategies and activities as may be prescribed by the Secretary.
(d) Grants for innovative, interdisciplinary approaches
The Secretary may make grants to States and political subdivisions of States for the development, implementation, and evaluation of innovative, interdisciplinary approaches to the prevention and control of sexually transmitted diseases.
(e) Authorization of appropriations; terms and conditions; payments; recordkeeping; audit; grant reduction; information disclosure
(1) For the purpose of making grants under subsections (b) through (d) of this section, there are authorized to be appropriated $85,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.
(2) Each recipient of a grant under this section shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant was given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(3) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipients of grants under this section that are pertinent to such grants.
(4) The Secretary, at the request of a recipient of a grant under this section, may reduce such grant by the fair market value of any supplies or equipment furnished to such recipient and by the amount of pay, allowances, travel expenses, and any other costs in connection with the detail of an officer or employee of the United States to the recipient when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such recipient and for the purpose of carrying out the program with respect to which the grant under this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies, equipment, or personal services on which the reduction of such grant is based.
(5) All information obtained in connection with the examination, care, or treatment of any individual under any program which is being carried out with a grant made under this section shall not, without such individual's consent, be disclosed except as may be necessary to provide service to him or as may be required by a law of a state or political subdivision of a State. Information derived from any such program may be disclosed—
(A) in summary, statistical, or other form; or
(B) for clinical or research purposes;
but only if the identity of the individuals diagnosed or provided care or treatment under such program is not disclosed.
(e) 1 Consent of individuals
Nothing in this section shall be construed to require any State or any political subdivision of a State to have a sexually transmitted diseases program which would require any person, who objects to any treatment provided under such a program, to be treated under such a program.
(July 1, 1944, ch. 373, title III, §318, as added Sept. 30, 1972,
Prior Provisions
A prior section 247c, act July 1, 1944, ch. 373 title III, §318, as added Aug. 18, 1964,
Amendments
1993—Subsec. (b)(3).
Subsec. (c)(3).
Subsec. (d).
Subsec. (e).
Subsec. (e)(1).
Subsec. (e)(5).
1988—
Subsec. (d).
Subsec. (d)(1).
Subsecs. (e) to (g).
1984—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsecs. (f), (g).
1981—Subsec. (d)(1).
1979—Subsec. (b).
1978—Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (f).
Subsec. (g).
1976—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Distribution of Information on Acquired Immune Deficiency Syndrome by Director of Centers for Disease Control to Every American Household
Congressional Findings and Declarations
Section 204(a) of
"(1) the number of reported cases of venereal disease persists in epidemic proportions in the United States;
"(2) the number of persons affected by venereal disease and reported to public health authorities is only a fraction of those actually affected;
"(3) the incidence of venereal disease continues to be particularly high among American youth, ages fifteen to twenty-nine, and among populations in metropolitan areas;
"(4) venereal disease accounts for severe permanent disabilities and sometimes death in newborns and causes reproductive dysfunction in women of childbearing age;
"(5) it is conservatively estimated that the public cost of health care for persons suffering from complications of venereal disease exceeds one-half billion dollars annually;
"(6) the number of trained Federal venereal disease prevention and control personnel has fallen to a dangerously inadequate level;
"(7) no vaccine for syphilis, gonorrhea, or any other venereal disease has yet been developed, nor does a blood test for the detection of asymptomatic gonorrhea in women exist, nor are safe and effective therapeutic agents available for some other venereal diseases;
"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup have all been found to be effective venereal disease prevention and control methodologies;
"(9) skilled and knowledgeable health care providers, informed and concerned individuals and active, well-coordinated voluntary groups are fundamental to venereal disease prevention and control;
"(10) biomedical research toward improved diagnostic and therapeutic tools is of singular importance to the elimination of venereal disease; and
"(11) an increasing number of sexually transmissible diseases besides syphilis and gonorrhea have become a public health hazard."
Section 203(a) of
"(1) the number of reported cases of venereal disease continues in epidemic proportions in the United States;
"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those actually infected;
"(3) the incidence of venereal disease is particularly high in the 15–29-year age group, and in metropolitan areas;
"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
"(5) the number of cases of congenital syphilis, a preventable disease, tends to parallel the incidence of syphilis in adults;
"(6) it is conservatively estimated that the public cost of care for persons suffering the complications of venereal disease exceed $80,000,000 annually;
"(7) medical researchers have no successful vaccine for syphilis or gonorrhea, and have no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females;
"(8) school health education programs, public information and awareness campaigns, mass diagnostic screening and case followup activities have all been found to be effective disease intervention methodologies;
"(9) knowledgeable health providers and concerned individuals and groups are fundamental to venereal disease prevention and control;
"(10) biomedical research leading to the development of vaccines for syphilis and gonorrhea is of singular importance for the eventual eradication of these dreaded diseases; and
"(11) a variety of other sexually transmitted diseases, in addition to syphilis and gonorrhea, have become of public health significance."
Section 202 of
"(a) The Congress finds and declares that—
"(1) the number or reported cases of venereal disease has reached epidemic proportions in the United States;
"(2) the number of patients with venereal disease reported to public health authorities is only a fraction of those treated by physicians;
"(3) the incidence of venereal disease is particularly high among individuals in the 20–24 age group, and in metropolitan areas;
"(4) venereal disease accounts for needless deaths and leads to such severe disabilities as sterility, insanity, blindness, and crippling conditions;
"(5) the number of cases of congenital syphilis, a preventable disease, in infants under one year of age increased by 331/3 per centum between 1970 and 1971;
"(6) health education programs in schools and through the mass media may prevent a substantial portion of the venereal disease problem; and
"(7) medical authorities have no successful vaccine for syphilis or gonorrhea and no blood test for the detection of gonorrhea among the large reservoir of asymptomatic females.
"(b) In order to preserve and protect the health and welfare of all citizens, it is the purpose of this Act [this chapter] to establish a national program for the prevention and control of venereal disease."
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "(f)".
§247c–1. Infertility and sexually transmitted diseases
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may make grants to States, political subdivisions of States, and other public or nonprofit private entities for the purpose of carrying out the activities described in subsection (c) of this section regarding any treatable sexually transmitted disease that can cause infertility in women if treatment is not received for the disease.
(b) Authority regarding individual diseases
With respect to diseases described in subsection (a) of this section, the Secretary shall, in making a grant under such subsection, specify the particular disease or diseases with respect to which the grant is to be made. The Secretary may not make the grant unless the applicant involved agrees to carry out this section only with respect to the disease or diseases so specified.
(c) Authorized activities
With respect to any sexually transmitted disease described in subsection (a) of this section, the activities referred to in such subsection are—
(1) screening women for the disease and for secondary conditions resulting from the disease, subject to compliance with criteria issued under subsection (f) of this section;
(2) providing treatment to women for the disease;
(3) providing counseling to women on the prevention and control of the disease (including, in the case of a woman with the disease, counseling on the benefits of locating and providing such counseling to any individual from whom the woman may have contracted the disease and any individual whom the woman may have exposed to the disease);
(4) providing follow-up services;
(5) referrals for necessary medical services for women screened pursuant to paragraph (1), including referrals for evaluation and treatment with respect to acquired immune deficiency syndrome and other sexually transmitted diseases;
(6) in the case of any woman receiving services pursuant to any of paragraphs (1) through (5), providing to the partner of the woman the services described in such paragraphs, as appropriate;
(7) providing outreach services to inform women of the availability of the services described in paragraphs (1) through (6);
(8) providing to the public information and education on the prevention and control of the disease, including disseminating such information; and
(9) providing training to health care providers in carrying out the screenings and counseling described in paragraphs (1) and (3).
(d) Requirement of availability of all services through each grantee
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that each activity authorized in subsection (c) of this section will be available through the applicant. With respect to compliance with such agreement, the applicant may expend the grant to carry out any of the activities directly, and may expend the grant to enter into agreements with other public or nonprofit private entities under which the entities carry out the activities.
(e) Required providers regarding certain services
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that, in expending the grant to carry out activities authorized in subsection (c) of this section, the services described in paragraphs (1) through (7) of such subsection will be provided only through entities that are State or local health departments, grantees under
(f) Quality assurance regarding screening for diseases
For purposes of this section, the Secretary shall establish criteria for ensuring the quality of screening procedures for diseases described in subsection (a) of this section.
(g) Confidentiality
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees, subject to applicable law, to maintain the confidentiality of information on individuals with respect to activities carried out under subsection (c) of this section.
(h) Limitation on imposition of fees for services
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that, if a charge is imposed for the provision of services or activities under the grant, such charge—
(1) will be made according to a schedule of charges that is made available to the public;
(2) will be adjusted to reflect the income of the individual involved; and
(3) will not be imposed on any individual with an income of less than 150 percent of the official poverty line, as established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with
(i) Limitations on certain expenditures
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that not less than 80 percent of the grant will be expended for the purpose of carrying out paragraphs (1) through (7) of subsection (c) of this section.
(j) Reports to Secretary
(1) Collection of data
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees, with respect to any disease selected under subsection (b) of this section for the applicant, to submit to the Secretary, for each fiscal year for which the applicant receives such a grant, a report providing—
(A) the incidence of the disease among the population of individuals served by the applicant;
(B) the number and demographic characteristics of individuals in such population;
(C) the types of interventions and treatments provided by the applicant, and the health conditions with respect to which referrals have been made pursuant to subsection (c)(5) of this section;
(D) an assessment of the extent to which the activities carried pursuant to subsection (a) of this section have reduced the incidence of infertility in the geographic area involved; and
(E) such other information as the Secretary may require with respect to the project carried out with the grant.
(2) Utility and comparability of data
The Secretary shall carry out activities for the purpose of ensuring the utility and comparability of data collected pursuant to paragraph (1).
(k) Maintenance of effort
With respect to activities for which a grant under subsection (a) of this section is authorized to be expended, the Secretary may make such a grant only if the applicant involved agrees to maintain expenditures of non-Federal amounts for such activities at a level that is not less than the average level of such expenditures maintained by the applicant for the 2-year period preceding the fiscal year for which the applicant is applying to receive such a grant.
(l) Requirement of application
(1) In general
The Secretary may make a grant under subsection (a) of this section only if an application for the grant is submitted to the Secretary, the application contains the plan required in paragraph (2), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(2) Submission of plan for program of grantee
(A) In general
The Secretary may make a grant under subsection (a) of this section only if the applicant involved submits to the Secretary a plan describing the manner in which the applicant will comply with the agreements required as a condition of receiving such a grant, including a specification of the entities through which activities authorized in subsection (c) of this section will be provided.
(B) Participation of certain entities
The Secretary may make a grant under subsection (a) of this section only if the applicant provides assurances satisfactory to the Secretary that the plan submitted under subparagraph (A) has been prepared in consultation with an appropriate number and variety of—
(i) representatives of entities in the geographic area involved that provide services for the prevention and control of sexually transmitted diseases, including programs to provide to the public information and education regarding such diseases; and
(ii) representatives of entities in such area that provide family planning services.
(m) Duration of grant
The period during which payments are made to an entity from a grant under subsection (a) of this section may not exceed 3 years. The provision of such payments shall be subject to annual approval by the Secretary of the payments and subject to the availability of appropriations for the fiscal year involved to make the payments in such year. The preceding sentence may not be construed to establish a limitation on the number of grants under such subsection that may be made to an entity.
(n) Technical assistance, and supplies and services in lieu of grant funds
(1) Technical assistance
The Secretary may provide training and technical assistance to grantees under subsection (a) of this section with respect to the planning, development, and operation of any program or service carried out under such subsection. The Secretary may provide such technical assistance directly or through grants or contracts.
(2) Supplies, equipment, and employee detail
The Secretary, at the request of a recipient of a grant under subsection (a) of this section, may reduce the amount of such grant by—
(A) the fair market value of any supplies or equipment furnished the grant recipient; and
(B) the amount of the pay, allowances, and travel expenses of any officer or employee of the Government when detailed to the grant recipient and the amount of any other costs incurred in connection with the detail of such officer or employee;
when the furnishing of such supplies or equipment or the detail of such an officer or employee is for the convenience of and at the request of such grant recipient and for the purpose of carrying out a program with respect to which the grant under subsection (a) of this section is made. The amount by which any such grant is so reduced shall be available for payment by the Secretary of the costs incurred in furnishing the supplies or equipment, or in detailing the personnel, on which the reduction of such grant is based, and such amount shall be deemed as part of the grant and shall be deemed to have been paid to the grant recipient.
(o) Evaluations and reports by Secretary
(1) Evaluations
The Secretary shall, directly or through contracts with public or private entities, provide for annual evaluations of programs carried out pursuant to subsection (a) of this section in order to determine the quality and effectiveness of the programs.
(2) Report to Congress
Not later than 1 year after the date on which amounts are first appropriated pursuant to subsection (q) of this section, and biennially thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report—
(A) summarizing the information provided to the Secretary in reports made pursuant to subsection (j)(1) of this section, including information on the incidence of sexually transmitted diseases described in subsection (a) of this section; and
(B) summarizing evaluations carried out pursuant to paragraph (1) during the preceding fiscal year.
(p) Coordination of Federal programs
The Secretary shall coordinate the program carried out under this section with any similar programs administered by the Secretary (including coordination between the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health).
(q) Authorization of appropriations
For the purpose of carrying out this section, other than subsections (o) and (r) of this section, there are authorized to be appropriated $25,000,000 for fiscal year 1993, and such sums as may be necessary for each of the fiscal years 1994 through 1998.
(r) Separate grants for research on delivery of services
(1) In general
The Secretary may make grants for the purpose of conducting research on the manner in which the delivery of services under subsection (a) of this section may be improved. The Secretary may make such grants only to grantees under such subsection and to public and nonprofit private entities that are carrying out programs substantially similar to programs carried out under such subsection.
(2) Authorization of appropriations
For the purpose of carrying out paragraph (1), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 through 1998.
(July 1, 1944, ch. 373, title III, §318A, as added Oct. 27, 1992,
Amendments
1993—
Subsec. (o)(2).
Subsec. (q).
Subsec. (r)(2).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
§247d. Public health emergencies
(a) Determination of existence of emergency; authorization to act
If the Secretary determines, after consultation with the Director of the National Institutes of Health, the Administrator of the Substance Abuse and Mental Health Services Administration, the Commissioner of the Food and Drug Administration, the Administrator of Health Resources and Services, or the Director of the Centers for Disease Control and Prevention, that—
(1) a disease or disorder presents a public health emergency, or
(2) a public health emergency otherwise exists and the Secretary has the authority to take action with respect to such emergency,
the Secretary, acting through such Directors, Administrator, or Commissioner, may take such action as may be appropriate to respond to the public health emergency, including making grants and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of a disease or disorder described in paragraph (1).
(b) Public Health Emergency Fund; authorization of appropriations; annual report to Congress
(1) There is established in the Treasury a fund designated the "Public Health Emergency Fund" to be available to the Secretary without fiscal year limitation to carry out subsection (a) of this section. There is authorized to be appropriated to the fund $30,000,000 for fiscal year 1984. For fiscal year 1985 and each fiscal year thereafter there is authorized to be appropriated to the fund such sums as may be necessary to have $45,000,000 in the fund at the beginning of such fiscal year.
(2) The Secretary shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate not later than ninety days after the end of a fiscal year—
(A) on the expenditures made from the Public Health Emergency Fund in such fiscal year; and
(B) describing each public health emergency for which the expenditures were made and the activities undertaken with respect to each emergency which were conducted or supported by expenditures from the Fund.
(July 1, 1944, ch. 373, title III, §319, as added July 13, 1983,
Prior Provisions
A prior section 247d, act July 1, 1944, ch. 373, title III, §319, formerly §310, as added Sept. 25, 1962,
Amendments
1992—Subsec. (a).
1988—Subsec. (a).
Subsec. (b)(1).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1992 Amendment
Amendment by
Section Referred to in Other Sections
This section is referred to in
Part C—Hospitals, Medical Examinations, and Medical Care
Amendments
1978—
1976—
§247e. Hansen's disease program
(a) Care and treatment
The Secretary—
(1) shall provide care and treatment (including outpatient care) without charge at the Gillis W. Long Hansen's Disease Center in Carville, Louisiana, to any person suffering from Hansen's disease who needs and requests care and treatment for that disease; and
(2) may provide for the care and treatment (including outpatient care) of Hansen's disease without charge for any person who requests such care and treatment.
(b) Payments to Board of Health of Hawaii
The Secretary shall make payments to the Board of Health of Hawaii for the care and treatment (including outpatient care) in its facilities of persons suffering from Hansen's disease at a rate, determined from time to time by the Secretary, which shall, subject to the availability of appropriations, be approximately equal to the operating cost per patient of those facilities, except that the rate determined by the Secretary shall not be greater than the comparable operating cost per Hansen's disease patient at the Gillis W. Long Hansen's Disease Center in Carville, Louisiana.
(July 1, 1944, ch. 373, title III, §320, formerly §331,
Codification
Section was classified to
Amendments
1985—
Subsec. (a).
Subsec. (b).
1979—Subsec. (a).
1978—
1960—
1952—Act June 25, 1952, provided for payments to Hawaiian Board of Health for expenditures made by them in care and treatment of patients.
1948—Act June 25, 1948, authorized payment of travel expenses of indigent leper patients.
Effective Date of 1960 Amendment
Amendment by
Section Referred to in Other Sections
This section is referred to in
§248. Control and management of hospitals; furnishing prosthetic and orthopedic devices; transfer of patients; disposal of articles produced by patients; disposal of money and effects of deceased patients; payment of burial expenses
The Surgeon General, pursuant to regulations, shall—
(a) Control, manage, and operate all institutions, hospitals, and stations of the Service, including minor repairs and maintenance, and provide for the care, treatment, and hospitalization of patients, including the furnishing of prosthetic and orthopedic devices; and from time to time, with the approval of the President, select suitable sites for and establish such additional institutions, hospitals, and stations in the States and possessions of the United States as in his judgment are necessary to enable the Service to discharge its functions and duties;
(b) Provide for the transfer of Public Health Service patients, in the care of attendants where necessary, between hospitals and stations operated by the Service or between such hospitals and stations and other hospitals and stations in which Public Health Service patients may be received, and the payment of expenses of such transfer;
(c) Provide for the disposal of articles produced by patients in the course of their curative treatment, either by allowing the patient to retain such articles or by selling them and depositing the money received therefor to the credit of the appropriation from which the materials for making the articles were purchased;
(d) Provide for the disposal of money and effects, in the custody of the hospitals or stations, of deceased patients; and
(e) Provide, to the extent the Surgeon General determines that other public or private funds are not available therefor, for the payment of expenses of preparing and transporting the remains of, or the payment of reasonable burial expenses for, any patient dying in a hospital or station.
(July 1, 1944, ch. 373, title III, §321,
Amendments
1978—Subsec. (a).
1948—Subsec. (a). Act June 25, 1948, §2(a), amended subsec. (a) generally, continuing authority of Service to furnish tobacco to patients being treated by it.
Subsec. (e). Act June 25, 1948, §2(b), added subsec. (e).
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§248a. Closing or transfer of hospitals; reduction of services; Congressional authorization required
(a) Except as provided in subsection (b) of this section, the Secretary of Health and Human Services shall take such action as may be necessary to assure that the hospitals of the Public Health Service, located in Seattle, Washington, Boston, Massachusetts, San Francisco, California, Galveston, Texas, New Orleans, Louisiana, Baltimore, Maryland, Staten Island, New York, and Norfolk, Virginia, shall continue—
(1) in operation as hospitals of the Public Health Service,
(2) to provide for all categories of individuals entitled or authorized to receive care and treatment at hospitals or other stations of the Public Health Service inpatient, outpatient, and other health care services in like manner as such services were provided on January 1, 1973, to such categories of individuals at the hospitals of the Public Health Service referred to in the matter preceding paragraph (1) and at a level and range at least as great as the level and range of such services which were provided (or authorized to be provided) by such hospitals on such date, and
(3) to conduct at such hospitals a level and range of other health-related activities (including training and research activities) which is not less than the level and range of such activities which were being conducted on January 1, 1973, at such hospitals.
(b)(1) The Secretary may—
(A) close or transfer control of a hospital of the Public Health Service to which subsection (a) of this section applies,
(B) reduce the level and range of health care services provided at such a hospital from the level and range required by subsection (a)(2) of this section or change the manner in which such services are provided at such a hospital from the manner required by such subsection, or
(C) reduce the level and range of the other health-related activities conducted at such hospital from the level and range required by subsection (a)(3) of this section,
if Congress by law (enacted after November 16, 1973) specifically authorizes such action.
(2) Any recommendation submitted to the Congress for legislation to authorize an action described in paragraph (1) with respect to a hospital of the Public Health Service shall be accompanied by a copy of the written, unqualified approval of the proposed action submitted to the Secretary by each (A) section 314(a) State health planning agency whose section 314(a) plan covers (in whole or in part) the area in which such hospital is located or which is served by such hospital, and (B) section 314(b) areawide health planning agency whose section 314(b) plan covers (in whole or in part) such area.
(3) For purposes of this subsection, the term "section 314(a) State health planning agency" means the agency of a State which administers or supervises the administration of a State's health planning functions under a State plan approved under section 314(a) of the Public Health Service Act (referred to in paragraph (2) as a "section 314(a) plan"); and the term "section 314(b) areawide health planning agency" means a public or nonprofit private agency or organization which has developed a comprehensive regional, metropolitan, or other local area plan or plans referred to in section 314(b) of that Act (referred to in paragraph (2) as a "section 314(b) plan").
(
References in Text
Section 314 of the Public Health Service Act, referred to in subsec. (b)(2), (3), is classified to
Codification
Section was enacted as part of the Department of Defense Appropriation Authorization Act, 1974, and not as part of the Public Health Service Act which comprises this chapter.
Prior Provisions
Provisions similar to those comprising this section were contained in
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (a) pursuant to section 509(b) of
Section Referred to in Other Sections
This section is referred to in
§248b. Transfer or financial self-sufficiency of public health service hospitals and clinics
(a) Deadline for closure, transfer, or financial self-sufficiency
The Secretary of Health and Human Services (hereinafter in this subtitle referred to as the "Secretary") shall, in accordance with this section and notwithstanding
(b) Proposals for transfer or financial self-sufficiency
Not later than July 1, 1981, the Secretary shall notify each Service hospital and other station, and the chief executive officer of each State and of each locality in which such a hospital or other station is located, that the Secretary will accept proposals for the transfer of each such hospital and station from the Service to a public (including Federal) or nonprofit private entity or for the achievement of financial self-sufficiency of each such hospital and station not later than September 30, 1982. No such proposal shall be considered by the Secretary if it is submitted later than September 1, 1981.
(c) Evaluation of proposals
The Secretary shall evaluate promptly each proposal submitted under subsection (b) of this section with respect to a hospital or other station and determine, not later than September 30, 1981, whether or not under such proposal the hospital or station—
(1) will be maintained as a general health care facility providing a range of services to the population within its service area,
(2) will continue to make services available to existing patient populations, and
(3) has a reasonable expectation of financial viability and, in the case of a hospital or station that is not proposed to be transferred, of financial self-sufficiency.
Paragraph (1) shall not apply in the case of a proposal for the transfer of a discrete, minor, freestanding part of a hospital or station to a local public entity for the purpose of continuing the provision of services to refugees.
(d) Rejection or approval of proposal
(1) If the Secretary determines that a proposal for a hospital or other station does not meet the standards of subsection (c) of this section or if there is no proposal submitted under subsection (b) of this section with respect to a hospital or other station, the Secretary shall provide for the closure of the hospital or station by not later than October 31, 1981.
(2) If the Secretary determines that a proposal for a hospital or other station meets the standards of subsection (c) of this section, the Secretary shall take such steps, within the amounts available through appropriations, as may be necessary and proper—
(A) to operate (or participate or assist in the operation of) the hospital or station by the Service until the transfer is accomplished or financial self-sufficiency is achieved,
(B) to bring the hospital or station into compliance with applicable licensure, accreditation, and local medical practice standards, and
(C) to provide for such other legal, administrative, personnel, and financial arrangements (including allowing payments made with respect to services provided by the hospital or station to be made directly to that hospital or station) as may be necessary to effect a timely and orderly transfer of such hospital or station (including the land, building, and equipment thereof) from the Service, or for the financial self-sufficiency of the hospital or station, not later than September 30, 1982.
(e) Establishment of identifiable administrative unit
There is established, within the Office of the Assistant Secretary for Health of the Department of Health and Human Services, an identifiable administrative unit which shall have direct responsibility and authority for overseeing the activities under this section.
(f) Finding of financial self-sufficiency
For purposes of this section, a hospital or station cannot be found to be financially self-sufficient if the hospital or station is relying, in whole or in part, on direct appropriated funds for its continued operations.
(
References in Text
This subtitle, referred to in subsec. (a), is subtitle J of title IX of
Codification
Section was enacted as part of the Omnibus Budget Reconciliation Act of 1981, and not as part of the Public Health Service Act which comprises this chapter.
Congressional Findings and Declaration of Purpose
Section 985 of
"(a) Congress finds that—
"(1) because of national budgetary considerations, it has become necessary to terminate Federal appropriations for Public Health Service hospitals and clinics,
"(2) with proper planning and coordination, some of these hospitals and clinics could be transferred to State, local, or private control or become financially self-sufficient and continue to provide effective and efficient health care to individuals in the areas in which they are located,
"(3) a precipitous closure of these hospitals and clinics will preclude the possibility of such orderly transfer to entities which are willing and able to take over operations at such facilities and will cause unnecessary and costly hardships on the patients and staffs at such facilities and on the communities in which the facilities are located, and
"(4) it is in the national interest, consistent with sound budgetary considerations, to assist in the orderly and prompt transfer of such operations to State, local, or private operation or in the achievement of financial self-sufficiency where feasible.
"(b) The purposes of this subtitle [enacting this section, amending
"(1) to provide for the prompt and orderly closure by October 31, 1981, of Public Health Service hospitals and clinics which cannot reasonably be transferred to State, local, or private operation or become financially self-sufficient and for the transfer or achievement of financial self-sufficiency by September 30, 1982, of those hospitals and clinics which can be so transferred or which can achieve such financial self-sufficiency, and
"(2) to provide for transitional assistance for merchant seamen whose entitlement to receive free care through Public Health Service hospitals and clinics is repealed and who are hospitalized at the end of fiscal year 1981 and require continuing hospitalization."
§248c. Continued use of former Public Health Service facilities
(a) Facilities providing medical or dental care to members and former members of uniformed services and dependents
Any Public Health Service hospital or other station which was transferred to a public or nonprofit private entity pursuant to the provisions of
(b) Termination of approved status
The Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Transportation when the Coast Guard is not operating as a service in the Navy may terminate, for purposes of
(c) Reimbursement of approved facilities for medical and dental care provided to members and former members of uniformed services and dependents
The Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Transportation when the Coast Guard is not operating as a service in the Navy shall reimburse any facility described in subsection (a) of this section for medical and dental care provided by such facility to members and former members of the uniformed services and their dependents who receive such care under
(
Codification
Section was enacted as part of the Military Construction Authorization Act, 1982, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1984—Subsecs. (b), (c).
1983—Subsec. (b).
Administration of Managed-Care Model of Uniformed Services Treatment Facilities
"(a)
"(2) A satellite facility referred to in paragraph (1) means a facility that—
"(A) is owned, operated, or staffed by a facility described in section 911(c) of the Military Construction Authorization Act, 1982 (
"(B) pursuant to an agreement entered into with the Secretary of Defense, is authorized for a designated service area to provide medical and dental care for persons eligible to receive such care in facilities of the uniformed services under
"(3) The authority of the Secretary of Defense under paragraph (1) shall take effect on the date on which the Secretary certifies to Congress that the managed-care delivery and reimbursement model required under section 718(c) of the National Defense Authorization Act for Fiscal Year 1991 (
"(b)
"(c)
"(d)
"(1) the law or regulation is inconsistent with a specific provision of the agreement or a regulation prescribed by the Secretary relating to the managed-care delivery and reimbursement model; or
"(2) the Secretary determines that preemption of the law or regulation is necessary to implement or operate the managed-care delivery and reimbursement model referred to in that section or to achieve some other Federal interest."
Managed-Care Delivery and Reimbursement Model for the Uniformed Services Treatment Facilities
Section 718(c) of
"(1)
"(2)
"(3)
"(B) Not later than December 31, 1995, the center conducting the evaluation and assessment shall submit to the Secretary of Defense and to Congress a report on the results of the evaluation and assessment. The report shall include such recommendations regarding the managed-care delivery and reimbursement model under this subsection as the entity considers to be appropriate.
"(4)
Section Referred to in Other Sections
This section is referred to in
§248d. Public Health Service facilities providing medical care for dependents, members, and former members of uniformed services
(a) Demonstration projects; comparisons with care furnished by contract providers
The Secretary of Defense, in consultation with the Secretary of Health and Human Services and the Secretary of Transportation when the Coast Guard is not operating as a service in the Navy, shall conduct demonstration projects for the purpose of comparing and evaluating the cost-effectiveness, accessibility, patient acceptance, and the quality of medical care contracted for by the Secretary of Defense under
(b) Alternative payment mechanisms
The projects carried out by the Secretary of Defense under this subsection shall utilize various alternative mechanisms for the payment of medical services provided eligible persons, including capitation, prospective payment, all-inclusive fee-for-service charges, and other concepts and programs consistent with the purpose of this section.
(c) Designation of additional civilian medical facilities
If the Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Transportation when the Coast Guard is not operating as a service in the Navy determine such action is necessary in order to permit a meaningful evaluation of alternative methods of providing medical care to persons eligible for such care under
(d) Reports to Congress on study and project results
The Secretary of Defense, in consultation with the Secretary of Health and Human Services and the Secretary of Transportation when the Coast Guard is not operating as a service in the Navy, shall submit annually to the Committees on Appropriations and on Armed Services of the Senate and the House of Representatives a written report on the results of the studies and projects carried out under this section. The first such report shall be submitted not later than one year after September 24, 1983. The last such report shall be submitted not later than one year after the completion of all such studies and projects.
(e) Termination of status
The Secretary of Defense, the Secretary of Health and Human Services, and the Secretary of Transportation when the Coast Guard is not operating as a service in the Navy may terminate, for purposes of
(f) Limitation on expenditures
The total amount of expenditures by the Secretary of Defense to carry out this section and
(
Codification
Section was enacted as part of the Department of Defense Authorization Act, 1984, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1993—Subsec. (e).
1991—Subsec. (f).
1990—Subsec. (e).
Subsec. (f).
1988—Subsec. (e).
1986—Subsec. (e).
1984—Subsecs. (a), (c) to (e).
Change of Name
Committee on Armed Services of House of Representatives changed to Committee on National Security of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Section Referred to in Other Sections
This section is referred to in
§249. Medical care and treatment of quarantined and detained persons
(a) Persons entitled to treatment
Any person when detained in accordance with quarantine laws, or, at the request of the Immigration and Naturalization Service, any person detained by that Service, may be treated and cared for by the Public Health Service.
(b) Temporary treatment in emergency cases
Persons not entitled to treatment and care at institutions, hospitals, and stations of the Service may, in accordance with regulations of the Surgeon General, be admitted thereto for temporary treatment and care in case of emergency.
(c) Authorization for outside treatment
Persons whose care and treatment is authorized by subsection (a) of this section may, in accordance with regulations, receive such care and treatment at the expense of the Service from public or private medical or hospital facilities other than those of the Service, when authorized by the officer in charge of the station at which the application is made.
(July 1, 1944, ch. 373, title III, §322,
Amendments
1981—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsecs. (d), (e).
1967—Subsec. (a)(7).
1964—Subsec. (a)(8).
1948—Subsec. (e). Act June 25, 1948, permitted Service to provide for care and treatment of individuals detained in accordance with our quarantine laws.
Effective Date of 1981 Amendment
Section 986(c) of
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of all other officers of Department of Justice and functions of all agencies and employees of such Department transferred, with a few exceptions, to Attorney General, with power vested in him to authorize their performance or the performance of any of his functions by any of such officers, agencies, and employees, by sections 1 and 2 of Reorg. Plan No. 2 of 1950, eff. May 24, 1950, 15 F.R. 3173,
Continued Care for Merchant Seamen Hospitalized in Public Health Service Hospitals
Section 988 of
"(a) The Secretary shall provide, by contract or other arrangement with a Federal entity and without charge but subject to subsection (b), for the continuation of inpatient hospital services (and outpatient services related to the condition of hospitalization) to any individual who—
"(1) on September 30, 1981, is receiving inpatient hospital services at a Public Health Service hospital on the basis of the entitlement contained in section 322(a) of the Public Health Service Act (
"(2) requires continued hospitalization after such date for treatment of that condition (or requires outpatient services related to such condition), and
"(3) the Secretary determines has no other source of inpatient hospital services available for continued treatment of that condition.
"(b) Services may not be provided under subsection (a) to an individual after the earlier of—
"(1) September 30, 1982,
"(2) the end of the first 60-day consecutive period (beginning after September 30, 1981) during the entire period of which the individual is not an inpatient of a hospital.
"(c) Notwithstanding any other provision of law, the head of any Federal department or agency which provides, under other authority of law and through federal facilities, inpatient hospital services or outpatient services, or both, is authorized to provide inpatient hospital services (and related outpatient services) to individuals under contract or other arrangement with the Secretary pursuant to this section."
Foreign Seamen
Section 810(c), formerly §710(c), of act July 1, 1944, as renumbered by acts Aug. 13, 1946, ch. 958, §5,
Cross References
Third party tort liability to United States for hospital and medical care, except for treatment of seamen, see
Section Referred to in Other Sections
This section is referred to in
§250. Medical care and treatment of Federal prisoners
The Service shall supervise and furnish medical treatment and other necessary medical, psychiatric, and related technical and scientific services, authorized by
(July 1, 1944, ch. 373, title III, §323,
Codification
"
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Cross References
Third party tort liability to United States for hospital and medical care, see
Transfer of appropriations for Federal Prison System to Public Health Service for expenditure for medical relief for inmates, see
Section Referred to in Other Sections
This section is referred to in
§250a. Transfer of appropriations
There may be transferred to the Health Resources and Services Administration such amounts as may be necessary, in the discretion of the Attorney General, for direct expenditures by that Administration for medical relief for inmates of Federal penal and correctional institutions.
(Aug. 26, 1994,
Codification
Section was enacted as part of the appropriation act cited as the credit to this section, and not as part of the Public Health Service Act which comprises this chapter.
Section was formerly classified to
Prior Provisions
Provisions similar to those in this section were contained in the following prior appropriation acts:
Oct. 27, 1993,
Oct. 6, 1992,
Oct. 28, 1991,
Nov. 5, 1990,
Nov. 21, 1989,
Oct. 1, 1988,
Dec. 22, 1987,
Oct. 18, 1986,
Dec. 13, 1985,
Aug. 30, 1984,
Nov. 28, 1983,
Dec. 21, 1982,
Dec. 15, 1981,
Dec. 16, 1980,
Sept. 24, 1979,
Oct. 10, 1978,
Aug. 2, 1977,
July 14, 1976,
Oct. 21, 1975,
Oct. 5, 1974,
Nov. 27, 1973,
Oct. 25, 1972,
Aug. 10, 1971,
Oct. 21, 1970,
Dec. 24, 1969,
Aug. 9, 1968,
Nov. 8, 1967,
Nov. 8, 1966,
Sept. 2, 1965,
Aug. 31, 1964,
Dec. 30, 1963,
Oct. 18, 1962,
Sept. 21, 1961,
Aug. 31, 1960,
July 13, 1959,
June 30, 1958,
June 11, 1957,
June 20, 1956, ch. 414, title II,
July 7, 1955, ch. 279, title II,
§251. Medical examination and treatment of Federal employees; medical care at remote stations
(a) The Surgeon General is authorized to provide at institutions, hospitals, and station of the Service medical, surgical, and hospital services and supplies for persons entitled to treatment under subchapter I of
(1) employees of the Federal Government for retirement purposes;
(2) employees in the Federal classified service, and applicants for appointment, as requested by the Director of the Office of Personnel Management for the purpose of promoting health and efficiency;
(3) seamen for purposes of qualifying for certificates of service; and
(4) employees eligible for benefits under the Longshore and Harbor Workers' Compensation Act, as amended [
(b) The Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization and optometric care for Federal employees (as defined in
(July 1, 1944, ch. 373, title III, §324,
References in Text
The Longshore and Harbor Workers' Compensation Act, as amended, referred to in subsec. (a)(4), is act Mar. 4, 1927, ch. 509,
Codification
In subsec. (a), "subchapter I of
Amendments
1984—Subsec. (a)(4).
1983—Subsec. (a)(1).
1967—Subsec. (a).
Subsec. (b).
Effective Date of 1984 Amendment
Amendment by
Effective Date of 1983 Amendment
Amendment by
Transfer of Functions
"Director of the Office of Personnel Management" substituted for "Civil Service Commission" in subsec. (a)(2), pursuant to Reorg. Plan No. 2 of 1978, §102, 43 F.R. 36037,
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Cross References
Third party tort liability to United States for hospital and medical care, see
Section Referred to in Other Sections
This section is referred to in
§252. Medical examination of aliens
The Surgeon General shall provide for making, at places within the United States or in other countries, such physical and mental examinations of aliens as are required by the immigration laws, subject to administrative regulations prescribed by the Attorney General and medical regulations prescribed by the Surgeon General with the approval of the Secretary.
(July 1, 1944, ch. 373, title III, §325,
References in Text
The immigration laws, referred to in text, mean
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§253. Medical services to Coast Guard, National Oceanic and Atmospheric Administration, and Public Health Service
(a) Persons entitled to medical services
Subject to regulations of the President—
(1) commissioned officers, chief warrant officers, warrant officers, cadets, and enlisted personnel of the Regular Coast Guard on active duty, including those on shore duty and those on detached duty; and Regular, and temporary members of the United States Coast Guard Reserve when on active duty;
(2) commissioned officers, ships' officers, and members of the crews of vessels of the National Oceanic and Atmospheric Administration on active duty, including those on shore duty and those on detached duty; and
(3) commissioned officers of the Regular or Reserve Corps of the Public Health Service on active duty;
shall be entitled to medical, surgical, and dental treatment and hospitalization by the Service. The Surgeon General may detail commissioned officers for duty aboard vessels of the Coast Guard or the National Oceanic and Atmospheric Administration.
(b) Health care for involuntarily separated officers and dependents
(1) The Secretary may provide health care for an officer of the Regular or Reserve Corps involuntarily separated from the Service, and for any dependent of such officer, if—
(A) the officer or dependent was receiving health care at the expense of the Service at the time of separation; and
(B) the Secretary finds that the officer or dependent is unable to obtain appropriate insurance for the conditions for which the officer or dependent was receiving health care.
(2) Health care may be provided under paragraph (1) for a period of not more than one year from the date of separation of the officer from the Service.
(c) Examination of personnel of Service assigned to Coast Guard or National Oceanic and Atmospheric Administration
The Service shall provide all services referred to in subsection (a) of this section required by the Coast Guard or National Oceanic and Atmospheric Administration and shall perform all duties prescribed by statute in connection with the examinations to determine physical or mental condition for purposes of appointment, enlistment, and reenlistment, promotion and retirement, and officers of the Service assigned to duty on Coast Guard or National Oceanic and Atmospheric Administration vessels may extend aid to the crews of American vessels engaged in deep-sea fishing.
(July 1, 1944, ch. 373, title III, §326,
Amendments
1985—Subsec. (b).
1963—Subsec. (b).
Subsec. (c).
1960—Subsec. (a).
1956—Subsec. (b). Act June 7, 1956, repealed subsec. (b) except insofar as it related to dependent members of families of ships' officers and members of crews of vessels of Coast and Geodetic Survey.
Change of Name
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services Administration, and commissioned officers of Survey transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff. July 13, 1965, 30 F.R. 8819,
Effective Date of 1956 Amendment
Amendment by act June 7, 1956, effective six months after June 7, 1956, see section 307 of act June 7, 1956.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855
Cross References
Members of Coast Guard Reserve entitled to benefits of subsecs. (a) and (b) of this section, see
Third party tort liability to United States for hospital and medical care, see
Section Referred to in Other Sections
This section is referred to in
§253a. Medical services to retired personnel of National Oceanic and Atmospheric Administration
(a) Eligibility
Subject to regulations of the President, retired ships' officers and retired members of the crews of vessels of the National Oceanic and Atmospheric Administration shall be entitled to medical, surgical, and dental treatment and hospitalization by the Public Health Service if the ships' officer or crew member, (1) was on active duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on July 19, 1963, whichever is later, and his employment as a vessel employee was continuous from that date until retirement, or (2) was retired as a vessel employee of the National Oceanic and Atmospheric Administration on or before July 1, 1963, or on July 19, 1963, whichever is later.
(b) Treatment of dependents of personnel
Subject to regulations of the President, dependent members of families (as defined in such regulations) of ships' officers and members of crews of vessels of the National Oceanic and Atmospheric Administration, whether such, ships' officers and members of crew are on active duty or retired, shall be furnished medical advice and outpatient treatment by the Public Health Service and, if suitable accommodations are available, they shall also be furnished hospitalization by the Public Health Service if the ships' officer or crew member (1) was on active duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on July 19, 1963, whichever is later, and his employment as a vessel employee has been continuous from that time, or (2) was on active duty as a vessel employee of the National Oceanic and Atmospheric Administration on July 1, 1963, or on July 19, 1963, whichever is later, and his employment as a vessel employee was continuous from that time until retirement, or (3) was retired as a vessel employee of the National Oceanic and Atmospheric Administration on or before July 1, 1963, or on July 19, 1963, whichever is later. When dependent members of families are hospitalized, a per diem charge, at such uniform rate as may be prescribed from time to time for the hospitalization of dependents of members of the uniformed services at hospitals of the uniformed services pursuant to
(c) Identification
The National Oceanic and Atmospheric Administration shall furnish proper identification to those persons entitled to medical treatment under the provisions of this section.
(
Codification
Section was not enacted as part of the Public Health Service Act which comprises this chapter.
Amendments
1984—Subsec. (a).
Subsec. (b).
Change of Name
Coast and Geodetic Survey consolidated with Weather Bureau to form a new agency in Department of Commerce to be known as Environmental Science Services Administration, and commissioned officers of Survey transferred to ESSA, by Reorg. Plan No. 2 of 1965, eff. July 13, 1965, 30 F.R. 8819,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Ex. Ord. No. 11160. Regulations Relating to Medical Care for Retired Personnel of Coast and Geodetic Survey [Now National Oceanic and Atmospheric Administration] and Their Dependents
Ex. Ord. No. 11160, July 6, 1964, 29 F.R. 9315, provided:
By virtue of the authority vested in me by the first section of the Act of July 19, 1963 (
(1) "Retired ships' officer and retired crew member" means a noncommissioned ships' officer or crew member of a vessel of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration] who either was on active duty as a vessel employee on July 19, 1963, and whose employment as such vessel employee was continuous from that date until the date of his retirement, or who had retired as a vessel employee on or before July 19, 1963.
(2) "Active duty ships' officer and active duty crew member" means a noncommissioned ships' officer or crew member on active duty as a vessel employee of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration] on July 19, 1963, and whose employment as such vessel employee has been continuous from that time.
(3) "Dependent members of families", with respect to active duty or retired ships' officers or crew members, means:
(A) the lawful wife;
(B) the unmarried legitimate child, including an adopted child or stepchild, who has not passed his twenty-first birthday; and
(C) the father or mother, if in fact dependent upon such active duty or retired ships' officer or crew member for over one-half of his or her support.
(4) "Relief stations" means Public Health Service outpatient clinics and outpatient offices.
(5) "Outpatient clinic" means a full-time outpatient medical facility, operated in Federally owned or leased space under the supervision of a commissioned medical officer or a full-time civil service medical officer (formerly known as a Second-Class Relief Station).
(6) "Outpatient office" means a part-time outpatient facility serving all classes of legal beneficiaries, located in other than Federal space, and in the charge of a local private physician under contract to the Service to provide medical care on an annual or fee basis (formerly known as a Third-Class Relief Station).
(1) Retired ships' officers and retired crew members of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration];
(2) Dependent members of families of persons described in paragraph (1) of this section;
(3) Dependent members of families of active duty ships' officers and crew members of the Coast and Geodetic Survey [now National Oceanic and Atmospheric Administration].
(1) Medical, surgical, and dental treatment at hospitals, outpatient clinics, and outpatient offices of the Service, and hospitalization at hospitals of the Service. The Service will not be responsible for defraying the cost of hospitalization, medical services, and supplies procured elsewhere.
(2) Dental treatment shall be furnished to the extent that facilities and services at hospitals and outpatient clinics of the Service having full-time dental officers on duty are available to provide such treatment. At other Service facilities, dental treatment shall be limited to emergency measures necessary to relieve pain.
(b) For the purpose of this section—
(1) Medical advice and outpatient treatment may include such services and supplies as the Medical Officer in Charge may deem to be necessary for reasonable and adequate treatment.
(2) Hospitalization shall be furnished when, in the opinion of the Medical Officer in Charge, suitable accommodations are available and the condition of the patient is such as to require hospitalization. When hospitalization is authorized, it may include such services and supplies as the Medical Officer in Charge may deem to be necessary for reasonable and adequate treatment.
(c) Charges shall be made for hospitalization of dependent members of families at the same per diem rate as is prescribed for dependents of members of the uniformed services pursuant to
(d) Dental treatment may be furnished to the extent that facilities and services at hospitals and outpatient clinics of the Service having full-time dental officers are available to provide such treatment. Dental care will not be furnished under any circumstances in private facilities at the expense of the Service.
Lyndon B. Johnson.
§253b. Former Lighthouse Service employees; medical service eligibility
Subject to regulations of the President, lightkeepers, assistant lightkeepers, and officers and crews of vessels of the former Lighthouse Service, including any such persons who subsequent to June 30, 1939, were involuntarily assigned to other civilian duty in the Coast Guard, who were entitled to medical relief at hospitals and other stations of the Public Health Service prior to July 1, 1944, and who retired under the provisions of
(
Codification
Section was enacted as a part of Health Services Research, Health Statistics, and Medical Libraries Act of 1974, and also as a part of Health Services Research and Evaluation and Health Statistics Act of 1974, and not as a part of the Public Health Service Act which comprises this chapter.
Effective Date
Section 108(b) of
§254. Interdepartmental work
Nothing contained in this part shall affect the authority of the Service to furnish any materials, supplies, or equipment, or perform any work of services, requested in accordance with
(July 1, 1944, ch. 373, title III, §327,
Codification
"
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§254a. Sharing of medical care facilities and resources
(a) Definitions
For purposes of this section—
(1) the term "specialized health resources" means health care resources (whether equipment, space, or personnel) which, because of cost, limited availability, or unusual nature, are either unique in the health care community or are subject to maximum utilization only through mutual use;
(2) the term "hospital", unless otherwise specified, includes (in addition to other hospitals) any Federal hospital.
(b) Statement of purpose; agreements or arrangements; reciprocity; reimbursement; credits
For the purpose of maintaining or improving the quality of care in Public Health Service facilities and to provide a professional environment therein which will help to attract and retain highly qualified and talented health personnel, to encourage mutually beneficial relationships between Public Health Service facilities and hospitals and other health facilities in the health care community, and to promote the full utilization of hospitals and other health facilities and resources, the Secretary may—
(1) enter into agreements or arrangements with schools of medicine, schools of osteopathic medicine, and with other health professions schools, agencies, or institutions, for such interchange or cooperative use of facilities and services on a reciprocal or reimbursable basis, as will be of benefit to the training or research programs of the participating agencies; and
(2) enter into agreements or arrangements with hospitals and other health care facilities for the mutual use or the exchange of use of specialized health resources, and providing for reciprocal reimbursement.
Any reimbursement pursuant to any such agreement or arrangement shall be based on charges covering the reasonable cost of such utilization, including normal depreciation and amortization costs of equipment. Any proceeds to the Government under this subsection shall be credited to the applicable appropriation of the Public Health Service for the year in which such proceeds are received.
(July 1, 1944, ch. 373, title III, §327A, formerly §328, as added Dec. 5, 1967,
Amendments
1988—Subsec. (b)(1).
Availability of Appropriations for Expenses of Sharing Medical Care Facilities and Resources
Similar provisions were contained in the following prior appropriation acts:
Part D—Primary Health Care
subpart i—primary health centers
Amendments
1978—
§254a–1. Repealed. Pub. L. 99–117, §12(c), Oct. 7, 1985, 99 Stat. 495
Section, act July 1, 1944, ch. 373, title III, §328, as added Nov. 10, 1978,
A prior section 328 of act July 1, 1944, ch. 373, title III, as added Dec. 5, 1967,
§254b. Migrant health centers
(a) Definitions
For purposes of this section:
(1) The term "migrant health center" means an entity which either through its staff and supporting resources or through contracts or cooperative arrangements with other public or private entities provides—
(A) primary health services,
(B) as may be appropriate for particular centers, supplemental health services necessary for the adequate support of primary health services,
(C) referral to providers of supplemental health services and payment, as appropriate and feasible, for their provision of such services,
(D) environmental health services, including, as may be appropriate for particular centers (as determined by the centers), the detection and alleviation of unhealthful conditions associated with water supply, sewage treatment, solid waste disposal, rodent and parasitic infestation, field sanitation, housing, and other environmental factors related to health,
(E) as may be appropriate for particular centers (as determined by the centers), infectious and parasitic disease screening and control,
(F) as may be appropriate for particular centers, accident prevention programs, including prevention of excessive pesticide exposure,
(G) information on the availability and proper use of health services and services which promote and facilitate optimal use of health services, including, if a substantial number of the individuals in the population served by a center are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a predominant number of such individuals, and
(H) patient case management services (including outreach, counseling, referral, and follow-up services),
for migratory agricultural workers, seasonal agricultural workers, and the members of the families of such migratory and seasonal workers, within the area it serves (referred to in this section as a "catchment area") and individuals who have previously been migratory agricultural workers but can no longer meet the requirements of paragraph (2) of this subsection because of age or disability and members of their families within the area it serves.
(2) The term "migratory agricultural worker" means an individual whose principal employment is in agriculture on a seasonal basis, who has been so employed within the last twentyfour months, and who establishes for the purposes of such employment a temporary abode.
(3) The term "seasonal agricultural workers" 1 means an individual whose principal employment is in agriculture on a seasonal basis and who is not a migratory agricultural worker.
(4) The term "agriculture" means farming in all its branches, including—
(A) cultivation and tillage of the soil,
(B) the production, cultivation, growing, and harvesting of any commodity grown on, in, or as an adjunct to or part of a commodity grown in or on, the land, and
(C) any practice (including preparation and processing for market and delivery to storage or to market or to carriers for transportation to market) performed by a farmer or on a farm incident to or in conjunction with an activity described in subparagraph (B).
(5) The term "high impact area" means a health service area or other area which has not less than four thousand migratory agricultural workers and seasonal agricultural workers residing within its boundaries for more than two months in any calendar year. In computing the number of workers residing in an area, there shall be included as workers the members of the families of such workers.
(6) The term "primary health services" means—
(A) services of physicians and, where feasible, services of physicians' assistants and nurse clinicians;
(B) diagnostic laboratory and radiologic services;
(C) preventive health services (including children's eye and ear examinations to determine the need for vision and hearing correction, perinatal services, well child services, immunizations against vaccine-preventable diseases, screenings for elevated blood lead levels, and family planning services);
(D) emergency medical services;
(E) transportation services as required for adequate patient care;
(F) preventive dental services; and
(G) pharmaceutical services, as may be appropriate for particular centers.
(7) The term "supplemental health services" means services which are not included as primary health services and which are—
(A) hospital services;
(B) home health services;
(C) extended care facility services;
(D) rehabilitative services (including physical therapy) and long-term physical medicine;
(E) mental health services;
(F) dental services;
(G) vision services;
(H) allied health services;
(I) therapeutic radiologic services;
(J) public health services (including, for the social and other nonmedical needs which affect health status, counseling, referral for assistance, and followup services);
(K) ambulatory surgical services;
(L) health education services (including nutrition education); and
(M) other services appropriate to meet the health needs of the population served by the migrant health center involved.
(b) Priority areas for project and program assistance; assignment and determination of priorities; approval of application for grant to area without migratory agricultural workers
(1) The Secretary shall assign to high impact areas and any other areas (where appropriate) priorities for the provision of assistance under this section to projects and programs in such areas. The highest priorities for such assistance shall be assigned to areas where the Secretary determines the greatest need exists.
(2) No application for a grant under subsection (c) or (d) of this section for a project in an area which has no migratory agricultural workers may be approved unless grants have been provided for all approved applications under such subsections for projects in areas with migratory agricultural workers.
(c) Grants pursuant to assigned priorities to public and nonprofit private entities for projects to plan and develop centers; costs includable and criteria for grants; grants or contracts with public and nonprofit private entities for projects to plan and develop programs in areas without centers and specified migratory population; scope of programs for grants or contracts; number of grants or contracts; determination of amount of grants
(1)(A) The Secretary may, in accordance with the priorities assigned under subsection (b)(1) of this section, make grants to public and nonprofit private entities for projects to plan and develop migrant health centers which will serve migratory agricultural workers, seasonal agricultural workers, and the members of the families of such migratory and seasonal workers, in high impact areas. A project for which a grant may be made under this subparagraph may include the cost of the acquisition, expansion, and modernization of existing buildings and construction of new buildings (including the costs of amortizing the principal of, and paying the interest on, loans) and the costs of providing training related to the management of migrant health center programs, and shall include—
(i) an assessment of the need that the workers (and the members of the families of such workers) proposed to be served by the migrant health center for which the project is undertaken have for primary health services, supplemental health services, and environmental health services;
(ii) the design of a migrant health center program for such workers and the members of their families, based on such assessment;
(iii) efforts to secure, within the proposed catchment area of such center, financial and professional assistance and support for the project; and
(iv) initiation and encouragement of continuing community involvement in the development and operation of the project.
(B) The Secretary may make grants to or enter into contracts with public and nonprofit private entities for projects to plan and develop programs in areas in which no migrant health center exists and in which not more than four thousand migratory agricultural workers and their families reside for more than two months—
(i) for the provision of emergency care to migratory agricultural workers, seasonal agricultural workers, and the members of families of such migratory and seasonal workers;
(ii) for the provision of primary care (as defined in regulations of the Secretary) for such workers and the members of their families;
(iii) for the development of arrangements with existing facilities to provide primary health services (not included as primary care as defined under regulations under clause (ii)) to such workers and the members of their families; or
(iv) which otherwise improve the health of such workers and their families.
Any such program may include the acquisition, expansion, and modernization of existing buildings, construction of new buildings, and providing training related to the management of programs assisted under this subparagraph.
(2) Not more than two grants may be made under paragraph (1)(A) for the same project, and if a grant or contract is made or entered into under paragraph (1)(B) for a project, no other grant or contract under that paragraph may be made or entered into for the project.
(3) The amount of any grant made under paragraph (1) for any project shall be determined by the Secretary.
(d) Grants for centers in high impact areas; programs in areas in which no migrant health center exists; health services provided on a prepaid basis; two-grant maximum; maximum amount of grant; payments
(1)(A)(i) The Secretary may, in accordance with priorities assigned under subsection (b)(1) of this section, make grants for the costs of operation of public and nonprofit private migrant health centers in high impact areas.
(ii) If the Secretary makes a determination that an area is a high impact area, the Secretary may alter the determination only after providing to the grantee under subclause (i) for the area, and to other interested entities in the area, reasonable notice with respect to such determination and a reasonable opportunity to offer information with respect to such determination.
(B) The Secretary may make grants to and enter into contracts with public and nonprofit private entities for projects for the operation of programs in areas in which no migrant health center exists and in which not more than four thousand migratory agricultural workers and their families reside for more than two months—
(i) for the provision of emergency care to migratory agricultural workers, seasonal agricultural workers, and the members of the families of such migratory and seasonal workers;
(ii) for the provision of primary care (as defined in regulations of the Secretary) for such workers and the members of their families;
(iii) for the development of arrangements with existing facilities to provide primary health services (not included as primary care as defined under regulations under clause (ii)) to such workers and the members of their families; or
(iv) which otherwise improve the health of such workers and the members of their families.
Any such program may include the acquisition, expansion, and modernization of existing buildings, construction of new buildings, and providing training related to the management of programs assisted under this subparagraph.
(C) The Secretary may make grants to migrant health centers to enable the centers to plan and develop the provision of health services on a prepaid basis to some or to all of the individuals which the centers serve. Such a grant may only be made for such a center if—
(i) the center has received grants under subparagraph (A) of this paragraph for at least two consecutive years preceding the year of the grant under this subparagraph;
(ii) the governing board of the center (described in subsection (f)(3)(G) of this section) requests, in a manner prescribed by the Secretary, that the center provide health services on a prepaid basis to some or to all of the population which the center serves; and
(iii) the center provides assurances satisfactory to the Secretary that the provision of such services on a prepaid basis will not result in the diminution of health services provided by the center to the population the center served prior to the grant under this subparagraph.
Any such grant may include the acquisition, expansion, and modernization of existing buildings, construction of new buildings, and providing training related to the management of the provision of health services on a prepaid basis.
(2) The costs for which a grant may be made under paragraph (1)(A) may include the costs of acquiring, expanding, and modernizing existing buildings and constructing new buildings (including the costs of amortizing the principal of, and paying the interest on, loans) and the costs of repaying loans made by the Farmers Home Administration for buildings; and the costs for which a grant or contract may be made under paragraph (1) may include the costs of providing training related to the provision of primary health services, supplemental health services, and environmental health services, and to the management of migrant health center programs.
(3) Not more than two grants may be made under paragraph (1)(C) for the same entity.
(4)(A) The amount of any grant made in any fiscal year under subparagraph (A) of paragraph (1) to a health center shall be determined by the Secretary, but may not exceed the amount by which the costs of operation of the center in such fiscal year exceed the total of—
(i) State, local, and other operational funding, and
(ii) the fees, premiums, and third-party reimbursements,
which the center may reasonably be expected to receive for its operations in such fiscal year. In determining the amount of such a grant for a center, if the application for the grant requests funds for a service described in subparagraph (D) or (E) of subsection (a)(1) of this section (other than to the extent the funds would be used for the improvement of private property) or a supplemental health service described in subparagraph (B), (F), (J), or (L) of subsection (a)(7) of this section, the Secretary shall include, in an amount determined by the Secretary and to the extent funds are available under appropriation Acts, funds for such service unless the Secretary makes a written finding that such service is not needed and provides the applicant with a copy of such finding.
(B) Payments under grants under subparagraph (A) of paragraph (1) shall be made in advance or by way of reimbursement and in such installments as the Secretary finds necessary and adjustments may be made for overpayments or underpayments, except that if in any fiscal year the sum of—
(i) the total of the amounts described in clauses (i) and (ii) of subparagraph (A) of this paragraph received by a center in such fiscal year, and
(ii) the amount of the grant to the center in such fiscal year,
exceeded the costs of the center's operation in such fiscal year because the amount received by the center from fees, premiums, and third-party reimbursements was greater than expected, an adjustment in the amount of the grant to the center in the succeeding fiscal year shall be made in such a manner that the center shall be entitled to retain the additional amount of fees, premiums, and other third party reimbursements as the center will use (I) to expand and improve its services, (II) to increase the number of persons (eligible under subsection (a) of this section to receive services from such a center) it is able to serve, (III) to construct, expand, and modernize its facilities, (IV) to improve the administration of its service programs, and (V) to establish the financial reserve required for the furnishing of services on a prepaid basis. Without the approval of the Secretary, not more than one-half of such retained sum may be used for construction and modernization of its facilities.
(C) With respect to amounts described in clauses (i) and (ii) of subparagraph (A), the Secretary may not restrict expenditures of such amounts by any grantee under paragraph (1)(A) for—
(i) repair or minor renovation of the physical plant;
(ii) establishment of a financial reserve as required for the furnishing of services on a prepaid basis or as needed to cover unanticipated expenses;
(iii) interest payments on short-term loans to cover cash shortfalls; or
(iv) necessary salary requirements to remain competitive in hiring health care practitioners.
(e) Contracts with public and private entities for implementation and enforcement of environmental health standards and projects and studies related to environmental health hazard problems
The Secretary may enter into contracts with public and private entities to—
(1) assist the States in the implementation and enforcement of acceptable environmental health standards, including enforcement of standards for sanitation in migrant labor camps and applicable Federal and State pesticide control standards; and
(2) conduct projects and studies to assist the several States and entities which have received grants or contracts under this section in the assessment of problems related to camp and field sanitation, pesticide hazards, and other environmental health hazards to which migratory agricultural workers, seasonal agricultural workers, and members of their families are exposed.
(f) Approval of application as prerequisite for grant or contract; form and manner of submission and contents of application; determination of entity as center as prerequisite for approval of application; criteria for determination; priorities for applications; improvements of private property; nonapplicability of statutory provisions to contracts; new building grant conditions
(1) No grant may be made under subsection (c) or (d) of this section and no contract may be entered into under subsection (c)(1)(B), (d)(1)(B), or (e) of this section unless an application therefore 2 is submitted to, and approved by, the Secretary. Such an application shall be submitted in such form and manner and shall contain such information as the Secretary shall prescribe. An application for a grant or contract which will cover the costs of modernizing a building shall include, in addition to other information required by the Secretary—
(A) a description of the site of the building,
(B) plans and specifications for its modernization, and
(C) reasonable assurance that all laborers and mechanics employed by contractors or subcontractors in the performance of work on the modernization of the building will be paid wages at rates not less than those prevailing on similar work in the locality as determined by the Secretary of Labor in accordance with the Act of March 3, 1931 (
The Secretary of Labor shall have with respect to the labor standards referred to in subparagraph (C) the authority and functions set forth in Reorganization Plan Numbered 14 of 1950 (15 F.R. 3176; 5 U.S.C. Appendix) and
(2) An application for a grant under subparagraph (A) of subsection (d)(1) of this section for a migrant health center shall include—
(A) a description of the need in the center's catchment area for each of the health services described in subparagraphs (D) and (E) of subsection (a)(1) of this section and in subparagraphs (B), (F), (J), and (L) of subsection (a)(7) of this section,
(B) if the applicant determines that any such service is not needed, the basis for such determination, and
(C) if the applicant does not request funds for any such service which the applicant determines is needed, the reason for not making such a request.
In considering an application for a grant under subparagraph (A) of subsection (d)(1) of this section, the Secretary may require as a condition to the approval of such application assurance that the applicant will provide any specified health service described in subsection (a) of this section which the Secretary finds is needed to meet specific health needs of the area to be served by the applicant. Such a finding shall be made in writing and a copy shall be provided the applicant.
(3) The Secretary may not approve an application for a grant under subsection (d)(1)(A) of this section unless the Secretary determines that the entity for which the application is submitted is a migrant health center (within the meaning of subsection (a)(1) of this section) and that—
(A) the primary health services of the center will be available and accessible in the center's catchment area promptly, as appropriate, and in a manner which assures continuity;
(B) the center will have organizational arrangements, established in accordance with regulations of the Secretary, for (i) an ongoing quality assurance program (including utilization and peer review systems) respecting the center's services, and (ii) maintaining the confidentiality of patient records;
(C) the center will demonstrate its financial responsibility by the use of such accounting procedures and other requirements as may be prescribed by the Secretary;
(D) the center (i) has or will have a contractual or other arrangement with the agency of the State, in which it provides services, which administers or supervises the administration of a State plan approved under title XIX of the Social Security Act [
(E) the center has made or will make and will continue to make every reasonable effort to collect appropriate reimbursement for its costs in providing health services to persons who are entitled to insurance benefits under title XVIII of the Social Security Act [
(F) the center (i) has prepared a schedule of fees or payments for the provision of its services consistent with locally prevailing rates or charges and designed to cover its reasonable costs of operation and has prepared a corresponding schedule of discounts to be applied to the payment of such fees or payments, which discounts are adjusted on the basis of the patient's ability to pay, (ii) has made and will continue to make every reasonable effort (I) to secure from patients payment for services in accordance with such schedules, and (II) to collect reimbursement for health services to persons described in subparagraph (E) on the basis of the full amount of fees and payments for such services without application of any discount, and (iii) has submitted to the Secretary such reports as he may require to determine compliance with this subparagraph;
(G) the center has established a governing board which (i) is composed of individuals a majority of whom are being served by the center and who, as a group, represent the individuals being served by the center, and (ii) selects the services to be provided by the center, schedules the hours during which such services will be provided, approves the center's annual budget, approves the selection of a director for the center, and, except in the case of a public center (as defined in the second sentence of this paragraph), establishes general policies for the center; and if the application is for a second or subsequent grant for a public center, the governing body of the center has approved the application or if the governing body has not approved the application, the failure of the governing body to approve the application was unreasonable;
(H) the center has developed, in accordance with regulations of the Secretary, (i) an overall plan and budget that meets the requirements of section 1861(z) of the Social Security Act [
(I) the center will review periodically its catchment area to (i) insure that the size of such area is such that the services to be provided through the center (including any satellite) are available and accessible to the migratory agricultural workers, seasonal agricultural workers, and the members of the families of such migratory and seasonal workers, in the area promptly and as appropriate, (ii) insure that the boundaries of such area conform, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and Federal and State health and social service programs, and (iii) insure that the boundaries of such area eliminate, to the extent possible, barriers to access to the services of the center, including barriers resulting from the area's physical characteristics, its residential patterns, its economic and social groupings, and available transportation; and
(J) in the case of a center which serves a population including a substantial proportion of individuals of limited English-speaking ability, the center has (i) developed a plan and made arrangements responsive to the needs of such population for providing services to the extent practicable in the language and cultural context most appropriate to such individuals, and (ii) identified an individual on its staff who is fluent in both that language and English and whose responsibilities shall include providing guidance to such individuals and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences.
For purposes of subparagraph (G) and subsection (h)(4) of this section, the term "public center" means a migrant health center funded (or to be funded) through a grant under this section to a public agency.
(4) In considering applications for grants and contracts under subsection (c) or (d)(1)(B) of this section, the Secretary shall give priority to applications submitted by community-based organizations which are representative of the populations to be served through the projects, programs, or centers to be assisted by such grants or contracts.
(5) The Secretary, in making a grant under this section to a migrant health center for the provision of environmental health services described in subsection (a)(1)(D) of this section, may designate a portion of the grant to be expended for improvements to private property for which the written consent of the owner has been obtained and which are necessary to alleviate a hazard to the health of those residing on, or otherwise using, the property and of other persons in the center's catchment area. A center may make such an expenditure for an improvement under a grant only after the Secretary has specifically approved such expenditure and has determined that funds for the improvement are not available from any other source.
(6) Contracts may be entered into under this section without regard to section 3324(a) and (b) of title 31 and
(7) The Secretary may make a grant under subsection (c) or (d) of this section for the construction of new buildings for a migrant health center or a migrant health program only if the Secretary determines that appropriate facilities are not available through acquiring, modernizing, or expanding existing buildings and that the entity to which the grant will be made has made reasonable efforts to secure from other sources funds, in lieu of the grant, to construct such facilities.
(g) Technical and other nonfinancial assistance for centers or public or private nonprofit entities operating as centers without determination of status; resources list
(1) The Secretary may provide (either through the Department of Health and Human Services or by grant or contract) all necessary technical and other nonfinancial assistance (including fiscal and program management assistance and training in such management) to any migrant health center or to any public or private nonprofit entity to assist it in developing plans for, and in operating as, a migrant health center, and in meeting the requirements of subsection (f)(2) of this section.
(2) The Secretary shall make available to each grant recipient under this section a list of available Federal and non-Federal resources to improve the environmental and nutritional status of individuals in the recipient's catchment area.
(h) Authorization of appropriations; reduction in infant mortality and health management for infants and pregnant women; obligation for grants and contracts
(1)(A) For the purposes of subsections (c) through (e) of this section, there are authorized to be appropriated $48,500,000 for fiscal year 1989, such sums as may be necessary for fiscal years 1990 and 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1994.
(B) Of the amounts appropriated pursuant to subparagraph (A) for a fiscal year, the Secretary may obligate for grants and contracts under subsection (c)(1) of this section not more than 2 percent, for grants under subsection (d)(1)(C) of this section not more than 5 percent, and for contracts under subsection (e) of this section not more than 10 percent.
(2)(A) For the purpose of carrying out subparagraph (B), there are authorized to be appropriated $1,500,000 for fiscal year 1989, $2,000,000 for fiscal year 1990, $2,500,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1994.
(B) The Secretary may make grants to migrant health centers for the purpose of assisting such centers in—
(i) providing comprehensive health care and support services for the reduction of (I) the incidence of infant mortality, and (II) morbidity among children who are less than 3 years of age; and
(ii) developing and coordinating service and referral arrangements between migrant health centers and other entities for the health management of pregnant women and children described in clause (i).
(C) In making grants under subparagraph (B), the Secretary shall give priority to migrant health centers providing services in any catchment area in which there is a substantial incidence of infant mortality or in which there is a significant increase in the incidence of infant mortality.
(D) The Secretary may make a grant under subparagraph (B) only if the migrant health center involved agrees to expend the grant for the following activities with respect to the purpose described in such subparagraph:
(i) Primary health services, including prenatal care.
(ii) Community education, outreach, and case finding.
(iii) Case management services.
(iv) Client education, including parenting and child development education.
(E) The purposes for which a migrant health center may expend a grant under subparagraph (B) include, with respect to the purpose described in such subparagraph, substance abuse screening, counseling and referral services, and other necessary nonmedical support services, including child care, translation services, and housing assistance.
(F) The Secretary may make a grant under subparagraph (B) only if the migrant health center involved agrees that—
(i) the center will coordinate the provision of services under the grant to each of the recipients of the services;
(ii) such services will be continuous for each such recipient;
(iii) the center will provide follow-up services for individuals who are referred by the center for services described in subparagraph (E); and
(iv) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health services (including prenatal care) with respect to the purpose described in such subparagraph.
(3) The Secretary may not expend in any fiscal year, for grants under this section to public centers (as defined in the second sentence of subsection (f)(3) of this section) the governing boards of which (as described in subsection (f)(3)(G)(ii) of this section) do not establish general policies for such centers, an amount which exceeds 5 per centum of the funds appropriated under this section for that fiscal year.
(i) Delegation of authority to administer programs; exception
The Secretary may delegate the authority to administer the programs authorized by this section to any office within the Service, except that the authority to enter into, modify, or issue approvals with respect to grants or contracts may be delegated only within the central office of the Health Resources and Services Administration.
(July 1, 1944, ch. 373, title III, §329, formerly §310, as added Sept. 25, 1962,
References in Text
The Social Security Act, referred to in subsec. (f)(3)(D), (E), is act Aug. 14, 1935, ch. 531,
Codification
In subsec. (f)(6), "section 3324(a) and (b) of title 31" substituted for reference to section 3648 of the Revised Statutes (
Prior to its renumbering as section 329 of act July 1, 1944 by section 102(a) of
Prior Provisions
A prior section 254b, act July 1, 1944, ch. 373, title III, §329, as added Dec. 31, 1970,
Amendments
1992—Subsec. (a)(6)(C).
Subsec. (d)(4)(C).
Subsec. (h)(2)(B).
"(i) providing services for the reduction of the incidence of infant mortality; and
"(ii) developing and coordinating referral arrangements between migrant health centers and other entities for the health management of infants and pregnant women."
Subsec. (h)(2)(D) to (F).
1990—Subsec. (h)(1)(A), (2)(A).
1988—Subsec. (a)(1)(H).
Subsec. (a)(7)(M).
Subsec. (c)(1)(A).
Subsec. (c)(1)(B).
Subsec. (d)(1)(A).
Subsec. (d)(1)(B).
Subsec. (d)(1)(C).
Subsec. (d)(2).
Subsec. (d)(4)(A)(i).
Subsec. (d)(4)(B).
Subsec. (d)(4)(B)(III).
Subsec. (f)(3)(F)(i).
Subsec. (f)(7).
Subsec. (h)(1).
Subsec. (h)(2), (3).
Subsec. (i).
1986—Subsec. (d)(2).
Subsec. (h)(1).
1982—Subsec. (f)(5).
1981—Subsec. (h).
1979—Subsec. (a)(7)(L).
1978—Subsec. (a)(1)(D), (E).
Subsec. (a)(1)(G).
Subsec. (a)(5).
Subsec. (a)(6)(G).
Subsec. (a)(7).
Subsec. (b)(1).
Subsec. (c)(1)(B).
Subsec. (d)(1).
Subsec. (d)(2).
Subsec. (d)(3).
Subsec. (d)(4).
Subsec. (f).
Subsec. (g).
Subsec. (h)(1).
Subsec. (h)(2).
Subsec. (h)(3).
Subsec. (h)(4).
1977—Subsec. (h)(1).
Subsec. (h)(2).
Subsec. (h)(3).
1976—Subsec. (a)(7).
1975—Subsec. (a).
Subsecs. (b) to (h).
1973—
1970—
1968—
1965—
Change of Name
"Department of Health and Human Services" substituted for "Department of Health, Education, and Welfare" in subsec. (g)(1) pursuant to section 509(b) of
Effective Date of 1988 Amendment
Section 5 of
Effective Date of 1978 Amendment
Section 103(g)(1)(C) of
Section 103(j) of
Effective Date of 1975 Amendment
Amendment by section 401(a) of
Short Title
This section is popularly known as the "Migrant Health Act".
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg, Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Study of Hospital Staff Privileges for Physicians Practicing in Community Health Centers
Study of Housing Conditions of Agricultural Migratory Workers; Consultations; Submission of Report to Congressional Committees
Section 401(c) of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "worker".
2 So in original. Probably should be "therefor".
§254c. Community health centers
(a) Definitions
For purposes of this section, the term "community health center" means an entity which either through its staff and supporting resources or through contracts or cooperative arrangements with other public or private entities provides—
(1) primarily health services,
(2) as may be appropriate for particular centers, supplemental health services necessary for the adequate support of primary health services,
(3) referral to providers of supplemental health services and payment, as appropriate and feasible, for their provision of such services,
(4) environmental health services, including, as may be appropriate for particular centers (as determined by the centers), the detection and alleviation of unhealthful conditions associated with water supply, sewage treatment, solid waste disposal, rodent and parasitic infestation, field sanitation, housing, and other environmental factors related to health,
(5) information on the availability and proper use of health services and services which promote and facilitate optimal use of health services, including, if a substantial number of the individuals in the population served by a center are of limited English-speaking ability, the services of appropriate personnel fluent in the language spoken by a predominant number of such individuals, and
(6) patient case management services (including outreach, counseling, referral, and follow-up services),
for all residents of the area it serves (referred to in this section as a "catchment area").
(b) Additional definitions; criteria to determine specific shortages of personal health services; designation of medically underserved population or termination of such designation
For purposes of this section:
(1) The term "primary health services" means—
(A) services of physicians and, where feasible, services of physicians' assistants and nurse clinicians;
(B) diagnostic laboratory and radiologic services;
(C) preventive health services (including children's eye and ear examinations to determine the need for vision and hearing correction, perinatal services, well child services, immunizations against vaccine-preventable diseases, screenings for elevated blood lead levels, and family planning services);
(D) emergency medical services;
(E) transportation services as required for adequate patient care;
(F) preventive dental services; and
(G) pharmaceutical services, as may be appropriate for particular centers.
(2) The term "supplemental health services" means services which are not included as primary health services and which are—
(A) hospital services;
(B) home health services;
(C) extended care facility services;
(D) rehabilitative services (including physical therapy) and long-term physical medicine;
(E) mental health services;
(F) dental services;
(G) vision services;
(H) allied health services;
(I) therapeutic radiologic services;
(J) public health services (including, for the social and other nonmedical needs which affect health status, counseling, referral for assistance, and followup services);
(K) ambulatory surgical services;
(L) health education services (including nutrition education); and
(M) other services appropriate to meet the health needs of the medically underserved population served by the community health center involved.
(3) The term "medically underserved population" means the population of an urban or rural area designated by the Secretary as an area with a shortage of personal health services or a population group designated by the Secretary as having a shortage of such services.
(4) In carrying out paragraph (3), the Secretary shall by regulation prescribe criteria for determining the specific shortages of personal health services of an area or population group. Such criteria shall—
(A) take into account comments received by the Secretary from the chief executive officer of a State and local officials in a State; and
(B) include infant mortality in an area or population group, other factors indicative of the health status of a population group or residents of an area, the ability of the residents of an area or of a population group to pay for health services and their accessibility to them, and the availability of health professionals to residents of an area or to a population group.
The Secretary may modify the criteria established in regulations issued under this paragraph only after affording public notice and an opportunity for comment on any such proposed modifications.
(5) The Secretary may not designate a medically underserved population in a State or terminate the designation of such a population unless, prior to such designation or termination, the Secretary provides reasonable notice and opportunity for comment and consults with—
(A) the chief executive officer of such State;
(B) local officials in such State; and
(C) the State organization, if any, which represents a majority of community health centers in such State.
(6) The Secretary may designate a medically underserved population that does not meet the criteria established under paragraph (4) if the chief executive officer of the State in which such population is located and local officials of such State recommend the designation of such population based on unusual local conditions which are a barrier to access to or the availability of personal health services.
(c) Grants to public and nonprofit private entities for projects to plan and develop centers; costs includable and criteria for grants; number of grants; determination of amount of grants
(1) The Secretary may make grants to public and nonprofit private entities for projects to plan and develop community health centers which will serve medically underserved populations. A project for which a grant may be made under this subsection may include the cost of the acquisition, expansion, and modernization of existing buildings and construction of new buildings (including the costs of amortizing the principal of, and paying the interest on, loans) and shall include—
(A) an assessment of the need that the population proposed to be served by the community health center for which the project is undertaken has for primary health services, supplemental health services, and environmental health services;
(B) the design of a community health center program for such population based on such assessment;
(C) efforts to secure, within the proposed catchment area of such center, financial and professional assistance and support for the project; and
(D) initiation and encouragement of continuing community involvement in the development and operation of the project.
(2) Not more than two grants may be made under this subsection for the same project.
(3) The amount of any grant made under this subsection for any project shall be determined by the Secretary.
(d) Grants to public and nonprofit private centers and related entities functioning without center determination for costs of operation; prepayment; costs includable for grants; number of grants; determination of amount of grants; payments
(1)(A) The Secretary may make grants for the costs of operation of public and nonprofit private community health centers which serve medically underserved populations.
(B) The Secretary may make grants for the costs of the operation of public and nonprofit private entities which provide health services to medically underserved populations but with respect to which he is unable to make each of the determinations required by subsection (e)(3) of this section.
(C) The Secretary may make grants to community health centers to enable the centers to plan and develop the provision of health services on a prepaid basis to some or to all of the individuals which the centers serve. Such a grant may only be made for such a center if—
(i) the center has received grants under subparagraph (A) of this paragraph for at least two consecutive years preceding the year of the grant under this subparagraph;
(ii) the governing board of the center (described in subsection (e)(3)(G) of this section) requests, in a manner prescribed by the Secretary, that the center provide health services on a prepaid basis to some or to all of the population which the center serves; and
(iii) the center provides assurances satisfactory to the Secretary that the provision of such services on a prepaid basis will not result in the diminution of health services provided by the center to the population the center served prior to the grant under this subparagraph.
Any such grant may include the acquisition, expansion, and modernization of existing buildings, construction of new buildings, and providing training related to management of the provision of health services on a prepaid basis.
(2) The costs for which a grant may be made under paragraph (1)(A) or (1)(B) may include the costs of acquiring, expanding, and modernizing existing buildings and constructing new buildings (including the costs of amortizing the principal of, and paying interest on, loans), the costs of repaying loans made by the Farmers Home Administration for buildings, and the costs of providing training related to the provision of primary health services, supplemental health services and environmental health services, and to the management of community health center programs.
(3) Not more than two grants may be made under paragraph (1)(B) or (1)(C) for the same entity.
(4)(A) The amount of any grant made in any fiscal year under paragraph (1) (other than subparagraph (C)) to a community health center shall be determined by the Secretary, but may not exceed the amount by which the costs of operation of the center in such fiscal year exceed the total of—
(i) State, local, and other operational funding, and
(ii) the fees, premiums, and third-party reimbursements,
which the center may reasonably be expected to receive for its operations in such fiscal year. In determining the amount of such a grant for a center, if the application for the grant requests funds for a service described in subsection (a)(4) of this section (other than to the extent the funds would be used for the improvement of private property) or a supplemental health service described in subparagraph (B), (F), (L), or (M) of subsection (b)(2) of this section, the Secretary shall include, in an amount determined by the Secretary and to the extent funds are available under appropriation Acts, funds for such service unless the Secretary makes a written finding that such service is not needed and provides the applicant with a copy of such finding.
(B) Payments under grants under subparagraph (A) or (B) of paragraph (1) shall be made in advance or by way of reimbursement and in such installments as the Secretary finds necessary and adjustments may be made for overpayments or underpayments, except that if in any fiscal year the sum of—
(i) the total of the amounts described in clauses (i) and (ii) of subparagraph (A) received by a center in such fiscal year, and
(ii) the amount of the grant to the center in such fiscal year,
exceeded the costs of the center's operation in such fiscal year because the amount received by the center from fees, premiums, and third-party reimbursements was greater than expected, an adjustment in the amount of the grant to the center in the succeeding fiscal year shall be made in such a manner that the center shall be entitled to retain the additional amount of fees, premiums, and other third party reimbursements as the center will use (I) to expand and improve its services, (II) to increase the number of persons (eligible to receive services from such a center) it is able to serve, (III) to construct, expand, and modernize its facilities, (IV) to improve the administration of its service programs, and (V) to establish the financial reserve required for the furnishing of services on a prepaid basis. Without the approval of the Secretary, not more than one-half of such retained sum may be used for construction and modernization of its facilities.
(C) With respect to amounts described in clauses (i) and (ii) of subparagraph (A), the Secretary may not restrict expenditures of such amounts by any grantee under paragraph (1) for—
(i) repair or minor renovation of the physical plant;
(ii) establishment of a financial reserve as required for the furnishing of services on a prepaid basis or as needed to cover unanticipated expenses;
(iii) interest payments on short-term loans to cover cash shortfalls; or
(iv) necessary salary requirements to remain competitive in hiring health care practitioners.
(e) Approval of application as prerequisite for grant; form and manner of submission and contents of application; determination of entity as center as prerequisite for approval of application; "public center" defined; improvement of private property; new building grant conditions
(1) No grant may be made under subsection (c) or (d) of this section unless an application therefor is submitted to, and approved by, the Secretary. Such an application shall be submitted in such form and manner and shall contain such information as the Secretary shall prescribe. An application for a grant which will cover the costs of modernizing a building shall include, in addition to other information required by the Secretary—
(A) a description of the site of the building,
(B) plans and specifications for its modernization, and
(C) reasonable assurance that all laborers and mechanics employed by contractors or subcontractors in the performance of work on the modernization of the building will be paid wages at rates not less than those prevailing on similar work in the locality as determined by the Secretary of Labor in accordance with the Act of March 3, 1931 (
The Secretary of Labor shall have with respect to the labor standards referred to in subparagraph (C) the authority and functions set forth in Reorganization Plan Numbered 14 of 1950 (15 F.R. 3176, 5 U.S.C. Appendix) and
(2) An application for a grant under subparagraph (A) or (B) of subsection (d)(1) of this section for a community health center shall include—
(A) a description of the need in the center's catchment area for each of the health services described in subsection (a)(4) of this section and in subparagraphs (B), (F), (L), and (M) of subsection (b)(2) of this section,
(B) if the applicant determines that any such service is not needed, the basis for such determination, and
(C) if the applicant does not request funds for any such service which the applicant determines is needed, the reason for not making such a request.
Such an application shall also include a demonstration by the applicant that the area or a population group to be served by the applicant has a shortage of personal health services and that the center will be located so that it will provide services to the greatest number of persons residing in such area or included in such population group. Such a demonstration shall be made on the basis of the criteria prescribed by the Secretary under subsection (b)(3) of this section or on any other criteria which the Secretary may prescribe to determine if the area or population group to be served by the applicant has a shortage of personal health services. In considering an application for a grant under subparagraph (A) or (B) of subsection (d)(1) of this section, the Secretary may require as a condition to the approval of such application assurance that the applicant will provide any specified health services described in subsection (a) or (b) of this section which the Secretary finds is needed to meet specific health needs of the area to be served by the applicant. Such a finding shall be made in writing and a copy shall be provided the applicant.
(3) Except as provided in subsection (d)(1)(B) of this section, the Secretary may not approve an application for a grant under paragraph (1)(A) or (1)(B) of subsection (d) of this section unless the Secretary determines that the entity for which the application is submitted is a community health center (within the meaning of subsection (a) of this section) and that—
(A) the primary health services of the center will be available and accessible in the center's catchment area promptly, as appropriate, and in a manner which assures continuity;
(B) the center will have organizational arrangements, established in accordance with regulations prescribed by the Secretary, or (i) an ongoing quality assurance program (including utilization and peer review systems) respecting the center's services, and (ii) maintaining the confidentiality of patient records;
(C) the center will demonstrate its financial responsibility by the use of such accounting procedures and other requirements as may be prescribed by the Secretary;
(D) the center (i) has or will have a contractual or other arrangement with the agency of the State, in which it provides services, which administers or supervises the administration of a State plan approved under title XIX of the Social Security Act [
(E) the center has made or will make and will continue to make every reasonable effort to collect appropriate reimbursement for its costs in providing health services to persons who are entitled to insurance benefits under title XVIII of the Social Security Act [
(F) the center (i) has prepared a schedule of fees or payments for the provision of its services consistent with locally prevailing rates or charges and designed to cover its reasonable costs of operation and has prepared a corresponding schedule of discounts to be applied to the payment of such fees or payments, which discounts are adjusted on the basis of the patient's ability to pay, (ii) has made and will continue to make every reasonable effort (I) to secure from patients payment for services in accordance with such schedules, and (II) to collect reimbursement for health services to persons described in subparagraph (E) on the basis of the full amount of fees and payments for such services without application of any discount, and (iii) has submitted to the Secretary such reports as he may require to determine compliance with this subparagraph;
(G) the center has established a governing board which (i) except in the case of an entity operated by an Indian tribe or tribal or Indian organization under the Indian Self-Determination Act [
(H) the center has developed, in accordance with regulations of the Secretary, (i) an overall plan and budget that meets the requirements of section 1861(z) of the Social Security Act [
(I) the center will review periodically its catchment area to (i) insure that the size of such area is such that the services to be provided through the center (including any satellite) are available and accessible to the residents of the area promptly and as appropriate, (ii) insure that the boundaries of such area conform, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and Federal and State health and social service programs, and (iii) insure that the boundaries of such area eliminate, to the extent possible, barriers to access to the services of the center, including barriers resulting from the area's physical characteristics, its residential patterns, its economic and social groupings, and available transportation;
(J) in the case of a center which serves a population including a substantial proportion of individuals of limited English-speaking ability, the center has (i) developed a plan and made arrangements responsive to the needs of such population for providing services to the extent practicable in the language and cultural context most appropriate to such individuals, and (ii) identified an individual on its staff who is fluent in both that language and in English and whose responsibilities shall include providing guidance to such individuals and to appropriate staff members with respect to cultural sensitivities and bridging linguistic and cultural differences; and
(K) the center, in accordance with regulations prescribed by the Secretary, has developed an on-going referral relationship with one or more hospitals.
For purposes of subparagraph (G) and subsection (g)(4) of this section, the term "public center" means a community health center funded (or to be funded) through a grant under this section to a public agency.
(4) The Secretary shall approve applications for grants under paragraph (1)(A) or (1)(B) of subsection (d) of this section for community health centers which—
(A) have not received a previous grant under such paragraph, or
(B) have applied for such a grant to expand their services,
in such a manner that the ratio of the medical underserved populations in rural areas which may be expected to use the services provided by such centers to the medical underserved populations in urban areas which may be expected to use the services provided by such centers is not less than two to three or greater than three to two.
(5) The Secretary, in making a grant under this section to a community health center for the provision of environmental health services described in subsection (a)(4) of this section, may designate a portion of the grant to be expended for improvements to private property for which the written consent of the owner has been obtained and which are necessary to alleviate a hazard to the health of those residing on, or otherwise using, the property and of other persons in the center's catchment area. A center may make such an expenditure for an improvement under a grant only after the Secretary has specifically approved such expenditure and has determined that funds for the improvement are not available from any other source.
(6) The Secretary may make a grant under subsection (c) or (d) of this section for the construction of new buildings for a community health center only if the Secretary determines that appropriate facilities are not available through acquiring, modernizing, or expanding existing buildings and that the entity to which the grant will be made has made reasonable efforts to secure from other sources funds, in lieu of the grant, to construct such facilities.
(f) Technical and other nonfinancial assistance; resources list
(1) The Secretary may provide (either through the Department of Health and Human Services or by grant or contract) all necessary technical and other nonfinancial assistance (including fiscal and program management assistance and training in such management) to any public or private nonprofit entity to assist it in developing plans for, and in operating as, a community health center, and in meeting requirements of subsection (e)(2) of this section.
(2) The Secretary shall make available to each grant recipient under this section a list of available Federal and non-Federal resources to improve the environmental and nutritional status of individuals in the recipient's catchment area.
(g) Authorization of appropriations; establishment of general policies by governing boards; reduction in infant mortality and health management for infants and pregnant women
(1)(A) For the purpose of payments under grants under this section, there are authorized to be appropriated $440,000,000 for fiscal year 1989, such sums as may be necessary for fiscal years 1990 and 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1994.
(B) The Secretary may not in any fiscal year—
(i) expend for grants to serve medically underserved populations designated under subsection (b)(6) of this section an amount which exceeds 5 percent of the funds appropriated under paragraph (1) for that fiscal year; and
(ii) expend for grants under subsection (d)(1)(C) of this section an amount which exceeds 5 percent of the funds appropriated under paragraph (1) for that fiscal year.
(2)(A) For the purpose of carrying out subparagraph (B), there are authorized to be appropriated $25,000,000 for fiscal year 1989, $30,000,000 for fiscal year 1990, $35,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 1994.
(B) The Secretary may make grants to community health centers for the purpose of assisting such centers in—
(i) providing comprehensive health care and support services for the reduction of (I) the incidence of infant mortality, and (II) morbidity among children who are less than 3 years of age; and
(ii) developing and coordinating service and referral arrangements between community health centers and other entities for the health management of pregnant women and children described in clause (i).
(C) In making grants under subparagraph (B), the Secretary shall give priority to community health centers providing services to any medically underserved population among which there is a substantial incidence of infant mortality or among which there is a significant increase in the incidence of infant mortality.
(D) The Secretary may make a grant under subparagraph (B) only if the community health center involved agrees to expend the grant for the following activities with respect to the purpose described in such subparagraph:
(i) Primary health services, including prenatal care.
(ii) Community education, outreach, and case finding.
(iii) Case management services.
(iv) Client education, including parenting and child development education.
(E) The purposes for which a community health center may expend a grant under subparagraph (B) include, with respect to the purpose described in such subparagraph, substance abuse screening, counseling and referral services, and other necessary nonmedical support services, including child care, translation services, and housing assistance.
(F) The Secretary may make a grant under subparagraph (B) only if the community health center involved agrees that—
(i) the center will coordinate the provision of services under the grant to each of the recipients of the services;
(ii) such services will be continuous for each such recipient;
(iii) the center will provide follow-up services for individuals who are referred by the center for services described in subparagraph (E); and
(iv) the grant will be expended to supplement, and not supplant, the expenditures of the center for primary health services (including prenatal care) with respect to the purpose described in such subparagraph.
(3) The Secretary may not expend in any fiscal year, for grants under this section to public centers (as defined in the second sentence of subsection (e)(3) of this section) the governing boards of which (as described in subsection (e)(3)(G)(ii) of this section) do not establish general policies for such centers, an amount which exceeds 5 per centum of the funds appropriated under this section for that fiscal year.
(h) Memorandum of agreement
In carrying out this section, the Secretary may enter into a memorandum of agreement with a State. Such memorandum may include, where appropriate, provisions permitting such State to—
(1) analyze the need for primary health services for medically underserved populations within such State;
(2) assist in the planning and development of new community health centers;
(3) review and comment upon annual program plans and budgets of community health centers, including comments upon allocations of health care resources in the State;
(4) assist community health centers in the development of clinical practices and fiscal and administrative systems through a technical assistance plan which is responsive to the requests of community health centers; and
(5) share information and data relevant to the operation of new and existing community health centers.
(i) Audit of grants; reports; records; waiver of audit
(1) Each entity which receives a grant under subsection (d) of this section shall provide for an independent annual financial audit of any books, accounts, financial records, files, and other papers and property which relate to the disposition or use of the funds received under such grant and such other funds received by or allocated to the project for which such grant was made. For purposes of assuring accurate, current, and complete disclosure of the disposition or use of the funds received, each such audit shall be conducted in accordance with generally accepted accounting principles. Each audit shall evaluate—
(A) the entity's implementation of the guidelines established by the Secretary respecting cost accounting,
(B) the processes used by the entity to meet the financial and program reporting requirements of the Secretary, and
(C) the billing and collection procedures of the entity and the relation of the procedures to its fee schedule and schedule of discounts and to the availability of health insurance and public programs to pay for the health services it provides.
A report of each such audit shall be filed with the Secretary at such time and in such manner as the Secretary may require.
(2) Each entity which receives a grant under subsection (d) of this section shall establish and maintain such records as the Secretary shall by regulation require to facilitate the audit required by paragraph (1). The Secretary may specify by regulation the form and manner in which such records shall be established and maintained.
(3) Each entity which is required to establish and maintain records or to provide for an audit under this subsection shall make such books, documents, papers, and records available to the Secretary or the Comptroller General of the United States, or any of their duly authorized representatives, for examination, copying, or mechanical reproduction on or off the premises of such entity upon a reasonable request therefor. The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have the authority to conduct such examination, copying, and reproduction.
(4) The Secretary may, under appropriate circumstances, waive the application of all or part of the requirements of this subsection to a community health center.
(j) Delegation of authority to administer programs; exception
The Secretary may delegate the authority to administer the programs authorized by this section to any office within the Service, except that the authority to enter into, modify, or issue approvals with respect to grants or contracts may be delegated only within the central office of the Health Resources and Services Administration.
(k) Special consideration of needs of frontier areas
In making grants under this section, the Secretary shall give special consideration to the unique needs of frontier areas.
(July 1, 1944, ch. 373, title III, §330, as added July 29, 1975,
References in Text
The Social Security Act, referred to in subsec. (e)(3)(D), (E), is act Aug. 14, 1935, ch. 531,
Act of March 3, 1931 (
The Indian Self-Determination Act, referred to in subsec. (e)(3)(G)(i), is title I of
Amendments
1992—Subsec. (b)(1)(C).
Subsec. (d)(4)(C).
Subsec. (g)(2)(B).
"(i) providing services for the reduction of the incidence of infant mortality; and
"(ii) developing and coordinating referral arrangements between community health centers and other entities for the health management of infants and pregnant women."
Subsec. (g)(2)(D) to (F).
1990—Subsec. (a)(5).
Subsec. (b)(2)(M), (N).
Subsec. (g)(1)(A), (2)(A).
1989—Subsec. (e)(3)(G).
1988—Subsec. (a)(6).
Subsec. (b)(2)(N).
Subsec. (b)(4).
Subsec. (c)(1).
Subsec. (d)(1)(C).
Subsec. (d)(2).
Subsec. (d)(4)(A)(i).
Subsec. (d)(4)(B).
Subsec. (d)(4)(B)(III).
Subsec. (e)(3)(F)(i).
Subsec. (e)(6).
Subsec. (g)(1)(A).
Subsec. (g)(1)(B).
Subsec. (g)(2).
Subsec. (j).
Subsec. (k).
1986—Subsec. (b)(3) to (6).
Subsec. (g)(1), (2).
"(1) There are authorized to be appropriated for payments pursuant to grants under subsection (c) of this section $5,000,000 for fiscal year 1976, $5,000,000 for the fiscal year ending September 30, 1977, $5,880,000 for the fiscal year ending September 30, 1978, $6,300,000 for the fiscal year ending September 30, 1979, $7,500,000 for the fiscal year ending September 30, 1980, and $9,000,000 for the fiscal year ending September 30, 1981.
"(2) There are authorized to be appropriated for payments pursuant to grants under subsection (d) of this section $215,000,000 for fiscal year 1976, $235,000,000 for the fiscal year ending September 30, 1977, $256,840,000 for the fiscal year ending September 30, 1978, $341,700,000 for the fiscal year ending September 30, 1979, $397,500,000 for the fiscal year ending September 30, 1980, $463,000,000 for the fiscal year ending September 30, 1981 and $280,000,000 for the fiscal year ending September 30, 1982. For authorizations for appropriations for fiscal years 1983 and 1984, see
Subsecs. (h), (i).
1983—Subsec. (d)(2).
1981—Subsec. (b)(3).
Subsec. (e)(2).
Subsec. (g)(2).
Subsec. (h).
1980—Subsec. (e)(5).
1979—Subsec. (d)(1)(B).
Subsec. (e)(3).
Subsec. (g)(2).
Subsec. (g)(3).
1978—Subsec. (a)(4).
Subsec. (b)(1)(G).
Subsec. (b)(2).
Subsec. (d)(1)(C).
Subsec. (d)(2).
Subsec. (d)(3).
Subsec. (d)(4).
Subsec. (e)(2).
Subsec. (e)(3).
Subsec. (e)(4), (5).
Subsec. (f).
Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (g)(3).
1977—Subsec. (b)(3).
Subsec. (e)(1).
Subsec. (g).
1976—Subsec. (b)(2).
Change of Name
"Department of Health and Human Services" substituted for "Department of Health, Education, and Welfare" in subsec. (f)(1) pursuant to section 509(b) of
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1978 Amendment
Section 104(d)(3)(C) of
Section 104(g) of
Effective Date
Section effective July 1, 1975, see section 608 of
Section Referred to in Other Sections
This section is referred to in
§254c–1. Grants for health services for Pacific Islanders
(a) Grants
The Secretary of Health and Human Services (hereafter in this section referred to as the "Secretary") shall provide grants to, or enter into contracts with, public or private nonprofit agencies that have demonstrated experience in serving the health needs of Pacific Islanders living in the Territory of American Samoa, the Commonwealth of Northern Mariana Islands, the Territory of Guam, the Republic of the Marshall Islands, the Republic of Palau, and the Federated States of Micronesia.
(b) Use of grants or contracts
Grants or contracts made or entered into under subsection (a) of this section shall be used, among other items—
(1) to continue, as a priority, the medical officer training program in Pohnpei, Federated States of Micronesia;
(2) to improve the quality and availability of health and mental health services and systems, with an emphasis therein on preventive health services and health promotion programs and projects, including improved health data systems;
(3) to improve the quality and availability of health manpower, including programs and projects to train new and upgrade the skills of existing health professionals by—
(A) establishing dental officer, dental assistant, nurse practitioner, or nurse clinical specialist training programs;
(B) providing technical training of new auxiliary health workers;
(C) upgrading the training of currently employed health personnel in special areas of need;
(D) developing long-term plans for meeting health profession needs;
(E) developing or improving programs for faculty enhancement or post-doctoral training; and
(F) providing innovative health professions training initiatives (including scholarships) targeted toward ensuring that residents of the Pacific Basin attend and graduate from recognized health professional programs;
(4) to improve the quality of health services, including laboratory, x-ray, and pharmacy, provided in ambulatory and inpatient settings through quality assurance, standard setting, and other culturally appropriate means;
(5) to improve facility and equipment repair and maintenance systems;
(6) to improve alcohol, drug abuse, and mental health prevention and treatment services and systems;
(7) to improve local and regional health planning systems; and
(8) to improve basic local public health systems, with particular attention to primary care and services to those most in need.
No funds under subsection (b) of this section shall be used for capital construction.
(c) Advisory Council
The Secretary of Health and Human Services shall establish a "Pacific Health Advisory Council" which shall consist of 12 members and shall include—
(1) the Directors of the Health Departments for the entities identified in subsection (a) of this section; and
(2) 6 members, including a representative of the Rehabilitation Hospital of the Pacific, representing organizations in the State of Hawaii actively involved in the provision of health services or technical assistance to the entities identified in subsection (a) of this section. The Secretary shall solicit the advice of the Governor of the State of Hawaii in appointing the 5 Council members in addition to the representative of the Rehabilitation Hospital of the Pacific from the State of Hawaii.
The Secretary shall be responsible for providing sufficient staff support to the Council.
(d) Advisory Council functions
The Council shall meet at least annually to—
(1) recommend priority areas of need for funding by the Public Health Service under this section; and
(2) review progress in addressing priority areas and make recommendations to the Secretary for needed program modifications.
(e) Report
The Secretary, in consultation with the Council, shall annually prepare and submit to the appropriate committees of Congress a report describing the expenditure of the funds authorized to be appropriated under this section and any recommendations that the Secretary may have.
(f) Authorization of appropriation
There is authorized to be appropriated to carry out this section $10,000,000 for each of the fiscal years 1991 through 1993.
(
Codification
Section was enacted as part of the Disadvantaged Minority Health Improvement Act of 1990, and not as part of the Public Health Service Act which comprises this chapter.
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
subpart ii—national health service corps program
Amendments
1976—
Subpart Referred to in Other Sections
This subpart is referred to in
§254d. National Health Service Corps
(a) Establishment; composition; purpose; definitions
(1) For the purpose of eliminating health manpower shortages in health professional shortage areas, there is established, within the Service, the National Health Service Corps, which shall consist of—
(A) such officers of the Regular and Reserve Corps of the Service as the Secretary may designate,
(B) such civilian employees of the United States as the Secretary may appoint, and
(C) such other individuals who are not employees of the United States.
(2) The Corps shall be utilized by the Secretary to provide primary health services in health professional shortage areas.
(3) For purposes of this subpart and subpart III:
(A) The term "Corps" means the National Health Service Corps.
(B) The term "Corps member" means each of the officers, employees, and individuals of which the Corps consists pursuant to paragraph (1).
(C) The term "health professional shortage area" has the meaning given such term in
(D) The term "primary health services" means health services regarding family medicine, internal medicine, pediatrics, obstetrics and gynecology, dentistry, or mental health, that are provided by physicians or other health professionals.
(b) Recruitment and fellowship programs
(1) The Secretary may conduct at schools of medicine, osteopathic medicine, dentistry, and, as appropriate, nursing and other schools of the health professions and at entities which train allied health personnel, recruiting programs for the Corps, the Scholarship Program, and the Loan Repayment Program. Such recruiting programs shall include efforts to recruit individuals who will serve in the Corps other than pursuant to obligated service under the Scholarship or Loan Repayment Program.
(2) In the case of physicians, dentists, certified nurse midwives, certified nurse practitioners, and physician assistants who have an interest and a commitment to providing primary health care, the Secretary may establish fellowship programs to enable such health professionals to gain exposure to and expertise in the delivery of primary health services in health professional shortage areas. To the maximum extent practicable, the Secretary shall ensure that any such programs are established in conjunction with accredited residency programs, and other training programs, regarding such health professions.
(c) Travel expenses; persons entitled; reimbursement; limitation
The Secretary may reimburse applicants for positions in the Corps (including individuals considering entering into a written agreement pursuant to
(d) Monthly pay adjustments of members directly engaged in delivery of health services in health professional shortage area; "monthly pay" defined; monthly pay adjustment of member with service obligation incurred under Scholarship Program or Loan Repayment Program; personnel system applicable
(1) The Secretary may, under regulations promulgated by the Secretary, adjust the monthly pay of each member of the Corps (other than a member described in subsection (a)(1)(C) of this section) who is directly engaged in the delivery of health services in a health professional shortage area as follows:
(A) During the first 36 months in which such a member is so engaged in the delivery of health services, his monthly pay may be increased by an amount which when added to the member's monthly pay and allowances will provide a monthly income competitive with the average monthly income from a practice of an individual who is a member of the profession of the Corps member, who has equivalent training, and who has been in practice for a period equivalent to the period during which the Corps member has been in practice.
(B) During the period beginning upon the expiration of the 36 months referred to in subparagraph (A) and ending with the month in which the member's monthly pay and allowances are equal to or exceed the monthly income he received for the last of such 36 months, the member may receive in addition to his monthly pay and allowances an amount which when added to such monthly pay and allowances equals the monthly income he received for such last month.
(C) For each month in which a member is directly engaged in the delivery of health services in a health professional shortage area in accordance with an agreement with the Secretary entered into under section 294n(f)(1)(C) 1 of this title, under which the Secretary is obligated to make payments in accordance with section 294n(f)(2) 1 of this title, the amount of any monthly increase under subparagraph (A) or (B) with respect to such member shall be decreased by an amount equal to one-twelfth of the amount which the Secretary is obligated to pay upon the completion of the year of practice in which such month occurs.
For purposes of subparagraphs (A) and (B), the term "monthly pay" includes special pay received under
(2) In the case of a member of the Corps who is directly engaged in the delivery of health services in a health professional shortage area in accordance with a service obligation incurred under the Scholarship Program or the Loan Repayment Program, the adjustment in pay authorized by paragraph (1) may be made for such a member only upon satisfactory completion of such service obligation, and the first 36 months of such member's being so engaged in the delivery of health services shall, for purposes of paragraph (1)(A), be deemed to begin upon such satisfactory completion.
(3) A member of the Corps described in subparagraph (C) of subsection (a)(1) of this section shall when assigned to an entity under
(e) Employment ceiling of Department not affected by Corps members
Corps members assigned under
(f) Assignment of personnel provisions inapplicable to members whose service obligation incurred under Scholarship Program or Loan Repayment Program
(g) Conversion from Corps member to commissioned officer; retirement credits
(1) The Secretary shall, by rule, prescribe conversion provisions applicable to any individual who, within a year after completion of service as a member of the Corps described in subsection (a)(1)(C) of this section, becomes a commissioned officer in the Regular or Reserve Corps of the Service.
(2) The rules prescribed under paragraph (1) shall provide that in applying the appropriate provisions of this chapter which relate to retirement, any individual who becomes such an officer shall be entitled to have credit for any period of service as a member of the Corps described in subsection (a)(1)(C) of this section.
(h) Effective administration of program
The Secretary shall ensure that adequate staff is provided to the Service with respect to effectively administering the program for the Corps.
(i) Definitions
For the purposes of this subpart and subpart III:
(1) The term "Department" means the Department of Health and Human Services.
(2) The term "Loan Repayment Program" means the National Health Service Corps Loan Repayment Program established under
(3) The term "Scholarship Program" means the National Health Service Corps Scholarship Program established under
(4) The term "State" includes, in addition to the several States, only the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, and the Trust Territory of the Pacific Islands.
(July 1, 1944, ch. 373, title III, §331, as added Oct. 12, 1976,
References in Text
Amendments
1990—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d)(1).
Subsec. (d)(1)(A).
Subsecs. (d)(2), (e).
Subsec. (h).
"(1) give priority to meeting the needs of the Indian Health Service and the needs of health programs or facilities operated by tribes or tribal organizations under the Indian Self-Determination Act (
"(2) provide special consideration to the homeless populations who do not have access to primary health care services."
Subsec. (i).
1988—Subsec. (b).
1987—Subsec. (b).
Subsec. (c).
Subsecs. (d)(2), (f).
Subsec. (h).
Subsec. (i).
1981—Subsec. (a)(1).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (g).
Subsec. (h).
Termination of Trust Territory of the Pacific Islands
For termination of Trust Territory of the Pacific Islands, see note set out preceding
Special Report on Present and Future Direction of National Health Service Corps; Submission to Congress Not Later Than February 1, 1979
Effective Date; Other Provisions: Health Manpower Shortage Area; Approval of Applications for Assignment of Corps Personnel; Assignment Period, Commencement; Credit for Months of Prior Health Care and Services for Additional Pay Benefit; National Advisory Council on the National Health Service Corps, Continuation of Council and Appointment of Members
Section 407(c) of
"(1) The amendment made by subsections (a) and (b) [enacting this subpart and repealing
"(2)(A) Any area for which a designation under section 329(b) of the Public Health Service Act (as in effect on September 30, 1977) [
"(B) The assignment period (within the meaning of such section 334) [
"(C) In the case of any physician or dentist member of the Corps who was providing health care and services on September 30, 1977, under an assignment made under section 329(b) of such Act (as in effect on September 30, 1977) [
"(3) The amendment made by subsection (b) which established an Advisory Council previously established under section 329 of the Public Health Service Act [
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254e. Health professional shortage areas
(a) Designation by Secretary; removal from areas designated; "medical facility" defined
(1) For purposes of this subpart the term "health professional shortage area" means (A) an area in an urban or rural area (which need not conform to the geographic boundaries of a political subdivision and which is a rational area for the delivery of health services) which the Secretary determines has a health manpower shortage and which is not reasonably accessible to an adequately served area, (B) a population group which the Secretary determines has such a shortage, or (C) a public or nonprofit private medical facility or other public facility which the Secretary determines has such a shortage. The Secretary shall not remove an area from the areas determined to be health professional shortage areas under subparagraph (A) of the preceding sentence until the Secretary has afforded interested persons and groups in such area an opportunity to provide data and information in support of the designation as a health professional shortage area or a population group described in subparagraph (B) of such sentence or a facility described in subparagraph (C) of such sentence, and has made a determination on the basis of the data and information submitted by such persons and groups and other data and information available to the Secretary.
(2) For purposes of this subsection, the term "medical facility" means a facility for the delivery of health services and includes—
(A) a hospital, State mental hospital, public health center, outpatient medical facility, rehabilitation facility, facility for long-term care, community mental health center, migrant health center, facility operated by a city or county health department, and community health center;
(B) such a facility of a State correctional institution or of the Indian Health Service, and a health program or facility operated by a tribe or tribal organization under the Indian Self-Determination Act [
(C) such a facility used in connection with the delivery of health services under
(D) a Federal medical facility.
(3) Homeless individuals (as defined in
(b) Criteria for designation of health professional shortage areas; promulgation of regulations
The Secretary shall establish by regulation criteria for the designation of areas, population groups, medical facilities, and other public facilities, in the States, as health professional shortage areas. In establishing such criteria, the Secretary shall take into consideration the following:
(1) The ratio of available health manpower to the number of individuals in an area or population group, or served by a medical facility or other public facility under consideration for designation.
(2) Indicators of a need, notwithstanding the supply of health manpower, for health services for the individuals in an area or population group or served by a medical facility or other public facility under consideration for designation, with special consideration to indicators of—
(A) infant mortality,
(B) access to health services,
(C) health status, and
(D) ability to pay for health services.
(3) The percentage of physicians serving an area, population group, medical facility, or other public facility under consideration for designation who are employed by hospitals and who are graduates of foreign medical schools.
(c) Considerations in determination of designation
In determining whether to make a designation, the Secretary shall take into consideration the following:
(1) The recommendations of the Governor of each State in which the area, population group, medical facility, or other public facility under consideration for designation is in whole or part located.
(2) The extent to which individuals who are (A) residents of the area, members of the population group, or patients in the medical facility or other public facility under consideration for designation, and (B) entitled to have payment made for medical services under title XVIII or XIX of the Social Security Act [
(d) Designation; publication of descriptive lists
(1) In accordance with the criteria established under subsection (b) of this section and the considerations listed in subsection (c) of this section the Secretary shall designate health professional shortage areas in the States, publish a descriptive list of the areas, population groups, medical facilities, and other public facilities so designated, and at least annually review and, as necessary, revise such designations.
(2) For purposes of paragraph (1), a complete descriptive list shall be published in the Federal Register not later than July 1 of 1991 and each subsequent year.
(e) Notice of proposed designation of areas and facilities; time for comment
(1) Prior to the designation of a public facility, including a Federal medical facility, as a health professional shortage area, the Secretary shall give written notice of such proposed designation to the chief administrative officer of such facility and request comments within 30 days with respect to such designation.
(2) Prior to the designation of a health professional shortage area under this section, the Secretary shall, to the extent practicable, give written notice of the proposed designation of such area to appropriate public or private nonprofit entities which are located or have a demonstrated interest in such area and request comments from such entities with respect to the proposed designation of such area.
(f) Notice of designation
The Secretary shall give written notice of the designation of a health professional shortage area, not later than 60 days from the date of such designation, to—
(1) the Governor of each State in which the area, population group, medical facility, or other public facility so designated is in whole or part located; and
(2) appropriate public or nonprofit private entities which are located or which have a demonstrated interest in the area so designated.
(g) Recommendations to Secretary
Any person may recommend to the Secretary the designation of an area, population group, medical facility, or other public facility as a health professional shortage area.
(h) Public information programs in designated areas
The Secretary may conduct such information programs in areas, among population groups, and in medical facilities and other public facilities designated under this section as health professional shortage areas as may be necessary to inform public and nonprofit private entities which are located or have a demonstrated interest in such areas of the assistance available under this subchapter by virtue of the designation of such areas.
(July 1, 1944, ch. 373, title III, §332, as added Oct. 12, 1976,
References in Text
The Indian Self-Determination Act, referred to in subsec. (a)(2)(B), is title I of
The Social Security Act, referred to in subsec. (c)(2), is act Aug. 14, 1935, ch. 531,
Amendments
1990—Subsec. (a)(1).
Subsec. (a)(2)(A).
Subsec. (a)(2)(B).
Subsec. (a)(2)(C).
Subsec. (b).
Subsec. (c).
"(A) The recommendations of each health systems agency (designated under
"(B) The recommendations of the State health planning and development agency (designated under
Subsec. (d).
Subsec. (e).
Subsec. (f).
"(A) each health systems agency (designated under
"(B) the State health planning and development agency of the State (designated under
Subsecs. (g), (h).
1988—Subsec. (a)(3).
1987—Subsec. (a)(1).
Subsec. (a)(3).
Subsec. (b)(2)(D).
1981—Subsec. (a)(1)(A).
Subsec. (a)(2)(C).
Subsec. (e).
Subsec. (h).
1979—Subsec. (a)(2)(C).
1977—Subsec. (c)(3).
Effective Date of 1988 Amendments
Amendment by
Amendment by
Effective Date of 1981 Amendment
Amendment by section 986(b)(4) of
Effective Date of 1977 Amendment
Section 7(e)(1) of
Evaluation of Criteria Used To Designate Health Manpower Shortage Areas; Report to Congress
Section 2702(c) of
Section Referred to in Other Sections
This section is referred to in
§254f. Corps personnel
(a) Conditions necessary for assignment of Corps personnel to area; contents of application for assignment; assignment to particular facility; approval of applications
(1) The Secretary may assign members of the Corps to provide, under regulations promulgated by the Secretary, health services in or to a health professional shortage area during the assignment period (specified in the agreement described in
(A) a public or nonprofit private entity, which is located or has a demonstrated interest in such area makes application to the Secretary for such assignment;
(B) such application has been approved by the Secretary;
(C) an agreement has been entered into between the entity which has applied and the Secretary, in accordance with
(D) the Secretary has (i) conducted an evaluation of the need and demand for health manpower for the area, the intended use of Corps members to be assigned to the area, community support for the assignment of Corps members to the area, the area's efforts to secure health manpower for the area, and the fiscal management capability of the entity to which Corps members would be assigned and (ii) on the basis of such evaluation has determined that—
(I) there is a need and demand for health manpower for the area;
(II) there has been appropriate and efficient use of any Corps members assigned to the entity for the area;
(III) there is general community support for the assignment of Corps members to the entity;
(IV) the area has made unsuccessful efforts to secure health manpower for the area; and
(V) there is a reasonable prospect of sound fiscal management, including efficient collection of fee-for-service, third-party, and other appropriate funds, by the entity with respect to Corps members assigned to such entity.
An application for assignment of a Corps member to a health professional shortage area shall include a demonstration by the applicant that the area or population group to be served by the applicant has a shortage of personal health services and that the Corps member will be located so that the member will provide services to the greatest number of persons residing in such area or included in such population group. Such a demonstration shall be made on the basis of the criteria prescribed by the Secretary under
(2) Corps members may be assigned to a Federal health care facility, but only upon the request of the head of the department or agency of which such facility is a part.
(3) In approving applications for assignment of members of the Corps the Secretary shall not discriminate against applications from entities which are not receiving Federal financial assistance under this chapter.
(b) Corps member income assurances; grants respecting sufficiency of financial resources
(1) The Secretary may not approve an application for the assignment of a member of the Corps described in subparagraph (C) of
(2)(A) If in approving an application of an entity for the assignment of a member of the Corps described in subparagraph (C) of
(B) The amount of any grant under subparagraph (A) shall be determined by the Secretary. Payments under such a grant may be made in advance or by way of reimbursement, and at such intervals and on such conditions, as the Secretary finds necessary. No grant may be made unless an application therefor is submitted to and approved by the Secretary. Such an application shall be in such form, submitted in such manner, and contain such information, as the Secretary shall by regulation prescribe.
(c) Assignment of members without regard to ability of area to pay for services
The Secretary shall assign Corps members to entities in health professional shortage areas without regard to the ability of the individuals in such areas, population groups, medical facilities, or other public facilities to pay for such services.
(d) Entities entitled to aid; forms of assistance; coordination of efforts; agreements for assignment of Corps members; qualified entity
(1) The Secretary may provide technical assistance to a public or nonprofit private entity which is located in a health professional shortage area and which desires to make an application under this section for assignment of a Corps member to such area. Assistance provided under this paragraph may include assistance to an entity in (A) analyzing the potential use of health professions personnel in defined health services delivery areas by the residents of such areas, (B) determining the need for such personnel in such areas, (C) determining the extent to which such areas will have a financial base to support the practice of such personnel and the extent to which additional financial resources are needed to adequately support the practice, and (D) determining the types of inpatient and other health services that should be provided by such personnel in such areas.
(2) The Secretary may provide, to public and nonprofit private entities which are located in a health professional shortage area to which area a Corps member has been assigned, technical assistance to assist in the retention of such member in such area after the completion of such member's assignment to the area.
(3) The Secretary may provide, to health professional shortage areas to which no Corps member has been assigned, (A) technical assistance to assist in the recruitment of health manpower for such areas, and (B) current information on public and private programs which provide assistance in the securing of health manpower.
(4)(A) The Secretary shall undertake to demonstrate the improvements that can be made in the assignment of members of the Corps to health professional shortage areas and in the delivery of health care by Corps members in such areas through coordination with States, political subdivisions of States, agencies of States and political subdivisions, and other public and nonprofit private entities which have expertise in the planning, development, and operation of centers for the delivery of primary health care. In carrying out this subparagraph, the Secretary shall enter into agreements with qualified entities which provide that if—
(i) the entity places in effect a program for the planning, development, and operation of centers for the delivery of primary health care in health professional shortage areas which reasonably addresses the need for such care in such areas, and
(ii) under the program the entity will perform the functions described in subparagraph (B),
the Secretary will assign under this section members of the Corps in accordance with the program.
(B) For purposes of subparagraph (A), the term "qualified entity" means a State, political subdivision of a State, an agency of a State or political subdivision, or other public or nonprofit private entity operating solely within one State, which the Secretary determines is able—
(i) to analyze the potential use of health professions personnel in defined health services delivery areas by the residents of such areas;
(ii) to determine the need for such personnel in such areas and to recruit, select, and retain health professions personnel (including members of the National Health Service Corps) to meet such need;
(iii) to determine the extent to which such areas will have a financial base to support the practice of such personnel and the extent to which additional financial resources are needed to adequately support the practice;
(iv) to determine the types of inpatient and other health services that should be provided by such personnel in such areas;
(v) to assist such personnel in the development of their clinical practice and fee schedules and in the management of their practice;
(vi) to assist in the planning and development of facilities for the delivery of primary health care; and
(vii) to assist in establishing the governing bodies of centers for the delivery of such care and to assist such bodies in defining and carrying out their responsibilities.
(e) Practice within State by Corps member
Notwithstanding any other law, any member of the Corps licensed to practice medicine, osteopathic medicine, dentistry, or any other health profession in any State shall, while serving in the Corps, be allowed to practice such profession in any State.
(July 1, 1944, ch. 373, title III, §333, as added Oct. 12, 1976,
Amendments
1990—Subsec. (a)(1).
Subsec. (a)(1)(D)(ii)(II).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
Subsecs. (j), (k).
1988—Subsec. (i).
1987—Subsec. (j).
Subsec. (k).
1981—Subsec. (a).
Subsec. (c).
Subsecs. (d) to (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
Effective Date of 1981 Amendment
Section 2703(d) of
Section Referred to in Other Sections
This section is referred to in
§254f–1. Priorities in assignment of Corps personnel
(a) In general
In approving applications made under
(1) give priority to any such application that—
(A) is made regarding the provision of primary health services to a health professional shortage area with the greatest such shortage, as determined in accordance with subsection (b) of this section; and
(B) is made by an entity that—
(i) serves a health professional shortage area described in subparagraph (A);
(ii) coordinates the delivery of primary health services with related health and social services;
(iii) has a documented record of sound fiscal management; and
(iv) will experience a negative impact on its capacity to provide primary health services if a Corps member is not assigned to the entity;
(2) with respect to the geographic area in which the health professional shortage area is located, take into consideration the willingness of individuals in the geographic area, and of the appropriate governmental agencies or health entities in the area, to assist and cooperate with the Corps in providing effective primary health services; and
(3) take into consideration comments of medical, osteopathic, dental, or other health professional societies whose members deliver services to the health professional shortage area, or if no such societies exist, comments of physicians, dentists, or other health professionals delivering services to the area.
(b) Exclusive factors for determining greatest shortages
In making a determination under subsection (a)(1)(A) of this section of the health professional shortage areas with the greatest such shortages, the Secretary may consider only the following factors:
(1) The ratio of available health manpower to the number of individuals in the area or population group involved, or served by the medical facility or other public facility involved.
(2) Indicators of need as follows:
(A) The rate of low birthweight births.
(B) The rate of infant mortality.
(C) The rate of poverty.
(D) Access to primary health services, taking into account the distance to such services.
(c) Establishment of criteria for determining priorities
(1) In general
The Secretary shall establish criteria specifying the manner in which the Secretary makes a determination under subsection (a)(1)(A) of this section of the health professional shortage areas with the greatest such shortages. Such criteria shall specify the manner in which the factors described in subsection (b) of this section are implemented regarding such a determination.
(2) Publication of criteria
The criteria required in paragraph (1) shall be published in the Federal Register not later than July 1, 1991. Any revisions made in the criteria by the Secretary shall be effective upon publication in the Federal Register.
(d) Notifications regarding priorities
(1) Preparation of list for applicable period
For the purpose of carrying out paragraph (2), the Secretary shall prepare a list of health professional shortage areas that are receiving priority under subsection (a)(1) of this section in the assignment of Corps members for the period applicable under subsection (f) of this section. Such list—
(A) shall include a specification, for each such health professional shortage area, of the entities for which the Secretary has provided an authorization to receive assignments of Corps members in the event that Corps members are available for the assignments; and
(B) shall, of the entities for which an authorization described in subparagraph (A) has been provided, specify—
(i) the entities provided such an authorization for the assignment of Corps members who are participating in the Scholarship Program;
(ii) the entities provided such an authorization for the assignment of Corps members who are participating in the Loan Repayment Program; and
(iii) the entities provided such an authorization for the assignment of Corps members who have become Corps members other than pursuant to contractual obligations under the Scholarship or Loan Repayment Programs.
The Secretary may set forth such specifications by medical specialty.
(2) Notification of affected parties
(A) Not later than 30 days after the preparation of each list under paragraph (1), the Secretary shall notify entities specified for purposes of subparagraph (A) of such paragraph of the fact that the entities have been provided an authorization to receive assignments of Corps members in the event that Corps members are available for the assignments.
(B) In the case of individuals with respect to whom a period of obligated service under the Scholarship Program will begin during the period under subsection (f) of this section for which a list under paragraph (1) is prepared, the Secretary shall, not later than 30 days after the preparation of each such list, provide to such individuals the names of each of the entities specified for purposes of paragraph (1)(B)(i) that is appropriate to the medical specialty of the individuals.
(3) Revisions in list
If the Secretary makes a revision in a list under paragraph (1) during the period under subsection (f) of this section to which the list is applicable, and the revision alters the status of an entity with respect to the list, the Secretary shall notify the entity of the effect on the entity of the revision. Such notification shall be provided not later than 30 days after the date on which the revision is made.
(e) Limitation on number of entities offered as assignment choices in Scholarship Program
(1) Determination of available Corps members
The Secretary shall determine the number of participants in the Scholarship Program who are available for assignments under
(2) Availability of 500 or fewer members
If the number of participants for purposes of paragraph (1) is less than 500, the Secretary shall limit the number of entities specified under subsection (d)(1)(B)(i) of this section to the lesser of—
(A) 500 such entities; and
(B) a number of such entities constituting 300 percent of the number of such participants available for assignment under
(3) Availability of more than 500 members
If the number of participants for purposes of paragraph (1) is equal to or greater than 500, the Secretary shall determine the number of entities to be specified under subsection (d)(1)(B)(i) of this section, subject to ensuring that assignments of such participants are made to 500 entities that serve health professional shortage areas that have chronic difficulty in recruiting and retaining health professionals to provide primary health services.
(4) Adjustment in base number
The number 500, as used for purposes of paragraphs (2) and (3), may by regulation be adjusted by the Secretary to a greater or a lesser number.
(f) Applicable period regarding priorities
(1) In general
With respect to determinations under subsection (a)(1) of this section of the applications that are to be given priority regarding the assignment of Corps members, the Secretary shall make such a determination not less than once each fiscal year. The first determination shall be made not later than July 1 of the year preceding the year in which the period of obligated service begins. If the Secretary revises the determination before July 1 of the following year, the revised determination shall be applicable with respect to assignments of Corps members made during the period beginning on the date of the issuance of the revised determination and ending on July 1 of such year.
(2) Date certain for preparation of notification list
A list under subsection (d)(1) of this section shall be prepared for each of the periods decribed 1 in paragraph (1). Each such list shall be prepared not later than the date on which a determination of priorities under such paragraph is required to be made for the period involved.
(July 1, 1944, ch. 373, title III, §333A, as added and amended Nov. 16, 1990,
Amendments
1990—
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "described".
§254g. Cost sharing
(a) Charges for services; collection of payments; payment to United States; calculation of payments; annual report
The Secretary shall require, as a condition to the approval of an application under
(1) the entity shall be responsible for charging, in accordance with subsection (d) of this section, for health services provided by Corps members assigned to the entity;
(2) the entity shall take such action as may be reasonable for the collection of payments for such health services, including, if a Federal agency, an agency of a State or local government, or other third party would be responsible for all or part of the cost of such health services if it had not been provided by Corps members under this subpart, the collection, on a fee-for-service or other basis, from such agency or third party, the portion of such cost for which it would be so responsible (and in determining the amount of such cost which such agency or third party would be responsible, the health services provided by Corps members shall be considered as being provided by private practitioners);
(3) the entity, if not a small health center, shall pay to the United States, as prescribed by the Secretary in each calendar quarter (or other period as may be specified in the agreement) during which any Corps member is assigned to such entity, the sum of—
(A) an amount calculated by the Secretary to reflect the average salary (including amounts paid in accordance with
(B) that portion of an amount calculated by the Secretary to reflect the average amount paid under the Scholarship Program or the Loan Repayment Program to or on behalf of comparable Corps members that bears the same ratio to the calculated amount as the number of days of service provided by the member during that quarter (or other period) bears to the number of days in his period of obligated service under the Scholarship Program or the Loan Repayment Program; and
(C) if such entity received a loan under
(4) the entity, if a small health center, shall pay to the United States, in each calendar quarter (or other period as may be specified in the agreement) during which any Corps member is assigned to such entity, an amount determined by the Secretary in accordance with subsection (f) of this section; and
(5) the entity shall prepare and submit to the Secretary an annual report, in such form and manner, as the Secretary may require.
(b) Waiver of payment; use of funds
(1) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of the requirement of subsection (a)(3) of this section for an entity which is not a small health center if he determines that the entity is financially unable to meet such requirement or if he determines that compliance with such requirement would unreasonably limit the ability of the entity to provide for the adequate support of the provision of health services by Corps members.
(2) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of the requirement of subsection (a)(3) of this section for any entity which is not a small health center and which is located in a health professional shortage area in which a significant percentage of the individuals are elderly, living in poverty, or have other characteristics which indicate an inability to repay, in whole or in part, the amounts required in subsection (a)(3) of this section.
(3) In the event that the Secretary grants a waiver under paragraph (1) or (2), and does not, pursuant to paragraph (5), require payment by the entity in the amount described in subsection (f)(1) of this section, the entity shall be required to use the total amount of funds collected by such entity in accordance with subsection (a)(2) of this section for the improvement of the capability of such entity to deliver health services to the individuals in, or served by, the health professional shortage area.
(4) In determining whether to grant a waiver under paragraph (1) or (2), the Secretary shall not discriminate against a public entity.
(5)(A) If the Secretary determines that an entity which is not a small health center is eligible for a waiver under paragraph (1) or (2), the Secretary may waive the application of subsection (a)(3) of this section for such entity and require such entity to make payment in an amount equal to the amount described in subsection (f)(1) of this section that would be payable by such entity if such entity were a small health center.
(B) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of the requirement of subparagraph (A) for any entity if the Secretary determines that the entity is financially unable to meet such requirement or that compliance with such requirement would unreasonably limit the ability of the entity to provide for the adequate support of the provision of health services by Corps members. Funds which would be paid to the United States but for a waiver under this subparagraph shall be used by an entity to—
(i) expand or improve its provision of health services;
(ii) increase the number of individuals served;
(iii) renovate or modernize facilities for its provision of health services;
(iv) improve the administration of its health service programs; or
(v) to establish a financial reserve to assure its ability to continue providing health services.
(c) Excess funds
The excess (if any) of the amount of funds collected by an entity which is not a small health center in accordance with subsection (a)(2) of this section over the amount paid to the United States in accordance with subsection (a)(3) of this section or subsection (b)(5)(A) of this section shall be used by the entity to expand and improve the provision of health services to the individuals in the health professional shortage area for which the entity submitted an application or to recruit and retain health manpower to provide health services for such individuals.
(d) Charge for services; reduced rate; no charge
Any person who receives health services provided by a Corps member under this subpart shall be charged for such services on a fee-for-service or other basis, at a rate approved by the Secretary, pursuant to regulations. Such rate shall be computed in such a way as to permit the recovery of the value of such services, except that if such person is determined under regulations of the Secretary to be unable to pay such charge, the Secretary shall provide for the furnishing of such services at a reduced rate or without charge.
(e) Deposit of funds in Treasury as miscellaneous receipts; appropriations unaffected
Funds received by the Secretary under an agreement entered into under this section shall be deposited in the Treasury as miscellaneous receipts and shall be disregarded in determining the amounts of appropriations to be requested and the amounts to be made available from appropriations made under
(f) Small health centers
(1) An entity which is a small health center shall pay to the United States, as prescribed by the Secretary in each calendar quarter (or other period as may be specified in the agreement) during which any Corps member is assigned to such entity, an amount equal to the amount (prorated for a calendar quarter or other period) by which the revenues that the center may reasonably expect to receive during an annual period for the provision of health services exceeds the costs that the center may reasonably expect to incur in the provision of such services, except that the amount that an entity shall pay to the United States under this paragraph shall not exceed the amount such entity would pay to the United States under paragraph (3) of subsection (a) of this section if such paragraph applied to such entity.
(2)(A) To determine for purposes of paragraph (1) the revenues and costs which an entity that is a small health center may reasonably be expected to receive and incur in an annual period for the provision of health services, the entity shall submit to the Secretary before the beginning of such period a proposed budget which—
(i) describes the primary and supplemental health services (as defined in
(ii) states the revenues and costs which the entity expects to receive and incur in providing such health services in such period.
(B) From the submission under subparagraph (A) and other information available to the Secretary, the Secretary shall determine—
(i) the primary and supplemental health services (as defined in
(ii) the fees, premiums, third party reimbursements, and other revenues the entity making the submission may reasonably expect to receive from the provision of such services; and
(iii) the costs which the entity may reasonably expect to incur in providing such services.
The revenues and costs determined by the Secretary shall be the revenues and costs used in making the determination under paragraph (1).
(C)(i) A determination under subparagraph (B) regarding the revenues and costs of an entity in an annual period shall be made by the Secretary utilizing criteria specific to the entity and shall be made without regard to whether the entity is making progress toward collecting sufficient revenues to provide an adequate level of primary health services without the assignment of Corps members.
(ii) In making a determination referred to in clause (i)—
(I) the Secretary may consider whether the proposed budget submitted under subparagraph (A) provides a reasonable estimate regarding the revenues and costs of the entity; and
(II) may not consider the reasonableness of the amount of revenues collected, or the amount of costs incurred by the entity, except to the extent necessary to ensure that the entity is operating in good faith and is operating efficiently with respect to fiscal matters within the control of the entity.
(iii) A determination of whether an entity is eligible for a waiver under paragraph (3) shall be made by the Secretary without regard to the revenues and costs determined by the Secretary under subparagraph (B).
(iv) A determination of whether an entity is a small health center shall be made by the Secretary without regard to the revenues and costs determined by the Secretary under subparagraph (B).
(3) The Secretary may waive in whole or in part, on a prospective or retrospective basis, the application of paragraph (1) for an entity which is a small health center if the Secretary determines that the entity needs all or part of the amounts otherwise payable under such paragraph to—
(A) expand or improve its provision of health services;
(B) increase the number of individuals served;
(C) renovate or modernize facilities for its provision of health services;
(D) improve the administration of its health service programs; or
(E) establish a financial reserve to assure its ability to continue providing health services.
(4) The excess (if any) of the amount of funds collected by an entity which is a small health center in accordance with subsection (a)(2) of this section over the amount paid to the United States in accordance with paragraph (1) of this subsection shall be used by the center for the purposes set out in subparagraphs (A) through (E) of paragraph (3) of this subsection or to recruit and retain health manpower to provide health services to the individuals in the health professional shortage area for which the entity submitted an application.
(5) For purposes of this section, the term "small health center" means an entity other than—
(A) a hospital (or part of a hospital);
(B) a public entity; or
(C) an entity that is receiving a grant under
(July 1, 1944, ch. 373, title III, §334, as added Oct. 12, 1976,
References in Text
Amendments
1990—Subsecs. (b)(2), (3), (c).
Subsec. (f)(2)(C).
Subsec. (f)(4).
1987—Subsec. (a)(3)(B).
1983—Subsec. (a)(3).
Subsec. (a)(4), (5).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (b)(5).
Subsec. (c).
Subsec. (f).
1981—Subsec. (a).
Subsec. (b)(4).
Subsec. (e).
Effective Date of 1983 Amendment
Section 4 of
Congressional Findings
Section 2 of
"(1) rural health clinics are an important part of America's health care delivery system;
"(2) National Health Service Corps personnel assigned to rural health clinics located in health manpower shortage areas have provided valuable and needed staffing help for such clinics;
"(3) rural health clinics receiving assistance from National Health Service Corps personnel should be expected to reimburse the Federal Government for a reasonable share of the costs of such personnel; and
"(4) the criteria which should be applied to reimbursement by such clinics for use of such personnel should be a fair and equitable one which reflects the needs of such clinics and the populations served by such clinics, as well as the value of the services rendered by such personnel."
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254h. Provision of health services by Corps members
(a) Means of delivery of services; cooperation with other health care providers
In providing health services in a health professional shortage area, Corps members shall utilize the techniques, facilities, and organizational forms most appropriate for the area, population group, medical facility, or other public facility, and shall, to the maximum extent feasible, provide such services (1) to all individuals in, or served by, such health professional shortage area regardless of their ability to pay for the services, and (2) in a manner which is cooperative with other health care providers serving such health professional shortage area.
(b) Utilization of existing health facilities; lease, acquisition, and use of equipment and supplies; permanent and temporary professional services
(1) Notwithstanding any other provision of law, the Secretary may (A) to the maximum extent feasible make such arrangements as he determines necessary to enable Corps members to utilize the health facilities in or serving the health professional shortage area in providing health services; (B) make such arrangements as he determines are necessary for the use of equipment and supplies of the Service and for the lease or acquisition of other equipment and supplies; and (C) secure the permanent or temporary services of physicians, dentists, nurses, administrators, and other health personnel. If there are no health facilities in or serving such area, the Secretary may arrange to have Corps members provide health services in the nearest health facilities of the Service or may lease or otherwise provide facilities in or serving such area for the provision of health services.
(2) If the individuals in or served by a health professional shortage area are being served (as determined under regulations of the Secretary) by a hospital or other health care delivery facility of the Service, the Secretary may, in addition to such other arrangements as he may make under paragraph (1), arrange for the utilization of such hospital or facility by Corps members in providing health services, but only to the extent that such utilization will not impair the delivery of health services and treatment through such hospital or facility to individuals who are entitled to health services and treatment through such hospital or facility.
(c) Loan; purposes; limitations
The Secretary may make one loan to any entity with an approved application under
(d) Property and equipment disposal; fair market value; sale at less than full market value
Upon the expiration of the assignment of all Corps members to a health professional shortage area, the Secretary may (notwithstanding any other provision of law) sell, to any appropriate local entity, equipment and other property of the United States utilized by such members in providing health services. Sales made under this subsection shall be made at the fair market value (as determined by the Secretary) of the equipment or such other property; except that the Secretary may make such sales for a lesser value to an appropriate local entity, if he determines that the entity is financially unable to pay the full market value.
(e) Admitting privileges denied to Corps member by hospital; notice and hearing; denial of Federal funds for violation; "hospital" defined
(1)(A) It shall be unlawful for any hospital to deny an authorized Corps member admitting privileges when such Corps member otherwise meets the professional qualifications established by the hospital for granting such privileges and agrees to abide by the published bylaws of the hospital and the published bylaws, rules, and regulations of its medical staff.
(B) Any hospital which is found by the Secretary, after notice and an opportunity for a hearing on the record, to have violated this subsection shall upon such finding cease, for a period to be determined by the Secretary, to receive and to be eligible to receive any Federal funds under this chapter or under titles XVIII or XIX of the Social Security Act [
(2) For purposes of this subsection, the term "hospital" includes a State or local public hospital, a private profit hospital, a private nonprofit hospital, a general or special hospital, and any other type of hospital (excluding a hospital owned or operated by an agency of the Federal Government), and any related facilities.
(July 1, 1944, ch. 373, title III, §335, as added Oct. 12, 1976,
References in Text
The Social Security Act, referred to in subsec. (e)(1)(B), is act Aug. 14, 1935, ch. 531,
Amendments
1990—Subsecs. (a), (b)(1)(A), (2), (d).
Subsec. (e)(1)(A).
1981—Subsec. (a)(2).
Subsec. (c)(4).
Section Referred to in Other Sections
This section is referred to in
§254h–1. Facilitation of effective provision of Corps services
(a) Consideration of individual characteristics of members in making assignments
In making an assignment of a Corps member to an entity that has had an application approved under
(b) Counseling on service in Corps
(1) In general
The Secretary shall, subject to paragraph (3), offer appropriate counseling on service in the Corps to individuals during the period of membership in the Corps, particularly during the initial period of each assignment.
(2) Career advisor regarding obligated service
(A) In the case of individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, counseling under paragraph (1) shall include appropriate counseling on matters particular to such obligated service. The Secretary shall ensure that career advisors for providing such counseling are available to such individuals throughout the period of participation in the Scholarship or Loan Repayment Program.
(B) With respect to the Scholarship Program, counseling under paragraph (1) shall include counseling individuals during the period in which the individuals are pursuing an educational degree in the health profession involved, including counseling to prepare the individual for service in the Corps.
(3) Extent of counseling services
With respect to individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, this subsection shall be carried out regarding such individuals throughout the period of obligated service (and, additionally, throughout the period specified in paragraph (2)(B), in the case of the Scholarship Program). With respect to Corps members generally, this subsection shall be carried out to the extent practicable.
(c) Grants regarding preparation of students for practice
With respect to individuals who have entered into contracts for obligated service under the Scholarship or Loan Repayment Program, the Secretary may make grants to, and enter into contracts with, public and nonprofit private entities (including health professions schools) for the conduct of programs designed to prepare such individuals for the effective provision of primary health services in the health manpower shortage areas to which the individuals are assigned.
(d) Assistance in establishing local professional relationships
The Secretary shall assist Corps members in establishing appropriate professional relationships between the Corps member involved and the health professions community of the geographic area with respect to which the member is assigned, including such relationships with hospitals, with health professions schools, with area health education centers under section 295g–1 1 of this title, with health education and training centers under such section, and with border health education and training centers under such section. Such assistance shall include assistance in obtaining faculty appointments at health professions schools.
(e) Temporary relief from Corps duties
(1) In general
The Secretary shall, subject to paragraph (4), provide assistance to Corps members in establishing arrangements through which Corps members may, as appropriate, be provided temporary relief from duties in the Corps in order to pursue continuing education in the health professions, to participate in exchange programs with teaching centers, to attend professional conferences, or to pursue other interests, including vacations.
(2) Assumption of duties of member
(A) Temporary relief under paragraph (1) may be provided only if the duties of the Corps member involved are assumed by another health professional. With respect to such temporary relief, the duties may be assumed by Corps members or by health professionals who are not Corps members, if the Secretary approves the professionals for such purpose. Any health professional so approved by the Secretary shall, during the period of providing such temporary relief, be deemed to be a Corps member for purposes of
(B) In carrying out paragraph (1), the Secretary shall provide for the formation and continued existence of a group of health professionals to provide temporary relief under such paragraph.
(3) Recruitment from general health professions community
In carrying out paragraph (1), the Secretary shall—
(A) encourage health professionals who are not Corps members to enter into arrangements under which the health professionals temporarily assume the duties of Corps members for purposes of paragraph (1); and
(B) with respect to the entities to which Corps members have been assigned under
(4) Limitation
In carrying out paragraph (1), the Secretary may not, except as provided in paragraph (5), obligate any amounts (other than for incidental expenses) for the purpose of—
(A) compensating a health professional who is not a Corps member for assuming the duties of a Corps member; or
(B) paying the costs of a vacation, or other interests that a Corps member may pursue during the period of temporary relief under such paragraph.
(5) Sole providers of health services
In the case of any Corps member who is the sole provider of health services in the geographic area involved, the Secretary may, from amounts appropriated under
(f) Determinations regarding effective service
In carrying out subsection (a) of this section and
(1) the characteristics of physicians, dentists, and other health professionals who are more likely to remain in practice in health manpower shortage areas after the completion of the period of service in the Corps;
(2) the characteristics of health manpower shortage areas, and of entities seeking assignments of Corps members, that are more likely to retain Corps members after the members have completed the period of service in the Corps; and
(3) the appropriate conditions for the assignment and utilization in health manpower shortage areas of certified nurse practitioners, certified nurse midwives, and physician assistants.
(July 1, 1944, ch. 373, title III, §336, as added Aug. 13, 1981,
References in Text
Prior Provisions
A prior section 336 of act July 1, 1944, was renumbered section 336A by
Amendments
1990—
"(a) The Secretary may make grants to and enter into contracts with public and private nonprofit entities for the conduct of programs which are designed to prepare individuals subject to a service obligation under the National Health Service Corps Scholarship Program or Loan Repayment Program to effectively provide health services in the health manpower shortage area to which they are assigned.
"(b) No grant may be made or contract entered into under subsection (a) of this section unless an application therefor is submitted to and approved by the Secretary. Such an application shall be in such form, submitted in such manner, and contain such information, as the Secretary shall by regulation prescribe."
Subsec. (a).
1987—Subsec. (a).
1 See References in Text note below.
§254i. Annual report to Congress; contents
The Secretary shall submit an annual report to Congress, and shall include in such report with respect to the previous calendar year—
(1) the number, identity, and priority of all health professional shortage areas designated in such year and the number of health professional shortage areas which the Secretary estimates will be designated in the subsequent year;
(2) the number of applications filed under
(3) the number and types of Corps members assigned in such year to health professional shortage areas, the number and types of additional Corps members which the Secretary estimates will be assigned to such areas in the subsequent year, and the need for additional members for the Corps;
(4) the recruitment efforts engaged in for the Corps in such year and the number of qualified individuals who applied for service in the Corps in such year;
(5) the number of patients seen and the number of patient visits recorded during such year with respect to each health professional shortage area to which a Corps member was assigned during such year;
(6) the number of Corps members who elected, and the number of Corps members who did not elect, to continue to provide health services in health professional shortage areas after termination of their service in the Corps and the reasons (as reported to the Secretary) of members who did not elect for not making such election;
(7) the results of evaluations and determinations made under
(8) the amount charged during such year for health services provided by Corps members, the amount which was collected in such year by entities in accordance with agreements under
(July 1, 1944, ch. 373, title III, §336A, formerly §336, as added Oct. 12, 1976,
Amendments
1990—Pars. (1), (3), (5), (6).
1982—
Section Referred to in Other Sections
This section is referred to in
§254j. National Advisory Council on National Health Service Corps
(a) Establishment; appointment of members
There is established a council to be known as the National Advisory Council on the National Health Service Corps (hereinafter in this section referred to as the "Council"). The Council shall be composed of not more than 15 members appointed by the Secretary. The Council shall consult with, advise, and make recommendations to, the Secretary with respect to his responsibilities in carrying out this subpart (other than section 254r 1 of this title), and shall review and comment upon regulations promulgated by the Secretary under this subpart.
(b) Term of members; compensation; expenses
(1) Members of the Council shall be appointed for a term of three years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed for the remainder of such term. No member shall be removed, except for cause. Members may not be reappointed to the Council.
(2) Members of the Council (other than members who are officers or employees of the United States), while attending meetings or conferences thereof or otherwise serving on the business of the Council, shall be entitled to receive for each day (including traveltime) in which they are so serving compensation at a rate fixed by the Secretary (but not to exceed the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule); and while so serving away from their homes or regular places of business all members may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by
(c) Termination
Section 14 of the Federal Advisory Committee Act shall not apply with respect to the Council.
(July 1, 1944, ch. 373, title III, §337, as added Oct. 12, 1976,
References in Text
Section 14 of the Federal Advisory Committee Act, referred to in subsec. (c), is section 14 of
Amendments
1993—Subsec. (b)(2).
1983—Subsec. (a).
1981—Subsec. (a).
Subsec. (b)(1).
1979—Subsec. (b)(2).
Termination of Advisory Committees
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254k. Authorization of appropriations
(a)(1) For the purpose of carrying out this subpart, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 2000.
(2) In the case of individuals who serve in the Corps other than pursuant to obligated service under the Scholarship or Loan Repayment Program, the Secretary each fiscal year shall, to the extent practicable, make assignments under
(b) An appropriation under an authorization under subsection (a) of this section for any fiscal year may be made at any time before that fiscal year and may be included in an Act making an appropriation under an authorization under subsection (a) of this section for another fiscal year; but no funds may be made available from any appropriation under such authorization for obligation under sections 254d through 254h, section 254i, and
(July 1, 1944, ch. 373, title III, §338, as added Oct. 12, 1976,
Amendments
1990—Subsec. (a).
1987—Subsec. (a).
1981—Subsec. (a).
Subsec. (b).
1979—Subsec. (a).
1978—Subsec. (a).
Section Referred to in Other Sections
This section is referred to in
subpart iii—scholarship program and loan repayment program
Amendments
1987—
Subpart Referred to in Other Sections
This subpart is referred to in
§254l. National Health Service Corps Scholarship Program
(a) Establishment
The Secretary shall establish the National Health Service Corps Scholarship Program to assure, with respect to the provision of primary health services pursuant to
(1) an adequate supply of physicians, dentists, certified nurse midwives, certified nurse practitioners, and physician assistants; and
(2) if needed by the Corps, an adequate supply of other health professionals.
(b) Eligibility; application; written contract
To be eligible to participate in the Scholarship Program, an individual must—
(1) be accepted for enrollment, or be enrolled, as a full-time student (A) in an accredited (as determined by the Secretary) educational institution in a State and (B) in a course of study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession;
(2) be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps;
(3) submit an application to participate in the Scholarship Program; and
(4) sign and submit to the Secretary, at the time of submittal of such application, a written contract (described in subsection (f) of this section) to accept payment of a scholarship and to serve (in accordance with this subpart) for the applicable period of obligated service in a health professional shortage area.
(c) Review and evaluation of information and forms by prospective applicant
(1) In disseminating application forms and contract forms to individuals desiring to participate in the Scholarship Program, the Secretary shall include with such forms—
(A) a fair summary of the rights and liabilities of an individual whose application is approved (and whose contract is accepted) by the Secretary, including in the summary a clear explanation of the damages to which the United States is entitled under section 254o 1 of this title in the case of the individual's breach of the contract; and
(B) information respecting meeting a service obligation through private practice under an agreement under section 254n 1 of this title and such other information as may be necessary for the individual to understand the individual's prospective participation in the Scholarship Program and service in the Corps, including a statement of all factors considered in approving applications for participation in the Program and in making assignments for participants in the Program.
(2) The application form, contract form, and all other information furnished by the Secretary under this subpart shall be written in a manner calculated to be understood by the average individual applying to participate in the Scholarship Program. The Secretary shall make such application forms, contract forms, and other information available to individuals desiring to participate in the Scholarship Program on a date sufficiently early to insure that such individuals have adequate time to carefully review and evaluate such forms and information.
(3)(A) The Secretary shall distribute to health professions schools materials providing information on the Scholarship Program and shall encourage the schools to disseminate the materials to the students of the schools.
(B)(i) In the case of any health professional whose period of obligated service under the Scholarship Program is nearing completion, the Secretary shall encourage the individual to remain in a health professional shortage area and to continue providing primary health services.
(ii) During the period in which a health professional is planning and making the transition to private practice from obligated service under the Scholarship Program, the Secretary may provide assistance to the professional regarding such transition if the professional is remaining in a health professional shortage area and is continuing to provide primary health services.
(C) In the case of entities to which participants in the Scholarship Program are assigned under
(d) Factors considered in providing contracts; priorities
(1) Subject to
(A) the Secretary shall consider the extent of the demonstrated interest of the applicants for the contracts in providing primary health services; and
(B) may consider such other factors regarding the applicants as the Secretary determines to be relevant to selecting qualified individuals to participate in such Program.
(2) In providing contracts under the Scholarship Program, the Secretary shall give priority—
(A) first, to any application for such a contract submitted by an individual who has previously received a scholarship under this section or under section 294z 1 of this title;
(B) second, to any application for such a contract submitted by an individual who has characteristics that increase the probability that the individual will continue to serve in a health professional shortage area after the period of obligated service pursuant to subsection (f) of this section is completed; and
(C) third, subject to subparagraph (B), to any application for such a contract submitted by an individual who is from a disadvantaged background.
(e) Commencement of participation in Scholarship Program; notice
(1) An individual becomes a participant in the Scholarship Program only upon the Secretary's approval of the individual's application submitted under subsection (b)(3) of this section and the Secretary's acceptance of the contract submitted by the individual under subsection (b)(4) of this section.
(2) The Secretary shall provide written notice to an individual promptly upon the Secretary's approving, under paragraph (1), of the individual's participation in the Scholarship Program.
(f) Written contract; contents
The written contract (referred to in this subpart) between the Secretary and an individual shall contain—
(1) an agreement that—
(A) subject to paragraph (2), the Secretary agrees (i) to provide the individual with a scholarship (described in subsection (g) of this section) in each such school year or years for a period of years (not to exceed four school years) determined by the individual, during which period the individual is pursuing a course of study described in subsection (b)(1)(B) of this section, and (ii) to accept (subject to the availability of appropriated funds for carrying out sections 254d through 254h and
(B) subject to paragraph (2), the individual agrees—
(i) to accept provision of such a scholarship to the individual;
(ii) to maintain enrollment in a course of study described in subsection (b)(1)(B) of this section until the individual completes the course of study;
(iii) while enrolled in such course of study, to maintain an acceptable level of academic standing (as determined under regulations of the Secretary by the educational institution offering such course of study); and
(iv) to serve for a time period (hereinafter in the subpart referred to as the "period of obligated service") equal to—
(I) one year for each school year for which the individual was provided a scholarship under the Scholarship Program, or
(II) two years,
whichever is greater, as a provider of primary health services in a health professional shortage area (designated under
(2) a provision that any financial obligation of the United States arising out of a contract entered into under this subpart and any obligation of the individual which is conditioned thereon, is contingent upon funds being appropriated for scholarships under this subpart and to carry out the purposes of sections 254d through 254h and
(3) a statement of the damages to which the United States is entitled, under section 254o 2 of this title, for the individual's breach of the contract; and
(4) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with the provisions of this subpart.
(g) Scholarship provisions; contract with educational institution; increase in monthly stipend
(1) A scholarship provided to a student for a school year under a written contract under the Scholarship Program shall consist of—
(A) payment to, or (in accordance with paragraph (2)) on behalf of, the student of the amount (except as provided in section 292k 2 of this title) of—
(i) the tuition of the student in such school year; and
(ii) all other reasonable educational expenses, including fees, books, and laboratory expenses, incurred by the student in such school year; and
(B) payment to the student of a stipend of $400 per month (adjusted in accordance with paragraph (3)) for each of the 12 consecutive months beginning with the first month of such school year.
(2) The Secretary may contract with an educational institution, in which a participant in the Scholarship Program is enrolled, for the payment to the educational institution of the amounts of tuition and other reasonable educational expenses described in paragraph (1)(A). Payment to such an educational institution may be made without regard to section 3324(a) and (b) of title 31.
(3) The amount of the monthly stipend, specified in paragraph (1)(B) and as previously adjusted (if at all) in accordance with this paragraph, shall be increased by the Secretary for each school year ending in a fiscal year beginning after September 30, 1978, by an amount (rounded to the next highest multiple of $1) equal to the amount of such stipend multiplied by the overall percentage (under
(h) Employment ceiling of Department unaffected
Notwithstanding any other provision of law, individuals who have entered into written contracts with the Secretary under this section, while undergoing academic training, shall not be counted against any employment ceiling affecting the Department.
(i) Annual report to Congress; contents
Not later than March 1 of each year, the Secretary shall submit to the Congress a report providing, with respect to the preceding fiscal year—
(1) the number, and type of health profession training, of students receiving scholarships under the Scholarship Program;
(2) the educational institutions at which such students are receiving their training;
(3) the number of applications filed under this section in the school year beginning in such year and in prior school years;
(4) the amount of scholarship payments made for each of tuition, stipends, and other expenses, in the aggregate and at each educational institution for the school year beginning in such year and for prior school years;
(5)(A) the number, and type of health professions training, of individuals who have breached the contract under subsection (f) of this section through any of the actions specified in subsection (a) or (b) of
(B) with respect to such individuals—
(i) the educational institutions with respect to which payments have been made or were to be made under the contract;
(ii) the amounts for which the individuals are liable to the United States under
(iii) the extent of payment by the individuals of such amounts; and
(iv) if known, the basis for the decision of the individuals to breach the contract under subsection (f) of this section; and
(6) the effectiveness of the Secretary in recruiting health professionals to participate in the Scholarship Program, and in encouraging and assisting such professionals with respect to providing primary health services to health professional shortage areas after the completion of the period of obligated service under such Program.
(July 1, 1944, ch. 373, title III, §338A, formerly title VII, §751, as added Oct. 12, 1976,
References in Text
Codification
In subsec. (g)(2), "section 3324(a) and (b) of title 31" substituted for "section 3648 of the Revised Statutes (
Section was formerly classified to
Amendments
1990—Subsec. (a).
Subsec. (b)(4).
Subsec. (c).
Subsec. (d).
"(1) first, to applications made (and contracts submitted) by individuals who have previously received scholarships under the Scholarship Program or under
"(2) second, to applications made (and contracts submitted)—
"(A) for the school year beginning in calendar year 1978, by individuals who are entering their first, second, or third year of study in a course of study or program described in subsection (b)(1)(B) of this section in such school year;
"(B) for the school year beginning in calendar year 1979, by individuals who are entering their first or second year of study in a course of study or program described in subsection (b)(1)(B) of this section in such school year; and
"(C) for each school year thereafter, by individuals who are entering their first year of study in a course of study or program described in subsection (b)(1)(B) of this section in such school year."
Subsec. (f)(1)(B)(iv).
Subsec. (g)(3).
Subsec. (i).
Subsec. (i)(4), (5).
Subsec. (i)(6).
1988—Subsec. (b)(1).
1985—Subsec. (g)(1).
1981—Subsec. (a).
Subsec. (c).
Subsec. (f).
Subsec. (j).
1979—Subsec. (g)(3).
1978—Subsec. (f).
Subsec. (i).
1977—Subsec. (d)(2).
Effective Date of 1990 Amendment
Amendment by
Effective Date of 1985 Amendment
Section 228 of
"(a) Except as provided in subsection (b), this Act and the amendments and repeals made by this Act [enacting
"(b)(1) The amendments made by section 101(a) of this Act [amending
"(2) The amendments made by section 208(e) of this Act [amending
"(3) The amendment made by section 208(h) of this Act [amending
"(4) The provisions of section 746 of the Public Health Service Act (as added by the amendment made by section 209(h)(2) of this Act) [
"(5) The amendments made by section 209(j) of this Act [amending
"(6) The amendments made by section 213(a) of this Act [amending
Effective Date of 1977 Amendment
Section 5 of
Effective Date
Section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
Section 408(b)(2) of
"(A) Except as provided in subparagraphs (B) and (C), the amendment made by paragraph (1) of this subsection [enacting this section and
"(B) The provisions of section 225(f)(1) of the Public Health Service Act (as in effect on September 30, 1977) [former
"(C) If an individual received a scholarship under the Public Health and National Health Service Corps Scholarship Program for any school year beginning before the date of the enactment of this Act [Oct. 12, 1976], periods of internship or residency served by such individual in a facility of the National Health Service Corps or other facility of the Public Health Service shall be creditable in satisfying such individual's service obligation incurred under that Program for such scholarship or for any scholarship received under the National Health Service Corps Scholarship Program for any subsequent school year. If an individual received a scholarship under the Public Health and National Health Service Corps Program for the first time from appropriations for such Program for the fiscal year ending September 30, 1977, periods of internship or residency served by such individual in such a facility shall be creditable in satisfying such individual's service obligation incurred under that Program for such scholarship."
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 See References in Text note below.
§254l–1. National Health Service Corps Loan Repayment Program
(a) Establishment
The Secretary shall establish a program to be known as the National Health Service Corps Loan Repayment Program to assure, with respect to the provision of primary health services pursuant to
(1) an adequate supply of physicians, dentists, certified nurse midwives, certified nurse practitioners, and physician assistants; and
(2) if needed by the Corps, an adequate supply of other health professionals (including mental health professionals).
(b) Eligibility
To be eligible to participate in the Loan Repayment Program, an individual must—
(1)(A) must 1 have a degree in medicine, osteopathic medicine, dentistry, or other health profession, or be certified as a nurse midwife, nurse practioner,2 or physician assistant;
(B) be enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession; or
(C) be enrolled as a full-time student—
(i) in an accredited (as determined by the Secretary) educational institution in a State; and
(ii) in the final year of a course of a study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession;
(2) be eligible for, or hold, an appointment as a commissioned officer in the Regular or Reserve Corps of the Service or be eligible for selection for civilian service in the Corps; and
(3) submit to the Secretary an application for a contract described in subsection (f) of this section (relating to the payment by the Secretary of the educational loans of the individual in consideration of the individual serving for a period of obligated service).
(c) Information to be included with application and contract forms; understandability; availability
(1) Summary and information
In disseminating application forms and contract forms to individuals desiring to participate in the Loan Repayment Program, the Secretary shall include with such forms—
(A) a fair summary of the rights and liabilities of an individual whose application is approved (and whose contract is accepted) by the Secretary, including in the summary a clear explanation of the damages to which the United States is entitled under
(B) information respecting meeting a service obligation through private practice under an agreement under
(2) Understandability
The application form, contract form, and all other information furnished by the Secretary under this subpart shall be written in a manner calculated to be understood by the average individual applying to participate in the Loan Repayment Program.
(3) Availability
The Secretary shall make such application forms, contract forms, and other information available to individuals desiring to participate in the Loan Repayment Program on a date sufficiently early to ensure that such individuals have adequate time to carefully review and evaluate such forms and information.
(4) Recruitment and retention
(A) The Secretary shall distribute to health professions schools materials providing information on the Loan Repayment Program and shall encourage the schools to disseminate the materials to the students of the schools.
(B)(i) In the case of any health professional whose period of obligated service under the Loan Repayment Program is nearing completion, the Secretary shall encourage the individual to remain in a health professional shortage area and to continue providing primary health services.
(ii) During the period in which a health professional is planning and making the transition to private practice from obligated service under the Loan Repayment Program, the Secretary may provide assistance to the professional regarding such transition if the professional is remaining in a health professional shortage area and is continuing to provide primary health services.
(C) In the case of entities to which participants in the Loan Repayment Program are assigned under
(d) Factors considered in providing contracts; priorities
(1) Subject to
(A) the Secretary shall consider the extent of the demonstrated interest of the applicants for the contracts in providing primary health services; and
(B) may consider such other factors regarding the applicants as the Secretary determines to be relevant to selecting qualified individuals to participate in such Program.
(2) In providing contracts under the Loan Repayment Program, the Secretary shall give priority—
(A) to any application for such a contract submitted by an individual whose training is in a health profession or specialty determined by the Secretary to be needed by the Corps;
(B) to any application for such a contract submitted by an individual who has (and whose spouse, if any, has) characteristics that increase the probability that the individual will continue to serve in a health professional shortage area after the period of obligated service pursuant to subsection (f) of this section is completed; and
(C) subject to subparagraph (B), to any application for such a contract submitted by an individual who is from a disadvantaged background.
(e) Approval required for participation
(1) In general
An individual becomes a participant in the Loan Repayment Program only upon the Secretary and the individual entering into a written contract described in subsection (f) of this section.
(2) Repealed. Pub. L. 101–597, title II, §202(b)(2)(B), Nov. 16, 1990, 104 Stat. 3024
(f) Contents of contracts
The written contract (referred to in this subpart) between the Secretary and an individual shall contain—
(1) an agreement that—
(A) subject to paragraph (3), the Secretary agrees—
(i) to pay on behalf of the individual loans in accordance with subsection (g) of this section; and
(ii) to accept (subject to the availability of appropriated funds for carrying out
(B) subject to paragraph (3), the individual agrees—
(i) to accept loan payments on behalf of the individual;
(ii) in the case of an individual described in subsection (b)(1)(C) of this section, to maintain enrollment in a course of study or training described in such subsection until the individual completes the course of study or training;
(iii) in the case of an individual described in subsection (b)(1)(C) of this section, while enrolled in such course of study or training, to maintain an acceptable level of academic standing (as determined under regulations of the Secretary by the educational institution offering such course of study or training); and
(iv) to serve for a time period (hereinafter in this subpart referred to as the "period of obligated service") equal to 2 years or such longer period as the individual may agree to, as a provider of primary health services in a health professional shortage area (designated under
(2) a provision permitting the Secretary to extend for such longer additional periods, as the individual may agree to, the period of obligated service agreed to by the individual under paragraph (1)(B)(iv), including extensions resulting in an aggregate period of obligated service in excess of 4 years;
(3) a provision that any financial obligation of the United States arising out of a contract entered into under this subpart and any obligation of the individual that is conditioned thereon, is contingent on funds being appropriated for loan repayments under this subpart and to carry out the purposes of
(4) a statement of the damages to which the United States is entitled, under
(5) such other statements of the rights and liabilities of the Secretary and of the individual, not inconsistent with this subpart.
(g) Payments
(1) In general
A loan repayment provided for an individual under a written contract under the Loan Repayment Program shall consist of payment, in accordance with paragraph (2), on behalf of the individual of the principal, interest, and related expenses on government and commercial loans received by the individual regarding the undergraduate or graduate education of the individual (or both), which loans were made for—
(A) tuition expenses;
(B) all other reasonable educational expenses, including fees, books, and laboratory expenses, incurred by the individual; or
(C) reasonable living expenses as determined by the Secretary.
(2) Payments for years served
(A) In general
For each year of obligated service that an individual contracts to serve under subsection (f) of this section the Secretary may pay up to $35,000 on behalf of the individual for loans described in paragraph (1). In making a determination of the amount to pay for a year of such service by an individual, the Secretary shall consider the extent to which each such determination—
(i) affects the ability of the Secretary to maximize the number of contracts that can be provided under the Loan Repayment Program from the amounts appropriated for such contracts;
(ii) provides an incentive to serve in health professional shortage areas with the greatest such shortages; and
(iii) provides an incentive with respect to the health professional involved remaining in a health professional shortage area, and continuing to provide primary health services, after the completion of the period of obligated service under the Loan Repayment Program.
(B) Repayment schedule
Any arrangement made by the Secretary for the making of loan repayments in accordance with this subsection shall provide that any repayments for a year of obligated service shall be made no later than the end of the fiscal year in which the individual completes such year of service.
(3) Tax liability
For the purpose of providing reimbursements for tax liability resulting from payments under paragraph (2) on behalf of an individual—
(A) the Secretary shall, in addition to such payments, make payments to the individual in an amount equal to 39 percent of the total amount of loan repayments made for the taxable year involved; and
(B) may make such additional payments as the Secretary determines to be appropriate with respect to such purpose.
(4) Payment schedule
The Secretary may enter into an agreement with the holder of any loan for which payments are made under the Loan Repayment Program to establish a schedule for the making of such payments.
(h) Employment ceiling
Notwithstanding any other provision of law, individuals who have entered into written contracts with the Secretary under this section, while undergoing academic or other training, shall not be counted against any employment ceiling affecting the Department.
(i) Reports
Not later than March 1 of each year, the Secretary shall submit to the Congress a report providing, with respect to the preceding fiscal year—
(1) the total amount of loan payments made under the Loan Repayment Program;
(2) the number of applications filed under this section;
(3) the number, and type of health profession training, of individuals receiving loan repayments under such Program;
(4) the educational institution at which such individuals received their training;
(5) the total amount of the indebtedness of such individuals for educational loans as of the date on which the individuals become participants in such Program;
(6) the number of years of obligated service specified for such individuals in the initial contracts under subsection (f) of this section, and, in the case of individuals whose period of such service has been completed, the total number of years for which the individuals served in the Corps (including any extensions made for purposes of paragraph (2) of such subsection);
(7)(A) the number, and type of health professions training, of such individuals who have breached the contract under subsection (f) of this section through any of the actions specified in subsection (a) or (b) of
(B) with respect to such individuals—
(i) the educational institutions with respect to which payments have been made or were to be made under the contract;
(ii) the amounts for which the individuals are liable to the United States under
(iii) the extent of payment by the individuals of such amounts; and
(iv) if known, the basis for the decision of the individuals to breach the contract under subsection (f) of this section; and
(8) the effectiveness of the Secretary in recruiting health professionals to participate in the Loan Repayment Program, and in encouraging and assisting such professionals with respect to providing primary health services to health professional shortage areas after the completion of the period of obligated service under such Program.
(July 1, 1944, ch. 373, title III, §338B, as added Dec. 1, 1987,
Prior Provisions
A prior section 338B of act July 1, 1944, was renumbered section 338C by section 201(2) of
Amendments
1990—Subsec. (a).
"(1) an adequate supply of trained physicians, dentists, and nurses for the Corps; and
"(2) if needed by the Corps, an adequate supply of podiatrists, optometrists, pharmacists, clinical psychologists, graduates of schools of veterinary medicine, graduates of schools of public health, graduates of programs in health administration, graduates of programs for the training of physician assistants, expanded function dental auxiliaries, and nurse practitioners (as defined in
Subsec. (b)(1).
"(A) be enrolled—
"(i) as a full-time student—
"(I) in an accredited (as determined by the Secretary) educational institution in a State; and
"(II) in the final year of a course of study or program, offered by such institution and approved by the Secretary, leading to a degree in medicine, osteopathic medicine, dentistry, or other health profession; or
"(ii) in an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession; or
"(B) have—
"(i) a degree in medicine, osteopathic medicine, dentistry, or other health profession;
"(ii) completed an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession in a State, except that the Secretary may waive the completion requirement of this clause for good cause; and
"(iii) a license to practice medicine, osteopathic medicine, dentistry, or other health profession in a State;".
Subsec. (b)(2) to (4).
"(3) submit an application to participate in the Loan Repayment Program; and
"(4) sign and submit to the Secretary, at the time of the submission of such application, a written contract (described in subsection (f) of this section) to accept repayment of educational loans and to serve (in accordance with this subpart) for the applicable period of obligated service in a health manpower shortage area."
Subsec. (c)(4).
Subsec. (d).
"(1) individuals whose training is in a health profession or specialty determined by the Secretary to be needed by the Corps; and
"(2) individuals who are committed to service in medically underserved areas."
Subsec. (e).
"(A) the Secretary's approving, under paragraph (1), of the individual's participation in the Loan Repayment Program; or
"(B) the Secretary's disapproving an individual's participation in such Program."
Subsec. (f)(1)(B)(ii), (iii).
Subsec. (f)(1)(B)(iv).
Subsec. (f)(2).
Subsec. (g)(1).
Subsec. (g)(2)(A).
Subsec. (g)(2)(B), (C).
Subsec. (g)(3).
Subsec. (i).
"(1) the number, and type of health profession training, of individuals receiving loan payments under the Loan Repayment Program;
"(2) the educational institution at which such individuals are receiving their training;
"(3) the number of applications filed under this section in the school year beginning in such year and in prior school years; and
"(4) the amount of loan payments made in the year reported on."
1988—Subsec. (b)(1).
Effective Date of 1990 Amendment
Section 202(g)(2) of
Regulations
Section 205 of title II of
Section Referred to in Other Sections
This section is referred to in
1 So in original. The word "must" probably should not appear.
2 So in original. Probably should be "practitioner,".
§254m. Obligated service under contract
(a) Service in full-time clinical practice
Except as provided in
(b) Notice to individual; information for informed decision; eligibility; notice to Secretary; qualification and appointment as commissioned officer; appointment as civilian member; designation of non-United States employee as member; deferment of obligated service
(1) If an individual is required under subsection (a) of this section to provide service as specified in
(A) as a member of the Corps who is a commissioned officer in the Regular or Reserve Corps of the Service or who is a civilian employee of the United States, or
(B) as a member of the Corps who is not such an officer or employee,
and shall notify such individual of such determination.
(2) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is a commissioned officer in the Service or a civilian employee of the United States, the Secretary shall, not later than sixty days before the date described in paragraph (5), provide such individual with sufficient information regarding the advantages and disadvantages of service as such a commissioned officer or civilian employee to enable the individual to make a decision on an informed basis. To be eligible to provide obligated service as a commissioned officer in the Service, an individual shall notify the Secretary, not later than thirty days before the date described in paragraph (5), of the individual's desire to provide such service as such an officer. If an individual qualifies for an appointment as such an officer, the Secretary shall, as soon as possible after the date described in paragraph (5), appoint the individual as a commissioned officer of the Regular or Reserve Corps of the Service and shall designate the individual as a member of the Corps.
(3) If an individual provided notice by the Secretary under paragraph (2) does not qualify for appointment as a commissioned officer in the Service, the Secretary shall, as soon as possible after the date described in paragraph (5), appoint such individual as a civilian employee of the United States and designate the individual as a member of the Corps.
(4) If the Secretary determines that an individual shall provide obligated service as a member of the Corps who is not an employee of the United States, the Secretary shall, as soon as possible after the date described in paragraph (5), designate such individual as a member of the Corps to provide such service.
(5)(A) In the case of the Scholarship Program, with respect to an individual receiving a degree from a school of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatry, or pharmacy, the date referred to in paragraphs (1) through (4) shall be the date on which the individual completes the training required for such degree, except that—
(i) at the request of such an individual with whom the Secretary has entered into a contract under
(ii) at the request of such an individual with whom the Secretary has entered into a contract under
(B)(i) In the case of the Scholarship Program, with respect to an individual receiving a degree from a school of medicine, osteopathic medicine, or dentistry, the number of years referred to in subparagraph (A)(i) shall be 3 years.
(ii) In the case of the Scholarship Program, with respect to an individual receiving a degree from a school of veterinary medicine, optometry, podiatry, or pharmacy, the number of years referred to in subparagraph (A)(i) shall be 1 year.
(C) No period of internship, residency, or other advanced clinical training shall be counted toward satisfying a period of obligated service under this subpart.
(D) In the case of the Scholarship Program, with respect to an individual receiving a degree from an institution other than a school referred to in subparagraph (A), the date referred to in paragraphs (1) through (4) shall be the date on which the individual completes the academic training of the individual leading to such degree.
(E) In the case of the Loan Repayment Program, if an individual is required to provide obligated service under such Program, the date referred to in paragraphs (1) through (4)—
(i) shall be the date determined under subparagraph (A), (B), or (D) in the case of an individual who is enrolled in the final year of a course of study;
(ii) shall, in the case of an individual who is enrolled in an approved graduate training program in medicine, osteopathic medicine, dentistry, or other health profession, be the date the individual completes such training program; and
(iii) shall, in the case of an individual who has a degree in medicine, osteopathic medicine, dentistry, or other health profession and who has completed graduate training, be the date the individual enters into an agreement with the Secretary under
(c) Obligated service period; commencement
An individual shall be considered to have begun serving a period of obligated service—
(1) on the date such individual is appointed as an officer in a Regular or Reserve Corps of the Service or is designated as a member of the Corps under subsection (b)(3) or (b)(4) of this section, or
(2) in the case of an individual who has entered into an agreement with the Secretary under
whichever is earlier.
(d) Assignment of personnel
The Secretary shall assign individuals performing obligated service in accordance with a written contract under the Scholarship Program to health professional shortage areas in accordance with sections 254d through 254h and
(e) Service under National Research Service Award program; credits against obligated service time
Notwithstanding any other provision of this subchapter, service of an individual under a National Research Service Award awarded under subparagraph (A) or (B) of section 288(a)(1) 1 of this title shall be counted against the period of obligated service which the individual is required to perform under the Scholarship Program or under section 234 2 of this title as in effect on September 30, 1977.
(July 1, 1944, ch. 373, title III, §338C, formerly title VII, §752, as added Oct. 12, 1976,
References in Text
Codification
Section was formerly classified to
Prior Provisions
A prior section 338C of act July 1, 1944, was renumbered section 338D by section 201(2) of
Amendments
1990—Subsec. (d).
1988—Subsec. (b)(5).
1987—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(5).
Subsec. (c)(2).
1983—Subsec. (e).
1981—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (e).
1979—Subsec. (b)(5)(A).
Subsec. (b)(5)(B).
1978—Subsec. (d).
Effective Date of 1981 Amendment
Section 2709(h) of
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Special Retention Pay for Regular or Reserve Officers for Period Officer Is Obligated Under This Section
Similar provisions were contained in the following prior appropriation acts:
Section Referred to in Other Sections
This section is referred to in
1 See Codification note below.
2 See References in Text note below.
§254n. Private practice
(a) Application for release of obligations; conditions
The Secretary shall, to the extent permitted by, and consistent with, the requirements of applicable State law, release an individual from all or part of his service obligation under
(1) in the case of an individual who received a scholarship under the Scholarship Program or a loan repayment under the Loan Repayment Program and who is performing obligated service as a member of the Corps in a health professional shortage area on the date of his application for such a release, in the health professional shortage area in which such individual is serving on such date or in the case of an individual for whom a loan payment was made under the Loan Repayment Program and who is performing obligated service as a member of the Corps in a health professional shortage area on the date of the application of the individual for such a release, in the health professional shortage area selected by the Secretary; or
(2) in the case of any other individual, in a health professional shortage area (designated under
(b) Written agreement; fee rates; ability to pay; health insurance; regulations; actions to ensure compliance
The written agreement described in subsection (a) of this section shall—
(1) provide that during the period of private practice by an individual pursuant to the agreement—
(A) any person who receives health services provided by the individual in connection with such practice will be charged for such services at the usual and customary rate prevailing in the area in which such services are provided, except that if such person is unable to pay such charge, such person shall be charged at a reduced rate or not charged any fee; and
(B) the individual in providing health services in connection with such practice (i) shall not discriminate against any person on the basis of such person's ability to pay for such services or because payment for the health services provided to such person will be made under the insurance program established under part A or B of title XVIII of the Social Security Act [
(2) contain such additional provisions as the Secretary may require to carry out the purposes of this section.
For purposes of paragraph (1)(A), the Secretary shall by regulation prescribe the method for determining a person's ability to pay a charge for health services and the method of determining the amount (if any) to be charged such person based on such ability. The Secretary shall take such action as may be appropriate to ensure that the conditions of the written agreement prescribed by this subsection are adhered to.
(c) Breach of service contract
If an individual breaches the contract entered into under
(d) Travel expenses
The Secretary may pay an individual who has entered into an agreement with the Secretary under subsection (a) of this section an amount to cover all or part of the individual's expenses reasonably incurred in transporting himself, his family, and his possessions to the location of his private clinical practice.
(e) Sale of equipment and supplies
Upon the expiration of the written agreement under subsection (a) of this section, the Secretary may (notwithstanding any other provision of law) sell to the individual who has entered into an agreement with the Secretary under subsection (a) of this section, equipment and other property of the United States utilized by such individual in providing health services. Sales made under this subsection shall be made at the fair market value (as determined by the Secretary) of the equipment or such other property, except that the Secretary may make such sales for a lesser value to the individual if he determines that the individual is financially unable to pay the full market value.
(f) Malpractice insurance
The Secretary may, out of appropriations authorized under
(1)(A) $10,000 in the first year of obligated service;
(B) $7,500 in the second year of obligated service;
(C) $5,000 in the third year of obligated service; and
(D) $2,500 in the fourth year of obligated service; or
(2) an amount determined by subtracting such individual's net income before taxes from the income the individual would have received as a member of the Corps for each such year of obligated service.
(g) Technical assistance
The Secretary shall, upon request, provide to each individual released from service obligation under this section technical assistance to assist such individual in fulfilling his or her agreement under this section.
(July 1, 1944, ch. 373, title III, §338D, formerly title VII, §753, as added Oct. 12, 1976,
References in Text
The Social Security Act, referred to in subsec. (b)(1)(B), is act Aug. 14, 1935, ch. 531,
Codification
Section was formerly classified to
Prior Provisions
A prior section 338D of act July 1, 1944, was renumbered section 338E by section 201(2) of
Amendments
1990—Subsec. (a)(1), (2).
1987—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (e).
1981—Subsec. (a).
Subsec. (b)(1)(B).
Subsecs. (c) to (g).
1980—Subsec. (a).
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§254o. Breach of scholarship contract or loan repayment contract
(a) Failure to maintain academic standing; dismissal from institution; voluntary termination; liability; failure to accept payment
(1) An individual who has entered into a written contract with the Secretary under
(A) fails to maintain an acceptable level of academic standing in the educational institution in which he is enrolled (such level determined by the educational institution under regulations of the Secretary),
(B) is dismissed from such educational institution for disciplinary reasons,
(C) voluntarily terminates the training in such an educational institution for which he is provided a scholarship under such contract, before the completion of such training, or
(D) fails to accept payment, or instructs the educational institution in which he is enrolled not to accept payment, in whole or in part, of a scholarship under such contract,
in lieu of any service obligation arising under such contract, shall be liable to the United States for the amount which has been paid to him, or on his behalf, under the contract.
(2) An individual who has entered into a written contract with the Secretary under
(A) in the case of an individual who is enrolled in the final year of a course of study, fails to maintain an acceptable level of academic standing in the educational institution in which such individual is enrolled (such level determined by the educational institution under regulations of the Secretary) or voluntarily terminates such enrollment or is dismissed from such educational institution before completion of such course of study; or
(B) in the case of an individual who is enrolled in a graduate training program, fails to complete such training program and does not receive a waiver from the Secretary under
in lieu of any service obligation arising under such contract shall be liable to the United States for the amount that has been paid on behalf of the individual under the contract.
(b) Failure to commence or complete service obligations; formula to determine liability; payment to United States; recovery of delinquent damages; disclosure to credit reporting agencies
(1)(A) Except as provided in paragraph (2), if an individual breaches his written contract by failing (for any reason not specified in subsection (a) of this section or section 254p(d) 1 of this title) either to begin such individual's service obligation under
t−s
A=3φ(------------------)
t
in which "A" is the amount the United States is entitled to recover, "φ" is the sum of the amounts paid under this subpart to or on behalf of the individual and the interest on such amounts which would be payable if at the time the amounts were paid they were loans bearing interest at the maximum legal prevailing rate, as determined by the Treasurer of the United States; "t" is the total number of months in the individual's period of obligated service; and "s" is the number of months of such period served by him in accordance with
(B)(i) Any amount of damages that the United States is entitled to recover under this subsection or under subsection (c) of this section shall, within the 1-year period beginning on the date of the breach of the written contract (or such longer period beginning on such date as specified by the Secretary), be paid to the United States. Amounts not paid within such period shall be subject to collection through deductions in Medicare payments pursuant to
(ii) If damages described in clause (i) are delinquent for 3 months, the Secretary shall, for the purpose of recovering such damages—
(I) utilize collection agencies contracted with by the Administrator of the General Services Administration; or
(II) enter into contracts for the recovery of such damages with collection agencies selected by the Secretary.
(iii) Each contract for recovering damages pursuant to this subsection shall provide that the contractor will, not less than once each 6 months, submit to the Secretary a status report on the success of the contractor in collecting such damages.
(iv) To the extent not otherwise prohibited by law, the Secretary shall disclose to all appropriate credit reporting agencies information relating to damages of more than $100 that are entitled to be recovered by the United States under this subsection and that are delinquent by more than 60 days or such longer period as is determined by the Secretary.
(2) If an individual is released under section 254n 1 of this title from a service obligation under section 234 1 of this title (as in effect on September 30, 1977) and if the individual does not meet the service obligation incurred under section 254n 1 of this title, subsection (f) of such section 234 1 of this title shall apply to such individual in lieu of paragraph (1) of this subsection.
(c) Failure to commence or complete service obligations for other reasons; determination of liability; payment to United States; waiver of recovery for extreme hardship or good cause shown
(1) If (for any reason not specified in subsection (a) of this section or section 254p(d) 1 of this title) an individual breaches the written contract of the individual under
(A) in the case of a contract for a 2-year period of obligated service—
(i) the total of the amounts paid by the United States under
(ii) an amount equal to the unserved obligation penalty;
(B) in the case of a contract for a period of obligated service of greater than 2 years, and the breach occurs before the end of the first 2 years of such period—
(i) the total of the amounts paid by the United States under
(ii) an amount equal to the unserved obligation penalty; and
(C) in the case of a contract for a period of obligated service of greater than 2 years, and the breach occurs after the first 2 years of such period—
(i) the total of the amounts paid by the United States under
(ii) if the individual breaching the contract failed to give the Secretary notice, that the individual intends to take action which constitutes a breach of the contract, at least 1 year (or such shorter period of time as the Secretary determines is adequate for finding a replacement) prior to the breach, $10,000.
(2) For purposes of paragraph (1), the term "unserved obligation penalty" means the amount equal to the product of the number of months of obligated service that were not completed by an individual, multiplied by $1,000, except that in any case in which the individual fails to serve 1 year, the unserved obligation penalty shall be equal to the full period of obligated service multiplied by $1,000.
(3) The Secretary may waive, in whole or in part, the rights of the United States to recover amounts under this section in any case of extreme hardship or other good cause shown, as determined by the Secretary.
(4) Damages that the United States is entitled to recover shall be paid in accordance with subsection (b)(1)(B) of this section.
(d) Cancellation of obligation upon death of individual; waiver or suspension of obligation for impossibility, hardship, or unconscionability; release of debt by discharge in bankruptcy, time limitations
(1) Any obligation of an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) for service or payment of damages shall be canceled upon the death of the individual.
(2) The Secretary shall by regulation provide for the partial or total waiver or suspension of any obligation of service or payment by an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) whenever compliance by the individual is impossible or would involve extreme hardship to the individual and if enforcement of such obligation with respect to any individual would be unconscionable.
(3)(A) Any obligation of an individual under the Scholarship Program (or a contract thereunder) or the Loan Repayment Program (or a contract thereunder) for payment of damages may be released by a discharge in bankruptcy under title 11 only if such discharge is granted after the expiration of the five-year period beginning on the first date that payment of such damages is required, and only if the bankruptcy court finds that nondischarge of the obligation would be unconscionable.
(B)(i) Subparagraph (A) shall apply to any financial obligation of an individual under the provision of law specified in clause (ii) to the same extent and in the same manner as such subparagraph applies to any obligation of an individual under the Scholarship or Loan Repayment Program (or contract thereunder) for payment of damages.
(ii) The provision of law referred to in clause (i) is subsection (f) of section 234 2 of this title, as in effect prior to the repeal of such section by section 408(b)(1) of
(July 1, 1944, ch. 373, title III, §338E, formerly title VII, §754, as added Oct. 12, 1976,
References in Text
Codification
Section was formerly classified to
Prior Provisions
A prior section 338E of act July 1, 1944, was renumbered section 338F by
Amendments
1990—Subsec. (d)(3).
1988—Subsec. (b)(1)(B)(i).
1987—
Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(1)(B)(i).
Subsec. (c).
Subsec. (d).
1983—Subsec. (b)(1).
1981—Subsec. (a).
Subsec. (b).
Subsecs. (c), (d).
1977—Subsec. (c).
Effective Date of 1990 Amendment
Section 203(b) of
Effective Date of 1988 Amendment
Except as specifically provided in section 411 of
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Special Repayment Provisions
Section 204 of
"(a)
"(1)
"(A)(i) breached a written contract entered into under section 338A of the Public Health Service Act (
"(ii) otherwise breached such a contract; and
"(B) as of November 1, 1987, is liable to the United States under section 338E(b) of such Act (as redesignated by section 201(2) of this Act) [subsec. (b) of this section],
shall be relieved of liability to the United States under such section if the individual provides notice to the Secretary in accordance with paragraph (2) and provides service in accordance with a written contract with the Secretary that obligates the individual to provide service in accordance with subsection (b) or (c). The Secretary may exclude an individual from relief from liability under this section for reasons related to the individual's professional competence or conduct.
"(2)
"(3)
"(4)
"(5)
"(6)
"(b)
"(1)
"(A)(i) is on the Health Manpower Shortage Area Placement Opportunity List created by the Secretary of Health and Human Services for obligated service under section 338C of the Public Health Service Act (as so redesignated) to begin in fiscal year 1988 and to which no individual who is not described in subsection (a)(1) has been assigned by a date determined by the Secretary; or
"(ii) is on the Health Manpower Shortage Area Placement Opportunity List created by the Secretary of Health and Human Services for obligated service under section 338C of the Public Health Service Act (as so redesignated) to begin in fiscal year 1989; and
"(B) has agreed to permit the individual to serve at such site.
"(2)
"(c)
"(1) to—
"(A) serve in accordance with subpart II of part D of title III of the Public Health Service Act (
"(B) pay, in accordance with guidelines established by the Secretary of Health and Human Services, to the United States the sum of the amounts paid under subpart II of part D of title III of such Act to or on behalf of the individual reduced by any amount paid, before entering into the contract, by such individual to the Secretary with respect to the individual's indebtedness under such part D [
"(2) to serve in accordance with such subpart II [
"(d)
"(1) shall include any site to which a National Health Service Corps member was previously assigned but which in fiscal year 1988 or 1989 will not have such member or a member of the National Health Service Corps to replace such member unless the Secretary of Health and Human Services determines that such site may reasonably be expected to recruit a health care professional from other than the Corps;
"(2) shall include any migrant health center receiving funds under section 329 of the Public Health Service Act (
"(3) may include any other site selected by the Secretary; and
"(4) shall designate the type of health care professional or medical specialist who is eligible to serve at the sites included on the list.
A site may be included on the supplemental list only if, at the time the list is created, the Secretary determines that the site meets the criteria prescribed by section 332 of such Act (
"(e)
"(1)
"(A) service by the individual in accordance with subsection (c) would be in the best interests of the National Health Service Corps; and
"(B) allowing such service would alleviate a substantial hardship for such individual.
"(2)
Existing Proceedings
Section 308(b) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 See References in Text note below.
§254o–1. Fund regarding use of amounts recovered for contract breach to replace services lost as result of breach
(a) Establishment of Fund
There is established in the Treasury of the United States a fund to be known as the National Health Service Corps Member Replacement Fund (hereafter in this section referred to as the "Fund"). The Fund shall consist of such amounts as may be appropriated under subsection (b) of this section to the Fund. Amounts appropriated for the Fund shall remain available until expended.
(b) Authorization of appropriations to Fund
For each fiscal year, there is authorized to be appropriated to the Fund an amount equal to the sum of—
(1) the amount collected during the preceding fiscal year by the Federal Government pursuant to the liability of individuals under
(2) the amount by which grants under
(3) the aggregate of the amount of interest accruing during the preceding fiscal year on obligations held in the Fund pursuant to subsection (d) of this section and the amount of proceeds from the sale or redemption of such obligations during such fiscal year.
(c) Use of Fund
(1) Payments to certain health facilities
Amounts in the Fund and available pursuant to appropriations Act may, subject to paragraph (2), be expended by the Secretary to make payments to any entity—
(A) to which a Corps member has been assigned under
(B) that has a need for a health professional to provide primary health services as a result of the Corps member having breached the contract entered into under
(2) Purpose of payments
An entity receiving payments pursuant to paragraph (1) may expend the payments to recruit and employ a health professional to provide primary health services to patients of the entity, or to enter into a contract with such a professional to provide the services to the patients.
(d) Investment
(1) In general
The Secretary of the Treasury shall invest such amounts of the Fund as such Secretary determines are not required to meet current withdrawals from the Fund. Such investments may be made only in interest-bearing obligations of the United States. For such purpose, such obligations may be acquired on original issue at the issue price, or by purchase of outstanding obligations at the market price.
(2) Sale of obligations
Any obligation acquired by the Fund may be sold by the Secretary of the Treasury at the market price.
(July 1, 1944, ch. 373, title III, §338F, as added Nov. 16, 1990,
Prior Provisions
A prior section 338F of act July 1, 1944, was renumbered section 338G by
Another prior section 338F of act July 1, 1944, was renumbered section 338G by section 201(2) of
§254p. Special loans for former Corps members to enter private practice
(a) Persons entitled; conditions
The Secretary may, out of appropriations authorized under
(1) to engage in the private full-time clinical practice of the profession of the member in a health professional shortage area (designated under
(A) in the case of a Corps member who is required to complete a period of obligated service under this subpart, begins not later than 1 year after the date on which such individual completes such period of obligated service; and
(B) in the case of an individual who is not required to complete a period of obligated service under this subpart, begins at such time as the Secretary considers appropriate;
(2) to conduct such practice in accordance with
(3) to such additional conditions as the Secretary may require to carry out this section.
Such a loan shall be used to assist such individual in meeting the costs of beginning the practice of such individual's profession in accordance with such agreement, including the costs of acquiring equipment and renovating facilities for use in providing health services, and of hiring nurses and other personnel to assist in providing health services. Such loan may not be used for the purchase or construction of any building.
(b) Amount of loan; maximum interest rate
(1) The amount of a loan under subsection (a) of this section to an individual shall not exceed $25,000.
(2) The interest rate for any such loan shall not exceed an annual rate of 5 percent.
(c) Application for loan; submission and approval; interest rates and repayment terms
The Secretary may not make a loan under this section unless an application therefor has been submitted to, and approved by, the Secretary. The Secretary shall, by regulation, set interest rates and repayment terms for loans under this section.
(d) Breach of agreement; notice; determination of liability
If the Secretary determines that an individual has breached a written agreement entered into under subsection (a) of this section, he shall, as soon as practicable after making such determination, notify the individual of such determination. If within 60 days after the date of giving such notice, such individual is not practicing his profession in accordance with the agreement under such subsection and has not provided assurances satisfactory to the Secretary that he will not knowingly violate such agreement again, the United States shall be entitled to recover from such individual—
(1) in the case of an individual who has received a grant under this section (as in effect prior to October 1, 1984), an amount determined under
(2) in the case of an individual who has received a loan under this section, the full amount of the principal and interest owed by such individual under this section.
(July 1, 1944, ch. 373, title III, §338G, formerly title VII, §755, as added Oct. 12, 1976,
Codification
Section was formerly classified to
Prior Provisions
A prior section 338G of act July 1, 1944, was renumbered section 338H by
Another prior section 338G of act July 1, 1944, was renumbered section 338I by section 201(1) of
Another prior section 338G of act July 1, 1944, was classified to
Amendments
1990—Subsec. (a)(1).
1987—Subsec. (a).
Subsec. (b).
"(1) $12,500 if the individual agrees to practice his profession in accordance with the agreement for a period of at least one year, but less than two years; or
"(2) $25,000 if the individual agrees to practice his profession in accordance with the agreement for a period of at least two years."
Subsec. (c).
Subsec. (d)(1).
1983—Subsec. (d)(1).
1981—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Effective Date
Section effective Oct. 1, 1977, see section 408(b)(1) of
Effective Date; Savings Provision; Credit for Period of Internship or Residency Before September 30, 1977, Towards Service Obligation
See section 408(b)(2) of
Section Referred to in Other Sections
This section is referred to in
§254q. Report and authorization of appropriations
(a) Report
The Secretary shall report on March 1 of each year to the Committee on Labor and Human Resources of the Senate, the Committee on Energy and Commerce of the House of Representatives, and the Committees on Appropriations of the Senate and the House of Representatives on—
(1) the number of providers of health care who will be needed for the Corps during the 5 fiscal years beginning after the date the report is filed; and
(2) the number—
(A) of scholarships the Secretary proposes to provide under the Scholarship Program during such 5 fiscal years;
(B) of individuals for whom the Secretary proposes to make loan repayments under the Loan Repayment Program during such 5 fiscal years; and
(C) of individuals who have no obligation under
in order to provide such number of health care providers.
(b) Funding
(1) Authorization of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $63,900,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 through 2000.
(2) Reservation of amounts
(A) Scholarships for new participants
Of the amounts appropriated under paragraph (1) for a fiscal year, the Secretary shall obligate not less than 30 percent for the purpose of providing contracts for scholarships under this subpart to individuals who have not previously received such scholarships.
(B) Scholarships for first-year study in certain fields
With respect to certification as a nurse practitioner, nurse midwife, or physician assistant, the Secretary shall, of the amounts appropriated under paragraph (1) for a fiscal year, obligate not less than 10 percent for the purpose of providing contracts for scholarships under this subpart to individuals who are entering the first year of study in a course of study or program described in subsection 1 254l(b)(1)(B) of this title that leads to such a certification. Amounts obligated under this subparagraph shall be in addition to amounts obligated under subparagraph (A).
(July 1, 1944, ch. 373, title III, §338H, formerly §338G, as added Dec. 1, 1987,
Prior Provisions
A prior section 254q, act July 1, 1944, ch. 373, title III, §338G, formerly title VII, §756, as added Oct. 12, 1976,
A prior section 338H of act July 1, 1944, was renumbered section 338I by
Amendments
1990—Subsec. (a).
Subsec. (b).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
1 So in original. Probably should be "section".
§254q–1. Grants to States for loan repayment programs
(a) In general
(1) Authority for grants
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants to States for the purpose of assisting the States in operating programs described in paragraph (2) in order to provide for the increased availability of primary health services in health professional shortage areas.
(2) Loan repayment programs
The programs referred to in paragraph (1) are, subject to subsection (c) of this section, programs of entering into contracts under which the State involved agrees to pay all or part of the principal, interest, and related expenses of the educational loans of health professionals in consideration of the professionals agreeing to provide primary health services in health professional shortage areas.
(3) Direct administration by State agency
The Secretary may not make a grant under paragraph (1) unless the State involved agrees that the program operated with the grant will be administered directly by a State agency.
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under subsection (a) of this section unless the State agrees that, with respect to the costs of making payments on behalf of individuals under contracts made pursuant to paragraph (2) of such subsection, the State will make available (directly or through donations from public or private entities) non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $1 of Federal funds provided in the grant.
(2) Determination of amount of non-Federal contribution
In determining the amount of non-Federal contributions in cash that a State has provided pursuant to paragraph (1), the Secretary may not include any amounts provided to the State by the Federal Government.
(c) Coordination with Federal program
(1) Assignments for health professional shortage areas under Federal program
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that, in carrying out the program operated with the grant, the State will assign health professionals participating in the program only to public and nonprofit private entities located in and providing health services in health professional shortage areas.
(2) Remedies for breach of contracts
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the contracts provided by the State pursuant to paragraph (2) of such subsection will provide remedies for any breach of the contracts by the health professionals involved.
(3) Limitation regarding contract inducements
(A) Except as provided in subparagraph (B), the Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the contracts provided by the State pursuant to paragraph (2) of such subsection will not be provided on terms that are more favorable to health professionals than the most favorable terms that the Secretary is authorized to provide for contracts under the Loan Repayment Program under
(i) the annual amount of payments provided on behalf of the professionals regarding educational loans; and
(ii) the availability of remedies for any breach of the contracts by the health professionals involved.
(B) With respect to the limitation established in subparagraph (A) regarding the annual amount of payments that may be provided to a health professional under a contract provided by a State pursuant to subsection (a)(2) of this section, such limitation shall not apply with respect to a contract if—
(i) the excess of such annual payments above the maximum amount authorized in
(ii) the contract provides that the health professional involved will satisfy the requirement of obligated service under the contract solely through the provision of primary health services in a health professional shortage area that is receiving priority for purposes of
(d) Restrictions on use of funds
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the grant will not be expended—
(1) to conduct activities for which Federal funds are expended—
(A) within the State to provide technical or other nonfinancial assistance under subsection (f) of
(B) under a memorandum of agreement entered into with the State under subsection (h) of such section; or
(C) under a grant under
(2) for any purpose other than making payments on behalf of health professionals under contracts entered into pursuant to subsection (a)(2) of this section.
(e) Reports
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees—
(1) to submit to the Secretary reports providing the same types of information regarding the program operated pursuant to such subsection as reports submitted pursuant to subsection (i) of
(2) to submit such a report not later than January 10 of each fiscal year immediately following any fiscal year for which the State has received such a grant.
(f) Requirement of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out such subsection.
(g) Noncompliance
(1) In general
The Secretary may not make payments under subsection (a) of this section to a State for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State has complied with each of the agreements made by the State under this section.
(2) Reduction in grant relative to number of breached contracts
(A) Before making a grant under subsection (a) of this section to a State for a fiscal year, the Secretary shall determine the number of contracts provided by the State under paragraph (2) of such subsection with respect to which there has been an initial breach by the health professionals involved during the fiscal year preceding the fiscal year for which the State is applying to receive the grant.
(B) Subject to paragraph (3), in the case of a State with 1 or more initial breaches for purposes of subparagraph (A), the Secretary shall reduce the amount of a grant under subsection (a) of this section to the State for the fiscal year involved by an amount equal to the sum of the expenditures of Federal funds made regarding the contracts involved and an amount representing interest on the amount of such expenditures, determined with respect to each contract on the basis of the maximum legal rate prevailing for loans made during the time amounts were paid under the contract, as determined by the Treasurer of the United States.
(3) Waiver regarding reduction in grant
The Secretary may waive the requirement established in paragraph (2)(B) with respect to the initial breach of a contract if the Secretary determines that such breach by the health professional involved was attributable solely to the professional having a serious illness.
(h) "State" defined
For purposes of this section, the term "State" means each of the several States.
(i) Authorization of appropriations
(1) In general
For the purpose of making grants under subsection (a) of this section, there is authorized to be appropriated $10,000,000 for each of the fiscal years 1991 through 1995.
(2) Availability
Amounts appropriated under paragraph (1) shall remain available until expended.
(July 1, 1944, ch. 373, title III, §338I, formerly §338H, as added Dec. 1, 1987,
Prior Provisions
A prior section 338I of act July 1, 1944, was classified to
Amendments
1990—
Section Referred to in Other Sections
This section is referred to in
§254r. Grants to States for operation of offices of rural health
(a) In general
The Secretary, acting through the Director of the Office of Rural Health Policy (established in
(b) Requirement of matching funds
(1) In general
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees, with respect to the costs to be incurred by the State in carrying out the purpose described in such subsection, to provide non-Federal contributions in cash toward such costs in an amount equal to—
(A) for the first fiscal year of payments under the grant, not less than $1 for each $3 of Federal funds provided in the grant;
(B) for any second fiscal year of such payments, not less than $1 for each $1 of Federal funds provided in the grant; and
(C) for any third fiscal year of such payments, not less than $3 for each $1 of Federal funds provided in the grant.
(2) Determination of amount of non-Federal contribution
(A) Subject to subparagraph (B), non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that—
(i) for the first fiscal year of payments under the grant, 100 percent or less of the non-Federal contributions required in paragraph (1) will be provided in the form of in-kind contributions;
(ii) for any second fiscal year of such payments, not more than 50 percent of such non-Federal contributions will be provided in the form of in-kind contributions; and
(iii) for any third fiscal year of such payments, such non-Federal contributions will be provided solely in the form of cash.
(c) Certain required activities
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that activities carried out by an office operated pursuant to such subsection will include—
(1) establishing and maintaining within the State a clearinghouse for collecting and disseminating information on—
(A) rural health care issues;
(B) research findings relating to rural health care; and
(C) innovative approaches to the delivery of health care in rural areas;
(2) coordinating the activities carried out in the State that relate to rural health care, including providing coordination for the purpose of avoiding redundancy in such activities; and
(3) identifying Federal and State programs regarding rural health, and providing technical assistance to public and nonprofit private entities regarding participation in such programs.
(d) Requirement regarding annual budget for office
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that, for any fiscal year for which the State receives such a grant, the office operated pursuant to subsection (a) of this section will be provided with an annual budget of not less than $50,000.
(e) Certain uses of funds
(1) Restrictions
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that—
(A) if research with respect to rural health is conducted pursuant to the grant, not more than 10 percent of the grant will be expended for such research; and
(B) the grant will not be expended—
(i) to provide health care (including providing cash payments regarding such care);
(ii) to conduct activities for which Federal funds are expended—
(I) within the State to provide technical and other nonfinancial assistance under subsection (f) of
(II) under a memorandum of agreement entered into with the State under subsection (h) of such section; or
(III) under a grant under
(iii) to purchase medical equipment, to purchase ambulances, aircraft, or other vehicles, or to purchase major communications equipment;
(iv) to purchase or improve real property; or
(v) to carry out any activity regarding a certificate of need.
(2) Authorities
Activities for which a State may expend a grant under subsection (a) of this section include—
(A) paying the costs of establishing an office of rural health for purposes of subsection (a) of this section;
(B) subject to paragraph (1)(B)(ii)(III), paying the costs of any activity carried out with respect to recruiting and retaining health professionals to serve in rural areas of the State; and
(C) providing grants and contracts to public and nonprofit private entities to carry out activities authorized in this section.
(f) Reports
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees—
(1) to submit to the Secretary reports containing such information as the Secretary may require regarding activities carried out under this section by the State; and
(2) to submit such a report not later than January 10 of each fiscal year immediately following any fiscal year for which the State has received such a grant.
(g) Requirement of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out such subsection.
(h) Noncompliance
The Secretary may not make payments under subsection (a) of this section to a State for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State has complied with each of the agreements made by the State under this section.
(i) "State" defined
For purposes of this section, the term "State" means each of the several States.
(j) Authorization of appropriations
(1) In general
For the purpose of making grants under subsection (a) of this section, there are authorized to be appropriated $3,000,000 for fiscal year 1991, $4,000,000 for fiscal year 1992, and $3,000,000 for fiscal year 1993.
(2) Availability
Amounts appropriated under paragraph (1) shall remain available until expended.
(k) Termination of program
No grant may be made under this section after the aggregate amounts appropriated under subsection (j)(1) of this section are equal to $10,000,000.
(July 1, 1944, ch. 373, title III, §338J, as added Nov. 16, 1990,
Prior Provisions
A prior section 254r, act July 1, 1944, ch. 373, title III, §338I, formerly title VII, §757, as added Aug. 1, 1977,
A prior section 338J of act July 1, 1944, was renumbered section 338K by
Communications for Rural Health Providers
Similar provisions were contained in
Section Referred to in Other Sections
This section is referred to in
§254s. Native Hawaiian Health Scholarships
(a) Eligibility
Subject to the availability of funds appropriated under the authority of subsection (d) of this section, the Secretary shall provide funds to Kamehameha Schools/Bishop Estate for the purpose of providing scholarship assistance to students who—
(1) meet the requirements of
(2) are Native Hawaiians.
(b) Terms and conditions
(1) The scholarship assistance provided under subsection (a) of this section shall be provided under the same terms and subject to the same conditions, regulations, and rules that apply to scholarship assistance provided under
(2) The Native Hawaiian Health Scholarship program shall not be administered by or through the Indian Health Service.
(c) "Native Hawaiian" defined
For purposes of this section, the term "Native Hawaiian" means any individual who is—
(1) a citizen of the United States,
(2) a resident of the State of Hawaii, and
(3) a descendant of the aboriginal people, who prior to 1778, occupied and exercised sovereignty in the area that now constitutes the State of Hawaii, as evidenced by—
(A) genealogical records,
(B) Kupuna (elders) or Kama'aina (long-term community residents) verification, or
(C) birth records of the State of Hawaii.
(d) Authorization of appropriations
There are authorized to be appropriated $1,800,000 for each of the fiscal years 1990, 1991, and 1992 for the purpose of funding the scholarship assistance provided under subsection (a) of this section.
(July 1, 1944, ch. 373, title III, §338k, formerly §338J, as added Nov. 23, 1988,
Amendments
1990—Subsec. (a).
"(1) meet the requirements of
"(2) are Native Hawaiians."
§254t. Demonstration grants to States for community scholarship programs
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, may make grants to States for the purpose of carrying out demonstration programs to increase the availability of primary health care in urban and rural health manpower shortage areas through assisting community organizations of such areas in educating individuals to serve as health professionals in such areas.
(b) Certain requirements for States
(1) Minimum qualifications
The Secretary may not make a grant under subsection (a) of this section unless the State involved will, under any provision of this chapter other than subsection (a) of this section, receive 1 or more grants, cooperative agreements, or contracts for the fiscal year for which the State is applying pursuant to subsection (h) of this section to receive a grant under subsection (a) of this section.
(2) Administration of program
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the program carried out by the State with the grant will be administered directly by a single State agency.
(c) Grants by States to community organizations for provision of scholarship contracts
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees, subject to subsections (d) and (e) of this section, to carry out the purpose described in subsection (a) of this section only through operating a program in which the State makes grants to community organizations located in health manpower 1 shortage areas in order to assist the organizations with the costs of entering into contracts under which—
(1) the community organizations agree to provide scholarships to individuals for attendance at health professions schools; and
(2) the individuals agree to provide, in the health manpower shortage areas in which the community organizations are located, primary health care for—
(A) a number of years equal to the number of years for which the scholarships are provided, or for a period of 2 years, whichever period is greater; or
(B) such greater period of time as the individuals and the community organizations may agree.
(d) Requirement of State and local matching funds
(1) In general
With respect to the costs of providing any scholarship pursuant to subsection (c) of this section, the Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that—
(A) 40 percent of the costs of the scholarship will be paid from the grant made under subsection (a) of this section to the State; and
(B) 60 percent of such costs will be paid from non-Federal contributions made in cash by both the State and the community organization through which the scholarship is provided, subject to—
(i) the State making available through such contributions not less than 15 percent, nor more than 25 percent, of such costs; and
(ii) the community organization making available through such contributions not less than 35 percent, nor more than 45 percent, of such costs.
(2) Determination of amount of non-Federal contributions
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that, in determining the amount of non-Federal contributions that have been provided in cash for purposes of paragraph (1), the State will not include any amounts provided by the Federal Government to the State or community organization involved, or to any other entity.
(3) Use of donations
Non-Federal contributions required in paragraph (1) may be provided directly by the State and community organization involved, and may be provided through donations from public and private entities.
(e) Specifications regarding scholarship contract
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees that the State will make a grant to a community organization for a contract described in subsection (c) of this section only if—
(1) the individual who is to receive the scholarship under the contract is a resident of the health manpower shortage area in which the community organization is located;
(2) the individual is enrolled or accepted for enrollment as a full-time student in a health professions school that is approved by the Secretary for purposes of this section;
(3) the individual agrees to maintain an acceptable level of academic standing at the school (as determined by the school in accordance with regulations issued by the Secretary for purposes of
(4) the individual and the community organization agree that the scholarship provided pursuant to the contract—
(A) will be expended only for—
(i) tuition expenses, other reasonable educational expenses, and reasonable living expenses incurred in attendance at the school; and
(ii) payment to the individual of a monthly stipend of not more than the amount authorized for purposes of
(B) will not, for any year of such attendance for which the scholarship is provided, be in an amount exceeding the total amount required for the year for the purposes authorized in subparagraph (A);
(5) the individual agrees to meet the educational and licensure requirements necessary to be a physician, certified nurse practitioner, certified nurse midwife, or physician assistant; and
(6) the individual agrees that, in providing primary health care pursuant to the scholarship, the individual—
(A) will not, in the case of an individual seeking such care, discriminate against the individual on the basis of the ability of the individual to pay for such care or on the basis that payment for such care will be made pursuant to the program established in title XVIII of the Social Security Act [
(B) will accept assignment under section 1842(b)(3)(B)(ii) of the Social Security Act [
(f) Reports to Secretary
The Secretary may not make a grant under subsection (a) of this section unless the State involved agrees—
(1) for each fiscal year for which such a grant is received by the State, to submit to the Secretary a report—
(A) identifying the community organizations providing scholarships pursuant to subsection (c) of this section and the health manpower shortage areas in which the organizations are located;
(B) providing the names of individuals receiving the scholarships, the health professions in which the individuals will engage pursuant to the scholarships, the number of years of service the individuals are obligated to provide pursuant to the scholarships, and the extent of compliance with the contracts under subsection (c) of this section on the part of the individuals and the community organizations; and
(C) providing such information as the Secretary may determine to be necessary for carrying out this section; and
(2) to submit each such report not later than January 10 of the fiscal year immediately following the fiscal year for which the report is prepared.
(g) Estimates regarding allocations between urban and rural areas
The Secretary may not make a grant under subsection (a) of this section unless the State involved submits to the Secretary, as part of the application required in subsection (h) of this section, an estimate of the amount of the grant that will be expended regarding the provision of primary health care in urban health manpower shortage areas of the State, and an estimate of the amount of the grant that will be expended regarding the provision of such care in rural health manpower shortage areas of the State.
(h) Requirement of application
The Secretary may not make a grant under subsection (a) of this section unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(i) Noncompliance
(1) In general
The Secretary may not make payments under subsection (a) of this section to a State for any fiscal year subsequent to the first fiscal year of such payments unless the Secretary determines that, for the immediately preceding fiscal year, the State has complied with each of the agreements made by the State under this section.
(2) Reduction in grant relative to number of breached contracts
(A) Before making a grant under subsection (a) of this section to a State for a fiscal year, the Secretary shall determine the number of contracts provided under subsection (c) of this section with respect to which there has been an initial breach by the community organizations or individuals involved during the fiscal year preceding the fiscal year for which the State is applying to receive the grant.
(B) In the case of a State with 1 or more initial breaches for purposes of subparagraph (A), the Secretary shall reduce the amount of a grant under subsection (a) of this section to the State for the fiscal year involved by an amount equal to the sum of—
(i) an amount equal to the expenditures of Federal funds made regarding the contracts involved; and
(ii) an amount representing interest on the amount of such expenditures, determined with respect to each contract on the basis of the maximum legal rate prevailing for loans made during the time amounts were paid under the contract, as determined by the Treasurer of the United States.
(C) If a State is not receiving a grant under subsection (a) of this section for a fiscal year for which a reduction under subparagraph (B) would have been made in the event that the State had received such a grant, the Secretary shall reduce the amount of payments due to the State under other grants, cooperative agreements, or contracts under this chapter by the amount specified in such subparagraph.
(D) With respect to contracts provided under subsection (c) of this section, the Secretary may carry out this paragraph on the basis of information submitted by the States involved, or on the basis of information collected through such other means as the Secretary determines to be appropriate.
(j) Reports to Congress
(1) In general
Each fiscal year the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report summarizing information received by the Secretary under subsection (f) of this section for the preceding fiscal year.
(2) Date for submission
With respect to a fiscal year, the report required in paragraph (1) shall be submitted for purposes of such paragraph by not later than the date on which the report required in
(k) Definitions
For purposes of this section:
(1) Community organization
The term "community organization" means a public or nonprofit private entity.
(2) Primary health care
The term "primary health care" means health services regarding family medicine, internal medicine, pediatrics, or obstetrics and gynecology, that are provided by physicians, certified nurse practitioners, certified nurse midwives, or physician assistants.
(3) State
The term "State" means each of the several States and the District of Columbia.
(l) Funding
(1) Authorization of appropriations
For the purpose of making grants under subsection (a) of this section, there are authorized to be appropriated $5,000,000 for fiscal year 1991, $10,000,000 for fiscal year 1992, and such sums as may be necessary for fiscal year 1993.
(2) Availability
Amounts appropriated under paragraph (1) shall remain available until expended.
(3) Allocations for rural areas
(A) In carrying out subsection (a) of this section, the Secretary shall, to the extent practicable, ensure that not less than 50 percent of the amounts appropriated under paragraph (1) are, in the aggregate, expended for making grants pursuant to subsection (c) of this section to community organizations that are located in rural health manpower shortage areas.
(B) Subparagraph (A) may not be construed to prohibit the Secretary from making grants under subsection (a) of this section to States in which no rural health manpower shortage areas are located.
(C) With respect to any fiscal year for which the Secretary is unable to comply with subparagraph (A), the Secretary shall, not later than April 1 of the subsequent fiscal year, submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report stating the fact of such noncompliance and an explanation of the reasons underlying such noncompliance.
(July 1, 1944, ch. 373, title III, §338L, as added Nov. 6, 1990,
References in Text
The Social Security Act, referred to in subsec. (e)(6), is act Aug. 14, 1935, ch. 531,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
1 So in original. Probably should be "professional".
subpart iv—home health services
Amendments
1987—
1983—
1978—
§255. Home health services
(a) Purpose; authorization of grants and loans; considerations; conditions on loans; appropriations
(1) For the purpose of encouraging the establishment and initial operation of home health programs to provide home health services in areas in which such services are inadequate or not readily accessible, the Secretary may, in accordance with the provisions of this section, make grants to public and nonprofit private entities and loans to proprietary entities to meet the initial costs of establishing and operating such home health programs. Such grants and loans may include funds to provide training for paraprofessionals (including homemaker home health aides) to provide home health services.
(2) In making grants and loans under this subsection, the Secretary shall—
(A) consider the relative needs of the several States for home health services;
(B) give preference to areas in which a high percentage of the population proposed to be served is composed of individuals who are elderly, medically indigent, or disabled; and
(C) give special consideration to areas with inadequate means of transportation to obtain necessary health services.
(3)(A) No loan may be made to a proprietary entity under this section unless the application of such entity for such loan contains assurances satisfactory to the Secretary that—
(i) at the time the application is made the entity is fiscally sound;
(ii) the entity is unable to secure a loan for the project for which the application is submitted from non-Federal lenders at the rate of interest prevailing in the area in which the entity is located; and
(iii) during the period of the loan, such entity will remain fiscally sound.
(B) Loans under this section shall be made at an interest rate comparable to the rate of interest prevailing on the date the loan is made with respect to the marketable obligations of the United States of comparable maturities, adjusted to provide for administrative costs.
(4) Applications for grants and loans under this subsection shall be in such form and contain such information as the Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and loans under this subsection $5,000,000 for each of the fiscal years ending on September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and September 30, 1987.
(b) Grants and contracts for training programs for paraprofessionals; considerations; applications; appropriations
(1) The Secretary may make grants to and enter into contracts with public and private entities to assist them in developing appropriate training programs for paraprofessionals (including homemaker home health aides) to provide home health services.
(2) Any program established with a grant or contract under this subsection to train homemaker home health aides shall—
(A) extend for at least forty hours, and consist of classroom instruction and at least twenty hours (in the aggregate) of supervised clinical instruction directed toward preparing students to deliver home health services;
(B) be carried out under appropriate professional supervision and be designed to train students to maintain or enhance the personal care of an individual in his home in a manner which promotes the functional independence of the individual; and
(C) include training in—
(i) personal care services designed to assist an individual in the activities of daily living such as bathing, exercising, personal grooming, and getting in and out of bed; and
(ii) household care services such as maintaining a safe living environment, light housekeeping, and assisting in providing good nutrition (by the purchasing and preparation of food).
(3) In making grants and entering into contracts under this subsection, special consideration shall be given to entities which establish or will establish programs to provide training for persons fifty years of age and older who wish to become paraprofessionals (including homemaker home health aides) to provide home health services.
(4) Applications for grants and contracts under this subsection shall be in such form and contain such information as the Secretary shall prescribe.
(5) There are authorized to be appropriated for grants and contracts under this subsection $2,000,000 for each of the fiscal years ending September 30, 1983, September 30, 1984, September 30, 1985, September 30, 1986, and September 30, 1987.
(c) Report to Congress with respect to grants and loans and training of personnel
The Secretary shall report to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives on or before January 1, 1984, with respect to—
(1) the impact of grants made and contracts entered into under subsections (a) and (b) of this section (as such subsections were in effect prior to October 1, 1981);
(2) the need to continue grants and loans under subsections (a) and (b) of this section (as such subsections are in effect on the day after January 4, 1983); and
(3) the extent to which standards have been applied to the training of personnel who provide home health services.
(d) "Home health services" defined
For purposes of this section, the term "home health services" has the meaning prescribed for the term by
(July 1, 1944, ch. 373, title III, §339, as added Jan. 4, 1983,
References in Text
Subsections (a) and (b) of this section (as such subsections were in effect prior to October 1, 1981), referred to in subsec. (c)(1), mean subsections (a) and (b) of
Prior Provisions
A prior section 255, act July 1, 1944, ch. 373, title III, §339, as added Nov. 10, 1978,
Another prior section 339 of act July 1, 1944, ch. 373, title III, formerly §331,
Amendments
1984—Subsecs. (a)(5), (b)(5).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Report to Congress Concerning Results of Studies Evaluating Home and Community Based Health Services; Studies of Reimbursement Methodologies; Investigation of Fraud; Demonstration Projects; Home Health Services, Defined
Section 6(b)–(f) of
subpart v—health services for the homeless
Amendments
1987—
1978—
§256. Grant program for certain health services for the homeless
(a) Establishment
(1) The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants for the purpose of enabling grantees, directly or through contracts, to provide for the delivery of health services to homeless individuals.
(2) In carrying out the program established in paragraph (1), the Administrator shall consult with the Director of the National Institute on Alcohol Abuse and Alcoholism and with the Director of the National Institute of Mental Health.
(b) Minimum qualifications of grantees
(1) Subject to paragraph (2), the Secretary may not make a grant under subsection (a) of this section to an applicant unless—
(A) the applicant is a public or nonprofit private entity;
(B) the applicant has the capacity to effectively administer a grant under subsection (a) of this section; and
(C) in the case of any health service that is covered in the State plan approved under title XIX of the Social Security Act [
(i) the applicant for the grant will provide the health service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(ii) the applicant for the grant will enter into an agreement with an organization under which the organization will provide the health service, and the organization has entered into such a participation agreement and is qualified to receive such payments.
(2)(A) In the case of an organization making an agreement under paragraph (1)(C)(ii) regarding the provision of health services under subsection (a) of this section, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the organization does not, in providing health care services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program.
(B) A determination by the Secretary of whether an organization referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the public.
(c) Preferences in making grants
The Secretary shall, in making grants under subsection (a) of this section, give preference to qualified applicants that—
(1)(A) are experienced in the direct delivery of primary health services to homeless individuals or medically underserved populations; or
(B) are experienced in the treatment of substance abuse in homeless individuals or medically underserved populations; and
(2) agree to provide for health services to homeless individuals through both public entities and private organizations.
(d) Requirement of submission of application containing certain agreements
(1) The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant has submitted to the Secretary an application for the grant containing agreements in accordance with—
(A) subsection (e)(1)(A)(ii) of this section, relating to the provision of matching funds;
(B) subsection (f) of this section, relating to the provision of certain health services;
(C) subsection (i) of this section, relating to restrictions on the use of funds;
(D) subsection (j) of this section, relating to a limitation on charges for services;
(E) subsection (k) of this section, relating to the administration of grants; and
(F) subsection (l) of this section, relating to a limitation on administrative expenses.
(2) An application required in paragraph (1) shall, with respect to agreements required to be contained in the application, provide assurances of compliance satisfactory to the Secretary and shall otherwise be in such form, be made in such manner, and contain such information in addition to information required in paragraph (1) as the Secretary determines to be necessary to carry out this section.
(e) Requirement of provision of matching funds
(1)(A) The Secretary may not make a grant under subsection (a) of this section to an applicant—
(i) in an amount exceeding 75 percent of the costs of providing health services for the first fiscal year of payments under the grant and 662/3 percent of the costs of providing such services for any subsequent fiscal year of payments under the grant; and
(ii) unless the applicant agrees that the applicant will make available, directly or through donations to the applicant, non-Federal contributions toward such costs in an amount equal to not less than $1 (in cash or in kind under subparagraph (B)) for each $3 of Federal funds provided for the first fiscal year of payments under the grant and not less than $1 (in cash or in kind under such subparagraph) for each $2 of Federal funds provided for any subsequent fiscal year of payments under the grant.
(B)(i) Non-Federal contributions required in subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(ii) Such determination may not include any cash or in-kind contributions that, prior to February 26, 1987, were made available by any public or private entity for the purpose of assisting homeless individuals (including assistance other than the provision of health services).
(2) The Secretary may waive the requirement established in paragraph (1)(A) if the applicant involved is a nonprofit private entity and the Secretary determines that it is not feasible for the applicant to comply with such requirement.
(f) Requirement of provision of certain health services
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant agrees that the applicant will, directly or through contract—
(1) provide health services at locations accessible to homeless individuals;
(2) provide to homeless individuals, at all hours, emergency health services;
(3) refer homeless individuals as appropriate to medical facilities for necessary hospital services;
(4) refer for mental health services homeless individuals who are mentally ill to entities that provide such services, unless the applicant will provide such services pursuant to subsection (g) of this section;
(5) provide outreach services to inform homeless individuals of the availability of health services; and
(6) aid homeless individuals in establishing eligibility for assistance, and in obtaining services, under entitlement programs.
(g) Optional provision of certain services
A grantee under subsection (a) of this section may expend amounts received pursuant to such subsection for the purpose of providing to homeless individuals mental health services, dental services (including dentures), services with respect to vision, and podiatry services.
(h) Temporary continued provision of services to certain former homeless individuals
If any grantee under subsection (a) of this section has provided services described in subsection (f) or (g) of this section to a homeless individual, any such grantee may, notwithstanding that the individual is no longer homeless as a result of becoming a resident in permanent housing, expend the grant to continue to provide such services to the individual for not more than 12 months.
(i) Restrictions on use of grant funds
(1) The Secretary may not, except as provided in paragraph (2), make a grant under subsection (a) of this section to an applicant unless the applicant agrees that amounts received pursuant to such subsection will not, directly or through contract, be expended—
(A) for any purpose other than the purposes described in subsections (a) and (g) of this section;
(B) to provide inpatient services, except with respect to residential treatment for substance abuse provided in settings other than hospitals;
(C) to make cash payments to intended recipients of health services or mental health services; or
(D) to purchase or improve real property (other than minor remodeling of existing improvements to real property) or to purchase major medical equipment.
(2) If the Secretary finds that the purpose described in subsection (a) of this section cannot otherwise be carried out, the Secretary may, with respect to an otherwise qualified applicant, waive the restriction established in paragraph (1)(D).
(j) Limitation on charges for services
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant agrees that, whether health services are provided directly or through contract—
(1) health services under the grant will be provided without regard to ability to pay for the health services; and
(2) if a charge is imposed for the delivery of health services, such charge—
(A) will be made according to a schedule of charges that is made available to the public;
(B) will not be imposed on any homeless individual with an income less than the official poverty level; and
(C) will be adjusted to reflect the income and resources of the homeless individual involved.
(k) Requirements with respect to administration
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant—
(1) agrees to establish such procedures for fiscal control and fund accounting as may be necessary to ensure proper disbursement and accounting with respect to the grant;
(2) agrees to establish an ongoing program of quality assurance with respect to the health services provided under the grant;
(3) agrees to ensure the confidentiality of records maintained on homeless individuals receiving health services under the grant;
(4) with respect to providing health services to any population of homeless individuals a substantial portion of which has a limited ability to speak the English language—
(A) has developed and has the ability to carry out a reasonable plan to provide health services under the grant through individuals who are able to communicate with the population involved in the language and cultural context that is most appropriate; and
(B) has designated at least one individual, fluent in both English and the appropriate language, to assist in carrying out the plan; and
(5) agrees to submit to the Secretary an annual report that describes the utilization and costs of health services provided under the grant and that provides such other information as the Secretary determines to be appropriate.
(l) Limitation on administrative expenses of grantee
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant agrees that the applicant will not expend more than 10 percent of amounts received pursuant to such subsection for the purpose of administering the grant.
(m) Use of grant funds for referrals to certain advocacy systems
A grantee under subsection (a) of this section may, with respect to title I of the Protection and Advocacy for Mentally Ill Individuals Act of 1986 [
(n) Use of self-help organizations
Any grantee under subsection (a) of this section may provide health services through contracts with nonprofit self-help organizations that—
(1) are established and managed by current and former recipients of mental health services, or substance abuse services, who have been homeless individuals; and
(2) with respect to the provision of health services described in subsection (b)(3) of this section, are organizations qualified under subparagraph (B) of such subsection.
(o) Technical assistance
(1) The Secretary may, without charge to any grantee under subsection (a) of this section, provide technical assistance to any such grantee with respect to the planning, development, and operation of programs to carry out the purpose described in such subsection. The Secretary may provide such technical assistance directly, through contract, or through grants.
(2) Of the amounts appropriated pursuant to subsection (q)(1) of this section for a fiscal year, the Secretary may expend not more than $2,000,000 for the purpose of carrying out paragraph (1).
(p) Annual reports by Secretary
Not later than January 10 of each year, the Secretary shall submit to the Congress a report describing the utilization and costs of health services provided under subsection (a) of this section during the immediately preceding fiscal year.
(q) Funding
(1) There are authorized to be appropriated to carry out this section $70,000,000 for fiscal year 1991, $80,000,000 for fiscal year 1992, and such sums as may be necessary for each of the fiscal years 1993 and 1994.
(2) Amounts received by a grantee pursuant to subsection (a) of this section remaining unobligated at the end of the fiscal year in which the amounts were received shall remain available to the grantee during the succeeding fiscal year for the purpose described in such subsection.
(r) Definitions
For purposes of this section:
(1) The term "health services" means primary health services and substance abuse services.
(2) The term "homeless individual" means an individual who lacks housing (without regard to whether the individual is a member of a family), including an individual whose primary residence during the night is a supervised public or private facility that provides temporary living accommodations and an individual who is a resident in transitional housing.
(3) The term "medically underserved population" has the meaning given such term in
(4) The term "official poverty level" means the nonfarm income official poverty line defined by the Office of Management and Budget and revised annually in accordance with
(5) The term "organization" includes individuals, corporations, partnerships, companies, and associations.
(6) The term "primary health services" has the meaning given such term in
(7) The term "substance abuse" has the meaning given such term in section 290cc–36(4) 1 of this title.
(8) The term "substance abuse services" includes detoxification and residential treatment for substance abuse provided in settings other than hospitals.
(s) Grants regarding outreach and primary health services for homeless children
(1) The Secretary may make grants to entities specified in paragraph (2) for the purpose of enabling the entities, directly or through contracts, to carry out demonstration programs—
(A) to provide comprehensive primary health services to homeless children and to children at imminent risk of homelessness, including such services provided through mobile medical units;
(B) to provide referrals for the provision of appropriate health services, social services, and education services to children receiving services under subparagraph (A) (including referrals regarding hospitals, the programs of
(C) to provide outreach services to identify children who are homeless and to inform the parents (or other guardians) of the children of the availability of services from the grantees and from the entities or programs specified in subparagraph (B).
(2) The entities referred to in paragraph (1) are—
(A) grantees under subsection (a) of this section, and other public and nonprofit private entities (other than children's hospitals) that provide primary health services, and substance abuse services, to a substantial number of homeless individuals; and
(B) public and nonprofit private children's hospitals that provide primary health services to a substantial number of such individuals.
(3)(A) The Secretary may not make a grant under paragraph (1) to a hospital unless the hospital agrees, with respect to the costs of providing services under such paragraph, to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than $1 for each $1 of Federal funds provided in the grant.
(B) Non-Federal contributions required in subparagraph (A) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(4) The Secretary may not make a grant under paragraph (1) unless the applicant for the grant agrees that subsections (b)(3), (h), (i), and (j) of this section will apply to the grant to the same extent and in the same manner as such subsections apply to any grant under subsection (a) of this section. For purposes of subsection (i)(1)(D) of this section (including as applied to this subsection by the preceding sentence), mobile medical units shall be considered to be major medical equipment.
(5) The Secretary may not make a grant under paragraph (1) unless the applicant for the grant agrees to collect such data as the Secretary determines to be necessary for assessing the efficacy of services provided under paragraph (1) to homeless children.
(6) The Secretary may not make a grant under paragraph (1) unless an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this subsection.
(7) In making grants under paragraph (1), the Secretary shall take into account the needs of homeless children in rural areas.
(8) For the purpose of carrying out this subsection, there is authorized to be appropriated $5,000,000 for each of the fiscal years 1991 through 1993.
(t) Infant mortality and morbidity
(1) In general
The Secretary may make grants to grantees under subsection (a) of this section for the purpose of assisting such grantees in—
(A) providing comprehensive health care and support services for the reduction of (i) the incidence of infant mortality, and (ii) morbidity among children who are less than 3 years of age; and
(B) developing and coordinating service and referral arrangements between such grantees and other entities for the health management of pregnant women and children described in subparagraph (A).
(2) Required activities
The Secretary may make a grant under paragraph (1) only if the applicant involved agrees to expend the grant for the following activities with respect to the purpose described in such paragraph:
(A) Primary health services, including prenatal care.
(B) Community education, outreach, and case finding.
(C) Case management services.
(D) Client education, including parenting and child development education.
(3) Certain authorized activities
The purposes for which a grant under paragraph (1) may be expended include, with respect to the purpose described in such paragraph, substance abuse screening, counseling and referral services, and other necessary nonmedical support services, including child care, translation services, and housing assistance.
(4) Certain requirements regarding provision of services
The Secretary may make a grant under paragraph (1) only if the applicant involved agrees that—
(A) the applicant will coordinate the provision of services under the grant to each of the recipients of the services;
(B) such services will be continuous for each such recipient;
(C) the applicant will provide follow-up services for individuals who are referred by the applicant for services described in paragraph (3); and
(D) the grant will be expended to supplement, and not supplant, the expenditures of the applicant for primary health services (including prenatal care) with respect to the purpose described in paragraph (1).
(5) Application for grant
The Secretary may make a grant under paragraph (1) only if an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this subsection.
(6) Authorization of appropriations
For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 and 1994.
(July 1, 1944, ch. 373, title III, §340, as added July 22, 1987,
References in Text
The Social Security Act, referred to in subsec. (b)(1)(C), is act Aug. 14, 1935, ch. 531,
The Protection and Advocacy for Mentally Ill Individuals Act of 1986, referred to in subsec. (m), is
The Head Start Act, referred to in subsec. (s)(1)(B), is subchapter B (§§635–657) of
Prior Provisions
A prior section 256, act July 1, 1944, ch. 373, title III, §340, as added Nov. 10, 1978,
Another prior section 256, act July 1, 1944, ch. 373, title III, §340, formerly §332,
Amendments
1992—Subsec. (t).
1990—Subsec. (b).
"(1) the applicant is a public or nonprofit private entity;
"(2) the applicant has the capacity to effectively administer a grant under subsection (a) of this section; and
"(3) with respect to health services that are covered in the appropriate State plan approved under title XIX of the Social Security Act—
"(A) if the applicant will provide under the grant any such health services directly—
"(i) the applicant has entered into a participation agreement under the appropriate State plan; and
"(ii) the applicant is qualified to receive payments under the appropriate State plan; and
"(B) if the applicant will provide under the grant any such health services through a contract with an organization—
"(i) the organization has entered into a participation agreement under the appropriate State plan; and
"(ii) the organization is qualified to receive payments under the appropriate State plan."
Subsec. (q)(1).
Subsec. (s).
1989—Subsecs. (d)(1), (e)(1)(A), (2).
Subsec. (g).
Subsecs. (h) to (r).
1988—Subsec. (d)(1).
Subsec. (e)(1)(A)(i).
Subsec. (e)(1)(A)(ii).
Subsec. (e)(2).
"(A) the applicant involved is a nonprofit private grantee under
"(B) the Secretary determines that it is not feasible for the applicant to comply with such requirement."
Subsec. (h).
Subsecs. (i) to (n).
Subsec. (o).
Subsec. (o)(2).
Subsec. (p).
Subsec. (q).
Subsec. (q)(1).
Subsec. (r).
Subsec. (r)(2).
Effective Date of 1988 Amendments
Section 601(b) of
Section 631 of title VI of
Section 801(b) of
Section 831 of title VIII of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
subpart vi—health services for residents of public housing
§256a. Health services for residents of public housing
(a) Establishment
(1) The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants for the purpose of enabling grantees, directly or through contracts, to provide to residents of public housing, subject to subsections (e) and (f) of this section—
(A) primary health services, including health screenings; and
(B) health counseling and education services.
(2) The Secretary may not make a grant under paragraph (1) unless the applicant for the grant agrees to expend the grant to carry out each of subparagraphs (A) and (B) of such paragraph.
(3) In carrying out the program established in paragraph (1), the Administrator shall consult with the Director of the Centers for Disease Control.
(b) Minimum qualifications of grantees
(1) Subject to paragraph (2), the Secretary may not make a grant under subsection (a) of this section to an applicant unless—
(A) the applicant is a public or nonprofit private entity;
(B) the applicant has the capacity to effectively administer a grant under subsection (a) of this section; and
(C) in the case of any service under this section that is available pursuant to the State plan approved under title XIX of the Social Security Act [
(i) the applicant for the grant will provide the service directly, and the applicant has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(ii) the applicant for the grant will enter into an agreement with a public or nonprofit private organization under which the organization will provide the service, and the organization has entered into such a participation agreement and is qualified to receive such payments.
(2)(A) In the case of an organization making an agreement pursuant to paragraph (1)(C)(ii) regarding the provision of services under subsection (a) of this section, the requirement established in such paragraph regarding a participation agreement shall be waived by the Secretary if the organization does not, in providing services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program.
(B) A determination by the Secretary of whether an organization referred to in subparagraph (A) meets the criteria for a waiver under such subparagraph shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the public.
(c) Preferences in making grants
The Secretary shall, in making grants under subsection (a) of this section, give preference to qualified applicants that—
(1) are resident management corporations under
(2) are receiving funds under
(d) Requirement of matching funds from public grantees
(1) In the case of a public entity applying for a grant under subsection (a) of this section, the Secretary may not make such a grant unless the public entity agrees that, with respect to the costs to be incurred by such entity in carrying out the purpose described in such subsection, the entity will make available non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $1 of Federal funds provided in the grant.
(2) In determining the amount of non-Federal contributions in cash that a public entity has provided pursuant to paragraph (1), the Secretary may not include any amounts provided to the public entity by the Federal Government.
(e) Requirements regarding services
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant agrees that the applicant will, directly or through contract—
(1) provide services under this section on the premises of public housing projects or at other locations immediately accessible to residents of public housing;
(2) refer such residents, as appropriate, to qualified facilities and practitioners for necessary follow-up services;
(3) provide outreach services to inform such residents of the availability of such services; and
(4) aid such residents in establishing eligibility for assistance, and in obtaining services, under Federal, State, and local programs providing health services, mental health services, or social services.
(f) Optional provision of certain services
(1) A grantee under subsection (a) of this section may expend the grant—
(A) to train residents of public housing to provide health screenings and to provide educational services; and
(B) to provide health services to individuals who are not residents of public housing.
(2) The Secretary may not make a grant under subsection (a) of this section unless the applicant for the grant agrees that if, pursuant to paragraph (1)(B), the applicant provides health services to individuals who are not residents of public housing, the health services will be provided to such individuals under the same terms and conditions as such services are provided to residents of public housing (including all terms and conditions in effect pursuant to this section).
(g) Consultation with residents
The Secretary may not make a grant under subsection (a) of this section unless, with respect to the residents of the public housing involved, the applicant for the grant—
(1) has consulted with the residents in the preparation of the application for the grant; and
(2) agrees to provide for ongoing consultation with the residents regarding the planning and administration of the program carried out with the grant.
(h) Restrictions on use of grant funds
(1) The Secretary may not, except as provided in paragraph (2), make a grant under subsection (a) of this section to an applicant unless the applicant agrees that amounts received pursuant to such subsection will not, directly or through contract, be expended—
(A) for any purpose other than the purposes authorized in this section;
(B) to provide inpatient services;
(C) to make cash payments to intended recipients of services under this section; or
(D) to purchase or improve real property (other than minor remodeling of existing improvements to real property) or to purchase major medical equipment or motor vehicles.
(2) If the Secretary finds that the purpose described in subsection (a) of this section cannot otherwise be carried out, the Secretary may, with respect to an otherwise qualified applicant, waive the restriction established in paragraph (1)(D).
(i) Limitation on charges for services
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant agrees that, whether the services are provided directly or through contract—
(1) services under the grant will be provided without regard to ability to pay for the services; and
(2) if a charge is imposed for the delivery of the services, such charge—
(A) will be made according to a schedule of charges that is made available to the public;
(B) will not be imposed on any resident of public housing with an income less than the official poverty level; and
(C) will be adjusted to reflect the income and resources of the resident of public housing involved.
(j) Requirements regarding administration
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant—
(1) agrees to establish such procedures for fiscal control and fund accounting as may be necessary to ensure proper disbursement and accounting with respect to the grant;
(2) agrees to establish an ongoing program of quality assurance with respect to the services provided under the grant;
(3) agrees to ensure the confidentiality of records maintained on residents of public housing that are receiving such services;
(4) with respect to providing services to any population of such residents a substantial portion of which has a limited ability to speak the English language—
(A) has developed and has the ability to carry out a reasonable plan to provide services under the grant through individuals who are able to communicate with the population involved in the language and cultural context that is most appropriate; and
(B) has designated at least one individual, fluent in both English and the appropriate language, to assist in carrying out the plan; and
(5) agrees to submit to the Secretary an annual report that describes the utilization and costs of services provided under the grant and that provides such other information as the Secretary determines to be appropriate.
(k) Limitation on administrative expenses of grantee
The Secretary may not make a grant under subsection (a) of this section to an applicant unless the applicant agrees that the applicant will not expend more than 10 percent of amounts received pursuant to such subsection for the purpose of administering the grant.
(l) Requirement of application
The Secretary may not provide financial assistance under subsection (a) of this section unless—
(1) an application for the assistance is submitted to the Secretary;
(2) with respect to carrying out the purpose for which the assistance is to be provided, the application provides assurances of compliance satisfactory to the Secretary; and
(3) the application otherwise is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(m) Technical assistance
(1) The Secretary may provide technical assistance to applicants and grantees under subsection (a) of this section regarding the planning, development, and operation of programs to carry out the purpose described in such subsection. The Secretary may provide such technical assistance directly, through contracts, or through grants.
(2) Any technical assistance provided by the Secretary under paragraph (1) shall be provided without charge to applicants and grantees under subsection (a) of this section.
(3) Of the amounts appropriated pursuant to subsection (p)(1) of this section for a fiscal year, the Secretary may expend not more than $2,000,000 for the purpose of carrying out paragraph (1).
(n) Annual reports by Secretary
Not later than January 10 of each year, the Secretary shall submit to the Congress a report describing the utilization and costs of services provided under this section during the immediately preceding fiscal year.
(o) Definitions
For purposes of this section:
(1) The term "official poverty level" means the nonfarm income official poverty line defined by the Office of Management and Budget and revised annually in accordance with
(2) The term "organization" includes individuals, corporations, partnerships, companies, and associations.
(3) The term "primary health services" has the meaning given such term in
(4) The term "public housing" has the meaning given such term in
(p) Funding
(1) For the purpose of carrying out this section, there are authorized to be appropriated $35,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
(2) Amounts received by a grantee pursuant to subsection (a) of this section remaining unobligated at the end of the fiscal year in which the amounts were received shall remain available to the grantee during the succeeding fiscal year for the purpose described in such subsection.
(q) Infant mortality and morbidity
(1) In general
The Secretary may make grants to grantees under subsection (a) of this section for the purpose of assisting such grantees in—
(A) providing comprehensive health care and support services for the reduction of (i) the incidence of infant mortality, and (ii) morbidity among children who are less than 3 years of age; and
(B) developing and coordinating service and referral arrangements between such grantees and other entities for the health management of pregnant women and children described in subparagraph (A).
(2) Required activities
The Secretary may make a grant under paragraph (1) only if the applicant involved agrees to expend the grant for the following activities with respect to the purpose described in such paragraph:
(A) Primary health services, including prenatal care.
(B) Community education, outreach, and case finding.
(C) Case management services.
(D) Client education, including parenting and child development education.
(3) Certain authorized activities
The purposes for which a grant under paragraph (1) may be expended include, with respect to the purpose described in such paragraph, substance abuse screening, counseling and referral services, and other necessary nonmedical support services, including child care, translation services, and housing assistance.
(4) Certain requirements regarding provision of services
The Secretary may make a grant under paragraph (1) only if the applicant involved agrees that—
(A) the applicant will coordinate the provision of services under the grant to each of the recipients of the services;
(B) such services will be continuous for each such recipient;
(C) the applicant will provide follow-up services for individuals who are referred by the applicant for services described in paragraph (3); and
(D) the grant will be expended to supplement, and not supplant, the expenditures of the applicant for primary health services (including prenatal care) with respect to the purpose described in paragraph (1).
(5) Application for grant
The Secretary may make a grant under paragraph (1) only if an application for the grant is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this subsection.
(6) Authorization of appropriations
For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1993 and 1994.
(July 1, 1944, ch. 373, title III, §340A, as added Nov. 6, 1990,
References in Text
The Social Security Act, referred to in subsec. (b)(1)(C), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 256a, act July 1, 1944, ch. 373, title III, §340A, as added Nov. 10, 1978,
Amendments
1992—Subsec. (q).
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Section Referred to in Other Sections
This section is referred to in
subpart vii—drug pricing agreements
§256b. Limitation on prices of drugs purchased by covered entities
(a) Requirements for agreement with Secretary
(1) In general
The Secretary shall enter into an agreement with each manufacturer of covered drugs under which the amount required to be paid (taking into account any rebate or discount, as provided by the Secretary) to the manufacturer for covered drugs (other than drugs described in paragraph (3)) purchased by a covered entity on or after the first day of the first month that begins after November 4, 1992, does not exceed an amount equal to the average manufacturer price for the drug under title XIX of the Social Security Act [
(2) "Rebate percentage" defined
(A) In general
For a covered outpatient drug purchased in a calendar quarter, the "rebate percentage" is the amount (expressed as a percentage) equal to—
(i) the average total rebate required under section 1927(c) of the Social Security Act [
(ii) the average manufacturer price for such a unit of the drug during such quarter.
(B) Over the counter drugs
(i) In general
For purposes of subparagraph (A), in the case of over the counter drugs, the "rebate percentage" shall be determined as if the rebate required under section 1927(c) of the Social Security Act [
(ii) "Over the counter drug" defined
The term "over the counter drug" means a drug that may be sold without a prescription and which is prescribed by a physician (or other persons authorized to prescribe such drug under State law).
(3) Drugs provided under State medicaid plans
Drugs described in this paragraph are drugs purchased by the entity for which payment is made by the State under the State plan for medical assistance under title XIX of the Social Security Act [
(4) "Covered entity" defined
In this section, the term "covered entity" means an entity that meets the requirements described in paragraph (5) and is one of the following:
(A) A Federally-qualified health center (as defined in section 1905(l)(2)(B) of the Social Security Act [
(B) An entity receiving a grant under
(C) A family planning project receiving a grant or contract under
(D) An entity receiving a grant under subpart II of part C of subchapter XXIV of this chapter (relating to categorical grants for outpatient early intervention services for HIV disease).
(E) A State-operated AIDS drug purchasing assistance program receiving financial assistance under subchapter XXIV of this chapter.
(F) A black lung clinic receiving funds under
(G) A comprehensive hemophilia diagnostic treatment center receiving a grant under section 501(a)(2) of the Social Security Act [
(H) A Native Hawaiian Health Center receiving funds under the Native Hawaiian Health Care Act of 1988.
(I) An urban Indian organization receiving funds under title V of the Indian Health Care Improvement Act [
(J) Any entity receiving assistance under subchapter XXIV of this chapter (other than a State or unit of local government or an entity described in subparagraph (D)), but only if the entity is certified by the Secretary pursuant to paragraph (7).
(K) An entity receiving funds under
(L) A subsection (d) hospital (as defined in section 1886(d)(1)(B) of the Social Security Act [
(i) is owned or operated by a unit of State or local government, is a public or private non-profit corporation which is formally granted governmental powers by a unit of State or local government, or is a private non-profit hospital which has a contract with a State or local government to provide health care services to low income individuals who are not entitled to benefits under title XVIII of the Social Security Act [
(ii) for the most recent cost reporting period that ended before the calendar quarter involved, had a disproportionate share adjustment percentage (as determined under section 1886(d)(5)(F) of the Social Security Act [
(iii) does not obtain covered outpatient drugs through a group purchasing organization or other group purchasing arrangement.
(5) Requirements for covered entities
(A) Prohibiting duplicate discounts or rebates
(i) In general
A covered entity shall not request payment under title XIX of the Social Security Act [
(ii) Establishment of mechanism
The Secretary shall establish a mechanism to ensure that covered entities comply with clause (i). If the Secretary does not establish a mechanism within 12 months under the previous sentence, the requirements of section 1927(a)(5)(C) of the Social Security Act [
(B) Prohibiting resale of drugs
With respect to any covered outpatient drug that is subject to an agreement under this subsection, a covered entity shall not resell or otherwise transfer the drug to a person who is not a patient of the entity.
(C) Auditing
A covered entity shall permit the Secretary and the manufacturer of a covered outpatient drug that is subject to an agreement under this subsection with the entity (acting in accordance with procedures established by the Secretary relating to the number, duration, and scope of audits) to audit at the Secretary's or the manufacturer's expense the records of the entity that directly pertain to the entity's compliance with the requirements described in subparagraphs 2 (A) or (B) with respect to drugs of the manufacturer.
(D) Additional sanction for noncompliance
If the Secretary finds, after notice and hearing, that a covered entity is in violation of a requirement described in subparagraphs 2 (A) or (B), the covered entity shall be liable to the manufacturer of the covered outpatient drug that is the subject of the violation in an amount equal to the reduction in the price of the drug (as described in subparagraph (A)) provided under the agreement between the entity and the manufacturer under this paragraph.
(6) Treatment of distinct units of hospitals
In the case of a covered entity that is a distinct part of a hospital, the hospital shall not be considered a covered entity under this paragraph unless the hospital is otherwise a covered entity under this subsection.
(7) Certification of certain covered entities
(A) Development of process
Not later than 60 days after November 4, 1992, the Secretary shall develop and implement a process for the certification of entities described in subparagraphs (J) and (K) of paragraph (4).
(B) Inclusion of purchase information
The process developed under subparagraph (A) shall include a requirement that an entity applying for certification under this paragraph submit information to the Secretary concerning the amount such entity expended for covered outpatient drugs in the preceding year so as to assist the Secretary in evaluating the validity of the entity's subsequent purchases of covered outpatient drugs at discounted prices.
(C) Criteria
The Secretary shall make available to all manufacturers of covered outpatient drugs a description of the criteria for certification under this paragraph.
(D) List of purchasers and dispensers
The certification process developed by the Secretary under subparagraph (A) shall include procedures under which each State shall, not later than 30 days after the submission of the descriptions under subparagraph (C), prepare and submit a report to the Secretary that contains a list of entities described in subparagraphs (J) and (K) of paragraph (4) that are located in the State.
(E) Recertification
The Secretary shall require the recertification of entities certified pursuant to this paragraph on a not more frequent than annual basis, and shall require that such entities submit information to the Secretary to permit the Secretary to evaluate the validity of subsequent purchases by such entities in the same manner as that required under subparagraph (B).
(8) Development of prime vendor program
The Secretary shall establish a prime vendor program under which covered entities may enter into contracts with prime vendors for the distribution of covered outpatient drugs. If a covered entity obtains drugs directly from a manufacturer, the manufacturer shall be responsible for the costs of distribution.
(9) Notice to manufacturers
The Secretary shall notify manufacturers of covered outpatient drugs and single State agencies under section 1902(a)(5) of the Social Security Act [
(10) No prohibition on larger discount
Nothing in this subsection shall prohibit a manufacturer from charging a price for a drug that is lower than the maximum price that may be charged under paragraph (1).
(b) Other definitions
In this section, the terms "average manufacturer price", "covered outpatient drug", and "manufacturer" have the meaning given such terms in section 1927(k) of the Social Security Act [
(c) References to Social Security Act
Any reference in this section to a provision of the Social Security Act [
(d) Compliance with requirements
A manufacturer is deemed to meet the requirements of subsection (a) of this section if the manufacturer establishes to the satisfaction of the Secretary that the manufacturer would comply (and has offered to comply) with the provisions of this section (as in effect immediately after November 4, 1992), as applied by the Secretary, and would have entered into an agreement under this section (as such section was in effect at such time), but for a legislative change in this section (or the application of this section) after November 4, 1992.
(July 1, 1944, ch. 373, title III, §340B, as added Nov. 4, 1992,
References in Text
The Social Security Act, referred to in subsecs. (a)(1), (3), (4)(L)(i), (5)(A)(i), and (c), is act Aug. 14, 1935, ch. 531,
The Native Hawaiian Health Care Act of 1988, referred to in subsec. (a)(4)(H), was
The Indian Health Care Improvement Act, referred to in subsec. (a)(4)(I), is
Codification
Another section 340B of act July 1, 1944, was renumbered section 340C and is classified to
Amendments
1993—
Study of Treatment of Certain Clinics as Covered Entities Eligible for Prescription Drug Discounts
Section 602(b) of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 So in original. Probably should be "subparagraph".
subpart viii—bulk purchases of vaccines for certain programs
Amendments
1993—
§256c. Bulk purchases of vaccines for certain programs
(a) Agreements for purchases
(1) In general
Not later than 180 days after October 27, 1992, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Administrator of the Health Resources and Services Administration, shall enter into negotiations with manufacturers of vaccines for the purpose of establishing and maintaining agreements under which entities described in paragraph (2) may purchase vaccines from the manufacturers at the prices specified in the agreements.
(2) Relevant entities
The entities referred to in paragraph (1) are entities that provide immunizations against vaccine-preventable diseases under the programs established in
(b) Negotiation of prices
In carrying out subsection (a) of this section, the Secretary shall, to the extent practicable, ensure that the prices provided for in agreements under such subsection are comparable to the prices provided for in agreements negotiated by the Secretary on behalf of grantees under
(c) Authority of Secretary
In carrying out subsection (a) of this section, the Secretary, in the discretion of the Secretary, may enter into the agreements described in such subsection (and may decline to enter into such agreements), may modify such agreements, may extend such agreements, and may terminate such agreements.
(d) Rule of construction
This section may not be construed as requiring any State to reduce or terminate the supply of vaccines provided by the State to any of the entities described in subsection (a)(2) of this section.
(July 1, 1944, ch. 373, title III, §340C, formerly §340B, as added Oct. 27, 1992,
§256d. Breast and cervical cancer information
(a) In general
As a condition of receiving grants, cooperative agreements, or contracts under this chapter, each of the entities specified in subsection (c) of this section shall, to the extent determined to be appropriate by the Secretary, make available information concerning breast and cervical cancer.
(b) Certain authorities
In carrying out subsection (a) of this section, an entity specified in subsection (c) of this section—
(1) may make the information involved available to such individuals as the entity determines appropriate;
(2) may, as appropriate, provide information under subsection (a) of this section on the need for self-examination of the breasts and on the skills for such self-examinations;
(3) shall provide information under subsection (a) of this section in the language and cultural context most appropriate to the individuals to whom the information is provided; and
(4) shall refer such clients as the entities determine appropriate for breast and cervical cancer screening, treatment, or other appropriate services.
(c) Relevant entities
The entities specified in this subsection are the following:
(1) Entities receiving assistance under
(2) Entities receiving assistance under
(3) Migrant health centers receiving assistance under
(4) Community health centers receiving assistance under
(5) Entities receiving assistance under
(6) Entities receiving assistance under
(7) Entities providing services with assistance under subchapter III–A of this chapter or subchapter XVII of this chapter.
(8) Entities receiving assistance under
(9) Entities receiving assistance under subchapter XXIV of this chapter (relating to services with respect to acquired immune deficiency syndrome).
(10) Non-Federal entities authorized under the Indian Self-Determination Act [
(July 1, 1944, ch. 373, title III, §340D, as added Dec. 14, 1993,
References in Text
The Indian Self-Determination Act, referred to in subsec. (c)(10), is title I of
Part E—Narcotic Addicts and Other Drug Abusers
Amendments
1970—
§257. Care and treatment of narcotic addicts
(a) Surgeon General authorized to provide programs
The Surgeon General is authorized to provide for the confinement, care, protection, treatment, and discipline of persons addicted to the use of habit-forming narcotic drugs who are civilly committed to treatment under the Narcotic Addict Rehabilitation Act of 1966, addicts and other persons with drug abuse and drug dependence problems who voluntarily submit themselves for treatment, and addicts convicted of offenses against the United States, including persons convicted by general courts-martial and consular courts. Such care and treatment shall be provided at hospitals of the Service especially equipped for the accommodation of such patients or elsewhere where authorized under other provisions of law, and shall be designed to rehabilitate such persons, to restore them to health, and, where necessary, to train them to be self-supporting and self-reliant; but nothing in this section or in this part shall be construed to limit the authority of the Surgeon General under other provisions of law to provide for the conditional release of patients and for aftercare under supervision. In carrying out this subsection, the Secretary shall establish in each hospital and other appropriate medical facility of the Service a treatment and rehabilitation program for drug addicts and other persons with drug abuse and drug dependence problems who are in the area served by such hospital or other facility; except that the requirement of this sentence shall not apply in the case of any such hospital or other facility with respect to which the Secretary determines that there is not sufficient need for such a program in such hospital or other facility.
(b) Furnishing of information relating to persons voluntarily undergoing care to Mayor of District of Columbia
Upon the admittance to, and departure from, a hospital of the Service of a person who voluntarily submitted himself for treatment pursuant to the provisions of this section, and who at the time of his admittance to such hospital was a resident of the District of Columbia, the Surgeon General shall furnish to the Mayor of the District of Columbia or his designated agent, the name, address, and such other pertinent information as may be useful in the rehabilitation to society of such person.
(c) Agreements with other departments and agencies
The Secretary may enter into agreements with the Secretary of Veterans Affairs, the Secretary of Defense, and the head of any other department or agency of the Government under which agreements hospitals and other appropriate medical facilities of the Service may be used in treatment and rehabilitation programs provided by such department or agency for drug addicts and other persons with drug abuse and other drug dependence problems who are in areas served by such hospitals or other facilities.
(July 1, 1944, ch. 373, title III, §341,
References in Text
The Narcotic Addict Rehabilitation Act of 1966, referred to in subsec. (a), is
Codification
Section is also set out in D.C. Code, §24–613.
Amendments
1991—Subsec. (c).
1986—Subsec. (a).
1984—Subsec. (a).
1972—Subsec. (a).
Subsec. (c).
1970—Subsec. (a).
1966—Subsec. (a).
Subsec. (b).
1956—Act July 24, 1956, required the Surgeon General to furnish to the Commissioners or their designated agent, the name, address, and any other useful information relating to persons who voluntarily submit themselves for treatment and who, at the time of submission, are residents of the District of Columbia.
1954—Act May 8, 1954, inserted in first sentence reference to addicts who are committed to the Service or to a hospital thereof pursuant to
Effective Date of 1986 Amendment
Section 22(b) of
Effective Date of 1984 Amendment
Amendment by
Transfer of Functions
Except as otherwise provided in Reorg. Plan No. 3 of 1967, functions of Board of Commissioners of District of Columbia transferred to Commissioner of District of Columbia by section 401 of Reorg. Plan No. 3 of 1967. Office of Commissioner of District of Columbia, as established by Reorg. Plan No. 3 of 1967, abolished as of noon Jan. 2, 1975, by
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Cross References
Third party tort liability to United States for hospital and medical care, see
Section Referred to in Other Sections
This section is referred to in
§257a. Medical treatment of narcotics addiction; report to Congress
The Secretary of Health and Human Services, after consultation with the Attorney General and with national organizations representative of persons with knowledge and experience in the treatment of narcotic addicts, shall determine the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts, and shall report thereon from time to time to the Congress.
(
Codification
Section was not enacted as part of the Public Health Service Act which comprises this chapter.
Change of Name
"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of
§258. Employment; establishment of industries, plants, etc.; sale of commodities; disposition of proceeds
Narcotic addicts or other persons with drug abuse and drug dependence problems in hospitals of the Service designated for their care shall be employed in such manner and under such conditions as the Surgeon General may direct. In such hospitals the Surgeon General may, in his discretion, establish industries, plants, factories, or shops for the production and manufacture of articles, commodities, and supplies for the United States Government. The Secretary of the Treasury may require any Government department, establishment, or other institution, for whom appropriations are made directly or indirectly by the Congress of the United States, to purchase at current market prices, as determined by him or his authorized representative, such of the articles, commodities, or supplies so produced or manufactured as meet their specifications; and the Surgeon General shall provide for payment to the inmates or their dependents of such pecuniary earnings as he may deem proper. The Secretary of Health and Human Services shall establish a working-capital fund for such industries, plants, factories, and shops out of any funds appropriated for Public Health Service hospitals at which addicts or other persons with drug abuse and drug dependence problems are treated and cared for; and such fund shall be available for the purchase, repair, or replacement of machinery or equipment, for the purchase of raw materials and supplies, for the purchase of uniforms and other distinctive wearing apparel of employees in the performance of their official duties, and for the employment of necessary civilian officers and employees. The Surgeon General may provide for the disposal of products of the industrial activities conducted pursuant to this section, and the proceeds of any sales thereof shall be covered into the Treasury of the United States to the credit of the working-capital fund.
(July 1, 1944, ch. 373, title III, §342,
Amendments
1970—
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§258a. Transfer of balances in working capital fund, narcotic hospitals, to surplus fund
As of June 30, 1947, and the end of each fiscal year thereafter any balances in the "Working capital fund, narcotic hospitals," in excess of $150,000 shall be transferred to the surplus fund of the Treasury.
(July 8, 1947, ch. 210, title II, §201,
Codification
Section was enacted as part of the Federal Security Agency Appropriation Act, 1948, and not as part of the Public Health Service Act which comprises this chapter.
§259. Convict addicts or other persons with drug abuse or drug dependence problems
(a) Transfers to and from hospitals; duty of prosecuting officers to report convicted persons believed to be addicts
The authority vested with the power to designate the place of confinement of a prisoner shall transfer to hospitals of the Service especially equipped for the accommodation of addicts or other persons with drug abuse and drug dependence problems, if accommodations are available, all addicts or other persons with drug abuse and drug dependence problems who have been or are hereafter sentenced to confinement, or who are now or shall hereafter be confined, in any penal, correctional, disciplinary, or reformatory institution of the United States, including those addicts or other persons with drug abuse and drug dependence problems convicted of offenses against the United States who are confined in State and Territorial prisons, penitentiaries, and reformatories, except that no addict or other person with a drug abuse or other drug dependence problem shall be transferred to a hospital of the Service who, in the opinion of the officer authorized to direct the transfer, is not a proper subject for confinement in such an institution either because of the nature of the crime he has committed or because of his apparent incorrigibility. The authority vested with the power to designate the place of confinement of a prisoner shall transfer from a hospital of the Service to the institution from which he was received, or to such other institution as may be designated by the proper authority, any addict or other person with a drug abuse or other drug dependence problem whose presence at a hospital of the Service is detrimental to the well-being of the hospital or who does not continue to be a narcotic addict or other person with a drug abuse or other drug dependence problem. All transfers of such prisoners to or from a hospital of the Service shall be accompanied by necessary attendants as directed by the officer in charge of such hospital and the actual and necessary expenses incident to such transfers shall be paid from the appropriation for the maintenance of such Service hospital except to the extent that other Federal agencies are authorized or required by law to pay expenses incident to such transfers. When sentence is pronounced against any person whom the prosecuting officer believes to be an addict or other person with a drug abuse or other drug dependence problem, such officer shall report to the authority vested with the power to designate the place of confinement, the name of such person, the reasons for his belief, all pertinent facts bearing on such addiction, drug abuse, or drug dependence, and the nature of the offense committed. Whenever an alien addict or other person with a drug abuse or other drug dependence problem transferred to a Service hospital pursuant to this subsection is entitled to his discharge but is subject to deportation, in lieu of being returned to the penal institution from which he came he shall be deported by the authority vested by law with power over deportation.
(b) Repealed. Pub. L. 92–293, §3, May 11, 1972, 86 Stat. 136
(c) Discharge; further treatment
Not later than one month prior to the expiration of the sentence of any addict or other person with a drug abuse or other drug dependence problem confined in a Service hospital, he shall be examined by the Surgeon General or his authorized representative. If the Surgeon General believes the person to be discharged is still an addict or other person with a drug abuse or other drug dependence problem and that he may by further treatment in a Service hospital be cured of his addiction, drug abuse, or drug dependence, the addict or other person with a drug abuse or other drug dependence problem shall be informed, in accordance with regulations, of the advisability of his submitting himself to further treatment. The addict or other person with a drug abuse or other drug dependence problem may then apply in writing to the Surgeon General for further treatment in a Service hospital for a period not exceeding the maximum length of time considered necessary by the Surgeon General. Upon approval of the application by the Surgeon General or his authorized agent, the addict or other person with a drug abuse or other drug dependence problem may be given such further treatment as is necessary to cure him of his addiction, drug abuse, or drug dependence.
(d) Gratuities and transportation furnished upon discharge or release on parole or supervised release
Every person convicted of an offense against the United States, upon discharge, or upon release on parole or supervised release, from a hospital of the Service, shall be furnished with the gratuities and transportation authorized by law to be furnished to prisoners upon release from a penal, correctional, disciplinary, or reformatory institution.
(e) Admission of probationers to hospitals for treatment
Any court of the United States having the power to suspend the imposition or execution of sentence and to place a defendant on probation under any existing laws may impose as one of the conditions of such probation that the defendant, if an addict or other person with a drug abuse or other drug dependence problem, shall submit himself for treatment at a hospital of the Service especially equipped for the accommodation of addicts or other persons with drug abuse and drug dependence problems until discharged therefrom as cured and that he shall be admitted thereto for such purpose. Upon the discharge of any such probationer from a hospital of the Service, he shall be furnished with the gratuities and transportation authorized by law to be furnished to prisoners upon release from a penal, correctional, disciplinary, or reformatory institution. The actual and necessary expense incident to transporting such probationer to such hospital and to furnishing such transportation and gratuities shall be paid from the appropriation for the maintenance of such hospital except to the extent that other Federal agencies are authorized or required by law to pay the cost of such transportation: Provided, That where existing law vests a discretion in any officer as to the place to which transportation shall be furnished or as to the amount of clothing and gratuities to be furnished, such discretion shall be exercised by the Surgeon General with respect to addicts or other persons with drug abuse and drug dependence problems discharged from hospitals of the Service.
(July 1, 1944, ch. 373, title III, §343,
Amendments
1984—Subsec. (d).
1972—Subsec. (b).
1970—
Effective Date of 1984 Amendment
Amendment by
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Cross References
Discharge from prison, transportation, clothing and money issued, see
§260. Addicts and persons with drug abuse or drug dependence problems
(a) Application for admission
Any addict or other person with a drug abuse or other drug dependence problem, whether or not he shall have been convicted of an offense against the United States, may apply to the Surgeon General for admission to a hospital of the Service especially equipped for the accommodation of addicts or other persons with drug abuse and drug dependence problems.
(b) Determination of addiction; conditions of admission; payment of subsistence, care, and treatment
Any applicant shall be examined by the Surgeon General who shall determine whether the applicant is an addict or other person with a drug abuse or other drug dependence problem, whether by treatment in a hospital of the Service he may probably be cured of his addiction, drug abuse, or drug dependence, and the estimated length of time necessary to effect his cure. The Surgeon General may, in his discretion, admit the applicant to a Service hospital. No such addict or other person with a drug abuse or other drug dependence problem shall be admitted unless he agrees to submit to treatment for the maximum amount of time estimated by the Surgeon General to be necessary to effect a cure, and unless suitable accommodations are available after all eligible addicts or other persons with drug abuse and drug dependence problems convicted of offenses against the United States have been admitted. Any such addict or other person with a drug abuse or other drug dependence problem may be required to pay for his subsistence, care, and treatment at rates fixed by the Surgeon General and amounts so paid shall be covered into the Treasury of the United States to the credit of the appropriation from which the expenditure for his subsistence, care, and treatment was made. Appropriations available for the care and treatment of addicts or other persons with drug abuse and drug dependence problems admitted to a hospital of the Service under this section shall be available, subject to regulations, for paying the cost of transportation to any place within the continental United States, including subsistence allowance while traveling, for any indigent addict or other person with a drug abuse or other drug dependence problem who is discharged as cured.
(c) Period of confinement
Any addict or other person with a drug abuse or other drug dependence problem admitted for treatment under this section, including any addict or other person with a drug abuse or other drug dependence problem, not convicted of an offense, who voluntarily submits himself for treatment, may be confined in a hospital of the Service for a period not exceeding the maximum amount of time estimated by the Surgeon General as necessary to effect a cure of the addiction, drug abuse, or drug dependence or until such time as he ceases to be an addict or other person with a drug abuse or other drug dependence problem.
(d) Other rights unaffected
Any addict or other person with a drug abuse or other drug dependence problem admitted for treatment under this section shall not thereby forfeit or abridge any of his rights as a citizen of the United States; nor shall such admission or treatment be used against him in any proceeding in any court; and the record of his voluntary commitment shall, except as otherwise provided by this chapter, be confidential and shall not be divulged.
(July 1, 1944, ch. 373, title III, §344,
Amendments
1970—
1956—Subsec. (d). Act July 24, 1956, substituted "shall, except as otherwise provided by this chapter, be confidential" for "shall be confidential".
1948—Subsec. (b). Act June 25, 1948, inserted sentence at end to continue authority to provide transportation for indigent narcotics who are discharged as cured.
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
§260a. Admission of addicts committed from District of Columbia
(a) Conditions
The Surgeon General is authorized to admit for care and treatment in any hospital of the Service suitably equipped therefor, and thereafter to transfer between hospitals of the Service in accordance with
(b) Discharge from hospitals; notice; delivery to court
Any person admitted to a hospital of the Service pursuant to subsection (a) of this section shall be discharged therefrom (1) upon order of the Superior Court of the District of Columbia, or (2) when he is found by the Surgeon General to be cured and rehabilitated. When any such person is so discharged, the Surgeon General shall give notice thereof to the Superior Court of the District of Columbia and shall deliver such person to such court for such further action as such court may deem necessary and proper under the provisions of the Act of June 24, 1953 (Public Law 76, Eighty-third Congress) [D.C. Code, §24–601 et seq.].
(c) Authority of Surgeon General and other officers
With respect to the detention, transfer, parole, or discharge of any person committed to a hospital of the Service in accordance with subsection (a) of this section, the Surgeon General and the officer in charge of the hospital, in addition to authority otherwise vested in them, shall have such authority as may be conferred upon them, respectively, by the order of the committing court.
(d) Payment of costs; determination; disposition of moneys; availability of appropriations
The cost of providing care and treatment for persons admitted to a hospital of the Service pursuant to subsection (a) of this section shall be a charge upon the District of Columbia and shall be paid by the District of Columbia to the Public Health Service, either in advance or otherwise, as may be determined by the Surgeon General. Such cost may be determined for each addict or on the basis of rates established for all or particular classes of patients, and shall include the cost of transportation to and from facilities of the Public Health Service. Moneys so paid to the Public Health Service shall be covered into the Treasury of the United States as miscellaneous receipts. Appropriations available for the care and treatment of addicts admitted to a hospital of the Service under this section shall be available, subject to regulations, for paying the cost of transportation to the District of Columbia, including subsistence allowance while traveling, for any such addict who is discharged.
(July 1, 1944, ch. 373, title III, §345, as added May 8, 1954, ch. 195, §2,
References in Text
Act of June 24, 1953 (Public Law 76, Eighty-third Congress), referred to in subsecs. (a) and (b), is act June 24, 1953, ch. 149,
Codification
Section is also set out in D.C. Code, §24–614.
Amendments
1970—Subsec. (b).
1956—Subsec. (a). Act July 24, 1956, substituted "July 1, 1958" for "July 1, 1956", and "one hundred" for "fifty".
Effective Date of 1970 Amendment
Amendment by
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Declaration of Purpose
With respect to enactment of this section and
§261. Penalties for introducing prohibited articles and substances into hospitals; escaping from, or aiding and abetting escape from hospitals
(a) Any person not authorized by law or by the Surgeon General who introduces or attempts to introduce into or upon the grounds of any hospital of the Service at which addicts or other persons with drug abuse and drug dependence problems are treated and cared for, any habit-forming narcotic drug or substance controlled under the Controlled Substances Act [
(b) It shall be unlawful for any person properly committed thereto to escape or attempt to escape from a hospital of the Service at which addicts or other persons with drug abuse and drug dependence problems are treated and cared for, and any such person upon apprehension and conviction in a United States court shall be punished by imprisonment for not more than five years, such sentence to begin upon the expiration of the sentence for which such person was originally confined.
(c) Any person who procures the escape of any person admitted to a hospital of the Service at which addicts or other persons with drug abuse and drug dependence problems are treated and cared for, or who advises, connives at, aids, or assists in such escape, or who conceals any such inmate after such escape, shall be punished upon conviction in a United States court by imprisonment in the penitentiary for not more than three years.
(July 1, 1944, ch. 373, title III, §346, formerly §345,
References in Text
The Controlled Substances Act, referred to in subsec. (a), is title II of
Amendments
1970—Subsec. (a).
Subsecs. (b), (c).
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
§261a. Release of patients; determination by Surgeon General
For purposes of this chapter, an individual shall be deemed cured of his addiction, drug abuse, or drug dependence and rehabilitated if the Surgeon General determines that he has received the maximum benefits of treatment and care by the Service for his addiction, drug abuse, or drug dependence or if the Surgeon General determines that his further treatment and care for such purpose would be detrimental to the interests of the Service.
(July 1, 1944, ch. 373, title III, §347, as added May 8, 1954, ch. 195, §4,
Codification
Section is also set out in D.C. Code, §24–615.
Amendments
1970—
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Part F—Licensing of Biological Products and Clinical Laboratories
subpart 1—biological products
§262. Regulation of biological products
(a) Intrastate and interstate traffic; suspension or revocation of license as affecting prior sales
No person shall sell, barter, or exchange, or offer for sale, barter, or exchange in the District of Columbia, or send, carry, or bring for sale, barter, or exchange from any State or possession into any other State or possession or into any foreign country, or from any foreign country into any State or possession, any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of man, unless (1) such virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product has been propagated or manufactured and prepared at an establishment holding an unsuspended and unrevoked license, issued by the Secretary as hereinafter authorized, to propagate or manufacture, and prepare such virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product for sale in the District of Columbia, or for sending, bringing, or carrying from place to place aforesaid; and (2) each package of such virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product is plainly marked with the proper name of the article contained therein, the name, address, and license number of the manufacturer, and the date beyond which the contents cannot be expected beyond reasonable doubt to yield their specific results. The suspension or revocation of any license shall not prevent the sale, barter, or exchange of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid which has been sold and delivered by the licensee prior to such suspension or revocation, unless the owner or custodian of such virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid has been notified by the Secretary not to sell, barter, or exchange the same.
(b) Falsely labeling or marking package or container; altering label or mark
No person shall falsely label or mark any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid; nor alter any label or mark on any package or container of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid so as to falsify such label or mark.
(c) Inspection of establishment for propagation and preparation
Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the purpose, may during all reasonable hours enter and inspect any establishment for the propagation or manufacture and preparation of any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or other product aforesaid for sale, barter, or exchange in the District of Columbia, or to be sent, carried, or brought from any State or possession into any other State or possession or into any foreign country, or from any foreign country into any State or possession.
(d) Regulations governing licenses; recall of product presenting imminent hazard; violations
(1) Licenses for the maintenance of establishments for the propagation or manufacture and preparation of products described in subsection (a) of this section may be issued only upon a showing that the establishment and the products for which a license is desired meet standards, designed to insure the continued safety, purity, and potency of such products, prescribed in regulations, and licenses for new products may be issued only upon a showing that they meet such standards. All such licenses shall be issued, suspended, and revoked as prescribed by regulations and all licenses issued for the maintenance of establishments for the propagation or manufacture and preparation, in any foreign country, of any such products for sale, barter, or exchange in any State or possession shall be issued upon condition that the licensees will permit the inspection of their establishments in accordance with subsection (c) of this section.
(2)(A) Upon a determination that a batch, lot, or other quantity of a product licensed under this section presents an imminent or substantial hazard to the public health, the Secretary shall issue an order immediately ordering the recall of such batch, lot, or other quantity of such product. An order under this paragraph shall be issued in accordance with
(B) Any violation of subparagraph (A) shall subject the violator to a civil penalty of up to $100,000 per day of violation. The amount of a civil penalty under this subparagraph shall, effective December 1 of each year beginning 1 year after the effective date of this subparagraph, be increased by the percent change in the Consumer Price Index for the base quarter of such year over the Consumer Price Index for the base quarter of the preceding year, adjusted to the nearest 1/10 of 1 percent. For purposes of this subparagraph, the term "base quarter", as used with respect to a year, means the calendar quarter ending on September 30 of such year and the price index for a base quarter is the arithmetical mean of such index for the 3 months comprising such quarter.
(e) Interference with officers
No person shall interfere with any officer, agent, or employee of the Service in the performance of any duty imposed upon him by this section or by regulations made by authority thereof.
(f) Penalties for offenses
Any person who shall violate, or aid or abet in violating, any of the provisions of this section shall be punished upon conviction by a fine not exceeding $500 or by imprisonment not exceeding one year, or by both such fine and imprisonment, in the discretion of the court.
(g) Construction with other laws
Nothing contained in this chapter shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act [
(h) Exportation of partially processed biological products
(1)(A) A partially processed biological product which is not in a form applicable to the prevention, treatment, or cure of diseases or injuries of man, which is not intended for sale in the United States, and which is intended for further manufacture into final dosage form outside the United States in a country listed under section 802(b)(A) 1 of the Federal Food, Drug, and Cosmetic Act [
(B) An application for the export of a partially processed biological product shall—
(i) describe the partially processed biological product to be exported,
(ii) list each country to which the product is to be exported,
(iii) contain a certification by the applicant that the product will not be exported to a country not listed under clause (ii),
(iv) identify the establishments in which the product is manufactured, and
(v) contain a certification by the applicant that the final product to be developed from the partially processed product is approved in the country to which it is to be exported or approval of the final product is being sought in such country.
(2) A product described in paragraph (1) is not subject to licensure under this section.
(3) If the Secretary determines that prohibiting the export of a product described in paragraph (1) is necessary for protection of the public health in the United States or the country to which it is to be exported, the Secretary may not approve an application under paragraph (1) for the export of such product.
(July 1, 1944, ch. 373, title III, §351,
References in Text
The effective date of this subparagraph, referred to in subsec. (d)(2)(B), is the effective date of section 315 of
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (g), is act June 25, 1938, ch. 675,
Amendments
1992—Subsec. (c).
1986—Subsec. (d).
Subsec. (h).
1970—Subsecs. (a) to (c).
1958—Subsec. (d).
Effective Date of 1986 Amendment
Section 105(b) of
Amendment by section 315 of
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
References to Secretary and Department of Health, Education, and Welfare substituted for references to Federal Security Administrator and Federal Security Agency, respectively, pursuant to Reorg. Plan No. 1 of 1953, §5, set out as a note under
Cross References
Regulation of biological products for use in treatment of domestic animals, see
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be section "802(b)(4)(A)".
§263. Preparation of biological products by Service
(a) The Service may prepare for its own use any product described in
(b) The Service may prepare any product described in
(July 1, 1944, ch. 373, title III, §352,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Section Referred to in Other Sections
This section is referred to in
subpart 2—clinical laboratories
§263a. Certification of laboratories
(a) "Laboratory" or "clinical laboratory" defined
As used in this section, the term "laboratory" or "clinical laboratory" means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
(b) Certificate requirement
No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.
(c) Issuance and renewal of certificates
(1) In general
The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d) of this section.
(2) Term
A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish.
(d) Requirements for certificates
(1) In general
A laboratory may be issued a certificate or have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e) of this section, the accreditation body which accredited the laboratory submits), an application—
(i) in such form and manner as the Secretary shall prescribe,
(ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including—
(I) the number and types of laboratory examinations and other procedures performed,
(II) the methodologies for laboratory examinations and other procedures employed, and
(III) the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(iii) that contains such other information as the Secretary may require to determine compliance with this section, and
the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to the accreditation body which accredited it) a description of any change in the information submitted under clause (ii) not later than 6 months after the change was put into effect,
(B) the laboratory provides the Secretary—
(i) with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f) of this section, or
(ii) with proof of accreditation under subsection (e) of this section,
(C) the laboratory agrees to permit inspections by the Secretary under subsection (g) of this section,
(D) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may reasonably require, and
(E) the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business.
(2) Requirements for certificates of waiver
(A) In general
A laboratory which only performs laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if—
(i) the laboratory submits an application—
(I) in such form and manner as the Secretary shall prescribe,
(II) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(III) that contains such other information as the Secretary may reasonably require to determine compliance with this section, and
(ii) the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may require.
(B) Changes
If a laboratory makes changes in the examinations and other procedures performed by it only with respect to examinations and procedures which are described in paragraph (3), the laboratory shall report such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory proposes to make changes in the examinations and procedures performed by it such that the laboratory will perform an examination or procedure not described in paragraph (3), the laboratory shall report such change to the Secretary before the change takes effect.
(C) Effect
Subsections (f) and (g) of this section shall not apply to a laboratory to which has been issued a certificate of waiver.
(3) Examinations and procedures
The examinations and procedures identified in paragraph (2) are simple laboratory examinations and procedures which, as determined by the Secretary, have an insignificant risk of an erroneous result, including those which—
(A) have been approved by the Food and Drug Administration for home use,
(B) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible, or
(C) the Secretary has determined pose no reasonable risk of harm to the patient if performed incorrectly.
(4) "Certificate" defined
As used in this section, the term "certificate" includes a certificate of waiver issued under paragraph (2).
(e) Accreditation
(1) In general
A laboratory may be accredited for purposes of obtaining a certificate if the laboratory—
(A) meets the standards of an approved accreditation body, and
(B) authorizes the accreditation body to submit to the Secretary (or such State agency as the Secretary may designate) such records or other information as the Secretary may require.
(2) Approval of accreditation bodies
(A) In general
The Secretary may approve a private nonprofit organization to be an accreditation body for the accreditation of laboratories if—
(i) using inspectors qualified to evaluate the methodologies used by the laboratories in performing laboratory examinations and other procedures, the accreditation body agrees to inspect a laboratory for purposes of accreditation with such frequency as determined by 1 Secretary,
(ii) the standards applied by the body in determining whether or not to accredit a laboratory are equal to or more stringent than the standards issued by the Secretary under subsection (f) of this section,
(iii) there is adequate provision for assuring that the standards of the accreditation body continue to be met by the laboratory,
(iv) in the case of any laboratory accredited by the body which has had its accreditation denied, suspended, withdrawn, or revoked or which has had any other action taken against it by the accrediting body, the accrediting body agrees to submit to the Secretary the name of such laboratory within 30 days of the action taken,
(v) the accreditation body agrees to notify the Secretary at least 30 days before it changes its standards, and
(vi) if the accreditation body has its approval withdrawn by the Secretary, the body agrees to notify each laboratory accredited by the body of the withdrawal within 10 days of the withdrawal.
(B) Criteria and procedures
The Secretary shall promulgate criteria and procedures for approving an accreditation body and for withdrawing such approval if the Secretary determines that the accreditation body does not meet the requirements of subparagraph (A).
(C) Effect of withdrawal of approval
If the Secretary withdraws the approval of an accreditation body under subparagraph (B), the certificate of any laboratory accredited by the body shall continue in effect for 60 days after the laboratory receives notification of the withdrawal of the approval, except that the Secretary may extend such period for a laboratory if it determines that the laboratory submitted an application for accreditation or a certificate in a timely manner after receipt of the notification of the withdrawal of approval. If an accreditation body withdraws or revokes the accreditation of a laboratory, the certificate of the laboratory shall continue in effect—
(i) for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or
(ii) until the effective date of any action taken by the Secretary under subsection (i) of this section.
(D) Evaluations
The Secretary shall evaluate annually the performance of each approved accreditation body by—
(i) inspecting under subsection (g) of this section a sufficient number of the laboratories accredited by such body to allow a reasonable estimate of the performance of such body, and
(ii) such other means as the Secretary determines appropriate.
(3) Report
The Secretary shall annually prepare and submit, to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report that describes the results of the evaluation conducted under paragraph (2)(D).
(f) Standards
(1) In general
The Secretary shall issue standards to assure consistent performance by laboratories issued a certificate under this section of valid and reliable laboratory examinations and other procedures. Such standards shall require each laboratory issued a certificate under this section—
(A) to maintain a quality assurance and quality control program adequate and appropriate for the validity and reliability of the laboratory examinations and other procedures of the laboratory and to meet requirements relating to the proper collection, transportation, and storage of specimens and the reporting of results,
(B) to maintain records, equipment, and facilities necessary for the proper and effective operation of the laboratory,
(C) in performing and carrying out its laboratory examinations and other procedures, to use only personnel meeting such qualifications as the Secretary may establish for the direction, supervision, and performance of examinations and procedures within the laboratory, which qualifications shall take into consideration competency, training, experience, job performance, and education and which qualifications shall, as appropriate, be different on the basis of the type of examinations and procedures being performed by the laboratory and the risks and consequences of erroneous results associated with such examinations and procedures,
(D) to qualify under a proficiency testing program meeting the standards established by the Secretary under paragraph (3), and
(E) to meet such other requirements as the Secretary determines necessary to assure consistent performance by such laboratories of accurate and reliable laboratory examinations and procedures.
(2) Considerations
In developing the standards to be issued under paragraph (1), the Secretary shall, within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take into consideration—
(A) the examinations and procedures performed and the methodologies employed,
(B) the degree of independent judgment involved,
(C) the amount of interpretation involved,
(D) the difficulty of the calculations involved,
(E) the calibration and quality control requirements of the instruments used,
(F) the type of training required to operate the instruments used in the methodology, and
(G) such other factors as the Secretary considers relevant.
(3) Proficiency testing program
(A) In general
The Secretary shall establish standards for the proficiency testing programs for laboratories issued a certificate under this section which are conducted by the Secretary, conducted by an organization approved under subparagraph (C), or conducted by an approved accrediting body. The standards shall require that a laboratory issued a certificate under this section be tested for each examination and procedure conducted within a category of examinations or procedures for which it has received a certificate, except for examinations and procedures for which the Secretary has determined that a proficiency test cannot reasonably be developed. The testing shall be conducted on a quarterly basis, except where the Secretary determines for technical and scientific reasons that a particular examination or procedure may be tested less frequently (but not less often than twice per year).
(B) Criteria
The standards established under subparagraph (A) shall include uniform criteria for acceptable performance under a proficiency testing program, based on the available technology and the clinical relevance of the laboratory examination or other procedure subject to such program. The criteria shall be established for all examinations and procedures and shall be uniform for each examination and procedure. The standards shall also include a system for grading proficiency testing performance to determine whether a laboratory has performed acceptably for a particular quarter and acceptably for a particular examination or procedure or category of examination or procedure over a period of successive quarters.
(C) Approved proficiency testing programs
For the purpose of administering proficiency testing programs which meet the standards established under subparagraph (A), the Secretary shall approve a proficiency testing program offered by a private nonprofit organization or a State if the program meets the standards established under subparagraph (A) and the organization or State provides technical assistance to laboratories seeking to qualify under the program. The Secretary shall evaluate each program approved under this subparagraph annually to determine if the program continues to meet the standards established under subparagraph (A) and shall withdraw the approval of any program that no longer meets such standards.
(D) Onsite testing
The Secretary shall perform, or shall direct a program approved under subparagraph (C) to perform, onsite proficiency testing to assure compliance with the requirements of subsection (d)(5) of this section. The Secretary shall perform, on an onsite or other basis, proficiency testing to evaluate the performance of a proficiency testing program approved under subparagraph (C) and to assure quality performance by a laboratory.
(E) Training, technical assistance, and enhanced proficiency testing
The Secretary may, in lieu of or in addition to actions authorized under subsection (h), (i), or (j) of this section, require any laboratory which fails to perform acceptably on an individual examination and procedure or a category of examination and procedures—
(i) to undertake training and to obtain the necessary technical assistance to meet the requirements of the proficency 2 testing program,
(ii) to enroll in a program of enhanced proficiency testing, or
(iii) to undertake any combination of the training, technical assistance, or testing described in clauses (i) and (ii).
(F) Testing results
The Secretary shall establish a system to make the results of the proficiency testing programs subject to the standards established by the Secretary under subparagraph (A) available, on a reasonable basis, upon request of any person. The Secretary shall include with results made available under this subparagraph such explanatory information as may be appropriate to assist in the interpretation of such results.
(4) National standards for quality assurance in cytology services
(A) Establishment
The Secretary shall establish national standards for quality assurance in cytology services designed to assure consistent performance by laboratories of valid and reliable cytological services.
(B) Standards
The standards established under subparagraph (A) shall include—
(i) the maximum number of cytology slides that any individual may screen in a 24-hour period,
(ii) requirements that a clinical laboratory maintain a record of (I) the number of cytology slides screened during each 24-hour period by each individual who examines cytology slides for the laboratory, and (II) the number of hours devoted during each 24-hour period to screening cytology slides by such individual,
(iii) criteria for requiring rescreening of cytological preparations, such as (I) random rescreening of cytology specimens determined to be in the benign category, (II) focused rescreening of such preparations in high risk groups, and (III) for each abnormal cytological result, rescreening of all prior cytological specimens for the patient, if available,
(iv) periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions,
(v) procedures for detecting inadequately prepared slides, for assuring that no cytological diagnosis is rendered on such slides, and for notifying referring physicians of such slides,
(vi) requirements that all cytological screening be done on the premises of a laboratory that is certified under this section,
(vii) requirements for the retention of cytology slides by laboratories for such periods of time as the Secretary considers appropriate, and
(viii) standards requiring periodic inspection of cytology services by persons capable of evaluating the quality of cytology services.
(g) Inspections
(1) In general
The Secretary may, on an announced or unannounced basis, enter and inspect, during regular hours of operation, laboratories which have been issued a certificate under this section. In conducting such inspections the Secretary shall have access to all facilities, equipment, materials, records, and information that the Secretary determines have a bearing on whether the laboratory is being operated in accordance with this section. As part of such an inspection the Secretary may copy any such material or require to it 3 be submitted to the Secretary. An inspection under this paragraph may be made only upon presenting identification to the owner, operator, or agent in charge of the laboratory being inspected.
(2) Compliance with requirements and standards
The Secretary shall conduct inspections of laboratories under paragraph (1) to determine their compliance with the requirements of subsection (d) of this section and the standards issued under subsection (f) of this section. Inspections of laboratories not accredited under subsection (e) of this section shall be conducted on a biennial basis or with such other frequency as the Secretary determines to be necessary to assure compliance with such requirements and standards. Inspections of laboratories accredited under subsection (e) of this section shall be conducted on such basis as the Secretary determines is necessary to assure compliance with such requirements and standards.
(h) Intermediate sanctions
(1) In general
If the Secretary determines that a laboratory which has been issued a certificate under this section no longer substantially meets the requirements for the issuance of a certificate, the Secretary may impose intermediate sanctions in lieu of the actions authorized by subsection (i) of this section.
(2) Types of sanctions
The intermediate sanctions which may be imposed under paragraph (1) shall consist of—
(A) directed plans of correction,
(B) civil money penalties in an amount not to exceed $10,000 for each violation listed in subsection (i)(1) of this section or for each day of substantial noncompliance with the requirements of this section,
(C) payment for the costs of onsite monitoring, or
(D) any combination of the actions described in subparagraphs (A), (B), and (C).
(3) Procedures
The Secretary shall develop and implement procedures with respect to when and how each of the intermediate sanctions is to be imposed under paragraph (1). Such procedures shall provide for notice to the laboratory and a reasonable opportunity to respond to the proposed sanction and appropriate procedures for appealing determinations relating to the imposition of intermediate sanctions 4
(i) Suspension, revocation, and limitation
(1) In general
Except as provided in paragraph (2), the certificate of a laboratory issued under this section may be suspended, revoked, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory—
(A) has been guilty of misrepresentation in obtaining the certificate,
(B) has performed or represented the laboratory as entitled to perform a laboratory examination or other procedure which is not within a category of laboratory examinations or other procedures authorized in the certificate,
(C) has failed to comply with the requirements of subsection (d) of this section or the standards prescribed by the Secretary under subsection (f) of this section,
(D) has failed to comply with reasonable requests of the Secretary for—
(i) any information or materials, or
(ii) work on materials,
that the Secretary concludes is necessary to determine the laboratory's continued eligibility for its certificate or continued compliance with the Secretary's standards under subsection (f) of this section,
(E) has refused a reasonable request of the Secretary, or any Federal officer or employee duly designated by the Secretary, for permission to inspect the laboratory and its operations and pertinent records during the hours the laboratory is in operation,
(F) has violated or aided and abetted in the violation of any provisions of this section or of any regulation promulgated thereunder, or
(G) has not complied with an intermediate sanction imposed under subsection (h) of this section.
(2) Action before a hearing
If the Secretary determines that—
(A) the failure of a laboratory to comply with the standards of the Secretary under subsection (f) of this section presents an imminent and serious risk to human health, or
(B) a laboratory has engaged in an action described in subparagraph (D) or (E) of paragraph (1),
the Secretary may suspend or limit the certificate of the laboratory before holding a hearing under paragraph (1) regarding such failure or refusal. The opportunity for a hearing shall be provided no later than 60 days from the effective date of the suspension or limitation. A suspension or limitation under this paragraph shall stay in effect until the decision of the Secretary made after the hearing under paragraph (1).
(3) Ineligibility to own or operate laboratories after revocation
No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section. The certificate of a laboratory which has been excluded from participation under the medicare program under title XVIII of the Social Security Act [
(4) Improper referrals
Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis shall have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in subsection (h) of this section.
(j) Injunctions
Whenever the Secretary has reason to believe that continuation of any activity by a laboratory would constitute a significant hazard to the public health the Secretary may bring suit in the district court of the United States for the district in which such laboratory is situated to enjoin continuation of such activity. Upon proper showing, a temporary injunction or restraining order against continuation of such activity pending issuance of a final order under this subsection shall be granted without bond by such court.
(k) Judicial review
(1) Petition
Any laboratory which has had an intermediate sanction imposed under subsection (h) of this section or has had its certificate suspended, revoked, or limited under subsection (i) of this section may, at any time within 60 days after the date the action of the Secretary under subsection (i) or (h) of this section becomes final, file a petition with the United States court of appeals for the circuit wherein the laboratory has its principal place of business for judicial review of such action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary for that purpose. As soon as practicable after receipt of the copy, the Secretary shall file in the court the record on which the action of the Secretary is based, as provided in
(2) Additional evidence
If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal of such additional evidence) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, by reason of the additional evidence so taken, and the Secretary shall file such modified or new findings, and the recommendations of the Secretary, if any, for the modification or setting aside of his original action, with the return of such additional evidence.
(3) Judgment of court
Upon the filing of the petition referred to in paragraph (1), the court shall have jurisdiction to affirm the action, or to set it aside in whole or in part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.
(4) Finality of judgment
The judgment of the court affirming or setting aside, in whole or in part, any such action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in
(l) Sanctions
Any person who intentionally violates any requirement of this section or any regulation promulgated thereunder shall be imprisoned for not more than one year or fined under title 18, or both, except that if the conviction is for a second or subsequent violation of such a requirement such person shall be imprisoned for not more than 3 years or fined in accordance with title 18, or both.
(m) Fees
(1) Certificate fees
The Secretary shall require payment of fees for the issuance and renewal of certificates, except that the Secretary shall only require a nominal fee for the issuance and renewal of certificates of waiver.
(2) Additional fees
The Secretary shall require the payment of fees for inspections of laboratories which are not accredited and for the cost of performing proficiency testing on laboratories which do not participate in proficiency testing programs approved under subsection (f)(3)(C) of this section.
(3) Criteria
(A) Fees under paragraph (1)
Fees imposed under paragraph (1) shall be sufficient to cover the general costs of administering this section, including evaluating and monitoring proficiency testing programs approved under subsection (f) of this section and accrediting bodies and implementing and monitoring compliance with the requirements of this section.
(B) Fees under paragraph (2)
Fees imposed under paragraph (2) shall be sufficient to cover the cost of the Secretary in carrying out the inspections and proficiency testing described in paragraph (2).
(C) Fees imposed under paragraphs (1) and (2)
Fees imposed under paragraphs (1) and (2) shall vary by group or classification of laboratory, based on such considerations as the Secretary determines are relevant, which may include the dollar volume and scope of the testing being performed by the laboratories.
(n) Information
On April 1, 1990 and annually thereafter, the Secretary shall compile and make available to physicians and the general public information, based on the previous calendar year, which the Secretary determines is useful in evaluating the performance of a laboratory, including—
(1) a list of laboratories which have been convicted under Federal or State laws relating to fraud and abuse, false billings, or kickbacks,
(2) a list of laboratories—
(A) which have had their certificates revoked, suspended, or limited under subsection (i) of this section, or
(B) which have been the subject of a sanction under subsection (l) of this section,
together with a statement of the reasons for the revocation, suspension, limitation, or sanction,
(3) a list of laboratories subject to intermediate sanctions under subsection (h) of this section together with a statement of the reasons for the sanctions,
(4) a list of laboratories whose accreditation has been withdrawn or revoked together with a statement of the reasons for the withdrawal or revocation,
(5) a list of laboratories against which the Secretary has taken action under subsection (j) of this section together with a statement of the reasons for such action, and
(6) a list of laboratories which have been excluded from participation under title XVIII or XIX of the Social Security Act [
The information to be compiled under paragraphs (1) through (6) shall be information for the calendar year preceding the date the information is to be made available to the public and shall be accompanied by such explanatory information as may be appropriate to assist in the interpretation of the information compiled under such paragraphs.
(o) Delegation
In carrying out this section, the Secretary may, pursuant to agreement, use the services or facilities of any Federal or State or local public agency or nonprofit private organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as the Secretary may determine.
(p) State laws
(1) Except as provided in paragraph (2), nothing in this section shall be construed as affecting the power of any State to enact and enforce laws relating to the matters covered by this section to the extent that such laws are not inconsistent with this section or with the regulations issued under this section.
(2) If a State enacts laws relating to matters covered by this section which provide for requirements equal to or more stringent than the requirements of this section or than the regulations issued under this section, the Secretary may exempt clinical laboratories in that State from compliance with this section.
(q) Consultations
In carrying out this section, the Secretary shall consult with appropriate private organizations and public agencies.
(July 1, 1944, ch. 373, title III, §353, as added Dec. 5, 1967,
References in Text
The Social Security Act, referred to in subsecs. (i)(3) and (n)(6), is act Aug. 14, 1935, ch. 531,
Amendments
1988—
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1988 Amendment; Exceptions; Continuing Applicability
Section 3 of
Effective Date
Section 5(b) of
Short Title
Section 5(c) of
Studies
Section 4 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "by the".
2 So in original. Probably should be "proficiency".
3 So in original. Probably should be "require it to".
4 So in original. Probably should be followed by a period.
§263a–1. Assisted reproductive technology programs
(a) In general
Effective 2 years after October 24, 1992, each assisted reproductive technology (as defined in section 263a–7 1 of this title) program shall annually report to the Secretary through the Centers for Disease Control—
(1) pregnancy success rates achieved by such program through each assisted reproductive technology, and
(2) the identity of each embryo laboratory (as defined in section 263a–7 1 of this title) used by such program and whether the laboratory is certified under
(b) Pregnancy success rates
(1) In general
For purposes of subsection (a)(1) of this section, the Secretary shall, in consultation with the organizations referenced in subsection (c) of this section, define pregnancy success rates and shall make public any proposed definition in such manner as to facilitate comment from any person (including any Federal or other public agency) during its development.
(2) Definition
In developing the definition of pregnancy success rates, the Secretary shall take into account the effect on success rates of age, diagnosis, and other significant factors and shall include in such rates—
(A) the basic live birth rate calculated for each assisted reproductive technology performed by an assisted reproductive technology program by dividing the number of pregnancies which result in live births by the number of ovarian stimulation procedures attempted by such program, and
(B) the live birth rate per successful oocyte retrieval procedure calculated for each assisted reproductive technology performed by an assisted reproductive technology program by dividing the number of pregnancies which result in live births by the number of successful oocyte retrieval procedures performed by such program.
(c) Consultation
In developing the definition under subsection (b) of this section, the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with assisted reproductive technologies.
(
References in Text
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section 9 of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§263a–2. Certification of embryo laboratories
(a) In general
(1) Development
Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease Control, shall develop a model program for the certification of embryo laboratories (referred to in this section as a "certification program") to be carried out by the States.
(2) Consultation
In developing the certification program under paragraph (1), the Secretary shall consult with appropriate consumer and professional organizations with expertise in using, providing, and evaluating professional services and embryo laboratories associated with the assisted reproductive technology programs.
(b) Distribution
The Secretary shall distribute a description of the certification program to—
(1) the Governor of each State,
(2) the presiding officers of each State legislature,
(3) the public health official of each State, and
(4) the official responsible in each State for the operation of the State's contract with the Secretary under
and shall encourage such officials to assist in the State adopting such program.
(c) Requirements
The certification program shall include the following requirements:
(1) Administration
The certification program shall be administered by the State and shall provide for the inspection and certification of embryo laboratories in the State by the State or by approved accreditation organizations.
(2) Application requirements
The certification program shall provide for the submission of an application to a State by an embryo laboratory for certification, in such form as may be specified by the State. Such an application shall include—
(A) assurances satisfactory to the State that the embryo laboratory will be operated in accordance with the standards under subsection (d) of this section,
(B) a report to the State identifying the assisted reproductive technology programs with which the laboratory is associated, and
(C) such other information as the State finds necessary.
An embryo laboratory which meets the requirements of
(d) Standards
The certification program shall include the following standards developed by the Secretary:
(1) A standard to assure consistent performance of procedures by each embryo laboratory certified under the certification program or by an approved accreditation organization in a State which has not adopted the certification program.
(2) A standard for a quality assurance and a quality control program to assure valid, reliable, and reproduceable 1 procedures in the laboratory.
(3) A standard for the maintenance of records (on a program by program basis) on laboratory tests and procedures performed, including the scientific basis of, and the methodology used for, the tests, procedures, and preparation of any standards or controls, criteria for acceptable and unacceptable outcomes, criteria for sample rejection, and procedures for safe sample disposal.
(4) A standard for the maintenance of written records on personnel and facilities necessary for proper and effective operation of the laboratory, schedules of preventive maintenance, function verification for equipment, and the release of such records to the State upon demand.
(5) A standard for the use of such personnel who meet such qualifications as the Secretary may develop.
(e) Certification under State programs
A State may qualify to adopt the certification program if the State has submitted an application to the Secretary to adopt such program and the Secretary has approved the application. Such an application shall include—
(1) assurances by the State satisfactory to the Secretary that the certification program within the State meets the requirements of this section,
(2) an agreement to make such reports as the Secretary may require, and
(3) information about any proposed use of accreditation organizations under subsection (g) 2 of this section.
(f) Use of accreditation organizations
A State which has adopted the certification program may use accreditation organizations approved under
(g) Inspections
(1) In general
A State which qualifies to adopt the certification program within the State shall conduct inspections in accordance with paragraph (2) to determine if laboratories in the State meet the requirements of such program. Such inspections shall be carried out by the State or by accreditation organizations used by the State under subsection (g) 2 of this section.
(2) Requirements
Inspections carried out under paragraph (1) shall—
(A) be periodic and unannounced, or
(B) be announced in such circumstances as the Secretary determines will not diminish the likelihood of discovering deficiencies in the operations of a laboratory.
Before making a determination under subparagraph (B), the Secretary shall make public, in such manner as to facilitate comment from any person (including any Federal or other public agency), a proposal indicating the circumstances under which announced inspections would be permitted.
(3) Results
The specific findings, including deficiencies, identified in an inspection carried out under paragraph (1) and any subsequent corrections to those deficiencies shall be announced and made available to the public upon request beginning no later than 60 days after the date of the inspection.
(h) Validation inspections
(1) In general
The Secretary may enter and inspect, during regular hours of operation, embryo laboratories—
(A) which have been certified by a State under the certification program, or
(B) which have been certified by an accreditation organization approved by the Secretary under
for the purpose of determining whether the laboratory is being operated in accordance with the standards in subsection (d) of this section.
(2) Access to facilities and records
In conducting an inspection of an embryo laboratory under paragraph (1), the Secretary shall have access to all facilities, equipment, materials, records, and information which the Secretary determines is necessary to determine if such laboratory is being operated in accordance with the standards in subsection (d) of this section. As part of such an inspection, the Secretary may copy any material, record, or information inspected or require it to be submitted to the Secretary. Such an inspection may be made only upon the presentation of identification to the owner, operator, or agent in charge of the laboratory being inspected.
(3) Failure to comply
If the Secretary determines as a result of an inspection under paragraph (1) that the embryo laboratory is not in compliance with the standards in subsection (d) of this section, the Secretary shall—
(A) notify the State in which the laboratory is located and, if appropriate, the accreditation organization which certified the laboratory,
(B) make available to the public the results of the inspection,
(C) conduct additional inspections of other embryo laboratories under paragraph (1) to determine if—
(i) such State in carrying out the certification program is reliably identifying the deficiencies of such laboratory, or
(ii) the accreditation organization which certified such laboratories is reliably identifying such deficencies,3 and
(D) if the Secretary determines—
(i) that such State in carrying out the certification program has not met the requirements applicable to such program, or
(ii) the accreditation organization which certified such laboratory has not met the requirements of
the Secretary may revoke the approval of the State certification program or revoke the approval of such accreditation organization.
(i) Limitation
(1) Secretary
In developing the certification program, the Secretary may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.
(2) State
In adopting the certification program, a State may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs.
(j) Term
The term of a certification issued by a State or an accreditation organization in a State shall be prescribed by the Secretary in the certification program and shall be valid for a period of time to be defined by the Secretary through the public comment process described in subsection (h)(2) 4 of this section. The Secretary shall provide an application for recertification to be submitted at the time of changes in the ownership of a certified laboratory or changes in the administration of such a laboratory.
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "reproducible".
2 So in original. Probably should be subsection "(f)".
3 So in original. Probably should be "deficiencies,".
4 So in original. Probably should be subsection "(g)(2)".
§263a–3. Accreditation organizations
(a) Approval of accreditation organizations
Not later than 2 years after October 24, 1992, the Secretary, through the Centers for Disease Control, shall promulgate criteria and procedures for the approval of accreditation organizations to inspect and certify embryo laboratories. The procedures shall require an application to the Secretary by an accreditation organization for approval. An accreditation organization which has received such an approval—
(1) may be used by States in the certification program under
(2) may certify embryo laboratories in States which have not adopted such a certification program.
(b) Criteria and procedures
The criteria and procedures promulgated under subsection (a) of this section shall include—
(1) requirements for submission of such reports and the maintenance of such records as the Secretary or a State may require, and
(2) requirements for the conduct of inspections under section 263a–2(h) 1 of this title.
(c) Evaluations
The Secretary shall evaluate annually the performance of each accreditation organization approved by the Secretary by—
(1) inspecting under section 263a–2(i) 2 of this title a sufficient number of embryo laboratories accredited by such an organization to allow a reasonable estimate of the performance of such organization, and
(2) such other means as the Secretary determines to be appropriate.
(d) Transition
If the Secretary revokes approval under section 263a–2(i)(3)(D) 3 of this title of an accreditation organization after an evaluation under subsection (c) of this section, the certification of any embryo laboratory accredited by the organization shall continue in effect for 60 days after the laboratory is notified by the Secretary of the withdrawal of approval, except that the Secretary may extend the period during which the certification shall remain in effect if the Secretary determines that the laboratory submitted an application to another approved accreditation organization for certification after receipt of such notice in a timely manner.
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be section "263a–2(g)".
2 So in original. Probably should be section "263a–2(h)".
3 So in original. Probably should be section "263a–2(h)(3)(D)".
§263a–4. Certification revocation and suspension
(a) In general
A certification issued by a State or an accreditation organization for an embryo laboratory shall be revoked or suspended if the State or organization finds, on the basis of inspections and after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that the owner or operator or any employee of the laboratory—
(1) has been guilty of misrepresentation in obtaining the certification,
(2) has failed to comply with any standards under
(3) has refused a request of the State or accreditation organization for permission to inspect the laboratory, its operations, and records.
(b) Effect
If the certification of an embryo laboratory is revoked or suspended, the certification of the laboratory shall continue in effect for 60 days after the laboratory receives notice of the revocation or suspension. If the certification of an embryo laboratory is revoked or suspended, the laboratory may apply for recertification after one year after the date of the revocation or suspension.
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
§263a–5. Publication
The Secretary, through the Centers for Disease Control, shall not later than 3 years after October 24, 1992, and annually thereafter publish and distribute to the States and the public—
(1)(A) 1 pregnancy success rates reported to the Secretary under
(B) from information reported under
(i) the identity of each embryo laboratory in a State which has adopted the certification program under such program and whether such laboratory is certified under
(ii) the identity of each embryo laboratory in a State which has not adopted such certification program and which has been certified by an accreditation organization approved by the Secretary under
(iii) in the case of an embryo laboratory which is not certified under
(
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. No par. (2) has been enacted.
§263a–6. Fees
The Secretary may require the payment of fees for the purpose of, and in an amount sufficient to cover the cost of, administering
(
References in Text
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
§263a–7. Definitions
For purposes of
(1) Assisted reproductive technology
The term "assisted reproductive technology" means all treatments or procedures which include the handling of human oocytes or embryos, including in vitro fertilization, gamete intrafallopian transfer, zygote intrafallopian transfer, and such other specific technologies as the Secretary may include in this definition, after making public any proposed definition in such manner as to facilitate comment from any person (including any Federal or other public agency).
(2) Embryo laboratory
The term "embryo laboratory" means a facility in which human oocytes are subject to assisted reproductive technology treatment or procedures based on manipulation of oocytes or embryos which are subject to implantation.
(3) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(
References in Text
Codification
Section was enacted as part of the Fertility Clinic Success Rate and Certification Act of 1992, and not as part of the Public Health Service Act which comprises this chapter.
Effective Date
Section effective upon expiration of 2 years after Oct. 24, 1992, see section 9 of
Section Referred to in Other Sections
This section is referred to in
subpart 3—mammography facilities
Prior Provisions
A prior subpart 3 of part F of title III of the Public Health Service Act, comprising this subpart, was renumbered subchapter C of chapter V of the Federal Food, Drug, and Cosmetic Act, by
§263b. Certification of mammography facilities
(a) Definitions
As used in this section:
(1) Accreditation body
The term "accreditation body" means a body that has been approved by the Secretary under subsection (e)(1)(A) of this section to accredit mammography facilities.
(2) Certificate
The term "certificate" means the certificate described in subsection (b)(1) of this section.
(3) Facility
(A) In general
The term "facility" means a hospital, outpatient department, clinic, radiology practice, or mobile unit, an office of a physician, or other facility as determined by the Secretary, that conducts breast cancer screening or diagnosis through mammography activities. Such term does not include a facility of the Department of Veterans Affairs.
(B) Activities
For the purposes of this section, the activities of a facility include the operation of equipment to produce the mammogram, the processing of the film, the initial interpretation of the mammogram and the viewing conditions for that interpretation. Where procedures such as the film processing, or the interpretation of the mammogram are performed in a location different from where the mammogram is performed, the facility performing the mammogram shall be responsible for meeting the quality standards described in subsection (f) of this section.
(4) Inspection
The term "inspection" means an onsite evaluation of the facility by the Secretary, or State agency on behalf of the Secretary.
(5) Mammogram
The term "mammogram" means a radiographic image produced through mammography.
(6) Mammography
The term "mammography" means radiography of the breast.
(7) Survey
The term "survey" means an onsite physics consultation and evaluation performed by a medical physicist as described in subsection (f)(1)(E) of this section.
(b) Certificate requirement
(1) Certificate
No facility may conduct an examination or procedure described in paragraph (2) involving mammography after October 1, 1994, unless the facility obtains—
(A) a certificate—
(i) that is issued, and, if applicable, renewed, by the Secretary in accordance with subsection (c)(1) of this section;
(ii) that is applicable to the examination or procedure to be conducted; and
(iii) that is displayed prominently in such facility; or
(B) a provisional certificate—
(i) that is issued by the Secretary in accordance with subsection (c)(2) of this section;
(ii) that is applicable to the examination or procedure to be conducted; and
(iii) that is displayed prominently in such facility.
The reference to a certificate in this section includes a provisional certificate.
(2) Examination or procedure
A facility shall obtain a certificate in order to—
(A) operate radiological equipment that is used to image the breast;
(B) provide for the interpretation of a mammogram produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed; and
(C) provide for the processing of film produced by such equipment at the facility or under arrangements with a qualified individual at a facility different from where the mammography examination is performed.
(c) Issuance and renewal of certificates
(1) In general
The Secretary may issue or renew a certificate for a facility if the person or agent described in subsection (d)(1)(A) of this section meets the applicable requirements of subsection (d)(1) of this section with respect to the facility. The Secretary may issue or renew a certificate under this paragraph for not more than 3 years.
(2) Provisional certificate
The Secretary may issue a provisional certificate for an entity to enable the entity to qualify as a facility. The applicant for a provisional certificate shall meet the requirements of subsection (d)(1) of this section, except providing information required by clauses (iii) and (iv) of subsection (d)(1)(A) of this section. A provisional certificate may be in effect no longer than 6 months from the date it is issued, except that it may be extended once for a period of not more than 90 days if the owner, lessor, or agent of the facility demonstrates to the Secretary that without such extension access to mammography in the geographic area served by the facility would be significantly reduced and if the owner, lessor, or agent of the facility will describe in a report to the Secretary steps that will be taken to qualify the facility for certification under subsection (b)(1) of this section.
(d) Application for certificate
(1) Submission
The Secretary may issue or renew a certificate for a facility if—
(A) the person who owns or leases the facility or an authorized agent of the person, submits to the Secretary, in such form and manner as the Secretary shall prescribe, an application that contains at a minimum—
(i) a description of the manufacturer, model, and type of each x-ray machine, image receptor, and processor operated in the performance of mammography by the facility;
(ii) a description of the procedures currently used to provide mammography at the facility, including—
(I) the types of procedures performed and the number of such procedures performed in the prior 12 months;
(II) the methodologies for mammography; and
(III) the names and qualifications (educational background, training, and experience) of the personnel performing mammography and the physicians reading and interpreting the results from the procedures;
(iii) proof of on-site survey by a qualified medical physicist as described in subsection (f)(1)(E) of this section; and
(iv) proof of accreditation in such manner as the Secretary shall prescribe; and
(B) the person or agent submits to the Secretary—
(i) a satisfactory assurance that the facility will be operated in accordance with standards established by the Secretary under subsection (f) of this section to assure the safety and accuracy of mammography;
(ii) a satisfactory assurance that the facility will—
(I) permit inspections under subsection (g) of this section;
(II) make such records and information available, and submit such reports, to the Secretary as the Secretary may require; and
(III) update the information submitted under subparagraph (A) or assurances submitted under this subparagraph on a timely basis as required by the Secretary; and
(iii) such other information as the Secretary may require.
An applicant shall not be required to provide in an application under subparagraph (A) any information which the applicant has supplied to the accreditation body which accredited the applicant, except as required by the Secretary.
(2) Appeal
If the Secretary denies an application for the certification of a facility submitted under paragraph (1)(A), the Secretary shall provide the owner or lessor of the facility or the agent of the owner or lessor who submitted such application—
(A) a statement of the grounds on which the denial is based, and
(B) an opportunity for an appeal in accordance with the procedures set forth in regulations of the Secretary published at 42 C.F.R. 498 and in effect on October 27, 1992.
(3) Effect of denial
If the application for the certification of a facility is denied, the facility may not operate unless the denial of the application is overturned at the conclusion of the administrative appeals process provided in the regulations referred to in paragraph (2)(B).
(e) Accreditation
(1) Approval of accreditation bodies
(A) In general
The Secretary may approve a private nonprofit organization or State agency to accredit facilities for purposes of subsection (d)(1)(A)(iv) of this section if the accreditation body meets the standards for accreditation established by the Secretary as described in subparagraph (B) and provides the assurances required by subparagraph (C).
(B) Standards
The Secretary shall establish standards for accreditation bodies, including—
(i) standards that require an accreditation body to perform—
(I) a review of clinical images from each facility accredited by such body not less often than every 3 years which review will be made by qualified practicing physicians; and
(II) a review of a random sample of clinical images from such facilities in each 3-year period beginning October 1, 1994, which review will be made by qualified practicing physicians;
(ii) standards that prohibit individuals conducting the reviews described in clause (i) from maintaining any financial relationship to the facility undergoing review which would constitute a conflict of interest;
(iii) standards that limit the imposition of fees for accreditation to reasonable amounts;
(iv) standards that require as a condition of accreditation that each facility undergo a survey at least annually by a medical physicist as described in subsection (f)(1)(E) of this section to ensure that the facility meets the standards described in subparagraphs (A) and (B) of subsection (f)(1) of this section;
(v) standards that require monitoring and evaluation of such survey, as prescribed by the Secretary;
(vi) standards that are equal to standards established under subsection (f) of this section which are relevant to accreditation as determined by the Secretary; and
(vii) such additional standards as the Secretary may require.
(C) Assurances
The accrediting body shall provide the Secretary satisfactory assurances that the body will—
(i) comply with the standards as described in subparagraph (B);
(ii) comply with the requirements described in paragraph (4);
(iii) submit to the Secretary the name of any facility for which the accreditation body denies, suspends, or revokes accreditation;
(iv) notify the Secretary in a timely manner before the accreditation body changes the standards of the body;
(v) notify each facility accredited by the accreditation body if the Secretary withdraws approval of the accreditation body under paragraph (2) in a timely manner; and
(vi) provide such other additional information as the Secretary may require.
(D) Regulations
Not later than 9 months after October 27, 1992, the Secretary shall promulgate regulations under which the Secretary may approve an accreditation body.
(2) Withdrawal of approval
(A) In general
The Secretary shall promulgate regulations under which the Secretary may withdraw the approval of an accreditation body if the Secretary determines that the accreditation body does not meet the standards under subparagraph (B) of paragraph (1), the requirements of clauses (i) through (vi) of subparagraph (C) of paragraph (1), or the requirements of paragraph (4).
(B) Effect of withdrawal
If the Secretary withdraws the approval of an accreditation body under subparagraph (A), the certificate of any facility accredited by the body shall continue in effect until the expiration of a reasonable period, as determined by the Secretary, for such facility to obtain another accreditation.
(3) Accreditation
To be accredited by an approved accreditation body a facility shall meet—
(A) the standards described in paragraph (1)(B) which the Secretary determines are applicable to the facility, and
(B) such other standards which the accreditation body may require.
(4) Compliance
To ensure that facilities accredited by an accreditation body will continue to meet the standards of the accreditation body, the accreditation body shall—
(A) make onsite visits on an annual basis of a sufficient number of the facilities accredited by the body to allow a reasonable estimate of the performance of the body; and
(B) take such additional measures as the Secretary determines to be appropriate.
Visits made under subparagraph (A) shall be made after providing such notice as the Secretary may require.
(5) Revocation of accreditation
If an accreditation body revokes the accreditation of a facility, the certificate of the facility shall continue in effect until such time as may be determined by the Secretary.
(6) Evaluation and report
(A) Evaluation
The Secretary shall evaluate annually the performance of each approved accreditation body by—
(i) inspecting under subsection (g)(2) of this section a sufficient number of the facilities accredited by the body to allow a reasonable estimate of the performance of the body; and
(ii) such additional means as the Secretary determines to be appropriate.
(B) Report
The Secretary shall annually prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that describes the results of the evaluation conducted in accordance with subparagraph (A).
(f) Quality standards
(1) In general
The standards referred to in subsection (d)(1)(B)(i) of this section are standards established by the Secretary which include—
(A) standards that require establishment and maintenance of a quality assurance and quality control program at each facility that is adequate and appropriate to ensure the reliability, clarity, and accuracy of interpretation of mammograms and standards for appropriate radiation dose;
(B) standards that require use of radiological equipment specifically designed for mammography, including radiologic standards and standards for other equipment and materials used in conjunction with such equipment;
(C) a requirement that personnel who perform mammography—
(i)(I) be licensed by a State to perform radiological procedures; or
(II) be certified as qualified to perform radiological procedures by an organization described in paragraph (2)(A); and
(ii) during the 2-year period beginning October 1, 1994, meet training standards for personnel who perform mammography or meet experience requirements which shall at a minimum include 1 year of experience in the performance of mammography; and
(iii) upon the expiration of such 2-year period meet minimum training standards for personnel who perform mammograms;
(D) a requirement that mammograms be interpreted by a physician who is certified as qualified to interpret radiological procedures, including mammography—
(i)(I) by a board described in paragraph (2)(B); or
(II) by a program that complies with the standards described in paragraph (2)(C); and
(ii) who meets training and continuing medical education requirements as established by the Secretary;
(E) a requirement that individuals who survey mammography facilities be medical physicists—
(i) licensed or approved by a State to perform such surveys, reviews, or inspections for mammography facilities;
(ii) certified in diagnostic radiological physics or certified as qualified to perform such surveys by a board as described in paragraph (2)(D); or
(iii) in the first 5 years after October 27, 1992, who meet other criteria established by the Secretary which are comparable to the criteria described in clause (i) or (ii);
(F) a requirement that a medical physicist who is qualified in mammography as described in subparagraph (E) survey mammography equipment and oversee quality assurance practices at each facility;
(G) a requirement that—
(i) a facility that performs any mammogram maintain the mammogram in the permanent medical records of the patient—
(I) for a period of not less than 5 years, or not less than 10 years if no additional mammograms of such patient are performed at the facility, or longer if mandated by State law; or
(II) until such time as the patient should request that the patient's medical records be forwarded to a medical institution or a physician of the patient;
whichever is longer; and
(ii)(I) a facility must assure the preparation of a written report of the results of any mammography examination signed by the interpreting physician;
(II) such written report shall be provided to the patient's physicians (if any);
(III) if such a physician is not available or if there is no such physician, the written report shall be sent directly to the patient; and
(IV) if such report is sent to the patient, the report shall include a summary written in terms easily understood by a lay person; and
(H) standards relating to special techniques for mammography of patients with breast implants.
Subparagraph (G) shall not be construed to limit a patient's access to the patient's medical records.
(2) Certification of personnel
The Secretary shall by regulation—
(A) specify organizations eligible to certify individuals to perform radiological procedures as required by paragraph (1)(C);
(B) specify boards eligible to certify physicians to interpret radiological procedures, including mammography, as required by paragraph (1)(D);
(C) establish standards for a program to certify physicians described in paragraph (1)(D); and
(D) specify boards eligible to certify medical physicists who are qualified to survey mammography equipment and to oversee quality assurance practices at mammography facilities.
(g) Inspections
(1) Annual inspections
(A) In general
The Secretary may enter and inspect certified facilities to determine compliance with the standards established under subsection (f) of this section. The Secretary shall, if feasible, delegate to a State agency the authority to make such inspections.
(B) Identification
The Secretary, or State agency acting on behalf of the Secretary, may conduct inspections only on presenting identification to the owner, operator, or agent in charge of the facility to be inspected.
(C) Scope of inspection
In conducting inspections, the Secretary or State agency acting on behalf of the Secretary—
(i) shall have access to all equipment, materials, records, and information that the Secretary or State agency considers necessary to determine whether the facility is being operated in accordance with this section; and
(ii) may copy, or require the facility to submit to the Secretary or the State agency, any of the materials, records, or information.
(D) Qualifications of inspectors
Qualified individuals, as determined by the Secretary, shall conduct all inspections. The Secretary may request that a State agency acting on behalf of the Secretary designate a qualified officer or employee to conduct the inspections, or designate a qualified Federal officer or employee to conduct inspections. The Secretary shall establish minimum qualifications and appropriate training for inspectors and criteria for certification of inspectors in order to inspect facilities for compliance with subsection (f) of this section.
(E) Frequency
The Secretary or State agency acting on behalf of the Secretary shall conduct inspections under this paragraph of each facility not less often than annually.
(F) Records and annual reports
The Secretary or a State agency acting on behalf of the Secretary which is responsible for inspecting mammography facilities shall maintain records of annual inspections required under this paragraph for a period as prescribed by the Secretary. Such a State agency shall annually prepare and submit to the Secretary a report concerning the inspections carried out under this paragraph. Such reports shall include a description of the facilities inspected and the results of such inspections.
(2) Inspection of accredited facilities
The Secretary shall inspect annually a sufficient number of the facilities accredited by an accreditation body to provide the Secretary with a reasonable estimate of the performance of such body.
(3) Inspection of facilities inspected by State agencies
The Secretary shall inspect annually facilities inspected by State agencies acting on behalf of the Secretary to assure a reasonable performance by such State agencies.
(4) Timing
The Secretary, or State agency, may conduct inspections under paragraphs (1), (2), and (3), during regular business hours or at a mutually agreeable time and after providing such notice as the Secretary may prescribe, except that the Secretary may waive such requirements if the continued performance of mammography at such facility threatens the public health.
(5) Limited reinspection
Nothing in this section limits the authority of the Secretary to conduct limited reinspections of facilities found not to be in compliance with this section.
(h) Sanctions
(1) In general
In order to promote voluntary compliance with this section, the Secretary may, in lieu of taking the actions authorized by subsection (i) of this section, impose one or more of the following sanctions:
(A) Directed plans of correction which afford a facility an opportunity to correct violations in a timely manner.
(B) Payment for the cost of onsite monitoring.
(2) Civil money penalties
The Secretary may assess civil money penalties in an amount not to exceed $10,000 for—
(A) failure to obtain a certificate as required by subsection (b) of this section,
(B) each failure by a facility to substantially comply with, or each day on which a facility fails to substantially comply with, the standards established under subsection (f) of this section or the requirements described in subclauses (I) through (III) of subsection (d)(1)(B)(ii) of this section, and
(C) each violation, or for each aiding and abetting in a violation of, any provision of, or regulation promulgated under, this section by an owner, operator, or any employee of a facility required to have a certificate.
(3) Procedures
The Secretary shall develop and implement procedures with respect to when and how each of the sanctions is to be imposed under paragraphs (1) and (2). Such procedures shall provide for notice to the owner or operator of the facility and a reasonable opportunity for the owner or operator to respond to the proposed sanctions and appropriate procedures for appealing determinations relating to the imposition of sanctions.
(i) Suspension and revocation
(1) In general
The certificate of a facility issued under subsection (c) of this section may be suspended or revoked if the Secretary finds, after providing, except as provided in paragraph (2), reasonable notice and an opportunity for a hearing to the owner or operator of the facility, that the owner, operator, or any employee of the facility—
(A) has been guilty of misrepresentation in obtaining the certificate;
(B) has failed to comply with the requirements of subsection (d)(1)(B)(ii)(III) of this section or the standards established by the Secretary under subsection (f) of this section;
(C) has failed to comply with reasonable requests of the Secretary for any record, information, report, or material that the Secretary concludes is necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards established under subsection (f) of this section;
(D) has refused a reasonable request of the Secretary, any Federal officer or employee duly designated by the Secretary, or any State officer or employee duly designated by the State, for permission to inspect the facility or the operations and pertinent records of the facility in accordance with subsection (g) of this section;
(E) has violated or aided and abetted in the violation of any provision of, or regulation promulgated under, this section; or
(F) has failed to comply with a sanction imposed under subsection (h) of this section.
(2) Action before a hearing
(A) In general
The Secretary may suspend the certificate of the facility before holding a hearing required by paragraph (1) if the Secretary makes the finding described in paragraph (1) and determines that—
(i) the failure of a facility to comply with the standards established by the Secretary under subsection (f) of this section presents a serious risk to human health; or
(ii) a facility has engaged in an action described in subparagraph (D) or (E) of paragraph (1).
(B) Hearing
If the Secretary suspends a certificate under subparagraph (A), the Secretary shall provide an opportunity for a hearing to the owner or operator of the facility not later than 60 days from the effective date of the suspension. The suspension shall remain in effect until the decision of the Secretary made after the hearing.
(3) Ineligibility to own or operate facilities after revocation
If the Secretary revokes the certificate of a facility on the basis of an act described in paragraph (1), no person who owned or operated the facility at the time of the act may, within 2 years of the revocation of the certificate, own or operate a facility that requires a certificate under this section.
(j) Injunctions
If the Secretary determines that—
(1) continuation of any activity related to the provision of mammography by a facility would constitute a serious risk to human health, the Secretary may bring suit in the district court of the United States for the district in which the facility is situated to enjoin continuation of the activity; and
(2) a facility is operating without a certificate as required by subsection (b) of this section, the Secretary may bring suit in the district court of the United States for the district in which the facility is situated to enjoin the operation of the facility.
Upon a proper showing, the district court shall grant a temporary injunction or restraining order against continuation of the activity or against operation of a facility, as the case may be, without requiring the Secretary to post a bond, pending issuance of a final order under this subsection.
(k) Judicial review
(1) Petition
If the Secretary imposes a sanction on a facility under subsection (h) of this section or suspends or revokes the certificate of a facility under subsection (i) of this section, the owner or operator of the facility may, not later than 60 days after the date the action of the Secretary becomes final, file a petition with the United States court of appeals for the circuit in which the facility is situated for judicial review of the action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary. As soon as practicable after receipt of the copy, the Secretary shall file in the court the record on which the action of the Secretary is based, as provided in
(2) Additional evidence
If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that the additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order the additional evidence (and evidence in rebuttal of the additional evidence) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may determine to be proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, by reason of the additional evidence so taken, and the Secretary shall file the modified or new findings, and the recommendations of the Secretary, if any, for the modification or setting aside of the original action of the Secretary with the return of the additional evidence.
(3) Judgment of court
Upon the filing of the petition referred to in paragraph (1), the court shall have jurisdiction to affirm the action, or to set the action aside in whole or in part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.
(4) Finality of judgment
The judgment of the court affirming or setting aside, in whole or in part, any action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in
(l) Information
(1) In general
Not later than October 1, 1996, and annually thereafter, the Secretary shall compile and make available to physicians and the general public information that the Secretary determines is useful in evaluating the performance of facilities, including a list of facilities—
(A) that have been convicted under Federal or State laws relating to fraud and abuse, false billings, or kickbacks;
(B) that have been subject to sanctions under subsection (h) of this section, together with a statement of the reasons for the sanctions;
(C) that have had certificates revoked or suspended under subsection (i) of this section, together with a statement of the reasons for the revocation or suspension;
(D) against which the Secretary has taken action under subsection (j) of this section, together with a statement of the reasons for the action;
(E) whose accreditation has been revoked, together with a statement of the reasons of the revocation;
(F) against which a State has taken adverse action; and
(G) that meets such other measures of performance as the Secretary may develop.
(2) Date
The information to be compiled under paragraph (1) shall be information for the calendar year preceding the date the information is to be made available to the public.
(3) Explanatory information
The information to be compiled under paragraph (1) shall be accompanied by such explanatory information as may be appropriate to assist in the interpretation of the information compiled under such paragraph.
(m) State laws
Nothing in this section shall be construed to limit the authority of any State to enact and enforce laws relating to the matters covered by this section that are at least as stringent as this section or the regulations issued under this section.
(n) National Advisory Committee
(1) Establishment
In carrying out this section, the Secretary shall establish an advisory committee to be known as the National Mammography Quality Assurance Advisory Committee (hereafter in this subsection referred to as the "Advisory Committee").
(2) Composition
The Advisory Committee shall be composed of not fewer than 13, nor more than 19 individuals, who are not officers or employees of the Federal Government. The Secretary shall make appointments to the Advisory Committee from among—
(A) physicians,
(B) practitioners, and
(C) other health professionals,
whose clinical practice, research specialization, or professional expertise include a significant focus on mammography. The Secretary shall appoint at least 4 individuals from among national breast cancer or consumer health organizations with expertise in mammography and at least 2 practicing physicians who provide mammography services.
(3) Functions and duties
The Advisory Committee shall—
(A) advise the Secretary on appropriate quality standards and regulations for mammography facilities;
(B) advise the Secretary on appropriate standards and regulations for accreditation bodies;
(C) advise the Secretary in the development of regulations with respect to sanctions;
(D) assist in developing procedures for monitoring compliance with standards under subsection (f) of this section;
(E) make recommendations and assist in the establishment of a mechanism to investigate consumer complaints;
(F) report on new developments concerning breast imaging that should be considered in the oversight of mammography facilities;
(G) determine whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determine the effects of personnel or other requirements of subsection (f) of this section on access to the services of such facilities in such areas;
(H) determine whether there will exist a sufficient number of medical physicists after October 1, 1999, to assure compliance with the requirements of subsection (f)(1)(E) of this section;
(I) determine the costs and benefits of compliance with the requirements of this section (including the requirements of regulations promulgated under this section); and
(J) perform other activities that the Secretary may require.
The Advisory Committee shall report the findings made under subparagraphs (G) and (I) to the Secretary and the Congress no later than October 1, 1993.
(4) Meetings
The Advisory Committee shall meet not less than quarterly for the first 3 years of the program and thereafter, at least biannually.
(5) Chairperson
The Secretary shall appoint a chairperson of the Advisory Committee.
(o) Consultations
In carrying out this section, the Secretary shall consult with appropriate Federal agencies within the Department of Health and Human Services for the purposes of developing standards, regulations, evaluations, and procedures for compliance and oversight.
(p) Breast cancer screening surveillance research grants
(1) Research
(A) Grants
The Secretary shall award grants to such entities as the Secretary may determine to be appropriate to establish surveillance systems in selected geographic areas to provide data to evaluate the functioning and effectiveness of breast cancer screening programs in the United States, including assessments of participation rates in screening mammography, diagnostic procedures, incidence of breast cancer, mode of detection (mammography screening or other methods), outcome and follow up information, and such related epidemiologic analyses that may improve early cancer detection and contribute to reduction in breast cancer mortality. Grants may be awarded for further research on breast cancer surveillance systems upon the Secretary's review of the evaluation of the program.
(B) Use of funds
Grants awarded under subparagraph (A) may be used—
(i) to study—
(I) methods to link mammography and clinical breast examination records with population-based cancer registry data;
(II) methods to provide diagnostic outcome data, or facilitate the communication of diagnostic outcome data, to radiology facilities for purposes of evaluating patterns of mammography interpretation; and
(III) mechanisms for limiting access and maintaining confidentiality of all stored data; and
(ii) to conduct pilot testing of the methods and mechanisms described in subclauses (I), (II), and (III) of clause (i) on a limited basis.
(C) Grant application
To be eligible to receive funds under this paragraph, an entity shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may require.
(D) Report
A recipient of a grant under this paragraph shall submit a report to the Secretary containing the results of the study and testing conducted under clauses (i) and (ii) of subparagraph (B), along with recommendations for methods of establishing a breast cancer screening surveillance system.
(2) Establishment
The Secretary shall establish a breast cancer screening surveillance system based on the recommendations contained in the report described in paragraph (1)(D).
(3) Standards and procedures
The Secretary shall establish standards and procedures for the operation of the breast cancer screening surveillance system, including procedures to maintain confidentiality of patient records.
(4) Information
The Secretary shall recruit facilities to provide to the breast cancer screening surveillance system relevant data that could help in the research of the causes, characteristics, and prevalence of, and potential treatments for, breast cancer and benign breast conditions, if the information may be disclosed under
(q) State program
(1) In general
The Secretary may, upon application, authorize a State—
(A) to carry out, subject to paragraph (2), the certification program requirements under subsections (b), (c), (d), (g)(1), (h), (i), and (j) of this section (including the requirements under regulations promulgated pursuant to such subsections), and
(B) to implement the standards established by the Secretary under subsection (f) of this section,
with respect to mammography facilities operating within the State.
(2) Approval
The Secretary may approve an application under paragraph (1) if the Secretary determines that—
(A) the State has enacted laws and issued regulations relating to mammography facilities which are the requirements of this section (including the requirements under regulations promulgated pursuant to such subsections), and
(B) the State has provided satisfactory assurances that the State—
(i) has the legal authority and qualified personnel necessary to enforce the requirements of and the regulations promulgated pursuant to this section (including the requirements under regulations promulgated pursuant to such subsections),
(ii) will devote adequate funds to the administration and enforcement of such requirements, and
(iii) will provide the Secretary with such information and reports as the Secretary may require.
(3) Authority of Secretary
In a State with an approved application—
(A) the Secretary shall carry out the Secretary's functions under subsections (e) and (f) of this section;
(B) the Secretary may take action under subsections (h), (i), and (j) of this section; and
(C) the Secretary shall conduct oversight functions under subsections (g)(2) and (g)(3) of this section.
(4) Withdrawal of approval
(A) In general
The Secretary may, after providing notice and opportunity for corrective action, withdraw the approval of a State's authority under paragraph (1) if the Secretary determines that the State does not meet the requirements of such paragraph. The Secretary shall promulgate regulations for the implementation of this subparagraph.
(B) Effect of withdrawal
If the Secretary withdraws the approval of a State under subparagraph (A), the certificate of any facility accredited by the State shall continue in effect until the expiration of a reasonable period, as determined by the Secretary, for such facility to obtain certification by the Secretary.
(r) Funding
(1) Fees
(A) In general
The Secretary shall, in accordance with this paragraph assess and collect fees from persons described in subsection (d)(1)(A) of this section (other than persons who are governmental entities, as determined by the Secretary) to cover the costs of inspections conducted under subsection (g)(1) of this section by the Secretary or a State acting under a delegation under subparagraph (A) of such subsection. Fees may be assessed and collected under this paragraph only in such manner as would result in an aggregate amount of fees collected during any fiscal year which equals the aggregate amount of costs for such fiscal year for inspections of facilities of such persons under subsection (g)(1) of this section. A person's liability for fees shall be reasonably based on the proportion of the inspection costs which relate to such person.
(B) Deposit and appropriations
(i) Deposit and availability
Fees collected under subparagraph (A) shall be deposited as an offsetting collection to the appropriations for the Department of Health and Human Services as provided in appropriation Acts and shall remain available without fiscal year limitation.
(ii) Appropriations
Fees collected under subparagraph (A) shall be collected and available only to the extent provided in advance in appropriation Acts.
(2) Authorization of appropriations
There are authorized to be appropriated to carry out this section—
(A) to award research grants under subsection (q) of this section, such sums as may be necessary for each of the fiscal years 1993 through 1997; and
(B) for the Secretary to carry out other activities which are not supported by fees authorized and collected under paragraph (1), such sums as may be necessary for fiscal year 1 1993 through 1997.
(July 1, 1944, ch. 373, title III, §354, as added Oct. 27, 1992,
Prior Provisions
A prior section 263b, act July 1, 1944, ch. 373, title III, §354, as added Oct. 18, 1968,
Sections 263c to 263n, act July 1, 1944, ch. 373, title III, §§355–360F, as added Oct. 18, 1968,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Termination of Advisory Committees
Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided for by law. See section 14 of
Regulations
"(1) under which the Secretary may approve accreditation bodies under section 354(e) of the Public Health Service Act (
"(2) establishing quality standards under section 354(f) of the Public Health Service Act (
Study
Section 3 of
"(a)
"(1) if the program has resulted in the improvement of the quality and accessibility of mammography services, and
"(2) if the program has reduced the frequency of poor quality mammography and improved the early detection of breast cancer.
"(b)
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "years".
Part G—Quarantine and Inspection
Part Referred to in Other Sections
This part is referred to in
§264. Regulations to control communicable diseases
(a) Promulgation and enforcement by Surgeon General
The Surgeon General, with the approval of the Secretary, is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. For purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary.
(b) Apprehension, detention, or conditional release of individuals
Regulations prescribed under this section shall not provide for the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon the recommendation of the National Advisory Health Council and the Surgeon General.
(c) Application of regulations to persons entering from foreign countries
Except as provided in subsection (d) of this section, regulations prescribed under this section, insofar as they provide for the apprehension, detention, examination, or conditional release of individuals, shall be applicable only to individuals coming into a State or possession from a foreign country or a possession.
(d) Apprehension and examination of persons reasonably believed to be infected
On recommendation of the National Advisory Health Council, regulations prescribed under this section may provide for the apprehension and examination of any individual reasonably believed to be infected with a communicable disease in a communicable stage and (1) to be moving or about to move from a State to another State; or (2) to be a probable source of infection to individuals who, while infected with such disease in a communicable stage, will be moving from a State to another State. Such regulations may provide that if upon examination any such individual is found to be infected, he may be detained for such time and in such manner as may be reasonably necessary. For purposes of this subsection, the term "State" includes, in addition to the several States, only the District of Columbia.
(July 1, 1944, ch. 373, title III, §361,
Amendments
1976—Subsec. (d).
1960—Subsec. (c).
Effective Date of 1960 Amendment
Amendment by
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
Ex. Ord. No. 12452. Revised List of Quarantinable Communicable Diseases
Ex. Ord. No. 12452, Dec. 22, 1983, 48 F.R. 56927, provided:
By the authority vested in me as President by the Constitution and laws of the United States of America, including
Ronald Reagan.
Cross References
Compliance with State laws, see
Removal of revenue officers, during epidemics, see
Section Referred to in Other Sections
This section is referred to in
§265. Suspension of entries and imports from designated places to prevent spread of communicable diseases
Whenever the Surgeon General determines that by reason of the existence of any communicable disease in a foreign country there is serious danger of the introduction of such disease into the United States, and that this danger is so increased by the introduction of persons or property from such country that a suspension of the right to introduce such persons and property is required in the interest of the public health, the Surgeon General, in accordance with regulations approved by the President, shall have the power to prohibit, in whole or in part, the introduction of persons and property from such countries or places as he shall designate in order to avert such danger, and for such period of time as he may deem necessary for such purpose.
(July 1, 1944, ch. 373, title III, §362,
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Section Referred to in Other Sections
This section is referred to in
§266. Special quarantine powers in time of war
To protect the military and naval forces and war workers of the United States, in time of war, against any communicable disease specified in Executive orders as provided in subsection (b) of
(July 1, 1944, ch. 373, title III, §363,
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Termination of War and Emergencies
Joint Res. July 25, 1947, ch. 327, §3,
Section Referred to in Other Sections
This section is referred to in
§267. Quarantine stations, grounds, and anchorages
(a) Control and management
Except as provided in title II of the Act of June 15, 1917, as amended [
(b) Hours of inspection
The Surgeon General shall establish the hours during which quarantine service shall be performed at each quarantine station, and, upon application by any interested party, may establish quarantine inspection during the twenty-four hours of the day, or any fraction thereof, at such quarantine stations as, in his opinion, require such extended service. He may restrict the performance of quarantine inspection to hours of daylight for such arriving vessels as cannot, in his opinion, be satisfactorily inspected during hours of darkness. No vessel shall be required to undergo quarantine inspection during the hours of darkness, unless the quarantine officer at such quarantine station shall deem an immediate inspection necessary to protect the public health. Uniformity shall not be required in the hours during which quarantine inspection may be obtained at the various ports of the United States.
(c) Overtime pay for employees of Service
The Surgeon General shall fix a reasonable rate of extra compensation for overtime services of employees of the United States Public Health Service, Foreign Quarantine Division, performing overtime duties including the operation of vessels, in connection with the inspection or quarantine treatment of persons (passengers and crews), conveyances, or goods arriving by land, water, or air in the United States or any place subject to the jurisdiction thereof, hereinafter referred to as "employees of the Public Health Service", when required to be on duty between the hours of 6 o'clock postmeridian and 6 o'clock antemeridian (or between the hours of 7 o'clock postmeridian and 7 o'clock antemeridian at stations which have a declared workday of from 7 o'clock antemeridian to 7 o'clock postmeridian), or on Sundays or holidays, such rate, in lieu of compensation under any other provision of law, to be fixed at two times the basic hourly rate for each hour that the overtime extends beyond 6 o'clock (or 7 o'clock as the case may be) postmeridian, and two times the basic hourly rate for each overtime hour worked on Sundays or holidays. As used in this subsection, the term "basic hourly rate" shall mean the regular basic rate of pay which is applicable to such employees for work performed within their regular scheduled tour of duty.
(d) Payment of extra compensation to United States; bond or deposit to assure payment; deposit of moneys to credit of appropriation
(1) The said extra compensation shall be paid to the United States by the owner, agent, consignee, operator, or master or other person in charge of any conveyance, for whom, at his request, services as described in this subsection (hereinafter referred to as overtime service) are performed. If such employees have been ordered to report for duty and have so reported, and the requested services are not performed by reason of circumstances beyond the control of the employees concerned, such extra compensation shall be paid on the same basis as though the overtime services had actually been performed during the period between the time the employees were ordered to report for duty and did so report, and the time they were notified that their services would not be required, and in any case as though their services had continued for not less than one hour. The Surgeon General with the approval of the Secretary of Health and Human Services may prescribe regulations requiring the owner, agent, consignee, operator, or master or other person for whom the overtime services are performed to file a bond in such amounts and containing such conditions and with such sureties, or in lieu of a bond, to deposit money or obligations of the United States in such amount, as will assure the payment of charges under this subsection, which bond or deposit may cover one or more transactions or all transactions during a specified period: Provided, That no charges shall be made for services performed in connection with the inspection of (1) persons arriving by international highways, ferries, bridges, or tunnels, or the conveyances in which they arrive, or (2) persons arriving by aircraft or railroad trains, the operations of which are covered by published schedules, or the aircraft or trains in which they arrive, or (3) persons arriving by vessels operated between Canadian ports and ports on Puget Sound or operated on the Great Lakes and connecting waterways, the operations of which are covered by published schedules, or the vessels in which they arrive.
(2) Moneys collected under this subsection shall be deposited in the Treasury of the United States to the credit of the appropriation charged with the expense of the services, and the appropriations so credited shall be available for the payment of such compensation to the said employees for services so rendered.
(July 1, 1944, ch. 373, title III, §364,
Amendments
1958—Subsec. (c).
1957—Subsecs. (c), (d).
Transfer of Functions
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (d) pursuant to section 509(b) of
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Delegation of Functions
Functions of President delegated to Secretary of Health Health and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R. 1637, as amended, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§268. Quarantine duties of consular and other officers
(a) Any consular or medical officer of the United States, designated for such purpose by the Secretary, shall make reports to the Surgeon General, on such forms and at such intervals as the Surgeon General may prescribe, of the health conditions at the port or place at which such officer is stationed.
(b) It shall be the duty of the customs officers and of Coast Guard officers to aid in the enforcement of quarantine rules and regulations; but no additional compensation, except actual and necessary traveling expenses, shall be allowed any such officer by reason of such services.
(July 1, 1944, ch. 373, title III, §365,
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Reference to Secretary of Health, Education, and Welfare substituted for reference to Federal Security Administrator pursuant to section 5 of Reorg. Plan No. 1, of 1953, set out as a note under
Section Referred to in Other Sections
This section is referred to in
§269. Bills of health
(a) Detail of medical officer; conditions precedent to issuance; consular officer to receive fees
Except as otherwise prescribed in regulations, any vessel at any foreign port or place clearing or departing for any port or place in a State or possession shall be required to obtain from the consular officer of the United States or from the Public Health Service officer, or other medical officer of the United States designated by the Surgeon General, at the port or place of departure, a bill of health in duplicate, in the form prescribed by the Surgeon General. The President, from time to time, shall specify the ports at which a medical officer shall be stationed for this purpose. Such bill of health shall set forth the sanitary history and condition of said vessel, and shall state that it has in all respects complied with the regulations prescribed pursuant to subsection (c) of this section. Before granting such duplicate bill of health, such consular or medical officer shall be satisfied that the matters and things therein stated are true. The consular officer shall be entitled to demand and receive the fees for bills of health and such fees shall be established by regulation.
(b) Collectors of customs to receive originals; duplicate copies as part of ship's papers
Original bills of health shall be delivered to the collectors of customs at the port of entry. Duplicate copies of such bills of health shall be delivered at the time of inspection to quarantine officers at such port. The bills of health herein prescribed shall be considered as part of the ship's papers, and when duly certified to by the proper consular or other officer of the United States, over his official signature and seal, shall be accepted as evidence of the statements therein contained in any court of the United States.
(c) Regulations to secure sanitary conditions of vessels
The Surgeon General shall from time to time prescribe regulations, applicable to vessels referred to in subsection (a) of this section for the purpose of preventing the introduction into the States or possessions of the United States of any communicable disease by securing the best sanitary condition of such vessels, their cargoes, passengers, and crews. Such regulations shall be observed by such vessels prior to departure, during the course of the voyage, and also during inspection, disinfection, or other quarantine procedure upon arrival at any United States quarantine station.
(d) Vessels from ports near frontier
The provisions of subsections (a) and (b) of this section shall not apply to vessels plying between such foreign ports on or near the frontiers of the United States and ports of the United States as are designated by treaty.
(e) Compliance with regulations
It shall be unlawful for any vessel to enter any port in any State or possession of the United States to discharge its cargo, or land its passengers, except upon a certificate of the quarantine officer that regulations prescribed under subsection (c) of this section have in all respects been complied with by such officer, the vessel, and its master. The master of every such vessel shall deliver such certificate to the collector of customs at the port of entry, together with the original bill of health and other papers of the vessel. The certificate required by this subsection shall be procurable from the quarantine officer, upon arrival of the vessel at the quarantine station and satisfactory inspection thereof, at any time within which quarantine services are performed at such station.
(July 1, 1944, ch. 373, title III, §366,
Transfer of Functions
Functions of Public Health Service, Surgeon General of Public Health Service, and all other officers and employees of Public Health Service, and functions of all agencies of or in Public Health Service transferred to Secretary of Health, Education, and Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
All offices of collector of customs, comptroller of customs, surveyor of customs, and appraiser of merchandise of Bureau of Customs of Department of the Treasury to which appointments were required to be made by the President with the advice and consent of the Senate ordered abolished, with such offices to be terminated not later than December 31, 1966, by Reorg. Plan No. 1, of 1965, eff. May 25, 1965, 30 F.R. 7035,
Section Referred to in Other Sections
This section is referred to in
§270. Quarantine regulations governing civil air navigation and civil aircraft
The Surgeon General is authorized to provide by regulations for the application to air navigation and aircraft of any of the provisions of
(July 1, 1944, ch. 373, title III, §367,
Abolition of Office of Surgeon General
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
§271. Penalties for violation of quarantine laws
(a) Penalties for persons violating quarantine laws
Any person who violates any regulation prescribed under
(b) Penalties for vessels violating quarantine laws
Any vessel which violates
(c) Remittance or mitigation of forfeitures
With the approval of the Secretary, the Surgeon General may, upon application therefor, remit or mitigate any forfeiture provided for under subsection (b) of this section, and he shall have authority to ascertain the facts upon all such applications.
(July 1, 1944, ch. 373, title III, §368,
Change of Name
Act June 25, 1948, eff. Sept. 1, 1948, substituted "United States attorney" for "United States district attorney". See
Transfer of Functions
Office of Surgeon General abolished by section 3 of Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855,
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out as a note under
§272. Administration of oaths by quarantine officers
Medical officers of the United States, when performing duties as quarantine officers at any port or place within the United States, are authorized to take declarations and administer oaths in matters pertaining to the administration of the quarantine laws and regulations of the United States.
(July 1, 1944, ch. 373, title III, §369,
Part H—Organ Transplants
Prior Provisions
A prior part H related to grants to Alaska for mental health, prior to the general revision of part H by
Another prior part H, entitled "National Library of Medicine", as added by act Aug. 3, 1956, ch. 907,
§273. Organ procurement organizations
(a) Grant authority of Secretary
(1) The Secretary may make grants for the planning of qualified organ procurement organizations described in subsection (b) of this section.
(2) The Secretary may make grants for the establishment, initial operation, consolidation, and expansion of qualified organ procurement organizations described in subsection (b) of this section.
(3) The Secretary may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors.
(b) Qualified organizations
(1) A qualified organ procurement organization for which grants may be made under subsection (a) of this section is an organization which, as determined by the Secretary, will carry out the functions described in paragraph (2) 1 and—
(A) is a nonprofit entity,
(B) has accounting and other fiscal procedures (as specified by the Secretary) necessary to assure the fiscal stability of the organization,
(C) has an agreement with the Secretary to be reimbursed under title XVIII of the Social Security Act [
(D) has procedures to obtain payment for non-renal organs provided to transplant centers,
(E) has a defined service area that is of sufficient size to assure maximum effectiveness in the procurement and equitable distribution of organs, and that either includes an entire metropolitan statistical area (as specified by the Director of the Office of Management and Budget) or does not include any part of the area,
(F) has a director and such other staff, including the organ donation coordinators and organ procurement specialists necessary to effectively obtain organs from donors in its service area, and
(G) has a board of directors or an advisory board which—
(i) is composed of—
(I) members who represent hospital administrators, intensive care or emergency room personnel, tissue banks, and voluntary health associations in its service area,
(II) members who represent the public residing in such area,
(III) a physician with knowledge, experience, or skill in the field of histocompatability 2 or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility,
(IV) a physician with knowledge or skill in the field of neurology, and
(V) from each transplant center in its service area which has arrangements described in paragraph (2)(G) 1 with the organization, a member who is a surgeon who has practicing privileges in such center and who performs organ transplant surgery,
(ii) has the authority to recommend policies for the procurement of organs and the other functions described in paragraph (2),1 and
(iii) has no authority over any other activity of the organization.
(2)(A) Not later than 90 days after November 16, 1990, the Secretary shall publish in the Federal Register a notice of proposed rulemaking to establish criteria for determining whether an entity meets the requirement established in paragraph (1)(E).
(B) Not later than 1 year after November 16, 1990, the Secretary shall publish in the Federal Register a final rule to establish the criteria described in subparagraph (A).
(3) An organ procurement organization shall—
(A) have effective agreements, to identify potential organ donors, with a substantial majority of the hospitals and other health care entities in its service area which have facilities for organ donations,
(B) conduct and participate in systematic efforts, including professional education, to acquire all useable organs from potential donors,
(C) arrange for the acquisition and preservation of donated organs and provide quality standards for the acquisition of organs which are consistent with the standards adopted by the Organ Procurement and Transplantation Network under
(D) arrange for the appropriate tissue typing of donated organs,
(E) have a system to allocate donated organs equitably among transplant patients according to established medical criteria,
(F) provide or arrange for the transportation of donated organs to transplant centers,
(G) have arrangements to coordinate its activities with transplant centers in its service area,
(H) participate in the Organ Procurement Transplantation Network established under
(I) have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage, and distribution of tissues as may be appropriate to assure that all useable tissues are obtained from potential donors,
(J) evaluate annually the effectiveness of the organization in acquiring potentially available organs, and
(K) assist hospitals in establishing and implementing protocols for making routine inquiries about organ donations by potential donors.
(July 1, 1944, ch. 373, title III, §371, as added Oct. 19, 1984,
References in Text
Paragraph (2), referred to in subsec. (b)(1), meaning paragraph (2) of subsec. (b) of this section, was redesignated paragraph (3) by section 201(d)(1) of
The Social Security Act, referred to in subsec. (b)(1)(C), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 273, act July 1, 1944, ch. 373, title III, §371, as added July 28, 1956, ch. 772, title II, §201,
A prior section 371 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (b)(1)(E).
Subsec. (b)(1)(G)(i)(III).
Subsec. (b)(2), (3).
Subsec. (c).
1988—Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (a)(4).
Subsec. (a)(4)(C).
Subsec. (b)(1)(E).
Subsec. (b)(1)(G)(i)(III).
Subsec. (b)(2)(C).
Subsec. (b)(2)(E).
Subsec. (b)(2)(K).
Subsec. (c).
Effective Date of 1990 Amendment
Section 207 of title II of
Effective Date of 1988 Amendment
Section 402(c)(3) of
Short Title
For short title of
Severability
Section 301 of
Study on Hospital Agreements With Organ Procurement Agencies
"(1)
"(2)
Task Force on Organ Procurement and Transplantation
Bone Marrow Registry Demonstration and Study
Section 401 of
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
2 So in original. Probably should be "histocompatibility".
§274. Organ procurement and transplantation network
(a) Contract authority of Secretary; limitation; available appropriations
The Secretary shall by contract provide for the establishment and operation of an Organ Procurement and Transplantation Network which meets the requirements of subsection (b) of this section. The amount provided under such contract in any fiscal year may not exceed $2,000,000. Funds for such contracts shall be made available from funds available to the Public Health Service from appropriations for fiscal years beginning after fiscal year 1984.
(b) Functions
(1) The Organ Procurement and Transplantation Network shall carry out the functions described in paragraph (2) and shall—
(A) be a private nonprofit entity that has an expertise in organ procurement and transplantation, and
(B) have a board of directors—
(i) that includes representatives of organ procurement organizations (including organizations that have received grants under
(ii) that shall establish an executive committee and other committees, whose chairpersons shall be selected to ensure continuity of leadership for the board.
(2) The Organ Procurement and Transplantation Network shall—
(A) establish in one location or through regional centers—
(i) a national list of individuals who need organs, and
(ii) a national system, through the use of computers and in accordance with established medical criteria, to match organs and individuals included in the list, especially individuals whose immune system makes it difficult for them to receive organs,
(B) establish membership criteria and medical criteria for allocating organs and provide to members of the public an opportunity to comment with respect to such criteria,
(C) maintain a twenty-four-hour telephone service to facilitate matching organs with individuals included in the list,
(D) assist organ procurement organizations in the nationwide distribution of organs equitably among transplant patients,
(E) adopt and use standards of quality for the acquisition and transportation of donated organs, including standards for preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,
(F) prepare and distribute, on a regionalized basis (and, to the extent practicable, among regions or on a national basis), samples of blood sera from individuals who are included on the list and whose immune system makes it difficult for them to receive organs, in order to facilitate matching the compatibility of such individuals with organ donors,
(G) coordinate, as appropriate, the transportation of organs from organ procurement organizations to transplant centers,
(H) provide information to physicians and other health professionals regarding organ donation,
(I) collect, analyze, and publish data concerning organ donation and transplants,
(J) carry out studies and demonstration projects for the purpose of improving procedures for organ procurement and allocation, and 1
(K) work actively to increase the supply of donated organs.2
(L) submit to the Secretary an annual report containing information on the comparative costs and patient outcomes at each transplant center affiliated with the organ procurement and transplantation network.
(c) Consideration of critical comments
The Secretary shall establish procedures for—
(1) receiving from interested persons critical comments relating to the manner in which the Organ Procurement and Transplantation Network is carrying out the duties of the Network under subsection (b) of this section; and
(2) the consideration by the Secretary of such critical comments.
(July 1, 1944, ch. 373, title III, §372, as added Oct. 19, 1984,
Prior Provisions
A prior section 274, act July 1, 1944, ch. 373, title III, §372, as added July 28, 1956, ch. 772, title II, §201,
Another section 372 of act July 1, 1944, added by act Aug. 3, 1956, ch. 941, §1,
Amendments
1990—Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(2)(D).
Subsec. (b)(2)(F).
Subsec. (b)(2)(K), (L).
1988—Subsec. (b)(2)(B), (C).
Subsec. (b)(2)(D).
Subsec. (b)(2)(E).
Subsec. (b)(2)(F).
Subsec. (b)(2)(G) to (I).
Subsec. (b)(2)(J).
Subsec. (c).
Effective Date of 1990 Amendment
Section 202(d) of
Section Referred to in Other Sections
This section is referred to in
1 So in original. The word "and" probably should not appear.
2 So in original. The period probably should be ", and".
§274a. Scientific registry
The Secretary shall, by grant or contract, develop and maintain a scientific registry of the recipients of organ transplants. The registry shall include such information respecting patients and transplant procedures as the Secretary deems necessary to an ongoing evaluation of the scientific and clinical status of organ transplantation. The Secretary shall prepare for inclusion in the report under
(July 1, 1944, ch. 373, title III, §373, as added Oct. 19, 1984,
Prior Provisions
A prior section 373 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
1988—
Section Referred to in Other Sections
This section is referred to in
§274b. General provisions respecting grants and contracts
(a) Application requirement
No grant may be made under this part or contract entered into under
(b) Special considerations and priority; planning and establishment grants
(1) A grant for planning under
(2) Grants under
(3) Grants or contracts under
(c) Determination of grant amount; terms of payment; recordkeeping; access for purposes of audits and examination of records
(1) The Secretary shall determine the amount of a grant or contract made under
(2)(A) Each recipient of a grant or contract under
(B) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of the recipient of a grant or contract under
(d) "Transplant center" and "organ" defined
For purposes of this part:
(1) The term "transplant center" means a health care facility in which transplants of organs are performed.
(2) The term "organ" means the human kidney, liver, heart, lung, pancreas, and any other human organ (other than corneas and eyes) specified by the Secretary by regulation and for purposes of
(July 1, 1944, ch. 373, title III, §374, as added Oct. 19, 1984,
Prior Provisions
A prior section 374 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—Subsec. (a).
Subsec. (b).
Subsec. (c).
1988—Subsec. (b)(3).
§274c. Administration
The Secretary shall designate and maintain an identifiable administrative unit in the Public Health Service to—
(1) administer this part and coordinate with the organ procurement activities under title XVIII of the Social Security Act [
(2) conduct a program of public information to inform the public of the need for organ donations,
(3) provide technical assistance to organ procurement organizations, the Organ Procurement and Transplantation Network established under
(4) provide information—
(i) to patients, their families, and their physicians about transplantation; and
(ii) to patients and their families about the resources available nationally and in each State, and the comparative costs and patient outcomes at each transplant center affiliated with the organ procurement and transplantation network, in order to assist the patients and families with the costs associated with transplantation.
(July 1, 1944, ch. 373, title III, §375, as added Oct. 19, 1984,
References in Text
The Social Security Act, referred to in par. (1), is act Aug. 14, 1935, ch. 531,
Prior Provisions
A prior section 375 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
Par. (3).
Par. (4).
1988—
§274d. Report
Not later than February 10 of 1991 and of each second year thereafter, the Secretary shall publish, and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.1 a report on the scientific and clinical status of organ transplantation. The Secretary shall consult with the Director of the National Institutes of Health and the Commissioner of the Food and Drug Administration in the preparation of the report.
(July 1, 1944, ch. 373, title III, §376, as added Oct. 19, 1984,
Prior Provisions
A prior section 376 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, §1,
Amendments
1990—
1988—
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Section Referred to in Other Sections
This section is referred to in
1 So in original. The period probably should be a comma.
§274e. Prohibition of organ purchases
(a) Prohibition
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce.
(b) Penalties
Any person who violates subsection (a) of this section shall be fined not more than $50,000 or imprisoned not more than five years, or both.
(c) Definitions
For purposes of subsection (a) of this section:
(1) The term "human organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation.
(2) The term "valuable consideration" does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.
(3) The term "interstate commerce" has the meaning prescribed for it by
(
Codification
Section was enacted as part of the National Organ Transplant Act, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
1988—Subsec. (c)(1).
§274f. Study by General Accounting Office
(a) In general
The Comptroller General of the United States shall conduct a study for the purpose of determining—
(1) the extent to which the procurement and allocation of organs have been equitable, efficient, and effective;
(2) the problems encountered in the procurement and allocation; and
(3) the effect of State required-request laws.
(b) Report
Not later than January 7, 1992, the Comptroller General of the United States shall complete the study required in subsection (a) of this section and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the findings made as a result of the study.
(July 1, 1944, ch. 373, title III, §377, as added Nov. 16, 1990,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
§274g. Authorization of appropriations
For the purpose of carrying out this part, there are authorized to be appropriated $8,000,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
(July 1, 1944, ch. 373, title III, §378, as added Nov. 16, 1990,
Part I—National Bone Marrow Donor Registry
Amendments
1990—
1985—
1970—
§274k. National Registry
(a) Establishment
The Secretary shall by contract establish and maintain a National Bone Marrow Donor Registry (referred to in this part as the "Registry") that meets the requirements of this section. The Registry shall be under the general supervision of the Secretary, and under the direction of a board of directors that shall include representatives of marrow donor centers, marrow transplant centers, persons with expertise in the social science, and the general public.
(b) Functions
The Registry shall—
(1) establish a system for finding marrow donors suitably matched to unrelated recipients for bone marrow transplantation;
(2) establish a system for patient advocacy, separate from mechanisms for donor advocacy, that directly assists patients, their families, and their physicians in the search for an unrelated marrow donor;
(3) increase the representation of individuals from racial and ethnic minority groups in the pool of potential donors for the Registry in order to enable an individual in a minority group, to the extent practicable, to have a comparable chance of finding a suitable unrelated donor as would an individual not in a minority group;
(4) provide information to physicians, other health care professionals, and the public regarding bone marrow transplantation;
(5) recruit potential bone marrow donors;
(6) collect, analyze, and publish data concerning bone marrow donation and transplantation; and
(7) support studies and demonstration projects for the purpose of increasing the number of individuals, especially minorities, who are willing to be marrow donors.
(c) Criteria, standards, and procedures
Not later than 180 days after November 16, 1990, the Secretary shall establish and enforce, for entities participating in the program, including the Registry, individual marrow donor centers, marrow donor registries, marrow collection centers, and marrow transplant centers—
(1) quality standards and standards for tissue typing, obtaining the informed consent of donors, and providing patient advocacy;
(2) donor selection criteria, based on established medical criteria, to protect both the donor and the recipient and to prevent the transmission of potentially harmful infectious diseases such as the viruses that cause hepatitis and the etiologic agent for Acquired Immune Deficiency Syndrome;
(3) procedures to ensure the proper collection and transportation of the marrow;
(4) standards that require the provision of information to patients, their families, and their physicians at the start of the search process concerning—
(A) the resources available through the Registry;
(B) all other marrow donor registries meeting the standards described in this paragraph; and
(C) in the case of the Registry—
(i) the comparative costs of all charges by marrow transplant centers incurred by patients prior to transplantation; and
(ii) the success rates of individual marrow transplant centers;
(5) standards that—
(A) require the establishment of a system of strict confidentiality of records relating to the identity, address, HLA type, and managing marrow donor center for marrow donors and potential marrow donors; and
(B) prescribe the purposes for which the records described in subparagraph (A) may be disclosed, and the circumstances and extent of the disclosure; and
(6) in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure the establishment of a method for integrating donor files, searches, and general procedures of the center or registry with the Registry.
(d) Comment procedures
The Secretary shall establish and provide information to the public on procedures, which may include establishment of a policy advisory committee, under which the Secretary shall receive and consider comments from interested persons relating to the manner in which the Registry is carrying out the duties of the Registry under subsection (b) of this section and complying with the criteria, standards, and procedures described in subsection (c) of this section.
(e) Consultation
The Secretary shall consult with the board of directors of the Registry and the bone marrow donor program of the Department of the Navy in developing policies affecting the Registry.
(f) Application
To be eligible to enter into a contract under this section, an entity shall submit to the Secretary and obtain approval of an application at such time, in such manner, and containing such information as the Secretary shall by regulation prescribe.
(g) Eligibility
Entities eligible to receive a contract under this section shall include private nonprofit entities.
(h) Records
(1) Recordkeeping
Each recipient of a contract or subcontract under subsection (a) of this section shall keep such records as the Secretary shall prescribe, including records that fully disclose the amount and disposition by the recipient of the proceeds of the contract, the total cost of the undertaking in connection with which the contract was made, and the amount of the portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(2) Examination of records
The Secretary and the Comptroller General of the United States shall have access to any books, documents, papers, and records of the recipient of a contract or subcontract entered into under this section that are pertinent to the contract, for the purpose of conducting audits and examinations.
(i) Penalties for disclosure
Any person who discloses the content of any record referred to in subsection (c)(5)(A) of this section without the prior written consent of the donor or potential donor with respect to whom the record is maintained, or in violation of the standards described in subsection (c)(5)(B) of this section, shall be imprisoned for not more than 2 years or fined in accordance with title 18, or both.
(j) Authorization of appropriations
There are authorized to be appropriated to carry out this section $15,000,000 for fiscal year 1991 and such sums as may be necessary for each of fiscal years 1992 and 1993.
(July 1, 1944, ch. 373, title III, §379, as added Nov. 16, 1990,
Savings Provision
Section 102 of title I of
"(a)
"(b)
"(c)
§274l. Study by General Accounting Office
(a) In general
The Comptroller General of the United States shall conduct a study that evaluates—
(1) the costs and benefits of the search process for an unrelated bone marrow donor among different marrow donor registries;
(2) the extent to which marrow donor registries protect donor confidentiality;
(3) the relationship between the Registry, individual marow 1 donor centers, and other marrow donor registries;
(4) the effectiveness and appropriateness of policies and procedures of marrow donor centers, marrow transplant centers, and marrow donor registries, including—
(A) the process of donor recruitment, including the policy of asking each donor whether the donor would want to donate more than one time;
(B) the maintenance and updating of donor files; and
(C) the policy of initially typing donors for A/B antigens only instead of initially typing for both A/B and D/R antigens;
(5) the ability of the marrow donor registries to incorporate changes in medical research and clinical practice; and
(6) the costs associated with tissue typing.
(b) Report
Not later than 1 year after November 16, 1990, the Comptroller General shall complete the study required under subsection (a) of this section and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the findings made by the study and recommendations for legislative reform.
(July 1, 1944, ch. 373, title III, §379A, as added Nov. 16, 1990,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
1 So in original. Probably should be "marrow".
§275. Repealed. Pub. L. 103–43, title I, §121(a), June 10, 1993, 107 Stat. 133
Section, act July 1, 1944, ch. 373, title III, §381, as added Nov. 20, 1985,
A prior section 275, act July 1, 1944, ch. 373, title III, §381, formerly §371, as added Aug. 3, 1956, ch. 907, §1,
§§276 to 280a–1. Repealed. Pub. L. 99–158, §3(b), Nov. 20, 1985, 99 Stat. 879
Section 276, act July 1, 1944, ch. 373, title III, §382, formerly §372, as added Aug. 3, 1956, ch. 907, §1,
Section 277, act July 1, 1944, ch. 373, title III, §383, formerly §373, as added Aug. 3, 1956, ch. 907, §1,
Section 278, act July 1, 1944, ch. 373, title III, §384, formerly §374, as added Aug. 3, 1956, ch. 907, §1,
Section 279, act July 1, 1944, ch. 373, title III, §385, formerly §375, as added Aug. 3, 1956, ch. 907 §1,
Section 280, act July 1, 1944, ch. 373, title III, §386, formerly §376, as added Aug. 3, 1956, ch. 907, §1,
Section 280a, act July 1, 1944, ch. 373, title III, §387, formerly §377, as added Aug. 3, 1956, ch. 907, §1,
Section 280a–1, act July 1, 1944, ch. 373, title III, §388, formerly §378, as added Oct. 22, 1965,
Part J—Prevention and Control of Injuries
Amendments
1993—
1990—
§280b. Research
(a) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall—
(1) conduct, and give assistance to public and nonprofit private entities, scientific institutions, and individuals engaged in the conduct of, research relating to the causes, mechanisms, prevention, diagnosis, treatment of injuries, and rehabilitation from injuries;
(2) make grants to, or enter into cooperative agreements or contracts with, public and nonprofit private entities (including academic institutions, hospitals, and laboratories) and individuals for the conduct of such research; and
(3) make grants to, or enter into cooperative agreements or contracts with, academic institutions for the purpose of providing training on the causes, mechanisms, prevention, diagnosis, treatment of injuries, and rehabilitation from injuries.
(b) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall collect and disseminate, through publications and other appropriate means, information concerning the practical applications of research conducted or assisted under subsection (a) of this section. In carrying out the preceding sentence, the Secretary shall disseminate such information to the public, including through elementary and secondary schools.
(July 1, 1944, ch. 373, title III, §391, as added Nov. 10, 1986,
Prior Provisions
A prior section 280b, act July 1, 1944, ch. 373, title III, §390, as added Oct. 22, 1965,
A prior section 391 of act July 1, 1944, ch. 373, title III, as added Oct. 22, 1965,
Amendments
1993—Subsec. (b).
1992—
1990—Subsec. (a)(2).
Subsec. (a)(3).
Findings and Purposes
Section 2 of
"(a) The Congress finds and declares that:
"(1) Injury is one of the principal public health problems in America, and causes over 140,000 deaths per year.
"(2) Injury rates are particularly high for children and the elderly.
"(3) Injury causes 50 percent of all deaths for children over the age of one year and two-thirds of all deaths for children over the age of 15 years, and is the leading cause of death for individuals under the age of 44 years. Individuals over the age of 65 years have the highest fatality rates for many injuries.
"(4) Injury control has not been given high priority in the United States, and the research being conducted on injury control and the number of personnel involved in injury control activities are not adequate.
"(b) The purposes of this Act [enacting this part] are—
"(1) to promote research into the causes, diagnosis, treatment, prevention, and control of injuries and rehabilitation from injuries;
"(2) to promote cooperation between specialists in fields involved in injury research; and
"(3) to promote coordination between Federal, State, and local governments and public and private entities in order to achieve a reduction in deaths from injuries."
Section Referred to in Other Sections
This section is referred to in
§280b–1. Prevention and control activities
(a) The Secretary, through the Director of the Centers for Disease Control and Prevention, shall—
(1) assist States and political subdivisions of States in activities for the prevention and control of injuries; and
(2) encourage regional activities between States designed to reduce injury rates.
(b) The Secretary, through the Director of the Centers for Disease Control and Prevention, may—
(1) enter into agreements between the Service and public and private community health agencies which provide for cooperative planning of activities to deal with problems relating to the prevention and control of injuries;
(2) work in cooperation with other Federal agencies, and with public and nonprofit private entities, to promote activities regarding the prevention and control of injuries; and
(3) make grants to States and, after consultation with State health agencies, to other public or nonprofit private entities for the purpose of carrying out demonstration projects for the prevention and control of injuries at sites that are not subject to the Occupational Safety and Health Act of 1970 [
(July 1, 1944, ch. 373, title III, §392, as added Nov. 10, 1986,
References in Text
The Occupational Safety and Health Act of 1970, referred to in subsec. (b)(3), is
Prior Provisions
A prior section 280b–1, act July 1, 1944, ch. 373, title III, §391, as added Oct. 22, 1965,
A prior section 392 of act July 1, 1944, ch. 373, title III, as added Oct. 22, 1965,
Amendments
1993—
Subsec. (a)(1).
Subsec. (b)(1).
Subsec. (b)(2).
1992—
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(3).
1990—Subsec. (b)(2).
Section Referred to in Other Sections
This section is referred to in
§280b–1a. Interpersonal violence within families and among acquaintances
(a) With respect to activities that are authorized in
(1) Collecting data relating to the incidence of such violence.
(2) Making grants to public and nonprofit private entities for the evaluation of programs whose purpose is to prevent such violence, including the evaluation of demonstration projects under paragraph (6).
(3) Making grants to public and nonprofit private entities for the conduct of research on identifying effective strategies for preventing such violence.
(4) Providing to the public information and education on such violence, including information and education to increase awareness of the public health consequences of such violence.
(5) Training health care providers as follows:
(A) To identify individuals whose medical conditions or statements indicate that the individuals are victims of such violence.
(B) To routinely determine, in examining patients, whether the medical conditions or statements of the patients so indicate.
(C) To refer individuals so identified to entities that provide services regarding such violence, including referrals for counseling, housing, legal services, and services of community organizations.
(6) Making grants to public and nonprofit private entities for demonstration projects with respect to such violence, including with respect to prevention.
(b) For purposes of this part, the term "interpersonal violence within families and among acquaintances" includes behavior commonly referred to as domestic violence, sexual assault, spousal abuse, woman battering, partner abuse, elder abuse, and acquaintance rape.
(July 1, 1944, ch. 373, title III, §393, as added Dec. 14, 1993,
Prior Provisions
A prior section 393 of act July 1, 1944, was renumbered section 394 and is classified to
Another prior section 393 of act July 1, 1944, was renumbered section 394 and was classified to
§280b–2. General provisions
(a) Advisory committee
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall establish an advisory committee to advise the Secretary and such Director with respect to the prevention and control of injuries.
(b) Technical assistance
The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may provide technical assistance to public and nonprofit private entities with respect to the planning, development, and operation of any program or service carried out pursuant to this part. The Secretary may provide such technical assistance directly or through grants or contracts.
(c) Biennial report
Not later than February 1 of 1995 and of every second year thereafter, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the activities carried out under this part during the preceding 2 fiscal years. Such report shall include a description of such activities that were carried out with respect to interpersonal violence within families and among acquaintances and with respect to rural areas.
(July 1, 1944, ch. 373, title III, §394, formerly §393, as added Nov. 10, 1986,
Prior Provisions
A prior section 280b–2, act July 1, 1944, ch. 373, title III, §392, as added Oct. 22, 1965,
A prior section 394 of act July 1, 1944, was renumbered section 394A and is classified to
Amendments
1993—
"(1) information regarding the practical applications of research conducted pursuant to subsection (a) of
"(2) information on such activities regarding the prevention and control of injuries in rural areas, including information regarding injuries that are particular to rural areas."
1992—
1990—
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Termination of Advisory Committees
Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 14 of
§280b–3. Authorization of appropriations
For the purpose of carrying out this part, there are authorized to be appropriated $50,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998.
(July 1, 1944, ch. 373, title III, §394A, formerly §394, as added Nov. 10, 1986,
Prior Provisions
A prior section 280b–3, act July 1, 1944, ch. 373, title III, §393, as added Oct. 22, 1965,
Prior sections 280b–4 to 280b–11 were repealed by
Section 280b–4, act July 1, 1944, ch. 373, title III, §393, formerly §394, as added Oct. 22, 1965,
Section 280b–5, act July 1, 1944, ch. 373, title III, §394, formerly §395, as added Oct. 22, 1965,
Section 280b–6, act July 1, 1944, ch. 373, title III, §396, as added Oct. 22, 1965,
Section 280b–7, act July 1, 1944, ch. 373, title III, §395, formerly §397, as added Oct. 22, 1965,
Section 280b–8, act July 1, 1944, ch. 373, title III, §396, formerly §398, as added Oct. 22, 1965,
Section 280b–9, act July 1, 1944, ch. 373, title III, §397, formerly §399, as added Oct. 22, 1965,
Section 280b–10, act July 1, 1944, ch. 373, title III, §398, formerly §399a, as added Oct. 22, 1965,
Section 280b–11, act July 1, 1944, ch. 373, title III, §399, formerly §399b, as added Oct. 22, 1965,
A prior section 280b–12, act July 1, 1944, ch. 373, title III, §399b, as added Mar. 13, 1970,
Amendments
1993—
1990—
Part K—Health Care Services in the Home
Amendments
1993—
1990—
Prior Provisions
A prior part K, added
subpart i—grants for demonstration projects
§280c. Establishment of program
(a) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make not less than 5, and not more than 20, grants to States for the purpose of assisting grantees in carrying out demonstration projects—
(1) to identify low-income individuals who can avoid institutionalization or prolonged hospitalization if skilled medical services, skilled nursing care services, homemaker or home health aide services, or personal care services are provided in the homes of the individuals;
(2) to pay the costs of the provision of such services in the homes of such individuals; and
(3) to coordinate the provision by public and private entities of such services, and other long-term care services, in the homes of such individuals.
(b) Requirement with respect to age of recipients of services
The Secretary may not make a grant under subsection (a) of this section to a State unless the State agrees to ensure that—
(1) not less than 25 percent of the grant is expended to provide services under such subsection to individuals who are not less than 65 years of age; and
(2) of the portion of the grant reserved by the State for purposes of complying with paragraph (1), not less than 10 percent is expended to provide such services to individuals who are not less than 85 years of age.
(c) Relationship to items and services under other programs
A State may not make payments from a grant under subsection (a) of this section for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services on a prepaid basis.
(July 1, 1944, ch. 373, title III, §395, as added Nov. 29, 1987,
Prior Provisions
A prior section 280C, act July 1, 1944, ch. 373, title III, §399A, formerly §399c, as added Dec. 29, 1973,
A prior section 395 of act July 1, 1944, ch. 373, title III, formerly §397, as added Oct. 22, 1965,
Amendments
1991—Subsec. (a)(1).
1990—Subsec. (a).
Subsec. (a)(1).
Subsec. (b).
Effective Date
Part effective Oct. 1, 1987, see section 701(a) of
Short Title
For short title of title VI of
Section Referred to in Other Sections
This section is referred to in
§280c–1. Limitation on duration of grant and requirement of matching funds
(a) Limitation on duration of grant
The period during which payments are made to a State from a grant under
(b) Requirement of matching funds
(1)(A) For the first year of payments to a State from a grant under
(B) For the second year of such payments to a State, the Secretary may not make such payments in an amount exceeding 65 percent of the costs of such services.
(C) For the third year of such payments to a State, the Secretary may not make such payments in an amount exceeding 55 percent of the costs of such services.
(2) The Secretary may not make a grant under
(A) for the first year of payments to the State from the grant, not less than $25 (in cash or in kind under subsection (c) of this section) for each $75 of Federal funds provided in the grant;
(B) for the second year of such payments to the State, not less than $35 (in cash or in kind under subsection (c) of this section) for each $65 of such Federal funds; and
(C) for the third year of such payments to the State, not less than $45 (in cash or in kind under subsection (c) of this section) for each $55 of such Federal funds.
(c) Determination of amount of non-Federal contribution
Non-Federal contributions required in subsection (b) of this section may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(July 1, 1944, ch. 373, title III, §396, as added Nov. 29, 1987,
Prior Provisions
A prior section 396 of act July 1, 1944, ch. 373, title III, formerly §398, as added Oct. 22, 1965,
§280c–2. General provisions
(a) Limitation on administrative expenses
The Secretary may not make a grant under
(b) Description of intended use of grant
The Secretary may not make a grant under
(1) the State submits to the Secretary a description of the purposes for which the State intends to expend the grant; and
(2) such description provides information relating to the programs and activities to be supported and services to be provided, including—
(A) the number of individuals who will receive services pursuant to
(B) a description of the manner in which such programs and activities will be coordinated with any similar programs and activities of public and private entities.
(c) Requirement of application
The Secretary may not make a grant under
(1) contain the description of intended expenditures required in subsection (b) of this section;
(2) with respect to carrying out the purpose for which the grant is to be made, provide assurances of compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such manner, and contain such information and agreements as the Secretary determines to be necessary to carry out this subpart.
(d) Evaluations and report by Secretary
The Secretary shall—
(1) provide for an evaluation of each demonstration project for which a grant is made under
(2) not later than 6 months after the completion of such evaluations, submit to the Congress a report describing the findings made as a result of the evaluations.
(e) Authorizations of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $5,000,000 for each of the fiscal years 1988 through 1990, $7,500,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
(July 1, 1944, ch. 373, title III, §397, as added Nov. 29, 1987,
Prior Provisions
A prior section 397 of act July 1, 1944, ch. 373, title III, formerly §399, as added Oct. 22, 1965,
Amendments
1990—Subsec. (e).
subpart ii—grants for demonstration projects with respect to alzheimer's disease
§280c–3. Establishment of program
(a) In general
The Secretary shall make not less than 5, and not more than 15, grants to States for the purpose of assisting grantees in carrying out demonstration projects for planning, establishing, and operating programs—
(1) to coordinate the development and operation with public and private organizations of diagnostic, treatment, care management, respite care, legal counseling, and education services provided within the State to individuals with Alzheimer's disease or related disorders and to the families and care providers of such individuals;
(2) to provide home health care, personal care, day care, companion services, short-term care in health facilities, and other respite care to individuals with Alzheimer's disease or related disorders; and
(3) to provide to health care providers, to individuals with Alzheimer's disease or related disorders, to the families of such individuals, to organizations established for such individuals and such families, and to the general public, information with respect to—
(A) diagnostic services, treatment services, and related services available to such individuals and to the families of such individuals;
(B) sources of assistance in obtaining such services, including assistance under entitlement programs; and
(C) the legal rights of such individuals and such families.
(b) Requirement with respect to certain expenditures
The Secretary may not make a grant under subsection (a) of this section to a State unless the State agrees to expend not less than 50 percent of the grant for the provision of services described in subsection (a)(2) of this section.
(c) Relationship to items and services under other programs
A State may not make payments from a grant under subsection (a) of this section for any item or service to the extent that payment has been made, or can reasonably be expected to be made, with respect to such item or service—
(1) under any State compensation program, under an insurance policy, or under any Federal or State health benefits program; or
(2) by an entity that provides health services on a prepaid basis.
(July 1, 1944, ch. 373, title III, §398, as added Nov. 29, 1987,
Prior Provisions
A prior section 398 of act July 1, 1944, ch. 373, title III, formerly §399a, as added Oct. 22, 1965,
Amendments
1990—Subsec. (a).
Subsec. (a)(1).
Section Referred to in Other Sections
This section is referred to in
§280c–4. Limitation on duration of grant and requirement of matching funds
(a) Limitation on duration of grant
The period during which payments are made to a State from a grant under
(b) Requirement of matching funds
(1)(A) For the first year of payments to a State from a grant under
(B) For the second year of such payments to a State, the Secretary may not make such payments in an amount exceeding 65 percent of the costs of such services.
(C) For the third year of such payments to a State, the Secretary may not make such payments in an amount exceeding 55 percent of the costs of such services.
(2) The Secretary may not make a grant under
(A) for the first year of payments to the State from the grant, not less than $25 (in cash or in kind under subsection (c) of this section) for each $75 of Federal funds provided in the grant;
(B) for the second year of such payments to the State, not less than $35 (in cash or in kind under subsection (c) of this section) for each $65 of such Federal funds; and
(C) for the third year of such payments to the State, not less than $45 (in cash or in kind under subsection (c) of this section) for each $55 of such Federal funds.
(c) Determination of amount of non-Federal contribution
Non-Federal contributions required in subsection (b) of this section may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(July 1, 1944, ch. 373, title III, §398A, formerly §399, as added Nov. 29, 1987,
§280c–5. General provisions
(a) Limitation on administrative expenses
The Secretary may not make a grant under
(b) Description of intended use of grant
The Secretary may not make a grant under
(1) the State submits to the Secretary a description of the purposes for which the State intends to expend the grant; and
(2) such description provides information relating to the programs and activities to be supported and services to be provided, including—
(A) the number of individuals who will receive services pursuant to
(B) a description of the manner in which such programs and activities will be coordinated with any similar programs and activities of public and private entities.
(c) Requirement of application
The Secretary may not make a grant under
(1) contain the description of intended expenditures required in subsection (b) of this section;
(2) with respect to carrying out the purpose for which the grant is to be made, provide assurances of compliance satisfactory to the Secretary; and
(3) otherwise be in such form, be made in such manner, and contain such information and agreements as the Secretary determines to be necessary to carry out this subpart.
(d) Evaluations and report by Secretary
The Secretary shall—
(1) provide for an evaluation of each demonstration project for which a grant is made under
(2) not later than 6 months after the completion of such evaluations, submit to the Congress a report describing the findings made as a result of the evaluations.
(e) Authorizations of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $5,000,000 for each of the fiscal years 1988 through 1990, $7,500,000 for fiscal year 1991, and such sums as may be necessary for each of the fiscal years 1992 and 1993.
(July 1, 1944, ch. 373, title III, §398B, formerly §399A, as added Nov. 29, 1987,
Amendments
1990—Subsec. (e).
subpart iii—grants for home visiting services for at-risk families
§280c–6. Projects to improve maternal, infant, and child health
(a) In general
(1) Establishment of program
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants to eligible entities to pay the Federal share of the cost of providing the services specified in subsection (b) of this section to families in which a member is—
(A) a pregnant woman at risk of delivering an infant with a health or developmental complication; or
(B) a child less than 3 years of age—
(i) who is experiencing or is at risk of a health or developmental complication, or of child abuse or neglect; or
(ii) who has been prenatally exposed to maternal substance abuse.
(2) Minimum period of awards; administrative consultations
(A) The Secretary shall award grants under paragraph (1) for periods of at least three years.
(B) The Administrator of the Administration for Children, Youth, and Families and the Director of the National Commission to Prevent Infant Mortality shall be consulted regarding the promulgation of program guidelines and funding priorities under this section.
(3) Requirement of status as medicaid provider
(A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the case of any service under such paragraph that is covered in the State plan approved under title XIX of the Social Security Act [
(i) the entity involved will provide the service directly, and the entity has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(ii) the entity will enter into an agreement with an organization under which the organization will provide the service, and the organization has entered into such a participation agreement and is qualified to receive such payments.
(B)(i) In the case of an organization making an agreement under subparagraph (A)(ii) regarding the provision of services under paragraph (1), the requirement established in such subparagraph regarding a participation agreement shall be waived by the Secretary if the organization does not, in providing health or mental health services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program.
(ii) A determination by the Secretary of whether an organization referred to in clause (i) meets the criteria for a waiver under such clause shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the public.
(b) Home visiting services for eligible families
With respect to an eligible family, each of the following services shall, directly or through arrangement with other public or nonprofit private entities, be available (as applicable to the family member involved) in each project operated with a grant under subsection (a) of this section:
(1) Prenatal and postnatal health care.
(2) Primary health care for the children, including developmental assessments.
(3) Education for the parents concerning infant care and child development, including the development and utilization of parent and teacher resource networks and other family resource and support networks where such networks are available.
(4) Upon the request of a parent, providing the education described in paragraph (3) to other individuals who have responsibility for caring for the children.
(5) Education for the parents concerning behaviors that adversely affect health.
(6) Assistance in obtaining necessary health, mental health, developmental, social, housing, and nutrition services and other assistance, including services and other assistance under maternal and child health programs; the special supplemental nutrition program for women, infants, and children;
(c) Considerations in making grants
In awarding grants under subsection (a) of this section, the Secretary shall take into consideration—
(1) the ability of the entity involved to provide, either directly or through linkages, a broad range of preventive and primary health care services and related social, family support, and developmental services;
(2) different combinations of professional and lay home visitors utilized within programs that are reflective of the identified service needs and characteristics of target populations;
(3) the extent to which the population to be targeted has limited access to health care, and related social, family support, and developmental services; and
(4) whether such grants are equitably distributed among urban and rural settings and whether entities serving Native American communities are represented among the grantees.
(d) Federal share
With respect to the costs of carrying out a project under subsection (a) of this section, a grant under such subsection for the project may not exceed 90 percent of such costs. To be eligible to receive such a grant, an applicant must provide assurances that the applicant will obtain at least 10 percent of such costs from non-Federal funds (and such contributions to such costs may be in cash or in-kind, including facilities and personnel).
(e) Rule of construction regarding at-risk births
For purposes of subsection (a)(1) of this section, a pregnant woman shall be considered to be at risk of delivering an infant with a health or developmental complication if during the pregnancy the woman—
(1) lacks appropriate access to, or information concerning, early and routine prenatal care;
(2) lacks the transportation necessary to gain access to the services described in subsection (b) of this section;
(3) lacks appropriate child care assistance, which results in impeding the ability of such woman to utilize health and related social services;
(4) is fearful of accessing substance abuse services or child and family support services; or
(5) is a minor with a low income.
(f) Delivery of services and case management
(1) Case management model
Home visiting services provided under this section shall be delivered according to a case management model, and a registered nurse, licensed social worker, or other licensed health care professional with experience and expertise in providing health and related social services in home and community settings shall be assigned as the case manager for individual cases under such model.
(2) Case manager
A case manager assigned under paragraph (1) shall have primary responsibility for coordinating and overseeing the development of a plan for each family that is to receive home visiting services under this section, and for coordinating the delivery of such services provided through appropriate personnel.
(3) Appropriate personnel
In determining which personnel shall be utilized in the delivery of services, the case manager shall consider—
(A) the stated objective of the project to be operated with the grant, as determined after considering identified gaps in the current service delivery system; and
(B) the nature of the needs of the family to be served, as determined at the initial assessment of the family that is conducted by the case manager, and through follow-up contacts by other providers of home visiting services.
(4) Family service plan
A case manager, in consultation with a team established in accordance with paragraph (5) for the family involved, shall develop a plan for the family following the initial visit to the home of the family. Such plan shall reflect—
(A) an assessment of the health and related social service needs of the family;
(B) a structured plan for the delivery of home visiting services to meet the identified needs of the family;
(C) the frequency with which such services are to be provided to the family;
(D) ongoing revisions made as the needs of family members change; and
(E) the continuing voluntary participation of the family in the plan.
(5) Home visiting services team
The team to be consulted under paragraph (4) on behalf of a family shall include, as appropriate, other nursing professionals, physician assistants, social workers, child welfare professionals, infant and early childhood specialists, nutritionists, and laypersons trained as home visitors. The case manager shall ensure that the plan is coordinated with those physician services that may be required by the mother or child.
(g) Outreach
Each grantee under subsection (a) of this section shall provide outreach and casefinding services to inform eligible families of the availability of home visiting services from the project.
(h) Confidentiality
In accordance with applicable State law, an entity receiving a grant under subsection (a) of this section shall maintain confidentiality with respect to services provided to families under this section.
(i) Certain assurances
The Secretary may award a grant under subsection (a) of this section only if the entity involved provides assurances satisfactory to the Secretary that—
(1) the entity will provide home visiting services with reasonable frequency—
(A) to families with pregnant women, as early in the pregnancy as is practicable, and until the infant reaches at least 2 years of age; and
(B) to other eligible families, for at least 2 years; and
(2) the entity will coordinate with public health and related social service agencies to prevent duplication of effort and improve the delivery of comprehensive health and related social services.
(j) Submission to Secretary of certain information
The Secretary may award a grant under subsection (a) of this section only if the entity involved submits to the Secretary—
(1) a description of the population to be targeted for home visiting services and methods of outreach and casefinding for identifying eligible families, including the use of lay home visitors where appropriate;
(2) a description of the types and qualifications of home visitors used by the entity and the process by which the entity will provide continuing training and sufficient support to the home visitors; and
(3) such other information as the Secretary determines to be appropriate.
(k) Limitation regarding administrative expenses
Not more than 10 percent of a grant under subsection (a) of this section may be expended for administrative expenses with respect to the grant. The costs of training individuals to serve in the project involved are not subject to the preceding sentence.
(l) Restrictions on use of grant
To be eligible to receive a grant under this section, an entity must agree that the grant will not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition for the receipt of Federal funds; or
(5) to provide financial assistance to any entity other than a public or nonprofit private entity.
(m) Reports to Secretary
To be eligible to receive a grant under this section, an entity must agree to submit an annual report on the services provided under this section to the Secretary in such manner and containing such information as the Secretary by regulation requires. At a minimum, the entity shall report information concerning eligible families, including—
(1) the characteristics of the families and children receiving services under this section;
(2) the usage, nature, and location of the provider, of preventive health services, including prenatal, primary infant, and child health care;
(3) the incidence of low birthweight and premature infants;
(4) the length of hospital stays for pre- and post-partum women and their children;
(5) the incidence of substantiated child abuse and neglect for all children within participating families;
(6) the number of emergency room visits for routine health care;
(7) the source of payment for health care services and the extent to which the utilization of health care services, other than routine screening and medical care, available to the individuals under the program established under title XIX of the Social Security Act [
(8) the number and type of referrals made for health and related social services, including alcohol and drug treatment services, and the utilization of such services provided by the grantee; and
(9) the incidence of developmental disabilities.
(n) Requirement of application
The Secretary may make a grant under subsection (a) of this section only if—
(1) an application for the grant is submitted to the Secretary;
(2) the application contains the agreements and assurances required in this section, and the information required in subsection (j) of this section;
(3) the application contains evidence that the preparation of the application has been coordinated with the State agencies responsible for maternal and child health and child welfare, and coordinated with services provided under part H of the Individuals with Disabilities Education Act [
(4) the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(o) Peer review
(1) Requirement
In making determinations for awarding grants under subsection (a) of this section, the Secretary shall rely on the recommendations of the peer review panel established under paragraph (2).
(2) Composition
The Secretary shall establish a review panel to make recommendations under paragraph (1) that shall be composed of—
(A) national experts in the fields of maternal and child health, child abuse and neglect, and the provision of community-based primary health services; and
(B) representatives of relevant Federal agencies, including the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, the Administration for Children, Youth, and Families, the U.S. Advisory Board on Child Abuse and Neglect, and the National Commission to Prevent Infant Mortality.
(p) Evaluations
(1) In general
The Secretary shall, directly or through contracts with public or private entities—
(A) conduct evaluations to determine the effectiveness of projects under subsection (a) of this section in reducing the incidence of children born with health or developmental complications, the incidence among children less than 3 years of age of such complications, and the incidence of child abuse and neglect; and
(B) not less than once during each 3-year period, prepare and submit to the appropriate committees of Congress a report concerning the results of such evaluations.
(2) Contents
The evaluations conducted under paragraph (1) shall—
(A) include a summary of the data contained in the annual reports submitted under subsection (m) of this section;
(B) assess the relative effectiveness of projects under subsection (a) of this section in urban and rural areas, and among programs utilizing differing combinations of professionals and trained home visitors recruited from the community to meet the needs of defined target service populations; and
(C) make further recommendations necessary or desirable to increase the effectiveness of such projects.
(q) Definitions
For purposes of this section:
(1) The term "eligible entity" includes public and nonprofit private entities that provide health or related social services, including community-based organizations, visiting nurse organizations, hospitals, local health departments, community health centers, Native Hawaiian health centers, nurse managed clinics, family service agencies, child welfare agencies, developmental service providers, family resource and support programs, and resource mothers projects.
(2) The term "eligible family" means a family described in subsection (a) of this section.
(3) The term "health or developmental complication", with respect to a child, means—
(A) being born in an unhealthy or potentially unhealthy condition, including premature birth, low birthweight, and prenatal exposure to maternal substance abuse;
(B) a condition arising from a condition described in subparagraph (A);
(C) a physical disability or delay; and
(D) a developmental disability or delay.
(4) The term "home visiting services" means the services specified in subsection (b) of this section, provided at the residence of the eligible family involved or provided pursuant to arrangements made for the family (including arrangements for services in community settings).
(5) The term "home visitors" means providers of home visiting services.
(r) Authorization of appropriations
For the purpose of carrying out this section, there is authorized to be appropriated $30,000,000 for each of the fiscal years 1993 and 1994.
(July 1, 1944, ch. 373, title III, §399, as added July 10, 1992,
References in Text
The Social Security Act, referred to in subsecs. (a)(3)(A), (b)(6), and (m)(7), is act Aug. 14, 1935, ch. 531,
The Individuals with Disabilities Education Act, referred to in subsec. (n)(3), is title VI of
Prior Provisions
A prior section 399 of act July 1, 1944, was renumbered section 398A by section 502(1) of
Another prior section 399 of act July 1, 1944, ch. 373, title III, formerly §399b, as added Oct. 22, 1965,
Amendments
1994—Subsec. (b)(6).
Effective Date of 1994 Amendment
Amendment by
Effective Date
Section effective July 10, 1992, with programs making awards providing financial assistance in fiscal year 1993 and subsequent years effective for awards made on or after Oct. 1, 1992, see section 801(b), (d)(1) of
Purpose
Section 501 of title V of
"(1) to increase the use of, and to provide information on the availability of early, continuous and comprehensive prenatal care;
"(2) to reduce the incidence of infant mortality and of infants born prematurely, with low birthweight, or with other impairments including those associated with maternal substance abuse;
"(3) for pregnant women and mothers of children below the age of 3 whose children have experienced or are at risk of experiencing a health or developmental complication, to provide assistance in obtaining health and related social services necessary to meet the special needs of the women and their children;
"(4) to assist, when requested, women who are pregnant and at-risk for poor birth outcomes, or who have young children and are abusing alcohol or other drugs, in obtaining appropriate treatment; and
"(5) to reduce the incidence of child abuse and neglect."
Part L—Services for Children of Substance Abusers
Amendments
1993—
1990—
§280d. Grants for services for children of substance abusers
(a) Establishment
(1) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall make grants to public and nonprofit private entities for the purpose of carrying out programs—
(A) to provide the services described in subsection (b) of this section to children of substance abusers;
(B) to provide the applicable services described in subsection (c) of this section to families in which a member is a substance abuser; and
(C) to identify such children and such families.
(2) Administrative consultations
The Administrator of the Administration for Children, Youth, and Families and the Administrator of the Substance Abuse and Mental Health Services Administration shall be consulted regarding the promulgation of program guidelines and funding priorities under this section.
(3) Requirement of status as medicaid provider
(A) Subject to subparagraph (B), the Secretary may make a grant under paragraph (1) only if, in the case of any service under such paragraph that is covered in the State plan approved under title XIX of the Social Security Act [
(i) the entity involved will provide the service directly, and the entity has entered into a participation agreement under the State plan and is qualified to receive payments under such plan; or
(ii) the entity will enter into an agreement with an organization under which the organization will provide the service, and the organization has entered into such a participation agreement and is qualified to receive such payments.
(B)(i) In the case of an organization making an agreement under subparagraph (A)(ii) regarding the provision of services under paragraph (1), the requirement established in such subparagraph regarding a participation agreement shall be waived by the Secretary if the organization does not, in providing health or mental health services, impose a charge or accept reimbursement available from any third-party payor, including reimbursement under any insurance policy or under any Federal or State health benefits program.
(ii) A determination by the Secretary of whether an organization referred to in clause (i) meets the criteria for a waiver under such clause shall be made without regard to whether the organization accepts voluntary donations regarding the provision of services to the public.
(b) Services for children of substance abusers
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees to make available (directly or through agreements with other entities) to children of substance abusers each of the following services:
(1) Periodic evaluation of children for developmental, psychological, and medical problems.
(2) Primary pediatric care.
(3) Other necessary health and mental health services.
(4) Therapeutic intervention services for children, including provision of therapeutic child care.
(5) Preventive counseling services.
(6) Counseling related to the witnessing of chronic violence.
(7) Referrals for, and assistance in establishing eligibility for, services provided under—
(A) education and special education programs;
(B) Head Start programs established under the Head Start Act [
(C) other early childhood programs;
(D) employment and training programs;
(E) public assistance programs provided by Federal, State, or local governments; and
(F) programs offered by vocational rehabilitation agencies, recreation departments, and housing agencies.
(8) Additional developmental services that are consistent with the provision of early intervention services, as such term is defined in part H of the Individuals with Disabilities Education Act [
(c) Services for affected families
The Secretary may make a grant under subsection (a) of this section only if, in the case of families in which a member is a substance abuser, the applicant involved agrees to make available (directly or through agreements with other entities) each of the following services, as applicable to the family member involved:
(1) Services as follows, to be provided by a public health nurse, social worker, or similar professional, or by a trained worker from the community who is supervised by a professional:
(A) Counseling to substance abusers on the benefits and availability of substance abuse treatment services and services for children of substance abusers.
(B) Assistance to substance abusers in obtaining and using substance abuse treatment services and in obtaining the services described in subsection (b) of this section for their children.
(C) Visiting and providing support to substance abusers, especially pregnant women, who are receiving substance abuse treatment services or whose children are receiving services under subsection (b) of this section.
(2) In the case of substance abusers:
(A) Encouragement and, where necessary, referrals to participate in appropriate substance abuse treatment.
(B) Primary health care and mental health services, including prenatal and post partum care for pregnant women.
(C) Consultation and referral regarding subsequent pregnancies and life options, including education and career planning.
(D) Where appropriate, counseling regarding family conflict and violence.
(E) Remedial education services.
(F) Referrals for, and assistance in establishing eligibility for, services described in subsection (b)(7) of this section.
(3) In the case of substance abusers, spouses of substance abusers, extended family members of substance abusers, caretakers of children of substance abusers, and other people significantly involved in the lives of substance abusers or the children of substance abusers:
(A) An assessment of the strengths and service needs of the family and the assignment of a case manager who will coordinate services for the family.
(B) Therapeutic intervention services, such as parental counseling, joint counseling sessions for families and children, and family therapy.
(C) Child care or other care for the child to enable the parent to attend treatment or other activities and respite care services.
(D) Parenting education services and parent support groups.
(E) Support services, including, where appropriate, transportation services.
(F) Where appropriate, referral of other family members to related services such as job training.
(G) Aftercare services, including continued support through parent groups and home visits.
(d) Considerations in making grants
In making grants under subsection (a) of this section, the Secretary shall ensure that the grants are reasonably distributed among the following types of entities:
(1) Alcohol and drug treatment programs, especially those providing treatment to pregnant women and mothers and their children.
(2) Public or nonprofit private entities that provide health or social services to disadvantaged populations, and that have—
(A) expertise in applying the services to the particular problems of substance abusers and the children of substance abusers; and
(B) an affiliation or contractual relationship with one or more substance abuse treatment programs.
(3) Consortia of public or nonprofit private entities that include at least one substance abuse treatment program.
(4) Indian tribes.
(e) Federal share
The Federal share of a program carried out under subsection (a) of this section shall be 90 percent. The Secretary shall accept the value of in-kind contributions, including facilities and personnel, made by the grant recipient as a part or all of the non-Federal share of grants.
(f) Coordination with other providers
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees to coordinate its activities with those of the State lead agency, and the State Interagency Coordinating Council, under part H of the Individuals with Disabilities Education Act [
(g) Restrictions on use of grant
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that the grant will not be expended—
(1) to provide inpatient hospital services;
(2) to make cash payments to intended recipients of services;
(3) to purchase or improve land, purchase, construct, or permanently improve (other than minor remodeling) any building or other facility, or purchase major medical equipment;
(4) to satisfy any requirement for the expenditure of non-Federal funds as a condition for the receipt of Federal funds; or
(5) to provide financial assistance to any entity other than a public or nonprofit private entity.
(h) Submission to Secretary of certain information
The Secretary may make a grant under subsection (a) of this section only if the applicant involved submits to the Secretary—
(1) a description of the population that is to receive services under this section and a description of such services that are to be provided and measurable goals and objectives;
(2) a description of the mechanism that will be used to involve the local public agencies responsible for health, mental health, child welfare, education, juvenile justice, developmental disabilities, and substance abuse treatment programs in planning and providing services under this section, as well as evidence that the proposal has been coordinated with the State agencies responsible for administering those programs and the State agency responsible for administering public maternal and child health services;
(3) information demonstrating that the applicant has established a collaborative relationship with child welfare agencies and child protective services that will enable the applicant, where appropriate, to—
(A) provide advocacy on behalf of substance abusers and the children of substance abusers in child protective services cases;
(B) provide services to help prevent the unnecessary placement of children in substitute care; and
(C) promote reunification of families or permanent plans for the placement of the child; and
(4) such other information as the Secretary determines to be appropriate.
(i) Reports to Secretary
The Secretary may make a grant under subsection (a) of this section only if the applicant involved agrees that for each fiscal year for which the applicant receives such a grant the applicant, in accordance with uniform standards developed by the Secretary, will submit to the Secretary a report containing—
(1) a description of specific services and activities provided under the grant;
(2) information regarding progress toward meeting the program's stated goals and objectives;
(3) information concerning the extent of use of services provided under the grant, including the number of referrals to related services and information on other programs or services accessed by children, parents, and other caretakers;
(4) information concerning the extent to which parents were able to access and receive treatment for alcohol and drug abuse and sustain participation in treatment over time until the provider and the individual receiving treatment agree to end such treatment, and the extent to which parents re-enter treatment after the successful or unsuccessful termination of treatment;
(5) information concerning the costs of the services provided and the source of financing for health care services;
(6) information concerning—
(A) the number and characteristics of families, parents, and children served, including a description of the type and severity of childhood disabilities, and an analysis of the number of children served by age;
(B) the number of children served who remained with their parents during the period in which entities provided services under this section;
(C) the number of children served who were placed in out-of-home care during the period in which entities provided services under this section;
(D) the number of children described in subparagraph (C) who were reunited with their families; and
(E) the number of children described in subparagraph (C) for whom a permanent plan has not been made or for whom the permanent plan is other than family reunification;
(7) information on hospitalization or emergency room use by the family members participating in the program; and
(8) such other information as the Secretary determines to be appropriate.
(j) Requirement of application
The Secretary may make any grant under subsection (a) of this section only if—
(1) an application for the grant is submitted to the Secretary;
(2) the application contains the agreements required in this section and the information required in subsection (h) of this section; and
(3) the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(k) Peer review
(1) Requirement
In making determinations for awarding grants under subsection (a) of this section, the Secretary shall rely on the recommendations of the peer review panel established under paragraph (2).
(2) Composition
The Secretary shall establish a review panel to make recommendations under paragraph (1) that shall be composed of—
(A) national experts in the fields of maternal and child health, substance abuse treatment, and child welfare; and
(B) representatives of relevant Federal agencies, including the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration, and the Administration for Children, Youth, and Families.
(l) Evaluations
The Secretary shall periodically conduct evaluations to determine the effectiveness of programs supported under subsection (a) of this section—
(1) in reducing the incidence of alcohol and drug abuse among substance abusers participating in the programs;
(2) in preventing adverse health conditions in children of substance abusers;
(3) in promoting better utilization of health and developmental services and improving the health, developmental, and psychological status of children receiving services under the program;
(4) in improving parental and family functioning;
(5) in reducing the incidence of out-of-home placement for children whose parents receive services under the program; and
(6) in facilitating the reunification of families after children have been placed in out-of-home care.
(m) Report to Congress
Not later than 2 years after the date on which amounts are first appropriated under subjection 1 (o) of this section, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report that contains a description of programs carried out under this section. At a minimum, the report shall contain—
(1) information concerning the number and type of programs receiving grants;
(2) information concerning the type and use of services offered;
(3) information concerning—
(A) the number and characteristics of families, parents, and children served;
(B) the number of children served who remained with their parents during or after the period in which entities provided services under this section;
(C) the number of children served who were placed in out-of-home care during the period in which entities provided services under this section;
(D) the number of children described in subparagraph (C) who were reunited with their families; and
(E) the number of children described in subparagraph (C) who were permanently placed in out-of-home care;
analyzed by the type of entity described in subsection (d) of this section that provided services;
(4) an analysis of the access provided to, and use of, related services and alcohol and drug treatment through programs carried out under this section; and
(5) a comparison of the costs of providing services through each of the types of entities described in subsection (d) of this section.
(n) Data collection
The Secretary shall periodically collect and report on information concerning the numbers of children in substance abusing families, including information on the age, gender and ethnicity of the children, the composition and income of the family, and the source of health care finances.
(o) Definitions
For purposes of this section:
(1) The term "caretaker", with respect to a child of a substance abuser, means any individual acting in a parental role regarding the child (including any birth parent, foster parent, adoptive parent, relative of such a child, or other individual acting in such a role).
(2) The term "children of substance abusers" means—
(A) children who have lived or are living in a household with a substance abuser who is acting in a parental role regarding the children; and
(B) children who have been prenatally exposed to alcohol or other dangerous drugs.
(3) The term "Indian tribe" means any tribe, band, nation, or other organized group or community of Indians, including any Alaska Native village (as defined in, or established pursuant to, the Alaska Native Claims Settlement Act [
(4) The term "public or nonprofit private entities that provide health or social services to disadvantaged populations" includes community-based organizations, local public health departments, community action agencies, hospitals, community health centers, child welfare agencies, developmental disabilities service providers, and family resource and support programs.
(5) The term "substance abuse" means the abuse of alcohol or other drugs.
(p) Funding
(1) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $50,000,000 for fiscal year 1993, and such sums as may be necessary for fiscal year 1994.
(2) Contingent authority regarding training of certain individuals
Of the amounts appropriated under paragraph (1) for a fiscal year in excess of $25,000,000, the Secretary may make available not more than 15 percent for the training of health care professionals and other personnel (including child welfare providers) who provide services to children and families of substance abusers.
(July 1, 1944, ch. 373, title III, §399D, as added July 10, 1992,
References in Text
The Social Security Act, referred to in subsec. (a)(3)(A), is act Aug. 14, 1935, ch. 531,
The Head Start Act, referred to in subsec. (b)(7)(B), is subchapter B (§§635–657) of
The Individuals with Disabilities Education Act, referred to in subsecs. (b)(8) and (f), is title VI of
The Alaska Native Claims Settlement Act, referred to in subsec. (o)(3), is
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date
Section effective July 10, 1992, with programs making awards providing financial assistance in fiscal year 1993 and subsequent years effective for awards made on or after Oct. 1, 1992, see section 801(b), (d)(1) of
Construction
Section 401(b) of
1 So in original. Probably should be "subsection".
Part 1 N—National Foundation for the Centers for Disease Control and Prevention
1 So in original. Probably should be part "M".
§280d–11. Establishment and duties of Foundation
(a) In general
There shall be established in accordance with this section a nonprofit private corporation to be known as the National Foundation for the Centers for Disease Control and Prevention (in this part referred to as the "Foundation"). The Foundation shall not be an agency or instrumentality of the Federal Government, and officers, employees, and members of the board of the Foundation shall not be officers or employees of the Federal Government.
(b) Purpose of Foundation
The purpose of the Foundation shall be to support and carry out activities for the prevention and control of diseases, disorders, injuries, and disabilities, and for promotion of public health.
(c) Endowment fund
(1) In general
In carrying out subsection (b) of this section, the Foundation shall establish a fund for providing endowments for positions that are associated with the Centers for Disease Control and Prevention and dedicated to the purpose described in such subsection. Subject to subsection (f)(1)(B) of this section, the fund shall consist of such donations as may be provided by non-Federal entities and such non-Federal assets of the Foundation (including earnings of the Foundation and the fund) as the Foundation may elect to transfer to the fund.
(2) Authorized expenditures of fund
The provision of endowments under paragraph (1) shall be the exclusive function of the fund established under such paragraph. Such endowments may be expended only for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the positions, and for recruiting individuals to hold the positions endowed by the fund.
(d) Certain activities of Foundation
In carrying out subsection (b) of this section, the Foundation may provide for the following with respect to the purpose described in such subsection:
(1) Programs of fellowships for State and local public health officials to work and study in association with the Centers for Disease Control and Prevention.
(2) Programs of international arrangements to provide opportunities for public health officials of other countries to serve in public health capacities in the United States in association with the Centers for Disease Control and Prevention or elsewhere, or opportunities for employees of such Centers (or other public health officials in the United States) to serve in such capacities in other countries, or both.
(3) Studies, projects, and research (which may include applied research on the effectiveness of prevention activities, demonstration projects, and programs and projects involving international, Federal, State, and local governments).
(4) Forums for government officials and appropriate private entities to exchange information. Participants in such forums may include institutions of higher education and appropriate international organizations.
(5) Meetings, conferences, courses, and training workshops.
(6) Programs to improve the collection and analysis of data on the health status of various populations.
(7) Programs for writing, editing, printing, and publishing of books and other materials.
(8) Other activities to carry out the purpose described in subsection (b) of this section.
(e) General structure of Foundation; nonprofit status
(1) Board of directors
The Foundation shall have a board of directors (in this part referred to as the "Board"), which shall be established and conducted in accordance with subsection (f) of this section. The Board shall establish the general policies of the Foundation for carrying out subsection (b) of this section, including the establishment of the bylaws of the Foundation.
(2) Executive director
The Foundation shall have an executive director (in this part referred to as the "Director"), who shall be appointed by the Board, who shall serve at the pleasure of the Board, and for whom the Board shall establish the rate of compensation. Subject to compliance with the policies and bylaws established by the Board pursuant to paragraph (1), the Director shall be responsible for the daily operations of the Foundation in carrying out subsection (b) of this section.
(3) Nonprofit status
In carrying out subsection (b) of this section, the Board shall establish such policies and bylaws under paragraph (1), and the Director shall carry out such activities under paragraph (2), as may be necessary to ensure that the Foundation maintains status as an organization that—
(A) is described in subsection (c)(3) of
(B) is, under subsection (a) of such section, exempt from taxation.
(f) Board of directors
(1) Certain bylaws
(A) In establishing bylaws under subsection (e)(1) of this section, the Board shall ensure that the bylaws of the Foundation include bylaws for the following:
(i) Policies for the selection of the officers, employees, agents, and contractors of the Foundation.
(ii) Policies, including ethical standards, for the acceptance and disposition of donations to the Foundation and for the disposition of the assets of the Foundation.
(iii) Policies for the conduct of the general operations of the Foundation.
(iv) Policies for writing, editing, printing, and publishing of books and other materials, and the acquisition of patents and licenses for devices and procedures developed by the Foundation.
(B) In establishing bylaws under subsection (e)(1) of this section, the Board shall ensure that the bylaws of the Foundation (and activities carried out under the bylaws) do not—
(i) reflect unfavorably upon the ability of the Foundation, or the Centers for Disease Control and Prevention, to carry out its responsibilities or official duties in a fair and objective manner; or
(ii) compromise, or appear to compromise, the integrity of any governmental program or any officer or employee involved in such program.
(2) Composition
(A) Subject to subparagraph (B), the Board shall be composed of 7 individuals, appointed in accordance with paragraph (4), who collectively possess education or experience appropriate for representing the general field of public health, the general field of international health, and the general public. Each such individual shall be a voting member of the Board.
(B) The Board may, through amendments to the bylaws of the Foundation, provide that the number of members of the Board shall be a greater number than the number specified in subparagraph (A).
(3) Chair
The Board shall, from among the members of the Board, designate an individual to serve as the chair of the Board (in this subsection referred to as the "Chair").
(4) Appointments, vacancies, and terms
Subject to subsection (j) of this section (regarding the initial membership of the Board), the following shall apply to the Board:
(A) Any vacancy in the membership of the Board shall be filled by appointment by the Board, after consideration of suggestions made by the Chair and the Director regarding the appointments. Any such vacancy shall be filled not later than the expiration of the 180-day period beginning on the date on which the vacancy occurs.
(B) The term of office of each member of the Board appointed under subparagraph (A) shall be 5 years. A member of the Board may continue to serve after the expiration of the term of the member until the expiration of the 180-day period beginning on the date on which the term of the member expires.
(C) A vacancy in the membership of the Board shall not affect the power of the Board to carry out the duties of the Board. If a member of the Board does not serve the full term applicable under subparagraph (B), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(5) Compensation
Members of the Board may not receive compensation for service on the Board. The members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board.
(g) Certain responsibilities of executive director
In carrying out subsection (e)(2) of this section, the Director shall carry out the following functions:
(1) Hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of the officers and employees.
(2) Accept and administer donations to the Foundation, and administer the assets of the Foundation.
(3) Establish a process for the selection of candidates for holding endowed positions under subsection (c) of this section.
(4) Enter into such financial agreements as are appropriate in carrying out the activities of the Foundation.
(5) Take such action as may be necessary to acquire patents and licenses for devices and procedures developed by the Foundation and the employees of the Foundation.
(6) Adopt, alter, and use a corporate seal, which shall be judicially noticed.
(7) Commence and respond to judicial proceedings in the name of the Foundation.
(8) Other functions that are appropriate in the determination of the Director.
(h) General provisions
(1) Authority for accepting funds
The Director of the Centers for Disease Control and Prevention may accept and utilize, on behalf of the Federal Government, any gift, donation, bequest, or devise of real or personal property from the Foundation for the purpose of aiding or facilitating the work of such Centers. Funds may be accepted and utilized by such Director under the preceding sentence without regard to whether the funds are designated as general-purpose funds or special-purpose funds.
(2) Authority for acceptance of voluntary services
(A) The Director of the Centers for Disease Control and Prevention may accept, on behalf of the Federal Government, any voluntary services provided to such Centers by the Foundation for the purpose of aiding or facilitating the work of such Centers. In the case of an individual, such Director may accept the services provided under the preceding sentence by the individual for not more than 2 years.
(B) The limitation established in subparagraph (A) regarding the period of time in which services may be accepted applies to each individual who is not an employee of the Federal Government and who serves in association with the Centers for Disease Control and Prevention pursuant to financial support from the Foundation.
(3) Administrative control
No officer, employee, or member of the Board of the Foundation may exercise any administrative or managerial control over any Federal employee.
(4) Applicability of certain standards to non-Federal employees
In the case of any individual who is not an employee of the Federal Government and who serves in association with the Centers for Disease Control and Prevention pursuant to financial support from the Foundation, the Foundation shall negotiate a memorandum of understanding with the individual and the Director of the Centers for Disease Control and Prevention specifying that the individual—
(A) shall be subject to the ethical and procedural standards regulating Federal employment, scientific investigation, and research findings (including publications and patents) that are required of individuals employed by the Centers for Disease Control and Prevention, including standards under this chapter, the Ethics in Government Act, and the Technology Transfer Act; 1 and
(B) shall be subject to such ethical and procedural standards under
(5) Financial conflicts of interest
Any individual who is an officer, employee, or member of the Board of the Foundation may not directly or indirectly participate in the consideration or determination by the Foundation of any question affecting—
(A) any direct or indirect financial interest of the individual; or
(B) any direct or indirect financial interest of any business organization or other entity of which the individual is an officer or employee or in which the individual has a direct or indirect financial interest.
(6) Audits; availability of records
The Foundation shall—
(A) provide for biennial audits of the financial condition of the Foundation; and
(B) make such audits, and all other records, documents, and other papers of the Foundation, available to the Secretary and the Comptroller General of the United States for examination or audit.
(7) Reports
(A) Not later than February 1 of each fiscal year, the Foundation shall publish a report describing the activities of the Foundation during the preceding fiscal year. Each such report shall include for the fiscal year involved a comprehensive statement of the operations, activities, financial condition, and accomplishments of the Foundation.
(B) With respect to the financial condition of the Foundation, each report under subparagraph (A) shall include the source, and a description of, all gifts to the Foundation of real or personal property, and the source and amount of all gifts to the Foundation of money. Each such report shall include a specification of any restrictions on the purposes for which gifts to the Foundation may be used.
(C) The Foundation shall make copies of each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy.
(8) Liaison from Centers for Disease Control and Prevention
The Director of the Centers for Disease Control and Prevention shall serve as the liaison representative of such Centers to the Board and the Foundation.
(i) Federal funding
(1) Authority for annual grants
(A) The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall—
(i) for fiscal year 1993, make a grant to an entity described in subsection (j)(9) of this section (relating to the establishment of a committee to establish the Foundation);
(ii) for fiscal year 1994, make a grant to the committee established under such subsection, or if the Foundation has been established, to the Foundation; and
(iii) for fiscal year 1995 and each subsequent fiscal year, make a grant to the Foundation.
(B) A grant under subparagraph (A) may be expended—
(i) in the case of an entity receiving the grant under subparagraph (A)(i), only for the purpose of carrying out the duties established in subsection (j)(9) of this section for the entity;
(ii) in the case of the committee established under such subsection, only for the purpose of carrying out the duties established in subsection (j) of this section for the committee; and
(iii) in the case of the Foundation, only for the purpose of the administrative expenses of the Foundation.
(C) A grant under subparagraph (A) may not be expended to provide amounts for the fund established under subsection (c) of this section.
(D) For the purposes described in subparagraph (B)—
(i) any portion of the grant made under subparagraph (A)(i) for fiscal year 1993 that remains unobligated after the entity receiving the grant completes the duties established in subsection (j)(9) of this section for the entity shall be available to the committee established under such subsection; and
(ii) any portion of a grant under subparagraph (A) made for fiscal year 1993 or 1994 that remains unobligated after such committee completes the duties established in such subsection for the committee shall be available to the Foundation.
(2) Funding for grants
(A) For the purpose of grants under paragraph (1), there is authorized to be appropriated $500,000 for each fiscal year.
(B) For the purpose of grants under paragraph (1), the Secretary may for each fiscal year make available not more than $500,000 from the amounts appropriated for the fiscal year for the programs of the Department of Health and Human Services. Such amounts may be made available without regard to whether amounts have been appropriated under subparagraph (A).
(3) Certain restriction
If the Foundation receives Federal funds for the purpose of serving as a fiscal intermediary between Federal agencies, the Foundation may not receive such funds for the indirect costs of carrying out such purpose in an amount exceeding 10 percent of the direct costs of carrying out such purpose. The preceding sentence may not be construed as authorizing the expenditure of any grant under paragraph (1) for such purpose.
(j) Committee for establishment of Foundation
(1) In general
There shall be established in accordance with this subsection a committee to carry out the functions described in paragraph (2) (which committee is referred to in this subsection as the "Committee").
(2) Functions
The functions referred to in paragraph (1) for the Committee are as follows:
(A) To carry out such activities as may be necessary to incorporate the Foundation under the laws of the State involved, including serving as incorporators for the Foundation. Such activities shall include ensuring that the articles of incorporation for the Foundation require that the Foundation be established and operated in accordance with the applicable provisions of this part (or any successor to this part), including such provisions as may be in effect pursuant to amendments enacted after October 27, 1992.
(B) To ensure that the Foundation qualifies for and maintains the status described in subsection (e)(3) of this section (regarding taxation).
(C) To establish the general policies and initial bylaws of the Foundation, which bylaws shall include the bylaws described in subsections (e)(3) and (f)(1) of this section.
(D) To provide for the initial operation of the Foundation, including providing for quarters, equipment, and staff.
(E) To appoint the initial members of the Board in accordance with the requirements established in subsection (f)(2)(A) of this section for the composition of the Board, and in accordance with such other qualifications as the Committee may determine to be appropriate regarding such composition. Of the members so appointed—
(i) 2 shall be appointed to serve for a term of 3 years;
(ii) 2 shall be appointed to serve for a term of 4 years; and
(iii) 3 shall be appointed to serve for a term of 5 years.
(3) Completion of functions of Committee; initial meeting of Board
(A) The Committee shall complete the functions required in paragraph (1) not later than September 30, 1994. The Committee shall terminate upon the expiration of the 30-day period beginning on the date on which the Secretary determines that the functions have been completed.
(B) The initial meeting of the Board shall be held not later than November 1, 1994.
(4) Composition
The Committee shall be composed of 5 members, each of whom shall be a voting member. Of the members of the Committee—
(A) no fewer than 2 shall have broad, general experience in public health; and
(B) no fewer than 2 shall have broad, general experience in nonprofit private organizations (without regard to whether the individuals have experience in public health).
(5) Chair
The Committee shall, from among the members of the Committee, designate an individual to serve as the chair of the Committee.
(6) Terms; vacancies
The term of members of the Committee shall be for the duration of the Committee. A vacancy in the membership of the Committee shall not affect the power of the Committee to carry out the duties of the Committee. If a member of the Committee does not serve the full term, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(7) Compensation
Members of the Committee may not receive compensation for service on the Committee. Members of the Committee may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Committee.
(8) Committee support
The Director of the Centers for Disease Control and Prevention may, from amounts available to the Director for the general administration of such Centers, provide staff and financial support to assist the Committee with carrying out the functions described in paragraph (2). In providing such staff and support, the Director may both detail employees and contract for assistance.
(9) Grant for establishment of Committee
(A) With respect to a grant under paragraph (1)(A)(i) of subsection (i) of this section for fiscal year 1993, an entity described in this paragraph is a private nonprofit entity with significant experience in domestic and international issues of public health. Not later than 180 days after October 27, 1992, the Secretary shall make the grant to such an entity (subject to the availability of funds under paragraph (2) of such subsection).
(B) The grant referred to in subparagraph (A) may be made to an entity only if the entity agrees that—
(i) the entity will establish a committee that is composed in accordance with paragraph (4); and
(ii) the entity will not select an individual for membership on the Committee unless the individual agrees that the Committee will operate in accordance with each of the provisions of this subsection that relate to the operation of the Committee.
(C) The Secretary may make a grant referred to in subparagraph (A) only if the applicant for the grant makes an agreement that the grant will not be expended for any purpose other than carrying out subparagraph (B). Such a grant may be made only if an application for the grant is submitted to the Secretary containing such agreement, and the application is in such form, is made in such manner, and contains such other agreements and such assurances and information as the Secretary determines to be necessary to carry out this paragraph.
(July 1, 1944, ch. 373, title III, §399F, as added Oct. 27, 1992,
References in Text
The Ethics in Government Act, referred to in subsec. (h)(4)(A), probably means the Ethics in Government Act of 1978,
The Technology Transfer Act, referred to in subsec. (h)(4)(A), may mean the Federal Technology Transfer Act of 1986,
1 See References in Text note below.
Part 1 M—National Program of Cancer Registries
1 So in original. Probably should be part "N".
§280e. National program of cancer registries
(a) In general
The Secretary, acting through the Director of the Centers for Disease Control, may make grants to States, or may make grants or enter into contracts with academic or nonprofit organizations designated by the State to operate the State's cancer registry in lieu of making a grant directly to the State, to support the operation of population-based, statewide cancer registries in order to collect, for each form of in-situ and invasive cancer (with the exception of basal cell and squamous cell carcinoma of the skin), data concerning—
(1) demographic information about each case of cancer;
(2) information on the industrial or occupational history of the individuals with the cancers, to the extent such information is available from the same record;
(3) administrative information, including date of diagnosis and source of information;
(4) pathological data characterizing the cancer, including the cancer site, stage of disease (pursuant to Staging Guide), incidence, and type of treatment; and
(5) other elements determined appropriate by the Secretary.
(b) Matching funds
(1) In general
The Secretary may make a grant under subsection (a) of this section only if the State, or the academic or nonprofit private organization designated by the State to operate the cancer registry of the State, involved agrees, with respect to the costs of the program, to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 25 percent of such costs or $1 for every $3 of Federal funds provided in the grant.
(2) Determination of amount of non-Federal contribution; maintenance of effort
(A) Non-Federal contributions required in paragraph (1) may be in cash or in kind, fairly evaluated, including plant, equipment, or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.
(B) With respect to a State in which the purpose described in subsection (a) of this section is to be carried out, the Secretary, in making a determination of the amount of non-Federal contributions provided under paragraph (1), may include only such contributions as are in excess of the amount of such contributions made by the State toward the collection of data on cancer for the fiscal year preceding the first year for which a grant under subsection (a) of this section is made with respect to the State. The Secretary may decrease the amount of non-Federal contributions that otherwise would have been required by this subsection in those cases in which the State can demonstrate that decreasing such amount is appropriate because of financial hardship.
(c) Eligibility for grants
(1) In general
No grant shall be made by the Secretary under subsection (a) of this section unless an application has been submitted to, and approved by, the Secretary. Such application shall be in such form, submitted in such a manner, and be accompanied by such information, as the Secretary may specify. No such application may be approved unless it contains assurances that the applicant will use the funds provided only for the purposes specified in the approved application and in accordance with the requirements of this section, that the application will establish such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement and accounting of Federal funds paid to the applicant under subsection (a) of this section, and that the applicant will comply with the peer review requirements under
(2) Assurances
Each applicant, prior to receiving Federal funds under subsection (a) of this section, shall provide assurances satisfactory to the Secretary that the applicant will—
(A) provide for the establishment of a registry in accordance with subsection (a) of this section;
(B) comply with appropriate standards of completeness, timeliness, and quality of population-based cancer registry data;
(C) provide for the annual publication of reports of cancer data under subsection (a) of this section; and
(D) provide for the authorization under State law of the statewide cancer registry, including promulgation of regulations providing—
(i) a means to assure complete reporting of cancer cases (as described in subsection (a) of this section) to the statewide cancer registry by hospitals or other facilities providing screening, diagnostic or therapeutic services to patients with respect to cancer;
(ii) a means to assure the complete reporting of cancer cases (as defined in subsection (a) of this section) to the statewide cancer registry by physicians, surgeons, and all other health care practitioners diagnosing or providing treatment for cancer patients, except for cases directly referred to or previously admitted to a hospital or other facility providing screening, diagnostic or therapeutic services to patients in that State and reported by those facilities;
(iii) a means for the statewide cancer registry to access all records of physicians and surgeons, hospitals, outpatient clinics, nursing homes, and all other facilities, individuals, or agencies providing such services to patients which would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified patient;
(iv) for the reporting of cancer case data to the statewide cancer registry in such a format, with such data elements, and in accordance with such standards of quality timeliness and completeness, as may be established by the Secretary;
(v) for the protection of the confidentiality of all cancer case data reported to the statewide cancer registry, including a prohibition on disclosure to any person of information reported to the statewide cancer registry that identifies, or could lead to the identification of, an individual cancer patient, except for disclosure to other State cancer registries and local and State health officers;
(vi) for a means by which confidential case data may in accordance with State law be disclosed to cancer researchers for the purposes of cancer prevention, control and research;
(vii) for the authorization or the conduct, by the statewide cancer registry or other persons and organizations, of studies utilizing statewide cancer registry data, including studies of the sources and causes of cancer, evaluations of the cost, quality, efficacy, and appropriateness of diagnostic, therapeutic, rehabilitative, and preventative services and programs relating to cancer, and any other clinical, epidemiological, or other cancer research; and
(viii) for protection for individuals complying with the law, including provisions specifying that no person shall be held liable in any civil action with respect to a cancer case report provided to the statewide cancer registry, or with respect to access to cancer case information provided to the statewide cancer registry.
(d) Relationship to certain programs
(1) In general
This section may not be construed to act as a replacement for or diminishment of the program carried out by the Director of the National Cancer Institute and designated by such Director as the Surveillance, Epidemiology, and End Results Program (SEER).
(2) Supplanting of activities
In areas where both such programs exist, the Secretary shall ensure that SEER support is not supplanted and that any additional activities are consistent with the guidelines provided for in subsection (c)(2)(C) and (D) of this section and are appropriately coordinated with the existing SEER program.
(3) Transfer of responsibility
The Secretary may not transfer administration responsibility for such SEER program from such Director.
(4) Coordination
To encourage the greatest possible efficiency and effectiveness of Federally supported efforts with respect to the activities described in this subsection, the Secretary shall take steps to assure the appropriate coordination of programs supported under this part with existing Federally supported cancer registry programs.
(e) Requirement regarding certain study on breast cancer
In the case of a grant under subsection (a) of this section to any State specified in
(July 1, 1944, ch. 373, title III, §399H, as added Oct. 24, 1992,
References in Text
Section 399C, included within the phrase "study carried out under section 399C", referred to in subsec. (e), was not translated because title III of act July 1, 1944, which is classified to this subchapter, does not contain a section 399C. Provisions in this subchapter relating to a study are contained in section 399K which is classified to
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Congressional Findings and Purpose
Section 2 of
"(a)
"(1) cancer control efforts, including prevention and early detection, are best addressed locally by State health departments that can identify unique needs;
"(2) cancer control programs and existing statewide population-based cancer registries have identified cancer incidence and cancer mortality rates that indicate the burden of cancer for Americans is substantial and varies widely by geographic location and by ethnicity;
"(3) statewide cancer incidence and cancer mortality data, can be used to identify cancer trends, patterns, and variation for directing cancer control intervention;
"(4) the American Association of Central Cancer Registries (AACCR) cites that of the 50 States, approximately 38 have established cancer registries, many are not statewide and 10 have no cancer registry; and
"(5) AACCR also cites that of the 50 States, 39 collect data on less than 100 percent of their population, and less than half have adequate resources for insuring minimum standards for quality and for completeness of case information.
"(b)
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§280e–1. Planning grants regarding registries
(a) In general
(1) States
The Secretary, acting through the Director of the Centers for Disease Control, may make grants to States for the purpose of developing plans that meet the assurances required by the Secretary under section 399B(c)(2).1
(2) Other entities
For the purpose described in paragraph (1), the Secretary may make grants to public entities other than States and to nonprofit private entities. Such a grant may be made to an entity only if the State in which the purpose is to be carried out has certified that the State approves the entity as qualified to carry out the purpose.
(b) Application
The Secretary may make a grant under subsection (a) of this section only if an application for the grant is submitted to the Secretary, the application contains the certification required in subsection (a)(2) of this section (if the application is for a grant under such subsection), and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(July 1, 1944, ch. 373, title III, §399I, as added Oct. 24, 1992,
References in Text
Section 399B(c)(2), included within the phrase "assurances required by the Secretary under section 399B(c)(2)", referred to in subsec. (a)(1), was not translated because title III of act July 1, 1944, which is classified to this subchapter, does not contain a section 399B. Provisions relating to assurances required by the Secretary are contained in section 399H(c)(2), which is classified to
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Section Referred to in Other Sections
This section is referred to in
1 See References in Text note below.
§280e–2. Technical assistance in operations of statewide cancer registries
The Secretary, acting through the Director of the Centers for Disease Control, may, directly or through grants and contracts, or both, provide technical assistance to the States in the establishment and operation of statewide registries, including assistance in the development of model legislation for statewide cancer registries and assistance in establishing a computerized reporting and data processing system.
(July 1, 1944, ch. 373, title III, §399J, as added Oct. 24, 1992,
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Section Referred to in Other Sections
This section is referred to in
§280e–3. Study in certain States to determine factors contributing to elevated breast cancer mortality rates
(a) In general
Subject to subsections (c) and (d) of this section, the Secretary, acting through the Director of the National Cancer Institute, shall conduct a study for the purpose of determining the factors contributing to the fact that breast cancer mortality rates in the States specified in subsection (b) of this section are elevated compared to rates in other States.
(b) Relevant States
The States referred to in subsection (a) of this section are Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Rhode Island, Vermont, and the District of Columbia.
(c) Cooperation of State
The Secretary may conduct the study required in subsection (a) of this section in a State only if the State agrees to cooperate with the Secretary in the conduct of the study, including providing information from any registry operated by the State pursuant to
(d) Planning, commencement, and duration
The Secretary shall, during each of the fiscal years 1993 and 1994, develop a plan for conducting the study required in subsection (a) of this section. The study shall be initiated by the Secretary not later than fiscal year 1994, and the collection of data under the study may continue through fiscal year 1998.
(e) Report
Not later than September 30, 1999, the Secretary shall complete the study required in subsection (a) of this section and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the findings and recommendations made as a result of the study.
(July 1, 1944, ch. 373, title III, §399K, as added Oct. 24, 1992,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Potential Environmental and Other Risks Contributing to Incidence of Breast Cancer
"(a)
"(1)
"(A) the Counties of Nassau and Suffolk, in the State of New York; and
"(B) the 2 counties in the northeastern United States that, as identified in the report specified in paragraph (2), had the highest age-adjusted mortality rate of such cancer that reflected not less than 30 deaths during the 5-year period for which findings are made in the report.
"(2)
"(b)
"(1) contaminated drinking water;
"(2) sources of indoor and ambient air pollution, including emissions from aircraft;
"(3) electromagnetic fields;
"(4) pesticides and other toxic chemicals;
"(5) hazardous and municipal waste; and
"(6) such other factors as the Director determines to be appropriate.
"(c)
"(d)
Section Referred to in Other Sections
This section is referred to in
§280e–4. Authorization of appropriations
(a) Registries
For the purpose of carrying out this part, there are authorized to be appropriated $30,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998. Of the amounts appropriated under the preceding sentence for any such fiscal year, the Secretary may obligate not more than 25 percent for carrying out
(b) Breast cancer study
Of the amounts appropriated for the National Cancer Institute under subpart 1 of part C of subchapter III of this chapter for any fiscal year in which the study required in
(July 1, 1944, ch. 373, title III, §399L, as added Oct. 24, 1992,
Amendments
1993—Subsec. (a).
1 So in original. Probably should be "section".
SUBCHAPTER III—NATIONAL RESEARCH INSTITUTES
Codification
Title IV of the Public Health Service Act, comprising this subchapter, was originally enacted by act July 1, 1944, ch. 373,
The provisions of title IV as originally enacted were subsequently redesignated as part A of title IV and amended, and parts B to I of title IV were added and amended by the following acts: June 16, 1948, ch. 481,
Title IV was subsequently amended generally and completely reorganized by
Subchapter Referred to in Other Sections
This subchapter is referred to in
Part A—National Institutes of Health
§281. Organization of National Institutes of Health
(a) Agency of Public Health Service
The National Institutes of Health is an agency of the Service.
(b) Agencies within
(1) The following national research institutes are agencies of the National Institutes of Health:
(A) The National Cancer Institute.
(B) The National Heart, Lung, and Blood Institute.
(C) The National Institute of Diabetes and Digestive and Kidney Diseases.
(D) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
(E) The National Institute on Aging.
(F) The National Institute of Allergy and Infectious Diseases.
(G) The National Institute of Child Health and Human Development.
(H) The National Institute of Dental Research.
(I) The National Eye Institute.
(J) The National Institute of Neurological Disorders and Stroke.
(K) The National Institute of General Medical Sciences.
(L) The National Institute of Environmental Health Sciences.
(M) The National Institute on Deafness and Other Communication Disorders.
(N) The National Institute on Alcohol Abuse and Alcoholism.
(O) The National Institute on Drug Abuse.
(P) The National Institute of Mental Health.
(Q) The National Institute of Nursing Research.
(2) The following entities are agencies of the National Institutes of Health:
(A) The National Library of Medicine.
(B) The National Center for Research Resources.
(C) The John E. Fogarty International Center for Advanced Study in the Health Sciences.
(D) The National Center for Human Genome Research.
(E) The Office of Dietary Supplements.
(c) Establishment of additional national research institutes; reorganization or abolition of institutes
(1) The Secretary may establish in the National Institutes of Health one or more additional national research institutes to conduct and support research, training, health information, and other programs with respect to any particular disease or groups of diseases or any other aspect of human health if—
(A) the Secretary determines that an additional institute is necessary to carry out such activities; and
(B) the additional institute is not established before the expiration of 180 days after the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate written notice of the determination made under subparagraph (A) with respect to the institute.
(2) The Secretary may reorganize the functions of any national research institute and may abolish any national research institute if the Secretary determines that the institute is no longer required. A reorganization or abolition may not take effect under this paragraph before the expiration of 180 days after the Secretary has provided the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate written notice of the reorganization or abolition.
(d) "National research institute" defined
For purposes of this subchapter, the term "national research institute" means a national research institute listed in subsection (b) of this section or established under subsection (c) of this section. A reference to the National Institutes of Health includes its agencies.
(July 1, 1944, ch. 373, title IV, §401, as added Nov. 20, 1985,
Amendments
1994—Subsec. (b)(2)(E).
1993—Subsec. (b)(1)(Q).
Subsec. (b)(2)(B).
Subsec. (b)(2)(D).
1992—Subsec. (b)(1)(N) to (P).
1988—Subsec. (b)(1)(J), (M).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1992 Amendment
Amendment by
Effective Date of 1988 Amendment
For effective date of amendment by
Report on Medical Uses of Biological Agents in Development of Defenses Against Biological Warfare
Section 1904 of
Research on Lupus Erythematosus
Section 5 of
"(a)
"(b)
"(A) the Director of the National Institute of Neurological and Communicative Disorders and Stroke (or the designee of such Director);
"(B) the Director of the National Institute of Allergy and Infectious Diseases (or the designee of such Director);
"(C) the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (or the designee of such Director);
"(D) the Director of the National Institute of General Medical Sciences (or the designee of such Director);
"(E) the Director of the National Heart, Lung, and Blood Institute (or the designee of such Director);
"(F) the Director of the National Institute of Diabetes and Digestive and Kidney Diseases (or the designee of such Director); and
"(G) the Director of the Centers for Disease Control and Prevention (or the designee of such Director).
"(2) The Committee shall meet at least four times a year. The Secretary shall designate as chairman of the Committee the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
"(c)
Interagency Committee on Learning Disabilities
Section 9 of
§282. Director of National Institutes of Health
(a) Appointment
The National Institutes of Health shall be headed by the Director of the National Institutes of Health (hereafter in this subchapter referred to as the "Director of NIH") who shall be appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) of this section and as the Secretary may otherwise prescribe.
(b) Duties and authority
In carrying out the purposes of
(1) shall be responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and operation of programs and activities within the National Institutes of Health;
(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health;
(3) shall assure that research at or supported by the National Institutes of Health is subject to review in accordance with
(4) for the national research institutes and administrative entities within the National Institutes of Health—
(A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal property, and
(B) may acquire, without regard to
(5) may secure resources for research conducted by or through the National Institutes of Health;
(6) may, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of
(7) may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad;
(8) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;
(9) may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment;
(10) may accept voluntary and uncompensated services;
(11) may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter; and
(12) after consultation with the Director of the Office of Research on Women's Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women's health that are identified under
The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (6). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States.
(c) Availability of substances and organisms for research
The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
(d) Services of experts or consultants; number; payment of expenses, conditions, recovery
(1) The Director of NIH may obtain (in accordance with
(2)(A) Except as provided in subparagraph (B), experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment.
(B) Expenses specified in subparagraph (A) shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph.
(e) Dissemination of research information
The Director of NIH shall—
(1) advise the agencies of the National Institutes of Health on medical applications of research;
(2) coordinate, review, and facilitate the systematic identification and evaluation of, clinically relevant information from research conducted by or through the national research institutes;
(3) promote the effective transfer of the information described in paragraph (2) to the health care community and to entities that require such information;
(4) monitor the effectiveness of the activities described in paragraph (3); and
(5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded by the National Institutes of Health and intended for the general public are in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (
(f) Associate Director for Prevention; functions; report to Director
There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—
(1) annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs;
(2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemination, using advanced technologies to the maximum extent practicable, of research results to such entities; and
(3) annually prepare and submit to the Director of NIH a report concerning the prevention and dissemination activities undertaken by the Associate Director, including—
(A) a summary of the Associate Director's review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and
(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities.
(g) Enhancing competitiveness of certain entities in obtaining research funds
(1)(A) In the case of entities described in subparagraph (B), the Director of NIH, acting through the Director of the National Center for Research Resources, shall establish a program to enhance the competitiveness of such entities in obtaining funds from the national research institutes for conducting biomedical and behavioral research.
(B) The entities referred to in subparagraph (A) are entities that conduct biomedical and behavioral research and are located in a State in which the aggregate success rate for applications to the national research institutes for assistance for such research by the entities in the State has historically constituted a low success rate of obtaining such funds, relative to such aggregate rate for such entities in other States.
(C) With respect to enhancing competitiveness for purposes of subparagraph (A), the Director of NIH, in carrying out the program established under such subparagraph, may—
(i) provide technical assistance to the entities involved, including technical assistance in the preparation of applications for obtaining funds from the national research institutes;
(ii) assist the entities in developing a plan for biomedical or behavioral research proposals; and
(iii) assist the entities in implementing such plan.
(2) The Director of NIH shall establish a program of supporting projects of biomedical or behavioral research whose principal researchers are individuals who have not previously served as the principal researchers of such projects supported by the Director.
(h) Increased participation of women and disadvantaged individuals in biomedical and behavioral research
The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.
(i) Discretionary fund; uses; report to Congressional committees; authorization of appropriations
(1) There is established a fund, consisting of amounts appropriated under paragraph (3) and made available for the fund, for use by the Director of NIH to carry out the activities authorized in this chapter for the National Institutes of Health. The purposes for which such fund may be expended include—
(A) providing for research on matters that have not received significant funding relative to other matters, responding to new issues and scientific emergencies, and acting on research opportunities of high priority;
(B) supporting research that is not exclusively within the authority of any single agency of such Institutes; and
(C) purchasing or renting equipment and quarters for activities of such Institutes.
(2) Not later than February 10 of each fiscal year, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the activities undertaken and expenditures made under this section during the preceding fiscal year. The report may contain such comments of the Secretary regarding this section as the Secretary determines to be appropriate.
(3) For the purpose of carrying out this subsection, there are authorized to be appropriated $25,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(j) Day care for children of employees
(1) The Director of NIH may establish a program to provide day care services for the employees of the National Institutes of Health similar to those services provided by other Federal agencies (including the availability of day care service on a 24-hour-a-day basis).
(2) Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee.
(3) For purposes regarding the provision of day care services, the Director of NIH may enter into rental or lease purchase agreements.
(k) Interagency research on trauma
The Director of NIH shall carry out the program established in part F of subchapter X of this chapter (relating to interagency research on trauma).
(July 1, 1944, ch. 373, title IV, §402, as added Nov. 20, 1985,
References in Text
The provisions of title 5 governing appointments in the competitive service, referred to in subsec. (b)(6), are classified generally to
The General Schedule, referred to in subsec. (b)(6), is set out under
The Federal Advisory Committee Act, referred to in subsec. (b), is
The provisions of title 5 relating to reimbursement for travel expenses, referred to in subsec. (d)(2)(A), are classified generally to
The National Literacy Act of 1991, referred to in subsec. (e)(5), is
Amendments
1993—Subsec. (b)(12).
Subsec. (e)(5).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
Subsec. (j).
Subsec. (k).
1992—Subsec. (d)(1).
1988—Subsec. (b)(6).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1992 Amendment
Amendment by
Chronic Fatigue Syndrome; Experts and Research Representatives on Advisory Committees and Boards
Section 902(c) of
Third-Party Payments Regarding Certain Clinical Trials and Certain Life-Threatening Illnesses
Section 1901(a) of
"(1) determining the policies of third-party payors regarding the payment of the costs of appropriate health services that are provided incident to the participation of individuals as subjects in clinical trials conducted in the development of drugs with respect to acquired immune deficiency syndrome, cancer, and other life-threatening illnesses; and
"(2) developing recommendations regarding such policies."
Personnel Study of Recruitment, Retention and Turnover
Section 1905 of
Chronic Pain Conditions
Section 1907 of
"(a)
"(b)
"(c)
Support for Bioengineering Research
Section 1912 of
Master Plan for Physical Infrastructure for Research
Section 2002 of
Section Referred to in Other Sections
This section is referred to in
§283. Biennial report of Director to President and Congress; contents
The Secretary shall transmit to the President and to the Congress a biennial report which shall be prepared by the Director of NIH and which shall consist of—
(1) a description of the activities carried out by and through the National Institutes of Health and the policies respecting the programs of the National Institutes of Health and such recommendations respecting such policies as the Secretary considers appropriate;
(2) a description of the activities undertaken to improve grants and contracting accountability and technical and scientific peer review procedures of the National Institutes of Health and the national research institutes;
(3) the reports made by the Associate Director for Prevention under
(4) a description of the health related behavioral research that has been supported by the National Institutes of Health in the preceding 2-year period, and a description of any plans for future activity in such area; and
(5) the biennial reports of the Directors of each of the national research institutes, the Director of the Division of Research Resources, and the Director of the National Center for Nursing Research.
The first report under this section shall be submitted not later than July 1, 1986, and shall relate to the fiscal year ending September 30, 1985. The next report shall be submitted not later than December 30, 1988, and shall relate to the two-fiscal-year period ending on the preceding September 30. Each subsequent report shall be submitted not later than 90 days after the end of the two-fiscal-year period for which the report is to be submitted.
(July 1, 1944, ch. 373, title IV, §403, as added Nov. 20, 1985,
Amendments
1988—Pars. (4), (5).
Change of Name
Division of Research Resources changed to National Center for Research Resources by
National Center for Nursing Research changed to National Institute of Nursing Research by
Section Referred to in Other Sections
This section is referred to in
§283a. Establishment of program regarding DES
(a) In general
The Director of NIH shall establish a program for the conduct and support of research and training, the dissemination of health information, and other programs with respect to the diagnosis and treatment of conditions associated with exposure to the drug diethylstilbestrol (in this section referred to as "DES").
(b) Education programs
In carrying out subsection (a) of this section, the Director of NIH, after consultation with nonprofit private entities representing individuals who have been exposed to DES, shall conduct or support programs to educate health professionals and the public on the drug, including the importance of identifying and treating individuals who have been exposed to the drug.
(c) Longitudinal studies
After consultation with the Office of Research on Women's Health, the Director of NIH, acting through the appropriate national research institutes, shall in carrying out subsection (a) of this section conduct or support one or more longitudinal studies to determine the incidence of the following diseases or disorders in the indicated populations and the relationship of DES to the diseases or disorders:
(1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant, the incidence of all diseases and disorders (including breast cancer, gynecological cancers, and impairments of the immune system, including autoimmune disease).
(2) In the case of women exposed to DES in utero, the incidence of clear cell cancer (including recurrences), the long-term health effects of such cancer, and the effects of treatments for such cancer.
(3) In the case of men and women exposed to DES in utero, the incidence of all diseases and disorders (including impairments of the reproductive and autoimmune systems).
(4) In the case of children of men or women exposed to DES in utero, the incidence of all diseases and disorders.
(d) Exposure to DES in utero
For purposes of this section, an individual shall be considered to have been exposed to DES in utero if, during the pregnancy that resulted in the birth of such individual, DES was (on or after January 1, 1938) administered to the biological mother of the individual.
(e) Authorization of appropriations
In addition to any other authorization of appropriations available for the purpose of carrying out this section, there are authorized to be appropriated for such purpose such sums as may be necessary for each of the fiscal years 1993 through 1996.
(July 1, 1944, ch. 373, title IV, §403A, as added Oct. 13, 1992,
§283b. Office of Research on Minority Health
(a) Establishment
There is established within the Office of the Director of NIH an office to be known as the Office of Research on Minority Health (in this section referred to as the "Office"). The Office shall be headed by a director, who shall be appointed by the Director of NIH.
(b) Purpose
The Director of the Office shall—
(1) identify projects of research on minority health that should be conducted or supported by the national research institutes;
(2) identify multidisciplinary research relating to research on minority health that should be so conducted or supported;
(3) promote coordination and collaboration among entities conducting research identified under paragraph (1) or (2);
(4) encourage the conduct of such research by entities receiving funds from the national research institutes;
(5) recommend an agenda for conducting and supporting such research;
(6) promote the sufficient allocation of the resources of the national research institutes for conducting and supporting such research; and
(7) assist in the administration of
(July 1, 1944, ch. 373, title IV, §404, as added June 10, 1993,
§283c. Office of Behavioral and Social Sciences Research
(a) There is established within the Office of the Director of NIH an office to be known as the Office of Behavioral and Social Sciences Research (in this section referred to as the "Office"). The Office shall be headed by a director, who shall be appointed by the Director of NIH.
(b)(1) With respect to research on the relationship between human behavior and the development, treatment, and prevention of medical conditions, the Director of the Office shall—
(A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and
(B) identify projects of behavioral and social sciences research that should be conducted or supported by the national research institutes, and develop such projects in cooperation with such institutes.
(2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent behavior, suicide, and homelessness. Such research does not include neurobiological research, or research in which the behavior of an organism is observed for the purpose of determining activity at the cellular or molecular level.
(July 1, 1944, ch. 373, title IV, §404A, as added June 10, 1993,
Effective Date
Section 203(c) of
§283d. Children's Vaccine Initiative
(a) Development of new vaccines
The Secretary, in consultation with the Director of the National Vaccine Program under subchapter XIX of this chapter and acting through the Directors of the National Institute for Allergy and Infectious Diseases, the National Institute for Child Health and Human Development, the National Institute for Aging, and other public and private programs, shall carry out activities, which shall be consistent with the global Children's Vaccine Initiative, to develop affordable new and improved vaccines to be used in the United States and in the developing world that will increase the efficacy and efficiency of the prevention of infectious diseases. In carrying out such activities, the Secretary shall, to the extent practicable, develop and make available vaccines that require fewer contacts to deliver, that can be given early in life, that provide long lasting protection, that obviate refrigeration, needles and syringes, and that protect against a larger number of diseases.
(b) Report
In the report required in
(c) Authorization of appropriations
In addition to any other amounts authorized to be appropriated for activities of the type described in this section, there are authorized to be appropriated to carry out this section $20,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(July 1, 1944, ch. 373, title IV, §404B, as added June 10, 1993,
§283e. Plan for use of animals in research
(a) Preparation
The Director of NIH, after consultation with the committee established under subsection (e) of this section, shall prepare a plan—
(1) for the National Institutes of Health to conduct or support research into—
(A) methods of biomedical research and experimentation that do not require the use of animals;
(B) methods of such research and experimentation that reduce the number of animals used in such research;
(C) methods of such research and experimentation that produce less pain and distress in such animals; and
(D) methods of such research and experimentation that involve the use of marine life (other than marine mammals);
(2) for establishing the validity and reliability of the methods described in paragraph (1);
(3) for encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable; and
(4) for training scientists in the use of such methods that have been found to be valid and reliable.
(b) Submission to Congressional committees
Not later than October 1, 1993, the Director of NIH shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, the plan required in subsection (a) of this section and shall begin implementation of the plan.
(c) Periodic review and revision
The Director of NIH shall periodically review, and as appropriate, make revisions in the plan required under subsection (a) of this section. A description of any revision made in the plan shall be included in the first biennial report under
(d) Dissemination of information
The Director of NIH shall take such actions as may be appropriate to convey to scientists and others who use animals in biomedical or behavioral research or experimentation information respecting the methods found to be valid and reliable under subsection (a)(2) of this section.
(e) Interagency Coordinating Committee on the Use of Animals in Research
(1) The Director of NIH shall establish within the National Institutes of Health a committee to be known as the Interagency Coordinating Committee on the Use of Animals in Research (in this subsection referred to as the "Committee").
(2) The Committee shall provide advice to the Director of NIH on the preparation of the plan required in subsection (a) of this section.
(3) The Committee shall be composed of—
(A) the Directors of each of the national research institutes and the Director of the Center for Research Resources (or the designees of such Directors); and
(B) representatives of the Environmental Protection Agency, the Food and Drug Administration, the Consumer Product Safety Commission, the National Science Foundation, and such additional agencies as the Director of NIH determines to be appropriate, which representatives shall include not less than one veterinarian with expertise in laboratory-animal medicine.
(July 1, 1944, ch. 373, title IV, §404C, as added June 10, 1993,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
§283f. Requirements regarding surveys of sexual behavior
With respect to any survey of human sexual behavior proposed to be conducted or supported through the National Institutes of Health, the survey may not be carried out unless—
(1) the proposal has undergone review in accordance with any applicable requirements of
(2) the Secretary, in accordance with
(A) in reducing the incidence of sexually transmitted diseases, the incidence of infection with the human immunodeficiency virus, or the incidence of any other infectious disease; or
(B) in improving reproductive health or other conditions of health.
(July 1, 1944, ch. 373, title IV, §404D, as added June 10, 1993,
Prohibition Against SHARP Adult Sex Survey and American Teenage Sex Survey
Section 2015 of
§283g. Office of Alternative Medicine
(a) Establishment
There is established within the Office of the Director of NIH an office to be known as the Office of Alternative Medicine (in this section referred to as the "Office"), which shall be headed by a director appointed by the Director of NIH.
(b) Purpose
The purpose of the Office is to facilitate the evaluation of alternative medical treatment modalities, including acupuncture and Oriental medicine, homeopathic medicine, and physical manipulation therapies.
(c) Advisory council
The Secretary shall establish an advisory council for the purpose of providing advice to the Director of the Office on carrying out this section.
(d) Duties
In carrying out subsection (b) of this section, the Director of the Office shall—
(1) establish an information clearinghouse to exchange information with the public about alternative medicine;
(2) support research training—
(A) for which fellowship support is not provided under
(B) that is not residency training of physicians or other health professionals; and
(3)(A) prepare biennial reports on the activities carried out or to be carried out by the Office; and
(B) submit each such report to the Director of NIH for inclusion in the biennial report under
(July 1, 1944, ch. 373, title IV, §404E, as added June 10, 1993,
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
Part B—General Provisions Respecting National Research Institutes
§284. Directors of national research institutes
(a) Appointment
The Director of the National Cancer Institute shall be appointed by the President and the Directors of the other national research institutes shall be appointed by the Secretary. Each Director of a national research institute shall report directly to the Director of NIH.
(b) Duties and authority; grants, contracts, and cooperative agreements
(1) In carrying out the purposes of
(A) shall encourage and support research, investigations, experiments, demonstrations, and studies in the health sciences related to—
(i) the maintenance of health,
(ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders,
(iii) the rehabilitation of individuals with human diseases, disorders, and disabilities, and
(iv) the expansion of knowledge of the processes underlying human diseases, disorders, and disabilities, the processes underlying the normal and pathological functioning of the body and its organ systems, and the processes underlying the interactions between the human organism and the environment;
(B) may, subject to the peer review prescribed under
(C) may conduct and support research training (i) for which fellowship support is not provided under
(D) may develop, implement, and support demonstrations and programs for the application of the results of the activities of the institute to clinical practice and disease prevention activities;
(E) may develop, conduct, and support public and professional education and information programs;
(F) may secure, develop and maintain, distribute, and support the development and maintenance of resources needed for research;
(G) may make available the facilities of the institute to appropriate entities and individuals engaged in research activities and cooperate with and assist Federal and State agencies charged with protecting the public health;
(H) may accept unconditional gifts made to the institute for its activities, and, in the case of gifts of a value in excess of $50,000, establish suitable memorials to the donor;
(I) may secure for the institute consultation services and advice of persons from the United States or abroad;
(J) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;
(K) may accept voluntary and uncompensated services; and
(L) may perform such other functions as the Secretary determines are needed to carry out effectively the purposes of the institute.
The indemnification provisions of
(2) Support for an activity or program under this subsection may be provided through grants, contracts, and cooperative agreements. The Secretary, acting through the Director of each national research institute—
(A) may enter into a contract for research, training, or demonstrations only if the contract has been recommended after technical and scientific peer review required by regulations under
(B) may make grants and cooperative agreements under paragraph (1) for research, training, or demonstrations, except that—
(i) if the direct cost of the grant or cooperative agreement to be made does not exceed $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under
(ii) if the direct cost of the grant or cooperative agreement to be made exceeds $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under
(C) shall, subject to
(c) Coordination with other public and private entities; cooperation with other national research institutes; appointment of additional peer review groups
In carrying out subsection (b) of this section, each Director of a national research institute—
(1) shall coordinate, as appropriate, the activities of the institute with similar programs of other public and private entities;
(2) shall cooperate with the Directors of the other national research institutes in the development and support of multidisciplinary research and research that involves more than one institute;
(3) may, in consultation with the advisory council for the Institute and with the approval of the Director of NIH—
(A) establish technical and scientific peer review groups in addition to those appointed under
(B) appoint the members of peer review groups established under subparagraph (A); and
(4) may publish, or arrange for the publication of, information with respect to the purpose of the Institute without regard to
The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (3).
(July 1, 1944, ch. 373, title IV, §405, as added Nov. 20, 1985,
References in Text
The Federal Advisory Committee Act, referred to in subsec. (c), is
Amendments
1993—Subsec. (b)(2)(C).
Subsec. (c).
Subsec. (c)(3).
1988—Subsec. (b)(1).
Subsec. (c)(3).
Subsec. (c)(4).
Effective Date of 1988 Amendment
Amendment by
Section Referred to in Other Sections
This section is referred to in
§284a. Advisory councils
(a) Establishment; acceptance of conditional gifts; functions
(1) Except as provided in subsection (h) of this section, the Secretary shall appoint an advisory council for each national research institute which (A) shall advise, assist, consult with, and make recommendations to the Secretary and the Director of such institute on matters related to the activities carried out by and through the institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C of this subchapter.
(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with
(3) Each advisory council for a national research institute—
(A)(i) may on the basis of the materials provided under
(ii) may review applications for grants and cooperative agreements for research or training and for which advisory council approval is required under
(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the institute;
(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspect of human health with respect to which the institute was established and with the approval of the Director of the institute make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and
(C) may appoint subcommittees and convene workshops and conferences.
(b) Membership; compensation
(1) Each advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. The ex officio members shall be nonvoting members.
(2) The ex officio members of an advisory council shall consist of—
(A) the Secretary, the Director of NIH, the Director of the national research institute for which the council is established, the Under Secretary for Health of the Department of Veterans Affairs or the Chief Dental Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and
(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions.
(3) The members of an advisory council who are not ex officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including not less than two individuals who are leaders in the fields of public health and the behavioral or social sciences) relevant to the activities of the national research institute for which the advisory council is established.
(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management.
(4) Members of an advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The other members of an advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule.
(c) Term of office; reappointment; vacancy
The term of office of an appointed member of an advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term for 180 days after the date of such expiration. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.
(d) Chairman; term of office
The chairman of an advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the national research institute for which the advisory council is established to be the chairman of the advisory council. The term of office of the chairman shall be two years.
(e) Meetings
The advisory council shall meet at the call of the chairman or upon the request of the Director of the national research institute for which it was established, but at least three times each fiscal year. The location of the meetings of each advisory council is subject to the approval of the Director of the national research institute for which the advisory council was established.
(f) Appointment of executive secretary; training and orientation for new members
The Director of the national research institute for which an advisory council is established shall designate a member of the staff of the institute to serve as the executive secretary of the advisory council. The Director of such institute shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of such institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council.
(g) Comments and recommendations for inclusion in biennial report; additional reports
Each advisory council may prepare, for inclusion in the biennial report made under
(h) Advisory councils in existence; application of section to National Cancer Advisory Board and advisory council to National Heart, Lung, and Blood Institute
(1) Except as provided in paragraph (2), this section does not terminate the membership of any advisory council for a national research institute which was in existence on November 20, 1985. After November 20, 1985—
(A) the Secretary shall make appointments to each such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section;
(B) each advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and
(C) the Director of each national research institute shall perform for such advisory council the functions prescribed by this section.
(2)(A) The National Cancer Advisory Board shall be the advisory council for the National Cancer Institute. This section applies to the National Cancer Advisory Board, except that—
(i) appointments to such Board shall be made by the President;
(ii) the term of office of an appointed member shall be 6 years;
(iii) of the members appointed to the Board not less than five members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors);
(iv) the chairman of the Board shall be selected by the President from the appointed members and shall serve as chairman for a term of two years;
(v) the ex officio members of the Board shall be nonvoting members and shall be the Secretary, the Director of the Office of Science and Technology Policy, the Director of NIH, the Under Secretary for Health of the Department of Veterans Affairs, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, the Assistant Secretary of Defense for Health Affairs, and the Director of the Office of Energy Research of the Department of Energy (or the designees of such officers); and
(vi) the Board shall meet at least four times each fiscal year.
(B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that the advisory council shall meet at least four times each fiscal year.
(July 1, 1944, ch. 373, title IV, §406, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a)(2).
Subsec. (b)(2)(A).
Subsec. (c).
Subsec. (h)(2)(A)(v).
1992—Subsecs. (b)(2)(A), (h)(2)(A)(v).
1990—Subsec. (a)(2).
1988—Subsec. (b)(1).
Subsec. (b)(3)(A).
Subsec. (h)(2)(A)(v).
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Section Referred to in Other Sections
This section is referred to in
§284b. Biennial report
The Director of each national research institute, after consultation with the advisory council for the institute, shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §407, as added Nov. 20, 1985,
Section Referred to in Other Sections
This section is referred to in
§284c. Certain uses of funds
(a)(1) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal year for administrative expenses of the National Institutes of Health may not exceed an amount which is 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health.
(2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing Research, the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G. Magnuson Clinical Center, and the Office of Medical Applications of Research.
(3) For purposes of paragraph (1), the term "administrative expenses" means expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health. In identifying expenses incurred for such support and administration the Secretary shall consult with the Comptroller General of the United States.
(4) Not later than December 31, 1987, and December 31 of each succeeding year, the Secretary shall report to the Congress the amount obligated in the fiscal year preceding such date for administrative expenses of the National Institutes of Health and the total amount appropriated for the National Institutes of Health for such fiscal year. The Secretary shall consult with the Comptroller General of the United States in preparing each report.
(b) For fiscal year 1989 and subsequent fiscal years, amounts made available to the National Institutes of Health shall be available for payment of nurses and allied health professionals in accordance with payment authorities, scheduling options, benefits, and other authorities provided under
(July 1, 1944, ch. 373, title IV, §408, as added Nov. 20, 1985,
Amendments
1993—
1988—Subsec. (a)(1), (2).
"(1)(A) For the National Cancer Institute (other than its programs under
"(B) For the programs under
"(2)(A) For the National Heart, Lung, and Blood Institute (other than its programs under
"(B) For the programs under
Subsec. (a)(2)(B).
Subsec. (b)(5).
Change of Name
National Center for Nursing Research changed to National Institute of Nursing Research by
Effective Date of 1988 Amendment
Amendment by
Warren G. Magnuson Clinical Center; Availability of Funds for Payment of Nurses; Rate of Pay and Options and Benefits
Section Referred to in Other Sections
This section is referred to in
§284d. "Health services research" defined
For purposes of this subchapter, the term "health services research" means research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions.
(July 1, 1944, ch. 373, title IV, §409, as added July 10, 1992,
Amendments
1993—
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
§284e. Research on osteoporosis, Paget's disease, and related bone disorders
(a) Establishment
The Directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the National Institute of Dental Research, and the National Institute of Diabetes and Digestive and Kidney Diseases, shall expand and intensify the programs of such Institutes with respect to research and related activities concerning osteoporosis, Paget's disease, and related bone disorders.
(b) Coordination
The Directors referred to in subsection (a) of this section shall jointly coordinate the programs referred to in such subsection and consult with the Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and the Interagency Task Force on Aging Research.
(c) Information clearinghouse
(1) In general
In order to assist in carrying out the purpose described in subsection (a) of this section, the Director of NIH shall provide for the establishment of an information clearinghouse on osteoporosis and related bone disorders to facilitate and enhance knowledge and understanding on the part of health professionals, patients, and the public through the effective dissemination of information.
(2) Establishment through grant or contract
For the purpose of carrying out paragraph (1), the Director of NIH shall enter into a grant, cooperative agreement, or contract with a nonprofit private entity involved in activities regarding the prevention and control of osteoporosis and related bone disorders.
(d) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $40,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(July 1, 1944, ch. 373, title IV, §409A, as added June 10, 1993,
Part C—Specific Provisions Respecting National Research Institutes
Part Referred to in Other Sections
This part is referred to in
subpart 1—national cancer institute
Subpart Referred to in Other Sections
This subpart is referred to in
§285. Purpose of Institute
The general purpose of the National Cancer Institute (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
(July 1, 1944, ch. 373, title IV, §410, as added Nov. 20, 1985,
Amendments
1988—
§285a. National Cancer Program
The National Cancer Program shall consist of (1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other national research institutes, including an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute.
(July 1, 1944, ch. 373, title IV, §411, as added Nov. 20, 1985,
§285a–1. Cancer control programs
The Director of the Institute shall establish and support demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this section shall include—
(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting—
(A) the detection, diagnosis, prevention, and treatment of cancer,
(B) the continuing care of cancer patients and the families of cancer patients, and
(C) rehabilitation and counseling respecting cancer,
to physicians and other health professionals who provide care to individuals who have cancer;
(2) the demonstration of and the education of students of the health professions and health professionals in—
(A) effective methods for the prevention and early detection of cancer and the identification of individuals with a high risk of developing cancer, and
(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and
(3) the demonstration of new methods for the dissemination of information to the general public concerning the prevention, early detection, diagnosis, and treatment and control of cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer.
(July 1, 1944, ch. 373, title IV, §412, as added Nov. 20, 1985,
Section Referred to in Other Sections
This section is referred to in
§285a–2. Special authorities of Director
(a)(1) The Director of the Institute shall establish an information and education program to collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to cancer patients and their families, physicians and other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer). The Director of the Institute may take such action as may be necessary to insure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and the public and between the Institute and other scientific, medical, and biomedical disciplines and organizations nationally and internationally.
(2) In carrying out paragraph (1), the Director of the Institute shall—
(A) provide public and patient information and education programs, providing information that will help individuals take personal steps to reduce their risk of cancer, to make them aware of early detection techniques and to motivate appropriate utilization of those techniques, to help individuals deal with cancer if it strikes, and to provide information to improve long-term survival;
(B) continue and expand programs to provide physicians and the public with state-of-the-art information on the treatment of particular forms of cancers, and to identify those clinical trials that might benefit patients while advancing knowledge of cancer treatment;
(C) assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessments in the biennial reports required under
(D) maintain and operate the International Cancer Research Data Bank, which shall collect, catalog, store, and disseminate insofar as feasible the results of cancer research and treatment undertaken in any country for the use of any person involved in cancer research and treatment in any country; and
(E) to the extent practicable, in disseminating the results of such cancer research and treatment, utilize information systems available to the public.
(b) The Director of the Institute in carrying out the National Cancer Program—
(1) shall establish or support the large-scale production or distribution of specialized biological materials and other therapeutic substances for cancer research and set standards of safety and care for persons using such materials;
(2) shall, in consultation with the advisory council for the Institute, support (A) research in the cancer field outside the United States by highly qualified foreign nationals which can be expected to benefit the American people, (B) collaborative research involving American and foreign participants, and (C) the training of American scientists abroad and foreign scientists in the United States;
(3) shall, in consultation with the advisory council for the Institute, support appropriate programs of education and training (including continuing education and laboratory and clinical research training);
(4) shall encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research;
(5) may obtain (after consultation with the advisory council for the Institute and in accordance with
(6)(A) may, in consultation with the advisory council for the Institute, acquire, construct, improve, repair, operate, and maintain laboratories, other research facilities, equipment, and such other real or personal property as the Director determines necessary;
(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and
(C) may, in consultation with the advisory council for the Institute, acquire, without regard to
(7) may, in consultation with the advisory council for the Institute, appoint one or more advisory committees composed of such private citizens and officials of Federal, State, and local governments to advise the Director with respect to the Director's functions;
(8) may, subject to
(9) shall, notwithstanding
Except as otherwise provided, experts and consultants whose services are obtained under paragraph (5) shall be paid or reimbursed, in accordance with title 5 for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (5) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence.
(July 1, 1944, ch. 373, title IV, §413, as added Nov. 20, 1985,
References in Text
The provisions of title 5 relating to reimbursement for travel expenses, referred to in subsec. (b), are classified generally to
Amendments
1993—Subsec. (b)(9).
1989—Subsec. (a)(1).
1988—Subsec. (a).
Subsec. (b)(5).
Subsec. (b)(8) to (10).
Section Referred to in Other Sections
This section is referred to in
§285a–3. National cancer research and demonstration centers
(a) Cooperative agreements and grants for establishing and supporting
(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of advanced diagnostic, prevention, control, and treatment methods for cancer.
(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute's advisory council.
(b) Uses for Federal payments under cooperative agreements or grants
Federal payments made under a cooperative agreement or grant under subsection (a) of this section may be used for—
(1) construction (notwithstanding any limitation under
(2) staffing and other basic operating costs, including such patient care costs as are required for research;
(3) clinical training, including training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer; and
(4) demonstration purposes.
As used in this paragraph, the term "construction" does not include the acquisition of land, and the term "training" does not include research training for which National Research Service Awards may be provided under
(c) Period of support; additional periods
Support of a center under subsection (a) of this section may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, §414, as added Nov. 20, 1985,
Amendments
1988—Subsec. (a)(1).
Section Referred to in Other Sections
This section is referred to in
§285a–4. President's Cancer Panel; establishment, membership, etc., functions
(a)(1) The President's Cancer Panel (hereafter in this section referred to as the "Panel") shall be composed of three persons appointed by the President who by virtue of their training, experience, and background are exceptionally qualified to appraise the National Cancer Program. At least two members of the Panel shall be distinguished scientists or physicians.
(2)(A) Members of the Panel shall be appointed for three-year terms, except that (i) any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of such term, and (ii) a member may serve until the member's successor has taken office. If a vacancy occurs in the Panel, the President shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred.
(B) The President shall designate one of the members to serve as the chairman of the Panel for a term of one year.
(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule for each day (including traveltime) during which they are engaged in the actual performance of duties as members of the Panel and shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment.
(3) The Panel shall meet at the call of the chairman, but not less often than four times a year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the chairman shall make such transcript available to the public.
(b) The Panel shall monitor the development and execution of the activities of the National Cancer Program, and shall report directly to the President. Any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the President. The Panel shall submit to the President periodic progress reports on the National Cancer Program and shall submit to the President, the Secretary, and the Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, and shall submit such other reports as the President shall direct.
(July 1, 1944, ch. 373, title IV, §415, as added Nov. 20, 1985,
References in Text
The provisions of title 5 relating to reimbursement for travel expenses, referred to in subsec. (a)(2)(C), are classified generally to
Termination of Advisory Panels
Advisory panels established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a panel established by the President or an officer of the Federal Government, such panel is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a panel established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
§285a–5. Associate Director for Prevention; appointment; function
(a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of cancer. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine.
(b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §416, as added Nov. 20, 1985,
§285a–6. Breast and gynecological cancers
(a) Expansion and coordination of activities
The Director of the Institute, in consultation with the National Cancer Advisory Board, shall expand, intensify, and coordinate the activities of the Institute with respect to research on breast cancer, ovarian cancer, and other cancers of the reproductive system of women.
(b) Coordination with other institutes
The Director of the Institute shall coordinate the activities of the Director under subsection (a) of this section with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes 1 and agencies have responsibilities that are related to breast cancer and other cancers of the reproductive system of women.
(c) Programs for breast cancer
(1) In general
In carrying out subsection (a) of this section, the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—
(A) basic research concerning the etiology and causes of breast cancer;
(B) clinical research and related activities concerning the causes, prevention, detection and treatment of breast cancer;
(C) control programs with respect to breast cancer in accordance with
(D) information and education programs with respect to breast cancer in accordance with
(E) research and demonstration centers with respect to breast cancer in accordance with
Not less than six centers shall be operated under subparagraph (E). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.
(2) Implementation of plan for programs
(A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are implemented in accordance with a plan for the programs. Such plan shall include comments and recommendations that the Director of the Institute considers appropriate, with due consideration provided to the professional judgment needs of the Institute as expressed in the annual budget estimate prepared in accordance with section 285a–2(9) 2 of this title. The Director of the Institute, in consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.
(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary and the Director of NIH.
(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.
(D) The Secretary shall provide a copy of the plan submitted under subparagraph (A), and any revisions submitted under subparagraph (C), to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.
(d) Other cancers
In carrying out subsection (a) of this section, the Director of the Institute shall conduct or support research on ovarian cancer and other cancers of the reproductive system of women. Activities under such subsection shall provide for the conduct and support of—
(1) basic research concerning the etiology and causes of ovarian cancer and other cancers of the reproductive system of women;
(2) clinical research and related activities into the causes, prevention, detection and treatment of ovarian cancer and other cancers of the reproductive system of women;
(3) control programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with
(4) information and education programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with
(5) research and demonstration centers with respect to ovarian cancer and cancers of the reproductive system in accordance with
(e) Report
The Director of the Institute shall prepare, for inclusion in the biennial report submitted under
(1) a description of the research plan with respect to breast cancer prepared under subsection (c) of this section;
(2) an assessment of the development, revision, and implementation of such plan;
(3) a description and evaluation of the progress made, during the period for which such report is prepared, in the research programs on breast cancer and cancers of the reproductive system of women;
(4) a summary and analysis of expenditures made, during the period for which such report is made, for activities with respect to breast cancer and cancers of the reproductive system of women conducted and supported by the National Institutes of Health; and
(5) such comments and recommendations as the Director considers appropriate.
(July 1, 1944, ch. 373, title IV, §417, as added June 10, 1993,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should not be capitalized.
2 So in original. Probably should be section "285a–2(b)(9)".
§285a–7. Prostate cancer
(a) Expansion and coordination of activities
The Director of the Institute, in consultation with the National Cancer Advisory Board, shall expand, intensify, and coordinate the activities of the Institute with respect to research on prostate cancer.
(b) Coordination with other institutes
The Director of the Institute shall coordinate the activities of the Director under subsection (a) of this section with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes 1 and agencies have responsibilities that are related to prostate cancer.
(c) Programs
(1) In general
In carrying out subsection (a) of this section, the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, prostate cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—
(A) basic research concerning the etiology and causes of prostate cancer;
(B) clinical research and related activities concerning the causes, prevention, detection and treatment of prostate cancer;
(C) prevention and control and early detection programs with respect to prostate cancer in accordance with
(D) an Inter-Institute Task Force, under the direction of the Director of the Institute, to provide coordination between relevant National Institutes of Health components of research efforts on prostate cancer;
(E) control programs with respect to prostate cancer in accordance with
(F) information and education programs with respect to prostate cancer in accordance with
(G) research and demonstration centers with respect to prostate cancer in accordance with
Not less than six centers shall be operated under subparagraph (G). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.
(2) Implementation of plan for programs
(A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are implemented in accordance with a plan for the programs. Such plan shall include comments and recommendations that the Director of the Institute considers appropriate, with due consideration provided to the professional judgment needs of the Institute as expressed in the annual budget estimate prepared in accordance with section 285a–2(9) 2 of this title. The Director of the Institute, in consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.
(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.
(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.
(D) The Secretary shall provide a copy of the plan submitted under subparagraph (A), and any revisions submitted under subparagraph (C), to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.
(July 1, 1944, ch. 373, title IV, §417A, as added June 10, 1993,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should not be capitalized
2 So in original. Probably should be section "285a–2(b)(9)".
§285a–8. Authorization of appropriations
(a) Activities generally
For the purpose of carrying out this subpart, there are authorized to be appropriated $2,728,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(b) Breast cancer and gynecological cancers
(1) Breast cancer
(A) For the purpose of carrying out subparagraph (A) of
(B) For the purpose of carrying out subparagraphs (B) through (E) of
(2) Other cancers
For the purpose of carrying out subsection (d) of
(c) Prostate cancer
For the purpose of carrying out
(d) Allocation regarding cancer control
(1) In general
Of the amounts appropriated for the National Cancer Institute for a fiscal year, the Director of the Institute shall make available not less than the applicable percentage specified in paragraph (2) for carrying out the cancer control activities authorized in
(2) Applicable percentage
The percentage referred to in paragraph (1) is—
(A) 7 percent, in the case of fiscal year 1994;
(B) 9 percent, in the case of fiscal year 1995; and
(C) 10 percent, in the case of fiscal year 1996 and each subsequent fiscal year.
(July 1, 1944, ch. 373, title IV, §417B, as added June 10, 1993,
subpart 2—national heart, lung, and blood institute
§285b. Purpose of Institute
The general purpose of the National Heart, Lung, and Blood Institute (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to heart, blood vessel, lung, and blood diseases and with respect to the use of blood and blood products and the management of blood resources.
(July 1, 1944, ch. 373, title IV, §418, as added Nov. 20, 1985,
§285b–1. Heart, blood vessel, lung, and blood disease prevention and control programs
(a) The Director of the Institute shall conduct and support programs for the prevention and control of heart, blood vessel, lung, and blood diseases. Such programs shall include community-based and population-based programs carried out in cooperation with other Federal agencies, with public health agencies of State or local governments, with nonprofit private entities that are community-based health agencies, or with other appropriate public or nonprofit private entities.
(b) In carrying out programs under subsection (a) of this section, the Director of the Institute shall give special consideration to the prevention and control of heart, blood vessel, lung, and blood diseases in children, and in populations that are at increased risk with respect to such diseases.
(July 1, 1944, ch. 373, title IV, §419, as added Nov. 20, 1985,
Amendments
1993—
§285b–2. Information and education
The Director of the Institute shall collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to patients, families of patients, physicians and other health professionals, and the general public, information on research, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, the maintenance of health to reduce the incidence of such diseases, and on the use of blood and blood products and the management of blood resources. In carrying out this section, the Director of the Institute shall place special emphasis upon the utilization of collaborative efforts with both the public and private sectors to—
(1) increase the awareness and knowledge of health care professionals and the public regarding the prevention of heart and blood vessel, lung, and blood diseases and the utilization of blood resources; and
(2) develop and disseminate to health professionals, patients and patient families, and the public information designed to encourage adults and children to adopt healthful practices concerning the prevention of such diseases.
(July 1, 1944, ch. 373, title IV, §420, as added Nov. 20, 1985,
Amendments
1988—
"(1) the dissemination of information regarding diet and nutrition, environmental pollutants, exercise, stress, hypertension, cigarette smoking, weight control, and other factors affecting the prevention of arteriosclerosis and other cardiovascular diseases and of pulmonary and blood diseases; and
"(2) the dissemination of information designed to encourage children to adopt healthful habits respecting the risk factors related to the prevention of such diseases."
§285b–3. National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program; administrative provisions
(a)(1) The National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program (hereafter in this subpart referred to as the "Program") may provide for—
(A) investigation into the epidemiology, etiology, and prevention of all forms and aspects of heart, blood vessel, lung, and blood diseases, including investigations into the social, environmental, behavioral, nutritional, biological, and genetic determinants and influences involved in the epidemiology, etiology, and prevention of such diseases;
(B) studies and research into the basic biological processes and mechanisms involved in the underlying normal and abnormal heart, blood vessel, lung, and blood phenomena;
(C) research into the development, trial, and evaluation of techniques, drugs, and devices (including computers) used in, and approaches to, the diagnosis, treatment (including the provision of emergency medical services), and prevention of heart, blood vessel, lung, and blood diseases and the rehabilitation of patients suffering from such diseases;
(D) establishment of programs that will focus and apply scientific and technological efforts involving the biological, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood diseases with emphasis on the refinement, development, and evaluation of technological devices that will assist, replace, or monitor vital organs and improve instrumentation for detection, diagnosis, and treatment of and rehabilitation from such diseases;
(E) establishment of programs for the conduct and direction of field studies, large-scale testing and evaluation, and demonstration of preventive, diagnostic, therapeutic, and rehabilitative approaches to, and emergency medical services for, such diseases;
(F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects of the management of blood resources in the United States, including the collection, preservation, fractionation, and distribution of blood and blood products;
(G) the education (including continuing education) and training of scientists, clinical investigators, and educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs respecting heart, blood vessel, lung, and blood diseases and blood resources;
(H) public and professional education relating to all aspects of such diseases, including the prevention of such diseases, and the use of blood and blood products and the management of blood resources;
(I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of children (including cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and Cooley's anemia, and hemophilic diseases) and for the development and demonstration of diagnostic, treatment, and preventive approaches to such diseases; and
(J) establishment of programs for study, research, development, demonstrations and evaluation of emergency medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases.
(2) The Program shall be coordinated with other national research institutes to the extent that they have responsibilities respecting such diseases and shall give special emphasis to the continued development in the Institute of programs related to the causes of stroke and to effective coordination of such programs with related stroke programs in the National Institute of Neurological and Communicative Disorders and Stroke. The Director of the Institute, with the advice of the advisory council for the Institute, shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan.
(b) In carrying out the Program, the Director of the Institute, under policies established by the Director of NIH—
(1) may, after consultation with the advisory council for the Institute, obtain (in accordance with
(2)(A) may, in consultation with the advisory council for the Institute, acquire and construct, improve, repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood resource laboratories, research, training, and other facilities, equipment, and such other real or personal property as the Director determines necessary;
(B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and
(C) may, in consultation with the advisory council for the Institute, acquire, without regard to
(3) subject to
(4) may make grants to public and nonprofit private entities to assist in meeting the cost of the care of patients in hospitals, clinics, and related facilities who are participating in research projects; and
(5) shall, in consultation with the advisory council for the Institute, conduct appropriate intramural training and education programs, including continuing education and laboratory and clinical research training programs.
Except as otherwise provided, experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence.
(July 1, 1944, ch. 373, title IV, §421, as added Nov. 20, 1985,
References in Text
The provisions of title 5 relating to reimbursement for travel expenses, referred to in subsec. (b), are classified generally to
Amendments
1993—Subsec. (b)(1).
Subsec. (b)(5).
1988—Subsec. (a)(1)(D).
Subsec. (b)(1).
§285b–4. National research and demonstration centers
(a) Heart, blood vessel, lung, blood diseases, and blood resources; utilization of centers for prevention programs
(1) The Director of the Institute may provide, in accordance with subsection (c) of this section, for the development of—
(A) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services) for heart and blood vessel diseases;
(B) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services) for lung diseases (including bronchitis, emphysema, asthma, cystic fibrosis, and other lung diseases of children);
(C) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for blood diseases and research into blood, in the use of blood products and in the management of blood resources; and
(D) three centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment (including genetic studies, intrauterine environment studies, postnatal studies, heart arrhythmias, and acquired heart disease and preventive cardiology) for cardiovascular diseases in children.
(2) The centers developed under paragraph (1) shall, in addition to being utilized for research, training, and demonstrations, be utilized for the following prevention programs for cardiovascular, pulmonary, and blood diseases:
(A) Programs to develop improved methods of detecting individuals with a high risk of developing cardiovascular, pulmonary, and blood diseases.
(B) Programs to develop improved methods of intervention against those factors which cause individuals to have a high risk of developing such diseases.
(C) Programs to develop health professions and allied health professions personnel highly skilled in the prevention of such diseases.
(D) Programs to develop improved methods of providing emergency medical services for persons with such diseases.
(E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and treatment of such diseases and the maintenance of health to reduce the incidence of such diseases and information programs for the public respecting the prevention and early diagnosis and treatment of such diseases and the maintenance of health.
(3) The research, training, and demonstration activities carried out through any such center may relate to any one or more of the diseases referred to in paragraph (1) of this subsection.
(b) Sickle cell anemia
The Director of the Institute shall provide, in accordance with subsection (c) of this section, for the development of ten centers for basic and clinical research into the diagnosis, treatment, and control of sickle cell anemia.
(c) Cooperative agreements and grants for establishing and supporting; uses for Federal payments; period of support, additional periods
(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of the management of blood resources and advanced diagnostic, prevention, and treatment methods for heart, blood vessel, lung, or blood diseases.
(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute's advisory council.
(3) Federal payments made under a cooperative agreement or grant under paragraph (1) may be used for—
(A) construction (notwithstanding any limitation under
(B) staffing and other basic operating costs, including such patient care costs as are required for research;
(C) training, including training for allied health professionals; and
(D) demonstration purposes.
As used in this subsection, the term "construction" does not include the acquisition of land, and the term "training" does not include research training for which National Research Service Awards may be provided under
(4) Support of a center under paragraph (1) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, §422, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a)(1)(D).
1988—Subsec. (a)(1)(A), (B).
§285b–5. Repealed. Pub. L. 100–607, title I, §129, Nov. 4, 1988, 102 Stat. 3055
Section, act July 1, 1944, ch. 373, title IV, §423, as added Nov. 20, 1985,
§285b–6. Associate Director for Prevention; appointment; function
(a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of heart, blood vessel, lung, and blood diseases. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine.
(b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §423, formerly §424, as added Nov. 20, 1985,
Prior Provisions
A prior section 423 of act July 1, 1944, was classified to
§285b–7. National Center on Sleep Disorders Research
(a) Establishment
Not later than 1 year after June 10, 1993, the Director of the Institute shall establish the National Center on Sleep Disorders Research (in this section referred to as the "Center"). The Center shall be headed by a director, who shall be appointed by the Director of the Institute.
(b) Purpose
The general purpose of the Center is—
(1) the conduct and support of research, training, health information dissemination, and other activities with respect to sleep disorders, including biological and circadian rhythm research, basic understanding of sleep, chronobiological and other sleep related research; and
(2) to coordinate the activities of the Center with similar activities of other Federal agencies, including the other agencies of the National Institutes of Health, and similar activities of other public entities and nonprofit entities.
(c) Sleep Disorders Research Advisory Board
(1) The Director of the National Institutes of Health shall establish a board to be known as the Sleep Disorders Research Advisory Board (in this section referred to as the "Advisory Board").
(2) The Advisory Board shall advise, assist, consult with, and make recommendations to the Director of the National Institutes of Health, through the Director of the Institute, and the Director of the Center concerning matters relating to the scientific activities carried out by and through the Center and the policies respecting such activities, including recommendations with respect to the plan required in subsection (c) 1 of this section.
(3)(A) The Director of the National Institutes of Health shall appoint to the Advisory Board 12 appropriately qualified representatives of the public who are not officers or employees of the Federal Government. Of such members, eight shall be representatives of health and scientific disciplines with respect to sleep disorders and four shall be individuals representing the interests of individuals with or undergoing treatment for sleep disorders.
(B) The following officials shall serve as ex officio members of the Advisory Board:
(i) The Director of the National Institutes of Health.
(ii) The Director of the Center.
(iii) The Director of the National Heart, Lung and Blood Institute.
(iv) The Director of the National Institute of Mental Health.
(v) The Director of the National Institute on Aging.
(vi) The Director of the National Institute of Child Health and Human Development.
(vii) The Director of the National Institute of Neurological Disorders and Stroke.
(viii) The Assistant Secretary for Health.
(ix) The Assistant Secretary of Defense (Health Affairs).
(x) The Chief Medical Director of the Veterans' Administration.
(4) The members of the Advisory Board shall, from among the members of the Advisory Board, designate an individual to serve as the chair of the Advisory Board.
(5) Except as inconsistent with, or inapplicable to, this section, the provisions of
(d) Development of comprehensive research plan; revision
(1) After consultation with the Director of the Center and the advisory board 2 established under subsection (c) of this section, the Director of the National Institutes of Health shall develop a comprehensive plan for the conduct and support of sleep disorders research.
(2) The plan developed under paragraph (1) shall identify priorities with respect to such research and shall provide for the coordination of such research conducted or supported by the agencies of the National Institutes of Health.
(3) The Director of the National Institutes of Health (after consultation with the Director of the Center and the advisory board 2 established under subsection (c) of this section) shall revise the plan developed under paragraph (1) as appropriate.
(e) Collection and dissemination of information
The Director of the Center, in cooperation with the Centers for Disease Control and Prevention, is authorized to coordinate activities with the Department of Transportation, the Department of Defense, the Department of Education, the Department of Labor, and the Department of Commerce to collect data, conduct studies, and disseminate public information concerning the impact of sleep disorders and sleep deprivation.
(July 1, 1944, ch. 373, title IV, §424, as added June 10, 1993,
Change of Name
Reference to Chief Medical Director of Department of Veterans Affairs deemed to refer to Under Secretary for Health of Department of Veterans Affairs pursuant to section 302(e) of
Reference to Chief Medical Director of Veterans' Administration deemed to refer to Chief Medical Director of Department of Veterans Affairs pursuant to section 10 of
Termination of Advisory Boards
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
1 So in original. Probably should be subsection "(d)".
2 So in original. Probably should be capitalized.
§285b–8. Authorization of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $1,500,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(July 1, 1944, ch. 373, title IV, §425, as added June 10, 1993,
subpart 3—national institute of diabetes and digestive and kidney diseases
§285c. Purpose of Institute
The general purpose of the National Institute of Diabetes and Digestive and Kidney Diseases (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional disorders, and kidney, urologic, and hematologic diseases.
(July 1, 1944, ch. 373, title IV, §426, as added Nov. 20, 1985,
Review of Disease Research Programs of the National Institute of Diabetes and Digestive and Kidney Diseases
Section 10 of
§285c–1. Data systems and information clearinghouses
(a) National Diabetes Data System and National Diabetes Clearinghouse
The Director of the Institute shall (1) establish the National Diabetes Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with diabetes, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing diabetes, and (2) establish the National Diabetes Information Clearinghouse to facilitate and enhance knowledge and understanding of diabetes on the part of health professionals, patients, and the public through the effective dissemination of information.
(b) National Digestive Diseases Data System and National Digestive Diseases Information Clearinghouse
The Director of the Institute shall (1) establish the National Digestive Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with digestive diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing digestive diseases, and (2) establish the National Digestive Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of digestive diseases on the part of health professionals, patients, and the public through the effective dissemination of information.
(c) National Kidney and Urologic Diseases Data System and National Kidney and Urologic Diseases Information Clearinghouse
The Director of the Institute shall (1) establish the National Kidney and Urologic Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with kidney and urologic diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing kidney and urologic diseases, and (2) establish the National Kidney and Urologic Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of kidney and urologic diseases on the part of health professionals, patients, and the public through the effective dissemination of information.
(July 1, 1944, ch. 373, title IV, §427, as added Nov. 20, 1985,
§285c–2. Division Directors for Diabetes, Endocrinology, and Metabolic Diseases, Digestive Diseases and Nutrition, and Kidney, Urologic, and Hematologic Diseases; functions
(a)(1) In the Institute there shall be a Division Director for Diabetes, Endocrinology, and Metabolic Diseases, a Division Director for Digestive Diseases and Nutrition, and a Division Director for Kidney, Urologic, and Hematologic Diseases. Such Division Directors, under the supervision of the Director of the Institute, shall be responsible for—
(A) developing a coordinated plan (including recommendations for expenditures) for each of the national research institutes within the National Institutes of Health with respect to research and training concerning diabetes, endocrine and metabolic diseases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases;
(B) assessing the adequacy of management approaches for the activities within such institutes concerning such diseases and nutrition and developing improved approaches if needed;
(C) monitoring and reviewing expenditures by such institutes concerning such diseases and nutrition; and
(D) identifying research opportunities concerning such diseases and nutrition and recommending ways to utilize such opportunities.
(2) The Director of the Institute shall transmit to the Director of NIH the plans, recommendations, and reviews of the Division Directors under subparagraphs (A) through (D) of paragraph (1) together with such comments and recommendations as the Director of the Institute determines appropriate.
(b) The Director of the Institute, acting through the Division Director for Diabetes, Endocrinology, and Metabolic Diseases, the Division Director for Digestive Diseases and Nutrition, and the Division Director for Kidney, Urologic, and Hematologic Diseases, shall—
(1) carry out programs of support for research and training (other than training for which National Research Service Awards may be made under
(2) establish programs of evaluation, planning, and dissemination of knowledge related to such research and training.
(July 1, 1944, ch. 373, title IV, §428, as added Nov. 20, 1985,
Amendments
1993—Subsec. (b).
§285c–3. Interagency coordinating committees
(a) Establishment and purpose
For the purpose of—
(1) better coordination of the research activities of all the national research institutes relating to diabetes mellitus, digestive diseases, and kidney, urologic, and hematologic diseases; and
(2) coordinating those aspects of all Federal health programs and activities relating to such diseases to assure the adequacy and technical soundness of such programs and activities and to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities;
the Secretary shall establish a Diabetes Mellitus Interagency Coordinating Committee, a Digestive Diseases Interagency Coordinating Committee, and a Kidney, Urologic, and Hematologic Diseases Coordinating Committee (hereafter in this section individually referred to as a "Committee").
(b) Membership; chairman; meetings
Each Committee shall be composed of the Directors of each of the national research institutes and divisions involved in research with respect to the diseases for which the Committee is established, the Division Director of the Institute for the diseases for which the Committee is established, the Under Secretary for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers) and shall include representation from all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, as determined by the Secretary. Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four times a year.
(c) Annual report
Each Committee shall prepare an annual report for—
(1) the Secretary;
(2) the Director of NIH; and
(3) the Advisory Board established under
detailing the work of the Committee in carrying out paragraphs (1) and (2) of subsection (a) of this section in the fiscal year for which the report was prepared. Such report shall be submitted not later than 120 days after the end of each fiscal year.
(July 1, 1944, ch. 373, title IV, §429, as added Nov. 20, 1985,
Amendments
1992—Subsec. (b).
1988—Subsec. (b).
Effective Date of 1988 Amendment
Amendment by
§285c–4. Advisory boards
(a) Establishment
The Secretary shall establish in the Institute the National Diabetes Advisory Board, the National Digestive Diseases Advisory Board, and the National Kidney and Urologic Diseases Advisory Board (hereafter in this section individually referred to as an "Advisory Board").
(b) Membership; ex officio members
Each Advisory Board shall be composed of eighteen appointed members and nonvoting ex officio members as follows:
(1) The Secretary shall appoint—
(A) twelve members from individuals who are scientists, physicians, and other health professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines relevant to the diseases with respect to which the Advisory Board is established; and
(B) six members from the general public who are knowledgeable with respect to such diseases, including at least one member who is a person who has such a disease and one member who is a parent of a person who has such a disease.
Of the appointed members at least five shall by virtue of training or experience be knowledgeable in the fields of health education, nursing, data systems, public information, and community program development.
(2)(A) The following shall be ex officio members of each Advisory Board:
(i) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, the Director of the Centers for Disease Control and Prevention, the Under Secretary for Health of the Department of Veterans Affairs, the Assistant Secretary of Defense for Health Affairs, and the Division Director of the National Institute of Diabetes and Digestive and Kidney Diseases for the diseases for which the Board is established (or the designees of such officers).
(ii) Such other officers and employees of the United States as the Secretary determines necessary for the Advisory Board to carry out its functions.
(B) In the case of the National Diabetes Advisory Board, the following shall also be ex officio members: The Director of the National Heart, Lung, and Blood Institute, the Director of the National Eye Institute, the Director of the National Institute of Child Health and Human Development, and the Administrator of the Health Resources and Services Administration (or the designees of such officers).
(c) Compensation
Members of an Advisory Board who are officers or employees of the Federal Government shall serve as members of the Advisory Board without compensation in addition to that received in their regular public employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Board.
(d) Term of office; vacancy
The term of office of an appointed member of an Advisory Board is four years, except that no term of office may extend beyond the expiration of the Advisory Board. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member's term until a successor has taken office. If a vacancy occurs in an Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90 days from the date the vacancy occurred.
(e) Chairman
The members of each Advisory Board shall select a chairman from among the appointed members.
(f) Executive director; professional and clerical staff; administrative support services and facilities
The Secretary shall, after consultation with and consideration of the recommendations of an Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, such services of consultants, such information, and (through contracts or other arrangements) such administrative support services and facilities, as the Secretary determines are necessary for the Advisory Board to carry out its functions.
(g) Meetings
Each Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year.
(h) Functions of National Diabetes Advisory Board and National Digestive Diseases Advisory Board
The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board shall—
(1) review and evaluate the implementation of the plan (referred to in
(2) for the purpose of assuring the most effective use and organization of resources respecting such diseases, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies related to Federal agencies involved in the implementation of such plan, the coordinating committee for such diseases, and with key non-Federal entities involved in activities affecting the control of such diseases.
(i) Subcommittees; establishment and membership
In carrying out its functions, each Advisory Board may establish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities.
(j) Annual report
Each Advisory Board shall prepare an annual report for the Secretary which—
(1) describes the Advisory Board's activities in the fiscal year for which the report is made;
(2) describes and evaluates the progress made in such fiscal year in research, treatment, education, and training with respect to the diseases with respect to which the Advisory Board was established;
(3) summarizes and analyzes expenditures made by the Federal Government for activities respecting such diseases in such fiscal year; and
(4) contains the Advisory Board's recommendations (if any) for changes in the plan referred to in
(k) Termination of predecessor boards; time within which to appoint members
The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board in existence on November 20, 1985, shall terminate upon the appointment of a successor Board under subsection (a) of this section. The Secretary shall make appointments to the Advisory Boards established under subsection (a) of this section before the expiration of 90 days after November 20, 1985. The members of the Boards in existence on November 20, 1985, may be appointed, in accordance with subsections (b) and (d) of this section, to the Boards established under subsection (a) of this section for diabetes and digestive diseases, except that at least one-half of the members of the National Diabetes Advisory Board in existence on November 20, 1985, shall be appointed to the National Diabetes Advisory Board first established under subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, §430, as added Nov. 20, 1985,
Amendments
1993—Subsec. (b)(2)(A)(i).
1992—Subsec. (b)(2)(A)(i).
1988—Subsecs. (k), (l).
Termination of Advisory Boards
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Section Referred to in Other Sections
This section is referred to in
§285c–5. Research and training centers; development or expansion
(a) Diabetes mellitus and related endocrine and metabolic diseases
(1) Consistent with applicable recommendations of the National Commission on Diabetes, the Director of the Institute shall provide for the development or substantial expansion of centers for research and training in diabetes mellitus and related endocrine and metabolic diseases. Each center developed or expanded under this subsection shall—
(A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research and training qualifications as may be prescribed by the Secretary; and
(B) conduct—
(i) research in the diagnosis and treatment of diabetes mellitus and related endocrine and metabolic diseases and the complications resulting from such diseases;
(ii) training programs for physicians and allied health personnel in current methods of diagnosis and treatment of such diseases and complications, and in research in diabetes; and
(iii) information programs for physicians and allied health personnel who provide primary care for patients with such diseases or complications.
(2) A center may use funds provided under paragraph (1) to provide stipends for nurses and allied health professionals enrolled in research training programs described in paragraph (1)(B)(ii).
(b) Digestive diseases and related functional, congenital, metabolic disorders, and normal development of digestive tract
Consistent with applicable recommendations of the National Digestive Diseases Advisory Board, the Director shall provide for the development or substantial expansion of centers for research in digestive diseases and related functional, congenital, metabolic disorders, and normal development of the digestive tract. Each center developed or expanded under this subsection—
(1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research qualifications as may be prescribed by the Secretary;
(2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of digestive diseases and nutritional disorders and related functional, congenital, or metabolic complications resulting from such diseases or disorders;
(3) shall encourage research into and programs for—
(A) providing information for patients with such diseases and the families of such patients, physicians and others who care for such patients, and the general public;
(B) model programs for cost effective and preventive patient care; and
(C) training physicians and scientists in research on such diseases, disorders, and complications; and
(4) may perform research and participate in epidemiological studies and data collection relevant to digestive diseases and disorders and disseminate such research, studies, and data to the health care profession and to the public.
(c) Kidney and urologic diseases
The Director shall provide for the development or substantial expansion of centers for research in kidney and urologic diseases. Each center developed or expanded under this subsection—
(1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research qualifications as may be prescribed by the Secretary;
(2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of kidney and urologic diseases;
(3) shall encourage research into and programs for—
(A) providing information for patients with such diseases, disorders, and complications and the families of such patients, physicians and others who care for such patients, and the general public;
(B) model programs for cost effective and preventive patient care; and
(C) training physicians and scientists in research on such diseases; and
(4) may perform research and participate in epidemiological studies and data collection relevant to kidney and urologic diseases in order to disseminate such research, studies, and data to the health care profession and to the public.
(d) Nutritional disorders
(1) The Director of the Institute shall, subject to the extent of amounts made available in appropriations Acts, provide for the development or substantial expansion of centers for research and training regarding nutritional disorders, including obesity.
(2) The Director of the Institute shall carry out paragraph (1) in collaboration with the Director of the National Cancer Institute and with the Directors of such other agencies of the National Institutes of Health as the Director of NIH determines to be appropriate.
(3) Each center developed or expanded under paragraph (1) shall—
(A) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research and training qualifications as may be prescribed by the Director;
(B) conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control and treatment of nutritional disorders, including obesity and the impact of nutrition and diet on child development;
(C) conduct training programs for physicians and allied health professionals in current methods of diagnosis and treatment of such diseases and complications, and in research in such disorders; and
(D) conduct information programs for physicians and allied health professionals who provide primary care for patients with such disorders or complications.
(e) Geographic distribution; period of support, additional periods
Insofar as practicable, centers developed or expanded under this section should be geographically dispersed throughout the United States and in environments with proven research capabilities. Support of a center under this section may be for a period of not to exceed five years and such period may be extended by the Director of the Institute for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, §431, as added Nov. 20, 1985,
Amendments
1993—Subsecs. (d), (e).
Section Referred to in Other Sections
This section is referred to in
§285c–6. Advisory council subcommittees
There are established within the advisory council for the Institute appointed under
(July 1, 1944, ch. 373, title IV, §432, as added Nov. 20, 1985,
§285c–7. Biennial report
The Director of the Institute shall prepare for inclusion in the biennial report made under
(1) under the current diabetes plan under the National Diabetes Mellitus Research and Education Act; and
(2) under the current digestive diseases plan formulated under the Arthritis, Diabetes, and Digestive Diseases Amendments of 1976.
The description submitted by the Director shall include an evaluation of the activities of the centers supported under
(July 1, 1944, ch. 373, title IV, §433, as added Nov. 20, 1985,
References in Text
The National Diabetes Mellitus Research and Education Act, referred to in par. (1), is
The Arthritis, Diabetes, and Digestive Diseases Amendments of 1976, referred to in par. (2), is
Section Referred to in Other Sections
This section is referred to in
§285c–8. Nutritional disorders program
(a) Establishment
The Director of the Institute, in consultation with the Director of NIH, shall establish a program of conducting and supporting research, training, health information dissemination, and other activities with respect to nutritional disorders, including obesity.
(b) Support of activities
In carrying out the program established under subsection (a) of this section, the Director of the Institute shall conduct and support each of the activities described in such subsection.
(c) Dissemination of information
In carrying out the program established under subsection (a) of this section, the Director of the Institute shall carry out activities to facilitate and enhance knowledge and understanding of nutritional disorders, including obesity, on the part of health professionals, patients, and the public through the effective dissemination of information.
(July 1, 1944, ch. 373, title IV, §434, as added June 10, 1993,
subpart 4—national institute of arthritis and musculoskeletal and skin diseases
§285d. Purpose of Institute
The general purpose of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (hereafter in this subpart referred to as the "Institute") is the conduct and support of research and training, the dissemination of health information, and other programs with respect to arthritis and musculoskeletal and skin diseases (including sports-related disorders), with particular attention to the effect of these diseases on children.
(July 1, 1944, ch. 373, title IV, §435, as added Nov. 20, 1985,
Amendments
1993—
§285d–1. National arthritis and musculoskeletal and skin diseases program
(a) Plan to expand, intensify, and coordinate activities; submission; periodic review and revision
The Director of the Institute, with the advice of the Institute's advisory council, shall prepare and transmit to the Director of NIH a plan for a national arthritis and musculoskeletal and skin diseases program to expand, intensify, and coordinate the activities of the Institute respecting arthritis and musculoskeletal and skin diseases. The plan shall include such comments and recommendations as the Director of the Institute determines appropriate. The plan shall place particular emphasis upon expanding research into better understanding the causes and the development of effective treatments for arthritis affecting children. The Director of the Institute shall periodically review and revise such plan and shall transmit any revisions of such plan to the Director of NIH.
(b) Coordination of activities with other national research institutes; minimum activities under program
Activities under the national arthritis and musculoskeletal and skin diseases program shall be coordinated with the other national research institutes to the extent that such institutes have responsibilities respecting arthritis and musculoskeletal and skin diseases, and shall, at least, provide for—
(1) investigation into the epidemiology, etiology, and prevention of all forms of arthritis and musculoskeletal and skin diseases, including sports-related disorders, primarily through the support of basic research in such areas as immunology, genetics, biochemistry, microbiology, physiology, bioengineering, and any other scientific discipline which can contribute important knowledge to the treatment and understanding of arthritis and musculoskeletal and skin diseases;
(2) research into the development, trial, and evaluation of techniques, drugs, and devices used in the diagnosis, treatment, including medical rehabilitation, and prevention of arthritis and musculoskeletal and skin diseases;
(3) research on the refinement, development, and evaluation of technological devices that will replace or be a substitute for damaged bone, muscle, and joints and other supporting structures;
(4) the establishment of mechanisms to monitor the causes of athletic injuries and identify ways of preventing such injuries on scholastic athletic fields; and
(5) research into the causes of arthritis affecting children and the development, trial, and evaluation of techniques, drugs and devices used in the diagnosis, treatment (including medical rehabilitation), and prevention of arthritis in children.
(c) Program to be carried out in accordance with plan
The Director of the Institute shall carry out the national arthritis and musculoskeletal and skin diseases program in accordance with the plan prepared under subsection (a) of this section and any revisions of such plan made under such subsection.
(July 1, 1944, ch. 373, title IV, §436, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a).
Subsec. (b)(5).
1988—
Section Referred to in Other Sections
This section is referred to in
§285d–2. Research and training
The Director of the Institute shall—
(1) carry out programs of support for research and training (other than training for which National Research Service Awards may be made under
(2) establish programs of evaluation, planning, and dissemination of knowledge related to such research and training.
(July 1, 1944, ch. 373, title IV, §437, as added Nov. 20, 1985,
§285d–3. Data system and information clearinghouse
(a) The Director of the Institute shall establish the National Arthritis and Musculoskeletal and Skin Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with arthritis and musculoskeletal and skin diseases, including where possible, data involving general populations for the purpose of detection of individuals with a risk of developing arthritis and musculoskeletal and skin diseases.
(b) The Director of the Institute shall establish the National Arthritis and Musculoskeletal and Skin Diseases Information Clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of arthritis and musculoskeletal and skin diseases by health professionals, patients, and the public.
(July 1, 1944, ch. 373, title IV, §438, as added Nov. 20, 1985,
§285d–4. Interagency coordinating committees
(a) Establishment and purpose
For the purpose of—
(1) better coordination of the research activities of all the national research institutes relating to arthritis, musculoskeletal diseases, and skin diseases, including sports-related disorders; and
(2) coordinating the aspects of all Federal health programs and activities relating to arthritis, musculoskeletal diseases, and skin diseases in order to assure the adequacy and technical soundness of such programs and activities and in order to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities,
the Secretary shall establish an Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and a Skin Diseases Interagency Coordinating Committee (hereafter in this section individually referred to as a "Committee").
(b) Membership; chairman; meetings
Each Committee shall be composed of the Directors of each of the national research institutes and divisions involved in research regarding the diseases with respect to which the Committee is established, the Under Secretary for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and representatives of all other Federal departments and agencies (as determined by the Secretary) whose programs involve health functions or responsibilities relevant to arthritis and musculoskeletal diseases or skin diseases, as the case may be. Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four times a year.
(c) Annual report
Not later than 120 days after the end of each fiscal year, each Committee shall prepare and transmit to the Secretary, the Director of NIH, the Director of the Institute, and the advisory council for the Institute a report detailing the activities of the Committee in such fiscal year in carrying out paragraphs (1) and (2) of subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, §439, as added Nov. 20, 1985,
Amendments
1993—Subsec. (b).
1992—Subsec. (b).
Section Referred to in Other Sections
This section is referred to in
§285d–5. Arthritis and musculoskeletal diseases demonstration projects
(a) Grants for establishment and support
The Director of the Institute may make grants to public and private nonprofit entities to establish and support projects for the development and demonstration of methods for screening, detection, and referral for treatment of arthritis and musculoskeletal diseases and for the dissemination of information on such methods to the health and allied health professions. Activities under such projects shall be coordinated with Federal, State, local, and regional health agencies, centers assisted under
(b) Programs included
Projects supported under this section shall include—
(1) programs which emphasize the development and demonstration of new and improved methods of screening and early detection, referral for treatment, and diagnosis of individuals with a risk of developing arthritis and musculoskeletal diseases;
(2) programs which emphasize the development and demonstration of new and improved methods for patient referral from local hospitals and physicians to appropriate centers for early diagnosis and treatment;
(3) programs which emphasize the development and demonstration of new and improved means of standardizing patient data and recordkeeping;
(4) programs which emphasize the development and demonstration of new and improved methods of dissemination of knowledge about the programs, methods, and means referred to in paragraphs (1), (2), and (3) of this subsection to health and allied health professionals;
(5) programs which emphasize the development and demonstration of new and improved methods for the dissemination to the general public of information—
(A) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treatment, and of following an appropriate regimen; and
(B) to discourage the promotion and use of unapproved and ineffective diagnostic, preventive treatment, and control methods for arthritis and unapproved and ineffective drugs and devices for arthritis and musculoskeletal diseases; and
(6) projects for investigation into the epidemiology of all forms and aspects of arthritis and musculoskeletal diseases, including investigations into the social, environmental, behavioral, nutritional, and genetic determinants and influences involved in the epidemiology of arthritis and musculoskeletal diseases.
(c) Standardization of patient data and recordkeeping
The Director shall provide for the standardization of patient data and recordkeeping for the collection, storage, analysis, retrieval, and dissemination of such data in cooperation with projects assisted under this section, centers assisted under
(July 1, 1944, ch. 373, title IV, §440, as added Nov. 20, 1985,
§285d–6. Multipurpose arthritis and musculoskeletal diseases centers
(a) Development, modernization, and operation
The Director of the Institute shall, after consultation with the advisory council for the Institute, provide for the development, modernization, and operation (including staffing and other operating costs such as the costs of patient care required for research) of new and existing centers for arthritis and musculoskeletal diseases. For purposes of this section, the term "modernization" means the alteration, remodeling, improvement, expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent necessary to make them suitable for use as centers described in the preceding sentence.
(b) Duties and functions
Each center assisted under this section shall—
(1)(A) use the facilities of a single institution or a consortium of cooperating institutions, and (B) meet such qualifications as may be prescribed by the Secretary; and
(2) conduct—
(A) basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of and rehabilitation from arthritis and musculoskeletal diseases and complications resulting from arthritis and musculoskeletal diseases, including research into implantable biomaterials and biomechanical and other orthopedic procedures;
(B) training programs for physicians, scientists, and other health and allied health professionals;
(C) information and continuing education programs for physicians and other health and allied health professionals who provide care for patients with arthritis and musculoskeletal diseases; and
(D) programs for the dissemination to the general public of information—
(i) on the importance of early detection of arthritis and musculoskeletal diseases, of seeking prompt treatment, and of following an appropriate regimen; and
(ii) to discourage the promotion and use of unapproved and ineffective diagnostic, preventive, treatment, and control methods and unapproved and ineffective drugs and devices.
A center may use funds provided under subsection (a) of this section to provide stipends for health professionals enrolled in training programs described in paragraph (2)(B).
(c) Optional programs
Each center assisted under this section may conduct programs to—
(1) establish the effectiveness of new and improved methods of detection, referral, and diagnosis of individuals with a risk of developing arthritis and musculoskeletal diseases;
(2) disseminate the results of research, screening, and other activities, and develop means of standardizing patient data and recordkeeping; and
(3) develop community consultative services to facilitate the referral of patients to centers for treatment.
(d) Geographical distribution
The Director of the Institute shall, insofar as practicable, provide for an equitable geographical distribution of centers assisted under this section. The Director shall give appropriate consideration to the need for centers especially suited to meeting the needs of children affected by arthritis and musculoskeletal diseases.
(e) Period of support; additional periods
Support of a center under this section may be for a period of not to exceed five years. Such period may be extended by the Director of the Institute for one or more additional periods of not more than five years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(f) Treatment and rehabilitation of children
Not later than October 1, 1993, the Director shall establish a multipurpose arthritis and musculoskeletal disease center for the purpose of expanding the level of research into the cause, diagnosis, early detection, prevention, control, and treatment of, and rehabilitation of children with arthritis and musculoskeletal diseases.
(July 1, 1944, ch. 373, title IV, §441, as added Nov. 20, 1985,
Amendments
1993—Subsec. (f).
1988—Subsec. (b)(2)(A).
Section Referred to in Other Sections
This section is referred to in
§285d–7. Advisory Board
(a) Establishment
The Secretary shall establish in the Institute the National Arthritis and Musculoskeletal and Skin Diseases Advisory Board (hereafter in this section referred to as the "Advisory Board").
(b) Membership; ex officio members
The Advisory Board shall be composed of twenty appointed members and nonvoting, ex officio members, as follows:
(1) The Secretary shall appoint—
(A) twelve members from individuals who are scientists, physicians, and other health professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines relevant to arthritis, musculoskeletal diseases, and skin diseases; and
(B) eight members from the general public who are knowledgeable with respect to such diseases, including one member who is a person who has such a disease, one person who is the parent of an adult with such a disease, and two members who are parents of children with arthritis.
Of the appointed members at least five shall by virtue of training or experience be knowledgeable in health education, nursing, data systems, public information, or community program development.
(2) The following shall be ex officio members of the Advisory Board:
(A) the Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Director of the Centers for Disease Control and Prevention, the Under Secretary for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and
(B) such other officers and employees of the United States as the Secretary determines necessary for the Advisory Board to carry out its functions.
(c) Compensation
Members of the Advisory Board who are officers or employees of the Federal Government shall serve as members of the Advisory Board without compensation in addition to that received in their regular public employment. Other members of the Advisory Board shall receive compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Advisory Board.
(d) Term of office; vacancy
The term of office of an appointed member of the Advisory Board is four years. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member's term until a successor has taken office. If a vacancy occurs in the Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred.
(e) Chairman
The members of the Advisory Board shall select a chairman from among the appointed members.
(f) Executive director, professional and clerical staff; administrative support services and facilities
The Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, and (through contracts or other arrangements) with such administrative support services and facilities, such information, and such services of consultants, as the Secretary determines are necessary for the Advisory Board to carry out its functions.
(g) Meetings
The Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year.
(h) Duties and functions
The Advisory Board shall—
(1) review and evaluate the implementation of the plan prepared under
(2) for the purpose of assuring the most effective use and organization of resources respecting arthritis, musculoskeletal diseases and skin diseases, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies for Federal agencies involved in the implementation of such plan, the interagency coordinating committees for such diseases established under
(i) Subcommittees; establishment and membership
In carrying out its functions, the Advisory Board may establish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities.
(j) Annual report
The Advisory Board shall prepare an annual report for the Secretary which—
(1) describes the Advisory Board's activities in the fiscal year for which the report is made;
(2) describes and evaluates the progress made in such fiscal year in research, treatment, education, and training with respect to arthritis, musculoskeletal diseases, and skin diseases;
(3) summarizes and analyzes expenditures made by the Federal Government for activities respecting such diseases in such fiscal year for which the report is made;
(4) contains the Advisory Board's recommendations (if any) for changes in the plan prepared under
(5) contains recommendations for expanding the Institute's funding of research directly applicable to the cause, diagnosis, early detection, prevention, control, and treatment of, and rehabilitation of children with arthritis and musculoskeletal diseases.
(k) Termination of predecessor board; time within which to appoint members
The National Arthritis Advisory Board in existence on November 20, 1985, shall terminate upon the appointment of a successor Board under subsection (a) of this section . The Secretary shall make appointments to the Advisory Board established under subsection (a) of this section before the expiration of 90 days after November 20, 1985. The member of the Board in existence on November 20, 1985, may be appointed, in accordance with subsections (b) and (d) of this section, to the Advisory Board established under subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, §442, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a).
Subsec. (b).
Subsec. (j)(5).
1992—Subsec. (b)(2)(A).
Termination of Advisory Boards
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
subpart 5—national institute on aging
§285e. Purpose of Institute
The general purpose of the National Institute on Aging (hereafter in this subpart referred to as the "Institute") is the conduct and support of biomedical, social, and behavioral research, training, health information dissemination, and other programs with respect to the aging process and the diseases and other special problems and needs of the aged.
(July 1, 1944, ch. 373, title IV, §443, as added Nov. 20, 1985,
Study of Malnutrition in Elderly
"(a)
"(1)
"(2)
"(A) if health or quality of life is measurably improved for elderly individuals who receive routine nutritional screening and treatment;
"(B) if federally subsidized home or institutional care is reduced because of increased independence of elderly individuals resulting from improved nutritional status;
"(C) if a multidisciplinary approach to nutritional care is effective in addressing the nutritional needs of elderly individuals; and
"(D) if reimbursement for nutrition screening and intervention activities is a cost-effective approach to improving the health status of elderly individuals.
"(3)
"(A) living independently, including—
"(i) individuals who receive home and community-based services or family support;
"(ii) individuals who do not receive additional services and support;
"(iii) individuals with low incomes; and
"(iv) individuals who are minorities;
"(B) hospitalized, including individuals admitted from home and from institutions; and
"(C) institutionalized in residential facilities such as nursing homes and adult homes.
"(b)
"(c)
"(d)
"(1)
"(2)
"(3)
"(A)
"(B)
"(4)
"(5)
"(6)
[References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Study of Personnel for Health Needs of Elderly
Section 8 of
§285e–1. Special functions
(a) Education and training of adequate numbers of personnel
In carrying out the training responsibilities under this chapter or any other Act for health and allied health professions personnel, the Secretary shall take appropriate steps to insure the education and training of adequate numbers of allied health, nursing, and paramedical personnel in the field of health care for the aged.
(b) Scientific studies
The Director of the Institute shall conduct scientific studies to measure the impact on the biological, medical, social, and psychological aspects of aging of programs and activities assisted or conducted by the Department of Health and Human Services.
(c) Public information and education programs
The Director of the Institute shall carry out public information and education programs designed to disseminate as widely as possible the findings of research sponsored by the Institute, other relevant aging research and studies, and other information about the process of aging which may assist elderly and near-elderly persons in dealing with, and all Americans in understanding, the problems and processes associated with growing older.
(d) Grants for research relating to Alzheimer's Disease
The Director of the Institute shall make grants to public and private nonprofit institutions to conduct research relating to Alzheimer's Disease.
(July 1, 1944, ch. 373, title IV, §444, as added Nov. 20, 1985,
Section Referred to in Other Sections
This section is referred to in
§285e–2. Alzheimer's Disease centers
(a) Cooperative agreements and grants for establishing and supporting
(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities (including university medical centers) to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support (including staffing) for centers for basic and clinical research (including multidisciplinary research) into, training in, and demonstration of advanced diagnostic, prevention, and treatment methods for Alzheimer's disease.
(2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute's advisory council.
(b) Use of Federal payments under cooperative agreement or grant
(1) Federal payments made under a cooperative agreement or grant under subsection (a) of this section may, with respect to Alzheimer's disease, be used for—
(A) diagnostic examinations, patient assessments, patient care costs, and other costs necessary for conducting research;
(B) training, including training for allied health professionals;
(C) diagnostic and treatment clinics designed to meet the special needs of minority and rural populations and other underserved populations;
(D) activities to educate the public; and
(E) the dissemination of information.
(2) For purposes of paragraph (1), the term "training" does not include research training for which National Research Service Awards may be provided under
(c) Support period; additional periods
Support of a center under subsection (a) of this section may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, §445, as added Nov. 20, 1985,
Amendments
1990—Subsec. (a)(1).
Subsec. (b).
"(1) construction (notwithstanding any limitation under
"(2) staffing and other basic operating costs, including such patient care costs as are required for research;
"(3) training, including training for allied health professionals; and
"(4) demonstration purposes.
As used in this subsection, the term 'construction' does not include the acquisition of land, and the term 'training' does not include research training for which National Research Service Awards may be provided under
Alzheimer's Disease Research
"SEC. 301. REQUIREMENT FOR CLINICAL TRIALS.
"(a)
"(b)
"SEC. 302. AUTHORIZATION OF APPROPRIATIONS.
"For the purpose of carrying out section 301, there is authorized to be appropriated $2,000,000 for fiscal year 1988."
Alzheimer's Disease Registry
Section 12 of
Section Referred to in Other Sections
This section is referred to in
§285e–3. Claude D. Pepper Older Americans Independence Centers
(a) Development and expansion of centers
The Director of the Institute shall enter into cooperative agreements with, and make grants to, public and private nonprofit entities for the development or expansion of not less than 10 centers of excellence in geriatric research and training of researchers. Each such center shall be known as a Claude D. Pepper Older Americans Independence Center.
(b) Functions of centers
Each center developed or expanded under this section shall—
(1) utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research and training qualifications as may be prescribed by the Director; and
(2) conduct—
(A) research into the aging processes and into the diagnosis and treatment of diseases, disorders, and complications related to aging, including menopause, which research includes research on such treatments, and on medical devices and other medical interventions regarding such diseases, disorders, and complications, that can assist individuals in avoiding institutionalization and prolonged hospitalization and in otherwise increasing the independence of the individuals; and
(B) programs to develop individuals capable of conducting research described in subparagraph (A).
(c) Geographic distribution of centers
In making cooperative agreements and grants under this section for the development or expansion of centers, the Director of the Institute shall ensure that, to the extent practicable, any such centers are distributed equitably among the principal geographic regions of the United States.
(d) "Independence" defined
For purposes of this section, the term "independence", with respect to diseases, disorders, and complications of aging, means the functional ability of individuals to perform activities of daily living or instrumental activities of daily living without assistance or supervision.
(July 1, 1944, ch. 373, title IV, §445A, as added Nov. 4, 1988,
Amendments
1990—
Subsec. (a).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (d).
§285e–4. Awards for leadership and excellence in Alzheimer's disease and related dementias
(a) Senior researchers in biomedical research
The Director of the Institute shall make awards to senior researchers who have made distinguished achievements in biomedical research in areas relating to Alzheimer's disease and related dementias. Awards under this section shall be used by the recipients to support research in areas relating to such disease and dementias, and may be used by the recipients to train junior researchers who demonstrate exceptional promise to conduct research in such areas.
(b) Eligible centers
The Director of the Institute may make awards under this section to researchers at centers supported under
(c) Required recommendation
The Director of the Institute shall make awards under this section only to researchers who have been recommended for such awards by the National Advisory Council on Aging.
(d) Selection procedures
The Director of the Institute shall establish procedures for the selection of the recipients of awards under this section.
(e) Term of award; renewal
Awards under this section shall be made for a one-year period, and may be renewed for not more than six additional consecutive one-year periods.
(July 1, 1944, ch. 373, title IV, §445B, formerly
Codification
Section was formerly classified to
Amendments
1988—
Subsec. (a).
Subsec. (b).
Subsecs. (c), (d).
Availability of Appropriations
Section 142(b) of
§285e–5. Research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families
(a) Grants for research
The Director of the Institute shall conduct, or make grants for the conduct of, research relevant to appropriate services for individuals with Alzheimer's disease and related dementias and their families.
(b) Preparation of plan; contents; revision
(1) Within 6 months after November 14, 1986, the Director of the Institute shall prepare and transmit to the Chairman of the Council on Alzheimer's Disease (in this section referred to as the "Council") a plan for the research to be conducted under subsection (a) of this section. The plan shall—
(A) provide for research concerning—
(i) the epidemiology of, and the identification of risk factors for, Alzheimer's disease and related dementias; and
(ii) the development and evaluation of reliable and valid multidimensional diagnostic and assessment procedures and instruments; and
(B) ensure that research carried out under the plan is coordinated with, and uses, to the maximum extent feasible, resources of, other Federal programs relating to Alzheimer's disease and related dementias, including centers supported under
(2) Within one year after transmitting the plan required under paragraph (1), and annually thereafter, the Director of the Institute shall prepare and transmit to the Chairman of the Council such revisions of such plan as the Director considers appropriate.
(c) Consultation for preparation and revision of plan
In preparing and revising the plan required by subsection (b) of this section, the Director of the Institute shall consult with the Chairman of the Council and the heads of agencies within the Department.
(d) Grants for promoting independence and preventing secondary disabilities
the 1 Director of the Institute may develop, or make grants to develop—
(1) model techniques to—
(A) promote greater independence, including enhanced independence in performing activities of daily living and instrumental activities of daily living, for persons with Alzheimer's disease and related disorders; and
(B) prevent or reduce the severity of secondary disabilities, including confusional episodes, falls, bladder and bowel incontinence, and adverse effects of prescription and over-the-counter medications, in such persons; and
(2) model curricula for health care professionals, health care paraprofessionals, and family caregivers, for training and application in the use of such techniques.
(e) "Council on Alzheimer's Disease" defined
For purposes of this section, the term "Council on Alzheimer's Disease" means the council established in
(July 1, 1944, ch. 373, title IV, §445C, formerly
Codification
Section was formerly classified to
Amendments
1993—Subsec. (b)(1).
Subsec. (e).
1992—Subsec. (d).
1988—
Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(1)(B).
Subsecs. (b)(2), (c).
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be capitalized.
§285e–6. Dissemination of research results
The Director of the Institute shall disseminate the results of research conducted under
(July 1, 1944, ch. 373, title IV, §445D, formerly
Codification
Section was formerly classified to
Amendments
1988—
§285e–7. Clearinghouse on Alzheimer's Disease
(a) Establishment; purpose; duties; publication of summary
The Director of the Institute shall establish the Clearinghouse on Alzheimer's Disease (hereinafter referred to as the "Clearinghouse"). The purpose of the Clearinghouse is the dissemination of information concerning services available for individuals with Alzheimer's disease and related dementias and their families. The Clearinghouse shall—
(1) compile, archive, and disseminate information concerning research, demonstration, evaluation, and training programs and projects concerning Alzheimer's disease and related dementias; and
(2) annually publish a summary of the information compiled under paragraph (1) during the preceding 12-month period, and make such information available upon request to appropriate individuals and entities, including educational institutions, research entities, and Federal and public agencies.
(b) Fee for information
The Clearinghouse may charge an appropriate fee for information provided through the toll-free telephone line established under subsection (a)(3).1
(c) Summaries of research findings from other agencies
The Director of the Institute, the Director of the National Institute of Mental Health, and the Director of the National Center for Health Services Research and Health Care Technology Assessment shall provide to the Clearinghouse summaries of the findings of research conducted under part D.
(July 1, 1944, ch. 373, title IV, §445E, formerly
References in Text
Part D, referred to in subsec. (c), probably means part D of title IX of
Codification
Section was formerly classified to
Amendments
1988—
Subsec. (a).
Subsec. (c).
1 So in original. No subsec. (a)(3) has been enacted.
§285e–8. Dissemination project
(a) Grant or contract for establishment
The Director of the Institute shall make a grant to, or enter into a contract with, a national organization representing individuals with Alzheimer's disease and related dementias for the conduct of the activities described in subsection (b) of this section.
(b) Project activities
The organization receiving a grant or contract under this section shall—
(1) establish a central computerized information system to—
(A) compile and disseminate information concerning initiatives by State and local governments and private entities to provide programs and services for individuals with Alzheimer's disease and related dementias; and
(B) translate scientific and technical information concerning such initiatives into information readily understandable by the general public, and make such information available upon request; and
(2) establish a national toll-free telephone line to make available the information described in paragraph (1), and information concerning Federal programs, services, and benefits for individuals with Alzheimer's disease and related dementias and their families.
(c) Fees for information; exception
The organization receiving a grant or contract under this section may charge appropriate fees for information provided through the toll-free telephone line established under subsection (b)(2) of this section, and may make exceptions to such fees for individuals and organizations who are not financially able to pay such fees.
(d) Application for grant or contract; contents
In order to receive a grant or contract under this section, an organization shall submit an application to the Director of the Institute. Such application shall contain—
(1) information demonstrating that such organization has a network of contacts which will enable such organization to receive information necessary to the operation of the central computerized information system described in subsection (b)(1) of this section;
(2) information demonstrating that, by the end of fiscal year 1991, such organization will be financially able to, and will, carry out the activities described in subsection (b) of this section without a grant or contract from the Federal Government; and
(3) such other information as the Director may prescribe.
(July 1, 1944, ch. 373, title IV, §445F, formerly
Codification
Section was formerly classified to
Amendments
1988—
Subsecs. (a), (d).
§285e–9. Alzheimer's disease registry
(a) In general
The Director of the Institute may make a grant to develop a registry for the collection of epidemiological data about Alzheimer's disease and its incidence in the United States, to train personnel in the collection of such data, and for other matters respecting such disease.
(b) Qualifications
To qualify for a grant under subsection (a) of this section an applicant shall—
(1) be an accredited school of medicine or public health which has expertise in the collection of epidemiological data about individuals with Alzheimer's disease and in the development of disease registries, and
(2) have access to a large patient population, including a patient population representative of diverse ethnic backgrounds.
(July 1, 1944, ch. 373, title IV, §445G, formerly
Codification
Section was formerly set out as a note under
Amendments
1993—
Subsec. (a).
Subsec. (c).
§285e–10. Aging processes regarding women
The Director of the Institute, in addition to other special functions specified in
(July 1, 1944, ch. 373, title IV, §445H, as added June 10, 1993,
§285e–11. Authorization of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $500,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(July 1, 1944, ch. 373, title IV, §445I, as added June 10, 1993,
subpart 6—national institute of allergy and infectious diseases
§285f. Purpose of Institute
The general purpose of the National Institute of Allergy and Infectious Diseases is the conduct and support of research, training, health information dissemination, and other programs with respect to allergic and immunologic diseases and disorders and infectious diseases, including tropical diseases.
(July 1, 1944, ch. 373, title IV, §446, as added Nov. 20, 1985,
Amendments
1993—
Section Referred to in Other Sections
This section is referred to in
§285f–1. Research centers regarding chronic fatigue syndrome
(a) The Director of the Institute, after consultation with the advisory council for the Institute, may make grants to, or enter into contracts with, public or nonprofit private entities for the development and operation of centers to conduct basic and clinical research on chronic fatigue syndrome.
(b) Each center assisted under this section shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of the Institute.
(July 1, 1944, ch. 373, title IV, §447, as added June 10, 1993,
Codification
Another section 447 of act July 1, 1944, is classified to
Extramural Study Section
Section 902(b) of
Research Activities on Chronic Fatigue Syndrome
Section 1903 of
§285f–2. Research and research training regarding tuberculosis
(a) In carrying out
(b) For the purpose of carrying out subsection (a) of this section, there are authorized to be appropriated $50,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 through 1998. Such authorization is in addition to any other authorization of appropriations that is available for such purpose.
(July 1, 1944, ch. 373, title IV, §447, as added Dec. 14, 1993,
Codification
Another section 447 of act July 1, 1944, is classified to
Research Through Food and Drug Administration
Section 303 of
"(1) provide assistance to other Federal agencies for the development of tuberculosis protocols;
"(2) review and evaluate medical devices designed for the diagnosis and control of airborne tuberculosis; and
"(3) conduct research concerning drugs or devices to be used in diagnosing, controlling and preventing tuberculosis."
subpart 7—national institute of child health and human development
§285g. Purpose of Institute
The general purpose of the National Institute of Child Health and Human Development (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to maternal health, child health, mental retardation, human growth and development, including prenatal development, population research, and special health problems and requirements of mothers and children.
(July 1, 1944, ch. 373, title IV, §448, as added Nov. 20, 1985,
National Commission to Prevent Infant Mortality; Composition; Voluntary Services; Duration
National Commission to Prevent Infant Mortality
"SEC. 201. SHORT TITLE.
"This title may be cited as the 'National Commission to Prevent Infant Mortality Act of 1986'.
"SEC. 202. DEFINITION.
"For the purposes of this title, the term 'infant mortality' refers to the number of infants born alive but who die before their first birthday.
"SEC. 203. ESTABLISHMENT OF A NATIONAL COMMISSION.
"(a)
"(b)
"(1) Two members of the Senate, one to be selected by the majority leader of the Senate, the other to be selected by the minority leader of the Senate.
"(2) Two members of the House, one to be selected by the Speaker of the House, the other to be selected by the minority leader of the House.
"(3) Three representatives of State government shall be jointly selected by the majority leader of the Senate and the Speaker of the House. One shall be a Governor; one shall be a chief State official responsible for administering the State medicaid program; and one shall be the chief State official responsible for administering the State maternal and child health programs.
"(4) The Secretary of Health and Human Services shall be a member.
"(5) The Comptroller General of the United States shall be a member.
"(6) Six at large members, with demonstrated expertise in maternal and child health, including representatives of health care consumer and provider organizations, shall be jointly selected by the majority leader of the Senate and the Speaker of the House.
"(c)
"(d)
"(e)
"(f)
"SEC. 204. DUTIES OF THE COMMISSION.
"(a)
"(1) Identify and examine comprehensively Federal, State, local, and private resources which impact infant mortality, including but not limited to—
"(A) the effectiveness and adequacy of programs such as the Supplemental Feeding Program for Women, Infants, and Children; the Maternal and Child Health Block Grant; Community Health Centers; prepregnancy services and other programs that increase access to prenatal and postnatal education, care, and nutrition;
"(B) the effectiveness of current Federal and State policies under the Medicaid Program to ensure adequate access to prenatal and post-natal care for low-income pregnant women, mothers, and infants up to age one;
"(C) the role of income maintenance and other programs that impact infant mortality such as Aid to Families with Dependent Children and Federal housing subsidies;
"(D) the adequacy of current Federal and State efforts to enable an appropriate distribution of properly trained health care professionals to provide comprehensive maternal and child health services;
"(E) the adequacy of private health care financing systems and mechanisms to enable pregnant women and infants to receive comprehensive health care; and
"(F) the adequacy of the national biostatistics registration system with respect to the collection and reporting of infant health statistics.
"(2) Identify current financial, intergovernmental, and within the Federal Government, interagency barriers to the health care needed to prevent high infant mortality.
"(3) Review recommendations made in recent regional and national reports that promote the health status of childbearing women and their infants and carry forward such recommendations as deemed appropriate.
"(4) Hold hearings, in accordance with section 205(a), in areas of the United States with high infant mortality rates.
"(b)
"(1) recommend a national policy designed to reduce and prevent infant mortality, including recommendations concerning populations at risk of high infant death rates and recommendations concerning appropriate roles for the Federal Government, States, local governments, and private sector;
"(2) recommend to the Congress and the President the specific changes needed within Federal laws and Federal programs to achieve an effective Federal role in preventing infant mortality, including the programs specified in subparagraphs (A) and (B) of subsection (a)(1);
"(3) recommend to the Congress and the President the specific changes needed to improve the national vital statistics registration system with respect to infant death statistics; and
"(4) present such recommendations to the President, the Committee on Energy and Commerce of the House of Representatives, and the Committees on Finance and Governmental Affairs of the Senate no later than one year after enactment of this Act [Nov. 14, 1986].
"SEC. 205. POWERS OF THE COMMISSION.
"(a)
"(b)
"(c)
"(d)
"SEC. 206. COMMISSION STAFF.
"(a)
"(b)
"(c)
"(d)
"SEC. 207. SUNSHINE PROVISION.
"The Commission shall establish procedures to ensure its proceedings are open to the public to the maximum extent practicable.
"SEC. 208. TERMINATION OF THE COMMISSION.
"Ninety days after the Commission submits its recommendations as required by section 204(b)(4) the Commission shall terminate.
"SEC. 209. AUTHORIZATION OF APPROPRIATIONS.
"There are authorized to be appropriated to the Commission such sums as may be necessary. Amounts appropriated under this section shall remain available until the day on which the Commission terminates under section 208."
§285g–1. Sudden infant death syndrome research
The Director of the Institute shall conduct and support research which specifically relates to sudden infant death syndrome.
(July 1, 1944, ch. 373, title IV, §449, as added Nov. 20, 1985,
§285g–2. Mental retardation research
The Director of the Institute shall conduct and support research and related activities into the causes, prevention, and treatment of mental retardation.
(July 1, 1944, ch. 373, title IV, §450, as added Nov. 20, 1985,
§285g–3. Associate Director for Prevention; appointment; function
(a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of health problems of mothers and children. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine.
(b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §451, as added Nov. 20, 1985,
§285g–4. National Center for Medical Rehabilitation Research
(a) Establishment of Center
There shall be in the Institute an agency to be known as the National Center for Medical Rehabilitation Research (hereafter in this section referred to as the "Center"). The Director of the Institute shall appoint a qualified individual to serve as Director of the Center. The Director of the Center shall report directly to the Director of the Institute.
(b) Purpose
The general purpose of the Center is the conduct and support of research and research training (including research on the development of orthotic and prosthetic devices), the dissemination of health information, and other programs with respect to the rehabilitation of individuals with physical disabilities resulting from diseases or disorders of the neurological, musculoskeletal, cardiovascular, pulmonary, or any other physiological system (hereafter in this section referred to as "medical rehabilitation").
(c) Authority of Director
(1) In carrying out the purpose described in subsection (b) of this section, the Director of the Center may—
(A) provide for clinical trials regarding medical rehabilitation;
(B) provide for research regarding model systems of medical rehabilitation;
(C) coordinate the activities of the Center with similar activities of other agencies of the Federal Government, including the other agencies of the National Institutes of Health, and with similar activities of other public entities and of private entities;
(D) support multidisciplinary medical rehabilitation research conducted or supported by more than one such agency;
(E) in consultation with the advisory council for the Institute and with the approval of the Director of NIH—
(i) establish technical and scientific peer review groups in addition to those appointed under
(ii) appoint the members of peer review groups established under subparagraph (A); and
(F) support medical rehabilitation research and training centers.
The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under subparagraph (E).
(2) In carrying out this section, the Director of the Center may make grants and enter into cooperative agreements and contracts.
(d) Research Plan
(1) In consultation with the Director of the Center, the coordinating committee established under subsection (e) of this section, and the advisory board established under subsection (f) of this section, the Director of the Institute shall develop a comprehensive plan for the conduct and support of medical rehabilitation research (hereafter in this section referred to as the "Research Plan").
(2) The Research Plan shall—
(A) identify current medical rehabilitation research activities conducted or supported by the Federal Government, opportunities and needs for additional research, and priorities for such research; and
(B) make recommendations for the coordination of such research conducted or supported by the National Institutes of Health and other agencies of the Federal Government.
(3)(A) Not later than 18 months after the date of the enactment of the National Institutes of Health Revitalization Amendments of 1990, the Director of the Institute shall transmit the Research Plan to the Director of NIH, who shall submit the Plan to the President and the Congress.
(B) Subparagraph (A) shall be carried out independently of the process of reporting that is required in
(4) The Director of the Institute shall periodically revise and update the Research Plan as appropriate, after consultation with the Director of the Center, the coordinating committee established under subsection (e) of this section, and the advisory board established under subsection (f) of this section. A description of any revisions in the Research Plan shall be contained in each report prepared under
(e) Medical Rehabilitation Coordinating Committee
(1) The Director of NIH shall establish a committee to be known as the Medical Rehabilitation Coordinating Committee (hereafter in this section referred to as the "Coordinating Committee").
(2) The Coordinating Committee shall make recommendations to the Director of the Institute and the Director of the Center with respect to the content of the Research Plan and with respect to the activities of the Center that are carried out in conjunction with other agencies of the National Institutes of Health and with other agencies of the Federal Government.
(3) The Coordinating Committee shall be composed of the Director of the Center, the Director of the Institute, and the Directors of the National Institute on Aging, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Heart, Lung, and Blood Institute, the National Institute of Neurological Disorders and Stroke, and such other national research institutes and such representatives of other agencies of the Federal Government as the Director of NIH determines to be appropriate.
(4) The Coordinating Committee shall be chaired by the Director of the Center.
(f) National Advisory Board on Medical Rehabilitation Research
(1) Not later than 90 days after the date of the enactment of the National Institutes of Health Revitalization Amendments of 1990, the Director of NIH shall establish a National Advisory Board on Medical Rehabilitation Research (hereafter in this section referred to as the "Advisory Board").
(2) The Advisory Board shall review and assess Federal research priorities, activities, and findings regarding medical rehabilitation research, and shall advise the Director of the Center and the Director of the Institute on the provisions of the Research Plan.
(3)(A) The Director of NIH shall appoint to the Advisory Board 18 qualified representatives of the public who are not officers or employees of the Federal Government. Of such members, 12 shall be representatives of health and scientific disciplines with respect to medical rehabilitation and 6 shall be individuals representing the interests of individuals undergoing, or in need of, medical rehabilitation.
(B) The following officials shall serve as ex officio members of the Advisory Board:
(i) The Director of the Center.
(ii) The Director of the Institute.
(iii) The Director of the National Institute on Aging.
(iv) The Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
(v) The Director of the National Institute on Deafness and Other Communication Disorders.
(vi) The Director of the National Heart, Lung, and Blood Institute.
(vii) The Director of the National Institute of Neurological Disorders and Stroke.
(viii) The Director of the National Institute on Disability and Rehabilitation Research.
(ix) The Commissioner for Rehabilitation Services Administration.
(x) The Assistant Secretary of Defense (Health Affairs).
(xi) The Under Secretary for Health of the Department of Veterans Affairs.
(4) The members of the Advisory Board shall, from among the members appointed under paragraph (3)(A), designate an individual to serve as the chair of the Advisory Board.
(July 1, 1944, ch. 373, title IV, §452, as added Nov. 16, 1990,
References in Text
The Federal Advisory Committee Act, referred to in subsec. (c)(1), is
The date of the enactment of the National Institutes of Health Revitalization Amendments of 1990, referred to in subsecs. (d)(3)(A) and (f)(1), probably means the date of enactment of the National Institutes of Health Amendments of 1990,
Amendments
1992—Subsec. (f)(3)(B)(xi).
Preventing Duplicative Programs of Medical Rehabilitation Research
Section 3(b) of
"(1)
"(A) jointly review the programs being carried out (or proposed to be carried out) by each such official with respect to medical rehabilitation research; and
"(B) as appropriate, enter into agreements for preventing duplication among such programs.
"(2)
"(3)
Termination of Advisory Boards
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
§285g–5. Research centers with respect to contraception and infertility
(a) Grants and contracts
The Director of the Institute, after consultation with the advisory council for the Institute, shall make grants to, or enter into contracts with, public or nonprofit private entities for the development and operation of centers to conduct activities for the purpose of improving methods of contraception and centers to conduct activities for the purpose of improving methods of diagnosis and treatment of infertility.
(b) Number of centers
In carrying out subsection (a) of this section, the Director of the Institute shall, subject to the extent of amounts made available in appropriations Acts, provide for the establishment of three centers with respect to contraception and for two centers with respect to infertility.
(c) Duties
(1) Each center assisted under this section shall, in carrying out the purpose of the center involved—
(A) conduct clinical and other applied research, including—
(i) for centers with respect to contraception, clinical trials of new or improved drugs and devices for use by males and females (including barrier methods); and
(ii) for centers with respect to infertility, clinical trials of new or improved drugs and devices for the diagnosis and treatment of infertility in males and females;
(B) develop protocols for training physicians, scientists, nurses, and other health and allied health professionals;
(C) conduct training programs for such individuals;
(D) develop model continuing education programs for such professionals; and
(E) disseminate information to such professionals and the public.
(2) A center may use funds provided under subsection (a) of this section to provide stipends for health and allied health professionals enrolled in programs described in subparagraph (C) of paragraph (1), and to provide fees to individuals serving as subjects in clinical trials conducted under such paragraph.
(d) Coordination of information
The Director of the Institute shall, as appropriate, provide for the coordination of information among the centers assisted under this section.
(e) Facilities
Each center assisted under subsection (a) of this section shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of the Institute.
(f) Period of support
Support of a center under subsection (a) of this section may be for a period not exceeding 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(g) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $30,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(July 1, 1944, ch. 373, title IV, §452A, as added June 10, 1993,
§285g–6. Program regarding obstetrics and gynecology
The Director of the Institute shall establish and maintain within the Institute an intramural laboratory and clinical research program in obstetrics and gynecology.
(July 1, 1944, ch. 373, title IV, §452B, as added June 10, 1993,
§285g–7. Child health research centers
The Director of the Institute shall develop and support centers for conducting research with respect to child health. Such centers shall give priority to the expeditious transfer of advances from basic science to clinical applications and improving the care of infants and children.
(July 1, 1944, ch. 373, title IV, §452C, as added June 10, 1993,
§285g–8. Prospective longitudinal study on adolescent health
(a) In general
Not later than October 1, 1993, the Director of the Institute shall commence a study for the purpose of providing information on the general health and well-being of adolescents in the United States, including, with respect to such adolescents, information on—
(1) the behaviors that promote health and the behaviors that are detrimental to health; and
(2) the influence on health of factors particular to the communities in which the adolescents reside.
(b) Design of study
(1) In general
The study required in subsection (a) of this section shall be a longitudinal study in which a substantial number of adolescents participate as subjects. With respect to the purpose described in such subsection, the study shall monitor the subjects throughout the period of the study to determine the health status of the subjects and any change in such status over time.
(2) Population-specific analyses
The study required in subsection (a) of this section shall be conducted with respect to the population of adolescents who are female, the population of adolescents who are male, various socioeconomic populations of adolescents, and various racial and ethnic populations of adolescents. The study shall be designed and conducted in a manner sufficient to provide for a valid analysis of whether there are significant differences among such populations in health status and whether and to what extent any such differences are due to factors particular to the populations involved.
(c) Coordination with Women's Health Initiative
With respect to the national study of women being conducted by the Secretary and known as the Women's Health Initiative, the Secretary shall ensure that such study is coordinated with the component of the study required in subsection (a) of this section that concerns adolescent females, including coordination in the design of the 2 studies.
(July 1, 1944, ch. 373, title IV, §452D, as added June 10, 1993,
subpart 8—national institute of dental research
§285h. Purpose of Institute
The general purpose of the National Institute of Dental Research is the conduct and support of research, training, health information dissemination, and other programs with respect to the cause, prevention, and methods of diagnosis and treatment of dental and oral diseases and conditions.
(July 1, 1944, ch. 373, title IV, §453, as added Nov. 20, 1985,
subpart 9—national eye institute
§285i. Purpose of Institute
The general purpose of the National Eye Institute (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind. Subject to
(July 1, 1944, ch. 373, title IV, §455, as added Nov. 20, 1985,
Amendments
1993—
§285i–1. Clinical research on eye care and diabetes
(a) Program of grants
The Director of the Institute, in consultation with the advisory council for the Institute, may award research grants to one or more Diabetes Eye Research Institutions for the support of programs in clinical or health services aimed at—
(1) providing comprehensive eye care services for people with diabetes, including a full complement of preventive, diagnostic and treatment procedures;
(2) developing new and improved techniques of patient care through basic and clinical research;
(3) assisting in translation of the latest research advances into clinical practice; and
(4) expanding the knowledge of the eye and diabetes through further research.
(b) Use of funds
Amounts received under a grant awarded under this section shall be used for the following:
(1) Establishing the biochemical, cellular, and genetic mechanisms associated with diabetic eye disease and the earlier detection of pending eye abnormalities. The focus of work under this paragraph shall require that ophthalmologists have training in the most up-to-date molecular and cell biological methods.
(2) Establishing new frontiers in technology, such as video-based diagnostic and research resources, to—
(A) provide improved patient care;
(B) provide for the evaluation of retinal physiology and its affect on diabetes; and
(C) provide for the assessment of risks for the development and progression of diabetic eye disease and a more immediate evaluation of various therapies aimed at preventing diabetic eye disease.
Such technologies shall be designed to permit evaluations to be performed both in humans and in animal models.
(3) The translation of the results of vision research into the improved care of patients with diabetic eye disease. Such translation shall require the application of institutional resources that encompass patient care, clinical research and basic laboratory research.
(4) The conduct of research concerning the outcomes of eye care treatments and eye health education programs as they relate to patients with diabetic eye disease, including the evaluation of regional approaches to such research.
(c) Authorized expenditures
The purposes for which a grant under subsection (a) of this section may be expended include equipment for the research described in such subsection.
(July 1, 1944, ch. 373, title IV, §456, as added June 10, 1993,
Section Referred to in Other Sections
This section is referred to in
subpart 10—national institute of neurological disorders and stroke
Amendments
1988—
§285j. Purpose of Institute
The general purpose of the National Institute of Neurological Disorders and Stroke (hereafter in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to neurological disease and disorder and stroke.
(July 1, 1944, ch. 373, title IV, §457, as added Nov. 20, 1985,
Amendments
1989—
1988—
Effective Date of 1988 Amendment
For effective date of amendment by
§285j–1. Spinal cord regeneration research
The Director of the Institute shall conduct and support research into spinal cord regeneration.
(July 1, 1944, ch. 373, title IV, §458, as added Nov. 20, 1985,
Interagency Committee on Spinal Cord Injury
Section 7 of
"(a)
"(b)
"(A) the National Institute on Neurological and Communicative Disorders and Stroke;
"(B) the Department of Defense;
"(C) the Department of Education;
"(D) the Veterans' Administration;
"(E) the Office of Science and Technology Policy; and
"(F) the National Science Foundation;
designated by the heads of such entities.
"(2) The Interagency Committee shall meet at least four times. The Secretary of Health and Human Services shall select the Chairman of the Interagency Committee from the members of the Interagency Committee.
"(c)
"(d)
§285j–2. Bioengineering research
The Director of the Institute shall make grants or enter into contracts for research on the means to overcome paralysis of the extremities through electrical stimulation and the use of computers.
(July 1, 1944, ch. 373, title IV, §459, as added Nov. 20, 1985,
§285j–3. Research on multiple sclerosis
The Director of the Institute shall conduct and support research on multiple sclerosis, especially research on effects of genetics and hormonal changes on the progress of the disease.
(July 1, 1944, ch. 373, title IV, §460, as added June 10, 1993,
subpart 11—national institute of general medical sciences
§285k. Purpose of Institute
The general purpose of the National Institute of General Medical Sciences is the conduct and support of research, training, and, as appropriate, health information dissemination, and other programs with respect to general or basic medical sciences and related natural or behavioral sciences which have significance for two or more other national research institutes or are outside the general area of responsibility of any other national research institute.
(July 1, 1944, ch. 373, title IV, §461, as added Nov. 20, 1985,
subpart 12—national institute of environmental health sciences
§285l. Purpose of Institute
The general purpose of the National Institute of Environmental Health Sciences (in this subpart referred to as the "Institute") is the conduct and support of research, training, health information dissemination, and other programs with respect to factors in the environment that affect human health, directly or indirectly.
(July 1, 1944, ch. 373, title IV, §463, as added Nov. 20, 1985,
Amendments
1993—
§285l–1. Applied Toxicological Research and Testing Program
(a) There is established within the Institute a program for conducting applied research and testing regarding toxicology, which program shall be known as the Applied Toxicological Research and Testing Program.
(b) In carrying out the program established under subsection (a) of this section, the Director of the Institute shall, with respect to toxicology, carry out activities—
(1) to expand knowledge of the health effects of environmental agents;
(2) to broaden the spectrum of toxicology information that is obtained on selected chemicals;
(3) to develop and validate assays and protocols, including alternative methods that can reduce or eliminate the use of animals in acute or chronic safety testing;
(4) to establish criteria for the validation and regulatory acceptance of alternative testing and to recommend a process through which scientifically validated alternative methods can be accepted for regulatory use;
(5) to communicate the results of research to government agencies, to medical, scientific, and regulatory communities, and to the public; and
(6) to integrate related activities of the Department of Health and Human Services.
(July 1, 1944, ch. 373, title IV, §463A, as added June 10, 1993,
subpart 13—national institute on deafness and other communication disorders
§285m. Purpose of Institute
The general purpose of the National Institute on Deafness and Other Communication Disorders (hereafter referred to in this subpart as the "Institute") is the conduct and support of research and training, the dissemination of health information, and other programs with respect to disorders of hearing and other communication processes, including diseases affecting hearing, balance, voice, speech, language, taste, and smell.
(July 1, 1944, ch. 373, title IV, §464, as added Oct. 28, 1988,
Codification
Amendments
1988—
Short Title of 1988 Amendment
For short title of
Effect of Enactment of Similar Provisions
Section 2613(b) of
"(1) Paragraphs (2) and (3) shall take effect immediately after the enactment of both the bill, S. 1727, of the One Hundredth Congress [
"(2)(A) The provisions of the Public Health Service Act referred to in subparagraph (B), as similarly amended by the enactment of the bill, S. 1727, of the One Hundredth Congress, by subtitle A of title I of the Health Omnibus Programs Extension of 1988, and by subsection (a)(1) of this section, are amended to read as if the amendments made by such subtitle A and such subsection (a)(1) had not been enacted.
"(B) The provisions of the Public Health Service Act referred to in subparagraph (A) are—
"(A) sections 401(b)(1) and 457 [
"(B) part C of title IV [this part]; and
"(C) the heading for subpart 10 of such part C [42 U.S.C. prec. 285j].
"(3) Subsection (a)(2) of this section [set out below] is repealed."
Transitional and Savings Provisions
Section 3 of
"(a)
"(b)
Section 2612(a)(2) of
§285m–1. National Deafness and Other Communication Disorders Program
(a) The Director of the Institute, with the advice of the Institute's advisory council, shall establish a National Deafness and Other Communication Disorders Program (hereafter in this section referred to as the "Program"). The Director or 1 the Institute shall, with respect to the Program, prepare and transmit to the Director of NIH a plan to initiate, expand, intensify and coordinate activities of the Institute respecting disorders of hearing (including tinnitus) and other communication processes, including diseases affecting hearing, balance, voice, speech, language, taste, and smell. The plan shall include such comments and recommendations as the Director of the Institute determines appropriate. The Director of the Institute shall periodically review and revise the plan and shall transmit any revisions of the plan to the Director of NIH.
(b) Activities under the Program shall include—
(1) investigation into the etiology, pathology, detection, treatment, and prevention of all forms of disorders of hearing and other communication processes, primarily through the support of basic research in such areas as anatomy, audiology, biochemistry, bioengineering, epidemiology, genetics, immunology, microbiology, molecular biology, the neurosciences, otolaryngology, psychology, pharmacology, physiology, speech and language pathology, and any other scientific disciplines that can contribute important knowledge to the understanding and elimination of disorders of hearing and other communication processes;
(2) research into the evaluation of techniques (including surgical, medical, and behavioral approaches) and devices (including hearing aids, implanted auditory and nonauditory prosthetic devices and other communication aids) used in diagnosis, treatment, rehabilitation, and prevention of disorders of hearing and other communication processes;
(3) research into prevention, and early detection and diagnosis, of hearing loss and speech and language disturbances (including stuttering) and research into preventing the effects of such disorders on learning and learning disabilities with extension of programs for appropriate referral and rehabilitation;
(4) research into the detection, treatment, and prevention of disorders of hearing and other communication processes in the growing elderly population with extension of rehabilitative programs to ensure continued effective communication skills in such population;
(5) research to expand knowledge of the effects of environmental agents that influence hearing or other communication processes; and
(6) developing and facilitating intramural programs on clinical and fundamental aspects of disorders of hearing and all other communication processes.
(July 1, 1944, ch. 373, title IV, §464A, as added Oct. 28, 1988,
Codification
Amendments
1988—
Effective Date of 1988 Amendment
For effective date of amendment by
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "of".
§285m–2. Data System and Information Clearinghouse
(a) The Director of the Institute shall establish a National Deafness and Other Communication Disorders Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with disorders of hearing or other communication processes, including where possible, data involving general populations for the purpose of identifying individuals at risk of developing such disorders.
(b) The Director of the Institute shall establish a National Deafness and Other Communication Disorders Information Clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of disorders of hearing and other communication processes by health professionals, patients, industry, and the public.
(July 1, 1944, ch. 373, title IV, §464B, as added Oct. 28, 1988,
Codification
Amendments
1988—
Effective Date of 1988 Amendment
For effective date of amendment by
§285m–3. Multipurpose deafness and other communication disorders center
(a) Development, modernization and operation; "modernization" defined
The Director of the Institute shall, after consultation with the advisory council for the Institute, provide for the development, modernization, and operation (including care required for research) of new and existing centers for studies of disorders of hearing and other communication processes. For purposes of this section, the term "modernization" means the alteration, remodeling, improvement, expansion, and repair of existing buildings and the provision of equipment for such buildings to the extent necessary to make them suitable for use as centers described in the preceding sentence.
(b) Use of facilities; qualifications
Each center assisted under this section shall—
(1) use the facilities of a single institution or a consortium of cooperating institutions; and
(2) meet such qualifications as may be prescribed by the Secretary.
(c) Requisite programs
Each center assisted under this section shall, at least, conduct—
(1) basic and clinical research into the cause diagnosis, early detection, prevention, control and treatment of disorders of hearing and other communication processes and complications resulting from such disorders, including research into rehabilitative aids, implantable biomaterials, auditory speech processors, speech production devices, and other otolaryngologic procedures;
(2) training programs for physicians, scientists, and other health and allied health professionals;
(3) information and continuing education programs for physicians and other health and allied health professionals who will provide care for patients with disorders of hearing or other communication processes; and
(4) programs for the dissemination to the general public of information—
(A) on the importance of early detection of disorders of hearing and other communication processes, of seeking prompt treatment, rehabilitation, and of following an appropriate regimen; and
(B) on the importance of avoiding exposure to noise and other environmental toxic agents that may affect disorders of hearing or other communication processes.
(d) Stipends
A center may use funds provided under subsection (a) of this section to provide stipends for health professionals enrolled in training programs described in subsection (c)(2) of this section.
(e) Discretionary programs
Each center assisted under this section may conduct programs—
(1) to establish the effectiveness of new and improved methods of detection, referral, and diagnosis of individuals at risk of developing disorders of hearing or other communication processes; and
(2) to disseminate the results of research, screening, and other activities, and develop means of standardizing patient data and recordkeeping.
(f) Equitable geographical distribution; needs of elderly and children
The Director of the Institute shall, to the extent practicable, provide for an equitable geographical distribution of centers assisted under this section. The Director shall give appropriate consideration to the need for centers especially suited to meeting the needs of the elderly, and of children (particularly with respect to their education and training), affected by disorders of hearing or other communication processes.
(g) Period of support; recommended extensions of peer review group
Support of a center under this section may be for a period not to exceed seven years. Such period may be extended by the Director of the Institute for one or more additional periods of not more than five years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director, with the advice of the Institute's advisory council, if such group has recommended to the Director that such period should be extended.
(July 1, 1944, ch. 373, title IV, §464C, as added Oct. 28, 1988,
Codification
Amendments
1988—
Effective Date of 1988 Amendment
For effective date of amendment by
§285m–4. National Institute on Deafness and Other Communication Disorders Advisory Board
(a) Establishment
The Secretary shall establish in the Institute the National Deafness and Other Communication Disorders Advisory Board (hereafter in this section referred to as the "Advisory Board").
(b) Composition; qualifications; appointed and ex officio members
The Advisory Board shall be composed of eighteen appointed members and nonvoting ex officio members as follows:
(1) The Secretary shall appoint—
(A) twelve members from individuals who are scientists, physicians, and other health and rehabilitation professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines relevant to deafness and other communication disorders, including not less than two persons with a communication disorder; and
(B) six members from the general public who are knowledgeable with respect to such disorders, including not less than one person with a communication disorder and not less than one person who is a parent of an individual with such a disorder.
Of the appointed members, not less than five shall by virtue of training or experience be knowledgeable in diagnoses and rehabilitation of communication disorders, education of the hearing, speech, or language impaired, public health, public information, community program development, occupational hazards to communications senses, or the aging process.
(2) The following shall be ex officio members of each Advisory Board:
(A) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute on Deafness and Other Communication Disorders, the Director of the Centers for Disease Control and Prevention, the Under Secretary for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers).
(B) Such other officers and employees of the United States as the Secretary determines necessary for the Advisory Board to carry out its functions.
(c) Compensation
Members of an Advisory Board who are officers or employees of the Federal Government shall serve as members of the Advisory Board without compensation in addition to that received in their regular public employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Board.
(d) Term of office; vacancies
The term of office of an appointed member of the Advisory Board is four years, except that no term of office may extend beyond the expiration of the Advisory Board. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member's term until a successor has taken office. If a vacancy occurs in the Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90 days from the date the vacancy occurred.
(e) Chairman
The members of the Advisory Board shall select a chairman from among the appointed members.
(f) Personnel; executive director; professional and clerical staff members; consultants; information and administrative support services and facilities
The Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, such services of consultants, such information, and (through contracts or other arrangements) such administrative support services and facilities, as the Secretary determines are necessary for the Advisory Board to carry out its functions.
(g) Meetings
The Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year.
(h) Functions
The Advisory Board shall—
(1) review and evaluate the implementation of the plan prepared under
(2) for the purpose of assuring the most effective use and organization of resources respecting deafness and other communication disorders, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies related to Federal agencies involved in the implementation of such plan and with key non-Federal entities involved in activities affecting the control of such disorders.
(i) Subcommittee activities; workshops and conferences; collection of data
In carrying out its functions, the Advisory Board may establish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities.
(j) Annual report
The Advisory Board shall prepare an annual report for the Secretary which—
(1) describes the Advisory Board's activities in the fiscal year for which the report is made;
(2) describes and evaluates the progress made in such fiscal year in research, treatment, education, and training with respect to the deafness and other communication disorders;
(3) summarizes and analyzes expenditures made by the Federal Government for activities respecting such disorders in such fiscal year; and
(4) contains the Advisory Board's recommendations (if any) for changes in the plan prepared under
(k) Commencement of existence
The National Deafness and Other Communication Disorders Advisory Board shall be established not later than April 1, 1989.
(July 1, 1944, ch. 373, title IV, §464D, as added Oct. 28, 1988,
Codification
Amendments
1993—Subsec. (b)(2)(A).
1992—Subsec. (b)(2)(A).
1989—Subsec. (k).
1988—
Effective Date of 1988 Amendment
For effective date of amendment by section 2613(b)(2) of
Termination of Advisory Boards
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
§285m–5. Interagency Coordinating Committee
(a) Establishment
The Secretary may establish a committee to be known as the Deafness and Other Communication Disorders Interagency Coordinating Committee (hereafter in this section referred to as the "Coordinating Committee").
(b) Functions
The Coordinating Committee shall, with respect to deafness and other communication disorders—
(1) provide for the coordination of the activities of the national research institutes; and
(2) coordinate the aspects of all Federal health programs and activities relating to deafness and other communication disorders in order to assure the adequacy and technical soundness of such programs and activities and in order to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities.
(c) Composition
The Coordinating Committee shall be composed of the directors of each of the national research institutes and divisions involved in research with respect to deafness and other communication disorders and representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to deafness and other communication disorders.
(d) Chairman; meetings
The Coordinating Committee shall be chaired by the Director of NIH (or the designee of the Director). The Committee shall meet at the call of the chair, but not less often than four times a year.
(e) Annual report; recipients of report
Not later than 120 days after the end of each fiscal year, the Coordinating Committee shall prepare and transmit to the Secretary, the Director of NIH, the Director of the Institute, and the advisory council for the Institute a report detailing the activities of the Committee in such fiscal year in carrying out subsection (b) of this section.
(July 1, 1944, ch. 373, title IV, §464E, as added Oct. 28, 1988,
Codification
Amendments
1993—Subsecs. (d), (e).
1988—
Effective Date of 1988 Amendment
For effective date of amendment by section 2613(b)(2) of
§285m–6. Limitation on administrative expenses
With respect to amounts appropriated for a fiscal year for the National Institutes of Health, the limitation established in
(July 1, 1944, ch. 373, title IV, §464F, as added Oct. 28, 1988,
Codification
Amendments
1993—
1988—
Effective Date of 1988 Amendment
For effective date of amendment by section 2613(b)(2) of
subpart 14—national institute on alcohol abuse and alcoholism
Subpart Referred to in Other Sections
This subpart is referred to in
§285n. Purpose of Institute
(a) In general
The general purpose of the National Institute on Alcohol Abuse and Alcoholism (hereafter in this subpart referred to as the "Institute") is the conduct and support of biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the prevention of alcohol abuse and the treatment of alcoholism.
(b) Research program
The research program established under this subpart shall encompass the social, behavioral, and biomedical etiology, mental and physical health consequences, and social and economic consequences of alcohol abuse and alcoholism. In carrying out the program, the Director of the Institute is authorized to—
(1) collect and disseminate through publications and other appropriate means (including the development of curriculum materials), information as to, and the practical application of, the research and other activities under the program;
(2) make available research facilities of the Public Health Service to appropriate public authorities, and to health officials and scientists engaged in special study;
(3) make grants to universities, hospitals, laboratories, and other public or nonprofit institutions, and to individuals for such research projects as are recommended by the National Advisory Council on Alcohol Abuse and Alcoholism, giving special consideration to projects relating to—
(A) the relationship between alcohol abuse and domestic violence,
(B) the effects of alcohol use during pregnancy,
(C) the impact of alcoholism and alcohol abuse on the family, the workplace, and systems for the delivery of health services,
(D) the relationship between the abuse of alcohol and other drugs,
(E) the effect on the incidence of alcohol abuse and alcoholism of social pressures, legal requirements respecting the use of alcoholic beverages, the cost of such beverages, and the economic status and education of users of such beverages,
(F) the interrelationship between alcohol use and other health problems,
(G) the comparison of the cost and effectiveness of various treatment methods for alcoholism and alcohol abuse and the effectiveness of prevention and intervention programs for alcoholism and alcohol abuse,
(H) alcoholism and alcohol abuse among women;
(4) secure from time to time and for such periods as he deems advisable, the assistance and advice of experts, scholars, and consultants from the United States or abroad;
(5) promote the coordination of research programs conducted by the Institute, and similar programs conducted by the National Institute of Drug Abuse and by other departments, agencies, organizations, and individuals, including all National Institutes of Health research activities which are or may be related to the problems of individuals suffering from alcoholism or alcohol abuse or those of their families or the impact of alcohol abuse on other health problems;
(6) conduct an intramural program of biomedical, behavioral, epidemiological, and social research, including research into the most effective means of treatment and service delivery, and including research involving human subjects, which is—
(A) located in an institution capable of providing all necessary medical care for such human subjects, including complete 24-hour medical diagnostic services by or under the supervision of physicians, acute and intensive medical care, including 24-hour emergency care, psychiatric care, and such other care as is determined to be necessary for individuals suffering from alcoholism and alcohol abuse; and
(B) associated with an accredited medical or research training institution;
(7) for purposes of study, admit and treat at institutions, hospitals, and stations of the Public Health Service, persons not otherwise eligible for such treatment;
(8) provide to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of statistical and other scientific research methods to experiments, studies, and surveys in health and medical fields;
(9) enter into contracts under this subchapter without regard to section 3324(a) and (b) of title 31 and
(10) adopt, upon recommendation of the National Advisory Council on Alcohol Abuse and Alcoholism, such additional means as he deems necessary or appropriate to carry out the purposes of this section.
(c) Collaboration
The Director of the Institute shall collaborate with the Administrator of the Substance Abuse and Mental Health Services Administration in focusing the services research activities of the Institute and in disseminating the results of such research to health professionals and the general public.
(d) Funding
(1) Authorization of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $300,000,000 for fiscal year 1993, and such sums as may be necessary for fiscal year 1994.
(2) Allocation for health services research
Of the amounts appropriated under paragraph (1) for a fiscal year, the Director shall obligate not less than 15 percent to carry out health services research relating to alcohol abuse and alcoholism.
(July 1, 1944, ch. 373, title IV, §464H, as added and amended July 10, 1992,
Codification
In subsec. (b)(9), "section 3324(a) and (b) of title 31" substituted for reference to section 3648 of the Revised Statutes (
Amendments
1992—Subsec. (a).
Subsec. (b).
Subsecs. (c), (d).
Effective Date of 1992 Amendment
Section 3 of
"(1) subsection (a) of section 2 [amending this section and
"(2) subsections (b) and (c) of section 2 [amending
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
Required Allocations for Health Services Research
"(1)
"(2)
"(A) section 464H(d)(2) of the Public Health Service Act, as added by section 122 of
"(B) section 464L(d)(2) of the Public Health Service Act, as added by section 123 of
"(C) section 464R(f)(2) of the Public Health Service Act, as added by section 124 of
Study on Fetal Alcohol Effect and Fetal Alcohol Syndrome
Section 705 of
Alcoholism and Alcohol Abuse Treatment Study
§285n–1. Associate Director for Prevention
(a) In general
There shall be in the Institute an Associate Director for Prevention who shall be responsible for the full-time coordination and promotion of the programs in the Institute concerning the prevention of alcohol abuse and alcoholism. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or expertise are experts in alcohol abuse and alcoholism or the prevention of such.
(b) Biennial report
The Associate Director for Prevention shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §464I, as added July 10, 1992,
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
§285n–2. National Alcohol Research Centers; mandatory grant for research of effects of alcohol on elderly
(a) Designation; procedures applicable for approval of applications
The Secretary acting through the Institute may designate National Alcohol Research Centers for the purpose of interdisciplinary research relating to alcoholism and other biomedical, behavioral, and social issues related to alcoholism and alcohol abuse. No entity may be designated as a Center unless an application therefor has been submitted to, and approved by, the Secretary. Such an application shall be submitted in such manner and contain such information as the Secretary may reasonably require. The Secretary may not approve such an application unless—
(1) the application contains or is supported by reasonable assurances that—
(A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social, and related disciplines, long-term research on alcoholism and other alcohol problems and to provide coordination of such research among such disciplines;
(B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis facilities) to carry out the research plan contained in the application;
(C) the applicant has facilities and personnel to provide training in the prevention and treatment of alcoholism and other alcohol problems;
(D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on alcoholism and other alcohol problems;
(E) the applicant has the capacity to conduct courses on alcohol problems and research on alcohol problems for undergraduate and graduate students, and for medical and osteopathic, nursing, social work, and other specialized graduate students; and
(F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and social service fields as the Secretary may require.1
(2) the application contains a detailed five-year plan for research relating to alcoholism and other alcohol problems.
(b) Annual grants; amount; limitation on uses
The Secretary shall, under such conditions as the Secretary may reasonably require, make annual grants to Centers which have been designated under this section. No funds provided under a grant under this subsection may be used for the purchase of any land or the purchase, construction, preservation, or repair of any building. For the purposes of the preceding sentence, the term "construction" has the meaning given that term by section 292a(1) 2 of this title. The Secretary shall include in the grants made under this section for fiscal years beginning after September 30, 1981, a grant to a designated Center for research on the effects of alcohol on the elderly.
(July 1, 1944, ch. 373, title IV, §464J, formerly title V, §511, formerly
References in Text
Codification
Section was formerly classified to
Section was formerly classified to
Section was formerly classified to
Amendments
1992—Subsec. (b).
1986—Subsec. (b).
1983—Subsec. (a).
Subsec. (b).
Subsec. (c).
1981—Subsec. (b).
1980—Subsec. (a).
Subsec. (b).
Subsec. (c).
1978—Subsec. (a).
Effective Date of 1992 Amendments
Amendment by
Amendment by
1 So in original. The period probably should be "; and".
2 See References in Text note below.
subpart 15—national institute on drug abuse
Subpart Referred to in Other Sections
This subpart is referred to in
§285o. Purpose of Institute
(a) In general
The general purpose of the National Institute on Drug Abuse (hereafter in this subpart referred to as the "Institute") is the conduct and support of biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the prevention of drug abuse and the treatment of drug abusers.
(b) Research program
The research program established under this subpart shall encompass the social, behavioral, and biomedical etiology, mental and physical health consequences, and social and economic consequences of drug abuse. In carrying out the program, the Director of the Institute shall give special consideration to projects relating to drug abuse among women (particularly with respect to pregnant women).
(c) Collaboration
The Director of the Institute shall collaborate with the Substance Abuse and Mental Health Services Administration in focusing the services research activities of the Institute and in disseminating the results of such research to health professionals and the general public.
(d) Funding
(1) Authorization of appropriations
For the purpose of carrying out this subpart, other than
(2) Allocation for health services research
Of the amounts appropriated under paragraph (1) for a fiscal year, the Director shall obligate not less than 15 percent to carry out health services research relating to drug abuse.
(July 1, 1944, ch. 373, title IV, §464L, as added July 10, 1992,
Amendments
1992—Subsec. (d)(1).
Effective Date of 1992 Amendment
Amendment by
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
Required Allocations for Health Services Research
With respect to fiscal year 1993 allocations for health services research required in subsec. (d)(2) of this section, the term "15 percent" deemed to be 12 percent, see section 2016(b) of
§285o–1. Associate Director for Prevention
(a) In general
There shall be in the Institute an Associate Director for Prevention who shall be responsible for the full-time coordination and promotion of the programs in the Institute concerning the prevention of drug abuse. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or expertise are experts in drug abuse and the prevention of such abuse.
(b) Report
The Associate Director for Prevention shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §464M, as added July 10, 1992,
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
§285o–2. Drug Abuse Research Centers
(a) Authority
The Director of the Institute may designate National Drug Abuse Research Centers for the purpose of interdisciplinary research relating to drug abuse and other biomedical, behavioral, and social issues related to drug abuse. No entity may be designated as a Center unless an application therefore has been submitted to, and approved by, the Secretary. Such an application shall be submitted in such manner and contain such information as the Secretary may reasonably require. The Secretary may not approve such an application unless—
(1) the application contains or is supported by reasonable assurances that—
(A) the applicant has the experience, or capability, to conduct, through biomedical, behavioral, social, and related disciplines, long-term research on drug abuse and to provide coordination of such research among such disciplines;
(B) the applicant has available to it sufficient facilities (including laboratory, reference, and data analysis facilities) to carry out the research plan contained in the application;
(C) the applicant has facilities and personnel to provide training in the prevention and treatment of drug abuse;
(D) the applicant has the capacity to train predoctoral and postdoctoral students for careers in research on drug abuse;
(E) the applicant has the capacity to conduct courses on drug abuse problems and research on drug abuse for undergraduate and graduate students, and medical and osteopathic, nursing, social work, and other specialized graduate students; and
(F) the applicant has the capacity to conduct programs of continuing education in such medical, legal, and social service fields as the Secretary may require.1
(2) the application contains a detailed five-year plan for research relating to drug abuse.
(b) Grants
The Director of the Institute shall, under such conditions as the Secretary may reasonably require, make annual grants to Centers which have been designated under this section. No funds provided under a grant under this subsection may be used for the purchase of any land or the purchase, construction, preservation, or repair of any building. For the purposes of the preceding sentence, the term "construction" has the meaning given that term by section 292a(1) 2 of this title.
(July 1, 1944, ch. 373, title IV, §464N, as added July 10, 1992,
References in Text
Amendments
1992—Subsec. (b).
Effective Date of 1992 Amendment
Amendment by
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
1 So in original. The period probably should be "; and".
2 See References in Text note below.
§285o–3. Office on AIDS
The Director of the Institute shall establish within the Institute an Office on AIDS. The Office shall be responsible for the coordination of research and determining the direction of the Institute with respect to AIDS research related to—
(1) primary prevention of the spread of HIV, including transmission via drug abuse;
(2) drug abuse services research; and
(3) other matters determined appropriate by the Director.
(July 1, 1944, ch. 373, title IV, §464O, as added July 10, 1992,
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
Study by National Academy of Sciences
Section 706 of
§285o–4. Medication Development Program
(a) Establishment
There is established in the Institute a Medication Development Program through which the Director of such Institute shall—
(1) conduct periodic meetings with the Commissioner of Food and Drugs to discuss measures that may facilitate the approval process of drug abuse treatments;
(2) encourage and promote (through grants, contracts, international collaboration, or otherwise) expanded research programs, investigations, experiments, community trials, and studies, into the development and use of medications to treat drug addiction;
(3) establish or provide for the establishment of research facilities;
(4) report on the activities of other relevant agencies relating to the development and use of pharmacotherapeutic treatments for drug addiction;
(5) collect, analyze, and disseminate data useful in the development and use of pharmacotherapeutic treatments for drug addiction and collect, catalog, analyze, and disseminate through international channels, the results of such research;
(6) directly or through grants, contracts, or cooperative agreements, support training in the fundamental sciences and clinical disciplines related to the pharmacotherapeutic treatment of drug abuse, including the use of training stipends, fellowships, and awards where appropriate; and
(7) coordinate the activities conducted under this section with related activities conducted within the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and other appropriate institutes and shall consult with the Directors of such Institutes.
(b) Duties
In carrying out the activities described in subsection (a) of this section, the Director of the Institute—
(1) shall collect and disseminate through publications and other appropriate means, information pertaining to the research and other activities under this section;
(2) shall make grants to or enter into contracts and cooperative agreements with individuals and public and private entities to further the goals of the program;
(3) may, in accordance with
(4) may accept voluntary and uncompensated services;
(5) may accept gifts, or donations of services, money, or property, real, personal, or mixed, tangible or intangible; and
(6) shall take necessary action to ensure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and the other scientific, medical, and biomedical disciplines and organizations nationally and internationally.
(c) Report
(1) In general
Not later than December 31, 1992, and each December 31 thereafter, the Director of the Institute shall submit to the Office of National Drug Control Policy established under
(2) National Drug Control Strategy
The Director of National Drug Control Policy shall incorporate, by reference or otherwise, each report submitted under this subsection in the National Drug Control Strategy submitted the following February 1 under
(d) "Pharmacotherapeutics" defined
For purposes of this section, the term "pharmacotherapeutics" means medications used to treat the symptoms and disease of drug abuse, including medications to—
(1) block the effects of abused drugs;
(2) reduce the craving for abused drugs;
(3) moderate or eliminate withdrawal symptoms;
(4) block or reverse the toxic effect of abused drugs; or
(5) prevent relapse in persons who have been detoxified from drugs of abuse.
(e) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $85,000,000 for fiscal year 1993, and $95,000,000 for fiscal year 1994.
(July 1, 1944, ch. 373, title IV, §464P, as added July 10, 1992,
Amendments
1993—Subsec. (b)(6).
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
Report by Institute on Medicine
Section 701 of
Section Referred to in Other Sections
This section is referred to in
subpart 16—national institute of mental health
Subpart Referred to in Other Sections
This subpart is referred to in
§285p. Purpose of Institute
(a) In general
The general purpose of the National Institute of Mental Health (hereafter in this subpart referred to as the "Institute") is the conduct and support of biomedical and behavioral research, health services research, research training, and health information dissemination with respect to the cause, diagnosis, treatment, control and prevention of mental illness.
(b) Research program
The research program established under this subpart shall include support for biomedical and behavioral neuroscience and shall be designed to further the treatment and prevention of mental illness, the promotion of mental health, and the study of the psychological, social and legal factors that influence behavior.
(c) Collaboration
The Director of the Institute shall collaborate with the Administrator of the Substance Abuse and Mental Health Services Administration in focusing the services research activities of the Institute and in disseminating the results of such research to health professionals and the general public.
(d) Information with respect to suicide
(1) In general
The Director of the Institute shall—
(A) develop and publish information with respect to the causes of suicide and the means of preventing suicide; and
(B) make such information generally available to the public and to health professionals.
(2) Youth suicide
Information described in paragraph (1) shall especially relate to suicide among individuals under 24 years of age.
(e) Associate Director for Special Populations
(1) In general
The Director of the Institute shall designate an Associate Director for Special Populations.
(2) Duties
The Associate Director for Special Populations shall—
(A) develop and coordinate research policies and programs to assure increased emphasis on the mental health needs of women and minority populations;
(B) support programs of basic and applied social and behavioral research on the mental health problems of women and minority populations;
(C) study the effects of discrimination on institutions and individuals, including majority institutions and individuals;
(D) support and develop research designed to eliminate institutional discrimination; and
(E) provide increased emphasis on the concerns of women and minority populations in training programs, service delivery programs, and research endeavors of the Institute.
(f) Funding
(1) Authorization of appropriations
For the purpose of carrying out this subpart, there are authorized to be appropriated $675,000,000 for fiscal year 1993, and such sums as may be necessary for fiscal year 1994.
(2) Allocation for health services research
Of the amounts appropriated under paragraph (1) for a fiscal year, the Director shall obligate not less than 15 percent to carry out health services research relating to mental health.
(July 1, 1944, ch. 373, title IV, §464R, as added July 10, 1992,
Amendments
1992—Subsec. (f)(1).
Effective Date of 1992 Amendment
Amendment by
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
Required Allocations for Health Services Research
With respect to fiscal year 1993 allocations for health services research required in subsec. (f)(2) of this section, the term "15 percent" deemed to be 12 percent, see section 2016(b) of
Study of Barriers to Insurance Coverage of Treatment for Mental Illness and Substance Abuse
Section 704 of
§285p–1. Associate Director for Prevention
(a) In general
There shall be in the Institute an Associate Director for Prevention who shall be responsible for the full-time coordination and promotion of the programs in the Institute concerning the prevention of mental disorder. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or expertise are experts in mental disorder and the prevention of such.
(b) Report
The Associate Director for Prevention shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §464S, as added July 10, 1992,
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
§285p–2. Office of Rural Mental Health Research
(a) In general
There is established within the Institute an office to be known as the Office of Rural Mental Health Research (hereafter in this section referred to as the "Office"). The Office shall be headed by a director, who shall be appointed by the Director of such Institute from among individuals experienced or knowledgeable in the provision of mental health services in rural areas. The Secretary shall carry out the authorities established in this section acting through the Director of the Office.
(b) Coordination of activities
The Director of the Office, in consultation with the Director of the Institute and with the Director of the Office of Rural Health Policy, shall—
(1) coordinate the research activities of the Department of Health and Human Services as such activities relate to the mental health of residents of rural areas; and
(2) coordinate the activities of the Office with similar activities of public and nonprofit private entities.
(c) Research, demonstrations, evaluations, and dissemination
The Director of the Office may, with respect to the mental health of adults and children residing in rural areas—
(1) conduct research on conditions that are unique to the residents of rural areas, or more serious or prevalent in such residents;
(2) conduct research on improving the delivery of services in such areas; and
(3) disseminate information to appropriate public and nonprofit private entities.
(d) Authority regarding grants and contracts
The Director of the Office may carry out the authorities established in subsection (c) of this section directly and through grants, cooperative agreements, or contracts with public or nonprofit private entities.
(e) Report to Congress
Not later than February 1, 1993, and each fiscal year thereafter, the Director shall submit to the Subcommittee on Health and the Environment of the Committee on Energy and Commerce (of the House of Representatives), and to the Committee on Labor and Human Resources (of the Senate), a report describing the activities of the Office during the preceding fiscal year, including a summary of the activities of demonstration projects and a summary of evaluations of the projects.
(July 1, 1944, ch. 373, title IV, §464T, as added July 10, 1992,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
§285p–3. Office on AIDS
The Director of the Institute shall establish within the Institute an Office on AIDS. The Office shall be responsible for the coordination of research and determining the direction of the Institute with respect to AIDS research related to—
(1) primary prevention of the spread of HIV, including transmission via sexual behavior;
(2) mental health services research; and
(3) other matters determined appropriate by the Director.
(July 1, 1944, ch. 373, title IV, §464U, as added July 10, 1992,
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
subpart 17—national institute of nursing research
§285q. Purpose of Institute
The general purpose of the National Institute of Nursing Research (in this subpart referred to as the "Institute") is the conduct and support of, and dissemination of information respecting, basic and clinical nursing research, training, and other programs in patient care research.
(July 1, 1944, ch. 373, title IV, §464V, formerly §483, as added Nov. 20, 1985,
Codification
Section was formerly classified to
Amendments
1993—
Study on Adequacy of Number of Nurses
Section 1512 of
Section Referred to in Other Sections
This section is referred to in
§285q–1. Specific authorities
To carry out
(July 1, 1944, ch. 373, title IV, §464W, formerly §484, as added Nov. 20, 1985,
Codification
Section was formerly classified to
Amendments
1993—
§285q–2. Advisory council
(a) Appointment; functions and duties; acceptance of conditional gifts; subcommittees
(1) The Secretary shall appoint an advisory council for the Institute which shall advise, assist, consult with, and make recommendations to the Secretary and the Director of the Institute on matters related to the activities carried out by and through the Institute and the policies respecting such activities.
(2) The advisory council for the Institute may recommend to the Secretary acceptance, in accordance with
(3) The advisory council for the Institute—
(A)(i) may make recommendations to the Director of the Institute respecting research conducted at the Institute,
(ii) may review applications for grants and cooperative agreements for research or training and recommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and
(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the Institute;
(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspects of human health with respect to which the Institute is concerned and with the approval of the Director of the Institute make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and
(C) may appoint subcommittees and convene workshops and conferences.
(b) Membership; ex officio members; compensation
(1) The advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary.
(2) The ex officio members of the advisory council shall consist of—
(A) the Secretary, the Director of NIH, the Director of the Institute, the chief nursing officer of the Department of Veterans Affairs, the Assistant Secretary of Defense for Health Affairs, the Director of the Division of Nursing of the Health Resources and Services Administration (or the designees of such officers), and
(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions.
(3) The members of the advisory council who are not ex officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behavioral or social sciences) relevant to the activities of the Institute. Of the members appointed pursuant to this subparagraph, at least seven shall be professional nurses who are recognized experts in the area of clinical practice, education, or research.
(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management.
(4) Members of the advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The other members of the advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule.
(c) Term of office; vacancy; reappointment
The term of office of an appointed member of the advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.
(d) Chairman; selection; term of office
The chairman of the advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the Institute to be the chairman of the advisory council. The term of office of the chairman shall be two years.
(e) Meetings
The advisory council shall meet at the call of the chairman or upon the request of the Director of the Institute, but at least three times each fiscal year. The location of the meetings of the advisory council is subject to the approval of the Director of the Institute.
(f) Executive secretary; staff; orientation and training for new members
The Director of the Institute shall designate a member of the staff of the Institute to serve as the executive secretary of the advisory council. The Director of the Institute shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of the Institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council.
(g) Material for inclusion in biennial report; additional reports
The advisory council may prepare, for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §464X, formerly §485, as added Nov. 20, 1985,
Codification
Section was formerly classified to
Amendments
1993—Subsec. (a).
Subsec. (a)(2).
Subsec. (b)(2)(A).
Subsec. (b)(3)(A).
Subsecs. (d) to (f).
Subsec. (g).
1991—Subsec. (b)(2)(A).
1990—Subsec. (a)(2).
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Section Referred to in Other Sections
This section is referred to in
§285q–3. Biennial report
The Director of the Institute after consultation with the advisory council for the Institute, shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §464Y, formerly §486, as added Nov. 20, 1985,
Codification
Section was formerly classified to
Amendments
1993—
Section Referred to in Other Sections
This section is referred to in
Part D—National Library of Medicine
subpart 1—general provisions
§286. National Library of Medicine
(a) Purpose and establishment
In order to assist the advancement of medical and related sciences and to aid the dissemination and exchange of scientific and other information important to the progress of medicine and to the public health, there is established the National Library of Medicine (hereafter in this part referred to as the "Library").
(b) Functions
The Secretary, through the Library and subject to subsection (d) of this section, shall—
(1) acquire and preserve books, periodicals, prints, films, recordings, and other library materials pertinent to medicine;
(2) organize the materials specified in paragraph (1) by appropriate cataloging, indexing, and bibliographical listings;
(3) publish and disseminate the catalogs, indexes, and bibliographies referred to in paragraph (2);
(4) make available, through loans, photographic or other copying procedures, or otherwise, such materials in the Library as the Secretary determines appropriate;
(5) provide reference and research assistance;
(6) publicize the availability from the Library of the products and services described in any of paragraphs (1) through (5);
(7) promote the use of computers and telecommunications by health professionals (including health professionals in rural areas) for the purpose of improving access to biomedical information for health care delivery and medical research; and
(8) engage in such other activities as the Secretary determines appropriate and as the Library's resources permit.
(c) Exchange, destruction, or disposal of materials not needed
The Secretary may exchange, destroy, or otherwise dispose of any books, periodicals, films, and other library materials not needed for the permanent use of the Library.
(d) Availability of publications, materials, facilities, or services; prescription of rules
(1) The Secretary may, after obtaining the advice and recommendations of the Board of Regents, prescribe rules under which the Library will—
(A) provide copies of its publications or materials,
(B) will make available its facilities for research, or
(C) will make available its bibliographic, reference, or other services,
to public and private entities and individuals.
(2) Rules prescribed under paragraph (1) may provide for making available such publications, materials, facilities, or services—
(A) without charge as a public service,
(B) upon a loan, exchange, or charge basis, or
(C) in appropriate circumstances, under contract arrangements made with a public or other nonprofit entity.
(e) Regional medical libraries; establishment
Whenever the Secretary, with the advice of the Board of Regents, determines that—
(1) in any geographic area of the United States there is no regional medical library adequate to serve such area;
(2) under criteria prescribed for the administration of
(3) because there is no medical library located in such area which, with financial assistance under
the Secretary may establish, as a branch of the Library, a regional medical library to serve the needs of such area.
(f) Acceptance and administration of gifts; memorials
(g) "Medicine" and "medical" defined
For purposes of this part, the terms "medicine" and "medical", except when used in
(July 1, 1944, ch. 373, title IV, §465, as added Nov. 20, 1985,
Amendments
1993—
Subsec. (b)(6) to (8).
Subsec. (f).
1990—Subsec. (f).
1988—Subsec. (f).
1987—
1986—Subsec. (f).
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1986 Amendment
Amendment by
Applicability of Certain New Authority
Section 1401(c)(2) of
Section Referred to in Other Sections
This section is referred to in
§286a. Board of Regents
(a) Membership; ex officio members
(1)(A) The Board of Regents of the National Library of Medicine consists of ex officio members and ten members appointed by the Secretary.
(B) The ex officio members are the Surgeons General of the Public Health Service, the Army, the Navy, and the Air Force, the Under Secretary for Health of the Department of Veterans Affairs, the Dean of the Uniformed Services University of the Health Sciences, the Assistant Director for Biological, Behavioral, and Social Sciences of the National Science Foundation, the Director of the National Agricultural Library, and the Librarian of Congress (or their designees).
(C) The appointed members shall be selected from among leaders in the various fields of the fundamental sciences, medicine, dentistry, public health, hospital administration, pharmacology, health communications technology, or scientific or medical library work, or in public affairs. At least six of the appointed members shall be selected from among leaders in the fields of medical, dental, or public health research or education.
(2) The Board shall annually elect one of the appointed members to serve as chairman until the next election. The Secretary shall designate a member of the Library staff to act as executive secretary of the Board.
(b) Recommendations on matters of policy; recommendations included in annual report; use of services of members by Secretary
The Board shall advise, consult with, and make recommendations to the Secretary on matters of policy in regard to the Library, including such matters as the acquisition of materials for the Library, the scope, content, and organization of the Library's services, and the rules under which its materials, publications, facilities, and services shall be made available to various kinds of users. The Secretary shall include in the annual report of the Secretary to the Congress a statement covering the recommendations made by the Board and the disposition thereof. The Secretary may use the services of any member of the Board in connection with matters related to the work of the Library, for such periods, in addition to conference periods, as the Secretary may determine.
(c) Term of office; vacancy; reappointment
Each appointed member of the Board shall hold office for a term of four years, except that any member appointed to fill a vacancy occurring prior to the expiration of the term for which the predecessor of such member was appointed shall be appointed for the remainder of such term. None of the appointed members shall be eligible for reappointment within one year after the end of the preceding term of such member.
(July 1, 1944, ch. 373, title IV, §466, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a)(1)(B).
1992—Subsec. (a)(1)(B).
Section Referred to in Other Sections
This section is referred to in
§286a–1. Library facilities
There are authorized to be appropriated amounts sufficient for the erection and equipment of suitable and adequate buildings and facilities for use of the Library. The Administrator of General Services may acquire, by purchase, condemnation, donation, or otherwise, a suitable site or sites, selected by the Secretary in accordance with the direction of the Board, for such buildings and facilities and to erect thereon, furnish, and equip such buildings and facilities. The amounts authorized to be appropriated by this section include the cost of preparation of drawings and specifications, supervision of construction, and other administrative expenses incident to the work. The Administrator of General Services shall prepare the plans and specifications, make all necessary contracts, and supervise construction.
(July 1, 1944, ch. 373, title IV, §467, as added Nov. 20, 1985,
§286a–2. Authorization of appropriations
(a) For the purpose of carrying out this part, there are authorized to be appropriated $150,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(b) Amounts appropriated under subsection (a) of this section and made available for grants or contracts under any of
(July 1, 1944, ch. 373, title IV, §468, as added June 10, 1993,
subpart 2—financial assistance
§286b. Repealed. Pub. L. 103–43, title XIV, §1402(b), June 10, 1993, 107 Stat. 171
Section, act July 1, 1944, ch. 373, title IV, §469, as added Nov. 20, 1985,
§286b–1. Definitions
As used in this subpart—
(1) the term "medical library" means a library related to the sciences related to health; and
(2) the term "sciences related to health" includes medicine, osteopathy, dentistry, and public health, and fundamental and applied sciences when related thereto.
(July 1, 1944, ch. 373, title IV, §470, as added Nov. 20, 1985,
§286b–2. National Medical Libraries Assistance Advisory Board
(a) Board of Regents of National Library of Medicine to serve as
The Board of Regents of the National Library of Medicine shall also serve as the National Medical Libraries Assistance Advisory Board (hereafter in this subpart referred to as the "Board").
(b) Functions
The Board shall advise and assist the Secretary in the preparation of general regulations and with respect to policy matters arising in the administration of this subpart.
(c) Use of services of members by Secretary
The Secretary may use the services of any member of the Board, in connection with matters related to the administration of this part for such periods, in addition to conference periods, as the Secretary may determine.
(d) Compensation
Appointed members of the Board who are not otherwise in the employ of the United States, while attending conferences of the Board or otherwise serving at the request of the Secretary in connection with the administration of this subpart, shall be entitled to receive compensation, per diem in lieu of subsistence, and travel expenses in the same manner and under the same conditions as that prescribed under
(July 1, 1944, ch. 373, title IV, §471, as added Nov. 20, 1985,
Termination of Advisory Boards
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
§286b–3. Grants for training in medical library sciences
The Secretary shall make grants—
(1) to individuals to enable them to accept traineeships and fellowships leading to postbaccalaureate academic degrees in the field of medical library science, in related fields pertaining to sciences related to health, or in the field of the communication of information;
(2) to individuals who are librarians or specialists in information on sciences relating to health, to enable them to undergo intensive training or retraining so as to attain greater competence in their occupations (including competence in the fields of automatic data processing and retrieval);
(3) to assist appropriate public and private nonprofit institutions in developing, expanding, and improving training programs in library science and the field of communications of information pertaining to sciences relating to health; and
(4) to assist in the establishment of internship programs in established medical libraries meeting standards which the Secretary shall prescribe.
(July 1, 1944, ch. 373, title IV, §472, as added Nov. 20, 1985,
Section Referred to in Other Sections
This section is referred to in
§286b–4. Assistance for projects in sciences related to health, for research and development in medical library science, and for development of education technologies
(a) Compilation of existing and original writings on health
The Secretary shall make grants to physicians and other practitioners in the sciences related to health, to scientists, and to public or nonprofit private institutions on behalf of such physicians, other practitioners, and scientists for the compilation of existing, or the writing of original, contributions relating to scientific, social, or cultural advancements in sciences related to health. In making such grants, the Secretary shall make appropriate arrangements under which the facilities of the Library and the facilities of libraries of public and private nonprofit institutions of higher learning may be made available in connection with the projects for which such grants are made.
(b) Medical library science and related activities
The Secretary shall make grants to appropriate public or private nonprofit institutions and enter into contracts with appropriate persons, for purposes of carrying out projects of research, investigations, and demonstrations in the field of medical library science and related activities and for the development of new techniques, systems, and equipment, for processing, storing, retrieving, and distributing information pertaining to sciences related to health.
(c) Development of education technologies
(1) The Secretary shall make grants to public or nonprofit private institutions for the purpose of carrying out projects of research on, and development and demonstration of, new education technologies.
(2) The purposes for which a grant under paragraph (1) may be made include projects concerning—
(A) computer-assisted teaching and testing of clinical competence at health professions and research institutions;
(B) the effective transfer of new information from research laboratories to appropriate clinical applications;
(C) the expansion of the laboratory and clinical uses of computer-stored research databases; and
(D) the testing of new technologies for training health care professionals.
(3) The Secretary may not make a grant under paragraph (1) unless the applicant for the grant agrees to make the projects available with respect to—
(A) assisting in the training of health professions students; and
(B) enhancing and improving the capabilities of health professionals regarding research and teaching.
(July 1, 1944, ch. 373, title IV, §473, as added Nov. 20, 1985,
Amendments
1993—Subsec. (c).
Section Referred to in Other Sections
This section is referred to in
§286b–5. Grants for establishing, expanding, and improving basic resources of medical libraries and related instrumentalities
(a) The Secretary shall make grants of money, materials, or both, to public or private nonprofit medical libraries and related scientific communication instrumentalities for the purpose of establishing, expanding, and improving their basic medical library or related resources. A grant under this subsection may be used for—
(1) the acquisition of books, journals, photographs, motion picture and other films, and other similar materials;
(2) cataloging, binding, and other services and procedures for processing library resource materials for use by those who are served by the library or related instrumentality;
(3) the acquisition of duplication devices, facsimile equipment, film projectors, recording equipment, and other equipment to facilitate the use of the resources of the library or related instrumentality by those who are served by it; and
(4) the introduction of new technologies in medical librarianship.
(b)(1) The amount of any grant under this section to any medical library or related instrumentality shall be determined by the Secretary on the basis of the scope of library or related services provided by such library or instrumentality in relation to the population and purposes served by it. In making a determination of the scope of services served by any medical library or related instrumentality, the Secretary shall take into account—
(A) the number of graduate and undergraduate students making use of the resources of such library or instrumentality;
(B) the number of physicians and other practitioners in the sciences related to health utilizing the resources of such library or instrumentality;
(C) the type of supportive staffs, if any, available to such library or instrumentality;
(D) the type, size, and qualifications of the faculty of any school with which such library or instrumentality is affiliated;
(E) the staff of any hospital or hospitals or of any clinic or clinics with which such library or instrumentality is affiliated; and
(F) the geographic area served by such library or instrumentality and the availability within such area of medical library or related services provided by other libraries or related instrumentalities.
(2) Grants to such medical libraries or related instrumentalities under this section shall be in such amounts as the Secretary may by regulation prescribe with a view to assuring adequate continuing financial support for such libraries or instrumentalities from other sources during and after the period for which grants are provided, except that in no case shall any grant under this section to a medical library or related instrumentality for any fiscal year exceed $1,000,000.
(July 1, 1944, ch. 373, title IV, §474, as added Nov. 20, 1985,
Amendments
1993—Subsec. (b)(2).
1988—Subsec. (b)(2).
Section Referred to in Other Sections
This section is referred to in
§286b–6. Grants and contracts for establishment of regional medical libraries
(a) Existing public or private nonprofit medical libraries
The Secretary, with the advice of the Board, shall make grants to and enter into contracts with existing public or private nonprofit medical libraries so as to enable each of them to serve as the regional medical library for the geographical area in which it is located.
(b) Uses for grants and contracts
The uses for which grants and contracts under this section may be employed include the—
(1) acquisition of books, journals, and other similar materials;
(2) cataloging, binding, and other procedures for processing library resource materials for use by those who are served by the library;
(3) acquisition of duplicating devices and other equipment to facilitate the use of the resources of the library by those who are served by it;
(4) acquisition of mechanisms and employment of personnel for the speedy transmission of materials from the regional library to local libraries in the geographic area served by the regional library; and
(5) planning for services and activities under this section.
(c) Conditions
(1) Grants and contracts under this section shall only be made to or entered into with medical libraries which agree—
(A) to modify and increase their library resources, and to supplement the resources of cooperating libraries in the region, so as to be able to provide adequate supportive services to all libraries in the region as well as to individual users of library services; and
(B) to provide free loan services to qualified users and make available photoduplicated or facsimile copies of biomedical materials which qualified requesters may retain.
(2) The Secretary, in awarding grants and contracts under this section, shall give priority to medical libraries having the greatest potential of fulfilling the needs for regional medical libraries. In determining the priority to be assigned to any medical library, the Secretary shall consider—
(A) the adequacy of the library (in terms of collections, personnel, equipment, and other facilities) as a basis for a regional medical library; and
(B) the size and nature of the population to be served in the region in which the library is located.
(d) Basic resources materials; limitation on grant or contract
Grants and contracts under this section for basic resource materials to a library may not exceed—
(1) 50 percent of the library's annual operating expense (exclusive of Federal financial assistance under this part) for the preceding year; or
(2) in case of the first year in which the library receives a grant under this section for basic resource materials, 50 percent of its average annual operating expenses over the past three years (or if it had been in operation for less than three years, its annual operating expenses determined by the Secretary in accordance with regulations).
(July 1, 1944, ch. 373, title IV, §475, as added Nov. 20, 1985,
Section Referred to in Other Sections
This section is referred to in
§286b–7. Financial support of biomedical scientific publications
(a) The Secretary, with the advice of the Board, shall make grants to, and enter into appropriate contracts with, public or private nonprofit institutions of higher education and individual scientists for the purpose of supporting biomedical scientific publications of a nonprofit nature and to procure the compilation, writing, editing, and publication of reviews, abstracts, indices, handbooks, bibliographies, and related matter pertaining to scientific works and scientific developments.
(b) Grants under subsection (a) of this section in support of any single periodical publication may not be made for more than three years, except in those cases in which the Secretary determines that further support is necessary to carry out the purposes of subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, §476, as added Nov. 20, 1985,
Section Referred to in Other Sections
This section is referred to in
§286b–8. Grant payments, records, and audit
(a) Payments under grants made under
(b)(1) Each recipient of a grant under this subpart shall keep such records as the Secretary shall prescribe, including records which fully disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the project or undertaking in connection with which such grant is given or used, and the amount of that portion of the cost of the project or undertaking supplied by other sources, and such other records as will facilitate an effective audit.
(2) The Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and records of such recipients that are pertinent to any grant received under this subpart.
(July 1, 1944, ch. 373, title IV, §477, as added Nov. 20, 1985,
subpart 3—national center for biotechnology information
§286c. Purpose, establishment, functions, and funding of National Center for Biotechnology Information
(a) Establishment
In order to focus and expand the collection, storage, retrieval, and dissemination of the results of biotechnology research by information systems, and to support and enhance the development of new information technologies to aid in the understanding of the molecular processes that control health and disease, there is established the National Center for Biotechnology Information (hereinafter in this section referred to as the "Center") in the National Library of Medicine.
(b) Functions
The Secretary, through the Center and subject to
(1) design, develop, implement, and manage automated systems for the collection, storage, retrieval, analysis, and dissemination of knowledge concerning human molecular biology, biochemistry, and genetics;
(2) perform research into advanced methods of computer-based information processing capable of representing and analyzing the vast number of biologically important molecules and compounds;
(3) enable persons engaged in biotechnology research and medical care to use systems developed under paragraph (1) and methods described in paragraph (2); and
(4) coordinate, as much as is practicable, efforts to gather biotechnology information on an international basis.
(July 1, 1944, ch. 373, title IV, §478, as added Nov. 4, 1988,
Amendments
1993—Subsec. (c).
subpart 4—national information center on health services research and health care technology
§286d. National Information Center
(a) Establishment
There is established within the Library an entity to be known as the National Information Center on Health Services Research and Health Care Technology (in this section referred to as the "Center").
(b) Purpose
The purpose of the Center is the collection, storage, analysis, retrieval, and dissemination of information on health services research, clinical practice guidelines, and on health care technology, including the assessment of such technology. Such purpose includes developing and maintaining data bases and developing and implementing methods of carrying out such purpose.
(c) Electronic, convenient format; criteria for inclusion
The Director of the Center shall ensure that information under subsection (b) of this section concerning clinical practice guidelines is collected and maintained electronically and in a convenient format. Such Director shall develop and publish criteria for the inclusion of practice guidelines and technology assessments in the information center database.
(d) Coordination with Administrator for Health Care Policy and Research
The Secretary, acting through the Center, shall coordinate the activities carried out under this section through the Center with related activities of the Administrator for Health Care Policy and Research.
(July 1, 1944, ch. 373, title IV, §478A, as added June 10, 1993,
Construction
Section 1422(b) of
Section Referred to in Other Sections
This section is referred to in
Part E—Other Agencies of NIH
subpart 1—national center for research resources
§287. General purpose
The general purpose of the National Center for Research Resources (in this subpart referred to as the "Center") is to strengthen and enhance the research environments of entities engaged in health-related research by developing and supporting essential research resources.
(July 1, 1944, ch. 373, title IV, §479, as added Nov. 20, 1985,
Amendments
1993—
§287a. Advisory council
(a) Appointment; functions and duties; acceptance of conditional gifts; subcommittees
(1) The Secretary shall appoint an advisory council for the Center which shall advise, assist, consult with, and make recommendations to the Secretary and the Director of the Center on matters related to the activities carried out by and through the Center and the policies respecting such activities.
(2) The advisory council for the Center may recommend to the Secretary acceptance, in accordance with
(3) The advisory council for the Center—
(A)(i) may make recommendations to the Director of the Center respecting research conducted at the Center,
(ii) may review applications for grants and cooperative agreements for research or training and recommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and
(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the Center;
(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspects of human health with respect to which the Center is concerned and with the approval of the Director of the Center make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and
(C) may appoint subcommittees and convene workshops and conferences.
(b) Membership; ex officio members; compensation
(1) The advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary.
(2) The ex officio members of the advisory council shall consist of—
(A) the Secretary, the Director of NIH, the Director of the Center, the Under Secretary for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and
(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions.
(3) The members of the advisory council who are not ex officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including public health and the behavioral or social sciences) relevant to the activities of the Center.
(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management.
(4) Members of the advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The other members of the advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule.
(c) Term of office; vacancy; reappointment
The term of office of an appointed member of the advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term until a successor has taken office. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.
(d) Chairman; selection; term of office
The chairman of the advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the Center to be the chairman of the advisory council. The term of office of the chairman shall be two years.
(e) Meetings
The advisory council shall meet at the call of the chairman or upon the request of the Director of the Center, but at least three times each fiscal year. The location of the meetings of the advisory council is subject to the approval of the Director of the Center.
(f) Executive secretary; staff; orientation and training for new members
The Director of the Center shall designate a member of the staff of the Center to serve as the executive secretary of the advisory council. The Director of the Center shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of the Center shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council.
(g) Material for inclusion in biennial report; additional reports
The advisory council may prepare, for inclusion in the biennial report made under
(h) Advisory council in existence on November 20, 1985
This section does not terminate the membership of the advisory council for the Center which was in existence on November 20, 1985. After November 20, 1985—
(1) the Secretary shall make appointments to such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section;
(2) the advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and
(3) the Director of the Center shall perform for such advisory council the functions prescribed by this section.
(July 1, 1944, ch. 373, title IV, §480, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a)(1).
Subsec. (a)(2).
Subsec. (a)(3).
Subsec. (b).
Subsec. (d).
Subsec. (e).
Subsec. (f).
Subsec. (g).
Subsec. (h).
1992—Subsec. (b)(2)(A).
1990—Subsec. (a)(2).
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Section Referred to in Other Sections
This section is referred to in
§287a–1. Biennial report
The Director of the Center, after consultation with the advisory council for the Center, shall prepare for inclusion in the biennial report made under
(July 1, 1944, ch. 373, title IV, §481, as added Nov. 20, 1985,
Amendments
1993—
Section Referred to in Other Sections
This section is referred to in
§287a–2. Biomedical and behavioral research facilities
(a) Modernization and construction of facilities
(1) In general
The Director of NIH, acting through the Director of the Center, may make grants to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities, subject to the provisions of this section.
(2) Construction and cost of construction
For purposes of this section, the terms "construction" and "cost of construction" include the construction of new buildings and the expansion, renovation, remodeling, and alteration of existing buildings, including architects' fees, but do not include the cost of acquisition of land or off-site improvements.
(b) Scientific and technical review boards for merit-based review of proposals
(1) In general; approval as precondition to grants
(A) There is established within the Center a Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities (referred to in this section as the "Board").
(B) The Director of the Center may approve an application for a grant under subsection (a) of this section only if the Board has under paragraph (2) recommended the application for approval.
(2) Duties
(A) The Board shall provide advice to the Director of the Center and the advisory council established under
(B) In carrying out subparagraph (A), the Board shall make a determination of the merit of each application submitted for a grant under subsection (a) of this section, after consideration of the requirements established in subsection (c) of this section, and shall report the results of the determination to the Director of the Center and the Advisory Council. Such determinations shall be conducted in a manner consistent with procedures established under
(C) In carrying out subparagraph (A), the Board shall, in the case of applications recommended for approval, make recommendations to the Director and the Advisory Council on the amount that should be provided in the grant.
(D) In carrying out subparagraph (A), the Board shall prepare an annual report for the Director of the Center and the Advisory Council describing the activities of the Board in the fiscal year for which the report is made. Each such report shall be available to the public, and shall—
(i) summarize and analyze expenditures made under this section;
(ii) provide a summary of the types, numbers, and amounts of applications that were recommended for grants under subsection (a) of this section but that were not approved by the Director of the Center; and
(iii) contain the recommendations of the Board for any changes in the administration of this section.
(3) Membership
(A) Subject to subparagraph (B), the Board shall be composed of 9 appointed members, and such ex officio members as the Director of the Center determines to be appropriate.
(B) Not more than 3 individuals who are officers or employees of the Federal Government may serve as members of the Board.
(4) Certain requirements regarding membership
In selecting individuals for membership on the Board, the Director of the Center shall ensure that the members are individuals who, by virtue of their training or experience, are eminently qualified to perform peer review functions. In selecting such individuals for such membership, the Director of the Center shall ensure that the members of the Board collectively—
(A) are experienced in the planning, construction, financing, and administration of entities that conduct biomedical or behavioral research sciences;
(B) are knowledgeable in making determinations of the need of entities for biomedical or behavioral research facilities, including such facilities for the dentistry, nursing, pharmacy, and allied health professions;
(C) are knowledgeable in evaluating the relative priorities for applications for grants under subsection (a) of this section in view of the overall research needs of the United States; and
(D) are experienced with emerging centers of excellence, as described in subsection (c)(3) of this section.
(5) Certain authorities
(A) In carrying out paragraph (2), the Board may convene workshops and conferences, and collect data as the Board considers appropriate.
(B) In carrying out paragraph (2), the Board may establish subcommittees within the Board. Such subcommittees may hold meetings as determined necessary to enable the subcommittee to carry out its duties.
(6) Terms
(A) Except as provided in subparagraph (B), each appointed member of the Board shall hold office for a term of 4 years. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which such member's predecessor was appointed shall be appointed for the remainder of the term of the predecessor.
(B) Of the initial members appointed to the Board (as specified by the Director of the Center when making the appointments)—
(i) 3 shall hold office for a term of 3 years;
(ii) 3 shall hold office for a term of 2 years; and
(iii) 3 shall hold office for a term of 1 year.
(C) No member is eligible for reappointment to the Board until 1 year has elapsed after the end of the most recent term of the member.
(7) Compensation
Members of the Board who are not officers or employees of the United States shall receive for each day the members are engaged in the performance of the functions of the Board compensation at the same rate received by members of other national advisory councils established under this subchapter.
(c) Requirements for grants
(1) In general
The Director of the Center may make a grant under subsection (a) of this section only if the applicant for the grant meets the following conditions:
(A) The applicant is determined by such Director to be competent to engage in the type of research for which the proposed facility is to be constructed.
(B) The applicant provides assurances satisfactory to the Director that—
(i) for not less than 20 years after completion of the construction, the facility will be used for the purposes of research for which it is to be constructed;
(ii) sufficient funds will be available to meet the non-Federal share of the cost of constructing the facility;
(iii) sufficient funds will be available, when construction is completed, for the effective use of the facility for the research for which it is being constructed; and
(iv) the proposed construction will expand the applicant's capacity for research, or is necessary to improve or maintain the quality of the applicant's research.
(C) The applicant meets reasonable qualifications established by the Director with respect to—
(i) the relative scientific and technical merit of the applications, and the relative effectiveness of the proposed facilities, in expanding the capacity for biomedical or behavioral research and in improving the quality of such research;
(ii) the quality of the research or training, or both, to be carried out in the facilities involved;
(iii) the need of the applicant for such facilities in order to maintain or expand the applicant's research and training mission;
(iv) the congruence of the research activities to be carried out within the facility with the research and investigator manpower needs of the United States; and
(v) the age and condition of existing research facilities and equipment.
(D) The applicant has demonstrated a commitment to enhancing and expanding the research productivity of the applicant.
(2) Consideration of certain factors
In making grants under subsection (a) of this section, the Director of the Center may, in addition to the requirements established in paragraph (1), consider the following factors:
(A) To what extent the applicant has the capacity to broaden the scope of research and research training programs of the applicant by promoting—
(i) interdisciplinary research;
(ii) research on emerging technologies, including those involving novel analytical techniques or computational methods; or
(iii) other novel research mechanisms or programs.
(B) To what extent the applicant has broadened the scope of research and research training programs of qualified institutions by promoting genomic research with an emphasis on interdisciplinary research, including research related to pediatric investigations.
(3) Institutions of emerging excellence
Of the amounts appropriated under subsection (h) of this section for a fiscal year, the Director of the Center shall make available 25 percent for grants under subsection (a) of this section to applicants that, in addition to meeting the requirements established in paragraph (1), have demonstrated emerging excellence in biomedical or behavioral research, as follows:
(A) The applicant has a plan for research or training advancement and possesses the ability to carry out the plan.
(B) The applicant carries out research and research training programs that have a special relevance to a problem, concern, or unmet health need of the United States.
(C) The applicant has been productive in research or research development and training.
(D) The applicant—
(i) has been designated as a center of excellence under
(ii) is located in a geographic area whose population includes a significant number of individuals with a health-status deficit, and the applicant provides health services to such individuals; or
(iii) is located in a geographic area in which a deficit in health care technology, services, or research resources may adversely affect health status of the population of the area in the future, and the applicant is carrying out activities with respect to protecting the health status of such population.
(d) Requirement of application
The Director of the Center may make a grant under subsection (a) of this section only if an application for the grant is submitted to the Director and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Director determines to be necessary to carry out this section.
(e) Amount of grant; payments
(1) Amount
The amount of any grant awarded under subsection (a) of this section shall be determined by the Director of the Center, except that such amount shall not exceed—
(A) 50 percent of the necessary cost of the construction of a proposed facility as determined by the Director; or
(B) in the case of a multipurpose facility, 40 percent of that part of the necessary cost of construction that the Director determines to be proportionate to the contemplated use of the facility.
(2) Reservation of amounts
On approval of any application for a grant under subsection (a) of this section, the Director of the Center shall reserve, from any appropriation available therefore, the amount of such grant, and shall pay such amount, in advance or by way of reimbursement, and in such installments consistent with the construction progress, as the Director may determine appropriate. The reservation of the Director of any amount by the Director under this paragraph may be amended by the Director, either on the approval of an amendment of the application or on the revision of the estimated cost of construction of the facility.
(3) Exclusion of certain costs
In determining the amount of any grant under this subsection (a) of this section, there shall be excluded from the cost of construction an amount equal to the sum of—
(A) the amount of any other Federal grant that the applicant has obtained, or is assured of obtaining, with respect to construction that is to be financed in part by a grant authorized under this section; and
(B) the amount of any non-Federal funds required to be expended as a condition of such other Federal grant.
(4) Waiver of limitations
The limitations imposed by paragraph (1) may be waived at the discretion of the Director for applicants meeting the conditions described in paragraphs (1) and (2) of subsection (c) of this section.
(f) Recapture of payments
If, not later than 20 years after the completion of construction for which a grant has been awarded under subsection (a) of this section—
(1) the applicant or other owner of the facility shall cease to be a public or nonprofit private entity; or
(2) the facility shall cease to be used for the research purposes for which it was constructed (unless the Director determines, in accordance with regulations, that there is good cause for releasing the applicant or other owner from obligation to do so);
the United States shall be entitled to recover from the applicant or other owner of the facility the amount bearing the same ratio to the current value (as determined by an agreement between the parties or by action brought in the United States District Court for the district in which such facility is situated) of the facility as the amount of the Federal participation bore to the cost of the construction of such facility.
(g) Guidelines
Not later than 6 months after June 10, 1993, the Director of the Center, after consultation with the Advisory Council, shall issue guidelines with respect to grants under subsection (a) of this section.
(h) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated $150,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996.
(July 1, 1944, ch. 373, title IV, §481A, as added June 10, 1993,
Section Referred to in Other Sections
This section is referred to in
§287a–3. Construction of regional centers for research on primates
(a) With respect to activities carried out by the National Center for Research Resources to support regional centers for research on primates, the Director of NIH shall, for each of the fiscal years 1994 through 1996, reserve from the amounts appropriated under
(b) The Director of NIH may not make a grant or enter into a contract under subsection (a) of this section unless the applicant for such assistance agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such subsection, to make available (directly or through donations from public or private entities) non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $4 of Federal funds provided in such assistance.
(July 1, 1944, ch. 373, title IV, §481B, as added June 10, 1993,
subpart 2—john e. fogarty international center for advanced study in health sciences
§287b. General purpose
The general purpose of the John E. Fogarty International Center for Advanced Study in the Health Sciences is to—
(1) facilitate the assembly of scientists and others in the biomedical, behavioral, and related fields for discussion, study, and research relating to the development of health science internationally;
(2) provide research programs, conferences, and seminars to further international cooperation and collaboration in the life sciences;
(3) provide postdoctorate fellowships for research training in the United States and abroad and promote exchanges of senior scientists between the United States and other countries;
(4) coordinate the activities of the National Institutes of Health concerned with the health sciences internationally; and
(5) receive foreign visitors to the National Institutes of Health.
(July 1, 1944, ch. 373, title IV, §482, as added Nov. 20, 1985,
subpart 3—national center for human genome research
§287c. Purpose of Center
(a) General purpose
The general purpose of the National Center for Human Genome Research (in this subpart referred to as the "Center") is to characterize the structure and function of the human genome, including the mapping and sequencing of individual genes. Such purpose includes—
(1) planning and coordinating the research goal of the genome project;
(2) reviewing and funding research proposals;
(3) developing training programs;
(4) coordinating international genome research;
(5) communicating advances in genome science to the public; and
(6) reviewing and funding proposals to address the ethical and legal issues associated with the genome project (including legal issues regarding patents).
(b) Research training
The Director of the Center may conduct and support research training—
(1) for which fellowship support is not provided under
(2) that is not residency training of physicians or other health professionals.
(c) Amount available for ethical and legal issues
(1) Except as provided in paragraph (2), of the amounts appropriated to carry out subsection (a) of this section for a fiscal year, the Director of the Center shall make available not less than 5 percent for carrying out paragraph (6) of such subsection.
(2) With respect to providing funds under subsection (a)(6) of this section for proposals to address the ethical issues associated with the genome project, paragraph (1) shall not apply for a fiscal year if the Director of the Center certifies to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, that the Director has determined that an insufficient number of such proposals meet the applicable requirements of
(July 1, 1944, ch. 373, title IV, §485B, as added June 10, 1993,
Prior Provisions
A prior section 287c, act July 1, 1944, ch. 373, title IV, §483, as added Nov. 20, 1985,
A prior section 287c–1, act July 1, 1944, ch. 373, title IV, §484, as added Nov. 20, 1985,
A prior section 287c–2, act July 1, 1944, ch. 373, title IV, §485, as added Nov. 20, 1985,
A prior section 287c–3, act July 1, 1944, ch. 373, title IV, §486, as added Nov. 20, 1985,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
subpart 4—office of dietary supplements
§287c–11. Dietary supplements
(a) Establishment
The Secretary shall establish an Office of Dietary Supplements within the National Institutes of Health.
(b) Purpose
The purposes of the Office are—
(1) to explore more fully the potential role of dietary supplements as a significant part of the efforts of the United States to improve health care; and
(2) to promote scientific study of the benefits of dietary supplements in maintaining health and preventing chronic disease and other health-related conditions.
(c) Duties
The Director of the Office of Dietary Supplements shall—
(1) conduct and coordinate scientific research within the National Institutes of Health relating to dietary supplements and the extent to which the use of dietary supplements can limit or reduce the risk of diseases such as heart disease, cancer, birth defects, osteoporosis, cataracts, or prostatism;
(2) collect and compile the results of scientific research relating to dietary supplements, including scientific data from foreign sources or the Office of Alternative Medicine;
(3) serve as the principal advisor to the Secretary and to the Assistant Secretary for Health and provide advice to the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, and the Commissioner of Food and Drugs on issues relating to dietary supplements including—
(A) dietary intake regulations;
(B) the safety of dietary supplements;
(C) claims characterizing the relationship between—
(i) dietary supplements; and
(ii)(I) prevention of disease or other health-related conditions; and
(II) maintenance of health; and
(D) scientific issues arising in connection with the labeling and composition of dietary supplements;
(4) compile a database of scientific research on dietary supplements and individual nutrients; and
(5) coordinate funding relating to dietary supplements for the National Institutes of Health.
(d) "Dietary supplement" defined
As used in this section, the term "dietary supplement" has the meaning given the term in
(e) Authorization of appropriations
There are authorized to be appropriated to carry out this section $5,000,000 for fiscal year 1994 and such sums as may be necessary for each subsequent fiscal year.
(July 1, 1944, ch. 373, title IV, §485C, as added Oct. 25, 1994,
Part F—Research on Women's Health
§287d. Office of Research on Women's Health
(a) Establishment
There is established within the Office of the Director of NIH an office to be known as the Office of Research on Women's Health (in this part referred to as the "Office"). The Office shall be headed by a director, who shall be appointed by the Director of NIH.
(b) Purpose
The Director of the Office shall—
(1) identify projects of research on women's health that should be conducted or supported by the national research institutes;
(2) identify multidisciplinary research relating to research on women's health that should be so conducted or supported;
(3) carry out paragraphs (1) and (2) with respect to the aging process in women, with priority given to menopause;
(4) promote coordination and collaboration among entities conducting research identified under any of paragraphs (1) through (3);
(5) encourage the conduct of such research by entities receiving funds from the national research institutes;
(6) recommend an agenda for conducting and supporting such research;
(7) promote the sufficient allocation of the resources of the national research institutes for conducting and supporting such research;
(8) assist in the administration of
(9) prepare the report required in
(c) Coordinating Committee
(1) In carrying out subsection (b) of this section, the Director of the Office shall establish a committee to be known as the Coordinating Committee on Research on Women's Health (in this subsection referred to as the "Coordinating Committee").
(2) The Coordinating Committee shall be composed of the Directors of the national research institutes (or the designees of the Directors).
(3) The Director of the Office shall serve as the chair of the Coordinating Committee.
(4) With respect to research on women's health, the Coordinating Committee shall assist the Director of the Office in—
(A) identifying the need for such research, and making an estimate each fiscal year of the funds needed to adequately support the research;
(B) identifying needs regarding the coordination of research activities, including intramural and extramural multidisciplinary activities;
(C) supporting the development of methodologies to determine the circumstances in which obtaining data specific to women (including data relating to the age of women and the membership of women in ethnic or racial groups) is an appropriate function of clinical trials of treatments and therapies;
(D) supporting the development and expansion of clinical trials of treatments and therapies for which obtaining such data has been determined to be an appropriate function; and
(E) encouraging the national research institutes to conduct and support such research, including such clinical trials.
(d) Advisory Committee
(1) In carrying out subsection (b) of this section, the Director of the Office shall establish an advisory committee to be known as the Advisory Committee on Research on Women's Health (in this subsection referred to as the "Advisory Committee").
(2) The Advisory Committee shall be composed of no fewer than 12, and not more than 18 individuals, who are not officers or employees of the Federal Government. The Director of the Office shall make appointments to the Advisory Committee from among physicians, practitioners, scientists, and other health professionals, whose clinical practice, research specialization, or professional expertise includes a significant focus on research on women's health. A majority of the members of the Advisory Committee shall be women.
(3) The Director of the Office shall serve as the chair of the Advisory Committee.
(4) The Advisory Committee shall—
(A) advise the Director of the Office on appropriate research activities to be undertaken by the national research institutes with respect to—
(i) research on women's health;
(ii) research on gender differences in clinical drug trials, including responses to pharmacological drugs;
(iii) research on gender differences in disease etiology, course, and treatment;
(iv) research on obstetrical and gynecological health conditions, diseases, and treatments; and
(v) research on women's health conditions which require a multidisciplinary approach;
(B) report to the Director of the Office on such research;
(C) provide recommendations to such Director regarding activities of the Office (including recommendations on the development of the methodologies described in subsection (c)(4)(C) of this section and recommendations on priorities in carrying out research described in subparagraph (A)); and
(D) assist in monitoring compliance with
(5)(A) The Advisory Committee shall prepare a biennial report describing the activities of the Committee, including findings made by the Committee regarding—
(i) compliance with
(ii) the extent of expenditures made for research on women's health by the agencies of the National Institutes of Health; and
(iii) the level of funding needed for such research.
(B) The report required in subparagraph (A) shall be submitted to the Director of NIH for inclusion in the report required in
(e) Representation of women among researchers
The Secretary, acting through the Assistant Secretary for Personnel and in collaboration with the Director of the Office, shall determine the extent to which women are represented among senior physicians and scientists of the national research institutes and among physicians and scientists conducting research with funds provided by such institutes, and as appropriate, carry out activities to increase the extent of such representation.
(f) Definitions
For purposes of this part:
(1) The term "women's health conditions", with respect to women of all age, ethnic, and racial groups, means all diseases, disorders, and conditions (including with respect to mental health)—
(A) unique to, more serious, or more prevalent in women;
(B) for which the factors of medical risk or types of medical intervention are different for women, or for which it is unknown whether such factors or types are different for women; or
(C) with respect to which there has been insufficient clinical research involving women as subjects or insufficient clinical data on women.
(2) The term "research on women's health" means research on women's health conditions, including research on preventing such conditions.
(July 1, 1944, ch. 373, title IV, §486, as added June 10, 1993,
Termination of Advisory Committees
Advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided for by law. See section 14 of
Section Referred to in Other Sections
This section is referred to in
§287d–1. National data system and clearinghouse on research on women's health
(a) Data system
(1) The Director of NIH, in consultation with the Director of the Office and the Director of the National Library of Medicine, shall establish a data system for the collection, storage, analysis, retrieval, and dissemination of information regarding research on women's health that is conducted or supported by the national research institutes. Information from the data system shall be available through information systems available to health care professionals and providers, researchers, and members of the public.
(2) The data system established under paragraph (1) shall include a registry of clinical trials of experimental treatments that have been developed for research on women's health. Such registry shall include information on subject eligibility criteria, sex, age, ethnicity or race, and the location of the trial site or sites. Principal investigators of such clinical trials shall provide this information to the registry within 30 days after it is available. Once a trial has been completed, the principal investigator shall provide the registry with information pertaining to the results, including potential toxicities or adverse effects associated with the experimental treatment or treatments evaluated.
(b) Clearinghouse
The Director of NIH, in consultation with the Director of the Office and with the National Library of Medicine, shall establish, maintain, and operate a program to provide information on research and prevention activities of the national research institutes that relate to research on women's health.
(July 1, 1944, ch. 373, title IV, §486A, as added June 10, 1993,
§287d–2. Biennial report
(a) In general
With respect to research on women's health, the Director of the Office shall, not later than February 1, 1994, and biennially thereafter, prepare a report—
(1) describing and evaluating the progress made during the preceding 2 fiscal years in research and treatment conducted or supported by the National Institutes of Health;
(2) describing and analyzing the professional status of women physicians and scientists of such Institutes, including the identification of problems and barriers regarding advancements;
(3) summarizing and analyzing expenditures made by the agencies of such Institutes (and by such Office) during the preceding 2 fiscal years; and
(4) making such recommendations for legislative and administrative initiatives as the Director of the Office determines to be appropriate.
(b) Inclusion in biennial report of Director of NIH
The Director of the Office shall submit each report prepared under subsection (a) of this section to the Director of NIH for inclusion in the report submitted to the President and the Congress under
(July 1, 1944, ch. 373, title IV, §486B, as added June 10, 1993,
Section Referred to in Other Sections
This section is referred to in
Part G—Awards and Training
Amendments
1993—
§288. National Research Service Awards
(a) Biomedical and behavioral research and research training; programs and institutions included; restriction; special consideration
(1) The Secretary shall—
(A) provide National Research Service Awards for—
(i) biomedical and behavioral research at the National Institutes of Health in matters relating to the cause, diagnosis, prevention, and treatment of the diseases or other health problems to which the activities of the National Institutes of Health and Administration 1 are directed;
(ii) training at the National Institutes of Health and at the Administration 1 of individuals to undertake such research;
(iii) biomedical and behavioral research and health services research (including research in primary medical care) at public and nonprofit private entities; and
(iv) pre-doctoral and post-doctoral training at public and private institutions of individuals to undertake biomedical and behavioral research;
(B) make grants to public and nonprofit private institutions to enable such institutions to make National Research Service Awards for research (and training to undertake biomedical and behavioral research) in the matters described in subparagraph (A)(i) to individuals selected by such institutions; and
(C) provide contracts for scholarships and loan repayments in accordance with
A reference in this subsection to the National Institutes of Health shall be considered to include the institutes, agencies, divisions, and bureaus included in the National Institutes of Health or under the Administration,1 as the case may be.
(2) National Research Service Awards may not be used to support residency training of physicians and other health professionals.
(3) In awarding National Research Service Awards under this section, the Secretary shall take account of the Nation's overall need for biomedical research personnel by giving special consideration to physicians who agree to undertake a minimum of two years of biomedical research.
(4) The Secretary shall carry out paragraph (1) in a manner that will result in the recruitment of women, and individuals from disadvantaged backgrounds (including racial and ethnic minorities), into fields of biomedical or behavioral research and in the provision of research training to women and such individuals.
(b) Prerequisites for Award; review and approval by appropriate advisory councils; Award period; uses for Award; payments to non-Federal public or nonprofit private institutions
(1) No National Research Service Award may be made by the Secretary to any individual unless—
(A) the individual has submitted to the Secretary an application therefor and the Secretary has approved the application;
(B) the individual provides, in such form and manner as the Secretary shall by regulation prescribe, assurances satisfactory to the Secretary that the individual will meet the service requirement of subsection (c) of this section; and
(C) in the case of a National Research Service Award for a purpose described in subsection (a)(1)(A)(iii) of this section, the individual has been sponsored (in such manner as the Secretary may by regulation require) by the institution at which the research or training under the award will be conducted.
An application for an award shall be in such form, submitted in such manner, and contain such information, as the Secretary may by regulation prescribe.
(2) The making of grants under subsection (a)(1)(B) of this section for National Research Service Awards shall be subject to review and approval by the appropriate advisory councils within the Department of Health and Human Services (A) whose activities relate to the research or training under the awards, or (B) for the entity at which such research or training will be conducted.
(3) No grant may be made under subsection (a)(1)(B) of this section unless an application therefor has been submitted to and approved by the Secretary. Such application shall be in such form, submitted in such manner, and contain such information, as the Secretary may by regulation prescribe. Subject to the provisions of this section (other than paragraph (1)), National Research Service Awards made under a grant under subsection (a)(1)(B) of this section shall be made in accordance with such regulations as the Secretary shall prescribe.
(4) The period of any National Research Service Award made to any individual under subsection (a) of this section may not exceed—
(A) five years in the aggregate for pre-doctoral training; and
(B) three years in the aggregate for post-doctoral training;
unless the Secretary for good cause shown waives the application of such limit to such individual.
(5) National Research Service Awards shall provide for such stipends, tuition, fees, and allowances (including travel and subsistence expenses and dependency allowances), adjusted periodically to reflect increases in the cost of living, for the recipients of the awards as the Secretary may deem necessary. A National Research Service Award made to an individual for research or research training at a non-Federal public or nonprofit private institution shall also provide for payments to be made to the institution for the cost of support services (including the cost of faculty salaries, supplies, equipment, general research support, and related items) provided such individual by such institution. The amount of any such payments to any institution shall be determined by the Secretary and shall bear a direct relationship to the reasonable costs of the institution for establishing and maintaining the quality of its biomedical and behavioral research and training programs.
(c) Health research or teaching; service period; recovery upon noncompliance with service requirement, formula; cancellation or waiver of obligation
(1) Each individual who is awarded a National Research Service Award for postdoctoral research training shall, in accordance with paragraph (3), engage in research training, research, or teaching that is health-related (or any combination thereof) for the period specified in paragraph (2). Such period shall be served in accordance with the usual patterns of scientific employment.
(2)(A) The period referred to in paragraph (1) is 12 months, or one month for each month for which the individual involved receives a National Research Service Award for postdoctoral research training, whichever is less.
(B) With respect to postdoctoral research training, in any case in which an individual receives a National Research Service Award for more than 12 months, the 13th month and each subsequent month of performing activities under the Award shall be considered to be activities engaged in toward satisfaction of the requirement established in paragraph (1) regarding a period of service.
(3) The requirement of paragraph (1) shall be complied with by any individual to whom it applies within such reasonable period of time, after the completion of such individual's award, as the Secretary shall by regulation prescribe. The Secretary shall by regulation prescribe the type of research and teaching in which an individual may engage to comply with such requirement and such other requirements respecting research and teaching as the Secretary considers appropriate.
(4)(A) If any individual to whom the requirement of paragraph (1) is applicable fails, within the period prescribed by paragraph (3), to comply with such requirements, the United States shall be entitled to recover from such individual an amount determined in accordance with the formula—
t−s
A=φ(------------------)
t
in which "A" is the amount the United States is entitled to recover; "φ" is the sum of the total amount paid under one or more National Research Service Awards to such individual; "t" is the total number of months in such individual's service obligation; and "s" is the number of months of such obligation served by such individual in accordance with paragraphs (1) and (2) of this subsection.
(B) Any amount which the United States is entitled to recover under subparagraph (A) shall, within the three-year period beginning on the date the United States becomes entitled to recover such amount, be paid to the United States. Until any amount due the United States under subparagraph (A) on account of any National Research Service Award is paid, there shall accrue to the United States interest on such amount at a rate fixed by the Secretary of the Treasury after taking into consideration private consumer rates of interest prevailing on the date the United States becomes entitled to such amount.
(5)(A) Any obligation of an individual under paragraph (1) shall be canceled upon the death of such individual.
(B) The Secretary shall by regulation provide for the waiver or suspension of any such obligation applicable to any individual whenever compliance by such individual is impossible or would involve substantial hardship to such individual or would be against equity and good conscience.
(d) Authorization of appropriations; apportionment
For the purpose of carrying out this section, there are authorized to be appropriated $400,000,000 for fiscal year 1994, and such sums as may be necessary for each of the fiscal years 1995 and 1996. Of the amounts appropriated under this subsection—
(1) not less than 15 percent shall be made available for payments under National Research Service Awards provided by the Secretary under subsection (a)(1)(A) of this section;
(2) not less than 50 percent shall be made available for grants under subsection (a)(1)(B) of this section for National Research Service Awards;
(3) 1 percent shall be made available to the Secretary, acting through the Administrator of the Health Resources and Services Administration, for payments under National Research Service Awards which (A) are made to individuals affiliated with entities which have received grants or contracts under
(4) not more than 4 percent may be obligated for National Research Service Awards for periods of three months or less.
(July 1, 1944, ch. 373, title IV, §487, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a)(1)(C).
Subsec. (a)(4).
Subsec. (c)(1), (2).
"(1) Each individual who is awarded a National Research Service Award (other than an individual who is a pre-baccalaureate student who is awarded a National Research Service Award for research training) shall, in accordance with paragraph (3), engage in health research or teaching or any combination thereof which is in accordance with the usual patterns of academic employment, for a period computed in accordance with paragraph (2).
"(2) For each month for which an individual receives a National Research Service Award which is made for a period in excess of twelve months, such individual shall engage in one month of health research or teaching or any combination thereof which is in accordance with the usual patterns of academic employment."
Subsec. (d).
Subsec. (d)(3).
1992—Subsec. (a)(1).
1989—Subsec. (d)(3).
Subsec. (d)(3)(B).
1988—Subsec. (d).
Subsec. (d)(3).
Effective Date of 1992 Amendment
Amendment by
Section Referred to in Other Sections
This section is referred to in
1 So in original. Reference to Administration probably should not appear.
§288–1. Loan repayment program for research with respect to acquired immune deficiency syndrome
(a) In general
The Secretary shall carry out a program of entering into agreements with appropriately qualified health professionals under which such health professionals agree to conduct, as employees of the National Institutes of Health, research with respect to acquired immune deficiency syndrome in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.
(b) Applicability of certain provisions
With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of subchapter II of this chapter, the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection (a) of this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program established in such subpart.
(c) Authorization of appropriations
For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1994 through 1996.
(July 1, 1944, ch. 373, title IV, §487A, as added Nov. 4, 1988,
Amendments
1993—
Effective Date of 1993 Amendment
Section 1611(b) of
§288–2. Loan repayment program for research with respect to contraception and infertility
(a) Establishment
The Secretary, in consultation with the Director of the National Institute of Child Health and Human Development, shall establish a program of entering into contracts with qualified health professionals (including graduate students) under which such health professionals agree to conduct research with respect to contraception, or with respect to infertility, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.
(b) Contracts, obligated service, breach of contract
The provisions of
(c) Availability of funds
Amounts available for carrying out this section shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were made available.
(July 1, 1944, ch. 373, title IV, §487B, as added June 10, 1993,
§288–3. Loan repayment program for research generally
(a) In general
(1) Authority for program
Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health professionals under which such health professionals agree to conduct research, as employees of the National Institutes of Health, in consideration of the Federal Government agreeing to repay, for each year of such service, not more than $20,000 of the principal and interest of the educational loans of such health professionals.
(2) Limitation
The Secretary may not enter into an agreement with a health professional pursuant to paragraph (1) unless such professional—
(A) has a substantial amount of educational loans relative to income; and
(B) agrees to serve as an employee of the National Institutes of Health for purposes of paragraph (1) for a period of not less than 3 years.
(b) Applicability of certain provisions
With respect to the National Health Service Corps Loan Repayment Program established in subpart III of part D of subchapter II of this chapter, the provisions of such subpart shall, except as inconsistent with subsection (a) of this section, apply to the program established in such subsection (a) of this section in the same manner and to the same extent as such provisions apply to the National Health Service Corps Loan Repayment Program established in such subpart.
(July 1, 1944, ch. 373, title IV, §487C, as added June 10, 1993,
§288–4. Undergraduate scholarship program regarding professions needed by National Research Institutes
(a) Establishment of program
(1) In general
Subject to
(A) the Director of NIH agrees to provide to the individuals scholarships for pursuing, as undergraduates at accredited institutions of higher education, academic programs appropriate for careers in professions needed by the National Institutes of Health; and
(B) the individuals agree to serve as employees of the National Institutes of Health, for the period described in subsection (c) of this section, in positions that are needed by the National Institutes of Health and for which the individuals are qualified.
(2) Individuals from disadvantaged backgrounds
The individuals referred to in paragraph (1) are individuals who—
(A) are enrolled or accepted for enrollment as full-time undergraduates at accredited institutions of higher education; and
(B) are from disadvantaged backgrounds.
(b) Facilitation of interest of students in careers at National Institutes of Health
In providing employment to individuals pursuant to contracts under subsection (a)(1) of this section, the Director of NIH shall carry out activities to facilitate the interest of the individuals in pursuing careers as employees of the National Institutes of Health.
(c) Period of obligated service
(1) Duration of service
For purposes of subparagraph (B) of subsection (a)(1) of this section, the period of service for which an individual is obligated to serve as an employee of the National Institutes of Health is, subject to paragraph (2)(A), 12 months for each academic year for which the scholarship under such subsection is provided.
(2) Schedule for service
(A) Subject to subparagraph (B), the Director of NIH may not provide a scholarship under subsection (a) of this section unless the individual applying for the scholarship agrees that—
(i) the individual will serve as an employee of the National Institutes of Health full-time for not less than 10 consecutive weeks of each year during which the individual is attending the educational institution involved and receiving such a scholarship;
(ii) the period of service as such an employee that the individual is obligated to provide under clause (i) is in addition to the period of service as such an employee that the individual is obligated to provide under subsection (a)(1)(B) of this section; and
(iii) not later than 60 days after obtaining the educational degree involved, the individual will begin serving full-time as such an employee in satisfaction of the period of service that the individual is obligated to provide under subsection (a)(1)(B) of this section.
(B) The Director of NIH may defer the obligation of an individual to provide a period of service under subsection (a)(1)(B) of this section, if the Director determines that such a deferral is appropriate.
(3) Applicability of certain provisions relating to appointment and compensation
For any period in which an individual provides service as an employee of the National Institutes of Health in satisfaction of the obligation of the individual under subsection (a)(1)(B) of this section or paragraph (2)(A)(i), the individual may be appointed as such an employee without regard to the provisions of title 5 relating to appointment and compensation.
(d) Provisions regarding scholarship
(1) Approval of academic program
The Director of NIH may not provide a scholarship under subsection (a) of this section for an academic year unless—
(A) the individual applying for the scholarship has submitted to the Director a proposed academic program for the year and the Director has approved the program; and
(B) the individual agrees that the program will not be altered without the approval of the Director.
(2) Academic standing
The Director of NIH may not provide a scholarship under subsection (a) of this section for an academic year unless the individual applying for the scholarship agrees to maintain an acceptable level of academic standing, as determined by the educational institution involved in accordance with regulations issued by the Secretary.
(3) Limitation on amount
The Director of NIH may not provide a scholarship under subsection (a) of this section for an academic year in an amount exceeding $20,000.
(4) Authorized uses
A scholarship provided under subsection (a) of this section may be expended only for tuition expenses, other reasonable educational expenses, and reasonable living expenses incurred in attending the school involved.
(5) Contract regarding direct payments to institution
In the case of an institution of higher education with respect to which a scholarship under subsection (a) of this section is provided, the Director of NIH may enter into a contract with the institution under which the amounts provided in the scholarship for tuition and other educational expenses are paid directly to the institution.
(e) Penalties for breach of scholarship contract
The provisions of
(f) Requirement of application
The Director of NIH may not provide a scholarship under subsection (a) of this section unless an application for the scholarship is submitted to the Director and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Director determines to be necessary to carry out this section.
(g) Availability of authorization of appropriations
Amounts appropriated for a fiscal year for scholarships under this section shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated.
(July 1, 1944, ch. 373, title IV, §487D, as added June 10, 1993,
References in Text
The provisions of title 5 relating to appointment and compensation, referred to in subsec. (c)(3), are classified generally to section 3301 et seq. and section 5301 et seq., respectively, of Title 5, Government Organization and Employees.
Section Referred to in Other Sections
This section is referred to in
§288–5. Loan repayment program regarding clinical researchers from disadvantaged backgrounds
(a) Implementation of program
(1) In general
Subject to
(2) Limitation
The Director of NIH may not enter into a contract with a health professional pursuant to paragraph (1) unless such professional has a substantial amount of education loans relative to income.
(3) Applicability of certain provisions regarding obligated service
Except to the extent inconsistent with this section, the provisions of
(b) Availability of authorization of appropriations
Amounts appropriated for a fiscal year for contracts under subsection (a) of this section shall remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated.
(July 1, 1944, ch. 373, title IV, §487E, as added June 10, 1993,
Section Referred to in Other Sections
This section is referred to in
§288a. Visiting Scientist Awards
(a) The Secretary may make awards (hereafter in this section referred to as "Visiting Scientist Awards") to outstanding scientists who agree to serve as visiting scientists at institutions of postsecondary education which have significant enrollments of disadvantaged students. Visiting Scientist Awards shall be made by the Secretary to enable the faculty and students of such institutions to draw upon the special talents of scientists from other institutions for the purpose of receiving guidance, advice, and instruction with regard to research, teaching, and curriculum development in the biomedical and behavioral sciences and such other aspects of these sciences as the Secretary shall deem appropriate.
(b) The amount of each Visiting Scientist Award shall include such sum as shall be commensurate with the salary or remuneration which the individual receiving the award would have been entitled to receive from the institution with which the individual has, or had, a permanent or immediately prior affiliation. Eligibility for and terms of Visiting Scientist Awards shall be determined in accordance with regulations the Secretary shall prescribe.
(July 1, 1944, ch. 373, title IV, §488, as added Nov. 20, 1985,
§288b. Studies respecting biomedical and behavioral research personnel
(a) Scope of undertaking
The Secretary shall, in accordance with subsection (b) of this section, arrange for the conduct of a continuing study to—
(1) establish (A) the Nation's overall need for biomedical and behavioral research personnel, (B) the subject areas in which such personnel are needed and the number of such personnel needed in each such area, and (C) the kinds and extent of training which should be provided such personnel;
(2) assess (A) current training programs available for the training of biomedical and behavioral research personnel which are conducted under this chapter, at or through national research institutes under the National Institutes of Health, and (B) other current training programs available for the training of such personnel;
(3) identify the kinds of research positions available to and held by individuals completing such programs;
(4) determine, to the extent feasible, whether the programs referred to in clause (B) of paragraph (2) would be adequate to meet the needs established under paragraph (1) if the programs referred to in clause (A) of paragraph (2) were terminated; and
(5) determine what modifications in the programs referred to in paragraph (2) are required to meet the needs established under paragraph (1).
(b) Arrangement with National Academy of Sciences or other nonprofit private groups or associations
(1) The Secretary shall request the National Academy of Sciences to conduct the study required by subsection (a) of this section under an arrangement under which the actual expenses incurred by such Academy in conducting such study will be paid by the Secretary. If the National Academy of Sciences is willing to do so, the Secretary shall enter into such an arrangement with such Academy for the conduct of such study.
(2) If the National Academy of Sciences is unwilling to conduct such study under such an arrangement, then the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associations under which such groups or associations will conduct such study and prepare and submit the reports thereon as provided in subsection (c) of this section.
(3) The National Academy of Sciences or other group or association conducting the study required by subsection (a) of this section shall conduct such study in consultation with the Director of NIH.
(c) Report to Congressional committees
A report on the results of the study required under subsection (a) of this section shall be submitted by the Secretary to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate at least once every four years.
(July 1, 1944, ch. 373, title IV, §489, as added Nov. 20, 1985,
Amendments
1992—Subsec. (a)(2).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1992 Amendment
Amendment by
Part H—General Provisions
Amendments
1993—
§289. Institutional review boards; ethics guidance program
(a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research involving human subjects submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that it has established (in accordance with regulations which the Secretary shall prescribe) a board (to be known as an "Institutional Review Board") to review biomedical and behavioral research involving human subjects conducted at or supported by such entity in order to protect the rights of the human subjects of such research.
(b)(1) The Secretary shall establish a program within the Department of Health and Human Services under which requests for clarification and guidance with respect to ethical issues raised in connection with biomedical or behavioral research involving human subjects are responded to promptly and appropriately.
(2) The Secretary shall establish a process for the prompt and appropriate response to information provided to the Director of NIH respecting incidences of violations of the rights of human subjects of research for which funds have been made available under this chapter. The process shall include procedures for the receiving of reports of such information from recipients of funds under this chapter and taking appropriate action with respect to such violations.
(July 1, 1944, ch. 373, title IV, §491, as added Nov. 20, 1985,
Section Referred to in Other Sections
This section is referred to in
§289a. Peer review requirements
(a) Applications for biomedical and behavioral research grants, cooperative agreements, and contracts; regulations
(1) The Secretary, acting through the Director of NIH, shall by regulation require appropriate technical and scientific peer review of—
(A) applications made for grants and cooperative agreements under this chapter for biomedical and behavioral research; and
(B) applications made for biomedical and behavioral research and development contracts to be administered through the National Institutes of Health.
(2) Regulations promulgated under paragraph (1) shall require that the review of applications made for grants, contracts, and cooperative agreements required by the regulations be conducted—
(A) to the extent practical, in a manner consistent with the system for technical and scientific peer review applicable on November 20, 1985, to grants under this chapter for biomedical and behavioral research, and
(B) to the extent practical, by technical and scientific peer review groups performing such review on or before November 20, 1985,
and shall authorize such review to be conducted by groups appointed under
(b) Periodic review of research at National Institutes of Health
The Director of NIH shall establish procedures for periodic technical and scientific peer review of research at the National Institutes of Health. Such procedures shall require that—
(1) the reviewing entity be provided a written description of the research to be reviewed, and
(2) the reviewing entity provide the advisory council of the national research institute involved with such description and the results of the review by the entity,
and shall authorize such review to be conducted by groups appointed under
(c) Compliance with requirements for inclusion of women and minorities in clinical research
(1) In technical and scientific peer review under this section of proposals for clinical research, the consideration of any such proposal (including the initial consideration) shall, except as provided in paragraph (2), include an evaluation of the technical and scientific merit of the proposal regarding compliance with
(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of
(July 1, 1944, ch. 373, title IV, §492, as added Nov. 20, 1985,
Amendments
1993—Subsec. (c).
Section Referred to in Other Sections
This section is referred to in
§289a–1. Certain provisions regarding review and approval of proposals for research
(a) Review as precondition to research
(1) Protection of human research subjects
(A) In the case of any application submitted to the Secretary for financial assistance to conduct research, the Secretary may not approve or fund any application that is subject to review under
(B) In the case of research that is subject to review under procedures established by the Secretary for the protection of human subjects in clinical research conducted by the National Institutes of Health, the Secretary may not authorize the conduct of the research unless the research has, pursuant to such procedures, been recommended for approval.
(2) Peer review
In the case of any proposal for the National Institutes of Health to conduct or support research, the Secretary may not approve or fund any proposal that is subject to technical and scientific peer review under
(b) Ethical review of research
(1) Procedures regarding withholding of funds
If research has been recommended for approval for purposes of subsection (a) of this section, the Secretary may not withhold funds for the research because of ethical considerations unless—
(A) the Secretary convenes an advisory board in accordance with paragraph (5) to study such considerations; and
(B)(i) the majority of the advisory board recommends that, because of such considerations, the Secretary withhold funds for the research; or
(ii) the majority of such board recommends that the Secretary not withhold funds for the research because of such considerations, but the Secretary finds, on the basis of the report submitted under paragraph (5)(B)(ii), that the recommendation is arbitrary and capricious.
(2) Rules of construction
Paragraph (1) may not be construed as prohibiting the Secretary from withholding funds for research on the basis of—
(A) the inadequacy of the qualifications of the entities that would be involved with the conduct of the research (including the entity that would directly receive the funds from the Secretary), subject to the condition that, with respect to the process of review through which the research was recommended for approval for purposes of subsection (a) of this section, all findings regarding such qualifications made in such process are conclusive; or
(B) the priorities established by the Secretary for the allocation of funds among projects of research that have been so recommended.
(3) Applicability
The limitation established in paragraph (1) regarding the authority to withhold funds because of ethical considerations shall apply without regard to whether the withholding of funds on such basis is characterized as a disapproval, a moratorium, a prohibition, or other characterization.
(4) Preliminary matters regarding use of procedures
(A) If the Secretary makes a determination that an advisory board should be convened for purposes of paragraph (1), the Secretary shall, through a statement published in the Federal Register, announce the intention of the Secretary to convene such a board.
(B) A statement issued under subparagraph (A) shall include a request that interested individuals submit to the Secretary recommendations specifying the particular individuals who should be appointed to the advisory board involved. The Secretary shall consider such recommendations in making appointments to the board.
(C) The Secretary may not make appointments to an advisory board under paragraph (1) until the expiration of the 30-day period beginning on the date on which the statement required in subparagraph (A) is made with respect to the board.
(5) Ethics advisory boards
(A) Any advisory board convened for purposes of paragraph (1) shall be known as an ethics advisory board (in this paragraph referred to as an "ethics board").
(B)(i) An ethics board shall advise, consult with, and make recommendations to the Secretary regarding the ethics of the project of biomedical or behavioral research with respect to which the board has been convened.
(ii) Not later than 180 days after the date on which the statement required in paragraph (4)(A) is made with respect to an ethics board, the board shall submit to the Secretary, and to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings of the board regarding the project of research involved and making a recommendation under clause (i) of whether the Secretary should or should not withhold funds for the project. The report shall include the information considered in making the findings.
(C) An ethics board shall be composed of no fewer than 14, and no more than 20, individuals who are not officers or employees of the United States. The Secretary shall make appointments to the board from among individuals with special qualifications and competence to provide advice and recommendations regarding ethical matters in biomedical and behavioral research. Of the members of the board—
(i) no fewer than 1 shall be an attorney;
(ii) no fewer than 1 shall be an ethicist;
(iii) no fewer than 1 shall be a practicing physician;
(iv) no fewer than 1 shall be a theologian; and
(v) no fewer than one-third, and no more than one-half, shall be scientists with substantial accomplishments in biomedical or behavioral research.
(D) The term of service as a member of an ethics board shall be for the life of the board. If such a member does not serve the full term of such service, the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(E) A member of an ethics board shall be subject to removal from the board by the Secretary for neglect of duty or malfeasance or for other good cause shown.
(F) The Secretary shall designate an individual from among the members of an ethics board to serve as the chair of the board.
(G) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall conduct inquiries and hold public hearings.
(H) In carrying out subparagraph (B)(i) with respect to a project of research, an ethics board shall have access to all relevant information possessed by the Department of Health and Human Services, or available to the Secretary from other agencies.
(I) Members of an ethics board shall receive compensation for each day engaged in carrying out the duties of the board, including time engaged in traveling for purposes of such duties. Such compensation may not be provided in an amount in excess of the maximum rate of basic pay payable for GS–18 of the General Schedule.
(J) The Secretary, acting through the Director of the National Institutes of Health, shall provide to each ethics board reasonable staff and assistance to carry out the duties of the board.
(K) An ethics board shall terminate 30 days after the date on which the report required in subparagraph (B)(ii) is submitted to the Secretary and the congressional committees specified in such subparagraph.
(6) "Ethical considerations" defined
For purposes of this subsection, the term "ethical considerations" means considerations as to whether the nature of the research involved is such that it is unethical to conduct or support the research.
(July 1, 1944, ch. 373, title IV, §492A, as added June 10, 1993,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Section Referred to in Other Sections
This section is referred to in
§289a–2. Inclusion of women and minorities in clinical research
(a) Requirement of inclusion
(1) In general
In conducting or supporting clinical research for purposes of this subchapter, the Director of NIH shall, subject to subsection (b) of this section, ensure that—
(A) women are included as subjects in each project of such research; and
(B) members of minority groups are included as subjects in such research.
(2) Outreach regarding participation as subjects
The Director of NIH, in consultation with the Director of the Office of Research on Women's Health and the Director of the Office of Research on Minority Health, shall conduct or support outreach programs for the recruitment of women and members of minority groups as subjects in projects of clinical research.
(b) Inapplicability of requirement
The requirement established in subsection (a) of this section regarding women and members of minority groups shall not apply to a project of clinical research if the inclusion, as subjects in the project, of women and members of minority groups, respectively—
(1) is inappropriate with respect to the health of the subjects;
(2) is inappropriate with respect to the purpose of the research; or
(3) is inappropriate under such other circumstances as the Director of NIH may designate.
(c) Design of clinical trials
In the case of any clinical trial in which women or members of minority groups will under subsection (a) of this section be included as subjects, the Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial.
(d) Guidelines
(1) In general
Subject to paragraph (2), the Director of NIH, in consultation with the Director of the Office of Research on Women's Health and the Director of the Office of Research on Minority Health, shall establish guidelines regarding the requirements of this section. The guidelines shall include guidelines regarding—
(A) the circumstances under which the inclusion of women and minorities as subjects in projects of clinical research is inappropriate for purposes of subsection (b) of this section;
(B) the manner in which clinical trials are required to be designed and carried out for purposes of subsection (c) of this section; and
(C) the operation of outreach programs under subsection (a) of this section.
(2) Certain provisions
With respect to the circumstances under which the inclusion of women or members of minority groups (as the case may be) as subjects in a project of clinical research is inappropriate for purposes of subsection (b) of this section, the following applies to guidelines under paragraph (1):
(A)(i) In the case of a clinical trial, the guidelines shall provide that the costs of such inclusion in the trial is not a permissible consideration in determining whether such inclusion is inappropriate.
(ii) In the case of other projects of clinical research, the guidelines shall provide that the costs of such inclusion in the project is not a permissible consideration in determining whether such inclusion is inappropriate unless the data regarding women or members of minority groups, respectively, that would be obtained in such project (in the event that such inclusion were required) have been or are being obtained through other means that provide data of comparable quality.
(B) In the case of a clinical trial, the guidelines may provide that such inclusion in the trial is not required if there is substantial scientific data demonstrating that there is no significant difference between—
(i) the effects that the variables to be studied in the trial have on women or members of minority groups, respectively; and
(ii) the effects that the variables have on the individuals who would serve as subjects in the trial in the event that such inclusion were not required.
(e) Date certain for guidelines; applicability
(1) Date certain
The guidelines required in subsection (d) of this section shall be established and published in the Federal Register not later than 180 days after June 10, 1993.
(2) Applicability
For fiscal year 1995 and subsequent fiscal years, the Director of NIH may not approve any proposal of clinical research to be conducted or supported by any agency of the National Institutes of Health unless the proposal specifies the manner in which the research will comply with this section.
(f) Reports by advisory councils
The advisory council of each national research institute shall prepare biennial reports describing the manner in which the institute has complied with this section. Each such report shall be submitted to the Director of the institute involved for inclusion in the biennial report under
(g) Definitions
For purposes of this section:
(1) The term "project of clinical research" includes a clinical trial.
(2) The term "minority group" includes subpopulations of minority groups. The Director of NIH shall, through the guidelines established under subsection (d) of this section, define the terms "minority group" and "subpopulation" for purposes of the preceding sentence.
(July 1, 1944, ch. 373, title IV, §492B, as added June 10, 1993,
Inapplicability to Current Projects
Section 133 of
Section Referred to in Other Sections
This section is referred to in
§289b. Office of Research Integrity
(a) In general
(1) Establishment of Office
Not later than 90 days after June 10, 1993, the Secretary shall establish an office to be known as the Office of Research Integrity (referred to in this section as the "Office"), which shall be established as an independent entity in the Department of Health and Human Services.
(2) Appointment of Director
The Office shall be headed by a Director, who shall be appointed by the Secretary, be experienced and specially trained in the conduct of research, and have experience in the conduct of investigations of research misconduct. The Secretary shall carry out this section acting through the Director of the Office. The Director shall report to the Secretary.
(3) Definitions
(A) The Secretary shall by regulation establish a definition for the term "research misconduct" for purposes of this section.
(B) For purposes of this section, the term "financial assistance" means a grant, contract, or cooperative agreement.
(b) Existence of administrative processes as condition of funding for research
The Secretary shall by regulation require that each entity that applies for financial assistance under this chapter for any project or program that involves the conduct of biomedical or behavioral research submit in or with its application for such assistance—
(1) assurances satisfactory to the Secretary that such entity has established and has in effect (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of research misconduct in connection with biomedical and behavioral research conducted at or sponsored by such entity;
(2) an agreement that the entity will report to the Director any investigation of alleged research misconduct in connection with projects for which funds have been made available under this chapter that appears substantial; and
(3) an agreement that the entity will comply with regulations issued under this section.
(c) Process for response of Director
The Secretary shall by regulation establish a process to be followed by the Director for the prompt and appropriate—
(1) response to information provided to the Director respecting research misconduct in connection with projects for which funds have been made available under this chapter;
(2) receipt of reports by the Director of such information from recipients of funds under this chapter;
(3) conduct of investigations, when appropriate; and
(4) taking of other actions, including appropriate remedies, with respect to such misconduct.
(d) Monitoring by Director
The Secretary shall by regulation establish procedures for the Director to monitor administrative processes and investigations that have been established or carried out under this section.
(e) Protection of whistleblowers
(1) In general
In the case of any entity required to establish administrative processes under subsection (b) of this section, the Secretary shall by regulation establish standards for preventing, and for responding to the occurrence of retaliation by such entity, its officials or agents, against an employee in the terms and conditions of employment in response to the employee having in good faith—
(A) made an allegation that the entity, its officials or agents, has engaged in or failed to adequately respond to an allegation of research misconduct; or
(B) cooperated with an investigation of such an allegation.
(2) Monitoring by Secretary
The Secretary shall by regulation establish procedures for the Director to monitor the implementation of the standards established by an entity under paragraph (1) for the purpose of determining whether the procedures have been established, and are being utilized, in accordance with the standards established under such paragraph.
(3) Noncompliance
The Secretary shall by regulation establish remedies for noncompliance by an entity, its officials or agents, which has engaged in retaliation in violation of the standards established under paragraph (1). Such remedies may include termination of funding provided by the Secretary for such project or recovery of funding being provided by the Secretary for such project, or other actions as appropriate.
(July 1, 1944, ch. 373, title IV, §493, as added Nov. 20, 1985,
Codification
June 10, 1993, referred to in subsec. (a)(1), was in the original "the date of enactment of this section" which was translated as meaning the date of enactment of
Amendments
1993—
"(a) The Secretary shall by regulation require that each entity which applies for a grant, contract, or cooperative agreement under this chapter for any project or program which involves the conduct of biomedical or behavioral research submit in or with its application for such grant, contract, or cooperative agreement assurances satisfactory to the Secretary that such entity—
"(1) has established (in accordance with regulations which the Secretary shall prescribe) an administrative process to review reports of scientific fraud in connection with biomedical and behavioral research conducted at or sponsored by such entity; and
"(2) will report to the Secretary any investigation of alleged scientific fraud which appears substantial.
"(b) The Director of NIH shall establish a process for the prompt and appropriate response to information provided the Director of NIH respecting scientific fraud in connection with projects for which funds have been made available under this chapter. The process shall include procedures for the receiving of reports of such information from recipients of funds under this chapter and taking appropriate action with respect to such fraud."
Subsec. (e).
Regulations
Section 165 of
"(a)
"(1)
"(2)
"(b)
"(c)
"(1) The term 'section 493 of the Public Health Service Act' means such section as amended by sections 161 and 163 of this Act [this section], except as indicated otherwise in subsection (b).
"(2) The term 'section 493A of the Public Health Service Act' means such section as added by section 164 of this Act [
"(3) The term 'Secretary' means the Secretary of Health and Human Services."
§289b–1. Protection against financial conflicts of interest in certain projects of research
(a) Issuance of regulations
The Secretary shall by regulation define the specific circumstances that constitute the existence of a financial interest in a project on the part of an entity or individual that will, or may be reasonably expected to, create a bias in favor of obtaining results in such project that are consistent with such financial interest. Such definition shall apply uniformly to each entity or individual conducting a research project under this chapter. In the case of any entity or individual receiving assistance from the Secretary for a project of research described in subsection (b) of this section, the Secretary shall by regulation establish standards for responding to, including managing, reducing, or eliminating, the existence of such a financial interest. The entity may adopt individualized procedures for implementing the standards.
(b) Relevant projects
A project of research referred to in subsection (a) of this section is a project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment and for which such entity is receiving assistance from the Secretary.
(c) Identifying and reporting to Secretary
The Secretary shall by regulation require that each entity described in subsection (a) of this section that applies for assistance under this chapter for any project described in subsection (b) of this section submit in or with its application for such assistance—
(1) assurances satisfactory to the Secretary that such entity has established and has in effect an administrative process under subsection (a) of this section to identify financial interests (as defined under subsection (a) of this section) that exist regarding the project; and
(2) an agreement that the entity will report to the Secretary such interests identified by the entity and how any such interests identified by the entity will be managed or eliminated in order that the project in question will be protected from bias that may stem from such interests; and
(3) an agreement that the entity will comply with regulations issued under this section.
(d) Monitoring of process
The Secretary shall monitor the establishment and conduct of the administrative process established by an entity pursuant to subsection (a) of this section.
(e) Response
In any case in which the Secretary determines that an entity has failed to comply with subsection (c) of this section regarding a project of research described in subsection (b) of this section, the Secretary—
(1) shall require that, as a condition of receiving assistance, the entity disclose the existence of a financial interest (as defined under subsection (a) of this section) in each public presentation of the results of such project; and
(2) may take such other actions as the Secretary determines to be appropriate.
(f) Definitions
For purposes of this section:
(1) The term "financial interest" includes the receipt of consulting fees or honoraria and the ownership of stock or equity.
(2) The term "assistance", with respect to conducting a project of research, means a grant, contract, or cooperative agreement.
(July 1, 1944, ch. 373, title IV, §493A, as added June 10, 1993,
Regulations
Final rule for regulations required in this section to be issued not later than 180 days after June 10, 1993, see section 165 of
§289c. Research on public health emergencies; report to Congressional committees
(a) If the Secretary determines, after consultation with the Director of NIH, the Commissioner of the Food and Drug Administration, or the Director of the Centers for Disease Control and Prevention, that a disease or disorder constitutes a public health emergency, the Secretary, acting through the Director of NIH—
(1) shall expedite the review by advisory councils under
(2) shall exercise the authority in
(3) may provide administrative supplemental increases in existing grants and contracts to support new research relevant to such disease or disorder; and
(4) shall disseminate, to health professionals and the public, information on the cause, prevention, and treatment of such disease or disorder that has been developed in research assisted under this section.
The amount of an increase in a grant or contract provided under paragraph (3) may not exceed one-half the original amount of the grant or contract.
(b) Not later than 90 days after the end of a fiscal year, the Secretary shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate on actions taken under subsection (a) of this section in such fiscal year.
(July 1, 1944, ch. 373, title IV, §494, as added Nov. 20, 1985,
Amendments
1992—Subsec. (a).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
§289c–1. Collaborative use of certain health services research funds
(a) In general
The Secretary shall ensure that amounts made available under subparts 14, 15 and 16 of part C for health services research relating to alcohol abuse and alcoholism, drug abuse and mental health be used collaboratively, as appropriate, and in consultation with the Agency for Health Care Policy Research.
(b) Report
Not later than September 30, 1993, and annually thereafter, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report concerning the activities carried out with the amounts referred to in subsection (a) of this section.
(July 1, 1944, ch. 373, title IV, §494A, as added July 10, 1992,
References in Text
Subparts 14, 15 and 16 of part C, referred to in subsec. (a), are classified to sections 285n et seq., 285o et seq., and 285p et seq., respectively, of this title.
Amendments
1993—Subsec. (b).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
§289d. Animals in research
(a) Establishment of guidelines
The Secretary, acting through the Director of NIH, shall establish guidelines for the following:
(1) The proper care of animals to be used in biomedical and behavioral research.
(2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall require—
(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and
(B) appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research.
Such guidelines shall not be construed to prescribe methods of research.
(3) The organization and operation of animal care committees in accordance with subsection (b) of this section.
(b) Animal care committees; establishment; membership; functions
(1) Guidelines of the Secretary under subsection (a)(3) of this section shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this chapter (including the National Institutes of Health and the national research institutes) to assure compliance with the guidelines established under subsection (a) of this section.
(2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the committee is established, shall be composed of not fewer than three members, and shall include at least one individual who has no association with such entity and at least one doctor of veterinary medicine.
(3) Each animal care committee of a research entity shall—
(A) review the care and treatment of animals in all animal study areas and facilities of the research entity at least semi-annually to evaluate compliance with applicable guidelines established under subsection (a) of this section for appropriate animal care and treatment;
(B) keep appropriate records of reviews conducted under subparagraph (A); and
(C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a certification that the review has been conducted, and (ii) reports of any violations of guidelines established under subsection (a) of this section or assurances required under paragraph (1) which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations.
Reports filed under subparagraph (C) shall include any minority views filed by members of the committee.
(c) Assurances required in application or contract proposal; reasons for use of animals; notice and comment requirements for promulgation of regulations
The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health or any national research institute to include in its application or contract proposal, submitted after the expiration of the twelve-month period beginning on November 20, 1985—
(1) assurances satisfactory to the Director of NIH that—
(A) the applicant meets the requirements of the guidelines established under paragraphs (1) and (2) of subsection (a) of this section and has an animal care committee which meets the requirements of subsection (b) of this section; and
(B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the applicant have available to them instruction or training in the humane practice of animal maintenance and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and
(2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract.
Notwithstanding subsection (a)(2) of
(d) Failure to meet guidelines; suspension or revocation of grant or contract
If the Director of NIH determines that—
(1) the conditions of animal care, treatment, or use in an entity which is receiving a grant, contract, or cooperative agreement involving research on animals under this subchapter do not meet applicable guidelines established under subsection (a) of this section;
(2) the entity has been notified by the Director of NIH of such determination and has been given a reasonable opportunity to take corrective action; and
(3) no action has been taken by the entity to correct such conditions;
the Director of NIH shall suspend or revoke such grant or contract under such conditions as the Director determines appropriate.
(e) Disclosure of trade secrets or privileged or confidential information
No guideline or regulation promulgated under subsection (a) or (c) of this section may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential.
(July 1, 1944, ch. 373, title IV, §495, as added Nov. 20, 1985,
Prohibition on Funding of Projects Involving Use of Chimpanzees Obtained From the Wild
Similar provisions were contained in the following prior appropriation acts:
Plan for Research Involving Animals
Section 4 of
§289e. Use of appropriations
(a) Appropriations to carry out the purposes of this subchapter, unless otherwise expressly provided, may be expended in the District of Columbia for—
(1) personal services;
(2) stenographic recording and translating services;
(3) travel expenses (including the expenses of attendance at meetings when specifically authorized by the Secretary);
(4) rental;
(5) supplies and equipment;
(6) purchase and exchange of medical books, books of reference, directories, periodicals, newspapers, and press clippings;
(7) purchase, operation, and maintenance of passenger motor vehicles;
(8) printing and binding (in addition to that otherwise provided by law); and
(9) all other necessary expenses in carrying out this subchapter.
Such appropriations may be expended by contract if deemed necessary, without regard to
(b)(1) None of the amounts appropriated under this chapter for the purposes of this subchapter may be obligated for the construction of facilities (including the acquisition of land) unless a provision of this subchapter establishes express authority for such purpose and unless the Act making appropriations under such provision specifies that the amounts appropriated are available for such purpose.
(2) Any grants, cooperative agreements, or contracts authorized in this subchapter for the construction of facilities may be awarded only on a competitive basis.
(July 1, 1944, ch. 373, title IV, §496, as added Nov. 20, 1985,
Amendments
1993—Subsec. (a).
1989—Subsec. (a).
Construction of Biomedical Facilities for Development and Breeding of Specialized Strains of Mice
Sections 1 to 7 of
Section Referred to in Other Sections
This section is referred to in
§289f. Gifts and donations; memorials
The Secretary may, in accordance with
(July 1, 1944, ch. 373, title IV, §497, as added Nov. 20, 1985,
Amendments
1993—
1990—
1988—
1986—
Effective Date of 1988 Amendment
Amendment by
Effective Date of 1986 Amendment
Amendment by
§289g. Fetal research
(a) Conduct or support by Secretary; restrictions
The Secretary may not conduct or support any research or experimentation, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation—
(1) may enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or
(2) will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
(b) Risk standard for fetuses intended to be aborted and fetuses intended to be carried to term to be same
In administering the regulations for the protection of human research subjects which—
(1) apply to research conducted or supported by the Secretary;
(2) involve living human fetuses in utero; and
(3) are published in section 46.208 of part 46 of title 45 of the Code of Federal Regulations;
or any successor to such regulations, the Secretary shall require that the risk standard (published in section 46.102(g) of such part 46 or any successor to such regulations) be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.
(July 1, 1944, ch. 373, title IV, §498, as added Nov. 20, 1985,
Amendments
1993—Subsec. (c).
1988—Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (c)(3).
Nullification of Certain Provisions
Section 121(c) of
Executive Order No. 12806. Establishment of Fetal Tissue Bank
Ex. Ord. No. 12806, May 19, 1992, 57 F.R. 21589, which established a human fetal tissue bank, was nullified by
Federal Funding of Fetal Tissue Transplantation Research
Memorandum of President of the United States, Jan. 22, 1993, 58 F.R. 7457, provided:
Memorandum for the Secretary of Health and Human Services
On March 22, 1988, the Assistant Secretary for Health of Health and Human Services ("HHS") imposed a temporary moratorium on Federal funding of research involving transplantation of fetal tissue from induced abortions. Contrary to the recommendations of a National Institutes of Health advisory panel, on November 2, 1989, the Secretary of Health and Human Services extended the moratorium indefinitely. This moratorium has significantly hampered the development of possible treatments for individuals afflicted with serious diseases and disorders, such as Parkinson's disease, Alzheimer's disease, diabetes, and leukemia. Accordingly, I hereby direct that you immediately lift the moratorium.
You are hereby authorized and directed to publish this memorandum in the Federal Register.
William J. Clinton.
§289g–1. Research on transplantation of fetal tissue
(a) Establishment of program
(1) In general
The Secretary may conduct or support research on the transplantation of human fetal tissue for therapeutic purposes.
(2) Source of tissue
Human fetal tissue may be used in research carried out under paragraph (1) regardless of whether the tissue is obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth.
(b) Informed consent of donor
(1) In general
In research carried out under subsection (a) of this section, human fetal tissue may be used only if the woman providing the tissue makes a statement, made in writing and signed by the woman, declaring that—
(A) the woman donates the fetal tissue for use in research described in subsection (a) of this section;
(B) the donation is made without any restriction regarding the identity of individuals who may be the recipients of transplantations of the tissue; and
(C) the woman has not been informed of the identity of any such individuals.
(2) Additional statement
In research carried out under subsection (a) of this section, human fetal tissue may be used only if the attending physician with respect to obtaining the tissue from the woman involved makes a statement, made in writing and signed by the physician, declaring that—
(A) in the case of tissue obtained pursuant to an induced abortion—
(i) the consent of the woman for the abortion was obtained prior to requesting or obtaining consent for a donation of the tissue for use in such research;
(ii) no alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue; and
(iii) the abortion was performed in accordance with applicable State law;
(B) the tissue has been donated by the woman in accordance with paragraph (1); and
(C) full disclosure has been provided to the woman with regard to—
(i) such physician's interest, if any, in the research to be conducted with the tissue; and
(ii) any known medical risks to the woman or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with the woman's medical care.
(c) Informed consent of researcher and donee
In research carried out under subsection (a) of this section, human fetal tissue may be used only if the individual with the principal responsibility for conducting the research involved makes a statement, made in writing and signed by the individual, declaring that the individual—
(1) is aware that—
(A) the tissue is human fetal tissue;
(B) the tissue may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and
(C) the tissue was donated for research purposes;
(2) has provided such information to other individuals with responsibilities regarding the research;
(3) will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgment of receipt of such information by such recipient; and
(4) has had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research.
(d) Availability of statements for audit
(1) In general
In research carried out under subsection (a) of this section, human fetal tissue may be used only if the head of the agency or other entity conducting the research involved certifies to the Secretary that the statements required under subsections (b)(2) and (c) of this section will be available for audit by the Secretary.
(2) Confidentiality of audit
Any audit conducted by the Secretary pursuant to paragraph (1) shall be conducted in a confidential manner to protect the privacy rights of the individuals and entities involved in such research, including such individuals and entities involved in the donation, transfer, receipt, or transplantation of human fetal tissue. With respect to any material or information obtained pursuant to such audit, the Secretary shall—
(A) use such material or information only for the purposes of verifying compliance with the requirements of this section;
(B) not disclose or publish such material or information, except where required by Federal law, in which case such material or information shall be coded in a manner such that the identities of such individuals and entities are protected; and
(C) not maintain such material or information after completion of such audit, except where necessary for the purposes of such audit.
(e) Applicability of State and local law
(1) Research conducted by recipients of assistance
The Secretary may not provide support for research under subsection (a) of this section unless the applicant for the financial assistance involved agrees to conduct the research in accordance with applicable State law.
(2) Research conducted by Secretary
The Secretary may conduct research under subsection (a) of this section only in accordance with applicable State and local law.
(f) Report
The Secretary shall annually submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the activities carried out under this section during the preceding fiscal year, including a description of whether and to what extent research under subsection (a) of this section has been conducted in accordance with this section.
(g) "Human fetal tissue" defined
For purposes of this section, the term "human fetal tissue" means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
(July 1, 1944, ch. 373, title IV, §498A, as added June 10, 1993,
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Nullification of Moratorium
Section 113 of
"(a)
"(b)
"(1)
"(A) the research has been approved for purposes of subsection (a) of such section 492A;
"(B) the research will be carried out in accordance with section 498A of such Act [this section] (as added by section 111 of this Act); and
"(C) there are reasonable assurances that the research will not utilize any human fetal tissue that has been obtained in violation of section 498B(a) of such Act [
"(2)
"(A) issued by an ethics advisory board pursuant to section 492A(b)(5)(B)(ii) of the Public Health Service Act (as added by section 101 of this Act); and
"(B) finding, on a basis that is neither arbitrary nor capricious, that the nature of the research is such that it is not unethical to conduct or support the research.
"(c)
"(d)
Report by General Accounting Office on Adequacy of Requirements
Section 114 of
"(a)
"(1) whether and to what extent such research conducted or supported by the Secretary of Health and Human Services has been conducted in accordance with section 498A of the Public Health Service Act [this section] (as added by section 111 of this Act); and
"(2) whether and to what extent there have been violations of section 498B of such Act [
"(b)
Section Referred to in Other Sections
This section is referred to in
§289g–2. Prohibitions regarding human fetal tissue
(a) Purchase of tissue
It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human fetal tissue for valuable consideration if the transfer affects interstate commerce.
(b) Solicitation or acceptance of tissue as directed donation for use in transplantation
It shall be unlawful for any person to solicit or knowingly acquire, receive, or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the donation affects interstate commerce, the tissue will be or is obtained pursuant to an induced abortion, and—
(1) the donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;
(2) the donated tissue will be transplanted into a relative of the donating individual; or
(3) the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.
(c) Criminal penalties for violations
(1) In general
Any person who violates subsection (a) or (b) of this section shall be fined in accordance with title 18, subject to paragraph (2), or imprisoned for not more than 10 years, or both.
(2) Penalties applicable to persons receiving consideration
With respect to the imposition of a fine under paragraph (1), if the person involved violates subsection (a) or (b)(3) of this section, a fine shall be imposed in an amount not less than twice the amount of the valuable consideration received.
(d) Definitions
For purposes of this section:
(1) The term "human fetal tissue" has the meaning given such term in section 289g–1(f) 1 of this title.
(2) The term "interstate commerce" has the meaning given such term in
(3) The term "valuable consideration" does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
(July 1, 1944, ch. 373, title IV, §498B, as added June 10, 1993,
1 So in original. Probably should be section "289g–1(g)".
§289h. Repealed. Pub. L. 103–43, title I, §121(b)(2), June 10, 1993, 107 Stat. 133
Section, act July 1, 1944, ch. 373, title IV, §499, as added Nov. 20, 1985,
§290. National Institutes of Health Management Fund; establishment; advancements; availability; final adjustments of advances
For the purpose of facilitating the economical and efficient conduct of operations in the National Institutes of Health which are financed by two or more appropriations where the costs of operation are not readily susceptible of distribution as charges to such appropriations, there is established the National Institutes of Health Management Fund. Such amounts as the Director of the National Institutes of Health may determine to represent a reasonable distribution of estimated costs among the various appropriations involved may be advanced each year to this fund and shall be available for expenditure for such costs under such regulations as may be prescribed by said Director, including the operation of facilities for the sale of meals to employees and others at rates to be determined by said Director to be sufficient to cover the reasonable value of the meals served and the proceeds thereof shall be deposited to the credit of this fund: Provided, That funds advanced to this fund shall be available only in the fiscal year in which they are advanced: Provided further, That final adjustments of advances in accordance with actual costs shall be effected wherever practicable with the appropriations from which such funds are advanced.
(
Codification
Section was enacted as a part of the Department of Health, Education, and Welfare Appropriation Act, 1958, and not as a part of the Public Health Service Act which comprises this chapter.
Amendments
1961—
§290a. Victims of fire
(a) Research on burns, burn injuries, and rehabilitation
The Secretary of Health and Human Services shall establish, within the National Institutes of Health and in cooperation with the Secretary of Commerce, an expanded program of research on burns, treatment of burn injuries, and rehabilitation of victims of fires. The National Institutes of Health shall—
(1) sponsor and encourage the establishment throughout the Nation of twenty-five additional burn centers, which shall comprise separate hospital facilities providing specialized burn treatment and including research and teaching programs and twenty-five additional burn units, which shall comprise specialized facilities in general hospitals used only for burn victims;
(2) provide training and continuing support of specialists to staff the new burn centers and burn units;
(3) sponsor and encourage the establishment of ninety burn programs in general hospitals which comprise staffs of burn injury specialists;
(4) provide special training in emergency care for burn victims;
(5) augment sponsorship of research on burns and burn treatment;
(6) administer and support a systematic program of research concerning smoke inhalation injuries; and
(7) sponsor and support other research and training programs in the treatment and rehabilitation of burn injury victims.
(b) Authorization of appropriations
For purposes of this section, there are authorized to be appropriated not to exceed $5,000,000 for the fiscal year ending June 30, 1975 and not to exceed $8,000,000 for the fiscal year ending June 30, 1976.
(
Codification
In subsec. (a), "Secretary of Commerce" substituted for "Secretary" pursuant to section 4(6) of the Federal Fire Prevention and Control Act of 1974,
Section was enacted as part of the Federal Fire Prevention and Control Act of 1974 (which is classified principally to
Change of Name
"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (a) pursuant to section 509(b) of
Part I—National Foundation for Biomedical Research
Amendments
1993—
§290b. Establishment and duties of Foundation
(a) In general
The Secretary shall, acting through the Director of NIH, establish a nonprofit corporation to be known as the National Foundation for Biomedical Research (hereafter in this section referred to as the "Foundation"). The Foundation shall not be an agency or instrumentality of the United States Government.
(b) Purpose of Foundation
The purpose of the Foundation shall be to support the National Institutes of Health in its mission, and to advance collaboration with biomedical researchers from universities, industry, and nonprofit organizations.
(c) Certain activities of Foundation
(1) In general
In carrying out subsection (b) of this section, the Foundation may solicit and accept gifts, grants, and other donations, establish accounts, and invest and expend funds in support of the following activities with respect to the purpose described in such subsection:
(A) A program to provide and administer endowed positions that are associated with the research program of the National Institutes of Health. Such endowments may be expended for the compensation of individuals holding the positions, for staff, equipment, quarters, travel, and other expenditures that are appropriate in supporting the endowed positions.
(B) A program to provide and administer fellowships and grants to research personnel in order to work and study in association with the National Institutes of Health. Such fellowships and grants may include stipends, travel, health insurance benefits and other appropriate expenses. The recipients of fellowships shall be selected by the donors and the Foundation upon the recommendation of the National Institutes of Health employees in the laboratory where the fellow would serve, and shall be subject to the agreement of the Director of the National Institutes of Health and the Executive Director of the Foundation.
(C) Supplementary programs to provide for—
(i) scientists of other countries to serve in research capacities in the United States in association with the National Institutes of Health or elsewhere, or opportunities for employees of the National Institutes of Health or other public health officials in the United States to serve in such capacities in other countries, or both;
(ii) the conduct and support of studies, projects, and research, which may include stipends, travel and other support for personnel in collaboration with national and international non-profit and for-profit organizations;
(iii) the conduct and support of forums, meetings, conferences, courses, and training workshops that may include undergraduate, graduate, post-graduate, and post-doctoral accredited courses and the maintenance of accreditation of such courses by the Foundation at the State and national level for college or continuing education credits or for degrees;
(iv) programs to support and encourage teachers and students of science at all levels of education and programs for the general public which promote the understanding of science;
(v) programs for writing, editing, printing, publishing, and vending of books and other materials; and
(vi) the conduct of other activities to carry out and support the purpose described in subsection (b) of this section.
(2) Fees
The Foundation may assess fees for the provision of professional, administrative and management services by the Foundation in amounts determined reasonable and appropriate by the Executive Director.
(3) Authority of Foundation
The Foundation shall be the sole entity responsible for carrying out the activities described in this subsection.
(d) Board of Directors
(1) Composition
(A) The Foundation shall have a Board of Directors (hereafter referred to in this section as the "Board"), which shall be composed of ex officio and appointed members in accordance with this subsection. All appointed members of the Board shall be voting members.
(B) The ex officio members of the Board shall be—
(i) the Chairman and ranking minority member of the Subcommittee on Health and the Environment (Committee on Energy and Commerce) or their designees, in the case of the House of Representatives;
(ii) the Chairman and ranking minority member of the Committee on Labor and Human Resources or their designees, in the case of the Senate; and
(iii) the Director of the National Institutes of Health.
(C) The ex officio members of the Board under subparagraph (B) shall appoint to the Board 11 individuals from among a list of candidates to be provided by the National Academy of Science. Of such appointed members—
(i) 4 shall be representative of the general biomedical field;
(ii) 2 shall be representatives of the general biobehavorial field; and
(iii) 5 shall be representatives of the general public.
(D)(i) Not later than 30 days after June 10, 1993, the Director of the National Institutes of Health shall convene a meeting of the ex officio members of the Board to—
(I) incorporate the Foundation and establish the general policies of the Foundation for carrying out the purposes of subsection (b) of this section, including the establishment of the bylaws of the Foundation; and
(II) appoint the members of the Board in accordance with subparagraph (C).
(ii) Upon the appointment of the members of the Board under clause (i)(II), the terms of service of the ex officio members of the Board as members of the Board shall terminate.
(E) The agreement of not less than three-fifths of the members of the ex officio members of the Board shall be required for the appointment of each member to the initial Board.
(F) No employee of the National Institutes of Health shall be appointed as a member of the Board.
(G) The Board may, through amendments to the bylaws of the Foundation, provide that the number of members of the Board shall be greater than the number specified in subparagraph (C).
(2) Chair
(A) The ex officio members of the Board under paragraph (1)(B) shall designate an individual to serve as the initial Chair of the Board.
(B) Upon the termination of the term of service of the initial Chair of the Board, the appointed members of the Board shall elect a member of the Board to serve as the Chair of the Board.
(3) Terms and vacancies
(A) The term of office of each member of the Board appointed under paragraph (1)(C) shall be 5 years, except that the terms of offices for the initial appointed members of the Board shall expire as determined by the ex officio members and the Chair.
(B) Any vacancy in the membership of the Board shall be filled in the manner in which the original position was made and shall not affect the power of the remaining members to execute the duties of the Board.
(C) If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.
(D) A member of the Board may continue to serve after the expiration of the term of the member until a successor is appointed.
(4) Compensation
Members of the Board may not receive compensation for service on the Board. Such members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the Board, as set forth in the bylaws issued by the Board.
(5) Meetings and quorum
A majority of the members of the Board shall constitute a quorum for purposes of conducting the business of the Board.
(6) Certain bylaws
(A) In establishing bylaws under this subsection, the Board shall ensure that the following are provided for:
(i) Policies for the selection of the officers, employees, agents, and contractors of the Foundation.
(ii) Policies, including ethical standards, for the acceptance, solicitation, and disposition of donations and grants to the Foundation and for the disposition of the assets of the Foundation. Policies with respect to ethical standards shall ensure that officers, employees and agents of the Foundation (including members of the Board) avoid encumbrances that would result in a conflict of interest, including a financial conflict of interest or a divided allegiance. Such policies shall include requirements for the provision of information concerning any ownership or controlling interest in entities related to the activities of the Foundation by such officers, employees and agents and their spouses and relatives.
(iii) Policies for the conduct of the general operations of the Foundation.
(iv) Policies for writing, editing, printing, publishing, and vending of books and other materials.
(B) In establishing bylaws under this subsection, the Board shall ensure that such bylaws (and activities carried out under the bylaws) do not—
(i) reflect unfavorably upon the ability of the Foundation or the National Institutes of Health to carry out its responsibilities or official duties in a fair and objective manner; or
(ii) compromise, or appear to compromise, the integrity of any governmental agency or program, or any officer or employee involved in such program.
(e) Redesignated (g)
(f) Incorporation
The initial members of the Board shall serve as incorporators and shall take whatever actions necessary to incorporate the Foundation.
(g) Nonprofit status
The Foundation shall be considered to be a corporation under
(h) Executive Director
(1) In general
The Foundation shall have an Executive Director who shall be appointed by the Board and shall serve at the pleasure of the Board. The Executive Director shall be responsible for the day-to-day operations of the Foundation and shall have such specific duties and responsibilities as the Board shall prescribe.
(2) Compensation
The rate of compensation of the Executive Director shall be fixed by the Board.
(i) Powers
In carrying out subsection (b) of this section, the Foundation may—
(1) operate under the direction of its Board;
(2) adopt, alter, and use a corporate seal, which shall be judicially noticed;
(3) provide for 1 or more officers, employees, and agents, as may be necessary, define their duties, and require surety bonds or make other provisions against losses occasioned by acts of such persons;
(4) hire, promote, compensate, and discharge officers and employees of the Foundation, and define the duties of the officers and employees;
(5) with the consent of any executive department or independent agency, use the information, services, staff, and facilities of such in carrying out this section;
(6) sue and be sued in its corporate name, and complain and defend in courts of competent jurisdiction;
(7) modify or consent to the modification of any contract or agreement to which it is a party or in which it has an interest under this part;
(8) establish a process for the selection of candidates for positions under subsection (c) of this section;
(9) enter into contracts with public and private organizations for the writing, editing, printing, and publishing of books and other material;
(10) take such action as may be necessary to obtain patents and licenses for devices and procedures developed by the Foundation and its employees;
(11) solicit 1 accept, hold, administer, invest, and spend any gift, devise, or bequest of real or personal property made to the Foundation;
(12) enter into such other contracts, leases, cooperative agreements, and other transactions as the Executive Director considers appropriate to conduct the activities of the Foundation;
(13) appoint other groups of advisors as may be determined necessary from time to time to carry out the functions of the Foundation;
(14) enter into such other contracts, leases, cooperative agreements, and other transactions as the Executive Director considers appropriate to conduct the activities of the Foundation; and
(15) exercise other powers as set forth in this section, and such other incidental powers as are necessary to carry out its powers, duties, and functions in accordance with this part.
(j) Administrative control
No participant in the program established under this part shall exercise any administrative control over any Federal employee.
(k) General provisions
(1) Foundation integrity
The members of the Board shall be accountable for the integrity of the operations of the Foundation and shall ensure such integrity through the development and enforcement of criteria and procedures relating to standards of conduct (including those developed under subsection (d)(2)(B)(i)(II)),2 financial disclosure statements, conflict of interest rules, recusal and waiver rules, audits and other matter determined appropriate by the Board.
(2) Financial conflicts of interest
Any individual who is an officer, employee, or member of the Board of the Foundation may not (in accordance with policies and requirements developed under subsection (d)(2)(B)(i)(II)) 2 personally or substantially participate in the consideration or determination by the Foundation of any matter that would directly or predictably affect any financial interest of the individual or a relative (as such term is defined in section 109(16) of the Ethics in Government Act of 1978) of the individual, of any business organization or other entity, or of which the individual is an officer or employee, or is negotiating for employment, or in which the individual has any other financial interest.
(3) Audits; availability of records
The Foundation shall—
(A) provide for annual audits of the financial condition of the Foundation; and
(B) make such audits, and all other records, documents, and other papers of the Foundation, available to the Secretary and the Comptroller General of the United States for examination or audit.
(4) Reports
(A) Not later than 5 months following the end of each fiscal year, the Foundation shall publish a report describing the activities of the Foundation during the preceding fiscal year. Each such report shall include for the fiscal year involved a comprehensive statement of the operations, activities, financial condition, and accomplishments of the Foundation.
(B) With respect to the financial condition of the Foundation, each report under subparagraph (A) shall include the source, and a description of, all gifts or grants to the Foundation of real or personal property, and the source and amount of all gifts or grants to the Foundation of money. Each such report shall include a specification of any restrictions on the purposes for which gifts or grants to the Foundation may be used.
(C) The Foundation shall make copies of each report submitted under subparagraph (A) available for public inspection, and shall upon request provide a copy of the report to any individual for a charge not exceeding the cost of providing the copy.
(D) The Board shall annually hold a public meeting to summarize the activities of the Foundation and distribute written reports concerning such activities and the scientific results derived from such activities.
(5) Service of Federal employees
Federal employees may serve on committees advisory to the Foundation and otherwise cooperate with and assist the Foundation in carrying out its function, so long as the employees do not direct or control Foundation activities.
(6) Relationship with existing entities
The Foundation may, pursuant to appropriate agreements, merge with, acquire, or use the resources of existing nonprofit private corporations with missions similar to the purposes of the Foundation, such as the Foundation for Advanced Education in the Sciences.
(7) Intellectual property rights
The Board shall adopt written standards with respect to the ownership of any intellectual property rights derived from the collaborative efforts of the Foundation prior to the commencement of such efforts.
(8) National Institutes of Health Amendments of 1990
The activities conducted in support of the National Institutes of Health Amendments of 1990 (
(9) Limitation of activities
The Foundation shall exist solely as an entity to work in collaboration with the research programs of the National Institutes of Health. The Foundation may not undertake activities (such as the operation of independent laboratories or competing for Federal research funds) that are independent of those of the National Institutes of Health research programs.
(10) Transfer of funds
The Foundation may not transfer funds to the National Institutes of Health.
(l) Duties of Director
(1) Applicability of certain standards to non-Federal employees
In the case of any individual who is not an employee of the Federal Government and who serves in association with the National Institutes of Health, with respect to financial assistance received from the Foundation, the Foundation may not provide the assistance of, or otherwise permit the work at the National Institutes of Health to begin until a memorandum of understanding between the individual and the Director of the National Institutes of Health, or the designee of such Director, has been executed specifying that the individual shall be subject to such ethical and procedural standards of conduct relating to duties performed at the National Institutes of Health, as the Director of the National Institutes of Health determines is appropriate.
(2) Support services
The Director of the National Institutes of Health may provide facilities, utilities and support services to the Foundation if it is determined by the Director to be advantageous to the research programs of the National Institutes of Health.
(m) Funding
(1) Authorization of appropriations
For the purpose of carrying out this part, there is authorized to be appropriated an aggregate $200,000 for the fiscal years 1994 and 1995.
(2) Limitation regarding other funds
Amounts appropriated under any provision of law other than paragraph (1) may not be expended to establish or operate the Foundation.
(n) Report on adequacy of compliance
(1) In general
With respect to the mission and function of the Foundation, the Comptroller General of the United States shall conduct an audit to determine—
(A) whether the Foundation is in compliance with the guidelines established under this section; and
(B) whether the procedures utilized under this section are adequate to prevent conflicts of interest involving the Foundation, the employees of the Foundation or members of the Board of the Foundation.
(2) Report
Not later than 18 months after the date on which the Foundation is incorporated, the Comptroller General of the United States shall complete the audit required under paragraph (1) and prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate, a report describing the findings made with respect to such audit.
(July 1, 1944, ch. 373, title IV, §499, formerly §499A, as added Nov. 16, 1990,
References in Text
Section 109(16) of the Ethics in Government Act of 1978, referred to in subsec. (k)(2), is section 109(16) of
The National Institutes of Health Amendments of 1990, referred to in subsec. (k)(8), is
Prior Provisions
A prior section 499 of act July 1, 1944, was classified to
Amendments
1993—Subsec. (a).
Subsec. (b).
Subsec. (c).
Subsec. (d).
Subsec. (d)(1).
Subsec. (d)(2).
Subsec. (d)(3)(A).
Subsec. (d)(5), (6).
Subsec. (e).
Subsecs. (f) to (h).
Subsec. (i).
Subsec. (i)(4).
Subsec. (i)(5), (6).
"(A) its officers, employees, and agents are selected;
"(B) its property is acquired, held, and transferred;
"(C) its general operations are to be conducted; and
"(D) the privileges granted by law are exercised and enjoyed;".
Subsec. (i)(7).
Subsec. (i)(8).
Subsec. (i)(9), (10).
Subsec. (i)(11).
Subsec. (i)(12), (13).
Subsec. (i)(14).
Subsec. (i)(15).
Subsec. (j).
Subsecs. (k), (l).
Subsec. (m).
"(1)
"(2)
"(A) Amounts appropriated under paragraph (1) or made available under subparagraph (C) may not be provided to the fund established under subsection (b)(1)(A) of this section.
"(B) For the first fiscal year for which amounts are appropriated under paragraph (1), $200,000 is authorized to be appropriated.
"(C) With respect to the first fiscal year for which amounts are appropriated under paragraph (1), the Secretary may, from amounts appropriated for such fiscal year for the programs of the Department of Health and Human Services, make available not more than $200,000 for carrying out this part, subject to subparagraph (A)."
Subsec. (n).
1992—Subsec. (g)(9).
1991—Subsec. (c)(1)(C).
Subsec. (c)(1)(C)(iii).
Change of Name
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1992 Amendment
Amendment by
1 So in original. Probably should be followed by a comma.
2 So in original. Probably should be subsection "(d)(6)(A)".
3 So in original. Probably should be "subsection".
SUBCHAPTER III–A—SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
Subchapter Referred to in Other Sections
This subchapter is referred to in
Part A—Organization and General Authorities
§290aa. Substance Abuse and Mental Health Services Administration
(a) Establishment
The Substance Abuse and Mental Health Services Administration (hereafter referred to in this subchapter as the "Administration") is an agency of the Service.
(b) Agencies
The following entities are agencies of the Administration:
(1) The Center for Substance Abuse Treatment.
(2) The Center for Substance Abuse Prevention.
(3) The Center for Mental Health Services.
(c) Administrator and Deputy Administrator
(1) Administrator
The Administration shall be headed by an Administrator (hereinafter in this subchapter referred to as the "Administrator") who shall be appointed by the President, by and with the advice and consent of the Senate.
(2) Deputy Administrator
The Administrator, with the approval of the Secretary, may appoint a Deputy Administrator and may employ and prescribe the functions of such officers and employees, including attorneys, as are necessary to administer the activities to be carried out through the Administration.
(d) Authorities
The Secretary, acting through the Administrator, shall—
(1) supervise the functions of the agencies of the Administration in order to assure that the programs carried out through each such agency receive appropriate and equitable support and that there is cooperation among the agencies in the implementation of such programs;
(2) establish and implement, through the respective agencies, a comprehensive program to improve the provision of treatment and related services to individuals with respect to substance abuse and mental illness and to improve prevention services, promote mental health and protect the legal rights of individuals with mental illnesses and individuals who are substance abusers;
(3) carry out the administrative and financial management, policy development and planning, evaluation, knowledge dissemination, and public information functions that are required for the implementation of this subchapter;
(4) assure that the Administration conduct and coordinate demonstration projects, evaluations, and service system assessments and other activities necessary to improve the availability and quality of treatment, prevention and related services;
(5) support activities that will improve the provision of treatment, prevention and related services, including the development of national mental health and substance abuse goals and model programs;
(6) in cooperation with the National Institutes of Health, the Centers for Disease Control and the Health Resources and Services Administration develop educational materials and intervention strategies to reduce the risks of HIV or tuberculosis among substance abusers and individuals with mental illness and to develop appropriate mental health services for individuals with such illnesses;
(7) coordinate Federal policy with respect to the provision of treatment services for substance abuse utilizing anti-addiction medications, including methadone;
(8) conduct programs, and assure the coordination of such programs with activities of the National Institutes of Health and the Agency for Health Care Policy Research, as appropriate, to evaluate the process, outcomes and community impact of treatment and prevention services and systems of care in order to identify the manner in which such services can most effectively be provided;
(9) collaborate with the Director of the National Institutes of Health in the development of a system by which the relevant research findings of the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Mental Health, and, as appropriate, the Agency for Health Care Policy Research are disseminated to service providers in a manner designed to improve the delivery and effectiveness of treatment and prevention services;
(10) encourage public and private entities that provide health insurance to provide benefits for substance abuse and mental health services;
(11) promote the integration of substance abuse and mental health services into the mainstream of the health care delivery system of the United States;
(12) monitor compliance by hospitals and other facilities with the requirements of
(13) with respect to grant programs authorized under this subchapter, assure that—
(A) all grants that are awarded for the provision of services are subject to performance and outcome evaluations; and
(B) all grants that are awarded to entities other than States are awarded only after the State in which the entity intends to provide services—
(i) is notified of the pendency of the grant application; and
(ii) is afforded an opportunity to comment on the merits of the application;
(14) assure that services provided with amounts appropriated under this subchapter are provided bilingually, if appropriate;
(15) improve coordination among prevention programs, treatment facilities and nonhealth care systems such as employers, labor unions, and schools, and encourage the adoption of employee assistance programs and student assistance programs;
(16) maintain a clearinghouse for substance abuse and mental health information to assure the widespread dissemination of such information to States, political subdivisions, educational agencies and institutions, treatment providers, and the general public;
(17) in collaboration with the National Institute on Aging, and in consultation with the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Mental Health, as appropriate, promote and evaluate substance abuse services for older Americans in need of such services, and mental health services for older Americans who are seriously mentally ill; and
(18) promote the coordination of service programs conducted by other departments, agencies, organizations and individuals that are or may be related to the problems of individuals suffering from mental illness or substance abuse, including liaisons with the Social Security Administration, Health Care Financing Administration, and other programs of the Department, as well as liaisons with the Department of Education, Department of Justice, and other Federal Departments and offices, as appropriate.
(e) Associate Administrator for Alcohol Prevention and Treatment Policy
(1) In general
There shall be in the Administration an Associate Administrator for Alcohol Prevention and Treatment Policy to whom the Administrator shall delegate the functions of promoting, monitoring, and evaluating service programs for the prevention and treatment of alcoholism and alcohol abuse within the Center for Substance Abuse Prevention, the Center for Substance Abuse Treatment, and the Center for Mental Health Services, and coordinating such programs among the Centers, and among the Centers and other public and private entities. The Associate Administrator also shall ensure that alcohol prevention, education, and policy strategies are integrated into all programs of the Centers that address substance abuse prevention, education, and policy, and that the Center for Substance Abuse Prevention addresses the Healthy People 2000 goals and the National Dietary Guidelines of the Department of Health and Human Services and the Department of Agriculture related to alcohol consumption.
(2) Plan
(A) The Administrator, acting through the Associate Administrator for Alcohol Prevention and Treatment Policy, shall develop, and periodically review and as appropriate revise, a plan for programs and policies to treat and prevent alcoholism and alcohol abuse. The plan shall be developed (and reviewed and revised) in collaboration with the Directors of the Centers of the Administration and in consultation with members of other Federal agencies and public and private entities.
(B) Not later than 1 year after July 10, 1992, the Administrator shall submit to the Congress the first plan developed under subparagraph (A).
(3) Report
(A) Not less than once during each 2 years, the Administrator, acting through the Associate Administrator for Alcohol Prevention and Treatment Policy, shall prepare a report describing the alcoholism and alcohol abuse prevention and treatment programs undertaken by the Administration and its agencies, and the report shall include a detailed statement of the expenditures made for the activities reported on and the personnel used in connection with such activities.
(B) Each report under subparagraph (A) shall include a description of any revisions in the plan under paragraph (2) made during the preceding 2 years.
(C) Each report under subparagraph (A) shall be submitted to the Administrator for inclusion in the biennial report under subsection (k) of this section.
(f) Associate Administrator for Women's Services
(1) Appointment
The Administrator, with the approval of the Secretary, shall appoint an Associate Administrator for Women's Services.
(2) Duties
The Associate Administrator appointed under paragraph (1) shall—
(A) establish a committee to be known as the Coordinating Committee for Women's Services (hereafter in this subparagraph referred to as the "Coordinating Committee"), which shall be composed of the Directors of the agencies of the Administration (or the designees of the Directors);
(B) acting through the Coordinating Committee, with respect to women's substance abuse and mental health services—
(i) identify the need for such services, and make an estimate each fiscal year of the funds needed to adequately support the services;
(ii) identify needs regarding the coordination of services;
(iii) encourage the agencies of the Administration to support such services; and
(iv) assure that the unique needs of minority women, including Native American, Hispanic, African-American and Asian women, are recognized and addressed within the activities of the Administration; and
(C) establish an advisory committee to be known as the Advisory Committee for Women's Services, which shall be composed of not more than 10 individuals, a majority of whom shall be women, who are not officers or employees of the Federal Government, to be appointed by the Administrator from among physicians, practitioners, treatment providers, and other health professionals, whose clinical practice, specialization, or professional expertise includes a significant focus on women's substance abuse and mental health conditions, that shall—
(i) advise the Associate Administrator on appropriate activities to be undertaken by the agencies of the Administration with respect to women's substance abuse and mental health services, including services which require a multidisciplinary approach;
(ii) collect and review data, including information provided by the Secretary (including the material referred to in paragraph (3)), and report biannually to the Administrator regarding the extent to which women are represented among senior personnel, and make recommendations regarding improvement in the participation of women in the workforce of the Administration; and
(iii) prepare, for inclusion in the biennial report required pursuant to subsection (k) of this section, a description of activities of the Committee, including findings made by the Committee regarding—
(I) the extent of expenditures made for women's substance abuse and mental health services by the agencies of the Administration; and
(II) the estimated level of funding needed for substance abuse and mental health services to meet the needs of women;
(D) improve the collection of data on women's health by—
(i) reviewing the current data at the Administration to determine its uniformity and applicability;
(ii) developing standards for all programs funded by the Administration so that data are, to the extent practicable, collected and reported using common reporting formats, linkages and definitions; and
(iii) reporting to the Administrator a plan for incorporating the standards developed under clause (ii) in all Administration programs and a plan to assure that the data so collected are accessible to health professionals, providers, researchers, and members of the public; and
(E) shall establish, maintain, and operate a program to provide information on women's substance abuse and mental health services.
(3) Study
(A) The Secretary, acting through the Assistant Secretary for Personnel, shall conduct a study to evaluate the extent to which women are represented among senior personnel at the Administration.
(B) Not later than 90 days after July 10, 1992, the Assistant Secretary for Personnel shall provide the Advisory Committee for Women's Services with a study plan, including the methodology of the study and any sampling frames. Not later than 180 days after July 10, 1992, the Assistant Secretary shall prepare and submit directly to the Advisory Committee a report concerning the results of the study conducted under subparagraph (A).
(C) The Secretary shall prepare and provide to the Advisory Committee for Women's Services any additional data as requested.
(4) Definition
For purposes of this subsection, the term "women's substance abuse and mental health conditions", with respect to women of all age, ethnic, and racial groups, means all aspects of substance abuse and mental illness—
(A) unique to or more prevalent among women; or
(B) with respect to which there have been insufficient services involving women or insufficient data.
(g) Services of experts
(1) In general
The Administrator may obtain (in accordance with
(2) Compensation and expenses
(A) Experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed for their expenses associated with traveling to and from their assignment location in accordance with
(B) Expenses specified in subparagraph (A) may not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1), unless and until the expert or consultant agrees in writing to complete the entire period of assignment or one year, whichever is shorter, unless separated or reassigned for reasons beyond the control of the expert or consultant that are acceptable to the Secretary. If the expert or consultant violates the agreement, the money spent by the United States for the expenses specified in subparagraph (A) is recoverable from the expert or consultant as a debt of the United States. The Secretary may waive in whole or in part a right of recovery under this subparagraph.
(h) Peer review groups
The Administrator shall, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of
(i) Voluntary services
The Administrator may accept voluntary and uncompensated services.
(j) Administration
The Administrator shall ensure that programs and activities assigned under this subchapter to the Administration are fully administered by the respective Centers to which such programs and activities are assigned.
(k) Report concerning activities and progress
Not later than February 10, 1994, and once every 2 years thereafter, the Administrator shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, the report containing—
(1) a description of the activities carried out by the Administration;
(2) a description of any measurable progress made in improving the availability and quality of substance abuse and mental health services;
(3) a description of the mechanisms by which relevant research findings of the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and the National Institute of Mental Health have been disseminated to service providers or otherwise utilized by the Administration to further the purposes of this subchapter; and
(4) any report required in this subchapter to be submitted to the Adminstrator 1 for inclusion in the report under this subsection.
(l) Applications for grants and contracts
With respect to awards of grants, cooperative agreements, and contracts under this subchapter, the Administrator, or the Director of the Center involved, as the case may be, may not make such an award unless—
(1) an application for the award is submitted to the official involved;
(2) with respect to carrying out the purpose for which the award is to be provided, the application provides assurances of compliance satisfactory to such official; and
(3) the application is otherwise in such form, is made in such manner, and contains such agreements, assurances, and information as the official determines to be necessary to carry out the purpose for which the award is to be provided.
(m) Authorization of appropriations
For the purpose of providing grants, cooperative agreements, and contracts under this section, there are authorized to be appropriated $25,000,000 for fiscal year 1993, and such sums as may be necessary for fiscal year 1994.
(July 1, 1944, ch. 373, title V, §501, formerly
References in Text
The provisions of title 5 governing appointments in the competitive service, referred to in subsec. (h), are classified generally to
The Federal Advisory Committee Act, referred to in subsec. (h), is
Codification
Section was formerly classified to
Prior Provisions
A prior section 501 of act July 1, 1944, which was classified to
Amendments
1992—
1989—Subsec. (b)(4).
Subsec. (j).
1988—Subsec. (b)(4).
Subsec. (e)(2).
Subsec. (f).
Subsecs. (k) to (m).
1986—
1984—
Subsec. (c).
Subsecs. (g), (h).
1983—
Subsec. (a).
Subsec. (c).
Subsec. (d).
Subsecs. (e), (f).
1976—Subsec. (d).
Change of Name
Centers for Disease Control changed to Centers for Disease Control and Prevention by
Section 161 of
Committee on Energy and Commerce of House of Representatives changed to Committee on Commerce of House of Representatives by House Resolution No. 6, One Hundred Fourth Congress, Jan. 4, 1995.
Effective Date of 1992 Amendment
Amendment by
Transfer Provisions
Subtitle D of title I of
"SEC. 141. TRANSFERS.
"(a)
"(b)
"(c)
"SEC. 142. TRANSFER AND ALLOCATIONS OF APPROPRIATIONS AND PERSONNEL.
"(a)
"(b)
"(c)
"SEC. 143. INCIDENTAL TRANSFERS.
"Prior to October 1, 1992, the Secretary of Health and Human Services is authorized to make such determinations as may be necessary with regard to the functions transferred by this subtitle, and to make such additional incidental dispositions of personnel, assets, liabilities, grants, contracts, property, records, and unexpended balances of appropriations, authorizations, allocations, and other funds held, used, arising from, available to, or to be made available in connection with such functions, as may be necessary to carry out the provisions of this subtitle and the Public Health Service Act [this chapter]. Such Secretary shall provide for the termination of the affairs of all entities terminated by this subtitle and for such further measures and dispositions as may be necessary to effectuate the purposes of this subtitle.
"SEC. 144. EFFECT ON PERSONNEL.
"(a)
"(b)
"SEC. 145. SAVINGS PROVISIONS.
"(a)
"(1) have been issued, made, granted, or allowed to become effective by the President, any Federal agency or official thereof, or by a court of competent jurisdiction, in the performance of functions which are transferred by this subtitle; and
"(2) are in effect on the date of enactment of this Act [July 10, 1992];
shall continue in effect according to their terms until modified, terminated, superseded, set aside, or revoked in accordance with law by the President, the Director of the National Institutes of Health, or the Administrator of the Substance Abuse and Mental Health Services Administration, as appropriate, a court of competent jurisdiction, or by operation of law.
"(b)
"(1)
"(2)
"(c)
"(1) the provisions of this subtitle do not affect actions commenced prior to the date of enactment of this Act [July 10, 1992]; and
"(2) in all such actions, proceedings shall be had, appeals taken, and judgments rendered in the same manner and effect as if this Act had not been enacted.
"(d)
"(e)
"(f)
"SEC. 146. TRANSITION.
"With the consent of the Secretary of Health and Human Services, the Administrator of the Substance Abuse and Mental Health Services Administration and the Directors of the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the National Institute of Mental Health are authorized to utilize—
"(1) the services of such officers, employees, and other personnel of the Department with respect to functions transferred to the Administrator of the Substance Abuse and Mental Health Services Administration and the Director of the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the National Institute of Mental Health by this subtitle; and
"(2) funds appropriated to such functions for such period of time as may reasonably be needed to facilitate the orderly implementation of this subtitle.
"SEC. 147. PEER REVIEW.
"With respect to fiscal years 1993 through 1996, the peer review systems, advisory councils and scientific advisory committees utilized, or approved for utilization, by the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse and the National Institute of Mental Health prior to the transfer of such Institutes to the National Institute of Health shall be utilized by such Institutes.
"SEC. 148. MERGERS.
"Notwithstanding the provisions of section 401(c)(2) of the Public Health Service Act (
"SEC. 149. CONDUCT OF MULTI-YEAR RESEARCH PROJECTS.
"With respect to multi-year grants awarded prior to fiscal year 1993 by the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute of Mental Health with amounts received under section 1911(b) [former
"SEC. 150. SEPARABILITY.
"If a provision of this subtitle or its application to any person or circumstance is held invalid, neither the remainder of this Act [see Tables for classification] nor the application of the provision to other persons or circumstances shall be affected.
"SEC. 151. BUDGETARY AUTHORITY.
"With respect to fiscal years 1994 and 1995, the Directors of the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute of Mental Health shall notwithstanding section 405(a) [
Report by Substance Abuse and Mental Health Services Administration
Section 708 of
Relationship Between Mental Illness and Substance Abuse
Section 2071 of
Report With Respect to Administration of Certain Research Programs
Section 2073 of
Congressional Statement of Policy for Alcohol and Drug Abuse Amendments of 1983
Section 1(b) of
"(1) a continued Federal commitment to research into the behavioral and biomedical etiology, the treatment, and the mental and physical health and social and economic consequences of alcohol abuse and alcoholism and drug abuse;
"(2) a commitment to—
"(A) extensive dissemination to States, units of local government, community organizations, and private groups of the most recent information and research findings with respect to alcohol abuse and alcoholism and drug abuse, including information with respect to the application of research findings; and
"(B) the accomplishment of such dissemination through up-to-date publications, demonstrations, educational programs, and other appropriate means;
"(3) the provision of technical assistance to research personnel; services personnel, and prevention personnel in the field of alcohol abuse and alcoholism and drug abuse;
"(4) the development and encouragement of prevention programs designed to combat the spread of alcoholism, alcohol abuse, drug abuse, and the abuse of other legal and illegal substances;
"(5) the development and encouragement of effective occupational prevention and treatment programs within Government and in cooperation with the private sector; and
"(6) the provision of a Federal response to alcohol abuse and alcoholism and drug abuse which encourages the greatest participation by the private sector, both financially and otherwise, and concentrates on carrying out functions relating to alcohol abuse and alcoholism and drug abuse which are truly national in scope."
Alcohol and Drug Abuse and Mental Health Reports by the Secretary
Section 3 of
Section Referred to in Other Sections
This section is referred to in
1 So in original. Probably should be "Administrator".
§290aa–1. Advisory councils
(a) Appointment
(1) In general
The Secretary shall appoint an advisory council for—
(A) the Substance Abuse and Mental Health Services Administration;
(B) the Center for Substance Abuse Treatment;
(C) the Center for Substance Abuse Prevention; and
(D) the Center for Mental Health Services.
Each such advisory council shall advise, consult with, and make recommendations to the Secretary and the Administrator or Director of the Administration or Center for which the advisory council is established concerning matters relating to the activities carried out by and through the Administration or Center and the policies respecting such activities.
(2) Function and activities
An advisory council—
(A)(i) may on the basis of the materials provided by the organization respecting activities conducted at the organization, make recommendations to the Administrator or Director of the Administration or Center for which it was established respecting such activities;
(ii) shall review applications submitted for grants and cooperative agreements for activities for which advisory council approval is required under
(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the organization;
(B) may collect, by correspondence or by personal investigation, information as to studies and services that are being carried on in the United States or any other country as to the diseases, disorders, or other aspects of human health with respect to which the organization was established and with the approval of the Administrator or Director, whichever is appropriate, make such information available through appropriate publications for the benefit of public and private health entities and health professions personnel and for the information of the general public; and
(C) may appoint subcommittees and convene workshops and conferences.
(b) Membership
(1) In general
Each advisory council shall consist of nonvoting ex officio members and not more than 12 members to be appointed by the Secretary under paragraph (3).
(2) Ex officio members
The ex officio members of an advisory council shall consist of—
(A) the Secretary;
(B) the Administrator;
(C) the Director of the Center for which the council is established;
(D) the Under Secretary for Health of the Department of Veterans Affairs;
(E) the Assistant Secretary for Defense for Health Affairs (or the designates of such officers); and
(F) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions.
(3) Appointed members
Individuals shall be appointed to an advisory council under paragraph (1) as follows:
(A) Nine of the members shall be appointed by the Secretary from among the leading representatives of the health disciplines (including public health and behavioral and social sciences) relevant to the activities of the Administration or Center for which the advisory council is established.
(B) Three of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, public relations, law, health policy economics, or management.
(4) Compensation
Members of an advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The remaining members of an advisory council shall receive, for each day (including travel time) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent to the annual rate in effect for grade GS–18 of the General Schedule.
(c) Terms of office
(1) In general
The term of office of a member of an advisory council appointed under subsection (b) of this section shall be 4 years, except that any member appointed to fill a vacancy for an unexpired term shall serve for the remainder of such term. The Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members not all expire in the same year. A member of an advisory council may serve after the expiration of such member's term until a successor has been appointed and taken office.
(2) Reappointments
A member who has been appointed to an advisory council for a term of 4 years may not be reappointed to an advisory council during the 2-year period beginning on the date on which such 4-year term expired.
(3) Time for appointment
If a vacancy occurs in an advisory council among the members under subsection (b) of this section, the Secretary shall make an appointment to fill such vacancy within 90 days from the date the vacancy occurs.
(d) Chair
The Secretary shall select a member of an advisory council to serve as the chair of the council. The Secretary may so select an individual from among the appointed members, or may select the Administrator or the Director of the Center involved. The term of office of the chair shall be 2 years.
(e) Meetings
An advisory council shall meet at the call of the chairperson or upon the request of the Administrator or Director of the Administration or Center for which the advisory council is established, but in no event less than 3 times during each fiscal year. The location of the meetings of each advisory council shall be subject to the approval of the Administrator or Director of Administration or Center for which the council was established.
(f) Executive Secretary and staff
The Administrator or Director of the Administration or Center for which the advisory council is established shall designate a member of the staff of the Administration or Center for which the advisory council is established to serve as the Executive Secretary of the advisory council. The Administrator or Director shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Administrator or Director shall provide orientation and training for new members of the advisory council to provide for their effective participation in the functions of the advisory council.
(July 1, 1944, ch. 373, title V, §502, formerly §505, as added Oct. 27, 1986,
Codification
Section was formerly classified to
Prior Provisions
A prior section 290aa–1, act July 1, 1944, ch. 373, title V, §502, formerly
A prior section 502 of act July 1, 1944, which was classified to
Amendments
1994—Subsec. (b)(2)(D).
1992—
1990—Subsec. (a)(2).
1988—Subsec. (b)(2)(A).
Effective Date of 1992 Amendments
Amendment by
Amendment by
Effective Date of 1988 Amendment
Amendment by
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
Continuation of Existing Advisory Councils
Section 4004(b) of
"(1) the Secretary of Health and Human Services shall make appointments to each such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by section 505 [now 502] of the Public Health Service Act [this section];
"(2) each advisory council shall organize itself in accordance with such section and exercise the functions prescribed by such section; and
"(3) the Director of each such institute shall perform for such advisory council the functions prescribed by such section."
§290aa–2. Reports: health consequences, current research, recommendations
(a) Alcoholism and alcohol abuse
The Secretary shall submit to Congress on or before January 15, 1984, and every three years thereafter a report—
(1) containing current information on the health consequences of using alcoholic beverages,
(2) containing a description of current research findings made with respect to alcohol abuse and alcoholism, and
(3) containing such recommendations for legislation and administrative action as the Secretary may deem appropriate.
(b) Drug abuse
The Secretary shall submit to Congress on or before January 15, 1984, and every three years thereafter a report—
(1) describing the health consequences and extent of drug abuse in the United States;
(2) describing current research findings made with respect to drug abuse, including current findings on the health effects of marihuana and the addictive property of tobacco; and
(3) containing such recommendations for legislation and administrative action as the Secretary may deem appropriate.
(July 1, 1944, ch. 373, title V, §503, formerly §505, as added Apr. 26, 1983,
Codification
Section was formerly classified to
Prior Provisions
A prior section 290aa–2, act July 1, 1944, ch. 373, title V, §503, formerly
A prior section 503 of act July 1, 1944, which was classified to
Regulations
Secretary of Health and Human Services to promulgate regulations, within 90 days of Oct. 19, 1984, for the administration of
Relationship Between Consumption of Legal and Illegal Drugs
"(a)
"(1) the effect of advertising and marketing campaigns that promote the use of legal drugs on the public;
"(2) the correlation of legal drug abuse with illegal drug abuse; and
"(3) other matters that the Secretary determines appropriate.
"(b)
§290aa–3. Peer review
(a) In general
The Secretary, after consultation with the Directors of the Center for Substance Abuse Treatment, the Center for Substance Abuse Prevention, and the Center for Mental Health Services, shall require appropriate peer review of grants, cooperative agreements, and contracts to be administered through such Centers.
(b) Members
The members of any peer review group established under regulations under subsection (a) of this section shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of the group. Not more than one-fourth of the members of any peer review group established under such regulation shall be officers or employees of the United States.
(c) Requirements
Regulations promulgated pursuant to subsection (a) of this section—
(1) shall require that the reviewing entity be provided a written description of the matter to be reviewed;
(2) shall require that the reviewing entity provide the advisory council of the Center involved with such description and the results of the review by the entity; and
(3) may specify the conditions under which limited exceptions may be granted to the limitations contained in the last sentence of subsection (b) of this section and subsection (d) of this section.
(d) Recommendations
(1) In general
If the direct cost of a grant, cooperative agreement, or contract (described in subsection (a) of this section) to be made does not exceed $50,000, the Secretary may make such grant, cooperative agreement, or contract only if such grant, cooperative agreement, or contract is recommended after peer review required by regulations under subsection (a) of this section.
(2) By appropriate advisory council
If the direct cost of a grant, cooperative agreement, or contract (described in subsection (a) of this section) to be made exceeds $50,000, the Secretary may make such grant, cooperative agreement, or contract only if such grant, cooperative agreement, or contract is recommended—
(A) after peer review required by regulations under subsection (a) of this section, and
(B) by the appropriate advisory council.
(July 1, 1944, ch. 373, title V, §504, formerly §506, as added Apr. 26, 1983,
Codification
Section was formerly classified to
Prior Provisions
A prior section 290aa–3, act July 1, 1944, ch. 373, title V, §504, formerly title IV, §455, as added May 14, 1974,