Part D—General Provisions

Part Referred to in Other Sections

This part is referred to in section 300ff–101 of this title.

§300ff–71. Grants for coordinated services and access to research for women, infants, children, and youth

(a) In general

The Secretary, acting through the Administrator of the Health Resources and Services Administration and in consultation with the Director of the National Institutes of Health, shall make grants to public and nonprofit private entities that provide primary care (directly or through contracts) for the following purposes:

(1) Providing through such entities, in accordance with this section, opportunities for women, infants, children, and youth to be voluntary participants in research of potential clinical benefit to individuals with HIV disease.

(2) In the case of women, infants, children, and youth with HIV disease, and the families of such individuals, providing to such individuals—

(A) health care on an outpatient basis; and

(B) additional services in accordance with subsection (d) of this section.

(b) Provisions regarding participation in research

(1) In general

With respect to the projects of research with which an applicant under subsection (a) of this section is concerned, the Secretary may make a grant under such subsection to the applicant only if the following conditions are met:

(A) The applicant agrees to make reasonable efforts—

(i) to identify which of the patients of the applicant are women, infants, children, and youth who would be appropriate participants in the projects;

(ii) to carry out clause (i) through the use of criteria provided for such purpose by the entities that will be conducting the projects of research; and

(iii) to offer women, infants, children, and youth the opportunity to participate in the projects (as appropriate), including the provision of services under subsection (d)(3) of this section.

(B) The applicant agrees that, in the case of the research-related functions to be carried out by the applicant pursuant to subsection (a)(1) of this section, the applicant will comply with accepted standards that are applicable to such functions (including accepted standards regarding informed consent and other protections for human subjects).

(C) For the first and second fiscal years for which grants under subsection (a) of this section are to be made to the applicant, the applicant agrees that, not later than the end of the second fiscal year of receiving such a grant, a significant number of women, infants, children, and youth who are patients of the applicant will be participating in the projects of research.

(D) Except as provided in paragraph (3) (and paragraph (4), as applicable), for the third and subsequent fiscal years for which such grants are to be made to the applicant, the Secretary has determined that a significant number of such individuals are participating in the projects.

(2) Prohibition

Receipt of services by a patient shall not be conditioned upon the consent of the patient to participate in research.

(3) Significant participation; consideration by Secretary of certain circumstances

In administering the requirement of paragraph (1)(D), the Secretary shall take into account circumstances in which a grantee under subsection (a) of this section is temporarily unable to comply with the requirement for reasons beyond the control of the grantee, and shall in such circumstances provide to the grantee a reasonable period of opportunity in which to reestablish compliance with the requirement.

(4) Significant participation; temporary waiver for original grantees

(A) In general

In the case of an applicant under subsection (a) of this section who received a grant under such subsection for fiscal year 1995, the Secretary may, subject to subparagraph (B), provide to the applicant a waiver of the requirement of paragraph (1)(D) if the Secretary determines that the applicant is making reasonable progress toward meeting the requirement.

(B) Termination of authority for waivers

The Secretary may not provide any waiver under subparagraph (A) on or after October 1, 1998. Any such waiver provided prior to such date terminates on such date, or on such earlier date as the Secretary may specify.

(c) Provisions regarding conduct of research

(1) In general

With respect to eligibility for a grant under subsection (a) of this section:

(A) A project of research for which subjects are sought pursuant to such subsection may be conducted by the applicant for the grant, or by an entity with which the applicant has made arrangements for purposes of the grant. The grant may not be expended for the conduct of any project of research, except for such research-related functions as are appropriate for providing opportunities under subsection (a)(1) of this section (including the functions specified in subsection (b)(1) of this section).

(B) The grant may be made only if the Secretary makes the following determinations:

(i) The applicant or other entity (as the case may be under subparagraph (A)) is appropriately qualified to conduct the project of research. An entity shall be considered to be so qualified if any research protocol of the entity has been recommended for funding under this chapter pursuant to technical and scientific peer review through the National Institutes of Health.

(ii) The project of research is being conducted in accordance with a research protocol to which the Secretary gives priority regarding the prevention or treatment of HIV disease in women, infants, children, or youth, subject to paragraph (2).

(2) List of research protocols

(A) In general

From among the research protocols described in paragraph (1)(B)(ii), the Secretary shall establish a list of research protocols that are appropriate for purposes of subsection (a)(1) of this section. Such list shall be established only after consultation with public and private entities that conduct such research, and with providers of services under subsection (a) of this section and recipients of such services.

(B) Discretion of Secretary

The Secretary may authorize the use, for purposes of subsection (a)(1) of this section, of a research protocol that is not included on the list under subparagraph (A). The Secretary may waive the requirement specified in paragraph (1)(B)(ii) in such circumstances as the Secretary determines to be appropriate.

(d) Additional services for patients and families

A grant under subsection (a) of this section may be made only if the applicant for the grant agrees as follows:

(1) The applicant will provide for the case management of the patient involved and the family of the patient.

(2) The applicant will provide for the patient and the family of the patient—

(A) referrals for inpatient hospital services, treatment for substance abuse, and mental health services; and

(B) referrals for other social and support services, as appropriate.

(3) The applicant will provide the patient and the family of the patient with such transportation, child care, and other incidental services as may be necessary to enable the patient and the family to participate in the program established by the applicant pursuant to such subsection.

(e) Coordination with other entities

A grant under subsection (a) of this section may be made only if the applicant for the grant agrees as follows:

(1) The applicant will coordinate activities under the grant with other providers of health care services under this chapter, and under title V of the Social Security Act [42 U.S.C. 701 et seq.].

(2) The applicant will participate in the statewide coordinated statement of need under part B of this subchapter (where it has been initiated by the public health agency responsible for administering grants under part B of this subchapter) and in revisions of such statement.

(f) Application

A grant under subsection (a) of this section may be made 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 section.

(g) Coordination with National Institutes of Health

The Secretary shall develop and implement a plan that provides for the coordination of the activities of the National Institutes of Health with the activities carried out under this section. In carrying out the preceding sentence, the Secretary shall ensure that projects of research conducted or supported by such Institutes are made aware of applicants and grantees under subsection (a) of this section, shall require that the projects, as appropriate, enter into arrangements for purposes of such subsection, and shall require that each project entering into such an arrangement inform the applicant or grantee under such subsection of the needs of the project for the participation of women, infants, children, and youth.

(h) Annual review of programs; evaluations

(1) Review regarding access to and participation in programs

With respect to a grant under subsection (a) of this section for an entity for a fiscal year, the Secretary shall, not later than 180 days after the end of the fiscal year, provide for the conduct and completion of a review of the operation during the year of the program carried out under such subsection by the entity. The purpose of such review shall be the development of recommendations, as appropriate, for improvements in the following:

(A) Procedures used by the entity to allocate opportunities and services under subsection (a) of this section among patients of the entity who are women, infants, children, or youth.

(B) Other procedures or policies of the entity regarding the participation of such individuals in such program.

(2) Evaluations

The Secretary shall, directly or through contracts with public and private entities, provide for evaluations of programs carried out pursuant to subsection (a) of this section.

(i) Training and technical assistance

Of the amounts appropriated under subsection (j) of this section for a fiscal year, the Secretary may use not more than five percent to provide, directly or through contracts with public and private entities (which may include grantees under subsection (a) of this section), training and technical assistance to assist applicants and grantees under subsection (a) of this section in complying with the requirements of this section.

(j) 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 1996 through 2000.

(July 1, 1944, ch. 373, title XXVI, §2671, as added Pub. L. 101–381, title IV, §401, Aug. 18, 1990, 104 Stat. 617; amended Pub. L. 104–146, §3(e), May 20, 1996, 110 Stat. 1358.)

References in Text

The Social Security Act, referred to in subsec. (e)(1), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title V of the Act is classified generally to subchapter V (§701 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

Amendments

1996—Pub. L. 104–146 amended section generally, substituting provisions authorizing grants for coordinated services and access to research for women, infants, children, and youth living with the HIV virus for provisions authorizing demonstration grants for research and services for pediatric patients regarding AIDS.

Effective Date of 1996 Amendment

Amendment by Pub. L. 104–146 effective Oct. 1, 1996, see section 13 of Pub. L. 104–146, set out as a note under section 300ff–11 of this title.

Section Referred to in Other Sections

This section is referred to in sections 300ff–12, 300ff–23, 300ff–41, 300ff–51 of this title.

§300ff–72. Provisions relating to blood banks

(a) Informational and training programs

The Secretary shall—

(1) develop and make available to technical and supervisory personnel employed at blood banks and facilities that produce blood products, materials and information concerning measures that may be implemented to protect the safety of the blood supply with respect to the activities of such personnel, including—

(A) state-of-the-art diagnostic and testing procedures relating to pathogens in the blood supply; and

(B) quality assurance procedures relating to the safety of the blood supply and of blood products; and

(2) develop and implement a training program that is designed to increase the number of employees of the Department of Health and Human Services who are qualified to conduct inspections of blood banks and facilities that produce blood products.

(b) Updates

The Secretary shall periodically review and update the materials and information made available under informational or training programs conducted under subsection (a) of this section.

(c) Authorization of appropriations

There are authorized to be appropriated to carry out this section, $1,500,000 for fiscal year 1991, and such sums as may be necessary in each of the fiscal years 1992 through 1995.

(July 1, 1944, ch. 373, title XXVI, §2672, as added Pub. L. 101–381, title IV, §401, Aug. 18, 1990, 104 Stat. 618.)

§300ff–73. Research, evaluation, and assessment program

(a) Establishment

The Secretary, acting through the Agency for Healthcare Research and Quality, shall establish a program to enable independent research to be conducted by individuals and organizations with appropriate expertise in the fields of health, health policy, and economics (particularly health care economics) to develop—

(1) a comparative assessment of the impact and cost-effectiveness of major models for organizing and delivering HIV-related health care, mental health care, early intervention, and support services, that shall include a report concerning patient outcomes, satisfaction, perceived quality of care, and total cumulative cost, and a review of the appropriateness of such models for the delivery of health and support services to infants, children, women, and families with HIV disease;

(2) through a review of private sector financing mechanisms for the delivery of HIV-related health and support services, an assessment of strategies for maintaining private health benefits for individuals with HIV disease and an assessment of specific business practices or regulatory barriers that could serve to reduce access to private sector benefit programs;

(3) an assessment of the manner in which different points-of-entry to the health care system affect the cost, quality, and outcome of the care and treatment of individuals and families with HIV disease; and

(4) a summary report concerning the major and continuing unmet needs in health care, mental health care, early intervention, and support services for individuals and families with HIV disease in urban and rural areas.

(b) Report

Not later than 2 years after August 18, 1990, and periodically 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 progress report that contains the findings and assessments developed under subsection (a) of this section.

(c) Authorization of appropriations

There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of the fiscal years 1991 through 1995.

(July 1, 1944, ch. 373, title XXVI, §2673, as added Pub. L. 101–381, title IV, §401, Aug. 18, 1990, 104 Stat. 619; amended Pub. L. 106–129, §2(b)(2), Dec. 6, 1999, 113 Stat. 1670.)

Amendments

1999—Subsec. (a). Pub. L. 106–129, in introductory provisions, substituted "Agency for Healthcare Research and Quality" for "Agency for Health Care Policy and Research".

Change of Name

Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress.

§300ff–74. Evaluations and reports

(a) Evaluations

The Secretary shall, directly or through grants and contracts, evaluate programs carried out under this subchapter.

(b) Report to Congress

The Secretary shall, not later than October 1, 1996, and annually thereafter, prepare and submit to the appropriate Committees of Congress a report—

(1) evaluating the programs carried out under this subchapter; and

(2) making such recommendations for administrative and legislative initiatives with respect to this subchapter as the Secretary determines to be appropriate.

(c) Authorization of appropriations

There are authorized to be appropriated to carry out this section, such sums as may be necessary for each of the fiscal years 1991 through 1995.

(d) Allocation of funds

The Secretary shall carry out this section with amounts available under section 238j of this title. Such amounts are in addition to any other amounts that are available to the Secretary for such purpose.

(July 1, 1944, ch. 373, title XXVI, §2674, as added Pub. L. 101–381, title IV, §401, Aug. 18, 1990, 104 Stat. 620; amended Pub. L. 104–146, §3(f), May 20, 1996, 110 Stat. 1362.)

Amendments

1996—Subsec. (b). Pub. L. 104–146, §3(f)(1)(A), substituted "not later than October 1, 1996," for "not later than 1 year after the date on which amounts are first appropriated under this subchapter," in introductory provisions.

Subsec. (b)(1). Pub. L. 104–146, §3(f)(1)(B), added par. (1) and struck out former par. (1) which read as follows: "summarizing all of the reports that are required to be submitted to the Secretary under this subchapter;".

Subsec. (b)(2) to (4). Pub. L. 104–146, §3(f)(1)(B), (C), redesignated par. (4) as (2) and struck out former pars. (2) and (3) which read as follows:

"(2) recommending criteria to be used in determining the geographic areas with the most substantial need for HIV-related health services;

"(3) summarizing all of the evaluations carried out pursuant to subsection (a) of this section during the period for which the report under this subsection is prepared; and".

Subsec. (d). Pub. L. 104–146, §3(f)(2), added subsec. (d).

Effective Date of 1996 Amendment

Amendment by Pub. L. 104–146 effective Oct. 1, 1996, see section 13 of Pub. L. 104–146, set out as a note under section 300ff–11 of this title.

§300ff–75. Coordination

(a) Requirement

The Secretary shall assure that the Health Resources and Services Administration and the Centers for Disease Control and Prevention will coordinate the planning of the funding of programs authorized under this subchapter to assure that health support services for individuals with HIV disease are integrated with each other and that the continuity of care of individuals with HIV disease is enhanced. In coordinating the allocation of funds made available under this subchapter the Health Resources and Services Administration and the Centers for Disease Control and Prevention shall utilize planning information submitted to such agencies by the States and entities eligible for support.

(b) Integration by State

As a condition of receipt of funds under this subchapter, a State shall assure the Secretary that health support services funded under this subchapter will be integrated with each other, that programs will be coordinated with other available programs (including Medicaid) and that the continuity of care of individuals with HIV disease is enhanced.

(c) Integration by local or private entities

As a condition of receipt of funds under this subchapter, a local government or private nonprofit entity shall assure the Secretary that services funded under this subchapter will be integrated with each other, that programs will be coordinated with other available programs (including Medicaid) and that the continuity of care of individuals with HIV is enhanced.

(July 1, 1944, ch. 373, title XXVI, §2675, as added Pub. L. 101–381, title IV, §401, Aug. 18, 1990, 104 Stat. 620; amended Pub. L. 102–531, title III, §312(d)(34), Oct. 27, 1992, 106 Stat. 3506.)

Amendments

1992—Subsec. (a). Pub. L. 102–531 substituted "Centers for Disease Control and Prevention" for "Centers for Disease Control" in two places.

§300ff–76. Definitions

For purposes of this subchapter:

(1) Counseling

The term "counseling" means such counseling provided by an individual trained to provide such counseling.

(2) Designated officer of emergency response employees

The term "designated officer of emergency response employees" means an individual designated under section 300ff–86 of this title by the public health officer of the State involved.

(3) Emergency

The term "emergency" means an emergency involving injury or illness.

(4) Emergency response employees

The term "emergency response employees" means firefighters, law enforcement officers, paramedics, emergency medical technicians, funeral-service practitioners, and other individuals (including employees of legally organized and recognized volunteer organizations, without regard to whether such employees receive nominal compensation) who, in the course of professional duties, respond to emergencies in the geographic area involved.

(5) Employer of emergency response employees

The term "employer of emergency response employees" means an organization that, in the course of professional duties, responds to emergencies in the geographic area involved.

(6) Exposed

The term "exposed", with respect to HIV disease or any other infectious disease, means to be in circumstances in which there is a significant risk of becoming infected with the etiologic agent for the disease involved.

(7) Families with HIV disease

The term "families with HIV disease" means families in which one or more members have HIV disease.

(8) HIV

The term "HIV" means infection with the etiologic agent for acquired immune deficiency syndrome.

(9) HIV disease

The term "HIV disease" means infection with the etiologic agent for acquired immune deficiency syndrome, and includes any condition arising from such syndrome.

(10) Official poverty line

The term "official poverty line" means the poverty line established by the Director of the Office of Management and Budget and revised by the Secretary in accordance with section 9902(2) of this title.

(11) Person

The term "person" includes one or more individuals, governments (including the Federal Government and the governments of the States), governmental agencies, political subdivisions, labor unions, partnerships, associations, corporations, legal representatives, mutual companies, joint-stock companies, trusts, unincorporated organizations, receivers, trustees, and trustees in cases under title 11.

(12) State

The term "State", except as otherwise specifically provided, means each of the 50 States, the District of Columbia, the Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, Puerto Rico, and the Republic of the Marshall Islands.

(July 1, 1944, ch. 373, title XXVI, §2676, as added Pub. L. 101–381, title IV, §401, Aug. 18, 1990, 104 Stat. 620; amended Pub. L. 104–146, §12(a), (c)(8), May 20, 1996, 110 Stat. 1373, 1374.)

Amendments

1996—Par. (2). Pub. L. 104–146, §12(c)(8)(A), substituted "section 300ff–86 of this title by the" for "section" and all that followed through "by the".

Par. (4). Pub. L. 104–146, §12(a), inserted "funeral-service practitioners," after "emergency medical technicians,".

Par. (10). Pub. L. 104–146, §12(c)(8)(B), substituted "section 9902(2)" for "section 9902(a)".

Effective Date of 1996 Amendment

Amendment by Pub. L. 104–146 effective Oct. 1, 1996, see section 13 of Pub. L. 104–146, set out as a note under section 300ff–11 of this title.

§300ff–77. Authorization of appropriations

(a) In general

Subject to subsection (b) of this section, there are authorized to be appropriated to make grants under parts A and B of this subchapter, such sums as may be necessary for each of the fiscal years 1996 through 2000.

(b) Development of methodology

(1) In general

With respect to each of the fiscal years 1997 through 2000, the Secretary shall develop and implement a methodology for adjusting the percentages allocated to part A of this subchapter and part B of this subchapter to account for grants to new eligible areas under part A of this subchapter and other relevant factors. Not later than July 1, 1996, the Secretary shall prepare and submit to the appropriate committees of Congress a report regarding the findings with respect to the methodology developed under this paragraph.

(2) Failure to implement

If the Secretary determines that such a methodology under paragraph (1) cannot be developed, there are authorized to be appropriated—

(A) such sums as may be necessary to carry out part A of this subchapter for each of the fiscal years 1997 through 2000; and

(B) such sums as may be necessary to carry out part B of this subchapter for each of the fiscal years 1997 through 2000.

(July 1, 1944, ch. 373, title XXVI, §2677, as added Pub. L. 104–146, §6(a), May 20, 1996, 110 Stat. 1367.)

Effective Date

Section effective May 20, 1996, see section 13(b) of Pub. L. 104–146, set out as an Effective Date of 1996 Amendment note under section 300ff–11 of this title.

Section Referred to in Other Sections

This section is referred to in sections 300ff–13, 300ff–15, 300ff–16, 300ff–28, 300ff–33 of this title.

§300ff–78. Prohibition on promotion of certain activities

None of the funds authorized under this subchapter shall be used to fund AIDS programs, or to develop materials, designed to promote or encourage, directly, intravenous drug use or sexual activity, whether homosexual or heterosexual. Funds authorized under this subchapter may be used to provide medical treatment and support services for individuals with HIV.

(July 1, 1944, ch. 373, title XXVI, §2678, as added Pub. L. 104–146, §10, May 20, 1996, 110 Stat. 1373.)

Effective Date

Section effective Oct. 1, 1996, see section 13 of Pub. L. 104–146, set out as an Effective Date of 1996 Amendment note under section 300ff–11 of this title.