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Title IV of the Public Health Service Act, comprising this subchapter, was originally enacted by act July 1, 1944, ch. 373,
The provisions of title IV as originally enacted were subsequently redesignated as part A of title IV and amended, and parts B to I of title IV were added and amended by the following acts: June 16, 1948, ch.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 and Craniofacial 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.
(F) The National Center for Complementary and Alternative Medicine.
(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
Amendments
1998—Subsec. (b)(1)(H).
Subsec. (b)(2)(F).
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 treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
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
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;
(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
(13) may conduct and support research training—
(A) for which fellowship support is not provided under
(B) which does not consist of residency training of physicians or other health professionals; and
(14) may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of
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
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; and
(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.
(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) Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions
(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the "data bank"). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information.
(B) The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.
(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers.
(3) The data bank shall include the following:
(A) A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to
(B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available—
(i) under a treatment investigational new drug application that has been submitted to the Secretary under
(ii) as a Group C cancer drug (as defined by the National Cancer Institute).
The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments.
(4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment.
(5) For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary. Fees collected under
(k) 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.
(l) 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
References in Text
The provisions of title 5 governing appointments in the competitive service, referred to in subsec. (b)(6), (14), are classified generally to
The General Schedule, referred to in subsec. (b)(6), is set out under
The provisions of title 5 relating to classifications, referred to in subsec. (b)(14), are classified generally to
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
1998—Subsec. (b)(13), (14).
Subsec. (f).
"(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."
1997—Subsecs. (j) to (l).
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 treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1992 Amendment
Amendment by
Collaboration and Report
Section 113(b) of
"(1)
"(2)
"(A) of the public health need, if any, for inclusion of device investigations within the scope of the data bank under section 402(j) of the Public Health Service Act;
"(B) on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations is required to be publicly disclosed; and
"(C) on such other issues relating to such section 402(j) as the Secretary determines to be appropriate."
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
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
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 2003.
(July 1, 1944, ch. 373, title IV, §403A, as added
Amendments
1998—Subsec. (e).
Section Referred to in Other Sections
This section is referred to in
§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
§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
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 section 300aa–4 1 of this title, the Secretary, acting through the Director of the National Vaccine Program under subchapter XIX of this chapter, shall include information with respect to activities and the progress made in implementing the provisions of this section and achieving its goals.
(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
References in Text
1 See References in Text note below.
§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
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
§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
Prohibition Against SHARP Adult Sex Survey and American Teenage Sex Survey
Section 2015 of
§283g. Repealed. Pub. L. 105–277, div. A, §101(f) [title VI, §601(1)], Oct. 21, 1998, 112 Stat. 2681–337 , 2681-387
Section, act July 1, 1944, ch. 373, title IV, §404E, as added
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
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 Science 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
Amendments
1998—Subsec. (h)(2)(A)(v).
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
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.
(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
Amendments
1998—Subsec. (a)(4).
1996—Subsec. (a)(3).
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
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 through 2003.
(July 1, 1944, ch. 373, title IV, §409A, as added
Amendments
1998—Subsec. (d).
§284f. Parkinson's disease
(a) In general
The Director of NIH shall establish a program for the conduct and support of research and training with respect to Parkinson's disease (subject to the extent of amounts appropriated under subsection (e) of this section).
(b) Inter-institute coordination
(1) In general
The Director of NIH shall provide for the coordination of the program established under subsection (a) of this section among all of the national research institutes conducting Parkinson's disease research.
(2) Conference
Coordination under paragraph (1) shall include the convening of a research planning conference not less frequently than once every 2 years. Each such conference shall prepare and submit to the Committee on Appropriations and the Committee on Labor and Human Resources of the Senate and the Committee on Appropriations and the Committee on Commerce of the House of Representatives a report concerning the conference.
(c) Morris K. Udall research centers
(1) In general
The Director of NIH is authorized to award Core Center Grants to encourage the development of innovative multidisciplinary research and provide training concerning Parkinson's disease. The Director is authorized to award not more than 10 Core Center Grants and designate each center funded under such grants as a Morris K. Udall Center for Research on Parkinson's Disease.
(2) Requirements
(A) In general
With respect to Parkinson's disease, each center assisted under this subsection shall—
(i) use the facilities of a single institution or a consortium of cooperating institutions, and meet such qualifications as may be prescribed by the Director of the NIH; and
(ii) conduct basic and clinical research.
(B) Discretionary requirements
With respect to Parkinson's disease, each center assisted under this subsection may—
(i) conduct training programs for scientists and health professionals;
(ii) conduct programs to provide information and continuing education to health professionals;
(iii) conduct programs for the dissemination of information to the public;
(iv) separately or in collaboration with other centers, establish a nationwide data system derived from patient populations with Parkinson's disease, and where possible, comparing relevant data involving general populations;
(v) separately or in collaboration with other centers, establish a Parkinson's Disease Information Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson's disease; and
(vi) separately or in collaboration with other centers, establish a national education program that fosters a national focus on Parkinson's disease and the care of those with Parkinson's disease.
(3) Stipends regarding training programs
A center may use funds provided under paragraph (1) to provide stipends for scientists and health professionals enrolled in training programs under paragraph (2)(B).
(4) Duration of support
Support of a center under this subsection may be for a period not exceeding five years. Such period may be extended by the Director of NIH 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.
(d) Morris K. Udall Awards for Excellence in Parkinson's Disease Research
The Director of NIH is authorized to establish a grant program to support investigators with a proven record of excellence and innovation in Parkinson's disease research and who demonstrate potential for significant future breakthroughs in the understanding of the pathogensis,1 diagnosis, and treatment of Parkinson's disease. Grants under this subsection shall be available for a period of not to exceed 5 years.
(e) Authorization of appropriations
For the purpose of carrying out this section and
(July 1, 1944, ch. 373, title IV, §409B, as added
Finding and Purpose
Section 603(b) of
"(1)
"(2)
1 So in original. Probably should be "pathogenesis,".
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
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
§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
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
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
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
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
§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
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
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
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
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
Amendments
1998—Subsec. (b)(1)(A), (B), (2).
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
§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
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
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
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
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
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
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–7a. Heart attack, stroke, and other cardiovascular diseases in women
(a) In general
The Director of the Institute shall expand, intensify, and coordinate research and related activities of the Institute with respect to heart attack, stroke, and other cardiovascular diseases in women.
(b) Coordination with other institutes
The Director of the Institute shall coordinate activities under subsection (a) of this section with similar activities conducted by the other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have responsibilities that are related to heart attack, stroke, and other cardiovascular diseases in women.
(c) Certain programs
In carrying out subsection (a) of this section, the Director of the Institute shall conduct or support research to expand the understanding of the causes of, and to develop methods for preventing, cardiovascular diseases in women. Activities under such subsection shall include conducting and supporting the following:
(1) Research to determine the reasons underlying the prevalence of heart attack, stroke, and other cardiovascular diseases in women, including African-American women and other women who are members of racial or ethnic minority groups.
(2) Basic research concerning the etiology and causes of cardiovascular diseases in women.
(3) Epidemiological studies to address the frequency and natural history of such diseases and the differences among men and women, and among racial and ethnic groups, with respect to such diseases.
(4) The development of safe, efficient, and cost-effective diagnostic approaches to evaluating women with suspected ischemic heart disease.
(5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation.
(6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women, including applications of effective methods for the control of blood pressure, lipids, and obesity.
(7) Information and education programs for patients and health care providers on risk factors associated with heart attack, stroke, and other cardiovascular diseases in women, and on the importance of the prevention or control of such risk factors and timely referral with appropriate diagnosis and treatment. Such programs shall include information and education on health-related behaviors that can improve such important risk factors as smoking, obesity, high blood cholesterol, and lack of exercise.
(d) 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 1999 through 2003. The authorization of appropriations established in the preceding sentence is in addition to any other authorization of appropriation that is available for such purpose.
(July 1, 1944, ch. 373, title IV, §424A, as added
§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
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
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
§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
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
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) 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
Amendments
1998—Subsecs. (j), (k).
"(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
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
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
§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
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
§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
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
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
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
§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
§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.
(July 1, 1944, ch. 373, title IV, §439, as added
Amendments
1998—Subsec. (c).
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
§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
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
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
Study of Malnutrition in Elderly
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
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
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
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 section 11211(a) 2 of this title.
(July 1, 1944, ch. 373, title IV, §445C, formerly
References in Text
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.
2 See References in Text note below.
§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
(a) The Director of the Institute, in addition to other special functions specified in
(b) 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 1999 through 2003. The authorization of appropriations established in the preceding sentence is in addition to any other authorization of appropriation that is available for such purpose.
(July 1, 1944, ch. 373, title IV, §445H, as added
Amendments
1998—
§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
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
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
Extramural Study Section
Section 902(b) of
Research Activities on Chronic Fatigue Syndrome
Section 1903 of
Codification
Another section 447 of act July 1, 1944, was renumbered section 447A and is classified to
§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, §447A, formerly §447, as added
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
National Commission to Prevent Infant Mortality; Composition; Voluntary Services; Duration
National Commission to Prevent Infant Mortality
§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
§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
§285g–3. Associate Director for Prevention; appointment; function
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.
(July 1, 1944, ch. 373, title IV, §451, as added
Amendments
1998—
§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
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
§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
§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
§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
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
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
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
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
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
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
§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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 section 1501 1 of title 21 a report, in accordance with paragraph (3), that describes the objectives and activities of the program assisted under this section.
(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 section 1504 1 of title 21.
(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
References in Text
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
1 See References in Text note below.
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
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
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
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
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
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
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
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
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
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
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
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
§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
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
§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
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
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
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
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
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
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
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
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.
[See main edition for text of (a) to (c)]
(d) Coordination with Director of the Agency for Healthcare Research and Quality
The Secretary, acting through the Center, shall coordinate the activities carried out under this section through the Center with related activities of the Director of the Agency for Healthcare Research and Quality.
(July 1, 1944, ch. 373, title IV, §478A, as added
Amendments
1999—Subsec. (d).
Construction
Section 1422(b) of
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
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
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
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 part B of subchapter V of this chapter;
(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
Amendments
1998—Subsec. (c)(3)(D)(i).
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 may, 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
Amendments
1998—Subsec. (a).
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
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
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 treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
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
subpart 5—national center for complementary and alternative medicine
§287c–21. Purpose of Center
(a) In general
The general purposes of the National Center for Complementary and Alternative Medicine (in this subpart referred to as the "Center") are the conduct and support of basic and applied research (including both intramural and extramural research), research training, the dissemination of health information, and other programs with respect to identifying, investigating, and validating complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems. The Center shall be headed by a director, who shall be appointed by the Secretary. The Director of the Center shall report directly to the Director of NIH.
(b) Advisory council
The Secretary shall establish an advisory council for the Center in accordance with
(c) Complement to conventional medicine
In carrying out subsection (a) of this section, the Director of the Center shall, as appropriate, study the integration of alternative treatment, diagnostic and prevention systems, modalities, and disciplines with the practice of conventional medicine as a complement to such medicine and into health care delivery systems in the United States.
(d) Appropriate scientific expertise and coordination with institutes and Federal agencies
The Director of the Center, after consultation with the advisory council for the Center and the division of research grants, shall ensure that scientists with appropriate expertise in research on complementary and alternative medicine are incorporated into the review, oversight, and management processes of all research projects and other activities funded by the Center. In carrying out this subsection, the Director of the Center, as necessary, may establish review groups with appropriate scientific expertise. The Director of the Center shall coordinate efforts with other Institutes and Federal agencies to ensure appropriate scientific input and management.
(e) Evaluation of various disciplines and systems
In carrying out subsection (a) of this section, the Director of the Center shall identify and evaluate alternative and complementary medical treatment, diagnostic and prevention modalities in each of the disciplines and systems with which the Center is concerned, including each discipline and system in which accreditation, national certification, or a State license is available.
(f) Ensuring high quality, rigorous scientific review
In order to ensure high quality, rigorous scientific review of complementary and alternative, diagnostic and prevention modalities, disciplines and systems, the Director of the Center shall conduct or support the following activities:
(1) Outcomes research and investigations.
(2) Epidemiological studies.
(3) Health services research.
(4) Basic science research.
(5) Clinical trials.
(6) Other appropriate research and investigational activities.
The Director of NIH, in coordination with the Director of the Center, shall designate specific personnel in each Institute to serve as full-time liaisons with the Center in facilitating appropriate coordination and scientific input.
(g) Data system; information clearinghouse
(1) Data system
The Director of the Center shall establish a bibliographic system for the collection, storage, and retrieval of worldwide research relating to complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems. Such a system shall be regularly updated and publicly accessible.
(2) Clearinghouse
The Director of the Center shall establish an information clearinghouse to facilitate and enhance, through the effective dissemination of information, knowledge and understanding of alternative medical treatment, diagnostic and prevention practices by health professionals, patients, industry, and the public.
(h) Research centers
The Director of the Center, after consultation with the advisory council for the Center, shall provide support for the development and operation of multipurpose centers to conduct research and other activities described in subsection (a) of this section with respect to complementary and alternative treatment, diagnostic and prevention modalities, disciplines and systems. The provision of support for the development and operation of such centers shall include accredited complementary and alternative medicine research and education facilities.
(i) Availability of resources
After consultation with the Director of the Center, the Director of NIH shall ensure that resources of the National Institutes of Health, including laboratory and clinical facilities, fellowships (including research training fellowship and junior and senior clinical fellowships), and other resources are sufficiently available to enable the Center to appropriately and effectively carry out its duties as described in subsection (a) of this section. The Director of NIH, in coordination with the Director of the Center, shall designate specific personnel in each Institute to serve as full-time liaisons with the Center in facilitating appropriate coordination and scientific input.
(j) Availability of appropriations
Amounts appropriated to carry out this section for fiscal year 1999 are available for obligation through September 30, 2001. Amounts appropriated to carry out this section for fiscal year 2000 are available for obligation through September 30, 2001.
(July 1, 1944, ch. 373, title IV, §485D, as added
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
Ex. Ord. No. 13147. White House Commission on Complementary and Alternative Medicine Policy
Ex. Ord. No. 13147, Mar. 7, 2000, 65 F.R. 13233, provided:
By the authority vested in me as President by the Constitution and the laws of the United States of America, including the Federal Advisory Committee Act, as amended (5 U.S.C. App.), and in order to establish the White House Commission on Complementary and Alternative Medicine Policy, it is hereby ordered as follows:
(a) the education and training of health care practitioners in complementary and alternative medicine;
(b) coordinated research to increase knowledge about complementary and alternative medicine practices and products;
(c) the provision to health care professionals of reliable and useful information about complementary and alternative medicine that can be made readily accessible and understandable to the general public; and
(d) guidance for appropriate access to and delivery of complementary and alternative medicine.
(b) Each member of the Commission shall receive compensation at a rate equal to the daily equivalent of the annual rate specified for Level IV of the Executive Schedule (
(c) The Department shall provide the Commission with funding and with administrative services, facilities, staff, and other support services necessary for the performance of the Commission's functions.
(d) In accordance with guidelines issued by the Administrator of General Services, the Secretary shall perform the functions of the President under the Federal Advisory Committee Act, as amended (5 U.S.C. App.), with respect to the Commission, except that of reporting to the Congress.
(e) The Commission shall terminate 2 years from the date of this order unless extended by the President prior to such date.
William J. Clinton.
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 NIH 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
Amendments
1998—Subsec. (d)(2).
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
§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
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.
[See main edition for text of (a) to (c)]
(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;
[See main edition for text of (1) and (2)]
(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 section 293k, 293l,2 or 293m 2 of this title, and (B) are for research in primary medical care; and 1 percent shall be made available for payments under National Research Service Awards made for health services research by the Agency for Healthcare Research and Quality under
[See main edition for text of (4)]
(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
References in Text
Amendments
1999—Subsec. (d)(3).
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.
2 See References in Text note below.
§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 $35,000 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 2001.
(July 1, 1944, ch. 373, title IV, §487A, as added
Amendments
1998—Subsec. (a).
Subsec. (c).
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 $35,000 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
Amendments
1998—Subsec. (a).
§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 $35,000 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
Amendments
1998—Subsec. (a)(1).
§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
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
Amendments
1998—Subsec. (a)(1).
Subsec. (a)(3).
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
§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
Amendments
1992—Subsec. (a)(2).
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
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
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
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
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
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
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
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
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
Amendments
1992—Subsec. (a).
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
§289c–1. Collaborative use of certain health services research funds
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 Healthcare Research and Quality.
(July 1, 1944, ch. 373, title IV, §494A, as added
References in Text
Subparts 14, 15 and 16 of part C, referred to in text, are classified to sections 285n et seq., 285o et seq., and 285p et seq., respectively, of this title.
Amendments
1999—
1998—
1995—Subsec. (b).
1993—Subsec. (b).
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
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
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
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
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
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
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
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
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—Foundation for the National Institutes of Health
Amendments
1998—
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 Foundation for the National Institutes of Health (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 transfer funds to the National Institutes of Health. Any funds transferred under this paragraph shall be subject to all Federal limitations relating to federally-funded research.
(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 $500,000 for each fiscal year.
(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.
(July 1, 1944, ch. 373, title IV, §499, formerly §499A, as added
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
1998—Subsec. (a).
Subsec. (k)(10).
Subsec. (m)(1).
1996—Subsec. (n).
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 treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
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)".