Collapse to view only § 285g-6. Program regarding obstetrics and gyne­cology

§ 285g. Purpose of Institute

The general purpose of the Eunice Kennedy Shriver 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 gynecologic health, maternal health, child health, intellectual disabilities, 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 Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856; amended Pub. L. 106–554, § 1(a)(1) [title II, § 215], Dec. 21, 2000, 114 Stat. 2763, 2763A–28; Pub. L. 110–154, § 1(d), Dec. 21, 2007, 121 Stat. 1828; Pub. L. 111–256, § 2(f)(2), Oct. 5, 2010, 124 Stat. 2644.)
§ 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 Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856.)
§ 285g–2. Research on intellectual disabilities

The Director of the Institute shall conduct and support research and related activities into the causes, prevention, and treatment of intellectual disabilities.

(July 1, 1944, ch. 373, title IV, § 450, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856; amended Pub. L. 111–256, § 2(f)(3), Oct. 5, 2010, 124 Stat. 2644.)
§ 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 Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 856; amended Pub. L. 105–362, title VI, § 601(a)(1)(E), Nov. 10, 1998, 112 Stat. 3285.)
§ 285g–4. National Center for Medical Rehabilitation Research
(a) Establishment of Center
(b) Purpose
(c) Authority of Director
(1) In carrying out the purpose described in subsection (b), 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 within 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 section 282(b)(16) of this title; and
(ii) appoint the members of peer review groups established under subparagraph (A); and
(F) support medical rehabilitation research and training centers.
Chapter 10 of title 5 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) The Director of the Center, in consultation with the Director of the Institute, the coordinating committee established under subsection (e), and the advisory board established under subsection (f), shall develop a comprehensive plan (referred to in this section as the “Research Plan”) for the conduct, support, and coordination of medical rehabilitation research.
(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;
(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; and
(C) include goals and objectives for conducting, supporting, and coordinating medical rehabilitation research, consistent with the purpose described in subsection (b).
(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 sections 283 and 284b 1
1 See References in Text note below.
of this title.
(4) The Director of the Center, in consultation with the Director of the Institute, the coordinating committee established under subsection (e), and the advisory board established under subsection (f), shall revise and update the Research Plan periodically, as appropriate, or not less than every 5 years. Not later than 30 days after the Research Plan is so revised and updated, the Director of the Center shall transmit the revised and updated Research Plan to the President, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives.
(5) The Director of the Center, in consultation with the Director of the Institute, shall, prior to revising and updating the Research Plan, prepare a report for the coordinating committee established under subsection (e) and the advisory board established under subsection (f) that describes and analyzes the progress during the preceding fiscal year in achieving the goals and objectives described in paragraph (2)(C) and includes expenditures for rehabilitation research at the National Institutes of Health. The report shall include recommendations for revising and updating the Research Plan, and such initiatives as the Director of the Center and the Director of the Institute determine appropriate. In preparing the report, the Director of the Center and the Director of the Institute shall consult with the Director of the National Institutes of Health.
(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 periodically host a scientific conference or workshop on medical rehabilitation research and make recommendations to the Director of the Institute and the Director of the Center with respect to the span 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 Division of Program Coordination, Planning, and Strategic Initiatives within the Office of the Director of the National Institutes of Health, 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 Director of the Division of Program Coordination, Planning, and Strategic Initiatives.
(x) The Commissioner for Rehabilitation Services Administration.
(xi) The Assistant Secretary of Defense (Health Affairs).
(xii) 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.
(g) Review and coordination of medical rehabilitation research programs
(1) The Secretary and the heads of other Federal agencies shall jointly review the programs carried out (or proposed to be carried out) by each such official with respect to medical rehabilitation research and, as appropriate, enter into agreements preventing duplication among such programs.
(2) The Secretary shall, as appropriate, enter into interagency agreements relating to the coordination of medical rehabilitation research conducted by agencies of the National Institutes of Health and other agencies of the Federal Government.
(h) “Medical rehabilitation research” defined
(July 1, 1944, ch. 373, title IV, § 452, as added Pub. L. 101–613, § 3(a), Nov. 16, 1990, 104 Stat. 3227; amended Pub. L. 102–405, title III, § 302(e)(1), Oct. 9, 1992, 106 Stat. 1985; Pub. L. 109–482, title I, § 102(f)(1)(B), Jan. 15, 2007, 120 Stat. 3685; Pub. L. 114–255, div. A, title II, § 2040(a), (b)(1), Dec. 13, 2016, 130 Stat. 1069, 1070; Pub. L. 117–286, § 4(a)(234), Dec. 27, 2022, 136 Stat. 4331.)
§ 285g–5. Research centers with respect to contraception and infertility
(a) Grants and contracts
(b) Number of centers
(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) 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
(e) Facilities
(f) Period of support
(July 1, 1944, ch. 373, title IV, § 452A, as added Pub. L. 103–43, title X, § 1001, June 10, 1993, 107 Stat. 165; amended Pub. L. 109–482, title I, § 103(b)(29), Jan. 15, 2007, 120 Stat. 3688.)
§ 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 Pub. L. 103–43, title X, § 1011, June 10, 1993, 107 Stat. 166.)
§ 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 Pub. L. 103–43, title X, § 1021, June 10, 1993, 107 Stat. 167.)
§ 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
(2) Population-specific analyses
(c) Coordination with Women’s Health Initiative
(July 1, 1944, ch. 373, title IV, § 452D, as added Pub. L. 103–43, title X, § 1031, June 10, 1993, 107 Stat. 167.)
§ 285g–9. Fragile X
(a) Expansion and coordination of research activities
(b) Research centers
(1) In general
(2) Number of centers
(A) In general
(B) Peer review requirement
(3) Activities
(4) Coordination among centers
(5) Certain administrative requirements
(6) Duration of support
(July 1, 1944, ch. 373, title IV, § 452E, as added Pub. L. 106–310, div. A, title II, § 201, Oct. 17, 2000, 114 Stat. 1109; amended Pub. L. 109–482, title I, § 103(b)(30), Jan. 15, 2007, 120 Stat. 3688.)
§ 285g–10. Investment in tomorrow’s pediatric researchers
In order to ensure the future supply of researchers dedicated to the care and research needs of children, the Director of the Institute, after consultation with the Administrator of the Health Resources and Services Administration, shall support activities to provide for—
(1) an increase in the number and size of institutional training grants to institutions supporting pediatric training; and
(2) an increase in the number of career development awards for health professionals who intend to build careers in pediatric basic and clinical research, including pediatric pharmacological research.
(July 1, 1944, ch. 373, title IV, § 452G, as added Pub. L. 106–310, div. A, title X, § 1002(a), Oct. 17, 2000, 114 Stat. 1128; amended Pub. L. 109–482, title I, § 103(b)(31), Jan. 15, 2007, 120 Stat. 3688; Pub. L. 110–85, title V, § 503(a), Sept. 27, 2007, 121 Stat. 890.)
§ 285g–11. Research on the health and development effects of media and related technology on infants, children, and adolescents
(a) In general
(b) Activities
In carrying out subsection (a), the Secretary, acting through the Director of the National Institutes of Health, shall, as appropriate, develop a research agenda to assess the effects of media and related technologies on infants, children, and adolescents, which may include consideration of the following, as appropriate:
(1) The cognitive development of infants, children, and adolescents, which may include effects related to language development, learning abilities, and other areas of cognitive development.
(2) The physical health of infants, children, and adolescents, which may include effects related to diet, exercise, sleeping and eating routines, and other areas of physical development.
(3) The mental health of infants, children, and adolescents, which may include effects related to self-awareness, social awareness, relationship skills, decision-making, violence, bullying, privacy, mental disorders, and other areas related to mental health.
(c) Consultation
(d) Report to Congress
Not later than 2 years after December 29, 2022, the Director of the National Institutes of Health shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report—
(1) on the progress made in improving data and expanding research on the health and developmental effects of media and related technology on infants, children, and adolescents in accordance with this section; and
(2) that summarizes the grants and research funded under this section for each of the years covered by the report.
(Pub. L. 117–328, div. FF, title I, § 1432, Dec. 29, 2022, 136 Stat. 5705.)