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42 U.S.C. § 284n — Certain demonstration projects
Federal law — U.S. Code and appendices · legal_authorities
**(a) Bridging the sciences**
(1) **In general** — From amounts to be appropriated under [section 282a(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282a/b&num=0&edition=prelim), the Secretary of Health and Human Services, acting through the Director of NIH, (in this subsection referred to as the “Secretary”) in consultation with the Director of the National Science Foundation, the Secretary of Energy, and other agency heads when necessary, may allocate funds for the national research institutes and national centers to make grants for the purpose of improving the public health through demonstration projects for biomedical research at the interface between the biological, behavioral, and social sciences and the physical, chemical, mathematical, and computational sciences.
(2) **Goals, priorities, and methods; interagency collaboration** — The Secretary shall establish goals, priorities, and methods of evaluation for research under paragraph (1), and shall provide for interagency collaboration with respect to such research. In developing such goals, priorities, and methods, the Secretary shall ensure that—
(A) the research reflects the vision of innovation and higher risk with long-term payoffs; and
(B) the research includes a wide spectrum of projects, funded at various levels, with varying timeframes.
(3) **Peer review** — A grant may be made under paragraph (1) only if the application for the grant has undergone technical and scientific peer review under [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim) and has been reviewed by the advisory council under [section 282(k) of this title](https://uscode.house.gov/view.xhtml?req=granulei
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Stable record: federal_law:legal_authorities:record_usc_47a45c50c0e3e8e5d46f2a66
Source file: Laws/federal/codes/united-states-code/title-42/section-284n-certain-demonstration-projects--4f095a4f51.md
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Source location: Title 42, Chapter 6A, § 284n; chapter-6a-public-health-service.md
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**(a) Bridging the sciences**
(1) **In general** — From amounts to be appropriated under [section 282a(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282a/b&num=0&edition=prelim), the Secretary of Health and Human Services, acting through the Director of NIH, (in this subsection referred to as the “Secretary”) in consultation with the Director of the National Science Foundation, the Secretary of Energy, and other agency heads when necessary, may allocate funds for the national research institutes and national centers to make grants for the purpose of improving the public health through demonstration projects for biomedical research at the interface between the biological, behavioral, and social sciences and the physical, chemical, mathematical, and computational sciences.
(2) **Goals, priorities, and methods; interagency collaboration** — The Secretary shall establish goals, priorities, and methods of evaluation for research under paragraph (1), and shall provide for interagency collaboration with respect to such research. In developing such goals, priorities, and methods, the Secretary shall ensure that—
(A) the research reflects the vision of innovation and higher risk with long-term payoffs; and
(B) the research includes a wide spectrum of projects, funded at various levels, with varying timeframes.
(3) **Peer review** — A grant may be made under paragraph (1) only if the application for the grant has undergone technical and scientific peer review under [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim) and has been reviewed by the advisory council under [section 282(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282/k&num=0&edition=prelim) or has been reviewed by an advisory council composed of representatives from appropriate scientific disciplines who can fully evaluate the applicant.
**(b) High-risk, high-reward research**
(1) **In general** — From amounts to be appropriated under [section 282a(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282a/b&num=0&edition=prelim), the Secretary, acting through the Director of NIH, may allocate funds for the national research institutes and national centers to make awards of grants or contracts or to engage in other transactions for demonstration projects for high-impact, cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, and treatment of diseases and disorders. The head of a national research institute or national center may conduct or support such high-impact, cutting-edge research (with funds allocated under the preceding sentence or otherwise available for such purpose) if the institute or center gives notice to the Director of NIH beforehand and submits a report to the Director of NIH on an annual basis on the activities of the institute or center relating to such research.
(2) **Special consideration** — In carrying out the program under paragraph (1), the Director of NIH shall give special consideration to coordinating activities with national research institutes whose budgets are substantial relative to a majority of the other institutes.
(3) **Administration of program** — Activities relating to research described in paragraph (1) shall be designed by the Director of NIH or the head of a national research institute or national center, as applicable, to enable such research to be carried out with maximum flexibility and speed.
(4) **Public-private partnerships** — In providing for research described in paragraph (1), the Director of NIH or the head of a national research institute or national center, as applicable, shall seek to facilitate partnerships between public and private entities and shall coordinate when appropriate with the Foundation for the National Institutes of Health.
(5) **Peer review** — A grant for research described in paragraph (1) may be made only if the application for the grant has undergone technical and scientific peer review under [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim) and has been reviewed by the advisory council under [section 282(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section282/k&num=0&edition=prelim).
**(c) Report to Congress** Not later than the end of fiscal year 2009, the Secretary, acting through the Director of NIH, shall conduct an evaluation of the activities under this section and submit a report to the Congress on the results of such evaluation.
**(d) Definitions** For purposes of this section, the terms “Director of NIH”, “national research institute”, and “national center” have the meanings given such terms in [section 281 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section281&num=0&edition=prelim).
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Federal law — U.S. Code and appendices · legal_authorities
**(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 sections 282(b)(16) and 284(c)(3) of this title.
**(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 sections
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 289a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Relation to Public Health Service** The National Institutes of Health is an agency of the Service.
**(b) National research institutes and national centers** The following agencies of the National Institutes of Health are national research institutes or national centers:
(1) The National Cancer Institute.
(2) The National Heart, Lung, and Blood Institute.
(3) The National Institute of Diabetes and Digestive and Kidney Diseases.
(4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
(5) The National Institute on Aging.
(6) The National Institute of Allergy and Infectious Diseases.
(7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
(8) The National Institute of Dental and Craniofacial Research.
(9) The National Eye Institute.
(10) The National Institute of Neurological Disorders and Stroke.
(11) The National Institute on Deafness and Other Communication Disorders.
(12) The National Institute on Alcohol Abuse and Alcoholism.
(13) The National Institute on Drug Abuse.
(14) The National Institute of Mental Health.
(15) The National Institute of General Medical Sciences.
(16) The National Institute of Environmental Health Sciences.
(17) The National Institute of Nursing Research.
(18) The National Institute of Biomedical Imaging and Bioengineering.
(19) The National Human Genome Research Institute.
(20) The National Library of Medicine.
(21) The National Center for Advancing Translational Sciences.
(22) The John E. Fogarty International Center for Advanced Study in the Health Sciences.
(23) The National Center for Complementary and Integrative Health.
(24) The National Institute on Minority Health and Health Disparities.
(25) Any other national center that, as an agency separate from
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 281
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Federal law — U.S. Code and appendices · legal_authorities
Page 690
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 284n
(B) identification of research priorities re-
lated to therapeutics (including drugs and
biological products) and medical devices for
pediatric populations and the need for addi-
tional diagnostics and treatments for spe-
cific pediatric diseases or conditions;
(C) the ethics, design, and analysis of clin-
ical trials related to pediatric therapeutics
(including drugs and biological products)
and medical devices; and
(D) the development of countermeasures
(as defined in section 360bbb–4(a) of title 21)
for pediatric populations.
(c) Composition
The advisory committee shall include rep-
resentatives of pediatric health organizations,
pediatric researchers, relevant patient and pa-
tient-family organizations, and other experts se-
lected by the Secretary.
(d) Continuation of Operation of Committee
Notwithstanding section 1013 of title 5, the ad-
visory committee shall continue to operate to
carry out the advisory committee’s responsibil-
ities under sections 355a, 355c, and 360j(m) of
title 21.
(Pub. L. 107–109, § 14, Jan. 4, 2002, 115 Stat. 1419,
as amended by Pub. L. 108–155, § 3(b)(2), Dec. 3,
2003, 117 Stat. 1941; Pub. L. 110–85, title III,
§ 306(b), title V, § 502(d), Sept. 27, 2007, 121 Stat.
865, 889; Pub. L. 112–144, title V, § 507(a), July 9,
2012, 126 Stat. 1045; Pub. L. 113–5, title III,
§ 307(c), Mar. 13, 2013, 127 Stat. 192; Pub. L.
117–286, § 4(a)(233), Dec. 27, 2022, 136 Stat. 4331.)
Editorial Notes
CODIFICATION
Section was formerly set out as a note under section
284m of this title.
Section was enacted as part of the Best Pharma-
ceuticals for Children Act, and not as part of the Public
Health Service Act which comprises this chapter.
AMENDMENTS
2022—Subsec. (d). Pub. L.
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 284n
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