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42 U.S.C. § 289a — Peer review requirements
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
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Source file: Laws/federal/codes/united-states-code/title-42/section-289a-peer-review-requirements--12b9fe4f59.md
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Source location: Title 42, Chapter 6A, § 289a; chapter-6a-public-health-service.md
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**(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 282(b)(6) 11 See References in Text note below. and 284(c)(3) of this title.
**(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 [section 289a–2 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a-2&num=0&edition=prelim).
(2) Paragraph (1) shall not apply to any proposal for clinical research that, pursuant to subsection (b) of [section 289a–2 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a-2&num=0&edition=prelim), is not subject to the requirement of subsection (a) of such section regarding the inclusion of women and members of minority groups as subjects in clinical research.
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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
For the purposes of this chapter—
**(a)**
(1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.
**(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.
**(c)** The term “Department” means Department of Health and Human Services.
**(d)** The term “Secretary” means the Secretary of Health and Human Services.
**(e)** The term “person” includes individual, partnership, corporation, and association.
**(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.
**(g)**
(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 321
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Appointment** The National Institutes of Health shall be headed by 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) and as the Secretary may otherwise prescribe.
**(b) Duties and authority** In carrying out the purposes of [section 241 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section241&num=0&edition=prelim), the Secretary, acting through the Director of NIH—
(1) shall carry out this subchapter, including being 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, national centers, and administrative entities within the National Institutes of Health;
(3) shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;
(4) shall assemble accurate data to be used to assess research priorities, including—
(A) information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities; and
(B) data on study populations of clinical research, funded by or conducted at each national research institute and
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 282
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Modernization and construction of facilities**
(1) **In general** — The Director of NIH, acting through the Office of the Director of NIH or the Director of the National Institute of Allergy and Infectious Diseases, may make grants or contracts 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) *Establishment* — There is established a Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities (referred to in this section as the “Board”).
(B) *Requirement* — The Director of NIH, acting through the Office of the Director of NIH, may approve an application for a grant under subsection (a) only if the Board has under paragraph (2) recommended the application for approval.
(2) **Duties**
(A) *Advice* — The Board shall provide advice to the Director of NIH and the Council of Councils established under section 282(l) of this title (in this section referred to as the “Council”) in carrying out this section.
(B) *Determination of merit* — In carrying out subparagraph (A), the Board shall make a determination of the merit of each application submitted for a grant under subsection (a), after consideratio
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 283k
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Requirements for grants** In determining whether to award a grant to an applicant under the Shared Instrumentation Grant Program, the Director of NIH, acting through the Office of the Director of NIH, shall consider—
(1) the extent to which an award for the specific instrument involved would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited;
(2) with respect to the instrument involved, the availability and commitment of the appropriate technical expertise within the major user group or the applicant institution for use of the instrumentation;
(3) the adequacy of the organizational plan for the use of the instrument involved and the internal advisory committee for oversight of the applicant, including sharing arrangements if any;
(4) the applicant’s commitment for continued support of the utilization and maintenance of the instrument; and
(5) the extent to which the specified instrument will be shared and the benefit of the proposed instrument to the overall research community to be served.
**(b) Peer review** In awarding grants under the program described in subsection (a), the Director of NIH, acting through the Office of the Director of NIH, shall comply with the peer review requirements in [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim).
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 283n
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Appointment**
(1) **In general** — The Director of the National Cancer Institute shall be appointed by the President, and the Directors of the other national research institutes and national centers shall be appointed by the Secretary, acting through the Director of National Institutes of Health. Each Director of a national research institute or national center shall report directly to the Director of National Institutes of Health.
(2) **Appointment**
(A) *Term* — A Director of a national research institute or national center who is appointed by the Secretary, acting through the Director of National Institutes of Health, shall be appointed for 5 years.
(B) *Reappointment* — At the end of the term of a Director of a national research institute or national center, the Director may be reappointed in accordance with standards applicable to the relevant appointment mechanism. There shall be no limit on the number of terms that a Director may serve.
(C) *Vacancies* — If the office of a Director of a national research institute or national center becomes vacant before the end of such Director’s term, the Director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.
(D) *Current directors* — Each Director of a national research institute or national center who is serving on December 13, 2016, shall be deemed to be appointed for a 5-year term under this subsection beginning on such date.
(E) *Rule of construction* — Nothing in this subsection shall be construed to limit the authority of the Secretary or the Director of National Institutes of Health to terminate the appointment of a director referred to in subparagraph (A) before the expiration of such director’s 5-year term.
(F) *Nature of appointm
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 284
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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
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 284n
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Children’s cancer biorepositories**
(1) **Award** — The Secretary, acting through the Director of NIH, may make awards to an entity or entities described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and demographic information of children, adolescents, and young adults with selected cancer subtypes (and their recurrences) for which current treatments are least effective, in order to achieve a better understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of treatments for such cancers.
(2) **Use of funds** — Amounts received under an award under paragraph (1) may be used to carry out the following:
(A) Collect and store high-quality, donated biospecimens and associated clinical and demographic information on children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children, adolescents, and young adults with cancer enrolled in clinical trials for whom current treatments are least effective. Activities under this subparagraph may include storage of biospecimens and associated clinical and demographic data at existing biorepositories supported by the National Cancer Institute, such as collected samples of both solid tumor cancer and paired samples.
(B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated clinical and demographic data from children, adolescents, and young adults with cancer for the purposes of research by scientists and qualified health care professionals.
(C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals.
(D) Prov
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 285a–11
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Expansion and coordination of research activities** The Director of the Institute, after consultation with the advisory council for the Institute, shall expand, intensify, and coordinate the activities of the Institute with respect to research on the disease known as fragile X.
**(b) Research centers**
(1) **In general** — The Director of the Institute shall make grants or enter into contracts for the development and operation of centers to conduct research for the purposes of improving the diagnosis and treatment of, and finding the cure for, fragile X.
(2) **Number of centers**
(A) *In general* — In carrying out paragraph (1), the Director of the Institute shall, to the extent that amounts are appropriated, and subject to subparagraph (B), provide for the establishment of at least three fragile X research centers.
(B) *Peer review requirement* — The Director of the Institute shall make a grant to, or enter into a contract with, an entity for purposes of establishing a center under paragraph (1) only if the grant or contract has been recommended after technical and scientific peer review required by regulations under [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim).
(3) **Activities** — The Director of the Institute, with the assistance of centers established under paragraph (1), shall conduct and support basic and biomedical research into the detection and treatment of fragile X.
(4) **Coordination among centers** — The Director of the Institute shall, as appropriate, provide for the coordination of the activities of the centers assisted under this section, including providing for the exchange of information among the centers.
(5) **Certain administrative requirements*
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 285g–9
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Federal law — U.S. Code and appendices · legal_authorities
**(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 [section 289(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289/a&num=0&edition=prelim) by an Institutional Review Board unless the application has undergone review in accordance with such section and has been recommended for approval by a majority of the members of the Board conducting such review.
(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 [section 289a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section289a&num=0&edition=prelim) unless the proposal has undergone such review in accordance with such section and has been recommended for approval by a majority of the members of the entity conducting such review, and unless a majority of the voting members of the appropriate advisory council under [section 284a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section284a&num=0&edition=prelim), or as applicable, of the advisory council u
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 289a–1
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