1. U.S. Code
  2. title 42
  3. chapter 6A
  4. subchapter III
  5. part A
  6. § 283

Collapse to view only § 283. Triennial reports of Director of NIH

§ 281. Organization of National Institutes of Health
(a) Relation to Public Health Service
(b) National research institutes and national centersThe 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 any national research institute, was established within the National Institutes of Health as of the day before January 15, 2007.
(c) Division of Program Coordination, Planning, and Strategic Initiatives
(1) In general
(2) Offices within Division
(A) Offices
(B) AuthoritiesEach office in the Division—
(i) shall continue to carry out the authorities that were in effect for the office before January 15, 2007; and
(ii) shall, as determined appropriate by the Director of NIH, support the Division with respect to the authorities described in section 282(b)(7) of this title.
(d) Organization
(1) Number of institutes and centers
(2) Reorganization of institutes
(A) In generalThe 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—
(i) the Secretary determines that an additional institute is necessary to carry out such activities; and
(ii) 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 Health, Education, Labor, and Pensions of the Senate written notice of the determination made under clause (i) with respect to the institute.
(B) Additional authority
(3) Reorganization of Office of Director
(4) Internal reorganization of institutes and centers
(e) Scientific Management Review Board for periodic organizational reviews
(1) In general
(2) Duties
(A) Reports on organizational issuesThe Board shall provide advice to the appropriate officials under subsection (d) regarding the use of the authorities established in paragraphs (2), (3), and (4) of such subsection to reorganize the National Institutes of Health (referred to in this subsection as “organizational authorities”). Not less frequently than once each 7 years, the Board shall—
(i) determine whether and to what extent the organizational authorities should be used; and
(ii) issue a report providing the recommendations of the Board regarding the use of the authorities and the reasons underlying the recommendations.
(B) Certain responsibilities regarding reportsThe activities of the Board with respect to a report under subparagraph (A) shall include the following:
(i) Reviewing the research portfolio of the National Institutes of Health (referred to in this subsection as “NIH”) in order to determine the progress and effectiveness and value of the portfolio and the allocation among the portfolio activities of the resources of NIH.
(ii) Determining pending scientific opportunities, and public health needs, with respect to research within the jurisdiction of NIH.
(iii) For any proposal for organizational changes to which the Board gives significant consideration as a possible recommendation in such report—(I) analyzing the budgetary and operational consequences of the proposed changes;(II) taking into account historical funding and support for research activities at national research institutes and centers that have been established recently relative to national research institutes and centers that have been in existence for more than two decades;(III) estimating the level of resources needed to implement the proposed changes;(IV) assuming the proposed changes will be made and making a recommendation for the allocation of the resources of NIH among the national research institutes and national centers; and(V) analyzing the consequences for the progress of research in the areas affected by the proposed changes.
(C) ConsultationIn carrying out subparagraph (A), the Board shall consult with—
(i) the heads of national research institutes and national centers whose directors are not members of the Board;
(ii) other scientific leaders who are officers or employees of NIH and are not members of the Board;
(iii) advisory councils of the national research institutes and national centers;
(iv) organizations representing the scientific community; and
(v) organizations representing patients.
(3) Composition of BoardThe Board shall consist of the Director of NIH, who shall be a permanent nonvoting member on an ex officio basis, and an odd number of additional members, not to exceed 21, all of whom shall be voting members. The voting members of the Board shall be the following:
(A) Not fewer than 9 officials who are directors of national research institutes or national centers. The Secretary shall designate such officials for membership and shall ensure that the group of officials so designated includes directors of—
(i) national research institutes whose budgets are substantial relative to a majority of the other institutes;
(ii) national research institutes whose budgets are small relative to a majority of the other institutes;
(iii) national research institutes that have been in existence for a substantial period of time without significant organizational change under subsection (d);
(iv) as applicable, national research institutes that have undergone significant organization changes under such subsection, or that have been established under such subsection, other than national research institutes for which such changes have been in place for a substantial period of time; and
(v) national centers.
(B) Members appointed by the Secretary from among individuals who are not officers or employees of the United States. Such members shall include—
(i) individuals representing the interests of public or private institutions of higher education that have historically received funds from NIH to conduct research; and
(ii) individuals representing the interests of private entities that have received funds from NIH to conduct research or that have broad expertise regarding how the National Institutes of Health functions, exclusive of private entities to which clause (i) applies.
(4) Chair
(5) Meetings
(A) In general
(B) Particular forumsOf the meetings held under subparagraph (A) with respect to a report under paragraph (2)(A)—
(i) one or more shall be directed toward the scientific community to address scientific needs and opportunities related to proposals for organizational changes under subsection (d), or as the case may be, related to a proposal that no such changes be made; and
(ii) one or more shall be directed toward consumer organizations to address the needs and opportunities of patients and their families with respect to proposals referred to in clause (i).
(C) Availability of information from forums
(6) Compensation; term of office
(7) Reports
(A) Recommendations for changesEach report under paragraph (2)(A) shall be submitted to—
(i) the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives;
(ii) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate;
(iii) the Secretary; and
(iv) officials with organizational authorities, other than any such official who served as a member of the Board with respect to the report involved.
(B) Availability to public
(C) Report on Board activities
(f) Organizational changes per recommendation of Scientific Management Review Board
(1) In generalWith respect to an official who has organizational authorities within the meaning of subsection (e)(2)(A), if a recommendation to the official for an organizational change is made in a report under such subsection, the official shall, except as provided in paragraphs (2), (3), and (4) of this subsection, make the change in accordance with the following:
(A) Not later than 100 days after the report is submitted under subsection (e)(7)(A), the official shall initiate the applicable public process required in subsection (d) toward making the change.
(B) The change shall be fully implemented not later than the expiration of the 3-year period beginning on the date on which such process is initiated.
(2) Inapplicability to certain reorganizationsParagraph (1) does not apply to a recommendation made in a report under subsection (e)(2)(A) if the recommendation is for—
(A) an organizational change under subsection (d)(2) that constitutes the establishment, termination, or consolidation of one or more national research institutes or national centers; or
(B) an organizational change under subsection (d)(3).
(3) Objection by Director of NIH
(A) In general
(B) Scope of objection
(4) Congressional review
(g) DefinitionsFor purposes of this subchapter:
(1) The term “Director of NIH” means the Director of the National Institutes of Health.
(2) The terms “national research institute” and “national center” mean an agency of the National Institutes of Health that is—
(A) listed in subsection (b) and not terminated under subsection (d)(2)(A); or
(B) established by the Director of NIH under such subsection.
(h) References to NIH
(July 1, 1944, ch. 373, title IV, § 401, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 822; amended Pub. L. 100–553, § 2(1), Oct. 28, 1988, 102 Stat. 2769; Pub. L. 100–607, title I, § 101(1), Nov. 4, 1988, 102 Stat. 3048; Pub. L. 100–690, title II, § 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238; Pub. L. 102–321, title I, § 121(a), July 10, 1992, 106 Stat. 358; Pub. L. 103–43, title XV, §§ 1501(1), 1511(b)(1), 1521(1), June 10, 1993, 107 Stat. 172, 179, 180; Pub. L. 103–417, § 13(b), Oct. 25, 1994, 108 Stat. 4335; Pub. L. 105–277, div. A, § 101(f) [title II, § 212, title VI, § 601(k)], Oct. 21, 1998, 112 Stat. 2681–337, 2681–359, 2681–388; Pub. L. 106–525, title I, § 101(b)(1), Nov. 22, 2000, 114 Stat. 2501; Pub. L. 106–580, § 3(e), Dec. 29, 2000, 114 Stat. 3091; Pub. L. 109–482, title I, §§ 101(a), (b), 108(a), Jan. 15, 2007, 120 Stat. 3675, 3676, 3697; Pub. L. 110–154, § 1(b)(1), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 111–148, title X, § 10334(c)(3)(A), Mar. 23, 2010, 124 Stat. 974; Pub. L. 112–74, div. F, title II, § 221(a)(2), (c)(2)(B), Dec. 23, 2011, 125 Stat. 1087, 1089; Pub. L. 113–235, div. G, title II, § 224(1), Dec. 16, 2014, 128 Stat. 2490.)

CITE AS: 42 USC 281

§ 282. Director of National Institutes of Health
(a) Appointment
(b) Duties and authorityIn carrying out the purposes of section 241 of this title, 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 national center, which—
(i) specifies the inclusion of—(I) women;(II) members of minority groups;(III) relevant age categories, including pediatric subgroups; and(IV) other demographic variables as the Director of the National Institutes of Health determines appropriate;
(ii) is disaggregated by research area, condition, and disease categories; and
(iii) is to be made publicly available on the Internet website of the National Institutes of Health;
(5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, and through the development, implementation, and updating of the strategic plan developed under subsection (m);
(6) shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans;
(7)
(A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—
(i) identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning;
(ii) include information on such research in reports under section 283 of this title; and
(iii) in the case of such research supported with funds referred to in subparagraph (B)—(I) require as appropriate that proposals include milestones and goals for the research;(II) require that the proposals include timeframes for funding of the research; and(III) ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health;
(B)
(i) may, with respect to funds reserved under section 282a(c)(1) of this title for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and
(ii) shall, with respect to funds appropriated to the Common Fund pursuant to section 282a(a)(2) of this title, allocate such funds to the national research institutes and national centers for making grants for pediatric research that is identified under subparagraph (A); and
(C) may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director;
(8) shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers—
(A) preserve an emphasis on investigator-initiated research project grants, including with respect to research involving collaboration between 2 or more such institutes or centers;
(B) when appropriate, maximize investigator-initiated research project grants in their annual research portfolios;
(C) foster collaboration between clinical research projects funded by the respective national research institutes and national centers that—
(i) conduct research involving human subjects; and
(ii) collect similar data; and
(D) encourage the collaboration described in subparagraph (C) to—
(i) allow for an increase in the number of subjects studied; and
(ii) utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;
(9) shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title and that, after such review, the research is reviewed in accordance with section 289a–1(a)(2) of this title by the appropriate advisory council under section 284a of this title before the research proposals are approved for funding;
(10) shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes;
(11)
(A) shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section 288 of this title; and
(B) may conduct and support research training—
(i) for which fellowship support is not provided under section 288 of this title; and
(ii) that does not consist of residency training of physicians or other health professionals;
(12) may, from funds appropriated under section 282a(b) of this title, reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority;
(13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;
(14) 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 section 8141 of title 40, by lease or otherwise through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for use for a period not to exceed ten years;
(15) may secure resources for research conducted by or through the National Institutes of Health;
(16) may, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups and scientific program advisory committees as are needed to carry out the requirements of this subchapter and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups;
(17) may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad;
(18) 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;
(19) may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment;
(20) may accept voluntary and uncompensated services;
(21) may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter;
(22) 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 chapter 74 of title 38;
(23) shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development;
(24) implement the Cures Acceleration Network described in section 287a of this title;
(25) may require recipients of National Institutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—
(A) human research participants, including with respect to privacy, security, informed consent, and protected health information; and
(B) proprietary interests, confidential commercial information, and the intellectual property rights of the funding recipient;
(26) shall consult with the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal agencies and offices, as appropriate, regarding research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging infectious diseases, chemical, radiological, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats;
(27) shall consult with the Director of the Office of National Security within the Department of Health and Human Services, the Assistant Secretary for Preparedness and Response, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other appropriate agencies on a regular basis, regarding biomedical research conducted or supported by the National Institutes of Health that may affect or be affected by matters of national security;
(28) shall ensure that recipients of awards from the National Institutes of Health, and, as appropriate and practicable, entities collaborating with such recipients, have in place and are adhering to appropriate technology practices and policies for the security of identifiable, sensitive information, including information collected, stored, managed, or analyzed by domestic and non-domestic entities; and
(29) shall ensure that recipients of awards from the National Institutes of Health are in compliance with the terms and conditions of such award, which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipients of the award.
Chapter 10 of title 5 shall not apply to the duration of a peer review group appointed under paragraph (16). 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
(d) Services of experts or consultants; number; payment of expenses, conditions, recovery
(1) The Director of NIH may obtain (in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of service) the services of not more than 220 experts or consultants, with scientific or other professional qualifications, for the National Institutes of Health.
(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 informationThe 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 (Public Law 102–73).
(f) Associate Director for Prevention; functionsThere 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) Transferred
(h) Increased participation of women and disadvantaged individuals in biomedical and behavioral research
(i) 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 section 355(i) of title 21, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, a point of contact for those wanting to enroll in the trial, and a description of whether, and through what procedure, the manufacturer or sponsor of the investigation of a new drug will respond to requests for protocol exception, with appropriate safeguards, for single-patient and expanded protocol use of the new drug, particularly in children, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol.
(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 section 360bbb(c) of title 21; or
(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) Fees collected under section 379h of title 21 shall not be used in carrying out this subsection.
(j) Expanded clinical trial registry data bank
(1) Definitions; requirement
(A) DefinitionsIn this subsection:
(i) Applicable clinical trial
(ii) Applicable device clinical trialThe term “applicable device clinical trial” means—(I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and(II) a pediatric postmarket surveillance as required under section 360l of title 21.
(iii) Applicable drug clinical trial(I) In general(II) Clinical investigation(III) Phase I
(iv) Clinical trial information
(v) Completion date
(vi) Device
(vii) Drug
(viii) OngoingThe term “ongoing” means, with respect to a clinical trial of a drug or a device and to a date, that—(I) 1 or more patients is enrolled in the clinical trial; and(II) the date is before the completion date of the clinical trial.
(ix) Responsible partyThe term “responsible party”, with respect to a clinical trial of a drug or device, means—(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.
(B) Requirement
(2) Expansion of clinical trial registry data bank with respect to clinical trial information
(A) In general
(i) Expansion of data bank
(ii) ContentThe clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include—(I) descriptive information, including—(aa) a brief title, intended for the lay public;(bb) a brief summary, intended for the lay public;(cc) the primary purpose;(dd) the study design;(ee) for an applicable drug clinical trial, the study phase;(ff) study type;(gg) the primary disease or condition being studied, or the focus of the study;(hh) the intervention name and intervention type;(ii) the study start date;(jj) the expected completion date;(kk) the target number of subjects; and(ll) outcomes, including primary and secondary outcome measures;(II) recruitment information, including—(aa) eligibility criteria;(bb) gender;(cc) age limits;(dd) whether the trial accepts healthy volunteers;(ee) overall recruitment status;(ff) individual site status; and(gg) in the case of an applicable drug clinical trial, if the drug is not approved under section 355 of title 21 or licensed under section 262 of this title, specify whether or not there is expanded access to the drug under section 360bbb of title 21 for those who do not qualify for enrollment in the clinical trial and how to obtain information about such access;(III) location and contact information, including—(aa) the name of the sponsor;(bb) the responsible party, by official title; and(cc) the facility name and facility contact information (including the city, State, and zip code for each clinical trial location, or a toll-free number through which such location information may be accessed); and(IV) administrative data (which the Secretary may make publicly available as necessary), including—(aa) the unique protocol identification number;(bb) other protocol identification numbers, if any; and(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
(iii) Modifications
(B) Format and structure
(i) Searchable categoriesThe Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.(II) The name of the intervention, including any drug or device being studied in the clinical trial.(III) The location of the clinical trial.(IV) The age group studied in the clinical trial, including pediatric subpopulations.(V) The study phase of the clinical trial.(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization.(VII) The recruitment status of the clinical trial.(VIII) The National Clinical Trial number or other study identification for the clinical trial.
(ii) Additional searchable category
(iii) Other elements
(iv) Format
(C) Data submissionThe responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, September 27, 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of 1
1 So in original. The word “of” probably should not appear.
subparagraph (A)(ii) not later than the later of—
(i) 90 days after September 27, 2007;
(ii) 21 days after the first patient is enrolled in such clinical trial; or
(iii) in the case of a clinical trial that is not for a serious or life-threatening disease or condition and that is ongoing on September 27, 2007, 1 year after September 27, 2007.
(D) Posting of data
(i) Applicable drug clinical trial
(ii) Applicable device clinical trialThe Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in the registry data bank—(I) not earlier than the date of clearance under section 360(k) of title 21, or approval under section 360e or 360j(m) of title 21, as applicable, for a device that was not previously cleared or approved, and not later than 30 days after such date, unless the responsible party affirmatively requests that the Director of the National Institutes of Health publicly post such clinical trial information for an applicable device clinical trial prior to such date of clearance or approval; or(II) for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary.
(iii) Option to make certain clinical trial information available earlier
(iv) Combination productsAn applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered—(I) an applicable drug clinical trial, if the Secretary determines under section 353(g) of title 21 that the primary mode of action of such product is that of a drug or biological product; or(II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.
(3) Expansion of registry data bank to include results of clinical trials
(A) Linking registry data bank to existing results
(i) In generalBeginning not later than 90 days after September 27, 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial—(I) not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or(II) not later than 30 days after the results information described in clause (ii) becomes publicly available.
(ii) Required information(I) FDA informationThe Secretary shall ensure that the registry data bank includes links to the following information:(aa) If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug Administration summary document regarding such applicable clinical trial.(bb) If an applicable drug clinical trial was conducted under section 355a or 355c of title 21, a link to the posted Food and Drug Administration assessment of the results of such trial.(cc) Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any.(dd) For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under section 355(l)(2) of title 21.(ee) For an applicable device clinical trial, in the case of a premarket application under section 360e of title 21, the detailed summary of information respecting the safety and effectiveness of the device required under section 360j(h)(1) of title 21, or, in the case of a report under section 360(k) of title 21, the section 360(k) summary of the safety and effectiveness data required under section 807.95(d) of title 21, Code of Federal Regulations (or any successor regulation).(II) NIH informationThe Secretary shall ensure that the registry data bank includes links to the following information:(aa) Medline citations to any publications focused on the results of an applicable clinical trial.(bb) The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available.
(iii) Results for existing data bank entries
(B) Inclusion of resultsThe Secretary, acting through the Director of NIH, shall—
(i) expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the “registry and results data bank”);
(ii) ensure that such results are made publicly available through the Internet;
(iii) post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and
(iv) in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public.
(C) Basic resultsNot later than 1 year after September 27, 2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21, the following elements:
(i) Demographic and baseline characteristics of patient sample
(ii) Primary and secondary outcomes
(iii) Point of contact
(iv) Certain agreements
(D) Expanded registry and results data bank
(i) Expansion by rulemaking
(ii) Clinical trials(I) Approved products(aa) each applicable drug clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title; and(bb) each applicable device clinical trial for a device that is cleared under section 360(k) of title 21 or approved under section 360e or 360j(m) of title 21.(II) Unapproved productsThe regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for—(aa) an applicable drug clinical trial for a drug that is not approved under section 355 of title 21 and not licensed under section 262 of this title (whether approval or licensure was sought or not); and(bb) an applicable device clinical trial for a device that is not cleared under section 360(k) of title 21 and not approved under section 360e or section 360j(m) of title 21 (whether clearance or approval was sought or not).
(iii) Required elementsThe regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories:(I) A summary of the clinical trial and its results that is written in non-technical, understandable language for patients, if the Secretary determines that such types of summary can be included without being misleading or promotional.(II) A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included without being misleading or promotional.(III) The full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial.(IV) Such other categories as the Secretary determines appropriate.
(iv) Results submissionThe results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine—(I) whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months;(II) whether the clinical trial information described in clause (iii) should be required to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and results data bank before the effective date of the regulations issued under this subparagraph; and(III) in the case when the clinical trial information described in clause (iii) is required to be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account—(aa) the certification process under subparagraph (E)(iii) when approval, licensure, or clearance is sought; and(bb) whether there should be a delay of submission when approval, licensure, or clearance will not be sought.
(v) Additional provisionsThe regulations under this subparagraph shall also establish—(I) a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank;(II) additional information on clinical trials and results that is written in nontechnical, understandable language for patients;(III) considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and span of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional;(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked;(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C).
(vi) Consideration of World Health Organization data set
(vii) Public meeting
(E) Submission of results information
(i) In generalExcept as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of—(I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); 2
2 So in original. The second closing parenthesis probably should not appear.
or(II) the actual date of completion.
(ii) Clinical trials describedAn applicable clinical trial described in this clause is an applicable clinical trial subject to—(I) paragraph (2)(C); and(II)(aa) subparagraph (C); or(bb) the regulations issued under subparagraph (D).
(iii) Delayed submission of results with certification
(iv) Seeking initial approval of a drug or device
(v) Seeking approval of a new use for the drug or device(I) In generalWith respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under section 355 of title 21, licensing under section 262 of this title, or clearance under section 360(k), or approval under section 360e or 360j(m) of title 21 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date—(aa) the new use of the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m);(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 355, 262, 360(k), 360e, or 360j(m); or(cc) except as provided in subclause (III), the application or premarket notification under such section 355, 262, 360(k), 360e, or 360j(m) is withdrawn without resubmission for no less than 210 days.(II) Requirement that each clinical trial in application be treated the same(III) Two-year limitation
(vi) Extensions
(F) Notice to Director of NIH
(G) Posting of data
(H) Waivers regarding certain clinical trial results
(I) Adverse events
(i) Regulations
(ii) Default
(iii) Additional elementsUpon the application of clause (ii), the Secretary shall include in the registry and results data bank for applicable clinical trials described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements:(I) Serious adverse events(II) Frequent adverse events
(iv) Posting of other information
(v) Relation to subparagraph (C)
(4) Additional submissions of clinical trial information
(A) Voluntary submissions
(B) Required submissions
(i) In generalNotwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry and results data bank of clinical trial information for such clinical trial is necessary to protect the public health—(I) the Secretary may require by notification that such information be submitted to the Secretary in accordance with paragraphs (2) and (3) except with regard to timing of submission;(II) unless the responsible party submits a certification under paragraph (3)(E)(iii), such information shall be submitted not later than 30 days after the date specified by the Secretary in the notification; and(III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of the corresponding requirement of such paragraphs.
(ii) Clinical trials describedA clinical trial described in this clause is—(I) an applicable clinical trial for a drug that is approved under section 355 of title 21 or licensed under section 262 of this title or for a device that is cleared under section 360(k) of title 21 or approved under section 360e or section 360j(m) of title 21, whose completion date is on or after the date 10 years before September 27, 2007; or(II) an applicable clinical trial that is described by both by 3
3 So in original.
paragraph (2)(C) and paragraph (3)(D)(ii)(II)).4
4 So in original. The second closing parenthesis probably should not appear.
(C) Updates to clinical trial data bank
(i) Submission of updatesThe responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates—(I) shall be provided not less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period;(II) shall include identification of the dates of any such changes;(III) not later than 30 days after the recruitment status of such clinical trial changes, shall include an update of the recruitment status; and(IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete.
(ii) Public availability of updates
(5) Coordination and compliance
(A) Clinical trials supported by grants from Federal agencies
(i) Grants from certain Federal agencies
(ii) Verification by Federal agencies
(iii) Notice and opportunity to remedy
(iv) Consultation with other Federal agenciesThe Secretary shall—(I) consult with other agencies that conduct research involving human subjects in accordance with any section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such research is an applicable clinical trial; and(II) develop with such agencies procedures comparable to those described in clauses (i), (ii), and (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under paragraphs (2) and (3).
(B) Certification to accompany drug, biological product, and device submissions
(C) Quality control
(i) Pilot quality control project
(ii) Notice of compliance
(D) Truthful clinical trial information
(i) In general
(ii) EffectClause (i) shall not have the effect of—(I) requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial involved; or(II) requiring clinical trial information described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C).
(E) Public notices
(i) Notice of violationsIf the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice—(I) that the responsible party is not in compliance with this chapter by—(aa) failing to submit required clinical trial information; or(bb) submitting false or misleading clinical trial information;(II) of the penalties imposed for the violation, if any; and(III) whether the responsible party has corrected the clinical trial information in the registry and results data bank.
(ii) Notice of failure to submit primary and secondary outcomes
(iii) Failure to submit statement
(iv) Submission of false information statement
(v) Non-submission of statement
(vi) Compliance searches
(6) Limitation on disclosure of clinical trial information
(A) In general
(B) Information describedInformation described in this subparagraph is—
(i) information submitted to the Director of NIH under this subsection, or information of the same general nature as (or integrally associated with) the information so submitted; and
(ii) information not otherwise publicly available, including because it is protected from disclosure under section 552 of title 5.
(7) Authorization of appropriations
(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) Council of Councils
(1) Establishment
(2) Membership
(A) In general
(B) Certain requirementsIn selecting the members of the Council, the Director of NIH shall ensure—
(i) the representation of a broad range of disciplines and perspectives; and
(ii) the ongoing inclusion of at least 1 representative from each national research institute whose budget is substantial relative to a majority of the other institutes.
(C) NominationThe Director of NIH shall maintain an updated list of individuals who have been nominated to serve on the Council, which list shall consist of the following:
(i) For each national research institute and national center, 3 individuals nominated by the head of such institute or center from among the members of the advisory council of the institute or center, of which—(I) two shall be scientists; and(II) one shall be from the general public or shall be a leader in the field of public policy, law, health policy, economics, or management.
(ii) For each office within the Division of Program Coordination, Planning, and Strategic Initiatives, 1 individual nominated by the head of such office.
(iii) Members of the Council of Public Representatives.
(3) Terms
(A) In general
(B) Terms of initial appointeesOf the initial members selected for the Council, the Director of NIH shall designate—
(i) nine for a term of 6 years;
(ii) nine for a term of 4 years; and
(iii) nine for a term of 2 years.
(C) Vacancies
(m) National Institutes of Health Strategic Plan
(1) In general
(2) RequirementsThe strategy under paragraph (1) shall—
(A) identify strategic research priorities and objectives across biomedical research, including—
(i) an assessment of the state of biomedical and behavioral research, including areas of opportunity with respect to basic, clinical, and translational research;
(ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions;
(iii) emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps; and
(iv) the identification of near-, mid-, and long-term scientific needs;
(B) consider, in carrying out subparagraph (A)—
(i) disease burden in the United States and the potential for return on investment to the United States;
(ii) rare diseases and conditions;
(iii) biological, social, and other determinants of health that contribute to health disparities; and
(iv) other factors the Director of National Institutes of Health determines appropriate;
(C) include multi-institute priorities, including coordination of research among institutes and centers;
(D) include strategic priorities for funding research through the Common Fund, in accordance with section 282a(c)(1)(C) of this title;
(E) address the National Institutes of Health’s proposed and ongoing activities related to training and the biomedical workforce; and
(F) describe opportunities for collaboration with other agencies and departments, as appropriate.
(3) Use of plans
(4) Consultation
(n) Unique research initiatives
(1) In generalThe Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out—
(A) the Precision Medicine Initiative under section 289g–5 of this title;
(B) subsection (b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under section 282a(c)(1) of this title for purposes of carrying out such subsection (b)(7) may be used to engage in such other transactions; or
(C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat.
(2) RequirementsThe authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office—
(A) submits a proposal to the Director of NIH for the use of such authority before conducting or supporting the research, including why the use of such authority is essential to promoting the success of the project;
(B) receives approval for the use of such authority from the Director of NIH; and
(C) for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activities of the institute, center, or office relating to such research.
(o) Regenerative medicine
(July 1, 1944, ch. 373, title IV, § 402, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 823; amended Pub. L. 100–607, title I, § 111, Nov. 4, 1988, 102 Stat. 3052; Pub. L. 102–321, title I, § 163(b)(3), July 10, 1992, 106 Stat. 376; Pub. L. 103–43, title I, § 141(b), title II, §§ 201, 202, 206, 208, 210(b), (c), title III, § 303(b), June 10, 1993, 107 Stat. 139, 144, 148–150, 153; Pub. L. 105–115, title I, § 113(a), Nov. 21, 1997, 111 Stat. 2310; Pub. L. 105–362, title VI, § 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 105–392, title IV, § 409, Nov. 13, 1998, 112 Stat. 3589; Pub. L. 107–109, § 15(c)(2), Jan. 4, 2002, 115 Stat. 1420; Pub. L. 109–482, title I, §§ 102(a)–(d), (f)(1)(A), 103(b)(1), Jan. 15, 2007, 120 Stat. 3681, 3683, 3684, 3687; Pub. L. 110–85, title III, § 304(a), title VIII, § 801(a), title XI, § 1104(2), Sept. 27, 2007, 121 Stat. 863, 904, 975; Pub. L. 110–316, title III, § 302, Aug. 14, 2008, 122 Stat. 3524; Pub. L. 111–148, title X, § 10409(b), Mar. 23, 2010, 124 Stat. 978; Pub. L. 112–74, div. F, title II, § 221(b)(5)(B), (d)(1), Dec. 23, 2011, 125 Stat. 1089, 1090; Pub. L. 113–94, § 3(a), Apr. 3, 2014, 128 Stat. 1086; Pub. L. 114–255, div. A, title II, §§ 2014(a), 2031(a), 2036(a), 2038(a), 2051, Dec. 13, 2016, 130 Stat. 1051, 1054, 1062, 1064, 1074; Pub. L. 115–271, title VII, § 7041, Oct. 24, 2018, 132 Stat. 4016; Pub. L. 117–15, § 4, May 26, 2021, 135 Stat. 278; Pub. L. 117–286, § 4(a)(231), Dec. 27, 2022, 136 Stat. 4331; Pub. L. 117–328, div. FF, title II, §§ 2302, 2323, Dec. 29, 2022, 136 Stat. 5757, 5767.)

CITE AS: 42 USC 282

§ 282a. Authorization of appropriations
(a) In general
(1) This subchapter
For purposes of carrying out this subchapter, there are authorized to be appropriated—
(A) $30,331,309,000 for fiscal year 2007;
(B) $32,831,309,000 for fiscal year 2008;
(C) such sums as may be necessary for fiscal year 2009;
(D) $34,851,000,000 for fiscal year 2018;
(E) $35,585,871,000 for fiscal year 2019; and
(F) $36,472,442,775 for fiscal year 2020.
(2) Funding for 10-year pediatric research initiative through Common Fund
(b) Office of the Director
(c) Trans-NIH research
(1) Common Fund
(A) Account
(B) Reservation
(i) In general
(ii) Minimum amount
(C) Common Fund strategic planning report
As part of the National Institutes of Health Strategic Plan required under section 282(m) of this title, the Secretary, acting through the Director of NIH, shall submit a report to the Congress containing a strategic plan for funding research described in section 282(b)(7)(A)(i) of this title (including personnel needs) through the Common Fund. Each such plan shall include the following:
(i) An estimate of the amounts determined by the Director of NIH to be appropriate for maximizing the potential of such research.
(ii) An estimate of the amounts determined by the Director of NIH to be sufficient only for continuing to fund research activities previously identified by the Division of Program Coordination, Planning, and Strategic Initiatives.
(iii)(I) that is in addition to the research activities described in clause (ii); and(II) for which there is the most substantial need.
(D) Evaluation
(2) Trans-NIH research reporting
(A) Limitation
(B) Reporting
(C) Determination
(D) Verification of amounts
(E) Waiver
(d) Transfer authority
(e) Rule of construction
(July 1, 1944, ch. 373, title IV, § 402A, as added Pub. L. 109–482, title I, § 103(a), Jan. 15, 2007, 120 Stat. 3685; amended Pub. L. 113–94, § 3(b), Apr. 3, 2014, 128 Stat. 1087; Pub. L. 114–255, div. A, title II, §§ 2001, 2031(b), 2042(a), Dec. 13, 2016, 130 Stat. 1047, 1056, 1073.)

CITE AS: 42 USC 282a

§ 282b. Electronic coding of grants and activities

The Secretary, acting through the Director of NIH, shall establish an electronic system to uniformly code research grants and activities of the Office of the Director and of all the national research institutes and national centers. The electronic system shall be searchable by a variety of codes, such as the type of research grant, the research entity managing the grant, and the public health area of interest. When permissible, the Secretary, acting through the Director of NIH, shall provide information on relevant literature and patents that are associated with research activities of the National Institutes of Health.

(July 1, 1944, ch. 373, title IV, § 402B, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3689.)

CITE AS: 42 USC 282b

§ 282c. Public access to funded investigators’ final manuscripts

The Director of the National Institutes of Health (“NIH”) shall require in the current fiscal year and thereafter that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.

(Pub. L. 111–8, div. F, title II, § 217, Mar. 11, 2009, 123 Stat. 782.)

CITE AS: 42 USC 282c

§ 282d. Transferred

CITE AS: 42 USC 282d

§ 283. Triennial reports of Director of NIH
(a) In generalThe Director of NIH shall submit to the Congress on a triennial basis a report in accordance with this section. The first report shall be submitted not later than 1 year after January 15, 2007. Each such report shall include the following information:
(1) An assessment of the state of biomedical and behavioral research.
(2) A description of the activities conducted or supported by the agencies of the National Institutes of Health and policies respecting the programs of such agencies.
(3) A description of intra-National Institutes of Health activities, including—
(A) identification of the percentage of funds made available by each national research institute and national center with respect to each applicable fiscal year for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers; and
(B) recommendations for promoting coordination of information among the centers of excellence.
(4) A catalog of all the research activities of the agencies, prepared in accordance with the following:
(A) The catalog shall, for each such activity—
(i) identify the agency or agencies involved;
(ii) state whether the activity was carried out directly by the agencies or was supported by the agencies and describe to what extent the agency was involved; and
(iii) identify whether the activity was carried out through a center of excellence.
(B) In the case of clinical research, the catalog shall, as appropriate, identify study populations by demographic variables, including biological and social variables and relevant age categories (such as pediatric subgroups), and determinants of health, that contribute to research on minority health and health disparities.
(C) Research activities listed in the catalog shall include, where applicable, the following:
(i) Epidemiological studies and longitudinal studies.
(ii) Disease registries, information clearinghouses, and other data systems.
(iii) Public education and information campaigns.
(iv) Training activities, including—(I) National Research Service Awards and Clinical Transformation Science Awards;(II) graduate medical education programs, including information on the number and type of graduate degrees awarded during the period in which the programs received funding under this subchapter;(III) investigator-initiated awards for postdoctoral training and postdoctoral training funded through research grants;(IV) a breakdown by demographic variables and other appropriate categories; and(V) an evaluation and comparison of outcomes and effectiveness of various training programs.
(v) Clinical trials, including a breakdown of participation by study populations and demographic variables, including relevant age categories (such as pediatric subgroups), information submitted by each national research institute and national center to the Director of National Institutes of Health under section 289a–2(f) of this title, and such other information as may be necessary to demonstrate compliance with section 289a–2 of this title and other applicable requirements regarding inclusion of demographic groups.
(vi) Translational research activities with other agencies of the Public Health Service.
(5) A summary of the research activities throughout the agencies, which summary shall be organized by the following categories, where applicable:
(A) Cancer.
(B) Neurosciences.
(C) Life stages, human development, and rehabilitation.
(D) Organ systems.
(E) Autoimmune diseases.
(F) Genomics.
(G) Molecular biology and basic science.
(H) Technology development.
(I) Chronic diseases, including pain and palliative care.
(J) Infectious diseases and bioterrorism.
(K) Minority health and health disparities.
(L) Such additional categories as the Director determines to be appropriate.
(6) A review of each entity receiving funding under this subchapter in its capacity as a center of excellence (in this paragraph referred to as a “center of excellence”), including the following—
(A) an evaluation of the performance and research outcomes of each center of excellence; and
(B) recommendations for improving the effectiveness, efficiency, and outcomes of the centers of excellence.
(b) Requirement regarding disease-specific research activitiesIn a report under subsection (a), the Director of NIH, when reporting on research activities relating to a specific disease, disorder, or other adverse health condition, shall—
(1) present information in a standardized format;
(2) identify the actual dollar amounts obligated for such activities; and
(3) include a plan for research on the specific disease, disorder, or other adverse health condition, including a statement of objectives regarding the research, the means for achieving the objectives, a date by which the objectives are expected to be achieved, and justifications for revisions to the plan.
(c) Additional reports
(July 1, 1944, ch. 373, title IV, § 403, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3689; amended Pub. L. 110–85, title XI, § 1104(3), Sept. 27, 2007, 121 Stat. 975; Pub. L. 114–255, div. A, title II, § 2032, Dec. 13, 2016, 130 Stat. 1056.)

CITE AS: 42 USC 283

§ 283a. Annual reporting to increase interagency collaboration and coordination
(a) Collaboration with other HHS agencies
(b) Clinical trials
(c) Human tissue samples
(d) First report
(July 1, 1944, ch. 373, title IV, § 403A, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3691.)

CITE AS: 42 USC 283a

§ 283a–1. Annual reporting to prevent fraud and abuse
(a) Whistleblower complaints
(1) In general
(2) Contents
For each whistleblower complaint pending during the year for which a report is submitted under this subsection, the report shall identify the following:
(A) Each agency of the National Institutes of Health involved.
(B) The status of the complaint.
(C) The resolution of the complaint to date.
(b) First report
(July 1, 1944, ch. 373, title IV, § 403B, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3691; amended Pub. L. 114–255, div. A, title II, § 2042(b), Dec. 13, 2016, 130 Stat. 1073.)

CITE AS: 42 USC 283a-1

§ 283a–2. Annual reporting regarding training of graduate students for doctoral degrees
(a) In general
Each institution receiving an award under this subchapter for the training of graduate students for doctoral degrees shall annually report to the Director of NIH, with respect to graduate students supported by the National Institutes of Health at such institution—
(1) the percentage of such students admitted for study who successfully attain a doctoral degree; and
(2) for students described in paragraph (1), the average time between the beginning of graduate study and the receipt of a doctoral degree.
(3)1
1 So in original. Probably should be “(b)”.
Provision of information to applicants
(July 1, 1944, ch. 373, title IV, § 403C, as added Pub. L. 109–482, title I, § 104(a)(3), Jan. 15, 2007, 120 Stat. 3692; amended Pub. L. 110–85, title XI, § 1104(5), Sept. 27, 2007, 121 Stat. 975; Pub. L. 114–255, div. A, title II, § 2042(c), Dec. 13, 2016, 130 Stat. 1073.)

CITE AS: 42 USC 283a-2

§ 283a–3. Establishment of program regarding DES
(a) In general
(b) Education programs
(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) 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
(July 1, 1944, ch. 373, title IV, § 403D, formerly § 403A, as added Pub. L. 102–409, § 2, Oct. 13, 1992, 106 Stat. 2092; amended Pub. L. 105–340, title I, § 101(a), Oct. 31, 1998, 112 Stat. 3191; renumbered § 403C and amended Pub. L. 109–482, title I, §§ 103(b)(2), 104(a)(1), Jan. 15, 2007, 120 Stat. 3687, 3689; renumbered § 403D, Pub. L. 110–85, title XI, § 1104(4), Sept. 27, 2007, 121 Stat. 975.)

CITE AS: 42 USC 283a-3

§ 283a–4. Notification to Director of personnel removed or disciplined for harassment, bullying, retaliation, or hostile working conditions

The Director of the National Institutes of Health shall hereafter require institutions that receive funds through a grant or cooperative agreement during fiscal year 2022 and in future years to notify the Director when individuals identified as a principal investigator or as key personnel in an NIH notice of award are removed from their position or are otherwise disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions. The Director may issue regulations consistent with this section.

(Pub. L. 117–103, div. H, title II, § 239, Mar. 15, 2022, 136 Stat. 474.)

CITE AS: 42 USC 283a-4

§ 283b. Repealed. Pub. L. 106–525, title I, § 101(b)(2), Nov. 22, 2000, 114 Stat. 2501

CITE AS: 42 USC 283b

§ 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 Pub. L. 103–43, title II, § 203(a), June 10, 1993, 107 Stat. 145.)

CITE AS: 42 USC 283c

§ 283d. Children’s Vaccine Initiative

The Secretary, in consultation with the Director of the National Vaccine Program under subchapter XIX and acting through the Directors of the National Institute for Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of 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.

(July 1, 1944, ch. 373, title IV, § 404B, as added Pub. L. 103–43, title II, § 204, June 10, 1993, 107 Stat. 146; amended Pub. L. 109–482, title I, § 103(b)(3), Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–154, § 1(b)(2), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 114–255, div. A, title II, § 2042(d), Dec. 13, 2016, 130 Stat. 1073.)

CITE AS: 42 USC 283d

§ 283e. Plan for use of animals in research
(a) PreparationThe Director of NIH, after consultation with the committee established under subsection (e), 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
(c) Periodic review and revision
(d) Dissemination of information
(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).
(3) The Committee shall be composed of—
(A) the Directors of each of the national research institutes (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 Pub. L. 103–43, title II, § 205(a), June 10, 1993, 107 Stat. 146; amended Pub. L. 112–74, div. F, title II, § 221(d)(2), Dec. 23, 2011, 125 Stat. 1090.)

CITE AS: 42 USC 283e

§ 283f. Requirements regarding surveys of sexual behaviorWith 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 sections 289 and 289a of this title; and
(2) the Secretary, in accordance with section 289a–1 of this title, makes a determination that the information expected to be obtained through the survey will assist—
(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 Pub. L. 103–43, title II, § 207, June 10, 1993, 107 Stat. 148.)

CITE AS: 42 USC 283f

§ 283g. Muscular dystrophy; initiative through Director of National Institutes of Health
(a) Expansion, intensification, and coordination of activities
(1) In general
(2) Coordination
(3) Allocations by Director of NIH
(b) Centers of excellence
(1) In general
(2) Research
(3) Coordination of centers
(4) Organization of centers
(5) Duration of support
(c) Facilitation of research
(d) Coordinating Committee
(1) In general
(2) Composition
The Coordinating Committee shall consist of not more than 18 members to be appointed by the Secretary, of which—
(A) ⅔ of such members shall represent governmental agencies, including the directors or their designees of each of the national research institutes involved in research with respect to muscular dystrophy and representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, including the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Food and Drug Administration, and the Administration for Community Living and representatives of other governmental agencies that serve children and adults with muscular dystrophy, including the Department of Education and the Social Security Administration; and
(B) ⅓ of such members shall be public members, including a broad cross section of persons affected with muscular dystrophies including parents or legal guardians, affected individuals, researchers, and clinicians.
Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an unlimited number of terms if reappointed.
(3) Chair
(A) In general
(B) Appointment
(4) Administrative support; terms of service; other provisions
The following shall apply with respect to the Coordinating Committee:
(A) The Coordinating Committee shall receive necessary and appropriate administrative support from the Department of Health and Human Services.
(B) The Coordinating Committee shall meet as appropriate as determined by the Secretary, in consultation with the chair,2
2 So in original. Probably should be capitalized.
but shall meet no fewer than two times per calendar year.
(e) Plan for HHS activities
(1) In general
Not later than 1 year after December 18, 2001, the Coordinating Committee shall develop a plan for conducting and supporting research and education on muscular dystrophy through the agencies represented on the Coordinating Committee pursuant to subsection (d)(2)(A) and shall periodically review and revise the plan. The plan shall—
(A) provide for a broad range of research and education activities relating to biomedical, epidemiological, psychosocial, public services, and rehabilitative issues, including studies of the impact of such diseases in rural and underserved communities, studies to demonstrate the cost-effectiveness of providing independent living resources and support to patients with various forms of muscular dystrophy, and studies to determine optimal clinical care interventions for adults with various forms of muscular dystrophy;
(B) identify priorities among the programs and activities of the National Institutes of Health regarding such diseases; and
(C) reflect input from a broad range of scientists, patients, and advocacy groups.
(2) Certain elements of plan
The plan under paragraph (1) shall, with respect to each form of muscular dystrophy, provide for the following as appropriate:
(A) Research to determine the reasons underlying the incidence and prevalence of various forms of muscular dystrophy.
(B) Basic research concerning the etiology and genetic links of the disease and potential causes of mutations.
(C) The development of improved screening techniques.
(D) Basic and clinical research for the development and evaluation of new treatments, including new biological agents and new clinical interventions to improve the health of those with muscular dystrophy.
(E) Information and education programs for health care professionals and the public.
(f) Public input
(g) Clinical research
(July 1, 1944, ch. 373, title IV, § 404E, as added Pub. L. 107–84, § 3, Dec. 18, 2001, 115 Stat. 824; amended Pub. L. 109–482, title I, §§ 103(b)(4), 104(b)(1)(A), Jan. 15, 2007, 120 Stat. 3687, 3692; Pub. L. 110–154, § 1(b)(3), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 110–361, § 2, Oct. 8, 2008, 122 Stat. 4010; Pub. L. 113–166, § 2, Sept. 26, 2014, 128 Stat. 1879.)

CITE AS: 42 USC 283g

§§ 283h, 283i. Transferred

CITE AS: 42 USC 283h, 283i

§ 283j. Repealed. Pub. L. 114–255, div. A, title II, § 2042(f)(1), Dec. 13, 2016, 130 Stat. 1073

CITE AS: 42 USC 283j

§ 283k. Biomedical and behavioral research facilities
(a) Modernization and construction of facilities
(1) In general
(2) Construction and cost of construction
(b) Scientific and technical review boards for merit-based review of proposals
(1) In general: approval as precondition to grants
(A) Establishment
(B) Requirement
(2) Duties
(A) Advice
(B) Determination of merit
(C) Amount
(D) Annual reportIn carrying out subparagraph (A), the Board shall prepare an annual report for the Director of NIH and the 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) but that were not approved by the Director of NIH; and
(iii) contain the recommendations of the Board for any changes in the administration of this section.
(3) Membership
(A) In general
(B) Limitation
(4) Certain requirements regarding membershipIn selecting individuals for membership on the Board, the Director of NIH, acting through the Office of the Director of NIH, 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 NIH, acting through the Office of the Director of NIH, 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) 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)(2).
(5) Certain authorities
(A) Workshops and conferences
(B) Subcommittees
(6) Terms
(A) In general
(B) Staggered terms
(C) Reappointment
(7) Compensation
(c) Requirements for grants
(1) In generalThe Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, may make a grant under subsection (a) 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 involved, the facility will be used for the purposes of the 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 congruence of the research activities to be carried out within the facility with the research and investigator manpower needs of the United States; and
(iv) the age and condition of existing research facilities.
(D) The applicant has demonstrated a commitment to enhancing and expanding the research productivity of the applicant.
(2) Institutions of emerging excellenceFrom the amount appropriated to carry out this section for a fiscal year up to $50,000,000, the Director of NIH, acting through the Office of the Director of NIH, shall make available 25 percent of such amount, and from the amount appropriated to carry out this section for a fiscal year that is over $50,000,000, the Director of NIH, acting through the Office of the Director of NIH, shall make available up to 25 percent of such amount, for grants under subsection (a) 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 section 293c 1
1 See References in Text note below.
of this title;
(ii) is located in a geographic area whose population includes a significant number of individuals with 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 the 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
(e) Amount of grant; payments
(1) AmountThe amount of any grant awarded under subsection (a) shall be determined by the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases,,2
2 So in original.
except that such amount shall not exceed—
(A) 50 percent (or, in the case of the Institute, 75 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 (or, in the case of the Institute, 75 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
(3) Exclusion of certain costsIn determining the amount of any grant under subsection (a), 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
(f) Recapture of paymentsIf, not later than 20 years after the completion of construction for which a grant has been awarded under subsection (a)—
(1) in the case of an award by the Director of NIH, acting through the Office of the Director of NIH, the applicant or other owner of the facility shall cease to be a public or non profit 3
3 So in original. Probably should be “nonprofit”.
private entity; or
(2) the facility shall cease to be used for the research purposes for which it was constructed (unless the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, 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
(July 1, 1944, ch. 373, title IV, § 404I, formerly § 481A, as added Pub. L. 103–43, title XV, § 1502, June 10, 1993, 107 Stat. 173; amended Pub. L. 105–392, title I, § 101(c), Nov. 13, 1998, 112 Stat. 3537; Pub. L. 106–505, title III, § 303, Nov. 13, 2000, 114 Stat. 2330; Pub. L. 108–276, § 2(b), July 21, 2004, 118 Stat. 841; Pub. L. 109–482, title I, §§ 103(b)(40), 104(b)(1)(M), Jan. 15, 2007, 120 Stat. 3688, 3693; renumbered § 404I and amended Pub. L. 112–74, div. F, title II, § 221(b)(1), Dec. 23, 2011, 125 Stat. 1087.)

CITE AS: 42 USC 283k

§ 283l. Construction of regional centers for research on primates
(a) With respect to activities carried out by the Director of NIH, acting through the Office of the Director of NIH, to support regional centers for research on primates, the Director of NIH may, for each of the fiscal years 2000 through 2002, reserve from the amounts appropriated to carry out section 283k of this title such sums as necessary for the purpose of making awards of grants and contracts to public or nonprofit private entities to construct, renovate, or otherwise improve such regional centers. The reservation of such amounts for any fiscal year is subject to the availability of qualified applicants for such awards.
(b) The Director of NIH may not make a grant or enter into a contract under subsection (a) 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.
(

CITE AS: 42 USC 283l

§ 283m. Sanctuary system for surplus chimpanzees
(a) In general
(b) Administration of sanctuary system
(c) Acceptance of chimpanzees into system
(d) Standards for permanent retirement of surplus chimpanzees
(1) In general
(2) Chimpanzees accepted into systemWith respect to chimpanzees that are accepted into the sanctuary system, standards under paragraph (1) shall include the following:
(A) A prohibition that the chimpanzees may not be used for research, except as authorized under paragraph (3).
(B) Provisions regarding the housing of the chimpanzees.
(C) Provisions regarding the behavioral well-being of the chimpanzees.
(D) A requirement that the chimpanzees be cared for in accordance with the Animal Welfare Act [7 U.S.C. 2131 et seq.].
(E) A requirement that the chimpanzees be prevented from breeding.
(F) A requirement that complete histories be maintained on the health and use in research of the chimpanzees.
(G) A requirement that the chimpanzees be monitored for the purpose of promptly detecting the presence in the chimpanzees of any condition that may be a threat to the public health or the health of other chimpanzees.
(H) A requirement that chimpanzees posing such a threat be contained in accordance with applicable recommendations of the Director of the Centers for Disease Control and Prevention.
(I) A prohibition that none of the chimpanzees may be subjected to euthanasia, except as in the best interests of the chimpanzee involved, as determined by the system and an attending veterinarian.
(J) A prohibition that the chimpanzees may not be discharged from the system.
(K) A provision that the Secretary may, in the discretion of the Secretary, accept into the system chimpanzees that are not surplus chimpanzees.
(L) Such additional standards as the Secretary determines to be appropriate.
(3) Restrictions regarding research
(A) In general
(B) Additional restriction
(4) Non-Federal chimpanzees offered for acceptance into systemWith respect to a chimpanzee that is not owned by the Federal Government and is offered for acceptance into the sanctuary system, standards under paragraph (1) shall include the following:
(A) A provision that the Secretary may authorize the imposition of a fee for accepting such chimpanzee into the system, except as follows:
(i) Such a fee may not be imposed for accepting the chimpanzee if, on the day before December 20, 2000, the chimpanzee was owned by the nonprofit private entity that receives the contract under subsection (e) or by any individual sanctuary facility receiving a subcontract or grant under subsection (e)(1).
(ii) Such a fee may not be imposed for accepting the chimpanzee if the chimpanzee is owned by an entity that operates a primate center, and if the chimpanzee is housed in the primate center pursuant to the program for regional centers for research on primates that is carried out by the Director of NIH, acting through the Office of the Director of NIH,.1
1 So in original. Comma probably should not appear.
Any fees collected under this subparagraph are available to the Secretary for the costs of operating the system. Any other fees received by the Secretary for the long-term care of chimpanzees (including any Federal fees that are collected for such purpose and are identified in the report under section 3 of the Chimpanzee Health Improvement, Maintenance, and Protection Act) are available for operating the system, in addition to availability for such other purposes as may be authorized for the use of the fees.
(B) A provision that the Secretary may deny such chimpanzee acceptance into the system if the capacity of the system is not sufficient to accept the chimpanzee, taking into account the physical capacity of the system; the financial resources of the system; the number of individuals serving as the staff of the system, including the number of professional staff; the necessity of providing for the safety of the staff and of the public; the necessity of caring for accepted chimpanzees in accordance with the standards under paragraph (1); and such other factors as may be appropriate.
(C) A provision that the Secretary may deny such chimpanzee acceptance into the system if a complete history of the health and use in research of the chimpanzee is not available to the Secretary.
(D) Such additional standards as the Secretary determines to be appropriate.
(e) Award of contract for operation of system
(1) In general
(2) RequirementsThe Secretary may make an award under paragraph (1) to a nonprofit private entity only if the entity meets the following requirements:
(A) The entity has a governing board of directors that is composed and appointed in accordance with paragraph (3) and is satisfactory to the Secretary.
(B) The terms of service for members of such board are in accordance with paragraph (3).
(C) The members of the board serve without compensation. The members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the board.
(D) The entity has an executive director meeting such requirements as the Secretary determines to be appropriate.
(E) The entity makes the agreement described in paragraph (4) (relating to non-Federal contributions).
(F) The entity agrees to comply with standards under subsection (d).
(G) The entity agrees to make necropsy reports on chimpanzees in the sanctuary system available on a reasonable basis to persons who conduct biomedical or behavioral research, with priority given to such persons who are Federal employees or who receive financial support from the Federal Government for research.
(H) Such other requirements as the Secretary determines to be appropriate.
(3) Board of directorsFor purposes of subparagraphs (A) and (B) of paragraph (2):
(A) The governing board of directors of the nonprofit private entity involved is composed and appointed in accordance with this paragraph if the following conditions are met:
(i) Such board is composed of not more than 13 voting members.
(ii) Such members include individuals with expertise and experience in the science of managing captive chimpanzees (including primate veterinary care), appointed from among individuals endorsed by organizations that represent individuals in such field.
(iii) Such members include individuals with expertise and experience in the field of animal protection, appointed from among individuals endorsed by organizations that represent individuals in such field.
(iv) Such members include individuals with expertise and experience in the zoological field (including behavioral primatology), appointed from among individuals endorsed by organizations that represent individuals in such field.
(v) Such members include individuals with expertise and experience in the field of the business and management of nonprofit organizations, appointed from among individuals endorsed by organizations that represent individuals in such field.
(vi) Such members include representatives from entities that provide accreditation in the field of laboratory animal medicine.
(vii) Such members include individuals with expertise and experience in the field of containing biohazards.
(viii) Such members include an additional member who serves as the chair of the board, appointed from among individuals who have been endorsed for purposes of clause (ii), (iii), (iv), or (v).
(ix) None of the members of the board has been fined for, or signed a consent decree for, any violation of the Animal Welfare Act [7 U.S.C. 2131 et seq.].
(B) The terms of service for members of the board of directors are in accordance with this paragraph if the following conditions are met:
(i) The term of the chair of the board is 3 years.
(ii) The initial members of the board select, by a random method, one member from each of the six fields specified in subparagraph (A) to serve a term of 2 years and (in addition to the chair) one member from each of such fields to serve a term of 3 years.
(iii) After the initial terms under clause (ii) expire, each member of the board (other than the chair) is appointed to serve a term of 2 years.
(iv) An individual whose term of service expires may be reappointed to the board.
(v) A vacancy in the membership of the board is filled in the manner in which the original appointment was made.
(vi) If a member of the board does not serve the full term applicable to the member, the individual appointed to fill the resulting vacancy is appointed for the remainder of the term of the predecessor member.
(4) Requirement of matching fundsThe agreement required in paragraph (2)(E) for a nonprofit private entity (relating to the award of the contract under paragraph (1)) is an agreement that, with respect to the costs to be incurred by the entity in establishing and operating the sanctuary system, the entity will make available (directly or through donations from public or private entities) non-Federal contributions toward such costs, in cash or in kind, in an amount not less than the following, as applicable:
(A) For expenses associated with establishing the sanctuary system (as determined by the Secretary), 10 percent of such costs ($1 for each $9 of Federal funds provided under the contract under paragraph (1)).
(B) For expenses associated with operating the sanctuary system (as determined by the Secretary), 25 percent of such costs ($1 for each $3 of Federal funds provided under such contract).
(5) Establishment of contract entity
(f) DefinitionsFor purposes of this section:
(1) Permanent retirement
(2) Sanctuary system
(3) Secretary
(4) Surplus chimpanzees
(g) Funding
(1) In generalOf the amount appropriated for the National Institutes of Health, there are authorized to be appropriated to carry out this section and for the care, maintenance, and transportation of all chimpanzees otherwise under the ownership or control of the National Institutes of Health, and to enable the National Institutes of Health to operate more efficiently and economically by decreasing the overall Federal cost of providing for the care, maintenance, and transportation of chimpanzees—
(A) for fiscal year 2014, $12,400,000;
(B) for fiscal year 2015, $11,650,000;
(C) for fiscal year 2016, $10,900,000;
(D) for fiscal year 2017, $10,150,000; and
(E) for fiscal year 2018, $9,400,000.
(2) Use of funds for other compliant facilities
(3) Biennial reportNot later than 180 days after November 27, 2013, the Director of the National Institutes of Health shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations in the House of Representatives a report, to be updated biennially, regarding—
(A) the care, maintenance, and transportation of the chimpanzees under the ownership or control of the National Institutes of Health;
(B) costs related to such care, maintenance, and transportation, and any other related costs; and
(C) the research status of such chimpanzees.
(July 1, 1944, ch. 373, title IV, § 404K, formerly § 481C, as added Pub. L. 106–551, § 2, Dec. 20, 2000, 114 Stat. 2752; amended Pub. L. 110–170, § 2(a), Dec. 26, 2007, 121 Stat. 2465; renumbered § 404K and amended Pub. L. 112–74, div. F, title II, § 221(b)(3), Dec. 23, 2011, 125 Stat. 1088; Pub. L. 113–55, title III, § 302(a), (c), Nov. 27, 2013, 127 Stat. 646, 647.)

CITE AS: 42 USC 283m

§ 283n. Shared Instrumentation Grant Program
(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
(July 1, 1944, ch. 373, title IV, § 404L, formerly Pub. L. 106–505, title III, § 305, Nov. 13, 2000, 114 Stat. 2335; renumbered July 1, 1944, ch. 373, title IV, § 404L, and amended Pub. L. 112–74, div. F, title II, § 221(b)(4), Dec. 23, 2011, 125 Stat. 1088.)

CITE AS: 42 USC 283n

§ 283o. Next generation of researchers
(a) Next generation of researchers initiative
(b) Activities
The Director of the National Institutes of Health, through the Initiative shall—
(1) promote policies and programs within the National Institutes of Health that are focused on improving opportunities for new researchers and promoting earlier research independence, including existing policies and programs, as appropriate;
(2) develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity;
(3) coordinate, as appropriate, with relevant agencies, professional and academic associations, academic institutions, and others, to improve and update existing information on the biomedical research workforce in order to inform programs related to the training, recruitment, and retention of biomedical researchers; and
(4) carry out other activities, including evaluation and oversight of existing programs, as appropriate, to promote the development of the next generation of researchers and earlier research independence.
(July 1, 1944, ch. 373, title IV, § 404M, as added Pub. L. 114–255, div. A, title II, § 2021(a), Dec. 13, 2016, 130 Stat. 1051.)

CITE AS: 42 USC 283o

§ 283p. Population focused research
The Director of the National Institutes of Health shall, as appropriate, encourage efforts to improve research related to the health of sexual and gender minority populations, including by—
(1) facilitating increased participation of sexual and gender minority populations in clinical research supported by the National Institutes of Health, and reporting on such participation, as applicable;
(2) facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations; and
(3) addressing methodological challenges.
(July 1, 1944, ch. 373, title IV, § 404N, as added Pub. L. 114–255, div. A, title II, § 2038(d), Dec. 13, 2016, 130 Stat. 1065.)

CITE AS: 42 USC 283p

§ 283q. Eureka prize competitions
(a) In generalPursuant to the authorities and processes established under section 3719 of title 15, the Director of the National Institutes of Health shall support prize competitions for one or both of the following goals:
(1) Identifying and funding areas of biomedical science that could realize significant advancements through a prize competition.
(2) Improving health outcomes, particularly with respect to human diseases and conditions—
(A) for which public and private investment in research is disproportionately small relative to Federal Government expenditures on prevention and treatment activities with respect to such diseases and conditions, such that Federal expenditures on health programs would be reduced;
(B) that are serious and represent a significant disease burden in the United States; or
(C) for which there is potential for significant return on investment to the United States.
(b) Tracking; reportingThe Director of the National Institutes of Health shall—
(1) collect information on—
(A) the effect of innovations funded through the prize competitions under this section in advancing biomedical science or improving health outcomes pursuant to subsection (a); and
(B) the effect of the innovations on Federal expenditures; and
(2) include the information collected under paragraph (1) in the triennial report under section 283 of this title (as amended by section 2032).
(Pub. L. 114–255, div. A, title II, § 2002, Dec. 13, 2016, 130 Stat. 1047.)

CITE AS: 42 USC 283q

§ 283r. National Science Advisory Board for Biosecurity
(a) Establishment
(b) Duties
(1)1
1 So in original. No par. (2) has been enacted.
The National Science Advisory Board for Biosecurity referred to in section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417) (referred to in this section as the “Board”) shall provide technical advice, guidance, or recommendations, to relevant Federal departments and agencies related to biosafety and biosecurity oversight of biomedical research, including—
(A) oversight of federally-conducted or federally-supported dual use biomedical research, such as the review of policies or frameworks used to assess and appropriately manage safety and security risks associated with such research, taking into consideration national security concerns, the potential benefits of such research, considerations related to the research community, transparency, and public availability of information, and international research collaboration; and
(B) continuing to carry out the activities required under section 205 of the Pandemic and All-Hazards Preparedness Act (Public Law 109–417).
(c) ConsiderationsIn carrying out the duties under subsection (b), the Board may consider strategies to improve the safety and security of biomedical research, including through—
(1) leveraging or using new technologies and scientific advancements to reduce safety and security risks associated with such research and improve containment of pathogens; and
(2) outreach to, and education and training of, researchers, laboratory personnel, and other appropriate individuals with respect to safety and security risks associated with such research and mitigation of such risks.
(d) MembershipThe Board shall be composed of the following:
(1) Non-voting, ex officio members, including the following:
(A) At least one representative of each of the following:
(i) The Department of Health and Human Services.
(ii) The Department of Defense.
(iii) The Department of Agriculture.
(iv) The Department of Homeland Security.
(v) The Department of Energy.
(vi) The Department of State.
(vii) The Office of Science and Technology Policy.
(viii) The Office of the Director of National Intelligence.
(B) Representatives of such other Federal departments or agencies as the Secretary determines appropriate to carry out the requirements of this section.
(2) Individuals, appointed by the Secretary, with expertise in biology, infectious diseases, public health, ethics, national security, and other fields, as the Secretary determines appropriate, who shall serve as voting members.
(July 1, 1944, ch. 373, title IV, § 404O, as added Pub. L. 117–328, div. FF, title II, § 2313(a), Dec. 29, 2022, 136 Stat. 5761.)

CITE AS: 42 USC 283r