Collapse to view only § 284b. Repealed.
- § 284. Directors of national research institutes
- § 284a. Advisory councils
- § 284b. Repealed.
- § 284c. Certain uses of funds
- § 284d. Definitions
- § 284e. Research on osteoporosis, Paget’s disease, and related bone disorders
- § 284f. Parkinson’s disease
- § 284g. Expansion, intensification, and coordination of activities of National Institutes of Health with respect to research on autism spectrum disorder
- § 284h. Pediatric Research Initiative
- § 284i. Autoimmune diseases
- § 284j. Muscular dystrophy research
- § 284k. Clinical research
- § 284l. Enhancement awards
- § 284m. Program for pediatric studies of drugs
- § 284m-1. Pediatric Advisory Committee
- § 284n. Certain demonstration projects
- § 284o. Activities of the National Institutes of Health with respect to research on paralysis
- § 284p. Activities of the National Institutes of Health with respect to research with implications for enhancing daily function for persons with paralysis
- § 284q. Pain research
- § 284q-1. NIH opioid research
- § 284r. Basic research
- § 284s. Tick-borne diseases
§ 284. Directors of national research institutes
(a) Appointment
(1) In general
(2) Appointment
(A) Term
(B) Reappointment
(C) Vacancies
(D) Current directors
(E) Rule of construction
(F) Nature of appointment
(3) Nonapplication of certain provision
(b) Duties and authority; grants, contracts, and cooperative agreements
(1) In carrying out the purposes of section 241 of this title with respect to human diseases or disorders or other aspects of human health for which the national research institutes were established, the Secretary, acting through the Director of each national research institute—
(A) shall encourage and support research, investigations, experiments, demonstrations, and studies in the health sciences related to—
(i) the maintenance of health,
(ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders,
(iii) the rehabilitation of individuals with human diseases, disorders, and disabilities, and
(iv) the expansion of knowledge of the processes underlying human diseases, disorders, and disabilities, the processes underlying the normal and pathological functioning of the body and its organ systems, and the processes underlying the interactions between the human organism and the environment;
(B) may, subject to the peer review prescribed under section 289a(b) of this title and any advisory council review under section 284a(a)(3)(A)(i) of this title, conduct the research, investigations, experiments, demonstrations, and studies referred to in subparagraph (A);
(C) shall, as appropriate, conduct and support research that has the potential to transform the scientific field, has inherently higher risk, and that seeks to address major current challenges;
(D) may conduct and support research training (i) for which fellowship support is not provided under section 288 of this title, and (ii) which is not residency training of physicians or other health professionals;
(E) may develop, implement, and support demonstrations and programs for the application of the results of the activities of the institute to clinical practice and disease prevention activities;
(F) may develop, conduct, and support public and professional education and information programs;
(G) may secure, develop and maintain, distribute, and support the development and maintenance of resources needed for research;
(H) may make available the facilities of the institute to appropriate entities and individuals engaged in research activities and cooperate with and assist Federal and State agencies charged with protecting the public health;
(I) may accept unconditional gifts made to the institute for its activities, and, in the case of gifts of a value in excess of $50,000, establish suitable memorials to the donor;
(J) may secure for the institute consultation services and advice of persons from the United States or abroad;
(K) 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;
(L) may accept voluntary and uncompensated services; and
(M) may perform such other functions as the Secretary determines are needed to carry out effectively the purposes of the institute.
The indemnification provisions of section 3861 of title 10 shall apply with respect to contracts entered into under this subsection and section 282(b) of this title.
(2) Support for an activity or program under this subsection may be provided through grants, contracts, and cooperative agreements. The Secretary, acting through the Director of each national research institute—
(A) may enter into a contract for research, training, or demonstrations only if the contract has been recommended after technical and scientific peer review required by regulations under section 289a of this title;
(B) may make grants and cooperative agreements under paragraph (1) for research, training, or demonstrations, except that—
(i) if the direct cost of the grant or cooperative agreement to be made does not exceed $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under section 289a of this title, and
(ii) if the direct cost of the grant or cooperative agreement to be made exceeds $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under section 289a of this title and is recommended under section 284a(a)(3)(A)(ii) of this title by the advisory council for the national research institute involved; and
(C) shall, subject to section 300cc–40c(d)(2) of this title, receive from the President and the Office of Management and Budget directly all funds appropriated by the Congress for obligation and expenditure by the Institute.
(3) Before an award is made by a national research institute or by a national center for a grant for a research program or project (commonly referred to as an “R-series grant”), other than an award constituting a noncompetitive renewal of such a grant, or a noncompetitive administrative supplement to such a grant, the Director of such national research institute or national center shall, consistent with the peer review process—
(A) review and make the final decision with respect to making the award; and
(B) take into consideration, as appropriate—
(i) the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section 282(m) of this title;
(ii) programs or projects funded by other agencies on similar research topics; and
(iii) advice by staff and the advisory council or board of such national research institute or national center.
(c) Coordination with other public and private entities; cooperation with other national research institutes; appointment of additional peer review groupsIn carrying out subsection (b), each Director of a national research institute—
(1) shall coordinate, as appropriate, the activities of the institute with similar programs of other public and private entities;
(2) shall cooperate with the Directors of the other national research institutes in the development and support of multidisciplinary research and research that involves more than one institute;
(3) may, in consultation with the advisory council for the Institute and with the approval of the Director of NIH—
(A) establish technical and scientific peer review groups in addition to those appointed under section 282(b)(16) of this title; and
(B) appoint the members of peer review groups established under subparagraph (A); and
(4) may publish, or arrange for the publication of, information with respect to the purpose of the Institute without regard to section 501 of title 44.
Chapter 10 of title 5 shall not apply to the duration of a peer review group appointed under paragraph (3).
(July 1, 1944, ch. 373, title IV, § 405, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 826; amended Pub. L. 100–607, title I, § 116, Nov. 4, 1988, 102 Stat. 3053; Pub. L. 100–690, title II, § 2613(c), Nov. 18, 1988, 102 Stat. 4239; Pub. L. 103–43, title III, § 301(a)(1), (b), June 10, 1993, 107 Stat. 150; Pub. L. 109–482, title I, § 102(f)(1)(B), Jan. 15, 2007, 120 Stat. 3685; Pub. L. 114–255, div. A, title II, §§ 2033(a), (b), 2036(c), Dec. 13, 2016, 130 Stat. 1057, 1058, 1063; Pub. L. 117–81, div. A, title XVII, § 1702(j)(1)(B), Dec. 27, 2021, 135 Stat. 2159; Pub. L. 117–286, § 4(a)(232), Dec. 27, 2022, 136 Stat. 4331.)
§ 284a. Advisory councils
(a) Establishment; acceptance of conditional gifts; functions
(1) Except as provided in subsection (h), the Secretary shall appoint an advisory council for each national research institute which (A) shall advise, assist, consult with, and make recommendations to the Secretary and the Director of such institute on matters related to the activities carried out by and through the institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C.
(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with section 238 of this title, of conditional gifts for study, investigation, or research respecting the diseases, disorders, or other aspect of human health with respect to which the institute was established, for the acquisition of grounds, or for the construction, equipping, or maintenance of facilities for the institute.
(3) Each advisory council for a national research institute—
(A)
(i) may on the basis of the materials provided under section 289a(b)(2) of this title respecting research conducted at the institute, make recommendations to the Director of the institute respecting such research,
(ii) may review applications for grants and cooperative agreements for research or training and for which advisory council approval is required under section 284(b)(2) of this title and recommend for approval applications for projects which show promise of making valuable contributions to human knowledge, and
(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the institute;
(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspect of human health with respect to which the institute was established and with the approval of the Director of the institute make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and
(C) may appoint subcommittees and convene workshops and conferences.
(b) Membership; compensation
(1) Each advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. The ex officio members shall be nonvoting members.
(2) The ex officio members of an advisory council shall consist of—
(A) the Secretary, the Director of NIH, the Director of the national research institute for which the council is established, the Under Secretary for Health of the Department of Veterans Affairs or the Chief Dental Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and
(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions.
(3) The members of an advisory council who are not ex officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including not less than two individuals who are leaders in the fields of public health and the behavioral or social sciences) relevant to the activities of the national research institute for which the advisory council is established.
(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management.
(4) Members of an advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The other members of an advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule.
(c) Term of office; reappointment; vacancy
(d) Chairman; term of office
(e) Meetings
(f) Appointment of executive secretary; training and orientation for new members
(g) Comments and recommendations for inclusion in biennial report; additional reports
(h) Advisory councils in existence; application of section to National Cancer Advisory Board and advisory council to National Heart, Lung, and Blood Institute
(1) Except as provided in paragraph (2), this section does not terminate the membership of any advisory council for a national research institute which was in existence on November 20, 1985. After November 20, 1985—
(A) the Secretary shall make appointments to each such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section;
(B) each advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and
(C) the Director of each national research institute shall perform for such advisory council the functions prescribed by this section.
(2)
(A) The National Cancer Advisory Board shall be the advisory council for the National Cancer Institute. This section applies to the National Cancer Advisory Board, except that—
(i) appointments to such Board shall be made by the President;
(ii) the term of office of an appointed member shall be 6 years;
(iii) of the members appointed to the Board—(I) not less than 5 members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors); and(II) not less than one member shall be an individual knowledgeable in pediatric oncology;
(iv) the chairman of the Board shall be selected by the President from the appointed members and shall serve as chairman for a term of two years;
(v) the ex officio members of the Board shall be nonvoting members and shall be the Secretary, the Director of the Office of Science and Technology Policy, the Director of NIH, the Under Secretary for Health of the Department of Veterans Affairs, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, the Assistant Secretary of Defense for Health Affairs, and the Director of the Office of Science of the Department of Energy (or the designees of such officers); and
(vi) the Board shall meet at least four times each fiscal year.
(B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that the advisory council shall meet at least four times each fiscal year.
(July 1, 1944, ch. 373, title IV, § 406, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 828; amended Pub. L. 100–607, title I, § 117, Nov. 4, 1988, 102 Stat. 3053; Pub. L. 101–381, title I, § 102(1), Aug. 18, 1990, 104 Stat. 585; Pub. L. 102–405, title III, § 302(e)(1), Oct. 9, 1992, 106 Stat. 1985; Pub. L. 103–43, title II, § 210(a), title XX, §§ 2008(b)(1), 2010(b)(2), June 10, 1993, 107 Stat. 149, 210, 214; Pub. L. 105–245, title III, § 309(b)(2)(C), Oct. 7, 1998, 112 Stat. 1853; Pub. L. 115–180, title I, § 111, June 5, 2018, 132 Stat. 1386.)
§ 284b. Repealed. Pub. L. 109–482, title I, § 104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693
§ 284c. Certain uses of funds
(a)
(1) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal year for administrative expenses of the National Institutes of Health may not exceed an amount which is 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health.
(2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing Research, the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G. Magnuson Clinical Center, and the Office of Medical Applications of Research.
(3) For purposes of paragraph (1), the term “administrative expenses” means expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health.
(b) For fiscal year 1989 and subsequent fiscal years, amounts made available to the National Institutes of Health shall be available for payment of nurses and allied health professionals in accordance with payment authorities, scheduling options, benefits, and other authorities provided under chapter 73 of title 38 for nurses of the Department of Veterans Affairs.
(July 1, 1944, ch. 373, title IV, § 408, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 831; amended Pub. L. 100–607, title I, § 118, Nov. 4, 1988, 102 Stat. 3053; Pub. L. 100–690, title II, § 2613(d), Nov. 18, 1988, 102 Stat. 4239; Pub. L. 103–43, title IV, § 403(b)(1), title XX, § 2008(b)(2), June 10, 1993, 107 Stat. 158, 211; Pub. L. 104–316, title I, § 122(a), Oct. 19, 1996, 110 Stat. 3836; Pub. L. 105–362, title VI, § 601(a)(1)(B), Nov. 10, 1998, 112 Stat. 3285.)
§ 284d. Definitions
(a) Health service research
(b) Clinical research
(July 1, 1944, ch. 373, title IV, § 409, as added
§ 284e. Research on osteoporosis, Paget’s disease, and related bone disorders
(a) Establishment
(b) Coordination
(c) Information clearinghouse
(1) In general
(2) Establishment through grant or contract
(July 1, 1944, ch. 373, title IV, § 409A, as added Pub. L. 103–43, title III, § 302, June 10, 1993, 107 Stat. 151; amended Pub. L. 105–340, title I, § 102, Oct. 31, 1998, 112 Stat. 3192; Pub. L. 109–482, title I, § 103(b)(7), Jan. 15, 2007, 120 Stat. 3687.)
§ 284f. Parkinson’s disease
(a) In general
(b) Inter-institute coordination
(1) In general
(2) Conference
(c) Morris K. Udall research centers
(1) In general
(2) Requirements
(A) In general
With respect to Parkinson’s disease, each center assisted under this subsection shall—
(i) use the facilities of a single institution or a consortium of cooperating institutions, and meet such qualifications as may be prescribed by the Director of the NIH; and
(ii) conduct basic and clinical research.
(B) Discretionary requirements
With respect to Parkinson’s disease, each center assisted under this subsection may—
(i) conduct training programs for scientists and health professionals;
(ii) conduct programs to provide information and continuing education to health professionals;
(iii) conduct programs for the dissemination of information to the public;
(iv) separately or in collaboration with other centers, establish a nationwide data system derived from patient populations with Parkinson’s disease, and where possible, comparing relevant data involving general populations;
(v) separately or in collaboration with other centers, establish a Parkinson’s Disease Information Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson’s disease; and
(vi) separately or in collaboration with other centers, establish a national education program that fosters a national focus on Parkinson’s disease and the care of those with Parkinson’s disease.
(3) Stipends regarding training programs
(4) Duration of support
(d) Morris K. Udall Awards for Excellence in Parkinson’s Disease Research
(July 1, 1944, ch. 373, title IV, § 409B, as added Pub. L. 105–78, title VI, § 603(c), Nov. 13, 1997, 111 Stat. 1520; amended Pub. L. 109–482, title I, § 103(b)(8), Jan. 15, 2007, 120 Stat. 3687.)
§ 284g. Expansion, intensification, and coordination of activities of National Institutes of Health with respect to research on autism spectrum disorder
(a) In general
(1) Expansion of activities
(2) Consolidation
(3) Administration of program; collaboration among agencies
(b) Centers of excellence
(1) In general
(2) Research
(3) Services for patients
(A) In general
(B) Referrals and costs
(C) Availability and access
(D) Reducing disparities
(4) Organization of centers
(5) Number of centers; duration of support
(A) In general
(B) Duration
(c) Facilitation of research
(d) Public input
(July 1, 1944, ch. 373, title IV, § 409C, as added Pub. L. 106–310, div. A, title I, § 101, Oct. 17, 2000, 114 Stat. 1105; amended Pub. L. 109–416, §§ 2(a), 4(b), Dec. 19, 2006, 120 Stat. 2821, 2830; Pub. L. 109–482, title I, §§ 103(b)(9), 104(b)(1)(D), Jan. 15, 2007, 120 Stat. 3687, 3693; Pub. L. 116–60, § 2, Sept. 30, 2019, 133 Stat. 1110.)
§ 284h. Pediatric Research Initiative
(a) Establishment
(b) PurposeThe purpose of the Initiative is to provide funds to enable the Director of NIH—
(1) to increase support for pediatric biomedical research within the National Institutes of Health to realize the expanding opportunities for advancement in scientific investigations and care for children;
(2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in the areas that the Director deems most promising; and
(3) in coordination with the Food and Drug Administration, to increase the development of adequate pediatric clinical trials and pediatric use information to promote the safer and more effective use of prescription drugs in the pediatric population.
(c) DutiesIn carrying out subsection (b), the Director of NIH shall—
(1) consult with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the other national research institutes, in considering their requests for new or expanded pediatric research efforts, and consult with the Administrator of the Health Resources and Services Administration and other advisors as the Director determines to be appropriate;
(2) have broad discretion in the allocation of any Initiative assistance among the Institutes, among types of grants, and between basic and clinical research so long as the assistance is directly related to the illnesses and conditions of children; and
(3) be responsible for the oversight of any newly appropriated Initiative funds and annually report to Congress and the public on the extent of the total funds obligated to conduct or support pediatric research across the National Institutes of Health, including the specific support and research awards allocated through the Initiative.
(d) National Pediatric Research Network
(1) NetworkIn carrying out the Initiative, the Director of NIH, in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support a National Pediatric Research Network in order to more effectively support pediatric research and optimize the use of Federal resources. Such National Pediatric Research Network may be comprised of, as appropriate—
(A) the pediatric research consortia receiving awards under paragraph (2); or
(B) other consortia, centers, or networks focused on pediatric research that are recognized by the Director of NIH and established pursuant to the authorities vested in the National Institutes of Health by other sections of this chapter.
(2) Pediatric research consortia
(A) In generalThe Director of NIH shall award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities for providing support for pediatric research consortia, including with respect to—
(i) basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and
(ii) training researchers in pediatric research techniques in order to address unmet pediatric research needs.
(B) ResearchThe Director of NIH shall, as appropriate, ensure that—
(i) each consortium receiving an award under subparagraph (A) conducts or supports at least one category of research described in subparagraph (A)(i) and collectively such consortia conduct or support such categories of research; and
(ii) one or more such consortia provide training described in subparagraph (A)(ii).
(C) Organization of consortiumEach consortium receiving an award under subparagraph (A) shall—
(i) be formed from a collaboration of cooperating institutions;
(ii) be coordinated by a lead institution or institutions;
(iii) agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to—(I) other consortia;(II) the National Institutes of Health;(III) the Food and Drug Administration;(IV) and 1
1 So in original. The word “and” probably should appear at end of subcl. (III).
other relevant agencies; and(iv) meet such requirements as may be prescribed by the Director of NIH.
(D) Supplement, not supplant
(E) Duration of support
(3) Coordination of consortia activitiesThe Director of NIH shall, as appropriate—
(A) provide for the coordination of activities (including the exchange of information and regular communication) among the consortia established pursuant to paragraph (2); and
(B) require the periodic preparation and submission to the Director of reports on the activities of each such consortium.
(4) Assistance with registries
(e) Research on pediatric rare diseases or conditionsIn making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH shall ensure that an appropriate number of such awards are awarded to such consortia that agree to—
(1) consider pediatric rare diseases or conditions, or those related to birth defects; and
(2) conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions.
(f) Transfer of funds
(July 1, 1944, ch. 373, title IV, § 409D, as added Pub. L. 106–310, div. A, title X, § 1001, Oct. 17, 2000, 114 Stat. 1127; amended Pub. L. 109–482, title I, § 103(b)(10), Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–154, § 1(b)(4), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 113–55, title II, § 202, Nov. 27, 2013, 127 Stat. 644; Pub. L. 114–255, div. A, title II, § 2071, Dec. 13, 2016, 130 Stat. 1083.)
§ 284i. Autoimmune diseases
(a) Expansion, intensification, and coordination of activities
(1) In general
(2) Allocations by Director of NIH
(3) Definition
(b) Coordinating Committee
(1) In general
(2) Composition
(3) Chair
(A) In general
(B) Director of NIH
(c) Plan for NIH activities
(1) In general
Not later than 1 year after October 17, 2000, the Coordinating Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases through the national research institutes 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, psychosocial, and rehabilitative issues, including studies of the disproportionate impact of such diseases on women;
(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 autoimmune diseases, provide for the following as appropriate:
(A) Research to determine the reasons underlying the incidence and prevalence of the diseases.
(B) Basic research concerning the etiology and causes of the diseases.
(C) Epidemiological studies to address the frequency and natural history of the diseases, including any differences among the sexes and among racial and ethnic groups.
(D) The development of improved screening techniques.
(E) Clinical research for the development and evaluation of new treatments, including new biological agents.
(F) Information and education programs for health care professionals and the public.
(3) Implementation of plan
(July 1, 1944, ch. 373, title IV, § 409E, as added Pub. L. 106–310, div. A, title XIX, § 1901, Oct. 17, 2000, 114 Stat. 1153; amended Pub. L. 109–482, title I, §§ 103(b)(11), 104(b)(1)(E), Jan. 15, 2007, 120 Stat. 3687, 3693.)
§ 284j. Muscular dystrophy research
(a) Coordination of activities
(b) Administration of program; collaboration among agencies
(July 1, 1944, ch. 373, title IV, § 409F, as added Pub. L. 106–310, div. A, title XXII, § 2201, Oct. 17, 2000, 114 Stat. 1157; amended Pub. L. 109–482, title I, § 103(b)(12), Jan. 15, 2007, 120 Stat. 3687.)
§ 284k. Clinical research
(a) In general
(b) Requirements
In carrying out subsection (a), the Director of National Institutes of Health shall—
(1) consider the recommendations of the Division of Research Grants Clinical Research Study Group and other recommendations for enhancing clinical research; and
(2) establish intramural and extramural clinical research fellowship programs directed specifically at medical and dental students and a continuing education clinical research training program at the National Institutes of Health.
(c) Support for the diverse needs of clinical research
(d) Peer review
(July 1, 1944, ch. 373, title IV, § 409G, formerly § 409C, as added Pub. L. 106–505, title II, § 203, Nov. 13, 2000, 114 Stat. 2326; renumbered § 409G, Pub. L. 107–109, § 3(1), Jan. 4, 2002, 115 Stat. 1408.)
§ 284l. Enhancement awards
(a) Mentored Patient-Oriented Research Career Development Awards
(1) Grants
(A) In general
(B) Use
(2) Applications
(b) Mid-Career Investigator Awards in Patient-Oriented Research
(1) Grants
(A) In general
(B) Use
(2) Applications
(c) Graduate Training in Clinical Investigation Award
(1) In general
(2) Applications
(3) Limitations
(4) Definition
As used in this subsection, the term “advanced degree programs in clinical investigation” means programs that award a master’s or Ph.D. degree in clinical investigation after 2 or more years of training in areas such as the following:
(A) Analytical methods, biostatistics, and study design.
(B) Principles of clinical pharmacology and pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(d) Clinical Research Curriculum Awards
(1) In general
The Director of the National Institutes of Health shall make grants (to be referred to as “Clinical Research Curriculum Awards”) to institutions for the development and support of programs of core curricula for training clinical investigators, including medical students. Such core curricula may include training in areas such as the following:
(A) Analytical methods, biostatistics, and study design.
(B) Principles of clinical pharmacology and pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(2) Applications
(3) Limitations
(July 1, 1944, ch. 373, title IV, § 409H, formerly § 409D, as added Pub. L. 106–505, title II, § 204(b), Nov. 13, 2000, 114 Stat. 2327; renumbered § 409H, Pub. L. 107–109, § 3(2), Jan. 4, 2002, 115 Stat. 1408; Pub. L. 109–482, title I, § 103(b)(13), Jan. 15, 2007, 120 Stat. 3687.)
§ 284m. Program for pediatric studies of drugs
(a) List of priority issues in pediatric therapeutics
(1) In general
(2) Consideration of available informationIn developing and prioritizing the list under paragraph (1), the Secretary—
(A) shall consider—
(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, and identification of biomarkers for such diseases, disorders, or conditions, may be beneficial in pediatric populations; and
(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and
(B) may consider the availability of qualified countermeasures (as defined in section 247d–6a of this title), security countermeasures (as defined in section 247d–6b of this title), and qualified pandemic or epidemic products (as defined in section 247d–6d of this title) to address the needs of pediatric populations, in consultation with the Assistant Secretary for Preparedness and Response, consistent with the purposes of this section.
(b) Pediatric studies and research
(c) Process for proposed pediatric study requests and labeling changes
(1) Submission of proposed pediatric study requestThe Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], or section 262(m) of this title, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which—
(A)
(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] or section 262(k) of this title; or
(ii) there is a submitted application that could be approved under the criteria of such section; and
(B) there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(b)(1)], and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], or applicable twelve-year period referred to in section 262(k)(7) of this title, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc] has ended for at least one form of the drug; and
(C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population.
(2) Written request to holders of approved applications
(3) Requests for proposals
(4) Disqualification
(5) Contracts, grants, or other funding mechanisms
(6) Reporting of studies
(A) In general
(B) Availability of reports
(i) In generalEach report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a(d)(4)]) and not later than 90 days after submission of such report, shall be—(I) posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—(aa) human research participants, including with respect to privacy, security, informed consent, and protected health information; and(bb) proprietary interests, confidential commercial information, and intellectual property rights; and(II) assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments.
(ii) Submission of comments
(C) Action by Commissioner
(7) Requests for labeling changeWithin the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall—
(A) review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied;
(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and
(C)
(i) include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of any requested labeling changes; and
(ii) publish through a posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested labeling changes.
(8) Dispute resolution
(A) Referral to Pediatric Advisory Committee
(B) Action by the Pediatric Advisory CommitteeNot later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory Committee shall—
(i) review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and
(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.
(9) FDA determination
(10) Failure to agree
(11) No effect on authority
(d) Authorization of appropriations
(1) In general
(2) Availability
(July 1, 1944, ch. 373, title IV, § 409I, as added Pub. L. 107–109, § 3(3), Jan. 4, 2002, 115 Stat. 1408; amended Pub. L. 108–155, § 3(b)(6), Dec. 3, 2003, 117 Stat. 1942; Pub. L. 109–482, title I, § 103(b)(14), Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–85, title V, § 502(b), Sept. 27, 2007, 121 Stat. 886; Pub. L. 111–148, title VII, § 7002(g)(2)(A), Mar. 23, 2010, 124 Stat. 820; Pub. L. 112–144, title V, §§ 507(d), 509(d), July 9, 2012, 126 Stat. 1045, 1049; Pub. L. 113–5, title III, § 307(b), Mar. 13, 2013, 127 Stat. 192; Pub. L. 115–52, title V, § 501, Aug. 18, 2017, 131 Stat. 1036; Pub. L. 117–180, div. F, title V, § 5001, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, § 302, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, § 3102, Dec. 29, 2022, 136 Stat. 5807.)
§ 284m–1. Pediatric Advisory Committee
(a) In general
(b) Purpose
(1) In general
(2) Matters included
The matters referred to in paragraph (1) include—
(A) pediatric research conducted under sections 262, 284m, and 290b of this title and sections 351, 352, 355, 355a, 355c, 360(k), 360e, and 360j(m) of title 21;
(B) identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;
(C) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices; and
(D) the development of countermeasures (as defined in section 360bbb–4(a) of title 21) for pediatric populations.
(c) Composition
(d) Continuation of Operation of Committee
(Pub. L. 107–109, § 14, Jan. 4, 2002, 115 Stat. 1419, as amended by Pub. L. 108–155, § 3(b)(2), Dec. 3, 2003, 117 Stat. 1941; Pub. L. 110–85, title III, § 306(b), title V, § 502(d), Sept. 27, 2007, 121 Stat. 865, 889; Pub. L. 112–144, title V, § 507(a), July 9, 2012, 126 Stat. 1045; Pub. L. 113–5, title III, § 307(c), Mar. 13, 2013, 127 Stat. 192; Pub. L. 117–286, § 4(a)(233), Dec. 27, 2022, 136 Stat. 4331.)
§ 284n. Certain demonstration projects
(a) Bridging the sciences
(1) In general
(2) Goals, priorities, and methods; interagency collaboration
The Secretary shall establish goals, priorities, and methods of evaluation for research under paragraph (1), and shall provide for interagency collaboration with respect to such research. In developing such goals, priorities, and methods, the Secretary shall ensure that—
(A) the research reflects the vision of innovation and higher risk with long-term payoffs; and
(B) the research includes a wide spectrum of projects, funded at various levels, with varying timeframes.
(3) Peer review
(b) High-risk, high-reward research
(1) In general
(2) Special consideration
(3) Administration of program
(4) Public-private partnerships
(5) Peer review
(c) Report to Congress
(d) Definitions
(Pub. L. 109–482, title I, § 105, Jan. 15, 2007, 120 Stat. 3694.)
§ 284o. Activities of the National Institutes of Health with respect to research on paralysis
(a) Coordination
(b) Christopher and Dana Reeve Paralysis Research Consortia
(1) In general
(2) Research
Each consortium under paragraph (1)—
(A) may conduct basic, translational, and clinical paralysis research;
(B) may focus on advancing treatments and developing therapies in paralysis research;
(C) may focus on one or more forms of paralysis that result from central nervous system trauma or stroke;
(D) may facilitate and enhance the dissemination of clinical and scientific findings; and
(E) may replicate the findings of consortia members or other researchers for scientific and translational purposes.
(3) Coordination of consortia; reports
(4) Organization of consortia
(c) Public input
(Pub. L. 111–11, title XIV, § 14101, Mar. 30, 2009, 123 Stat. 1452.)
§ 284p. Activities of the National Institutes of Health with respect to research with implications for enhancing daily function for persons with paralysis
(a) In general
(b) ResearchA multicenter network of clinical sites funded through this section may—
(1) focus on areas of key scientific concern, including—
(A) improving functional mobility;
(B) promoting behavioral adaptation to functional losses, especially to prevent secondary complications;
(C) assessing the efficacy and outcomes of medical rehabilitation therapies and practices and assisting technologies;
(D) developing improved assistive technology to improve function and independence; and
(E) understanding whole body system responses to physical impairments, disabilities, and societal and functional limitations; and
(2) replicate the findings of network members or other researchers for scientific and translation purposes.
(c) Coordination of clinical trials networks; reports
(Pub. L. 111–11, title XIV, § 14201, Mar. 30, 2009, 123 Stat. 1453.)
§ 284q. Pain research
(a) Research initiatives
(1) In general
(2) Annual recommendations
(3) Definition
(b) Interagency Pain Research Coordinating Committee
(1) Establishment
(2) Membership
(A) In generalThe Committee shall be composed of the following voting members:
(i) Not more than 7 voting Federal representatives appoint 1
1 So in original. Probably should be “appointed”.
by the Secretary from agencies that conduct pain care research and treatment.(ii) 12 additional voting members appointed under subparagraph (B).
(B) Additional membersThe Committee shall include additional voting members appointed by the Secretary as follows:
(i) 6 non-Federal members shall be appointed from among scientists, physicians, and other health professionals.
(ii) 6 members shall be appointed from members of the general public, who are representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions.
(C) Nonvoting members
(3) Chairperson
(4) Meetings
(5) DutiesThe Committee shall—
(A) develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for the utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration;
(B) identify critical gaps in basic and clinical research on—
(i) the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain;
(ii) the diagnosis, prevention, treatment, and management of acute and chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and
(iii) risk factors for, and early warning signs of, substance use disorders in populations with acute and chronic pain; and
(C) make recommendations to the Director of NIH—
(i) to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort;
(ii) on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and
(iii) on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research.
(6) Report
(7) Review
(July 1, 1944, ch. 373, title IV, § 409J, as added Pub. L. 111–148, title IV, § 4305(b), Mar. 23, 2010, 124 Stat. 585; amended Pub. L. 115–271, title VII, § 7042, Oct. 24, 2018, 132 Stat. 4016.)
§ 284q–1. NIH opioid research
(a) In general
The Director of the National Institutes of Health (referred to in this section as the “NIH”) may intensify and coordinate fundamental, translational, and clinical research of the NIH with respect to—
(1) the understanding of pain;
(2) the discovery and development of therapies for chronic pain; and
(3) the development of alternatives to opioids for effective pain treatments.
(b) Priority and direction
(Pub. L. 114–198, title I, § 108, July 22, 2016, 130 Stat. 705.)
§ 284r. Basic research
(1) Developing policiesNot later than 2 years after December 13, 2016, the Director of the National Institutes of Health (referred to in this section as the “Director of the National Institutes of Health”), taking into consideration the recommendations developed under section 2039,1
1 See References in Text note below.
shall develop policies for projects of basic research funded by National Institutes of Health to assess—(A) relevant biological variables including sex, as appropriate; and
(B) how differences between male and female cells, tissues, or animals may be examined and analyzed.
(2) Revising policies
(3) Consultation and outreachIn developing, updating, or revising the policies under this section, the Director of the National Institutes of Health shall—
(A) consult with—
(i) the Office of Research on Women’s Health;
(ii) the Office of Laboratory Animal Welfare; and
(iii) appropriate members of the scientific and academic communities; and
(B) conduct outreach to solicit feedback from members of the scientific and academic communities on the influence of sex as a variable in basic research, including feedback on when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals.
(4) Additional requirementsThe Director of the National Institutes of Health shall—
(A) ensure that projects of basic research funded by the National Institutes of Health are conducted in accordance with the policies developed, updated, or revised under this section, as applicable; and
(B) encourage that the results of such research, when published or reported, be disaggregated as appropriate with respect to the analysis of any sex differences.
(Pub. L. 114–255, div. A, title II, § 2038(g), Dec. 13, 2016, 130 Stat. 1066.)
§ 284s. Tick-borne diseases
(a) In general
(b) Reports
(c) Tick-Borne Diseases Working Group
(1) Establishment
(2) ResponsibilitiesThe working group shall—
(A) not later than 2 years after December 13, 2016, develop or update a summary of—
(i) ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;
(ii) advances made pursuant to such research;
(iii) Federal activities related to tick-borne diseases, including—(I) epidemiological activities related to tick-borne diseases; and(II) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;
(iv) gaps in tick-borne disease research described in clause (iii)(II);
(v) the Working Group’s meetings required under paragraph (4); and
(vi) the comments received by the Working Group;
(B) make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
(C) solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.
(3) MembershipThe members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members:
(A) Federal membersSeven Federal members, consisting of one or more representatives of each of the following:
(i) The Office of the Assistant Secretary for Health.
(ii) The Food and Drug Administration.
(iii) The Centers for Disease Control and Prevention.
(iv) The National Institutes of Health.
(v) Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate.
(B) Non–Federal public membersSeven non–Federal public members, consisting of representatives of the following categories:
(i) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases.
(ii) Scientists or researchers with expertise.
(iii) Patients and their family members.
(iv) Nonprofit organizations that advocate for patients with respect to tick-borne diseases.
(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.
(4) Meetings
(5) ReportingNot later than 2 years after December 13, 2016, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group shall—
(A) submit a report on its activities under paragraph (2)(A) and any recommendations under paragraph (2)(B) to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate; and
(B) make such report publicly available on the Internet website of the Department of Health and Human Services.
(6) Applicability of FACA
(7) Sunset
(Pub. L. 114–255, div. A, title II, § 2062, Dec. 13, 2016, 130 Stat. 1079.)