Collapse to view only § 284c. Certain uses of funds
- § 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 Repealed.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
The Director of the National Cancer Institute shall be appointed by the President, and the Directors of the other national research institutes and national centers shall be appointed by the Secretary, acting through the Director of National Institutes of Health. Each Director of a national research institute or national center shall report directly to the Director of National Institutes of Health.
A Director of a national research institute or national center who is appointed by the Secretary, acting through the Director of National Institutes of Health, shall be appointed for 5 years.
At the end of the term of a Director of a national research institute or national center, the Director may be reappointed in accordance with standards applicable to the relevant appointment mechanism. There shall be no limit on the number of terms that a Director may serve.
If the office of a Director of a national research institute or national center becomes vacant before the end of such Director’s term, the Director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.
Each Director of a national research institute or national center who is serving on December 13, 2016, shall be deemed to be appointed for a 5-year term under this subsection beginning on such date.
Nothing in this subsection shall be construed to limit the authority of the Secretary or the Director of National Institutes of Health to terminate the appointment of a director referred to in subparagraph (A) before the expiration of such director’s 5-year term.
Appointments and reappointments under this subsection shall be made on the basis of ability and experience as it relates to the mission of the National Institutes of Health and its components, including compliance with any legal requirement that the Secretary or Director of National Institutes of Health determines relevant.
The restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) related to consultants and individual scientists appointed for limited periods of time shall not apply to Directors appointed under this subsection.
The term of office of an appointed member of an advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member’s term for 180 days after the date of such expiration. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.
The chairman of an advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the national research institute for which the advisory council is established to be the chairman of the advisory council. The term of office of the chairman shall be two years.
The advisory council shall meet at the call of the chairman or upon the request of the Director of the national research institute for which it was established, but at least three times each fiscal year. The location of the meetings of each advisory council is subject to the approval of the Director of the national research institute for which the advisory council was established.
The Director of the national research institute for which an advisory council is established shall designate a member of the staff of the institute to serve as the executive secretary of the advisory council. The Director of such institute shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of such institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council.
Each advisory council may prepare, for inclusion in the biennial report made under section 284b 1
For purposes of this subchapter, the term “health services research” means research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions.
As used in this subchapter, the term “clinical research” means patient oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.
The Directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the National Institute of Dental Research, and the National Institute of Diabetes and Digestive and Kidney Diseases, shall expand and intensify the programs of such Institutes with respect to research and related activities concerning osteoporosis, Paget’s disease, and related bone disorders.
The Directors referred to in subsection (a) shall jointly coordinate the programs referred to in such subsection and consult with the Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and the Interagency Task Force on Aging Research.
In order to assist in carrying out the purpose described in subsection (a), the Director of NIH shall provide for the establishment of an information clearinghouse on osteoporosis and related bone disorders to facilitate and enhance knowledge and understanding on the part of health professionals, patients, and the public through the effective dissemination of information.
For the purpose of carrying out paragraph (1), the Director of NIH shall enter into a grant, cooperative agreement, or contract with a nonprofit private entity involved in activities regarding the prevention and control of osteoporosis and related bone disorders.
The Director of NIH shall establish a program for the conduct and support of research and training with respect to Parkinson’s disease (subject to the extent of amounts appropriated to carry out this section).
The Director of NIH shall provide for the coordination of the program established under subsection (a) among all of the national research institutes conducting Parkinson’s disease research.
Coordination under paragraph (1) shall include the convening of a research planning conference not less frequently than once every 2 years. Each such conference shall prepare and submit to the Committee on Appropriations and the Committee on Labor and Human Resources of the Senate and the Committee on Appropriations and the Committee on Commerce of the House of Representatives a report concerning the conference.
The Director of NIH is authorized to award Core Center Grants to encourage the development of innovative multidisciplinary research and provide training concerning Parkinson’s disease. The Director is authorized to award not more than 10 Core Center Grants and designate each center funded under such grants as a Morris K. Udall Center for Research on Parkinson’s Disease.
A center may use funds provided under paragraph (1) to provide stipends for scientists and health professionals enrolled in training programs under paragraph (2)(B).
Support of a center under this subsection may be for a period not exceeding five years. Such period may be extended by the Director of NIH for one or more additional periods of not more than five years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
The Director of NIH is authorized to establish a grant program to support investigators with a proven record of excellence and innovation in Parkinson’s disease research and who demonstrate potential for significant future breakthroughs in the understanding of the pathogensis,1
The Director of NIH (in this section referred to as the “Director”) shall, subject to the availability of appropriations, expand, intensify, and coordinate the activities of the National Institutes of Health with respect to research on autism spectrum disorder, including basic and clinical research in fields including pathology, developmental neurobiology, genetics, epigenetics, pharmacology, nutrition, immunology, neuroimmunology, neurobehavioral development, endocrinology, gastroenterology, toxicology, and interventions to maximize outcomes for individuals with autism spectrum disorder. Such research shall investigate the causes (including possible environmental causes), diagnosis or ruling out, early and ongoing detection, prevention, services across the lifespan, supports, intervention, and treatment of autism spectrum disorder, including dissemination and implementation of clinical care, supports, interventions, and treatments.
The Director may consolidate program activities under this section if such consolidation would improve program efficiencies and outcomes.
The Director shall carry out this section acting through the Director of the National Institute of Mental Health and in collaboration with any other agencies that the Director determines appropriate.
The Director shall under subsection (a)(1) make awards of grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on autism spectrum disorder.
Each center under paragraph (1) shall conduct basic and clinical research into autism spectrum disorder. Such research should include investigations into the causes, diagnosis, early and ongoing detection, prevention, and treatment of autism spectrum disorder across the lifespan. The centers, as a group, shall conduct research including the fields of developmental neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral psychology, and clinical psychology.
A center under paragraph (1) may expend amounts provided under such paragraph to carry out a program to make individuals aware of opportunities to participate as subjects in research conducted by the centers.
A program under subparagraph (A) may, in accordance with such criteria as the Director may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and such patient care costs as are required for research.
The extent to which a center can demonstrate availability and access to clinical services shall be considered by the Director in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section.
The Director may consider, as appropriate, the extent to which a center can demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic, geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section.
Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director.
The Director shall provide for the establishment of not less than five centers under paragraph (1).
Support for a center established under paragraph (1) may be provided under this section for a period of not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
The Director shall under subsection (a)(1) provide for a program under which samples of tissues and genetic materials that are of use in research on autism spectrum disorder are donated, collected, preserved, and made available for such research. The program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples.
The Director shall under subsection (a)(1) provide for means through which the public can obtain information on the existing and planned programs and activities of the National Institutes of Health with respect to autism spectrum disorder and through which the Director can receive comments from the public regarding such programs and activities.
The Secretary shall establish within the Office of the Director of NIH a Pediatric Research Initiative (referred to in this section as the “Initiative”) to conduct and support research that is directly related to diseases, disorders, and other conditions in children. The Initiative shall be headed by the Director of NIH.
Any support received by a consortium under subparagraph (A) shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported under this paragraph.
Support of a consortium under subparagraph (A) shall be for a period of not to exceed 5 years. Such period may be extended at the discretion of the Director of NIH.
Each consortium receiving an award under paragraph (2)(A) may provide assistance, as appropriate, to the Centers for Disease Control and Prevention for activities related to patient registries and other surveillance systems upon request by the Director of the Centers for Disease Control and Prevention.
The Director of NIH may transfer amounts appropriated under this section to any of the Institutes for a fiscal year to carry out the purposes of the Initiative under this section.
The Director of NIH shall expand, intensify, and coordinate research and other activities of the National Institutes of Health with respect to autoimmune diseases.
With respect to amounts appropriated to carry out this section for a fiscal year, the Director of NIH shall allocate the amounts among the national research institutes that are carrying out paragraph (1).
The term “autoimmune disease” includes, for purposes of this section such diseases or disorders with evidence of autoimmune pathogensis 1
The Secretary shall ensure that the Autoimmune Diseases Coordinating Committee (referred to in this section as the “Coordinating Committee”) coordinates activities across the National Institutes and with other Federal health programs and activities relating to such diseases.
The Coordinating Committee shall be composed of the directors or their designees of each of the national research institutes involved in research with respect to autoimmune diseases 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 and the Food and Drug Administration.
With respect to autoimmune diseases, the Chair of the Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and other relevant agencies.
The Chair of the Committee shall be directly responsible to the Director of NIH.
The Director of NIH shall ensure that programs and activities of the National Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph (1).
The Director of NIH shall expand and increase coordination in the activities of the National Institutes of Health with respect to research on muscular dystrophies, including Duchenne muscular dystrophy.
The Director of NIH shall carry out this section through the appropriate institutes, including the National Institute of Neurological Disorders and Stroke and in collaboration with any other agencies that the Director determines appropriate.
The Director of National Institutes of Health shall undertake activities to support and expand the involvement of the National Institutes of Health in clinical research.
The Director of National Institutes of Health, in cooperation with the Directors of the Institutes, Centers, and Divisions of the National Institutes of Health, shall support and expand the resources available for the diverse needs of the clinical research community, including inpatient, outpatient, and critical care clinical research.
The Director of National Institutes of Health shall establish peer review mechanisms to evaluate applications for the awards and fellowships provided for in subsection (b)(2) and section 284l of this title. Such review mechanisms shall include individuals who are exceptionally qualified to appraise the merits of potential clinical research training and research grant proposals.
The Director of the National Institutes of Health shall make grants (to be referred to as “Mentored Patient-Oriented Research Career Development Awards”) to support individual careers in clinical research at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.
Grants under subparagraph (A) shall be used to support clinical investigators in the early phases of their independent careers by providing salary and such other support for a period of supervised study.
An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director may require.
The Director of the National Institutes of Health shall make grants (to be referred to as “Mid-Career Investigator Awards in Patient-Oriented Research”) to support individual clinical research projects at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.
Grants under subparagraph (A) shall be used to provide support for mid-career level clinicians to allow such clinicians to devote time to clinical research and to act as mentors for beginning clinical investigators.
An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director requires.
The Director of the National Institutes of Health shall make grants (to be referred to as “Graduate Training in Clinical Investigation Awards”) to support individuals pursuing master’s or doctoral degrees in clinical investigation.
An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director may require.
Grants under this subsection shall be for terms of 2 years or more and shall provide stipend, tuition, and institutional support for individual advanced degree programs in clinical investigation.
An application for a grant under this subsection shall be submitted by an individual institution or a consortium of institutions at such time as the Director may require. An institution may submit only one such application.
Grants under this subsection shall be for terms of up to 5 years and may be renewable.
Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or indications that require study. The list shall be revised every three years.
The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues described in paragraphs (1) and (2)(A) of subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection.
The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug. Such a written request shall be made in a manner equivalent to the manner in which a written request is 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 information provided on the pediatric studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study is requested.
If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (2) not later than 30 days after the date on which a request was issued, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric studies described in the written request in accordance with subsection (b).
A holder that receives a first right of refusal shall not be entitled to respond to a request for proposals under paragraph (3).
A contract, grant, or other funding may be awarded under this section only if a proposal is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
On completion of a pediatric study in accordance with an award under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study, including a written request if issued.
An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.
The Commissioner of Food and Drugs shall take action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).
If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric Advisory Committee.
Not later than 30 days after receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate.
If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.
There are authorized to be appropriated to carry out this section, $5,753,425 for the period beginning on October 1, 2022 and ending on December 23, 2022.1
Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.
The Secretary of Health and Human Services shall, under section 217a of this title or other appropriate authority, convene and consult an advisory committee on pediatric therapeutics (including drugs and biological products) and medical devices (referred to in this section as the “advisory committee”).
The advisory committee shall advise and make recommendations to the Secretary, through the Commissioner of Food and Drugs, on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices.
The advisory committee shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the Secretary.
Notwithstanding section 1013 of title 5, the advisory committee shall continue to operate to carry out the advisory committee’s responsibilities under sections 355a, 355c, and 360j(m) of title 21.
From amounts to be appropriated under section 282a(b) of this title, the Secretary of Health and Human Services, acting through the Director of NIH, (in this subsection referred to as the “Secretary”) in consultation with the Director of the National Science Foundation, the Secretary of Energy, and other agency heads when necessary, may allocate funds for the national research institutes and national centers to make grants for the purpose of improving the public health through demonstration projects for biomedical research at the interface between the biological, behavioral, and social sciences and the physical, chemical, mathematical, and computational sciences.
A grant may be made under paragraph (1) only if the application for the grant has undergone technical and scientific peer review under section 289a of this title and has been reviewed by the advisory council under section 282(k) of this title or has been reviewed by an advisory council composed of representatives from appropriate scientific disciplines who can fully evaluate the applicant.
From amounts to be appropriated under section 282a(b) of this title, the Secretary, acting through the Director of NIH, may allocate funds for the national research institutes and national centers to make awards of grants or contracts or to engage in other transactions for demonstration projects for high-impact, cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, and treatment of diseases and disorders. The head of a national research institute or national center may conduct or support such high-impact, cutting-edge research (with funds allocated under the preceding sentence or otherwise available for such purpose) if the institute or center gives notice to the Director of NIH beforehand and submits a report to the Director of NIH on an annual basis on the activities of the institute or center relating to such research.
In carrying out the program under paragraph (1), the Director of NIH shall give special consideration to coordinating activities with national research institutes whose budgets are substantial relative to a majority of the other institutes.
Activities relating to research described in paragraph (1) shall be designed by the Director of NIH or the head of a national research institute or national center, as applicable, to enable such research to be carried out with maximum flexibility and speed.
In providing for research described in paragraph (1), the Director of NIH or the head of a national research institute or national center, as applicable, shall seek to facilitate partnerships between public and private entities and shall coordinate when appropriate with the Foundation for the National Institutes of Health.
A grant for research described in paragraph (1) may be made only if the application for the grant has undergone technical and scientific peer review under section 289a of this title and has been reviewed by the advisory council under section 282(k) of this title.
Not later than the end of fiscal year 2009, the Secretary, acting through the Director of NIH, shall conduct an evaluation of the activities under this section and submit a report to the Congress on the results of such evaluation.
For purposes of this section, the terms “Director of NIH”, “national research institute”, and “national center” have the meanings given such terms in section 281 of this title.
The Director of the National Institutes of Health (referred to in this section and sections 280g–9 and 284p of this title as the “Director”), pursuant to the general authority of the Director, may develop mechanisms to coordinate the paralysis research and rehabilitation activities of the Institutes and Centers of the National Institutes of Health in order to further advance such activities and avoid duplication of activities.
The Director may make awards of grants to public or private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for consortia in paralysis research. The Director shall designate each consortium funded through such grants as a Christopher and Dana Reeve Paralysis Research Consortium.
The Director may, as appropriate, provide for the coordination of information among consortia under paragraph (1) and ensure regular communication among members of the consortia, and may require the periodic preparation of reports on the activities of the consortia and the submission of the reports to the Director.
Each consortium under paragraph (1) may use the facilities of a single lead institution, or be formed from several cooperating institutions, meeting such requirements as may be prescribed by the Director.
The Director may provide for a mechanism to educate and disseminate information on the existing and planned programs and research activities of the National Institutes of Health with respect to paralysis and through which the Director can receive comments from the public regarding such programs and activities.
The Director, pursuant to the general authority of the Director, may make awards of grants to public or private entities to pay all or part of the costs of planning, establishing, improving, and providing basic operating support to multicenter networks of clinical sites that will collaborate to design clinical rehabilitation intervention protocols and measures of outcomes on one or more forms of paralysis that result from central nervous system trauma, disorders, or stroke, or any combination of such conditions.
The Director may, as appropriate, provide for the coordination of information among networks funded through this section and ensure regular communication among members of the networks, and may require the periodic preparation of reports on the activities of the networks and submission of reports to the Director.
The Director of NIH is encouraged to continue and expand, through the Pain Consortium, an aggressive program of basic and clinical research on the causes of and potential treatments for pain.
Not less than annually, the Pain Consortium, in consultation with the Division of Program Coordination, Planning, and Strategic Initiatives, shall develop and submit to the Director of NIH recommendations on appropriate pain research initiatives that could be undertaken with funds reserved under section 282a(c)(1) of this title for the Common Fund or otherwise available for such initiatives.
In this subsection, the term “Pain Consortium” means the Pain Consortium of the National Institutes of Health or a similar trans-National Institutes of Health coordinating entity designated by the Secretary for purposes of this subsection.
The Secretary shall establish not later than 1 year after March 23, 2010, and as necessary maintain a committee, to be known as the Interagency Pain Research Coordinating Committee (in this section referred to as the “Committee”), to coordinate all efforts within the Department of Health and Human Services and other Federal agencies that relate to pain research.
The Committee shall include such nonvoting members as the Secretary determines to be appropriate.
The voting members of the Committee shall select a chairperson from among such members. The selection of a chairperson shall be subject to the approval of the Director of NIH.
The Committee shall meet at the call of the chairperson of the Committee or upon the request of the Director of NIH, but in no case less often than once each year.
The Secretary shall ensure that recommendations and actions taken by the Director with respect to the topics discussed at the meetings described in paragraph (4) are included in appropriate reports to Congress.
The Secretary shall review the necessity of the Committee at least once every 2 years.
The prioritization and direction of the Federally funded portfolio of pain research studies shall consider recommendations made by the Interagency Pain Research Coordinating Committee in concert with the Pain Management Best Practices Inter-Agency Task Force, and in accordance with the National Pain Strategy, the Federal Pain Research Strategy, and the NIH-Wide Strategic Plan for Fiscal Years 2016–2020, the latter of which calls for the relative burdens of individual diseases and medical disorders to be regarded as crucial considerations in balancing the priorities of the Federal research portfolio.
The Director of the National Institutes of Health may update or revise the policies developed under paragraph (1) as appropriate.
The Secretary of Health and Human Services (referred to in this section as “the Secretary”) shall continue to conduct or support epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases.
The Secretary shall ensure that each triennial report under section 283 of this title (as amended by section 2032) includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to tick-borne diseases.
The Secretary shall establish a working group, to be known as the Tick-Borne Disease Working Group (referred to in this section as the “Working Group”), comprised of representatives of appropriate Federal agencies and other non-Federal entities, to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities.
The Working Group shall meet not less than twice each year.
The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.).1
The Working Group under this section shall terminate 6 years after December 13, 2016.