§ 282. Director of National Institutes of Health

Pub. L. 114–255, div. A, title II, § 2039, Dec. 13, 2016, 130 Stat. 1068, provided that: “(a) Establishment.—Not later than 1 year after the date of enactment of this Act [Dec. 13, 2016], the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall convene a working group under the Advisory Committee to the Director of the National Institutes of Health (referred to in this section as the ‘Advisory Committee’), appointed under section 222 of the Public Health Service Act (42 U.S.C. 217a), to develop and issue recommendations through the Advisory Committee for a formal policy, which may incorporate or be informed by relevant existing and ongoing activities, to enhance rigor and reproducibility of scientific research funded by the National Institutes of Health. “(b) Considerations.—In developing and issuing recommendations through the Advisory Committee under subsection (a), the working group established under such subsection shall consider, as appropriate—“(1) preclinical experiment design, including analysis of sex as a biological variable; “(2) clinical experiment design, including—“(A) the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities; “(B) the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and “(C) the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities; “(3) applicable levels of rigor in statistical methods, methodology, and analysis; “(4) data and information sharing in accordance with applicable privacy laws and regulations; and “(5) any other matter the working group determines relevant. “(c) Policies.—Not later than 18 months after the date of enactment of this Act, the Director of the National Institutes of Health shall consider the recommendations developed by the working group and issued by the Advisory Committee under subsection (a) and develop or update policies as appropriate. “(d) Report.—Not later than 2 years after the date of enactment of this Act, the Director of the National Institutes of Health shall issue a report to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives regarding recommendations developed under subsection (a) and any subsequent policy changes implemented, to enhance rigor and reproducibility in scientific research funded by the National Institutes of Health. “(e) Confidentiality.—Nothing in this section authorizes the Secretary of Health and Human Services to disclose any information that is a trade secret, or other privileged or confidential information, described in section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.”

Demonstration Grants for Improving Pediatric Device Availability

Pub. L. 110–85, title III, § 305, Sept. 27, 2007, 121 Stat. 863, as amended by Pub. L. 112–144, title VI, § 620(a), July 9, 2012, 126 Stat. 1064; Pub. L. 115–52, title V, § 502(c), Aug. 18, 2017, 131 Stat. 1037; Pub. L. 117–180, div. F, title V, § 5003, Sept. 30, 2022, 136 Stat. 2167; Pub. L. 117–229, div. C, title III, § 304, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, § 3104, Dec. 29, 2022, 136 Stat. 5807, provided that: “(a) In General.—“(1) Request for proposals.—Not later than 90 days after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue a request for proposals for 1 or more grants or contracts to nonprofit consortia for demonstration projects to promote pediatric device development. “(2) Determination on grants or contracts.—Not later than 180 days after the date the Secretary of Health and Human Services issues a request for proposals under paragraph (1), the Secretary shall make a determination on the grants or contracts under this section. “(b) Application.—A nonprofit consortium that desires to receive a grant or contract under this section shall submit an application to the Secretary of Health and Human Services at such time, in such manner, and containing such information as the Secretary may require. “(c) Use of Funds.—A nonprofit consortium that receives a grant or contract under this section shall facilitate the development, production, and distribution of pediatric medical devices by—“(1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers; “(2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing; “(3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology; “(4) assessing the scientific and medical merit of proposed pediatric device projects; “(5) providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and “(6) providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate. “(d) Coordination.—“(1) National institutes of health.—Each consortium that receives a grant or contract under this section shall—“(A) coordinate with the National Institutes of Health’s pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act [42 U.S.C. 282(b)(23)], as added by section 304(a) of this Act; and “(B) provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest. “(2) Food and drug administration.—Each consortium that receives a grant or contract under this section shall coordinate with the Commissioner of Food and Drugs and device companies to facilitate the application for approval or clearance of devices labeled for pediatric use. “(3) Effectiveness and outcomes.—Each consortium that receives a grant or contract under this section shall annually report to the Secretary of Health and Human Services on the status of pediatric device development, production, and distribution that has been facilitated by the consortium. “(e) Authorization of Appropriations.—There are authorized to be appropriated to carry out this section $1,610,959 for the period beginning on October 1, 2022 and ending on December 23, 2022.”

[Pub. L. 117–328, div. FF, title III, § 3104, Dec. 29, 2022, 136 Stat. 5807, which directed amendment of section 305(e) of Pub. L. 110–85, set out above, by substituting “$7,000,000 for each of fiscal years 2023 through 2027” for “$1,107,534 for the period beginning on October 1, 2022, and ending on December 23, 2022”, could not be executed because “$1,107,534” did not appear after the intervening amendment by section 304 of Pub. L. 117–229.]

Surveillances

Pub. L. 110–85, title VIII, § 801(c), Sept. 27, 2007, 121 Stat. 921, provided that: “Not later than 12 months after the date of the enactment of this Act [Sept. 27, 2007], the Secretary of Health and Human Services shall issue guidance on how the requirements of section 402(j) of the Public Health Service Act [42 U.S.C. 282(j)], as added by this section, apply to a pediatric postmarket surveillance described in paragraph (1)(A)(ii)(II) of such section 402(j) that is not a clinical trial.”

Preemption

Pub. L. 110–85, title VIII, § 801(d), Sept. 27, 2007, 121 Stat. 922, provided that: “(1) In general.—Upon the expansion of the registry and results data bank under section 402(j)(3)(D) of the Public Health Service Act [42 U.S.C. 282(j)(3)(D)], as added by this section, no State or political subdivision of a State may establish or continue in effect any requirement for the registration of clinical trials or for the inclusion of information relating to the results of clinical trials in a database. “(2) Rule of construction.—The fact of submission of clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act (as amended by this section), that relates to a use of a drug or device not included in the official labeling of the approved drug or device shall not be construed by the Secretary of Health and Human Services or in any administrative or judicial proceeding, as evidence of a new intended use of the drug or device that is different from the intended use of the drug or device set forth in the official labeling of the drug or device. The availability of clinical trial information through the registry and results data bank under such subsection (j), if submitted in compliance with such subsection, shall not be considered as labeling, adulteration, or misbranding of the drug or device under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).”

Collaboration and Report

Pub. L. 105–115, title I, § 113(b), Nov. 21, 1997, 111 Stat. 2312, directed the Secretary of Health and Human Services, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs to collaborate to determine the feasibility of including device investigations within the scope of the data bank under subsec. (j) of this section, with the Secretary to report to Congress, not later than two years after Nov. 21, 1997, on the public health need, if any, for inclusion of device investigations within the scope of the data bank under subsec. (j), and on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations was required to be publicly disclosed.

Chronic Fatigue Syndrome; Experts and Research Representatives on Advisory Committees and Boards

Pub. L. 103–43, title IX, § 902(c), June 10, 1993, 107 Stat. 164, provided that: “The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall ensure that appropriate individuals with expertise in chronic fatigue syndrome or neuromuscular diseases and representative of a variety of disciplines and fields within the research community are appointed to appropriate National Institutes of Health advisory committees and boards.”

Third-Party Payments Regarding Certain Clinical Trials and Certain Life-Threatening Illnesses

Pub. L. 103–43, title XIX, § 1901(a), June 10, 1993, 107 Stat. 200, provided that: “The Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall conduct a study for the purpose of— “(1) determining the policies of third-party payors regarding the payment of the costs of appropriate health services that are provided incident to the participation of individuals as subjects in clinical trials conducted in the development of drugs with respect to acquired immune deficiency syndrome, cancer, and other life-threatening illnesses; and “(2) developing recommendations regarding such policies.”

Personnel Study of Recruitment, Retention and Turnover

Pub. L. 103–43, title XIX, § 1905, June 10, 1993, 107 Stat. 203, directed Secretary of Health and Human Services, acting through Director of National Institutes of Health, to conduct a study to review the retention, recruitment, vacancy and turnover rates of support staff, including firefighters, law enforcement, procurement officers, technicians, nurses and clerical employees, to ensure that National Institutes of Health is adequately supporting conduct of efficient, effective and high quality research for the American public, and to submit a report to Congress on results of such study not later than 1 year after June 10, 1993.

Chronic Pain Conditions

Pub. L. 103–43, title XIX, § 1907, June 10, 1993, 107 Stat. 204, directed Director of the National Institutes of Health to submit to Congress, not later than 2 years after June 10, 1993, a report and study on the incidence in the United States of cases of chronic pain, including chronic pain resulting from back injuries, reflex sympathetic dystrophy syndrome, temporomandibular joint disorder, post-herpetic neuropathy, painful diabetic neuropathy, phantom pain, and post-stroke pain, and the effect of such cases on the costs of health care in the United States.

Support for Bioengineering Research

Pub. L. 103–43, title XIX, § 1912, June 10, 1993, 107 Stat. 206, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, to conduct a study for the purpose of determining the sources and amounts of public and private funding devoted to basic research in bioengineering, including biomaterials sciences, cellular bioprocessing, tissue and rehabilitation engineering, evaluating whether that commitment is sufficient to maintain the innovative edge that the United States has in these technologies, evaluating the role of the National Institutes of Health or any other Federal agency to achieve a greater commitment to innovation in bioengineering, and evaluating the need for better coordination and collaboration among Federal agencies and between the public and private sectors, and, not later than 1 year after June 10, 1993, to prepare and submit to Committee on Labor and Human Resources of Senate, and Committee on Energy and Commerce of House of Representatives, a report containing the findings of the study together with recommendations concerning the enactment of legislation to implement the results of such study.

Master Plan for Physical Infrastructure for Research

Pub. L. 103–43, title XX, § 2002, June 10, 1993, 107 Stat. 208, directed Secretary of Health and Human Services, acting through Director of the National Institutes of Health, not later than June 1, 1994, to present to Congress a master plan to provide for replacement or refurbishment of less than adequate buildings, utility equipment and distribution systems (including the resources that provide electrical and other utilities, chilled water, air handling, and other services that the Secretary, acting through the Director, deemed necessary), roads, walkways, parking areas, and grounds that underpin the laboratory and clinical facilities of the National Institutes of Health, and provided that the plan could make recommendations for the undertaking of new projects that are consistent with the objectives of this section, such as encircling the National Institutes of Health Federal enclave with an adequate chilled water conduit.