Sec. 4. Annual report on progress to increase diversity in clinical trials and studies
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Beginning not later than 2 years after the date of the enactment of this Act, and each year thereafter, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit to Congress, and publish on the public website of the Food and Drug Administration, a report that addresses progress on increasing diversity in clinical trial and study enrollment. The report submitted under subsection
(a)shall include, with respect to applications for drugs or devices approved or cleared under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360(k), or 360e) or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) during the calendar year that immediately precedes the year in which the report is submitted— an analysis of the extent to which clinical trials conducted with respect to such applications have met the demographic subgroup enrollment targets for clinical trials and studies required by the regulations amended pursuant to section 2 and the amendments made by section 3; the frequency with which enrollment targets by demographic subgroup set for a clinical trial conducted under an exemption for investigational use of a drug under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) or section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) or an exemption for investigational use of a device under section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ) do not adequately reflect the incidence in the United States population of the disease or condition being studied in the clinical trial and a summary of the rationales provided for enrollment targets by demographic subgroup in such cases; a summary of the justifications sponsors provided in the cases where sponsors did not meet the enrollment targets specified pursuant to section 2, disaggregated by demographic subgroup; and the Secretary’s recommendations, as appropriate, for strategies presented in such diversity plans to attain enrollment targets that should be adopted by sponsors as best practices. Beginning 3 years after the first instance in which the Secretary requires the sponsor of an application for a drug or device approved or cleared under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360(k), or 360e) or licensed under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) to conduct postmarket studies or postmarket surveillance under clause
(iv)of section 505(o)(3)(B) and clause
(iv)of section 522(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (as added by subsections
(a)and
(b)of section 3), and each year thereafter, the report submitted under subsection
(a)shall also include— the number of such applications that were required to initiate postmarket studies or surveillance in the previous calendar year under clause
(iv)of section 505(o)(3)(B) and clause
(iv)of section 522(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (as added by subsections
(a)and
(b)of section 3), the numbers of such applications that have, as of the end of the calendar year immediately preceding the year in which the report is submitted, in-progress postmarket requirements, and the number of such applications that have completed postmarket requirements for each year, beginning on the date of the enactment of this Act; an analysis of the average amount of time for completion of such postmarket requirements, disaggregated by type of application and type of postmarket requirement; an analysis of how the imposition of such postmarket requirements has impacted the availability of demographic subgroup-specific safety and efficacy data for drugs, biologics, and devices; and the Secretary’s recommendations, as appropriate, for additional guidance or postmarket requirements to facilitate the collection and reporting of representative demographic subgroup data in support of applications for the approval or clearance of, or updates to the labeling of, drugs and devices under section 505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360(k), or 360e) or licensure of biological products under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ). Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.
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Sec. 4
Annual report on progress to increase diversity in clinical trials and studies
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