Sec. 504. Annual summary report on progress to increase diversity in clinical studies
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Beginning not later than 2 years after the date of enactment of this Act, and each year thereafter, the Secretary of Health and Human Services shall submit to the Congress, and publish on the public website of the Food and Drug Administration, a report that— summarizes, in aggregate, the diversity action plans received pursuant to section 505(i)(5) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by subsection
(a)or
(b)of section 501 of this Act; and contains information on— for drugs, biological products, and devices approved, licensed, cleared, or classified under section 505, 515, 510(k), or 513(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ; 360e; 360(k); and 360(f)(2)), or section 351(a) of the Public Health Service Act ( 42 U.S.C. 262(a) ), whether the clinical studies conducted with respect to such applications met the demographic subgroup enrollment goals from the diversity action plan submitted for such applications; the reasons provided for why enrollment goals from submitted diversity action plans were not met; and any postmarket studies of a drug or device in a demographic subgroup or subgroups required or recommended by the Secretary based on inadequate premarket clinical study diversity or based on other reasons where a premarket study lacked adequate diversity, including the status and completion date of any such study. Nothing in this section shall be construed as authorizing the Secretary of Health and Human Services 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. 504
Annual summary report on progress to increase diversity in clinical studies
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