ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE DIVERSITY IN CLINICAL STUDIES.

SEC. 3604. ANNUAL SUMMARY REPORT ON PROGRESS TO INCREASE DIVERSITY IN CLINICAL STUDIES.(a) In General.—Beginning not later than 2 years after the date of enactment of this Act, and each year thereafter, the Secretary shall submit to the Congress, and publish on the public website of the Food and Drug Administration, a report that—(1) summarizes, in aggregate, the diversity action plans received pursuant to section 505(z) or 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, as added by section 3601; and (2) contains information, in the aggregate, on—(A) 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; and (B) the reasons provided, if any, for why enrollment goals from submitted diversity action plans were not met. (b) Confidentiality.—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.