H.R. 340 — The HCT/P Modernization Act of 2025

This section defines terms used in the Act, including (1) "human cell and tissue product," which has the meaning given "human cells, tissues, or cellular or tissue-based products" (HCT/Ps) in 21 C.F.R. §1271.3(d) (or successor regulations); (2) "Secretary," meaning the Secretary of Health and Human Services; and (3) "Tissue Reference Group," meaning the Tissue Reference Group of the Food and Drug Administration (FDA).

This section directs the Secretary of Health and Human Services (HHS), acting through the Food and Drug Administration (FDA) Commissioner, to (1) publish on the FDA website educational materials on the Tissue Reference Group (TRG)—which advises FDA on human cell and tissue products (HCT/Ps) regulated under section 361 of the Public Health Service Act (42 U.S.C. 264)—and best practices for obtaining timely TRG recommendations; (2) publish specified public information on HCT/P establishments registered and inspected since January 1, 2019 (including comparisons to blood establishments), TRG inquiries, and response times, initially by one year after enactment and annually for the next three years; and (3) provide information and conduct workshops for stakeholders (e.g., industry, tissue establishments, patients) on HCT/P regulation to support predictability and advancement. This section further (1) amends section 3205 of the Food and Drug Omnibus Reform Act of 2022 to specify best practices and scientific information on developing stem cell and other cellular therapies; (2) requires FDA to establish a public docket within 60 days of enactment for comments on modernizing HCT/P regulation, including minimal manipulation and homologous use (as defined in 21 C.F.R. 1271.3); and (3) requires a report to Congress by September 30, 2026, summarizing a prior public workshop and the docket with recommendations on HCT/P regulation under 21 C.F.R. 1271.10(a) and 1271.3, considering regulatory burden, scientific developments, access, and public health.