H.R. 1082 — Shandra Eisenga Human Cell and Tissue Product Safety Act

This section establishes the short title of the Act as the “Shandra Eisenga Human Cell and Tissue Product Safety Act.”

This section establishes definitions for the Act by defining “human cell and tissue product” and “human cell and tissue products” to mean “human cells, tissues, or cellular or tissue-based products” under 21 C.F.R. § 1271.3(d) (or successor regulations), defining “Secretary” to mean the Secretary of Health and Human Services, and defining “Tissue Reference Group” to mean the Tissue Reference Group of the Food and Drug Administration.

This section directs the Secretary of Health and Human Services to support the development and dissemination of educational materials for health care professionals and other appropriate professionals about organ, tissue, and eye donation, including evidence-based methods for approaching patients and their families, the availability of donor screening tests, and other relevant aspects of donation.

This section establishes civil penalties for violations of federal human cell and tissue product safety requirements under 21 C.F.R. subparts C and D for products regulated under section 361 of the Public Health Service Act. A person who violates those requirements on or after the date of enactment of the Shandra Eisenga Human Cell and Tissue Product Safety Act would be liable for up to $20,000 per violation, plus $20,000 for each day a violation continues after the Secretary provides written notice, and an additional amount equal to the retail value of the human cell and tissue products involved. The total civil penalty for all violations adjudicated in a single proceeding may not exceed $10 million. The section defines “human cell and tissue products” by reference to the definition of “human cells, tissues, or cellular or tissue-based products” in 21 C.F.R. § 1271.3(d).

This section revises the regulation of human cell and tissue products by directing the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish new public information and educational materials on the Food and Drug Administration (FDA) website, establish a public docket, and report to Congress by September 30, 2026. Specifically, it requires FDA to publish: (1) educational materials about the Tissue Reference Group and best practices for obtaining a timely, accurate recommendation from that group; (2) within 1 year after enactment and annually for the next 3 years, data on the number of human cell and tissue establishments registered on or after January 1, 2019, the number of inspections conducted on or after January 1, 2019, a comparison of inspections of blood establishments and human cell and tissue establishments, the number and type of Tissue Reference Group inquiries in the preceding year, and the average initial and final response times for those inquiries; and (3) information and workshops for stakeholders, including industry, tissue establishments, academic health centers, biomedical consortia, research organizations, and patients, to support regulatory predictability and scientific advancement. It also amends section 3205 of the Food and Drug Omnibus Reform Act of 2022 to replace the existing workshop topic on “best practices” with best practices for generating scientific data needed to facilitate the development of certain human cell-, tissue-, and cellular-based medical products, including stem cell and other cellular therapies. In addition, it requires the Secretary to establish, within 60 days after enactment, a public docket for written comments on the workshop approaches and on modernizing regulation of human cell and tissue products, including the assessment of minimal manipulation and homologous use under 21 C.F.R. § 1271.3. The Secretary must then summarize the workshop and docket comments and submit recommendations to Congress by September 30, 2026, considering regulatory burden, scientific developments, access to products regulated under section 361 of the Public Health Service Act (42 U.S.C. 264), and public health protection.