Summary

Requires HHS/FDA to expand education and public information about organ, tissue, and eye donation and the FDA Tissue Reference Group; creates civil money penalties for violations of FDA requirements for human cell and tissue products; and directs the FDA to open a public docket (60 days) and deliver a report to Congress with recommendations by September 30, 2026. Also updates a prior statutory phrase to align language on cellular therapies. Affects health care professionals, laboratories, tissue banks and suppliers, and other entities that handle human cell and tissue products by increasing education expectations and adding a new enforcement/penalty tool for regulatory violations.

• Requires HHS/FDA to develop and share education materials for clinicians and other professionals about organ, tissue, and eye donation and donor screening.
• Adds a new civil-penalty authority for violations involving human cell and tissue products, including per-violation and daily penalties and liability tied to retail value, with a cap per proceeding.
• Directs the FDA to publish information about the Tissue Reference Group, open a 60-day public docket for comment, and submit a recommendations report to Congress by Sept 30, 2026.
• Uses the existing regulatory definition of “human cell and tissue product” (21 C.F.R. §1271.3(d)) to identify covered products and activities.
• Does not appropriate new funds or change the tax code; responsibilities are assigned to HHS/FDA and impose compliance/administrative burdens on regulated entities.
• Amends prior statutory language to update wording concerning cellular therapies for consistency with current terms and the new provisions.
• Targets both informational outreach (to increase donation awareness and best practices) and enforcement (to strengthen penalties for noncompliance).