This bill directs the Secretary of Health and Human Services to develop and share national, evidence-based education materials for the public and health care providers about human cell and tissue product transplants. It directs materials on organ, tissue, and eye donation, how to approach patients and families, available donor screening tests, and other donation topics. The bill requires the Food and Drug Administration (FDA) to publish materials about the FDA Tissue Reference Group and best practices for getting timely recommendations from that group. The FDA must also publish annual information (for up to 4 years) on registered human cell and tissue establishments since 2019, inspection numbers and comparisons with blood establishments, number and types of inquiries to the Tissue Reference Group, and average response times.
The bill adds civil penalties for violations of certain parts of the FDA human cells and tissues regulations (subparts C or D of 21 CFR 1271) for products regulated under section 361 of the Public Health Service Act. Penalties can be up to $20,000 per violation, $20,000 for each day a violation continues after written notice, and an amount equal to the retail value of the affected products. The total civil penalty in a single proceeding may not exceed $10,000,000.
The bill requires the FDA to provide information and run workshops for stakeholders, opens a public docket to receive comments on modernizing regulation (including issues like minimal manipulation and homologous use), and requires a report to Congress by September 30, 2026 with recommendations about regulation that consider regulatory burden, scientific developments, access to products regulated under section 361, and protecting public health. It also updates language in a prior statute to focus on scientific data for stem cell and other cellular therapies.
No publicly available information.
No publicly available information.