Bill > HR1082

This bill, named the Shandra Eisenga Human Cell and Tissue Product Safety Act, aims to improve the regulation and public understanding of human cell and tissue products (HCTPs), which are medical products derived from human biological materials. The bill requires the Secretary of Health and Human Services to develop and distribute educational materials for healthcare professionals about organ, tissue, and eye donation, including donor screening tests and donation approaches. It establishes civil penalties for violations of HCTP regulations, with fines up to $20,000 per violation and a maximum total penalty of $10 million. The bill also mandates the FDA to publish comprehensive information on its website, including the number of registered HCTP establishments, inspection data, and Tissue Reference Group inquiry details. Additionally, the legislation requires the Secretary to conduct stakeholder workshops, create a public docket for comments on HCTP regulation, and submit a report to Congress by September 30, 2026, with recommendations for modernizing HCTP regulations. The bill's goal is to enhance regulatory oversight, scientific understanding, and public awareness of human cell and tissue products while balancing regulatory burden, scientific development, and public health protection.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/119th-congress/house-bill/1082/all-info