Bill > HR340

This bill aims to modernize and streamline the regulatory oversight of human cell and tissue products (HCT/Ps) by directing the Secretary of Health and Human Services to take several key actions. The bill requires the FDA to publish a website with educational materials about the Tissue Reference Group, which helps classify and regulate cell and tissue products, and provide best practices for obtaining recommendations. For the next four years, the FDA must annually publish public information including the number of HCT/P establishments registered, inspection details, types of inquiries to the Tissue Reference Group, and average response times. The bill also mandates that the FDA provide educational resources and conduct workshops for stakeholders like industry, academic centers, and research organizations to support regulatory predictability. Additionally, the bill requires the establishment of a public docket within 60 days to gather comments on approaches for modernizing HCT/P regulation, with a focus on scientific data, minimal manipulation, and homologous use of these products. By September 30, 2026, the Secretary must submit a report to Congress summarizing workshop discussions and public comments, and develop recommendations for HCT/P regulation that balance regulatory burden, scientific developments, product access, and public health protection.

Business and Industry

https://www.congress.gov/bill/119th-congress/house-bill/340/all-info