Shandra Eisenga Human Cell and Tissue Product Safety Act
What changed between versions
The public awareness campaign was drastically scaled back. The original required a national evidence-based education campaign with grants to nonprofits, stakeholder expert input, and multimedia campaigns (TV, radio, social media, etc.). The new version only requires the Secretary to support development and dissemination of educational materials about organ/tissue/eye donation approaches, donor screening test availability, and other relevant aspects of donation.
A new Section 6 on streamlining regulatory oversight was added. It requires FDA to publish Tissue Reference Group information and best practices on its website, publish annual data on registrations, inspections, inquiries, and response times for 4 years, conduct stakeholder education workshops, establish a public docket within 60 days for comments on modernizing HCT/P regulation (including minimal manipulation and homologous use), and submit a report to Congress by September 30, 2026 with recommendations on regulating HCT/Ps considering regulatory burden, scientific developments, access, and public health.
Civil penalties were narrowed in scope. Originally applied to any violation of section 361 of the PHS Act or all of part 1271 of title 21 CFR. Now applies only to violations of subparts C or D of section 1271. Additionally, per-day penalties for continuing violations now require that the Secretary first provide written notice to the violator before the daily penalty accrues.
The guidance update requirement was made discretionary. Originally the Secretary was required to issue updated donor eligibility guidance within 3 years. Now it says 'if appropriate' - if the Secretary determines updating is not appropriate, they must provide a written explanation to the House Energy and Commerce Committee and Senate HELP Committee.
The definition of 'human cell and tissue establishment' was removed from the bill. A new definition for 'Tissue Reference Group' (the Tissue Reference Group of FDA) was added in its place.
The grant program allowing the Secretary to award grants to nonprofit organizations for public awareness activities, as well as the provision for multimedia campaigns through contracts or grants, was removed entirely.
