Bill · H.R. 1082· House(119-HR-1082)
Shandra Eisenga Human Cell and Tissue Product Safety Act
- Introduced
- 2/6/2025
- Last activity
- 6/24/2025 — Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Sponsored by
- John Moolenaar
- Cosponsors
- - 0 - 1
- Introduced
- Passed House
- In Senate committee
What this bill would do
The Shandra Eisenga Human Cell and Tissue Product Safety Act directs the Secretary of Health and Human Services to lead a national education campaign regarding human cell and tissue product transplants. This campaign aims to inform healthcare providers about donation methods, donor screening, and other relevant details. The bill also establishes significant civil penalties for those who violate specific federal regulations regarding these products. Additionally, it seeks to streamline regulatory oversight by requiring the FDA to publish specific data on the website. Finally, the Act mandates the creation of a public docket and a report to Congress to modernize regulations while considering scientific advances and public health.
Yes· 3 of 4
Does this make what the government does easier for the public to see?+5
The bill requires the FDA to publish specific data regarding establishments, inspections, and response times on its public website.
Does this make health care easier to get in general?+3
The bill aims to improve access to human cell and tissue products through regulatory modernization and scientific updates.
Does this put more money into medical research?+2
The act supports scientific advancement and research by providing workshops and updated scientific information to stakeholders.
The opposite
Does this make it easier to run a small business?-2
The bill imposes significant civil penalties of up to $20,000 per violation for those handling human cell and tissue products.
Who it would affect, and how
Potential Positive Impacts for People
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Increased Awareness and Education: The Secretary will support educational materials for healthcare professionals regarding organ, tissue, and eye donation, including evidence-based methods for approaching patients and families (Section 3).
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Enhanced Transparency: The Secretary, through the FDA, must publish information on the website regarding the Tissue Reference Group, including best practices for obtaining recommendations (Section 5(a)(1)).
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Public Data Accessibility: The FDA will be required to publish annual data regarding the number of registered establishments, the number of inspections conducted, and the response times for inquiries to the Tissue Reference Group (Section 5(a)(2)).
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Stakeholder Support: The Secretary will provide information to various stakeholders, such as industry, academic health centers, and patients, and conduct workshops to support scientific advancement and regulatory predictability (Section 5(a)(3)).
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Regulatory Modernization: The bill establishes a public docket to receive comments on modernizing regulations and requires a report to Congress that considers scientific developments and access to products (Section 5(c) and 5(d)).
Potential Negative Impacts for People
- Increased Financial Penalties for Violations: Any person who violates specific federal regulations regarding human cell or tissue products may be held liable for civil penalties of up to $20,000 per violation, $20,000 for each subsequent day a violation continues, and an amount equal to the retail value of the products, with total penalties potentially reaching $10,000,000 in a single proceeding (Section 4).
Groups and Interests Ranking
Every group the model scored this bill for, from -10 to +10. Hover a score for the reason it gave.
- Governance And Ideology
- Improves Government Transparency+5
- Healthcare
- Improves Healthcare Access+3Increases Research Funding+2
- Economy And Finance
- Improves Small Business Support-2
- Education And Technology
- Increases Scientific Research Funding+2
- 6/24/2025
- Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 6/23/2025
- Motion to reconsider laid on the table Agreed to without objection.
- Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
- On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
- DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.
- Considered under suspension of the rules. (consideration: CR H2860-2862)
- Mr. Bilirakis moved to suspend the rules and pass the bill.
- 6/12/2025
- Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
- Placed on the Union Calendar, Calendar No. 127.
- 4/29/2025
- Committee Consideration and Mark-up Session Held
- Ordered to be Reported by Voice Vote.
- 2/6/2025
- Referred to the House Committee on Energy and Commerce.
- 1 Cosponsor added.
- Introduced in House
2 bills Congress.gov lists as related to this one — companions in the other chamber, earlier versions, and bills this one absorbed or was folded into.
Debbie DingellDemocrat · Michigan