119th Congress Health
H.R. 1082: Shandra Eisenga Human Cell and Tissue Product Safety Act
Passed House
- Introduced (completed)
- Passed House (completed)
- Passed Senate (not reached)
- To the President (not reached)
- Became law (not reached)
Summary
This bill establishes civil penalties for violations of regulations governing the donation and handling of human cell and tissue products. It also requires the Food and Drug Administration (FDA) to report on the regulation of these products and to provide related information to stakeholders. (Human cell and tissue products are articles containing or consisting of human cells or tissues that are intended for use in a human recipient.)
Specifically, the bill establishes civil penalties for violations of the FDA’s regulations on donor eligibility and current good tissue practice for manufacturing and distributing human cell and tissue products.
Also, the bill requires the FDA to conduct workshops to educate stakeholders and facilitate discussion on the science and regulation of human cell and tissue products. The FDA must establish a public docket to receive written comments on this topic, and report to Congress with recommendations. The bill also requires the FDA to support the development of educational materials for health care professionals regarding organ, tissue, and eye donations and related topics.
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Additionally, the bill requires the FDA to publish on its website educational materials about the Tissue Reference Group (a working group within the FDA) and best practices for obtaining a recommendation from them about human cell and tissue products. Also, annually for three years, the FDA must publish on its website information on inquiries submitted to the Tissue Reference Group and FDA registrations and inspections regarding human cell and tissue manufacturers.
Written by the Congressional Research Service, Library of Congress.
Roll calls
No roll call votes have been held on this bill.
Amendments
No amendments were offered to this bill.
Cosponsors
- Debbie Dingell D-MIOriginal
Who scored on this bill
- 1John Moolenaar SponsorDrew cross-party cosponsors, introduced, marked up, reported, passed House5 events+68
- 2Debbie DingellCosponsored; cosponsored bill passed2 events+4
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Introductions and cosponsorships count toward weekly caps and show no points.
Other bills by John Moolenaar
- H.R. 2306: Adams Memorial-Great American Heroes Act
- H.R. 9642: Medicare Access to Rural Anesthesiology Act
- H.R. 1723: Tribal Labor Sovereignty Act of 2025
- H.R. 8667: To rename the community-based outpatient clinic of the Department of Veterans Affairs in Cadillac, Michigan, as the "Duane E. Dewey VA Clinic".
- H.R. 7188: Shandra Eisenga Human Cell and Tissue Product Safety Act
History
- Passed the House by voice vote.
- Introduced in the House by John Moolenaar.
Show the full action history (13 actions)
- Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Mr. Bilirakis moved to suspend the rules and pass the bill.
- Considered under suspension of the rules. (consideration: CR H2860-2862)
- DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.
- 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)
- Motion to reconsider laid on the table Agreed to without objection.
- Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
- Placed on the Union Calendar, Calendar No. 127.
- Committee Consideration and Mark-up Session Held
- Ordered to be Reported by Voice Vote.
- Introduced in House
- Referred to the House Committee on Energy and Commerce.