Shandra Eisenga Human Cell and Tissue Product Safety Act
Latest action · Jun 24, 2025 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedFeb 6, 2025
- Passed HouseJun 23, 2025
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
Shandra Eisenga Human Cell and Tissue Product Safety Act
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.
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.
Cosponsors 1
Members who signed on, in the order they did. All signed on Feb 6, 2025.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-MI | Debbie Dingell | Original | Feb 6, 2025 |
Committees 2
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Feb 6, 2025Markup Apr 29, 2025Reported Jun 12, 2025 |
| Senate | Health, Education, Labor, and Pensions Committee | Referred Jun 24, 2025 |
Actions 12
Everything that happened, newest first.
- Jun 24, 2025Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Jun 23, 2025Mr. Bilirakis moved to suspend the rules and pass the bill.
- Jun 23, 2025Considered under suspension of the rules. (consideration: CR H2860-2862)
- Jun 23, 2025DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.
- Jun 23, 2025Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
- Jun 23, 2025Motion to reconsider laid on the table Agreed to without objection.
- Jun 12, 2025Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
- Jun 12, 2025Placed on the Union Calendar, Calendar No. 127.
- Apr 29, 2025Committee Consideration and Mark-up Session Held
- Apr 29, 2025Ordered to be Reported by Voice Vote.
- Feb 6, 2025Introduced in House
- Feb 6, 2025Referred to the House Committee on Energy and Commerce.
In the Congressional Record 1
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H2860–H2862Text printed H2860 | Debbie Dingell D-MI, Earl L. "Buddy" Carter R-GA, Frank Pallone, Jr. D-NJ, Gus M. Bilirakis R-FL, John R. Moolenaar R-MI | Jun 23, 2025 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Congressional Budget Office cost estimate
- Nov 6, 2025H.R. 1082, Shandra Eisenga Human Cell and Tissue Product Safety ActAs passed by the House of Representatives on June 23, 2025
Related bills 2
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| HR 340 | The HCT/P Modernization Act of 2025 | Related bill | Jan 13, 2025 |
| S 4885 | Shandra Eisenga Human Cell and Tissue Product Safety Act | Identical bill | Jun 24, 2026 |
Titles 6
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes.
- Short Title(s) as Introduced
- Shandra Eisenga Human Cell and Tissue Product Safety Act
- Short Title(s) as Reported to House
- Shandra Eisenga Human Cell and Tissue Product Safety Act
- Short Title(s) as Passed House
- Shandra Eisenga Human Cell and Tissue Product Safety Act
- Short Titles from RFS (Referred to Senate) bill text
- Shandra Eisenga Human Cell and Tissue Product Safety Act
- Official Title from EH (Engrossed in House) bill text
- To require the Secretary of Health and Human Services to conduct a national, evidence-based education campaign to increase public and health care provider awareness regarding the potential risks and benefits of human cell and tissue products transplants, and for other purposes.
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 4
Each version as it was printed, newest first.
- Jun 24, 2025Referred in Senate
- Jun 23, 2025Engrossed in House
- Jun 12, 2025Reported in House
- Feb 6, 2025Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
