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H.R.1082 / 119th Congress

Shandra Eisenga Human Cell and Tissue Product Safety Act

Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Official summary

Version 00 · Introduced in House · Feb 6, 2025

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.

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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. 

Read the summary on Congress.gov
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Who introduced it

Rep. Moolenaar, John R. [R-MI-2] · R–MI

Committees

  • Health, Education, Labor, and Pensions Committee
  • Energy and Commerce Committee
1 cosponsorship records, including any withdrawals

Actions

A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.

  1. Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  2. Motion to reconsider laid on the table Agreed to without objection.

  3. On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)

  4. Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)

  5. DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.

  6. Considered under suspension of the rules. (consideration: CR H2860-2862)

  7. Mr. Bilirakis moved to suspend the rules and pass the bill.

  8. Placed on the Union Calendar, Calendar No. 127.

  9. Reported by the Committee on Energy and Commerce. H. Rept. 119-160.

  10. Reported by the Committee on Energy and Commerce. H. Rept. 119-160.

  11. Ordered to be Reported by Voice Vote.

  12. Committee Consideration and Mark-up Session Held

  13. Referred to the House Committee on Energy and Commerce.

  14. Introduced in House

  15. Introduced in House

Bill text & related measures

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Related bills identified by Congress.gov

Source last updated: Sep 2, 2026. Consult Congress.gov for the current record.

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