Shandra Eisenga Human Cell and Tissue Product Safety Act

Bill: 119-hr-1082
Sponsor: Rep. Moolenaar, John R. [R-MI-2]
Introduced: 2025-02-06 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Civil actions and liability
Congressional oversight
Department of Health and Human Services
Health programs administration and funding
Health promotion and preventive care
Organ and tissue donation and transplantation

Summary:
action_date: 2025-02-06
text: 

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. 


Legislative actions:
action_date: 2025-06-24
text: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2025-06-23
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2025-06-23
text: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
action_date: 2025-06-23
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
action_date: 2025-06-23
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.
action_date: 2025-06-23
text: Considered under suspension of the rules. (consideration: CR H2860-2862)
action_date: 2025-06-23
text: Mr. Bilirakis moved to suspend the rules and pass the bill.
action_date: 2025-06-12
text: Placed on the Union Calendar, Calendar No. 127.
action_date: 2025-06-12
text: Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
action_date: 2025-06-12
text: Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
action_date: 2025-04-29
text: Ordered to be Reported by Voice Vote.
action_date: 2025-04-29
text: Committee Consideration and Mark-up Session Held
action_date: 2025-02-06
text: Referred to the House Committee on Energy and Commerce.
action_date: 2025-02-06
text: Introduced in House
action_date: 2025-02-06
text: Introduced in House