Legis Daily

Shandra Eisenga Human Cell and Tissue Product Safety Act

USA119th CongressHR-1082| House 
| Updated: 6/24/2025
John R. Moolenaar

John R. Moolenaar

Republican Representative

Michigan

Cosponsors (1)
Debbie Dingell (Democratic)

Health, Education, Labor, and Pensions Committee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
The Shandra Eisenga Human Cell and Tissue Product Safety Act seeks to improve the safety and public understanding of human cell and tissue products (HCT/Ps). It directs the Secretary of Health and Human Services to conduct a national, evidence-based education campaign. This campaign will inform both the public and healthcare providers about the potential risks and benefits of HCT/P transplants, as well as best practices for organ, tissue, and eye donation. The Act introduces new civil penalties for violations of HCT/P regulations, specifically subparts C or D of section 1271 of title 21, Code of Federal Regulations. Violators could face penalties of up to $20,000 per day for continuing violations, plus an amount equal to the retail value of the products involved, with a total cap of $10,000,000 per proceeding. These penalties aim to strengthen compliance and deter unsafe practices within the HCT/P industry. Furthermore, the legislation mandates the Food and Drug Administration (FDA) to streamline regulatory oversight and increase transparency. The FDA must publish educational materials and best practices for its Tissue Reference Group on its public website. It will also annually publish data on registered HCT/P establishments, inspections conducted, and the number and average response times for inquiries to the Tissue Reference Group, enhancing public access to crucial regulatory information. Finally, the Act requires the Secretary to engage stakeholders through information sharing and workshops to support regulatory predictability and scientific advancement. It also establishes a public docket for comments on modernizing HCT/P regulation and mandates a report to Congress by September 2026 with recommendations for regulatory improvements, considering factors like regulatory burden, scientific developments, and public health protection.

Bill Text Versions

View Text
4 versions available

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Timeline

Bill from Previous Congress

HR 118-7188
Shandra Eisenga Human Cell and Tissue Product Safety Act
Feb 6, 2025
Introduced in House
Feb 6, 2025
Referred to the House Committee on Energy and Commerce.
Apr 29, 2025
Committee Consideration and Mark-up Session Held
Apr 29, 2025
Ordered to be Reported by Voice Vote.
Jun 12, 2025
Placed on the Union Calendar, Calendar No. 127.
Jun 12, 2025
Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
Jun 23, 2025
Mr. Bilirakis moved to suspend the rules and pass the bill.
Jun 23, 2025
Considered under suspension of the rules. (consideration: CR H2860-2862)
Jun 23, 2025
DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.
Jun 23, 2025
Passed/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, 2025
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.
Jun 23, 2025
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
Jun 23, 2025
Motion to reconsider laid on the table Agreed to without objection.
Jun 24, 2025
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    HR 118-7188
    Shandra Eisenga Human Cell and Tissue Product Safety Act


  • February 6, 2025
    Introduced in House


  • February 6, 2025
    Referred to the House Committee on Energy and Commerce.


  • April 29, 2025
    Committee Consideration and Mark-up Session Held


  • April 29, 2025
    Ordered to be Reported by Voice Vote.


  • June 12, 2025
    Placed on the Union Calendar, Calendar No. 127.


  • June 12, 2025
    Reported by the Committee on Energy and Commerce. H. Rept. 119-160.


  • June 23, 2025
    Mr. Bilirakis moved to suspend the rules and pass the bill.


  • June 23, 2025
    Considered under suspension of the rules. (consideration: CR H2860-2862)


  • June 23, 2025
    DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.


  • June 23, 2025
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)


  • June 23, 2025
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.


  • June 23, 2025
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)


  • June 23, 2025
    Motion to reconsider laid on the table Agreed to without objection.


  • June 24, 2025
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health

Related Bills

  • HR 119-340: The HCT/P Modernization Act of 2025
Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesHealth programs administration and fundingHealth promotion and preventive careOrgan and tissue donation and transplantation

Shandra Eisenga Human Cell and Tissue Product Safety Act

USA119th CongressHR-1082| House 
| Updated: 6/24/2025
The Shandra Eisenga Human Cell and Tissue Product Safety Act seeks to improve the safety and public understanding of human cell and tissue products (HCT/Ps). It directs the Secretary of Health and Human Services to conduct a national, evidence-based education campaign. This campaign will inform both the public and healthcare providers about the potential risks and benefits of HCT/P transplants, as well as best practices for organ, tissue, and eye donation. The Act introduces new civil penalties for violations of HCT/P regulations, specifically subparts C or D of section 1271 of title 21, Code of Federal Regulations. Violators could face penalties of up to $20,000 per day for continuing violations, plus an amount equal to the retail value of the products involved, with a total cap of $10,000,000 per proceeding. These penalties aim to strengthen compliance and deter unsafe practices within the HCT/P industry. Furthermore, the legislation mandates the Food and Drug Administration (FDA) to streamline regulatory oversight and increase transparency. The FDA must publish educational materials and best practices for its Tissue Reference Group on its public website. It will also annually publish data on registered HCT/P establishments, inspections conducted, and the number and average response times for inquiries to the Tissue Reference Group, enhancing public access to crucial regulatory information. Finally, the Act requires the Secretary to engage stakeholders through information sharing and workshops to support regulatory predictability and scientific advancement. It also establishes a public docket for comments on modernizing HCT/P regulation and mandates a report to Congress by September 2026 with recommendations for regulatory improvements, considering factors like regulatory burden, scientific developments, and public health protection.

Bill Text Versions

View Text
4 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline

Bill from Previous Congress

HR 118-7188
Shandra Eisenga Human Cell and Tissue Product Safety Act
Feb 6, 2025
Introduced in House
Feb 6, 2025
Referred to the House Committee on Energy and Commerce.
Apr 29, 2025
Committee Consideration and Mark-up Session Held
Apr 29, 2025
Ordered to be Reported by Voice Vote.
Jun 12, 2025
Placed on the Union Calendar, Calendar No. 127.
Jun 12, 2025
Reported by the Committee on Energy and Commerce. H. Rept. 119-160.
Jun 23, 2025
Mr. Bilirakis moved to suspend the rules and pass the bill.
Jun 23, 2025
Considered under suspension of the rules. (consideration: CR H2860-2862)
Jun 23, 2025
DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.
Jun 23, 2025
Passed/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, 2025
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.
Jun 23, 2025
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)
Jun 23, 2025
Motion to reconsider laid on the table Agreed to without objection.
Jun 24, 2025
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
  • Bill from Previous Congress

    HR 118-7188
    Shandra Eisenga Human Cell and Tissue Product Safety Act


  • February 6, 2025
    Introduced in House


  • February 6, 2025
    Referred to the House Committee on Energy and Commerce.


  • April 29, 2025
    Committee Consideration and Mark-up Session Held


  • April 29, 2025
    Ordered to be Reported by Voice Vote.


  • June 12, 2025
    Placed on the Union Calendar, Calendar No. 127.


  • June 12, 2025
    Reported by the Committee on Energy and Commerce. H. Rept. 119-160.


  • June 23, 2025
    Mr. Bilirakis moved to suspend the rules and pass the bill.


  • June 23, 2025
    Considered under suspension of the rules. (consideration: CR H2860-2862)


  • June 23, 2025
    DEBATE - The House proceeded with forty minutes of debate on H.R. 1082.


  • June 23, 2025
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)


  • June 23, 2025
    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote.


  • June 23, 2025
    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H2860-2861)


  • June 23, 2025
    Motion to reconsider laid on the table Agreed to without objection.


  • June 24, 2025
    Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
John R. Moolenaar

John R. Moolenaar

Republican Representative

Michigan

Cosponsors (1)
Debbie Dingell (Democratic)

Health, Education, Labor, and Pensions Committee, Energy and Commerce Committee

Health

Related Bills

  • HR 119-340: The HCT/P Modernization Act of 2025
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresCivil actions and liabilityCongressional oversightDepartment of Health and Human ServicesHealth programs administration and fundingHealth promotion and preventive careOrgan and tissue donation and transplantation