Shandra Eisenga Human Cell and Tissue Product Safety Act
Click any stage to learn more about the legislative process.
Would establish civil penalties of up to $20,000 per violation — and up to $10 million per proceeding — for violations of FDA rules governing human cell and tissue products, and would require new FDA transparency, education, and reporting measures for the tissue-transplant sector.
The bill would give federal regulators a new financial enforcement tool for a sector previously lacking explicit civil penalties, while directing the FDA to improve stakeholder guidance and report to Congress with recommendations for modernizing oversight of these products.
What this bill would do
What it would do
The bill would amend the Public Health Service Act to create civil penalties for violations of FDA regulations covering donor eligibility and good tissue-practice standards for manufacturing and distributing human cell and tissue products. Violators could face up to $20,000 per violation plus $20,000 per day if a violation continues after written notice, plus an amount equal to the retail value of the affected products — with total penalties capped at $10 million per proceeding. It would also direct the Secretary of HHS to support development of educational materials for health care professionals on organ, tissue, and eye donation.
The bill would further require the FDA to publish educational materials and best practices about its internal Tissue Reference Group on its website, and to post annual data on tissue-establishment registrations, inspections, and Tissue Reference Group inquiries for three years. The FDA would hold stakeholder workshops and open a public comment docket within 60 days of enactment. By September 30, 2026, the Secretary must deliver a report to Congress with regulatory recommendations, weighing regulatory burden, scientific developments, product access, and public health protection.
Key provisions
- 1Would require the Secretary of HHS to support development of educational materials for health care professionals on organ, tissue, and eye donation, including evidence-based approaches to patients and families.
- 2Would amend the Public Health Service Act to impose civil penalties up to $20,000 per violation — plus $20,000 per continued day after written notice and the retail value of affected products — for violations of FDA donor-eligibility and good-tissue-practice regulations, capped at $10 million per proceeding.
- 3Would require the FDA to publish on its website educational materials about the Tissue Reference Group and best practices for obtaining timely recommendations on human cell and tissue products.
- 4Would require the FDA to publish annual data for three years on tissue-establishment registrations, FDA inspections, and Tissue Reference Group inquiries and response times.
- 5Would require HHS to establish a public docket within 60 days of enactment for comments on modernizing FDA regulation of human cell and tissue products.
- 6Would require the Secretary to report to Congress by September 30, 2026, with recommendations on regulating human cell and tissue products, drawing on workshops and public docket comments.
Who would be affected
Manufacturers, tissue establishments, and distributors of human cell and tissue products subject to FDA donor-eligibility and good-tissue-practice regulations; health care professionals who receive new educational materials on donation; patients who receive tissue transplants; and academic health centers, biomedical consortia, research organizations, and industry stakeholders who interact with the FDA's Tissue Reference Group.
Why it matters
Companies that violate FDA donor-eligibility or tissue-practice rules would face meaningful financial penalties for the first time, creating a new compliance incentive. The transparency and education requirements would give industry participants clearer guidance on navigating FDA oversight, and the 2026 Congressional report could lay the groundwork for future regulatory changes affecting which tissue products face stricter federal scrutiny.
What would change
Changes to existing law
Amends Public Health Service Act, Section 368 (42 U.S.C. 271) (Sec. 4)
Adds a new subsection creating civil penalties for violations of FDA regulations on donor eligibility and good tissue practices for human cell and tissue products.
Amends Food and Drug Omnibus Reform Act of 2022, Section 3205 (Public Law 117-328) (Sec. 5(b))
Revises language describing the scope of best-practices topics covered in required public workshops on stem cell and other cellular therapies.
Agencies directed to act
Effective dates
- Civil penalties for violations of FDA tissue-product regulations take effect
- HHS must establish public docket for written comments on regulatory modernization
- First annual publication of tissue-establishment and Tissue Reference Group data on FDA website
- Secretary's report to Congress with regulatory recommendations due
Funding and costs
Congressional Budget Office estimate
CBO estimates H.R. 1082 would cost $2 million in discretionary spending over the 2026–2030 period, with no effect on direct spending and less than $500,000 in additional revenues over 2026–2035.
CBO estimates that implementing H.R. 1082 would increase administrative costs for the Department of Health and Human Services by $2 million over the 2026–2030 period; this spending is discretionary (subject to annual appropriations) and falls within budget function 550 (health). The bill would have no effect on direct (mandatory) spending over the 2026–2035 window. The bill also establishes civil penalties for violations of human cell and tissue product requirements, which are recorded as revenues; CBO expects broad compliance, so additional revenues collected would be less than $500,000 over 2026–2035. CBO identified no intergovernmental or private-sector mandates in the bill.
How implementation would work
Upon enactment, civil penalties would apply immediately, enforced through the Public Health Service Act framework. Within 60 days, HHS must open a public docket for written comments on regulatory modernization. The FDA Commissioner would publish Tissue Reference Group educational materials and best practices on the FDA website and conduct stakeholder workshops on an ongoing basis. Starting one year after enactment and annually for three more years, FDA would post data on tissue-establishment registrations, inspections, and Tissue Reference Group inquiries. By September 30, 2026, the Secretary must synthesize workshop and docket input and deliver a report with regulatory recommendations to Congress.
Legislative status & sources
Latest action
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Official CRS summary
Show the CRS summaryHide the CRS 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.
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 subjects
Administrative law and regulatory procedures; Civil actions and liability; Congressional oversight; Department of Health and Human Services; Health; Health programs administration and funding; Health promotion and preventive care; Organ and tissue donation and transplantation
Committee report
H. Rept. 119-160