Shandra Eisenga Human Cell and Tissue Product Safety Act
Take action
Record your position on this measure.
Create an account to record your position, submit testimony, or contact your legislator.
Progress
Where this bill stands in the legislative process.
- Introduced
- Passed House
- Passed Senate
- To President
- Became Law
Overview
The Shandra Eisenga Human Cell and Tissue Product Safety Act aims to improve public awareness and regulation of human cell and tissue products. It establishes civil penalties for violations of existing FDA regulations, requires the FDA to conduct a public education campaign about donation and transplant risks and benefits, and mandates the FDA to publish data on inspections, inquiries to the Tissue Reference Group, and response times. The bill also directs the FDA to establish a public docket for feedback and to submit a report to Congress with recommendations for modernizing the regulation of these products.
Key provisions
- Establishes civil penalties for violations of FDA regulations regarding human cell and tissue products.
- Requires the FDA to conduct a national public awareness campaign on organ, tissue, and eye donation.
- Mandates the FDA to publish educational materials about the Tissue Reference Group and best practices for obtaining recommendations.
- Requires the FDA to publish data on human cell and tissue establishment inspections and inquiries to the Tissue Reference Group.
- Directs the FDA to establish a public docket for stakeholder feedback.
- Requires the FDA to submit a report to Congress with recommendations for regulating human cell and tissue products.
- Amends the Public Health Service Act to include civil penalties for non-compliance with specific FDA regulations.
- Updates FDA regulations to include best practices for generating scientific data related to stem cell and other cellular therapies.
Bill text
Read the latest version inline or switch to a previous version.
Text extraction is in progress. View the official source.
Sponsors
Official sponsors from legislative records.
2 on record
Primary sponsor
Cosponsor
Arguments
Reasons offered for and against this legislation.
Arguments in favor
No arguments in favor have been submitted.
Submit yoursArguments opposed
No arguments opposed have been submitted.
Submit yours