Shandra Eisenga Human Cell and Tissue Product Safety Act
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Progress
Where this bill stands in the legislative process.
- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Overview
The Shandra Eisenga Human Cell and Tissue Product Safety Act aims to improve public awareness and understanding of human cell and tissue transplants. It mandates a national education campaign led by the Secretary of Health and Human Services to inform both healthcare professionals and the public about the potential risks and benefits of these products. The bill also establishes civil penalties for violations of regulations governing these products and seeks to streamline regulatory oversight through increased transparency and data collection.
Key provisions
- Requires a national public awareness campaign on human cell and tissue transplant risks and benefits.
- Establishes civil penalties for violations of regulations related to human cell and tissue products.
- Directs the FDA to publish educational materials and best practices on its website.
- Mandates the FDA to publish data on human cell and tissue establishment inspections and inquiries to the Tissue Reference Group.
- Requires the Secretary to conduct workshops and educational sessions for stakeholders.
- Amends the Public Health Service Act to include penalties for non-compliance.
- Updates the Food and Drug Omnibus Reform Act to prioritize scientific data for cellular therapies.
- Creates a public docket for comments on modernizing human cell and tissue product regulation.
Who is affected
- Healthcare professionals
Bill text
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2 on record
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