H.R. 1082 · SPONSOR JOHN R. MOOLENAAR R-MI-2 (NOT ON COMMITTEE)
Shandra Eisenga Human Cell and Tissue Product Safety Act
- Adds civil penalties for violations: For covered human cell and tissue products, a person who violates FDA rules on donor eligibility or safe tissue practices could face up to $20,000 per violation, plus $20,000 for each day it continues after written notice and an amount equal to the products’ retail value. The total penalty for violations handled in one proceeding could not exceed $10 million
- Publishes FDA oversight and response data: FDA would publish information on registered establishments, inspections, inquiries to the Tissue Reference Group, and its response times. The information would include a comparison of inspections of human cell and tissue establishments with inspections of blood establishments
- Supports education for professionals and stakeholders: The Secretary of Health and Human Services would support educational materials for health care and other professionals about organ, tissue, and eye donation, donor screening tests, and related topics. FDA would also share regulatory information with stakeholders and hold workshops and other educational sessions
- Introduced
- In committee
- Reported
- Passed House
- Passed Senate
- Law
What’s next: Passed the House. Next step: the Senate.
RESULTS NOT POSTED YET
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