HR 1082
Passed a chamber
Requires the Health and Human Services Secretary to run an education effort on human cell and tissue product transplants, adds civil penalties for violations of federal rules on these products, and directs the Food and Drug Administration to publish data and seek recommendations for regulating them.
Official title: Shandra Eisenga Human Cell and Tissue Product Safety Act
Timeline each lane is a chamber; dates pull from congress.gov actions
House
Introduced
06-FEB-2025
Referred
06-FEB-2025
Approved by committee
29-APR-2025
Reported
12-JUN-2025
On the calendar
12-JUN-2025
Passed
23-JUN-2025
Senate
Received
24-JUN-2025
- Requires the Secretary to support educational materials for health care professionals on organ, tissue, and eye donation and the availability of donor screening tests.
- Sets civil penalties of up to $20,000 per violation, plus $20,000 per day for violations continuing after written notice, plus an amount equal to the products' retail value, with a $10,000,000 cap per proceeding.
- Directs the FDA to publish Tissue Reference Group information and counts of facility registrations, inspections, and inquiries, with response times, within one year and annually for three years after.
- Requires a public comment docket within 60 days and a report to Congress by September 30, 2026 with recommendations on regulating these products, weighing regulatory burden, scientific developments, access, and public health.
Covers an older version. The newest CRS summary describes the bill as of "Introduced in House" (06-FEB-2025); the text has changed since (Engrossed in House, 23-JUN-2025).
CRS is the Library of Congress's nonpartisan research office. Read it on congress.govHealth
■ 1 D
1 Democrat