summary
Introduced
04/10/2025
04/10/2025
In Committee
05/21/2026
05/21/2026
Crossed Over
07/21/2026
07/21/2026
Passed
Dead
Introduced Session
119th Congress
Bill Summary
AN ACT To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.
AI Summary
This bill, titled the "FDA Modernization Act 3.0," requires the Secretary of Health and Human Services, through the Commissioner of Food and Drugs (FDA), to publish an interim final rule within one year of enactment. This rule will update regulations to replace references to "animal" testing, data, studies, models, and research with "nonclinical" testing, data, studies, models, and research, aligning with recent changes to the Federal Food, Drug, and Cosmetic Act. The bill also mandates the inclusion of the definition of "nonclinical test" in specific sections of the Code of Federal Regulations, which are detailed in the bill, and makes a technical amendment to renumber a subsection of the Federal Food, Drug, and Cosmetic Act. The interim final rule will take effect immediately without requiring the usual justification for immediate implementation.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (42)
Buddy Carter (R)*,
Nanette Barragán (D),
Gus Bilirakis (R),
Vern Buchanan (R),
Ken Calvert (R),
Mike Carey (R),
Troy Carter (D),
Judy Chu (D),
Dan Crenshaw (R),
Jason Crow (D),
Rosa DeLauro (D),
Lloyd Doggett (D),
Scott Fitzgerald (R),
Brian Fitzpatrick (R),
Lois Frankel (D),
Dan Goldman (D),
Josh Gottheimer (D),
Josh Harder (D),
Diana Harshbarger (R),
Julie Johnson (D),
Tom Kean (R),
Young Kim (R),
Raja Krishnamoorthi (D),
Nick Langworthy (R),
Mike Lawler (R),
Laurel Lee (R),
Ted Lieu (D),
Nicole Malliotakis (R),
Jerry Nadler (D),
Joe Neguse (D),
Eleanor Holmes Norton (D),
Jay Obernolte (R),
Mark Pocan (D),
María Salazar (R),
Hillary Scholten (D),
Chris Smith (R),
Darren Soto (D),
Claudia Tenney (R),
Shri Thanedar (D),
David Valadao (R),
Eugene Vindman (D),
Randy Weber (R),
Last Action
Received in the Senate. (on 07/21/2026)
Bill Topics
Health
- ‐ Regulation of Drug Industry and Pharmacies
- ‐ Research and Development
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/119th-congress/house-bill/2821/all-info | 04/11/2025 |
| BillText | https://www.congress.gov/119/bills/hr2821/BILLS-119hr2821eh.pdf | 07/22/2026 |
| BillText | https://www.congress.gov/119/bills/hr2821/BILLS-119hr2821rh.pdf | 06/19/2026 |
| BillText | https://www.congress.gov/119/bills/hr2821/BILLS-119hr2821ih.pdf | 04/25/2025 |
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