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Bill > HR2821


US HR2821

US HR2821
FDA Modernization Act 3.0


summary

Introduced
04/10/2025
In Committee
05/21/2026
Crossed Over
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

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