HR 2821
Passed a chamber
Requires the FDA to issue a rule replacing references to animal testing with nonclinical testing in federal drug and device regulations, and makes the rule take effect immediately.
Official title: FDA Modernization Act 3.0
Timeline each lane is a chamber; dates pull from congress.gov actions
House
Introduced
10-APR-2025
Referred
10-APR-2025
Approved by committee
21-MAY-2026
Reported
18-JUN-2026
On the calendar
18-JUN-2026
Passed
20-JUL-2026
Senate
Received
21-JUL-2026
- Requires HHS, acting through the FDA Commissioner, to publish an interim final rule within one year of enactment.
- Replaces references to "animal" tests, data, studies, models, and research with "nonclinical" in listed sections of Title 21 of the Code of Federal Regulations.
- Adds a definition of "nonclinical test" from section 505(z) of the Federal Food, Drug, and Cosmetic Act to four CFR sections covering investigational drugs, new drug applications, and biologics.
- Makes the interim final rule effective immediately without the agency having to show good cause.
- Redesignates the second subsection (z), on clinical trial diversity action plans, as subsection (aa).
Covers an older version. The newest CRS summary describes the bill as of "Introduced in House" (10-APR-2025); the text has changed since (Engrossed in House, 20-JUL-2026).
CRS is the Library of Congress's nonpartisan research office. Read it on congress.govHealth
■ 21 D■ 20 R
21 Democrats
- Nanette Diaz Barragán
- Troy A. Carter
- Judy Chu
- Jason Crow
- Rosa L. DeLauro
- Lloyd Doggett
- Lois Frankel
- Daniel S. Goldman
- Josh Gottheimer
- Josh Harder
- Julie Johnson
- Raja Krishnamoorthi
- Ted Lieu
- Jerrold Nadler
- Joe Neguse
- Eleanor Holmes Norton
- Mark Pocan
- Hillary J. Scholten
- Darren Soto
- Shri Thanedar
- Eugene Simon Vindman
20 Republicans
- Gus M. Bilirakis
- Vern Buchanan
- Ken Calvert
- Mike Carey
- Dan Crenshaw
- Scott Fitzgerald
- Brian K. Fitzpatrick
- Diana Harshbarger
- Thomas H. Kean
- Young Kim
- Nicholas A. Langworthy
- Michael Lawler
- Laurel M. Lee
- Nicole Malliotakis
- Jay Obernolte
- Maria Elvira Salazar
- Christopher H. Smith
- Claudia Tenney
- David G. Valadao
- Randy K. Weber, Sr.