FDA Modernization Act 3.0
HR 2821, the FDA Modernization Act 3.0, requires the FDA to update regulatory language within one year of enactment. It directs the agency to replace all references to "animal tests" with "nonclinical tests" in 22 specific sections of the Code of Federal Regulations related to drug development and approval processes. The bill also adds a definition for "nonclinical test" into relevant FDA regulations to align with prior legislative changes. This update applies directly to pharmaceutical manufacturers and FDA reviewers who follow these regulatory guidelines during drug development. The changes aim to modernize terminology without altering current testing requirements.
Bill status
passed
3 of 5 stages cleared
Introduction
Apr 2025
Committee Review
Jun 2026
House Passage
Jul 2026
Senate Passage
President
Introduced Apr 10, 2025
Last action Jul 21, 2026
Floor votes
How they voted
This bill passed the House by voice vote (no roll call recorded).
Full legislative history
Actions timeline
Total actions
16
Key actions
5
Committee
6
Jul 20, 2026
Lower · Passed
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
lower
Jun 18, 2026
Lower · Passed
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
lower
May 21, 2026
Lower · Passed
Committee Consideration and Mark-up Session Held
lower
May 13, 2026
Lower · Passed
Forwarded by Subcommittee to Full Committee by Voice Vote.
lower
May 13, 2026
Lower · Passed
Subcommittee Consideration and Mark-up Session Held
lower
Apr 10, 2026
Committee
Referred to the Subcommittee on Health.
lower
Apr 10, 2025
Committee
Referred to the House Committee on Energy and Commerce.
lower
Apr 10, 2025
Introduced
Introduced in House
lower
1 primary · 41 co-sponsors
Sponsors
Role
Legislator
Party
State
District
P
Earl L. "Buddy" Carter
RRepublican
Co
Brian K. Fitzpatrick
RRepublican
Co
Christopher H. Smith
RRepublican
Co
Claudia Tenney
RRepublican
Co
Dan Crenshaw
RRepublican
Co
Daniel S. Goldman
DDemocratic
Co
Darren Soto
DDemocratic
Co
David G. Valadao
RRepublican
Co
Diana Harshbarger
RRepublican
Co
Eleanor Holmes Norton
DDemocratic
Co
Eugene Simon Vindman
DDemocratic
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