FDA Modernization Act 3.0
Sponsored By: Representative Carter, Earl L. "Buddy" [R-GA-1]
Introduced
Summary
Allows FDA to accept nonclinical tests in place of animal tests in regulatory rules. The bill would require the Department of Health and Human Services, acting through the FDA Commissioner, to publish an interim final rule within one year that replaces references to animal tests with a defined term for 'nonclinical tests' across specified FDA regulations.
Show full summary
- Drug and device developers: Would let sponsors use alternative nonclinical tests, models, and data in place of animal studies once the named Code of Federal Regulations sections are updated.
- Researchers and animals: Would encourage wider use of non‑animal testing methods and could reduce reliance on animal studies in preclinical work.
- Regulators and legal text: The interim final rule would take immediate effect without a showing of 'good cause' under 5 U.S.C. 553(b). The bill also renumbers a subsection so FDA references to clinical trial diversity action plans stay consistent.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
New FDA rules for nonclinical tests
If enacted, FDA would have to publish an interim final rule within 1 year. The rule would update many drug and biologic regulations to use "nonclinical" instead of "animal" tests. It would add a clear definition of "nonclinical test" and apply it across related FDA rules. The rule would take effect as soon as it is published, without the usual delay.
Sponsors & CoSponsors
Sponsor
Carter, Earl L. "Buddy" [R-GA-1]
GA • R
Cosponsors
Rep. Carter, Troy A. [D-LA-2]
LA • D
Sponsored 4/10/2025
Rep. Doggett, Lloyd [D-TX-37]
TX • D
Sponsored 4/14/2025
Rep. Nadler, Jerrold [D-NY-12]
NY • D
Sponsored 4/17/2025
Barragan
CA • D
Sponsored 4/10/2025
Buchanan
FL • R
Sponsored 4/10/2025
Rep. DeLauro, Rosa L. [D-CT-3]
CT • D
Sponsored 4/10/2025
Rep. Harshbarger, Diana [R-TN-1]
TN • R
Sponsored 4/10/2025
Rep. Carey, Mike [R-OH-15]
OH • R
Sponsored 4/17/2025
Rep. Fitzpatrick, Brian K. [R-PA-1]
PA • R
Sponsored 4/17/2025
Rep. Malliotakis, Nicole [R-NY-11]
NY • R
Sponsored 4/17/2025
Crenshaw
TX • R
Sponsored 4/17/2025
Rep. Chu, Judy [D-CA-28]
CA • D
Sponsored 4/29/2025
Rep. Scholten, Hillary J. [D-MI-3]
MI • D
Sponsored 4/29/2025
Soto
FL • D
Sponsored 4/29/2025
Rep. Goldman, Daniel S. [D-NY-10]
NY • D
Sponsored 4/29/2025
Obernolte
CA • R
Sponsored 5/13/2025
Rep. Gottheimer, Josh [D-NJ-5]
NJ • D
Sponsored 5/20/2025
Crow
CO • D
Sponsored 6/6/2025
Rep. Lieu, Ted [D-CA-36]
CA • D
Sponsored 6/27/2025
Rep. Tenney, Claudia [R-NY-24]
NY • R
Sponsored 7/2/2025
Rep. Smith, Christopher H. [R-NJ-4]
NJ • R
Sponsored 7/2/2025
Del. Norton, Eleanor Holmes [D-DC-At Large]
DC • D
Sponsored 7/10/2025
Salazar
FL • R
Sponsored 7/10/2025
Rep. Frankel, Lois [D-FL-22]
FL • D
Sponsored 7/14/2025
Rep. Valadao, David G. [R-CA-22]
CA • R
Sponsored 7/14/2025
Rep. Harder, Josh [D-CA-9]
CA • D
Sponsored 7/14/2025
Fitzgerald
WI • R
Sponsored 7/16/2025
Bilirakis
FL • R
Sponsored 7/16/2025
Lee (FL)
FL • R
Sponsored 7/17/2025
Rep. Calvert, Ken [R-CA-41]
CA • R
Sponsored 7/22/2025
Rep. Vindman, Eugene Simon [D-VA-7]
VA • D
Sponsored 9/11/2025
Rep. Pocan, Mark [D-WI-2]
WI • D
Sponsored 11/4/2025
Rep. Lawler, Michael [R-NY-17]
NY • R
Sponsored 11/20/2025
Rep. Weber, Randy K. Sr. [R-TX-14]
TX • R
Sponsored 12/2/2025
Rep. Neguse, Joe [D-CO-2]
CO • D
Sponsored 12/11/2025
Rep. Krishnamoorthi, Raja [D-IL-8]
IL • D
Sponsored 12/15/2025
Kean
NJ • R
Sponsored 1/7/2026
Rep. Johnson, Julie [D-TX-32]
TX • D
Sponsored 1/15/2026
Rep. Kim, Young [R-CA-40]
CA • R
Sponsored 4/22/2026
Langworthy
NY • R
Sponsored 5/12/2026
Roll Call Votes
No roll call votes available for this bill.
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