H.R. 2821 Passed the House Health

FDA Modernization Act 3.0

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.

  1. Introduced
  2. Committee
  3. Passed House
  4. Passed Senate
  5. To President
  6. Became law
Sponsor Rep. Carter, Earl L. "Buddy" [R-GA-1] Introduced April 10, 2025 Cosponsors 41 (21 D, 20 R) Latest action July 21, 2026

Summary

FDA Modernization Act 3.0
This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug. 
The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications. 
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule. 

Summary by the Congressional Research Service, Library of Congress.

Congress.gov

Actions

  1. Jul 21, 2026 Received in the Senate.
  2. Jul 20, 2026 Motion to reconsider laid on the table Agreed to without objection.
  3. Jul 20, 2026 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
  4. Jul 20, 2026 DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
  5. Jul 20, 2026 Considered under suspension of the rules. (consideration: CR H4639-4640)
  6. Jul 20, 2026 Mr. Guthrie moved to suspend the rules and pass the bill.
  7. Jun 18, 2026 Placed on the Union Calendar, Calendar No. 614.
  8. Jun 18, 2026 Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
  9. May 21, 2026 Ordered to be Reported by the Yeas and Nays: 44 - 0.
  10. May 21, 2026 Committee Consideration and Mark-up Session Held
  11. May 13, 2026 Forwarded by Subcommittee to Full Committee by Voice Vote.
  12. May 13, 2026 Subcommittee Consideration and Mark-up Session Held

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