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H.R. 2821 House Health

FDA Modernization Act 3.0

Introduced
Apr 10, 2025
Sponsor
Rep. Carter, Earl L. "Buddy" (R-GA-1)
View on Congress.gov

STAGE 4 OF 8 — HOUSE FLOOR

Currently in the House. Last action: received in the senate on Jul 21, 2026.

  1. House Introduced in House Apr 10, 2025
  2. House Referred to the House Committee on Energy and Commerce. Apr 10, 2025
  3. House Referred to the Subcommittee on Health. Apr 10, 2026
  4. House Subcommittee Consideration and Mark-up Session Held May 13, 2026
  5. House Forwarded by Subcommittee to Full Committee by Voice Vote. May 13, 2026
  6. House Committee Consideration and Mark-up Session Held May 21, 2026
  7. House Ordered to be Reported by the Yeas and Nays: 44 - 0. May 21, 2026
  8. House Reported by the Committee on Energy and Commerce. H. Rept. 119-706. Jun 18, 2026
  9. House Placed on the Union Calendar, Calendar No. 614. Jun 18, 2026
  10. House Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639) Jul 20, 2026
  11. House Mr. Guthrie moved to suspend the rules and pass the bill. Jul 20, 2026
  12. House Considered under suspension of the rules. (consideration: CR H4639-4640) Jul 20, 2026
  13. House DEBATE - The House proceeded with forty minutes of debate on H.R. 2821. Jul 20, 2026
  14. House Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. Jul 20, 2026
  15. House On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639) Jul 20, 2026
  16. House Motion to reconsider laid on the table Agreed to without objection. Jul 20, 2026
  17. Senate Received in the Senate. Jul 21, 2026

Cosponsors

41

Subjects

Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding

Committees

  • Energy and Commerce Committee
    • [Reported By, Jun 18, 2026]
    • [Markup By, May 21, 2026]
    • [Referred To, Apr 10, 2025]

Summary

FDA Modernization Act 3.0This 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 as of: Introduced in House]

Bill Text

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