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H.R. 2821

FDA Modernization Act 3.0

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. 

Received in the Senate.

Rep. Carter, Earl L. "Buddy" [R-GA-1](R-GA)Sponsor
41 cosponsors21 D20 R
41cosponsors1committees18actions1related bills5subjects
  1. IntroReferral

    Received in the Senate.

  2. FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  3. FloorH37300

    On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)

  4. Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)

  5. FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.

  6. FloorH30000

    Considered under suspension of the rules. (consideration: CR H4639-4640)

  7. FloorH30300

    Mr. Guthrie moved to suspend the rules and pass the bill.

  8. CalendarsH12410

    Placed on the Union Calendar, Calendar No. 614.

  9. CommitteeH12200

    Reported by the Committee on Energy and Commerce. H. Rept. 119-706.

    Energy and Commerce Committee
  10. Committee5000

    Reported by the Committee on Energy and Commerce. H. Rept. 119-706.

    Energy and Commerce Committee
  11. Committee

    Ordered to be Reported by the Yeas and Nays: 44 - 0.

    Energy and Commerce Committee
  12. Committee

    Committee Consideration and Mark-up Session Held

    Energy and Commerce Committee
  13. Committee

    Forwarded by Subcommittee to Full Committee by Voice Vote.

    Health Subcommittee
  14. Committee

    Subcommittee Consideration and Mark-up Session Held

    Health Subcommittee
  15. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  16. IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

    Energy and Commerce Committee
  17. IntroReferralIntro-H

    Introduced in House

  18. IntroReferral1000

    Introduced in House