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Bill · HR

H.R. 2821 (119th)

FDA Modernization Act 3.0

Original

openUnited States· United States Congress· EN

Introduced

10 April 2025

Last action

21 July 2026 · Introduced

Status

Received in the Senate.

Sponsors

Rep. Carter, Earl L. "Buddy" [R-GA-1], Nanette Barragán, Rep. Buchanan, Vern [R-FL-16], Rosa DeLauro, Diana Harshbarger, Troy Carter, Lloyd Doggett, Jerrold Nadler, Mike Carey, Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Malliotakis, Nicole [R-NY-11], Rep. Crenshaw, Dan [R-TX-2], Judy Chu, Hillary Scholten, Darren Soto, Daniel Goldman, Jay Obernolte, Rep. Gottheimer, Josh [D-NJ-5], Jason Crow, Ted Lieu, Rep. Tenney, Claudia [R-NY-24], Rep. Smith, Christopher H. [R-NJ-4], Del. Norton, Eleanor Holmes [D-DC-At Large], Maria Salazar, Lois Frankel, David Valadao, Josh Harder, Rep. Fitzgerald, Scott [R-WI-5], Rep. Bilirakis, Gus M. [R-FL-12], Laurel Lee, Rep. Calvert, Ken [R-CA-41], Rep. Vindman, Eugene Simon [D-VA-7], Mark Pocan, Rep. Lawler, Michael [R-NY-17], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Neguse, Joe [D-CO-2], Raja Krishnamoorthi, Thomas Kean, Julie Johnson, Young Kim, Nicholas Langworthy, Shri Thanedar

Subjects

Healthcare

Source updated

20 August 2026

Healthcare

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. 

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

  1. 10 April 2025

    Introduced

    Referred to the House Committee on Energy and Commerce.

    Source: IntroReferral

  2. 10 April 2025

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 10 April 2025

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 10 April 2026

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

  5. 13 May 2026

    Committee

    Forwarded by Subcommittee to Full Committee by Voice Vote.

    Source: Committee

  6. 13 May 2026

    Committee

    Subcommittee Consideration and Mark-up Session Held

    Source: Committee

  7. 21 May 2026

    Vote

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

    Source: Committee

  8. 21 May 2026

    Committee

    Committee Consideration and Mark-up Session Held

    Source: Committee

  9. 18 June 2026

    Calendars

    Placed on the Union Calendar, Calendar No. 614.

    Source: Calendars

  10. 18 June 2026

    Reported

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

    Source: Committee

  11. 18 June 2026

    Reported

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

    Source: Committee

  12. 20 July 2026

    Passed

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

    Source: Floor

  13. 20 July 2026

    Passed

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

    Source: Floor

  14. 20 July 2026

    Passed

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

    Source: Floor

  15. 20 July 2026

    Floor

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

    Source: Floor

  16. 20 July 2026

    Floor

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

    Source: Floor

  17. 20 July 2026

    Floor

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

    Source: Floor

  18. 21 July 2026

    Introduced

    Received in the Senate.

    Source: IntroReferral

Votes

No vote records are attached yet.

Versions

No version snapshots stored. Document URLs remain at the source.

Documents

4 official files

Sponsors

Related records

Sources

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