H.R. 2821 · 119th Congress

FDA Modernization Act 3.0

Introduced Apr 10, 2025Policy area: Health

Status: Passed House

  1. Introduced (done)
  2. Committee (done)
  3. Passed House (current)
  4. Passed Senate
  5. To President
  6. Law

Latest action

: Received in the Senate.

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.

Actions

  1. Senate

    Received in the Senate.

  2. House

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

  3. House

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

  4. House

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

  5. House

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

  6. House

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

  7. House

    Placed on the Union Calendar, Calendar No. 614.

  8. House

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

  9. House

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

  10. House

    Committee Consideration and Mark-up Session Held

  11. House

    Forwarded by Subcommittee to Full Committee by Voice Vote.

  12. House

    Subcommittee Consideration and Mark-up Session Held

Show 3 earlier actions
  1. House

    Referred to the Subcommittee on Health.

  2. House

    Referred to the House Committee on Energy and Commerce.

  3. Introduced in House