FDA Modernization Act 3.0

U.S. Congress · HR2821 · Introduced

Progression

Timing in context

Primary sponsor's contributions received (same period)

Adjacency in time is shown for context; it is not evidence of cause. Funded ≠ false — see the methodology.

What the bill says

HR2821 · U.S. Congress · Introduced

Introduced 2025-04-10. Latest action: Received in the Senate.

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Summary (plain-language)

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.

Sponsors

Text versions

  • Introduced in House — 2025-04-10 — XML
  • Reported in House — 2026-06-18 — XML
  • Engrossed in House — 2026-07-20 — XML

What analysts say

Committee reports

  • H. Rept. 119-706
    Pursuant to clause 3(c)(3) of rule XIII, at the time this report was filed, the cost estimate prepared by the Director of the Congressional Budget Off…

    Pursuant to clause 3(c)(3) of rule XIII, at the time this report was filed, the cost estimate prepared by the Director of the Congressional Budget Office pursuant to section 402 of the Congressional Budget Act of 1974 was not available.

    CBO cost estimate from the committee report (public domain).

What politicians say

No linked claims or utterances yet — no one on record has cited this measure to justify a public argument.

Action History

DateAction
2026-07-21Received in the Senate.
2026-07-20Mr. Guthrie moved to suspend the rules and pass the bill.
2026-07-20Considered under suspension of the rules. (consideration: CR H4639-4640)
2026-07-20DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
2026-07-20Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
2026-07-20On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
2026-07-20Motion to reconsider laid on the table Agreed to without objection.
2026-06-18Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
2026-06-18Placed on the Union Calendar, Calendar No. 614.
2026-05-21Committee Consideration and Mark-up Session Held
2026-05-21Ordered to be Reported by the Yeas and Nays: 44 - 0.
2026-05-13Subcommittee Consideration and Mark-up Session Held
2026-05-13Forwarded by Subcommittee to Full Committee by Voice Vote.
2026-04-10Referred to the Subcommittee on Health.
2025-04-10Introduced in House
2025-04-10Referred to the House Committee on Energy and Commerce.

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