PlainBillCongress, translated.Legislation. Context. Public interest.Congressional Research Service
Version 00 · Introduced in House · Apr 10, 2025
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.
People & committees
Rep. Carter, Earl L. "Buddy" [R-GA-1] · R–GA
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Received in the Senate.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
Considered under suspension of the rules. (consideration: CR H4639-4640)
Mr. Guthrie moved to suspend the rules and pass the bill.
Placed on the Union Calendar, Calendar No. 614.
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
Ordered to be Reported by the Yeas and Nays: 44 - 0.
Committee Consideration and Mark-up Session Held
Forwarded by Subcommittee to Full Committee by Voice Vote.
Subcommittee Consideration and Mark-up Session Held
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Sep 19, 2026. Consult Congress.gov for the current record.
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Analyze H.R.2821 as objectively as possible. Explain its main provisions, who would be affected, possible benefits and harms, implementation, exceptions, and uncertainties. Present the strongest arguments for and against it, and identify evidence needed to assess its public impact.
Examine H.R.2821 through a progressive lens, focusing on fairness, access, economic inequality, and effects on vulnerable communities. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and distinguish stated goals from demonstrated outcomes.
Examine H.R.2821 through a conservative lens, focusing on fiscal responsibility, institutional stability, federalism, and the scope of government. Explain potential benefits, costs, and unintended consequences. Consider the strongest counterarguments and any provisions that challenge this perspective.
Examine H.R.2821 through a civil-liberties and limited-government lens. Consider individual rights, privacy, voluntary choice, accountability, and government power. Explain tradeoffs, possible safeguards, and the strongest counterarguments without assuming the proposal is beneficial or harmful.