HR 2821

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. 

Bill status

Status

Passed House

Sponsor

Rep. Earl L. "Buddy" Carter [R-GA-1]

Cosponsors

41

Policy area

Health

Introduced

2025-04-10

Latest action

2026-07-21: Received in the Senate.

Committee referrals

• Energy and Commerce Committee: House · Reported By · 2026-06-18
• Energy and Commerce Committee: House · Markup By · 2026-05-21
• Energy and Commerce Committee: House · Referred To · 2025-04-10

Recent actions

• 2026-07-21: Received in the Senate.
• 2026-07-20: Motion to reconsider laid on the table Agreed to without objection.
• 2026-07-20: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
• 2026-07-20: Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
• 2026-07-20: DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.