H.R. 2821 · Passed House · Health

FDA Modernization Act 3.0

Sponsor: Earl L. "Buddy" Carter (R-GA)

What it does

• Require the FDA to publish an interim final rule within one year implementing alternatives to animal testing for investigational drug use.
• Replace all references to animal tests, data, studies, models, and research with nonclinical tests, data, studies, models, and research in FDA regulations governing investigational new drug applications.
• Make the interim final rule take immediate effect upon publication without waiting for standard comment periods.

Official 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.

Latest action

Jul 21, 2026: Received in the Senate.

Committee: House Energy and Commerce