← Back to browse
HR 2821 Passed a chamber

Requires the FDA to issue a rule replacing references to animal testing with nonclinical testing in federal drug and device regulations, and makes the rule take effect immediately.

Official title: FDA Modernization Act 3.0

Next stop Senate: awaiting action
Timeline each lane is a chamber; dates pull from congress.gov actions
House
Introduced 10-APR-2025
Referred 10-APR-2025
Approved by committee 21-MAY-2026
Reported 18-JUN-2026
On the calendar 18-JUN-2026
Passed 20-JUL-2026
Senate
Received 21-JUL-2026
Key points
  • Requires HHS, acting through the FDA Commissioner, to publish an interim final rule within one year of enactment.
  • Replaces references to "animal" tests, data, studies, models, and research with "nonclinical" in listed sections of Title 21 of the Code of Federal Regulations.
  • Adds a definition of "nonclinical test" from section 505(z) of the Federal Food, Drug, and Cosmetic Act to four CFR sections covering investigational drugs, new drug applications, and biologics.
  • Makes the interim final rule effective immediately without the agency having to show good cause.
  • Redesignates the second subsection (z), on clinical trial diversity action plans, as subsection (aa).
AI-generated from the Engrossed in House text of 20-JUL-2026 · verify · report an error
Official CRS summary

Covers an older version. The newest CRS summary describes the bill as of "Introduced in House" (10-APR-2025); the text has changed since (Engrossed in House, 20-JUL-2026).

CRS is the Library of Congress's nonpartisan research office. Read it on congress.gov
Committee referrals (2) Policy area

Health

Sponsor Earl L. "Buddy" Carter (R-GA) Cosponsors · 41
■ 21 D■ 20 R