FDA Modernization Act 3.0
- Last Action
- 6/18/2026
Actions
- 2026-07-21Received in the Senate.
- 2026-07-20Motion to reconsider laid on the table Agreed to without objection.
- 2026-07-20On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
- 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)
- 2026-07-20DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
- 2026-07-20Considered under suspension of the rules. (consideration: CR H4639-4640)
- 2026-07-20Mr. Guthrie moved to suspend the rules and pass the bill.
- 2026-06-18Placed on the Union Calendar, Calendar No. 614.
- 2026-06-18Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
- 2026-06-18Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
- 2026-05-21Ordered to be Reported by the Yeas and Nays: 44 - 0.
- 2026-05-21Committee Consideration and Mark-up Session Held
- 2026-05-13Forwarded by Subcommittee to Full Committee by Voice Vote.
- 2026-05-13Subcommittee Consideration and Mark-up Session Held
- 2026-04-10Referred to the Subcommittee on Health.
Showing 15 of 18 actions. Full history on Congress.gov.
CRS Summary
As of 2025-04-10 (00)
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.
Cosponsors (20)
- Nanette Barragán (D-CA)
- Vern Buchanan (R-FL)
- Rosa DeLauro (D-CT)
- Diana Harshbarger (R-TN)
- Troy Carter (D-LA)
- Lloyd Doggett (D-TX)
- Jerrold Nadler (D-NY)
- Mike Carey (R-OH)
- Brian Fitzpatrick (R-PA)
- Nicole Malliotakis (R-NY)
- Dan Crenshaw (R-TX)
- Judy Chu (D-CA)
- Hillary Scholten (D-MI)
- Darren Soto (D-FL)
- Daniel Goldman (D-NY)
- Jay Obernolte (R-CA)
- Josh Gottheimer (D-NJ)
- Jason Crow (D-CO)
- Ted Lieu (D-CA)
- Claudia Tenney (R-NY)
Subjects
- Administrative law and regulatory procedures
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Medical research
- Research administration and funding
Sourced from Congress.gov (public domain).
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