FDA Modernization Act 3.0
Latest action · Jul 21, 2026 Received in the Senate.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedApr 10, 2025
- Passed HouseJul 20, 2026
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
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.
Cosponsors 41
Members who signed on, in the order they did. Signatures ran from Apr 10, 2025 to Jun 2, 2026; 5 are original cosponsors, there from the day it was introduced.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| R-TN | Diana Harshbarger | Original | Apr 10, 2025 |
| D-CA | Nanette Diaz Barragán | Original | Apr 10, 2025 |
| D-CT | Rosa L. DeLauro | Original | Apr 10, 2025 |
| D-LA | Troy A. Carter | Original | Apr 10, 2025 |
| R-FL | Vern Buchanan | Original | Apr 10, 2025 |
| D-TX | Lloyd Doggett | Apr 14, 2025 | |
| R-PA | Brian K. Fitzpatrick | Apr 17, 2025 | |
| R-TX | Dan Crenshaw | Apr 17, 2025 | |
| D-NY | Jerrold Nadler | Apr 17, 2025 | |
| R-OH | Mike Carey | Apr 17, 2025 | |
| R-NY | Nicole Malliotakis | Apr 17, 2025 | |
| D-NY | Daniel S. Goldman | Apr 29, 2025 | |
| D-FL | Darren Soto | Apr 29, 2025 | |
| D-MI | Hillary J. Scholten | Apr 29, 2025 | |
| D-CA | Judy Chu | Apr 29, 2025 | |
| R-CA | Jay Obernolte | May 13, 2025 | |
| D-NJ | Josh Gottheimer | May 20, 2025 | |
| D-CO | Jason Crow | Jun 6, 2025 | |
| D-CA | Ted Lieu | Jun 27, 2025 | |
| R-NJ | Christopher H. Smith | Jul 2, 2025 | |
| R-NY | Claudia Tenney | Jul 2, 2025 | |
| D-DC | Eleanor Holmes Norton | Jul 10, 2025 | |
| R-FL | Maria Elvira Salazar | Jul 10, 2025 | |
| R-CA | David G. Valadao | Jul 14, 2025 | |
| D-CA | Josh Harder | Jul 14, 2025 | |
| D-FL | Lois Frankel | Jul 14, 2025 | |
| R-FL | Gus M. Bilirakis | Jul 16, 2025 | |
| R-WI | Scott Fitzgerald | Jul 16, 2025 | |
| R-FL | Laurel M. Lee | Jul 17, 2025 | |
| R-CA | Ken Calvert | Jul 22, 2025 | |
| D-VA | Eugene Simon Vindman | Sep 11, 2025 | |
| D-WI | Mark Pocan | Nov 4, 2025 | |
| R-NY | Michael Lawler | Nov 20, 2025 | |
| R-TX | Randy K. Weber, Sr. | Dec 2, 2025 | |
| D-CO | Joe Neguse | Dec 11, 2025 | |
| D-IL | Raja Krishnamoorthi | Dec 15, 2025 | |
| R-NJ | Thomas H. Kean, Jr. | Jan 7, 2026 | |
| D-TX | Julie Johnson | Jan 15, 2026 | |
| R-CA | Young Kim | Apr 22, 2026 | |
| R-NY | Nicholas A. Langworthy | May 12, 2026 | |
| D-MI | Shri Thanedar | Jun 2, 2026 |
Committees 1
Where it was sent and what each committee and subcommittee did with it, in order.
| Chamber | Committee | What it did |
|---|---|---|
| House | Energy and Commerce Committee | Referred Apr 10, 2025Markup May 21, 2026Reported Jun 18, 2026 |
| Health Subcommittee | Referred Apr 10, 2026Markup May 13, 2026Reported May 13, 2026 |
Actions 15
Everything that happened, newest first.
- Jul 21, 2026Received in the Senate.
- Jul 20, 2026Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
- Jul 20, 2026Considered under suspension of the rules. (consideration: CR H4639-4640)
- Jul 20, 2026Mr. Guthrie moved to suspend the rules and pass the bill.
- Jul 20, 2026DEBATE - The House proceeded with forty minutes of debate on H.R. 2821.
In the Congressional Record 1
Days the Record’s own index lists this bill, newest first, with the pages and the members it names. Pages starting H are the House, S the Senate, E Extensions of Remarks.
| Where | In the Record | Members | Date |
|---|---|---|---|
| House | Debate and remarks H4639, H4640Text printed H4639 | Brett Guthrie R-KY, Frank Pallone, Jr. D-NJ, Troy A. Carter D-LA | Jul 20, 2026 |
Research
What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.
Committee report
Constitutional authority
The sponsor’s statement, as printed in the Congressional Record, vol. 171, no. 65, April 10, 2025, page H1601.
Printed hearings 1
Hearings whose printed record names this bill, newest first: hearings on it, and wider hearings where it came up.
| Number | Hearing | Committee | Held |
|---|---|---|---|
| Serial No. 119-31 | LEGISLATIVE PROPOSALS TO MAINTAIN AND IMPROVE THE PUBLIC HEALTH WORKFORCE, RURAL HEALTH, AND OVER-THE-COUNTER MEDICINES159 pages | Energy and Commerce Committee | Jul 16, 2025 |
Related bills 1
Companion bills and other measures the record links to this one.
| Bill | Title | Relationship | Latest action |
|---|---|---|---|
| S 355 | FDA Modernization Act 3.0 | Identical bill | Dec 17, 2025 |
Titles 5
Every title it has carried, official and short, at each stage.
- Official Title as Introduced
- To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.
- Short Title(s) as Introduced
- FDA Modernization Act 3.0
- Short Title(s) as Reported to House
- FDA Modernization Act 3.0
- Short Title(s) as Passed House
- FDA Modernization Act 3.0
- Official Title from EH (Engrossed in House) bill text
- To require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.
Subjects
Assigned by the Library of Congress. Policy area: Health.
Text 3
Each version as it was printed, newest first.
- Jul 20, 2026Engrossed in House
- Jun 18, 2026Reported in House
- Apr 10, 2025Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.
