# 119-hr-2821: FDA Modernization Act 3.0

119-hr-2821, FDA Modernization Act 3.0, is a 119th Congress bill sponsored by Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-GA); status passed_house; PRIA reads it as touching household money (as of 2026-09-21).

- Canonical: https://policyrisk.com/legislation/119-hr-2821
- As of: 2026-09-21
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-hr-2821
- Congress: 119
- Title: FDA Modernization Act 3.0
- Status: passed_house
- Introduced: 2025-04-10
- Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] (R-GA)
- Cosponsors: 41
- Policy area: Health
- Touches household money: yes
- Last recorded action: 2026-09-21

## Summary

**Shifts FDA regulation language from 'animal' tests to broader 'nonclinical' tests.** This bill would require HHS, through the FDA Commissioner, to issue an interim final rule within one year that replaces references to "animal" tests, data, studies, models, and research with references to "nonclinical" tests and to add a definition of "nonclinical test" into specified FDA regulations.

## Cosponsors (41)

- Rep. Carter, Troy A. [D-LA-2] (D-LA), 2025-04-10T00:00:00.000Z
- Rep. Doggett, Lloyd [D-TX-37] (D-TX), 2025-04-14T00:00:00.000Z
- Rep. Nadler, Jerrold [D-NY-12] (D-NY), 2025-04-17T00:00:00.000Z
- Rep. Barragán, Nanette Diaz [D-CA-44] (D-CA), 2025-04-10T00:00:00.000Z
- Rep. Buchanan, Vern [R-FL-16] (R-FL), 2025-04-10T00:00:00.000Z
- Rep. DeLauro, Rosa L. [D-CT-3] (D-CT), 2025-04-10T00:00:00.000Z
- Rep. Harshbarger, Diana [R-TN-1] (R-TN), 2025-04-10T00:00:00.000Z
- Rep. Carey, Mike [R-OH-15] (R-OH), 2025-04-17T00:00:00.000Z
- Rep. Fitzpatrick, Brian K. [R-PA-1] (R-PA), 2025-04-17T00:00:00.000Z
- Rep. Malliotakis, Nicole [R-NY-11] (R-NY), 2025-04-17T00:00:00.000Z
- Rep. Crenshaw, Dan [R-TX-2] (R-TX), 2025-04-17T00:00:00.000Z
- Rep. Chu, Judy [D-CA-28] (D-CA), 2025-04-29T00:00:00.000Z
- Rep. Scholten, Hillary J. [D-MI-3] (D-MI), 2025-04-29T00:00:00.000Z
- Rep. Soto, Darren [D-FL-9] (D-FL), 2025-04-29T00:00:00.000Z
- Rep. Goldman, Daniel S. [D-NY-10] (D-NY), 2025-04-29T00:00:00.000Z
- Rep. Obernolte, Jay [R-CA-23] (R-CA), 2025-05-13T00:00:00.000Z
- Rep. Gottheimer, Josh [D-NJ-5] (D-NJ), 2025-05-20T00:00:00.000Z
- Rep. Crow, Jason [D-CO-6] (D-CO), 2025-06-06T00:00:00.000Z
- Rep. Lieu, Ted [D-CA-36] (D-CA), 2025-06-27T00:00:00.000Z
- Rep. Tenney, Claudia [R-NY-24] (R-NY), 2025-07-02T00:00:00.000Z
- Rep. Smith, Christopher H. [R-NJ-4] (R-NJ), 2025-07-02T00:00:00.000Z
- Del. Norton, Eleanor Holmes [D-DC-At Large] (D-DC), 2025-07-10T00:00:00.000Z
- Rep. Salazar, Maria Elvira [R-FL-27] (R-FL), 2025-07-10T00:00:00.000Z
- Rep. Frankel, Lois [D-FL-22] (D-FL), 2025-07-14T00:00:00.000Z
- Rep. Valadao, David G. [R-CA-22] (R-CA), 2025-07-14T00:00:00.000Z
- Rep. Harder, Josh [D-CA-9] (D-CA), 2025-07-14T00:00:00.000Z
- Rep. Fitzgerald, Scott [R-WI-5] (R-WI), 2025-07-16T00:00:00.000Z
- Rep. Bilirakis, Gus M. [R-FL-12] (R-FL), 2025-07-16T00:00:00.000Z
- Rep. Lee, Laurel M. [R-FL-15] (R-FL), 2025-07-17T00:00:00.000Z
- Rep. Calvert, Ken [R-CA-41] (R-CA), 2025-07-22T00:00:00.000Z
- Rep. Vindman, Eugene Simon [D-VA-7] (D-VA), 2025-09-11T00:00:00.000Z
- Rep. Pocan, Mark [D-WI-2] (D-WI), 2025-11-04T00:00:00.000Z
- Rep. Lawler, Michael [R-NY-17] (R-NY), 2025-11-20T00:00:00.000Z
- Rep. Weber, Randy K. Sr. [R-TX-14] (R-TX), 2025-12-02T00:00:00.000Z
- Rep. Neguse, Joe [D-CO-2] (D-CO), 2025-12-11T00:00:00.000Z
- Rep. Krishnamoorthi, Raja [D-IL-8] (D-IL), 2025-12-15T00:00:00.000Z
- Rep. Kean, Thomas H. [R-NJ-7] (R-NJ), 2026-01-07T00:00:00.000Z
- Rep. Johnson, Julie [D-TX-32] (D-TX), 2026-01-15T00:00:00.000Z
- Rep. Kim, Young [R-CA-40] (R-CA), 2026-04-22T00:00:00.000Z
- Rep. Langworthy, Nicholas A. [R-NY-23] (R-NY), 2026-05-12T00:00:00.000Z
- Rep. Thanedar, Shri [D-MI-13] (D-MI), 2026-06-02T00:00:00.000Z

## Provisions PRIA read

- New rules for drug testing methods: mixed, medium. Within 1 year of enactment, HHS, through the FDA Commissioner, would publish an interim final rule. It would replace “animal” testing references with “nonclinical” across several FDA rules for drugs and biologics. It would add the law’s definition of “nonclinical test” to those rules. The rule woul…

## Related bills

- 119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
- 119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025
- 119-hr-2102: Major Richard Star Act
- 119-hr-1262: Mikaela Naylon Give Kids a Chance Act
- 119-hr-909: Crime Victims Fund Stabilization Act of 2025
- 119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act

## Sources
- [119-hr-2821 on Congress.gov](https://www.congress.gov/bill/119th-congress/house-bill/2821)

## Related
- [119-hr-842: Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage A…](https://policyrisk.com/legislation/119-hr-842)
- [119-hr-3514: Improving Seniors’ Timely Access to Care Act of 2025](https://policyrisk.com/legislation/119-hr-3514)
- [119-hr-2102: Major Richard Star Act](https://policyrisk.com/legislation/119-hr-2102)
- [119-hr-1262: Mikaela Naylon Give Kids a Chance Act](https://policyrisk.com/legislation/119-hr-1262)
- [119-hr-909: Crime Victims Fund Stabilization Act of 2025](https://policyrisk.com/legislation/119-hr-909)
- [119-hr-4382: America’s Olympic and Paralympic Games Commemorative Coins Act](https://policyrisk.com/legislation/119-hr-4382)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-hr-2821 (as of 2026-09-21).