FDA Modernization Act 3.0
- Bill Number
- H.R. 2821
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-06-18: Placed on the Union Calendar, Calendar No. 614.
- Last Updated
- 2026-07-08T20:06:15Z
AI-Generated Summary
Purpose The legislation requires the Secretary of Health and Human Services, acting through the Food and Drug Administration Commissioner, to issue updated regulations that align federal rules with prior changes allowing non-animal testing methods for drug development.
Key Provisions
- The Secretary must publish an interim final rule within one year of enactment.
- This rule updates multiple sections of Title 21 of the Code of Federal Regulations by replacing references to "animal" tests, data, studies, models, and research with "nonclinical" equivalents.
- The rule adds the definition of "nonclinical test" (from the Federal Food, Drug, and Cosmetic Act) to specific regulatory sections.
- The interim rule takes effect immediately upon publication, bypassing standard procedural requirements for demonstrating good cause.
- A technical correction fixes duplicate subsection numbering in section 505 of the Federal Food, Drug, and Cosmetic Act.
Significant Changes to Existing Law
- Builds directly on amendments made by the Consolidated Appropriations Act, 2023, which expanded acceptance of non-animal testing methods under section 505(i) of the Federal Food, Drug, and Cosmetic Act.
- Mandates regulatory updates across listed CFR sections (such as 312.22, 312.23, 314.50, and others) to ensure consistency.
- Introduces an expedited rulemaking process for these specific changes.
Potential Impacts
- On government agencies: Requires the FDA to revise its review processes for investigational new drugs and related submissions within a set timeline.
- On citizens: May support faster evaluation of new medicines by recognizing a broader range of testing approaches.
- On international relations: No direct effects identified in the legislation.
Main Stakeholders Affected
- The Food and Drug Administration and Department of Health and Human Services.
- Pharmaceutical companies and drug developers submitting applications.
- Researchers and laboratories using nonclinical testing methods.
- Sponsors of clinical trials and manufacturers of biological products.
Notable Legal, Constitutional, or Political Implications
- Ensures regulatory language matches statutory changes from 2023, reducing potential inconsistencies in enforcement.
- Uses an interim final rule mechanism to accelerate implementation without full notice-and-comment procedures.
- Contains only a minor technical fix for statutory subsection labeling, with no broader constitutional issues addressed in the text.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Rep. Carter, Earl L. "Buddy" [R-GA-1]
Cosponsors (41)
Rep. Barragán, Nanette Diaz [D-CA-44], Rep. Buchanan, Vern [R-FL-16], Rep. DeLauro, Rosa L. [D-CT-3], Rep. Harshbarger, Diana [R-TN-1], Rep. Carter, Troy A. [D-LA-2], Rep. Doggett, Lloyd [D-TX-37], Rep. Nadler, Jerrold [D-NY-12], Rep. Carey, Mike [R-OH-15], Rep. Fitzpatrick, Brian K. [R-PA-1], Rep. Malliotakis, Nicole [R-NY-11], Rep. Crenshaw, Dan [R-TX-2], Rep. Chu, Judy [D-CA-28], Rep. Scholten, Hillary J. [D-MI-3], Rep. Soto, Darren [D-FL-9], Rep. Goldman, Daniel S. [D-NY-10], Rep. Obernolte, Jay [R-CA-23], Rep. Gottheimer, Josh [D-NJ-5], Rep. Crow, Jason [D-CO-6], Rep. Lieu, Ted [D-CA-36], Rep. Tenney, Claudia [R-NY-24], Rep. Smith, Christopher H. [R-NJ-4], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Salazar, Maria Elvira [R-FL-27], Rep. Frankel, Lois [D-FL-22], Rep. Valadao, David G. [R-CA-22], Rep. Harder, Josh [D-CA-9], Rep. Fitzgerald, Scott [R-WI-5], Rep. Bilirakis, Gus M. [R-FL-12], Rep. Lee, Laurel M. [R-FL-15], Rep. Calvert, Ken [R-CA-41], Rep. Vindman, Eugene Simon [D-VA-7], Rep. Pocan, Mark [D-WI-2], Rep. Lawler, Michael [R-NY-17], Rep. Weber, Randy K. Sr. [R-TX-14], Rep. Neguse, Joe [D-CO-2], Rep. Krishnamoorthi, Raja [D-IL-8], Rep. Kean, Thomas H. [R-NJ-7], Rep. Johnson, Julie [D-TX-32], Rep. Kim, Young [R-CA-40], Rep. Langworthy, Nicholas A. [R-NY-23], Rep. Thanedar, Shri [D-MI-13]
Recent Actions
- 2026-06-18: Placed on the Union Calendar, Calendar No. 614.
- 2026-06-18: Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
- 2026-06-18: Reported by the Committee on Energy and Commerce. H. Rept. 119-706.
- 2026-05-21: Ordered to be Reported by the Yeas and Nays: 44 - 0.
- 2026-05-21: Committee Consideration and Mark-up Session Held
- 2026-05-13: Forwarded by Subcommittee to Full Committee by Voice Vote.
- 2026-05-13: Subcommittee Consideration and Mark-up Session Held
- 2026-04-10: Referred to the Subcommittee on Health.
- 2025-04-10: Referred to the House Committee on Energy and Commerce.
- 2025-04-10: Introduced in House
- 2025-04-10: Introduced in House
Bill Versions
- FDA Modernization Act 3.0 — issued 2025-04-10 — PDF (4 pages)
- FDA Modernization Act 3.0 — issued 2026-06-18 — PDF (8 pages)