FDA Modernization Act 3.0
What does the FDA Modernization Act 3.0 do?
HR 2821 is a House bill sponsored by Rep. Earl L. "Buddy" Carter (R-GA-1). Section 3209(a) of the Consolidated Appropriations Act, 2023 (Public Law 117-328) amended Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to replace "preclinical tests (including tests on animals)" with "nonclinical tests" and added a statutory definition of "nonclinical test" — a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test occurring before or during clinical trials — but FDA regulations in title 21 of the Code of Federal Regulations still refer to "animal" tests. This bill requires the HHS Secretary, acting through the FDA Commissioner, to publish within 1 year an interim final rule replacing "animal" references in a listed set of 21 CFR sections with "nonclinical" and adding the statutory "nonclinical test" definition to CFR sections 312.3, 314.3, 315.2, and 601.31. The interim final rule takes effect immediately without requiring FDA to demonstrate good cause.
Did HR 2821 pass? Where it stands
As of July 24, 2026, HR 2821 has passed the House.
Status: Passed House
Latest vote: House Passed by voice vote on July 20, 2026
Outlook: Likely
Key provisions
- Rulemaking Mandate
- FDA must publish an interim final rule within 1 year of enactment
- Rule takes effect immediately without demonstrating good cause
- Rule implements 2023 statutory changes to FFDCA Section 505(i)
- Terminology Update in 21 CFR
- Replaces references to "animal" tests, data, studies, models, and research with "nonclinical"
- Applies to 21 specifically listed CFR sections across 21 CFR parts 312, 314, 315, 330, and 601
- Plus "any other section necessary to ensure regulatory consistency"
- Statutory Definition Ported to CFR
- Adds "nonclinical test" definition to 21 CFR 312.3, 314.3, 315.2, and 601.31
- Definition from FFDCA Section 505(z): tests conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test
- Test may occur before or during the clinical trial phase
- Technical Amendment
- Redesignates the second Section 505(z) — clinical trial diversity action plans, added by section 3601(a) of division FF of Public Law 117-328 — as subsection (aa)
- Resolves duplicate-subsection numbering in Section 505
Last updated July 23, 2026