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HR 2821
Passed House Re-checks Congress.gov for new actions and updates the bill's status, and fills in any sponsors, committees, or related bills that are missing. It does not re-pull sponsors/cosponsors/committees/related — those rarely change — and it skips all work if nothing has changed upstream, so it's cheap to click.

FDA Modernization Act 3.0

Introduced Apr 10, 2025

Latest action (Jul 21, 2026) Received in the Senate.

Referred to
Energy and Commerce Committee
Policy area
Health
Legislative subjects (5)
Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationMedical researchResearch administration and funding

Summary
  • Requires the FDA to publish an interim final rule within one year to implement amendments allowing use of nonclinical testing methods in FDA drug and biologics applications.
  • Requires the interim final rule to replace references to "animal" tests and data with "nonclinical" tests and data throughout FDA regulations in title 21, Code of Federal Regulations.
  • Requires the rule to add the definition of "nonclinical test" to specified sections of FDA regulations affecting drug applications and biologics licensure.
  • Makes the interim final rule immediately effective without requiring the FDA to demonstrate good cause for the effective date.

AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.

Sponsor (1)
41 cosponsors

Money behind the sponsor

Top reported contributors to Earl L. "Buddy" Carter’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.

  • NULL $80,924
  • INTERNATIONAL AUTO LOGISTICS $7,500
  • SAVANNAH PILOTS ASSOC $6,600
  • HENNESSY AUTOMOBILE COMPANIES $6,600
  • SADOWSKI CO $6,600

Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Earl L. "Buddy" Carter → · Outside spending →

Actions (16)
  1. Jul 21, 2026 Received in the Senate. · senate
  2. Jul 20, 2026 Motion to reconsider laid on the table Agreed to without objection. · house
  3. Jul 20, 2026 On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639) · house
  4. Jul 20, 2026 Passed/agreed to in House: On motion to suspend the rules and pass the bill Agreed to by voice vote. (text: CR H4639)
  5. Jul 20, 2026 DEBATE - The House proceeded with forty minutes of debate on H.R. 2821. · house
  6. Jul 20, 2026 Considered under suspension of the rules. (consideration: CR H4639-4640) · house
  7. Jul 20, 2026 Mr. Guthrie moved to suspend the rules and pass the bill. · house
  8. Jun 18, 2026 Placed on the Union Calendar, Calendar No. 614. · house
  9. Jun 18, 2026 Reported by the Committee on Energy and Commerce. H. Rept. 119-706. · house
  10. May 21, 2026 Ordered to be Reported by the Yeas and Nays: 44 - 0. · house
  11. May 21, 2026 Committee Consideration and Mark-up Session Held · house
  12. May 13, 2026 Forwarded by Subcommittee to Full Committee by Voice Vote. · house
  13. May 13, 2026 Subcommittee Consideration and Mark-up Session Held · house
  14. Apr 10, 2026 Referred to the Subcommittee on Health. · house
  15. Apr 10, 2025 Referred to the House Committee on Energy and Commerce. · house
  16. Apr 10, 2025 Introduced in House

More bills on these subjects (8)

Other bills that carry the most legislative subjects in common with this one (topical discovery — distinct from the procedural related bills above).

  • HR 191 — Inflation Reduction Act of 2025 (shares 5 subjects)
  • S 2296 — National Defense Authorization Act for Fiscal Year 2026 (shares 4 subjects)
  • HR 3358 — Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2018 (shares 4 subjects)
  • HR 8205 — Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (shares 3 subjects)
  • HR 9770 — Continuing Appropriations Act, 2027 (shares 3 subjects)
  • HR 7148 — Consolidated Appropriations Act, 2026 (shares 3 subjects)
  • S 1071 — National Defense Authorization Act for Fiscal Year 2026 (shares 3 subjects)
  • HR 6509 — SAFE Drugs Act of 2025 (shares 3 subjects)

Text versions (3)
  • Engrossed in House · Jul 20, 2026
  • Reported in House · Jun 18, 2026
  • Introduced in House · Apr 10, 2025

Committee action

What happened to this bill in committee — the meetings where it was considered and every recorded vote taken on it.

Meetings where this bill was on the agenda

Full text

AN ACT

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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “FDA Modernization Act 3.0”.

SEC. 2. REGULATIONS ON NONCLINICAL TESTING METHODS.

(a) Interim Final Rule.—

(1) In general.—In order to ensure implementation of the amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) made by section 3209(a) of the Consolidated Appropriations Act, 2023 (Public Law 117-328; 136 Stat. 5821), not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish an interim final rule—

(A) to amend the sections of title 21, Code of Federal Regulations, described in paragraph (2) to replace any references to “animal” tests, data, studies, models, and research with a reference to nonclinical tests, data, studies, models, and research; and

(B) to add the definition of “nonclinical test” in section 505(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)) to sections 312.3, 314.3, 315.2, and 601.31 of title 21, Code of Federal Regulations.

(2) CFR sections described.—The sections of title 21, Code of Federal Regulations, described in this paragraph are the following:

(A) Section 312.22(c).

(B) Section 312.23(a)(3)(iv).

(C) Section 312.23(a)(5)(ii).

(D) Section 312.23(a)(5)(iii).

(E) Section 312.23(a)(8).

(F) Section 312.23(a)(8)(i).

(G) Section 312.23(a)(8)(ii).

(H) Section 312.23(a)(10)(i).

(I) Section 312.23(a)(10)(ii).

(J) Section 312.33(b)(6).

(K) Section 312.82(a).

(L) Section 312.88.

(M) Section 314.50(d)(2).

(N) Section 314.50(d)(2)(iv).

(O) Section 314.50(d)(5)(i).

(P) Section 314.50(d)(5)(vi)(a).

(Q) Section 314.50(d)(5)(vi)(b).

(R) Section 314.93(e)(2).

(S) Section 315.6(d).

(T) Section 330.10(a)(2).

(U) Section 601.35(d).

(V) Any other section necessary to ensure regulatory consistency with the amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) made by section 3209(a) of the Consolidated Appropriations Act, 2023 (Public Law 117- 328; 136 Stat. 5821).

(3) Effectiveness of interim final rule.—Notwithstanding subparagraph (B) of section 553(b) of title 5, United States Code, the interim final rule issued by the Secretary of Health and Human Services under paragraph (1) shall become immediately effective as an interim final rule without requiring the Secretary of Health and Human Services to demonstrate good cause therefor.

(b) Technical Amendment.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by designating the second subsection (z) (relating to clinical trial diversity action plans), as added by section 3601(a) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022 (division FF of Public Law 117-328), as subsection (aa).

Passed the House of Representatives July 20, 2026.

Attest:

Clerk. 119th CONGRESS

2d Session

H. R. 2821

AN ACT

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.

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