HR2821Reported by Committee

FDA Modernization Act 3.0

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Introduced
In Committee
3
Passed One Chamber
4
Passed Both
5
Signed into Law
119th
Congress
2025-04-10
Introduced
41
Cosponsors
HR
ⓘ
Type

Sponsor

Earl L. "Buddy" Carter
Earl L. "Buddy" Carter
Republican · GA · Representative
Votes with party: 98.8% (574 recorded votes)

Full profile: /officials/C001103

Source: Congress.gov · FEC

Cosponsors (41)

Members who have signed on to support this bill since introduction. Source: Congress.gov.

Latest Action

The most recent step in the bill's legislative path. Committee Activity below shows referrals and reports; the full action-by-action history including floor proceedings lives at Congress.gov →

Placed on the Union Calendar, Calendar No. 614.

2026-06-18

Source: Congress.gov

Committee Activity

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Plain-English 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.

Plain-English rewrite of the Congressional Research Service summary published on Congress.gov. Cached and reviewed.

Subjects

Health

Full Bill Text

Verbatim text published on Congress.gov via GovInfo. Use Cmd+F / Ctrl+F to search within this excerpt.

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 2821 Introduced in House (IH)] <DOC> 119th CONGRESS 1st Session H. R. 2821 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. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES April 10, 2025 Mr. Carter of Georgia (for himself, Ms. Barragan, Mr. Buchanan, Ms. DeLauro, Mrs. Harshbarger, and Mr. Carter of Louisiana) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL 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). <all>
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