S 355 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.
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.
Summary
This bill would require the FDA to issue an interim final rule within one year that updates FDA regulations to replace references to "animal" testing with "nonclinical" testing. The rule would implement amendments to the Federal Food, Drug, and Cosmetic Act made in 2023 that expanded the types of testing methods acceptable for drug development beyond traditional animal tests. The updated regulations would affect multiple FDA regulatory sections related to drug development and approval processes. The interim final rule would become effective immediately upon publication without requiring the FDA to demonstrate good cause. The bill also updates FDA regulations to include the formal definition of "nonclinical test" in relevant sections.
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)
- Sen. Booker, Cory A. [D-NJ] (D-NJ)
9 cosponsors
- Sen. Blumenthal, Richard [D-CT] (D-CT)
- Sen. Kennedy, John [R-LA] (R-LA)
- Sen. King, Angus S., Jr. [I-ME] (I-ME)
- Sen. Luján, Ben Ray [D-NM] (D-NM)
- Sen. Marshall, Roger [R-KS] (R-KS)
- Sen. Paul, Rand [R-KY] (R-KY)
- Sen. Schiff, Adam B. [D-CA] (D-CA)
- Sen. Schmitt, Eric [R-MO] (R-MO)
- Sen. Whitehouse, Sheldon [D-RI] (D-RI)
Money behind the sponsor
Top reported contributors to Cory A. Booker’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
- NULL $92,425
- PRIME HEALTHCARE $19,800
- APOLLO $15,800
- LOWENSTEIN SANDLER LLP $15,700
- HARVARD UNIVERSITY $14,100
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Cory A. Booker → · Outside spending →
Actions (9)
- Dec 17, 2025 Held at the desk. · house
- Dec 17, 2025 Received in the House. · house
- Dec 17, 2025 Message on Senate action sent to the House. · senate
- Dec 16, 2025 Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S8794) · senate
- Dec 16, 2025 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
- Dec 16, 2025 Measure laid before Senate by unanimous consent. (consideration: CR S8793-8794) · senate
- Dec 16, 2025 Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. · senate
- Feb 3, 2025 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. · senate
- Feb 3, 2025 Introduced in Senate
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
IN THE SENATE OF THE UNITED STATES
February 3, 2025
Mr. Booker (for himself, Mr. Schmitt, Mr. King, Mr. Kennedy, Mr. Whitehouse, Mr. Marshall, Mr. Blumenthal, Mr. Paul, and Mr. Lujan) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
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.—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 pursuant to subsections (b) and (c) 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).
(2) 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) Inclusions.—
(1) In general.—The interim final rule shall replace any references to “animal” tests, data, studies, models, and research with a reference to nonclinical tests, data, studies, models, and research in the following sections of title 21, Code of Federal Regulations:
(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).
(2) Additional changes.—The Secretary may make such additional changes to the sections of title 21, Code of Federal Regulations, described in subparagraphs (A) through (V) of paragraph (1) as the Secretary determines appropriate to fully implement the replacement required under such paragraph.
(c) Definition of Nonclinical Test.—The definition of “nonclinical test” in section 505(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)) shall be added to sections 312.3, 314.3, 315.2, and 601.31 of title 21, Code of Federal Regulations.
(d) 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>
Comments