S 355 — FDA Modernization Act 3.0

355 IntroducedEngrossed in Senate (IS)](ES)] <DOC> 119th CONGRESS 1st Session S.

355 _______________________________________________________________________ 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.

_______________________________________________________________________ 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.

(a) Interim Final Rule.-- (1) In general.--Notgeneral.--In laterorder 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.

5821).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;

(2)and Effectiveness of interim final rule.--Notwithstanding subparagraph (B) ofto sectionadd 553(b) of title 5, United States Code, the interimdefinition finalof rule``nonclinical issuedtest'' byin thesection Secretary505(z) of Health and Human Services under paragraph (1) shall become immediately effective as an interim final rule without requiring the SecretaryFederal ofFood, HealthDrug, and HumanCosmetic ServicesAct to(21 demonstrateU.S.C. good cause therefor.

(b)355(z)) Inclusions.-- (1) In general.--The interim final rule shall replace any references to ``animal''sections tests,312.3, data,314.3, studies,315.2, models, and research601.31 with a reference to nonclinical tests, data, studies, models, and research in the following sections of title 21, Code of Federal Regulations:Regulations.

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

(2)(3) AdditionalEffectiveness changes.--Theof Secretaryinterim mayfinal makerule.--Notwithstanding suchsubparagraph additional(B) changesof tosection the553(b) sections of title 21,5, CodeUnited ofStates FederalCode, Regulations,the describedinterim infinal subparagraphsrule (A)issued throughby (V)the Secretary of Health and Human Services under paragraph (1) shall become immediately effective as an interim final rule without requiring the Secretary determinesof appropriateHealth toand fullyHuman implementServices theto replacementdemonstrate requiredgood undercause suchtherefor. paragraph.

(c)(b) DefinitionTechnical ofAmendment.--Section Nonclinical505 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.

<all>Passed the Senate Attest:

Secretary.

119th CONGRESS 1st Session S.

355 _______________________________________________________________________ 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.