[Congressional Record Volume 170, Number 185 (Thursday, December 12, 2024)]
[Senate]
[Page S7040]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 3328. Mr. SCHUMER (for Mr. Booker (for himself and Mr. Schmitt)) 
proposed an amendment to the bill S. 5046, to require the Secretary of 
Health and Human Service, acting through the Commissioner of Food and 
Drugs, to publish a final rule relating to nonclinical testing methods; 
as follows:

        Strike all after the enacting clause and insert the 
     following:

     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).
                                 ______