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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5046 Engrossed in Senate (ES)]

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118th CONGRESS
  2d Session
                                S. 5046

_______________________________________________________________________

                                 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.--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).

            Passed the Senate December 12, 2024.

            Attest:

                                                             Secretary.
118th CONGRESS

  2d Session

                                S. 5046

_______________________________________________________________________

                                 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.
```