119-s355

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 355 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 355

 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.

 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) .
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