119-hr2821

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2821 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 2821

 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 HOUSE OF REPRESENTATIVES

 April 10, 2025

 Mr. Carter of Georgia (for himself, Ms. Barragan, Mr. Buchanan, Ms. 
DeLauro, Mrs. Harshbarger, and Mr. Carter of Louisiana) introduced the 
 following bill; which was referred to the Committee on Energy and 
 Commerce

_______________________________________________________________________

 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.--In order 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), 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; 
 and
        (B) to add the definition of ``nonclinical test'' 
 in 

section 505

    (z) of the Federal Food, Drug, and 
 Cosmetic Act (21 U.S.C. 355

    (z) ) to sections 312.3, 
 314.3, 315.2, and 601.31 of title 21, Code of Federal 
 Regulations.

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

    (3) 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) 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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