FDA Modernization Act 3.0

[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).
                                 <all>