In the nature of a substitute.

SA 4057. Mr. THUNE (for Mr. Booker (for himself and Mr. Schmitt))
proposed an amendment to the bill 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;
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.--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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