[Congressional Record Volume 170, Number 185 (Thursday, December 12, 2024)]
[Senate]
[Page S7044]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FDA MODERNIZATION ACT 3.0
Mr. SCHUMER. Mr. President, I ask unanimous consent that the
Committee on Health, Education, Labor, and Pensions be discharged from
further consideration of S. 5046 and the Senate proceed to its
immediate consideration.
The PRESIDING OFFICER. The clerk will report the bill by title.
The senior assistant legislative clerk read as follows:
A bill (S. 5046) 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.
There being no objection, the committee was discharged, and the
Senate proceeded to consider the bill.
Mr. SCHUMER. I ask unanimous consent that the Booker-Schmitt
substitute amendment at the desk be considered and agreed to; that the
bill, as amended, be considered read a third time and passed; and that
the motion to reconsider be considered made and laid upon the table.
The PRESIDING OFFICER. Without objection, it is so ordered.
The amendment (No. 3328) in the nature of a substitute was agreed to,
as follows:
(Purpose: In the nature of a substitute)
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.--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).
The bill (S. 5046), as amended, was ordered to be engrossed for a
third reading, was read the third time, and passed.
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