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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 355 Engrossed in Senate (ES)]
<DOC>
119th CONGRESS
1st Session
S. 355
_______________________________________________________________________
AN ACT
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).
Passed the Senate
Attest:
Secretary.
119th CONGRESS
1st Session
S. 355
_______________________________________________________________________
AN ACT
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.