II
119THCONGRESS
1
STSESSION 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.
IN THE SENATE OF THE UNITED STATES
FEBRUARY3, 2025
Mr. B
OOKER(for himself, Mr. SCHMITT, Mr. KING, Mr. KENNEDY, Mr.
W
HITEHOUSE, Mr. MARSHALL, Mr. BLUMENTHAL, Mr. PAUL, and Mr.
L
UJA´N) introduced the following bill; which was read twice and referred
to the Committee on Health, Education, Labor, and Pensions
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 Representa-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘FDA Modernization 4
Act 3.0’’. 5
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•S 355 IS
SEC. 2. REGULATIONS ON NONCLINICAL TESTING METH-1
ODS. 2
(a) I
NTERIMFINALRULE.— 3
(1) I
N GENERAL.—Not later than 1 year after 4
the date of enactment of this Act, the Secretary of 5
Health and Human Services, acting through the 6
Commissioner of Food and Drugs, shall publish an 7
interim final rule pursuant to subsections (b) and 8
(c) to ensure implementation of the amendments to 9
section 505(i) of the Federal Food, Drug, and Cos-10
metic Act (21 U.S.C. 355(i)) made by section 11
3209(a) of the Consolidated Appropriations Act, 12
2023 (Public Law 117–328; 136 Stat. 5821). 13
(2) E
FFECTIVENESS OF INTERIM FINAL 14
RULE.—Notwithstanding subparagraph (B) of sec-15
tion 553(b) of title 5, United States Code, the in-16
terim final rule issued by the Secretary of Health 17
and Human Services under paragraph (1) shall be-18
come immediately effective as an interim final rule 19
without requiring the Secretary of Health and 20
Human Services to demonstrate good cause therefor. 21
(b) I
NCLUSIONS.— 22
(1) I
N GENERAL.—The interim final rule shall 23
replace any references to ‘‘animal’’ tests, data, stud-24
ies, models, and research with a reference to non-25
clinical tests, data, studies, models, and research in 26
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•S 355 IS
the following sections of title 21, Code of Federal 1
Regulations: 2
(A) Section 312.22(c). 3
(B) Section 312.23(a)(3)(iv). 4
(C) Section 312.23(a)(5)(ii). 5
(D) Section 312.23(a)(5)(iii). 6
(E) Section 312.23(a)(8). 7
(F) Section 312.23(a)(8)(i). 8
(G) Section 312.23(a)(8)(ii). 9
(H) Section 312.23(a)(10)(i). 10
(I) Section 312.23(a)(10)(ii). 11
(J) Section 312.33(b)(6). 12
(K) Section 312.82(a). 13
(L) Section 312.88. 14
(M) Section 314.50(d)(2). 15
(N) Section 314.50(d)(2)(iv). 16
(O) Section 314.50(d)(5)(i). 17
(P) Section 314.50(d)(5)(vi)(a). 18
(Q) Section 314.50(d)(5)(vi)(b). 19
(R) Section 314.93(e)(2). 20
(S) Section 315.6(d). 21
(T) Section 330.10(a)(2). 22
(U) Section 601.35(d). 23
(V) Any other section necessary to ensure 24
regulatory consistency with the amendments to 25
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•S 355 IS
section 505(i) of the Federal Food, Drug, and 1
Cosmetic Act (21 U.S.C. 355(i)) made by sec-2
tion 3209(a) of the Consolidated Appropriations 3
Act, 2023 (Public Law 117–328; 136 Stat. 4
5821). 5
(2) A
DDITIONAL CHANGES .—The Secretary 6
may make such additional changes to the sections of 7
title 21, Code of Federal Regulations, described in 8
subparagraphs (A) through (V) of paragraph (1) as 9
the Secretary determines appropriate to fully imple-10
ment the replacement required under such para-11
graph. 12
(c) D
EFINITION OFNONCLINICALTEST.—The defi-13
nition of ‘‘nonclinical test’’ in section 505(z) of the Fed-14
eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)) 15
shall be added to sections 312.3, 314.3, 315.2, and 601.31 16
of title 21, Code of Federal Regulations. 17
(d) T
ECHNICALAMENDMENT.—Section 505 of the 18
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 19
is amended by designating the second subsection (z) (re-20
lating to clinical trial diversity action plans), as added by 21
section 3601(a) of the Health Extenders, Improving Ac-22
cess to Medicare, Medicaid, and CHIP, and Strengthening 23
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•S 355 IS
Public Health Act of 2022 (division FF of Public Law 1
117–328), as subsection (aa). 2
Æ
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