I
119THCONGRESS
1
STSESSION 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
APRIL10, 2025
Mr. C
ARTERof Georgia (for himself, Ms. BARRAGA´N, Mr. BUCHANAN, Ms.
D
ELAURO, Mrs. HARSHBARGER, and Mr. CARTERof Louisiana) intro-
duced 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 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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•HR 2821 IH
SEC. 2. REGULATIONS ON NONCLINICAL TESTING METH-1
ODS. 2
(a) I
NTERIMFINALRULE.— 3
(1) I
N GENERAL.—In order to ensure imple-4
mentation of the amendments to section 505(i) of 5
the Federal Food, Drug, and Cosmetic Act (21 6
U.S.C. 355(i)) made by section 3209(a) of the Con-7
solidated Appropriations Act, 2023 (Public Law 8
117–328; 136 Stat. 5821), not later than 1 year 9
after the date of enactment of this Act, the Sec-10
retary of Health and Human Services, acting 11
through the Commissioner of Food and Drugs, shall 12
publish an interim final rule— 13
(A) to amend the sections of title 21, Code 14
of Federal Regulations, described in paragraph 15
(2) to replace any references to ‘‘animal’’ tests, 16
data, studies, models, and research with a ref-17
erence to nonclinical tests, data, studies, mod-18
els, and research; and 19
(B) to add the definition of ‘‘nonclinical 20
test’’ in section 505(z) of the Federal Food, 21
Drug, and Cosmetic Act (21 U.S.C. 355(z)) to 22
sections 312.3, 314.3, 315.2, and 601.31 of 23
title 21, Code of Federal Regulations. 24
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•HR 2821 IH
(2) CFR SECTIONS DESCRIBED.—The sections 1
of title 21, Code of Federal Regulations, described 2
in this paragraph are the following: 3
(A) Section 312.22(c). 4
(B) Section 312.23(a)(3)(iv). 5
(C) Section 312.23(a)(5)(ii). 6
(D) Section 312.23(a)(5)(iii). 7
(E) Section 312.23(a)(8). 8
(F) Section 312.23(a)(8)(i). 9
(G) Section 312.23(a)(8)(ii). 10
(H) Section 312.23(a)(10)(i). 11
(I) Section 312.23(a)(10)(ii). 12
(J) Section 312.33(b)(6). 13
(K) Section 312.82(a). 14
(L) Section 312.88. 15
(M) Section 314.50(d)(2). 16
(N) Section 314.50(d)(2)(iv). 17
(O) Section 314.50(d)(5)(i). 18
(P) Section 314.50(d)(5)(vi)(a). 19
(Q) Section 314.50(d)(5)(vi)(b). 20
(R) Section 314.93(e)(2). 21
(S) Section 315.6(d). 22
(T) Section 330.10(a)(2). 23
(U) Section 601.35(d). 24
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(V) Any other section necessary to ensure 1
regulatory consistency with the amendments to 2
section 505(i) of the Federal Food, Drug, and 3
Cosmetic Act (21 U.S.C. 355(i)) made by sec-4
tion 3209(a) of the Consolidated Appropriations 5
Act, 2023 (Public Law 117–328; 136 Stat. 6
5821). 7
(3) E
FFECTIVENESS OF INTERIM FINAL 8
RULE.—Notwithstanding subparagraph (B) of sec-9
tion 553(b) of title 5, United States Code, the in-10
terim final rule issued by the Secretary of Health 11
and Human Services under paragraph (1) shall be-12
come immediately effective as an interim final rule 13
without requiring the Secretary of Health and 14
Human Services to demonstrate good cause therefor. 15
(b) T
ECHNICALAMENDMENT.—Section 505 of the 16
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 17
is amended by designating the second subsection (z) (re-18
lating to clinical trial diversity action plans), as added by 19
section 3601(a) of the Health Extenders, Improving Ac-20
cess to Medicare, Medicaid, and CHIP, and Strengthening 21
Public Health Act of 2022 (division FF of Public Law 22
117–328), as subsection (aa). 23
Æ
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