I 
★
118TH CONGRESS 
2D SESSION 
H. R. 7248 
To amend the Federal Food, Drug, and Cosmetic Act to establish a process 
for the qualification of nonclinical testing methods to reduce and replace 
the use of animals in nonclinical research, improve the predictivity of 
nonclinical testing methods, and reduce development time for a biological 
product or other drug, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 6, 2024 
Mr. CARTER of Georgia (for himself, Ms. BARRAGA´N, Mrs. HARSHBARGER, 
Mr. BUCHANAN, Mr. CARTER of Louisiana, Mr. WALTZ, Ms. DELAURO, 
Mr. NEHLS, Mr. GOODEN
of Texas, Mr. CRENSHAW, and Mr. 
FITZPATRICK) introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
establish a process for the qualification of nonclinical 
testing methods to reduce and replace the use of animals 
in nonclinical research, improve the predictivity of non-
clinical testing methods, and reduce development time 
for a biological product or other drug, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘FDA Modernization 
Act 3.0’’. 
SEC. 2. NONCLINICAL TESTING METHODS QUALIFICATION 
PROCESS AT THE FOOD AND DRUG ADMINIS-
TRATION. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by inserting after section 507 the fol-
lowing: 
‘‘SEC. 507A. NONCLINICAL TESTING METHODS QUALIFICA-
TION PROCESS. 
‘‘(a) IN GENERAL.— 
‘‘(1) PROCESS
DESCRIPTION.—The Secretary 
shall establish a process for the qualification of a 
nonclinical testing method, with respect to drugs, 
under which— 
‘‘(A) persons may request qualification of 
a nonclinical testing method for a particular 
context of use; and 
‘‘(B) the Secretary shall grant or deny 
such request in accordance with this section. 
‘‘(2) INITIATION.—The Secretary shall initiate 
the process under paragraph (1) not later than 1 
year after the date of enactment of this section. 
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‘‘(b) ELIGIBLE NONCLINICAL TESTING METHODS.— 
To be eligible for qualification under this section, a non-
clinical testing method shall— 
‘‘(1) be intended to replace or reduce animal 
testing; and 
‘‘(2) either— 
‘‘(A) improve the predictivity of nonclinical 
testing for safety and efficacy; or 
‘‘(B) reduce development time for a drug 
(including any biological product). 
‘‘(c) QUALIFICATION
OF
NONCLINICAL
TESTING 
METHODS.— 
‘‘(1) PROCESS.—The Secretary shall establish a 
process for submission of a request under subsection 
(a). 
‘‘(2) CONTENTS.—At a minimum, a request 
under subsection (a) shall include preliminary infor-
mation demonstrating that the nonclinical testing 
method meets the criteria described in subsection (b) 
in a particular context of use. 
‘‘(3) ADVICE
REGARDING
THE
METHOD
OF 
NONCLINICAL TESTING.—The Secretary may facili-
tate the development and review of preliminary in-
formation submitted pursuant to paragraph (2) in a 
request under subsection (a) by— 
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‘‘(A) providing timely advice to, and inter-
action with, the person submitting the request 
regarding the development of the method of 
nonclinical testing; and 
‘‘(B) involving senior managers and experi-
enced staff of the Food and Drug Administra-
tion, as appropriate, in a collaborative, cross- 
disciplinary review of the proposed method of 
nonclinical testing. 
‘‘(4) ENGAGEMENT OF EXTERNAL EXPERTS.— 
In reviewing a request under subsection (a), the Sec-
retary may— 
‘‘(A) through the use of cooperative agree-
ments or other appropriate mechanisms, consult 
with biomedical research consortia and other 
expert stakeholders with specific expertise in 
nonclinical testing methods; and 
‘‘(B) consider recommendations of bio-
medical research consortia or other qualified ex-
perts in deciding whether to grant or deny the 
request. 
‘‘(5) REVIEW OF REQUESTS.— 
‘‘(A) TIMING.—Not later than 180 cal-
endar days after the receipt of a request under 
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subsection (a), the Secretary shall determine 
whether to grant or deny the request. 
‘‘(B) DETERMINATION.—In reviewing a 
nonclinical testing method pursuant to a re-
quest under subsection (a), the Secretary shall 
determine whether to grant or deny the request 
based on whether the method satisfies the cri-
teria listed in subsection (b) as demonstrated 
by— 
‘‘(i) the information submitted in the 
request or supplements thereto; and 
‘‘(ii) any additional information pro-
vided by external experts. 
‘‘(C) QUALIFICATION
DECISION.—If the 
Secretary determines pursuant to subparagraph 
(B) that a nonclinical testing method satisfies 
the criteria listed in subsection (b), the Sec-
retary shall grant the request for qualification 
of the method in a particular context of use. 
‘‘(d) EFFECTS OF QUALIFICATION.—If the Secretary 
qualifies a nonclinical testing method pursuant to a re-
quest under this section— 
‘‘(1) the method shall be available for use by 
the holder of the qualification or a person authorized 
by such holder for drug development in the par-
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ticular context of use for which the method is quali-
fied; and 
‘‘(2) the Secretary shall— 
‘‘(A) expedite the development and review 
of an application submitted under section 505 
of this Act or section 351 of the Public Health 
Service Act, including supplemental applica-
tions, for drugs that are developed using the 
qualified nonclinical testing method; and 
‘‘(B) allow the holder of the qualification 
or a person authorized by such holder to ref-
erence or rely upon, in an application submitted 
under section 505 of this Act or section 351 of 
the Public Health Service Act, including a sup-
plemental application, data and information 
about the qualification of the nonclinical testing 
method in the same context of use for which the 
qualification was granted. 
‘‘(e) REVIEW OF APPLICATIONS UTILIZING QUALI-
FIED NONCLINICAL TESTING METHODS.—The Secretary 
shall expedite the development and review of an applica-
tion submitted under section 505 of this Act or section 
351 of the Public Health Service Act for drugs for which 
a nonclinical testing method qualified under this section 
is used. 
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‘‘(f) TRANSPARENCY.— 
‘‘(1) SUBMISSION OF REPORT TO CONGRESS.— 
Not later than 2 years after the date of enactment 
of this section and annually thereafter, the Secretary 
shall publish on the website of the Food and Drug 
Administration and submit to the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate and the Committee on Energy and Commerce of 
the House of Representatives a report containing an 
evaluation of the process under this section. 
‘‘(2) CONTENTS
OF
REPORT.—Each report 
under paragraph (1) shall include— 
‘‘(A) for the period covered by the report— 
‘‘(i) the types of nonclinical testing 
methods qualified under the process; 
‘‘(ii) the number of requests for quali-
fication under subsection (a), and the 
number of such requests that have been 
granted; 
‘‘(iii) the average number of calendar 
days for the review of requests under sub-
section (a) before granting or denying such 
requests; 
‘‘(iv) an analysis of the factors that 
result in determinations to qualify or not 
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qualify a nonclinical testing method under 
this section; and 
‘‘(v) the number of applications re-
ceived under section 505 of this Act or sec-
tion 351 of the Public Health Service Act 
that rely on a nonclinical testing method 
qualified under this section, and the num-
ber of such applications approved; and 
‘‘(B) for the period beginning on the date 
of enactment of this section through the end of 
the period covered by the report, the number of 
animals estimated to have been saved as a re-
sult of the process under this section. 
‘‘(g) NONCLINICAL TESTING METHOD DEFINED.— 
In this section, the term ‘nonclinical testing method’ has 
the meaning given to such term in section 505(z) except 
that such term excludes any animal test.’’. 
(b) PUBLIC MEETING.— Not later than 180 days 
after the date of enactment of this Act, the Secretary of 
Health and Human Services shall publish in the Federal 
Register a notice to convene a public meeting to discuss 
and obtain input and recommendations from relevant 
stakeholders, including regulated industry, biomedical con-
sortia, contract research organizations, and patients, re-
garding— 
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(1) the goals and scope of the process under 
507A of the Federal Food, Drug, and Cosmetic Act, 
as added by subsection (a); 
(2) a framework, procedures, and requirements 
for such process; and 
(3) ways in which the Food and Drug Adminis-
tration will support the use of nonclinical testing 
methods to replace or reduce the use of animals in 
nonclinical testing. 
(c) FDA GUIDANCE.— 
(1) NONCLINICAL
TESTING
METHODS
QUALI-
FICATION PROCESS.—The Secretary of Health and 
Human Services, acting through the Commissioner 
of Food and Drugs, shall— 
(A) not later than 1 year after the date of 
the public meeting under subsection (b), pro-
pose guidance on the goals and implementation 
of the process under section 507A of the Fed-
eral Food, Drug, and Cosmetic Act, as added 
by subsection (a); 
(B) provide a period for public comment 
on such proposed guidance; and 
(C) not later than 1 year after the end of 
such public comment period, finalize such guid-
ance. 
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(2) CONTENTS.—The guidance under para-
graph (1) shall address— 
(A) the process by which a person may re-
quest qualification under section 507A of the 
Federal Food, Drug, and Cosmetic Act, as 
added by subsection (a); 
(B) the eligibility criteria under subsection 
(b) of such section 507A; 
(C) the information that a person request-
ing such qualification is required to submit 
under subsection (c) of such section 507A; and 
(D) how the Secretary intends to evaluate 
requests under such section 507A. 
SEC. 3. REGULATIONS ON NONCLINICAL TESTING METH-
ODS. 
(a) IN GENERAL.—Not later than 90 days after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall initiate a rulemaking under section 
553 of title 5, United States Code, to implement section 
505(z) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(z)). 
(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) (re-
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lating to clinical trial diversity action plans), as added by 
section 3601(a) of the Health Extenders, Improving Ac-
cess to Medicare, Medicaid, and CHIP, and Strengthening 
Public Health Act of 2022 (division FF of Public Law 
117–328), as subsection (aa). 
Æ 
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