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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 nonclinical testing methods, and reduce development time 

for a biological product or other drug, and for other 

purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘FDA Modernization 

3 Act 3.0’’. 

4 SEC. 2. NONCLINICAL TESTING METHODS QUALIFICATION 

5 PROCESS AT THE FOOD AND DRUG ADMINIS6 TRATION. 

7 (a) IN GENERAL.—Subchapter A of chapter V of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 

9 et seq.) is amended by inserting after section 507 the fol10 lowing: 

11 ‘‘SEC. 507A. NONCLINICAL TESTING METHODS QUALIFICA12 TION PROCESS. 

13 ‘‘(a) IN GENERAL.— 

14 ‘‘(1) PROCESS DESCRIPTION.—The Secretary 

15 shall establish a process for the qualification of a 

16 nonclinical testing method, with respect to drugs, 

17 under which— 

18 ‘‘(A) persons may request qualification of 

19 a nonclinical testing method for a particular 

20 context of use; and 

21 ‘‘(B) the Secretary shall grant or deny 

22 such request in accordance with this section. 

23 ‘‘(2) INITIATION.—The Secretary shall initiate 

24 the process under paragraph (1) not later than 1 

25 year after the date of enactment of this section. 


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1 ‘‘(b) ELIGIBLE NONCLINICAL TESTING METHODS.— 

2 To be eligible for qualification under this section, a non3 clinical testing method shall— 

4 ‘‘(1) be intended to replace or reduce animal 

5 testing; and 

6 ‘‘(2) either— 

7 ‘‘(A) improve the predictivity of nonclinical 

8 testing for safety and efficacy; or 

9 ‘‘(B) reduce development time for a drug 

10 (including any biological product). 

11 ‘‘(c) QUALIFICATION OF NONCLINICAL TESTING

12 METHODS.— 

13 ‘‘(1) PROCESS.—The Secretary shall establish a 

14 process for submission of a request under subsection 

15 (a). 

16 ‘‘(2) CONTENTS.—At a minimum, a request 

17 under subsection (a) shall include preliminary infor18 mation demonstrating that the nonclinical testing 

19 method meets the criteria described in subsection (b) 

20 in a particular context of use. 

21 ‘‘(3) ADVICE REGARDING THE METHOD OF

22 NONCLINICAL TESTING.—The Secretary may facili23 tate the development and review of preliminary in24 formation submitted pursuant to paragraph (2) in a 

25 request under subsection (a) by— 


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1 ‘‘(A) providing timely advice to, and inter2 action with, the person submitting the request 

3 regarding the development of the method of 

4 nonclinical testing; and 

5 ‘‘(B) involving senior managers and experi6 enced staff of the Food and Drug Administra7 tion, as appropriate, in a collaborative, cross8 disciplinary review of the proposed method of 

9 nonclinical testing. 

10 ‘‘(4) ENGAGEMENT OF EXTERNAL EXPERTS.— 

11 In reviewing a request under subsection (a), the Sec12 retary may— 

13 ‘‘(A) through the use of cooperative agree14 ments or other appropriate mechanisms, consult 

15 with biomedical research consortia and other 

16 expert stakeholders with specific expertise in 

17 nonclinical testing methods; and 

18 ‘‘(B) consider recommendations of bio19 medical research consortia or other qualified ex20 perts in deciding whether to grant or deny the 

21 request. 

22 ‘‘(5) REVIEW OF REQUESTS.— 

23 ‘‘(A) TIMING.—Not later than 180 cal24 endar days after the receipt of a request under 


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1 subsection (a), the Secretary shall determine 

2 whether to grant or deny the request. 

3 ‘‘(B) DETERMINATION.—In reviewing a 

4 nonclinical testing method pursuant to a re5 quest under subsection (a), the Secretary shall 

6 determine whether to grant or deny the request 

7 based on whether the method satisfies the cri8 teria listed in subsection (b) as demonstrated 

9 by— 

10 ‘‘(i) the information submitted in the 

11 request or supplements thereto; and 

12 ‘‘(ii) any additional information pro13 vided by external experts. 

14 ‘‘(C) QUALIFICATION DECISION.—If the 

15 Secretary determines pursuant to subparagraph 

16 (B) that a nonclinical testing method satisfies 

17 the criteria listed in subsection (b), the Sec18 retary shall grant the request for qualification 

19 of the method in a particular context of use. 

20 ‘‘(d) EFFECTS OF QUALIFICATION.—If the Secretary 

21 qualifies a nonclinical testing method pursuant to a re22 quest under this section— 

23 ‘‘(1) the method shall be available for use by 

24 the holder of the qualification or a person authorized 

25 by such holder for drug development in the parVerDate Sep 11 2014 22:31 Feb 23, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H7248.IH H7248

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1 ticular context of use for which the method is quali2 fied; and 

3 ‘‘(2) the Secretary shall— 

4 ‘‘(A) expedite the development and review 

5 of an application submitted under section 505 

6 of this Act or section 351 of the Public Health 

7 Service Act, including supplemental applica8 tions, for drugs that are developed using the 

9 qualified nonclinical testing method; and 

10 ‘‘(B) allow the holder of the qualification 

11 or a person authorized by such holder to ref12 erence or rely upon, in an application submitted 

13 under section 505 of this Act or section 351 of 

14 the Public Health Service Act, including a sup15 plemental application, data and information 

16 about the qualification of the nonclinical testing 

17 method in the same context of use for which the 

18 qualification was granted. 

19 ‘‘(e) REVIEW OF APPLICATIONS UTILIZING QUALI20 FIED NONCLINICAL TESTING METHODS.—The Secretary 

21 shall expedite the development and review of an applica22 tion submitted under section 505 of this Act or section 

23 351 of the Public Health Service Act for drugs for which 

24 a nonclinical testing method qualified under this section 

25 is used. 


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1 ‘‘(f) TRANSPARENCY.— 

2 ‘‘(1) SUBMISSION OF REPORT TO CONGRESS.— 

3 Not later than 2 years after the date of enactment 

4 of this section and annually thereafter, the Secretary 

5 shall publish on the website of the Food and Drug 

6 Administration and submit to the Committee on 

7 Health, Education, Labor, and Pensions of the Sen8 ate and the Committee on Energy and Commerce of 

9 the House of Representatives a report containing an 

10 evaluation of the process under this section. 

11 ‘‘(2) CONTENTS OF REPORT.—Each report 

12 under paragraph (1) shall include— 

13 ‘‘(A) for the period covered by the report— 

14 ‘‘(i) the types of nonclinical testing 

15 methods qualified under the process; 

16 ‘‘(ii) the number of requests for quali17 fication under subsection (a), and the 

18 number of such requests that have been 

19 granted; 

20 ‘‘(iii) the average number of calendar 

21 days for the review of requests under sub22 section (a) before granting or denying such 

23 requests; 

24 ‘‘(iv) an analysis of the factors that 

25 result in determinations to qualify or not 


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1 qualify a nonclinical testing method under 

2 this section; and 

3 ‘‘(v) the number of applications re4 ceived under section 505 of this Act or sec5 tion 351 of the Public Health Service Act 

6 that rely on a nonclinical testing method 

7 qualified under this section, and the num8 ber of such applications approved; and 

9 ‘‘(B) for the period beginning on the date 

10 of enactment of this section through the end of 

11 the period covered by the report, the number of 

12 animals estimated to have been saved as a re13 sult of the process under this section. 

14 ‘‘(g) NONCLINICAL TESTING METHOD DEFINED.— 

15 In this section, the term ‘nonclinical testing method’ has 

16 the meaning given to such term in section 505(z) except 

17 that such term excludes any animal test.’’. 

18 (b) PUBLIC MEETING.— Not later than 180 days 

19 after the date of enactment of this Act, the Secretary of 

20 Health and Human Services shall publish in the Federal 

21 Register a notice to convene a public meeting to discuss 

22 and obtain input and recommendations from relevant 

23 stakeholders, including regulated industry, biomedical con24 sortia, contract research organizations, and patients, re25 garding— 


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1 (1) the goals and scope of the process under 

2 507A of the Federal Food, Drug, and Cosmetic Act, 

3 as added by subsection (a); 

4 (2) a framework, procedures, and requirements 

5 for such process; and 

6 (3) ways in which the Food and Drug Adminis7 tration will support the use of nonclinical testing 

8 methods to replace or reduce the use of animals in 

9 nonclinical testing. 

10 (c) FDA GUIDANCE.— 

11 (1) NONCLINICAL TESTING METHODS QUALI12 FICATION PROCESS.—The Secretary of Health and 

13 Human Services, acting through the Commissioner 

14 of Food and Drugs, shall— 

15 (A) not later than 1 year after the date of 

16 the public meeting under subsection (b), pro17 pose guidance on the goals and implementation 

18 of the process under section 507A of the Fed19 eral Food, Drug, and Cosmetic Act, as added 

20 by subsection (a); 

21 (B) provide a period for public comment 

22 on such proposed guidance; and 

23 (C) not later than 1 year after the end of 

24 such public comment period, finalize such guid25 ance. 


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1 (2) CONTENTS.—The guidance under para2 graph (1) shall address— 

3 (A) the process by which a person may re4 quest qualification under section 507A of the 

5 Federal Food, Drug, and Cosmetic Act, as 

6 added by subsection (a); 

7 (B) the eligibility criteria under subsection 

8 (b) of such section 507A; 

9 (C) the information that a person request10 ing such qualification is required to submit 

11 under subsection (c) of such section 507A; and 

12 (D) how the Secretary intends to evaluate 

13 requests under such section 507A. 

14 SEC. 3. REGULATIONS ON NONCLINICAL TESTING METH15 ODS. 

16 (a) IN GENERAL.—Not later than 90 days after the 

17 date of enactment of this Act, the Secretary of Health and 

18 Human Services, acting through the Commissioner of 

19 Food and Drugs, shall initiate a rulemaking under section 

20 553 of title 5, United States Code, to implement section 

21 505(z) of the Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 355(z)). 

23 (b) TECHNICAL AMENDMENT.—Section 505 of the 

24 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 

25 is amended by designating the second subsection (z) (reVerDate Sep 11 2014 22:31 Feb 23, 2024 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H7248.IH H7248

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1 lating to clinical trial diversity action plans), as added by 

2 section 3601(a) of the Health Extenders, Improving Ac3 cess to Medicare, Medicaid, and CHIP, and Strengthening 

4 Public Health Act of 2022 (division FF of Public Law 

5 117–328), as subsection (aa). 

Æ 


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