118TH CONGRESS 

2D SESSION S. 5046 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 
2 

†S 5046 ES

1 SECTION 1. SHORT TITLE. 

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

3 Act 3.0’’. 

4 SEC. 2. REGULATIONS ON NONCLINICAL TESTING METH5 ODS. 

6 (a) INTERIM FINAL RULE.— 

7 (1) IN GENERAL.—Not later than 1 year after 

8 the date of enactment of this Act, the Secretary of 

9 Health and Human Services, acting through the 

10 Commissioner of Food and Drugs, shall publish an 

11 interim final rule pursuant to subsections (b) and 

12 (c) to ensure implementation of the amendments to 

13 section 505(i) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 355(i)) made by section 

15 3209(a) of the Consolidated Appropriations Act, 

16 2023 (Public Law 117–328; 136 Stat. 5821). 

17 (2) EFFECTIVENESS OF INTERIM FINAL

18 RULE.—Notwithstanding subparagraph (B) of sec19 tion 553(b) of title 5, United States Code, the in20 terim final rule issued by the Secretary of Health 

21 and Human Services under paragraph (1) shall be22 come immediately effective as an interim final rule 

23 without requiring the Secretary of Health and 

24 Human Services to demonstrate good cause therefor. 

25 (b) INCLUSIONS.— 
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†S 5046 ES

1 (1) IN GENERAL.—The interim final rule shall 

2 replace any references to ‘‘animal’’ tests, data, stud3 ies, models, and research with a reference to non4 clinical tests, data, studies, models, and research in 

5 the following sections of title 21, Code of Federal 

6 Regulations: 

7 (A) Section 312.22(c). 

8 (B) Section 312.23(a)(3)(iv). 

9 (C) Section 312.23(a)(5)(ii). 

10 (D) Section 312.23(a)(5)(iii). 

11 (E) Section 312.23(a)(8). 

12 (F) Section 312.23(a)(8)(i). 

13 (G) Section 312.23(a)(8)(ii). 

14 (H) Section 312.23(a)(10)(i). 

15 (I) Section 312.23(a)(10)(ii). 

16 (J) Section 312.33(b)(6). 

17 (K) Section 312.82(a). 

18 (L) Section 312.88. 

19 (M) Section 314.50(d)(2). 

20 (N) Section 314.50(d)(2)(iv). 

21 (O) Section 314.50(d)(5)(i). 

22 (P) Section 314.50(d)(5)(vi)(a). 

23 (Q) Section 314.50(d)(5)(vi)(b). 

24 (R) Section 314.93(e)(2). 

25 (S) Section 315.6(d). 
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†S 5046 ES

1 (T) Section 330.10(a)(2). 

2 (U) Section 601.35(d). 

3 (V) Any other section necessary to ensure 

4 regulatory consistency with the amendments to 

5 section 505(i) of the Federal Food, Drug, and 

6 Cosmetic Act (21 U.S.C. 355(i)) made by sec7 tion 3209(a) of the Consolidated Appropriations 

8 Act, 2023 (Public Law 117–328; 136 Stat. 

9 5821). 

10 (2) ADDITIONAL CHANGES.—The Secretary 

11 may make such additional changes to the sections of 

12 title 21, Code of Federal Regulations, described in 

13 subparagraphs (A) through (V) of paragraph (1) as 

14 the Secretary determines appropriate to fully imple15 ment the replacement required under such para16 graph. 

17 (c) DEFINITION OF NONCLINICAL TEST.—The defi18 nition of ‘‘nonclinical test’’ in section 505(z) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)) 

20 shall be added to sections 312.3, 314.3, 315.2, and 601.31 

21 of title 21, Code of Federal Regulations. 

22 (d) TECHNICAL AMENDMENT.—Section 505 of the 

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

24 is amended by designating the second subsection (z) (re25 lating to clinical trial diversity action plans), as added by 
5 

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1 section 3601(a) of the Health Extenders, Improving Ac2 cess to Medicare, Medicaid, and CHIP, and Strengthening 

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

4 117–328), as subsection (aa). 

Passed the Senate December 12, 2024. 

Attest: 

Secretary. 
118TH CONGRESS 

2D SESSION S. 5046 

AN ACT 

To require the Secretary of Health and Human 

to nonclinical testing methods. Food and Drugs, to publish a final rule relating Services, acting through the Commissioner of