FDA Modernization Act 3.0
Officially: “FDA Modernization Act 3.0” Read the full text
What it does
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1Short title
This section would give the Act the short title "FDA Modernization Act 3.0."
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1. Short title This Act may be cited as the FDA Modernization Act 3.0 .
2Regulations on nonclinical testing methods
This section would require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish an interim final rule no later than 1 year after this Act becomes law. The rule would carry out the amendments already made to section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) by section 3209(a) of the Consolidated Appropriations Act, 2023 (Public Law 117-328; 136 Stat. 5821). The interim final rule would take effect immediately when published, and the Secretary would not have to show good cause for skipping the usual requirement, under section 553(b)(B) of title 5, United States Code, that an agency justify issuing a rule without prior notice and public comment. The rule would replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research in the following sections of title 21 of the Code of Federal Regulations: 312.22(c); 312.23(a)(3)(iv), (a)(5)(ii), (a)(5)(iii), (a)(8), (a)(8)(i), (a)(8)(ii), (a)(10)(i), and (a)(10)(ii); 312.33(b)(6); 312.82(a); 312.88; 314.50(d)(2), (d)(2)(iv), (d)(5)(i), (d)(5)(vi)(a), and (d)(5)(vi)(b); 314.93(e)(2); 315.6(d); 330.10(a)(2); and 601.35(d). The rule would also make this same replacement in any other section of title 21 that is necessary to keep the regulations consistent with the 2023 law's amendments, and the Secretary could make any additional changes to these listed sections that the Secretary decides are needed to fully carry out the required replacement. The rule would also add the definition of "nonclinical test" that already appears in section 505(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)) to four more sections of title 21: 312.3, 314.3, 315.2, and 601.31. Finally, this section would fix a numbering conflict in the Federal Food, Drug, and Cosmetic Act: an earlier law had created two separate provisions both labeled subsection (z) of section 505, one defining nonclinical tests and a second, added by section 3601(a) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022 (division FF of Public Law 117-328), covering clinical trial diversity action plans; this section would relabel that second provision, on clinical trial diversity action plans, as subsection (aa), so it no longer shares a label with the nonclinical test definition.
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2. Regulations on nonclinical testing methods (a) Interim final rule (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish an interim final rule pursuant to subsections (b) and (c) to ensure implementation of the amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) made by section 3209(a) of the Consolidated Appropriations Act, 2023 ( Public Law 117–328 ; 136 Stat. 5821). (2) Effectiveness of interim final rule Notwithstanding subparagraph (B) of section 553(b) of title 5, United States Code, the interim final rule issued by the Secretary of Health and Human Services under paragraph (1) shall become immediately effective as an interim final rule without requiring the Secretary of Health and Human Services to demonstrate good cause therefor. (b) Inclusions (1) In general The interim final rule shall replace any references to animal tests, data, studies, models, and research with a reference to nonclinical tests, data, studies, models, and research in the following sections of title 21, Code of Federal Regulations: (A) Section 312.22(c). (B) Section 312.23(a)(3)(iv). (C) Section 312.23(a)(5)(ii). (D) Section 312.23(a)(5)(iii). (E) Section 312.23(a)(8). (F) Section 312.23(a)(8)(i). (G) Section 312.23(a)(8)(ii). (H) Section 312.23(a)(10)(i). (I) Section 312.23(a)(10)(ii). (J) Section 312.33(b)(6). (K) Section 312.82(a). (L) Section 312.88. (M) Section 314.50(d)(2). (N) Section 314.50(d)(2)(iv). (O) Section 314.50(d)(5)(i). (P) Section 314.50(d)(5)(vi)(a). (Q) Section 314.50(d)(5)(vi)(b). (R) Section 314.93(e)(2). (S) Section 315.6(d). (T) Section 330.10(a)(2). (U) Section 601.35(d). (V) Any other section necessary to ensure regulatory consistency with the amendments to section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) made by section 3209(a) of the Consolidated Appropriations Act, 2023 ( Public Law 117–328 ; 136 Stat. 5821). (2) Additional changes The Secretary may make such additional changes to the sections of title 21, Code of Federal Regulations, described in subparagraphs (A) through (V) of paragraph (1) as the Secretary determines appropriate to fully implement the replacement required under such paragraph. (c) Definition of nonclinical test The definition of nonclinical test in section 505(z) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(z) ) shall be added to sections 312.3, 314.3, 315.2, and 601.31 of title 21, Code of Federal Regulations. (d) 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) (relating to clinical trial diversity action plans), as added by section 3601(a) of the Health Extenders, Improving Access to Medicare, Medicaid, and CHIP, and Strengthening Public Health Act of 2022 (division FF of Public Law 117–328 ), as subsection (aa).
Where it is
In the Senate.