FDA Modernization Act 3.0

Bill: 118-s-5046
Sponsor: full_name: Sen. Booker, Cory A. [D-NJ]
Introduced: 2024-09-12
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Medical research

Research administration and funding
Latest action: action_date: 2024-12-16
text: Held at the desk.

Summaries:
action_date: 2024-12-12
action_desc: Passed Senate
text: <p><strong>FDA Modernization Act 3.0</strong></p><p>This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug.&nbsp;</p><p>The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications, and may make other changes to the regulations as appropriate.&nbsp;</p><p>The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.&nbsp;</p>

tv_txt: 118th CONGRESS 2d Session S. 5046 IN THE SENATE OF THE UNITED STATES 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. Short title This Act may be cited as the FDA Modernization Act 3.0 . 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).

Passed the Senate December 12, 2024. Secretary

tv_txt: II 118th CONGRESS 2d Session S. 5046 IN THE SENATE OF THE UNITED STATES September 12, 2024 Mr. Booker (for himself, Mr. Schmitt , Mr. Paul , Mr. King , Mr. Braun , Mr. Whitehouse , Mr. Kennedy , Mr. Luján , and Mr. Blumenthal ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 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.

1. Short title This Act may be cited as the FDA Modernization Act 3.0 . 2. Regulations on nonclinical testing methods (a) In general Not later than 180 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 publish a final rule 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) (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).