FDA Modernization Act 3.0

117 S355 ES: FDA Modernization Act 3.0 U.S. Senate text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. 119th CONGRESS1st SessionS. 355IN THE SENATE OF THE UNITED STATESAN ACTTo 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 titleThis Act may be cited as the FDA Modernization Act 3.0.2.Regulations on nonclinical testing methods(a)Interim final rule(1)In generalIn order 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), 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—(A)to amend the sections of title 21, Code of Federal Regulations, described in paragraph (2) to replace any references to animal tests, data, studies, models, and research with a reference to nonclinical tests, data, studies, models, and research; and(B)to add the definition of nonclinical test in section 505(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(z)) to sections 312.3, 314.3, 315.2, and 601.31 of title 21, Code of Federal Regulations. (2)CFR sections describedThe sections of title 21, Code of Federal Regulations, described in this paragraph are the following:(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). (3)Effectiveness of interim final ruleNotwithstanding 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)Technical amendmentSection 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 SenateSecretary

117 S355 IS: FDA Modernization Act 3.0 U.S. Senate 2025-02-03 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II119th CONGRESS1st SessionS. 355IN THE SENATE OF THE UNITED STATESFebruary 3, 2025Mr. Booker (for himself, Mr. Schmitt, Mr. King, Mr. Kennedy, Mr. Whitehouse, Mr. Marshall, Mr. Blumenthal, Mr. Paul, and Mr. Luján) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsA BILLTo 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 titleThis Act may be cited as the FDA Modernization Act 3.0.2.Regulations on nonclinical testing methods(a)Interim final rule(1)In generalNot 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 ruleNotwithstanding 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 generalThe 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 changesThe 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 testThe 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 amendmentSection 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).