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) In 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). (2) Effectiveness 5821), not later than 1 year after the date of interim final rule Notwithstanding subparagraph (B) enactment of section 553(b) of title 5, United States Code, the interim final rule issued by this Act, the Secretary of Health and Human Services under paragraph (1) Services, acting through the Commissioner of Food and Drugs, shall become immediately effective as publish an interim final rule without requiring rule— (A) to amend the Secretary sections of Health and Human Services title 21, Code of Federal Regulations, described in paragraph (2) 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 research; and (B) to add the definition of nonclinical test in section 505(z) of the following 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 described The sections of title 21, Code of Federal Regulations: 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). (2) Additional changes The Secretary may make such additional changes to the sections (3) Effectiveness of interim final rule Notwithstanding subparagraph (B) of section 553(b) of title 21, Code 5, United States Code, the interim final rule issued by the Secretary of Federal Regulations, described in subparagraphs (A) through (V) of Health and Human Services under paragraph (1) shall become immediately effective as an interim final rule without requiring the Secretary determines appropriate of Health and Human Services 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) demonstrate good cause therefor. (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).