U.S. Congress legislation · 119th Congress
HB2821: FDA Modernization Act 3.0
Status: Passed one chamber, July 21, 2026
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.
What the bill says
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 described The sections of title 21, Code of Federal Regulations, described in this paragraph are the following: (A) Se.
From the engrossed text, July 20, 2026:
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 described The 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 rule Notwithstanding subparagraph (B) of section 553(b) of title …