FDA Modernization Act 3.0

119 HR 2821 EH: FDA Modernization Act 3.0 U.S. House of Representatives 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. IB 119th CONGRESS2d Session H. R. 2821

IN THE HOUSE OF REPRESENTATIVES 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 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 House of Representatives July 20, 2026.Kevin F. McCumber,Clerk.

119 HR 2821 IH: FDA Modernization Act 3.0 U.S. House of Representatives 2025-04-10 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. I119th CONGRESS1st SessionH. R. 2821IN THE HOUSE OF REPRESENTATIVESApril 10, 2025Mr. Carter of Georgia (for himself, Ms. Barragán, Mr. Buchanan, Ms. DeLauro, Mrs. Harshbarger, and Mr. Carter of Louisiana) introduced the following bill; which was referred to the Committee on Energy and CommerceA 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 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).

117 HR 2821 RH: FDA Modernization Act 3.0 U.S. House of Representatives 2026-06-18 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. IBUnion Calendar No. 614119th CONGRESS2d SessionH. R. 2821[Report No. 119–706]IN THE HOUSE OF REPRESENTATIVESApril 10, 2025Mr. Carter of Georgia (for himself, Ms. Barragán, Mr. Buchanan, Ms. DeLauro, Mrs. Harshbarger, and Mr. Carter of Louisiana) introduced the following bill; which was referred to the Committee on Energy and CommerceJune 18, 2026Additional sponsors: Mr. Doggett, Mr. Nadler, Mr. Carey, Mr. Fitzpatrick, Ms. Malliotakis, Mr. Crenshaw, Ms. Chu, Ms. Scholten, Mr. Soto, Mr. Goldman of New York, Mr. Obernolte, Mr. Gottheimer, Mr. Crow, Mr. Lieu, Ms. Tenney, Mr. Smith of New Jersey, Ms. Norton, Ms. Salazar, Ms. Lois Frankel of Florida, Mr. Valadao, Mr. Harder of California, Mr. Fitzgerald, Mr. Bilirakis, Ms. Lee of Florida, Mr. Calvert, Mr. Vindman, Mr. Pocan, Mr. Lawler, Mr. Weber of Texas, Mr. Neguse, Mr. Krishnamoorthi, Mr. Kean, Ms. Johnson of Texas, Mrs. Kim, Mr. Langworthy, and Mr. ThanedarJune 18, 2026Committed to the Committee of the Whole House on the State of the Union and ordered to be printedA 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 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). June 18, 2026Committed to the Committee of the Whole House on the State of the Union and ordered to be printed