S. 5046 — Introduced in Senate

II 118th CONGRESS 2d Session S. 5046 IN THE SENATE OF THE UNITED STATES September 12, 2024Mr. 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).