FDA Modernization Act 3.0

The FDA Modernization Act 3.0 requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish an interim final rule within one year of the bill's enactment. This rule is designed to implement recent amendments to the Federal Food, Drug, and Cosmetic Act, specifically those made by the Consolidated Appropriations Act, 2023. The core purpose of this interim final rule is to update various sections of Title 21, Code of Federal Regulations. It mandates the replacement of all references to "animal" tests, data, studies, models, and research with the broader term " nonclinical " tests, data, studies, models, and research. Additionally, the rule will incorporate the definition of "nonclinical test" from section 505(z) of the Federal Food, Drug, and Cosmetic Act into several specified regulatory sections. This interim final rule will become effective immediately upon publication, without the usual requirement for demonstrating good cause. The bill also includes a technical amendment to section 505 of the Federal Food, Drug, and Cosmetic Act, redesignating a duplicate subsection (z) as subsection (aa) to ensure proper statutory numbering.