FDA Modernization Act 3.0

This bill, known as 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 its enactment. The primary purpose of this rule is to ensure the full implementation of amendments made by the Consolidated Appropriations Act, 2023, specifically section 3209(a), which updated drug approval requirements. This interim final rule will become immediately effective upon publication without requiring a demonstration of good cause. A core provision of the interim final rule is to systematically replace all references to "animal" tests, data, studies, models, and research with the term " nonclinical " in numerous specified sections of Title 21, Code of Federal Regulations. This change aims to align regulatory language with the updated statutory framework that permits alternative testing methods for drug development. Furthermore, the bill mandates that the definition of "nonclinical test" from the Federal Food, Drug, and Cosmetic Act be incorporated into several key regulatory sections to ensure clarity and consistency.