Bill > S5046

This bill, 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. The rule will replace references to "animal" tests, data, studies, models, and research with "nonclinical" tests, data, studies, models, and research in various sections of the Code of Federal Regulations related to new drug applications and other FDA regulations. The bill also defines the term "nonclinical test" in the relevant sections of the regulations. Additionally, the bill makes a technical amendment to the Federal Food, Drug, and Cosmetic Act to designate a new subsection.