Bill > S355

This bill requires the Secretary of Health and Human Services, through the Food and Drug Administration (FDA), to publish an interim final rule within one year of enactment that updates multiple sections of federal regulations to replace references to "animal" tests with the term "nonclinical" tests. The bill specifically targets over 20 sections of Title 21 of the Code of Federal Regulations, which govern clinical trials and drug development, to ensure consistent language that moves away from animal-based research terminology. The rule will add a definition of "nonclinical test" to several regulatory sections and will become immediately effective without requiring the usual administrative review process. Additionally, the bill makes a technical amendment to the Federal Food, Drug, and Cosmetic Act by renumbering a subsection related to clinical trial diversity action plans. This legislation appears to be part of a broader effort to modernize research methodologies and potentially encourage alternative testing methods that do not rely on animal models.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/355/all-info