Bill > HR2821

This bill requires the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to publish an interim final rule within one year of enactment that updates various regulations in the Code of Federal Regulations to replace references to "animal" tests with the term "nonclinical" tests. Specifically, the bill aims to modify over 20 different sections of Title 21, including regulations related to investigational new drug applications, new drug applications, and biologics license applications. The changes will add a definition of "nonclinical test" to several regulatory sections and ensure consistency with amendments made in the Consolidated Appropriations Act of 2023. The interim final rule will become immediately effective without the typical requirement of demonstrating "good cause" for immediate implementation. Additionally, the bill makes a technical amendment to the Federal Food, Drug, and Cosmetic Act by redesignating a subsection related to clinical trial diversity action plans. The overall goal appears to be modernizing regulatory language and potentially promoting alternative testing methods that do not involve animals.

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https://www.congress.gov/bill/119th-congress/house-bill/2821/all-info