The Secretary of Health and Human Services will amend regulations to replace "animal" tests with nonclinical tests and add a definition for "nonclinical test."
Several sections of the Code of Federal Regulations are to be amended to ensure consistency with the amendments.
The interim final rule issued by the Secretary of Health and Human Services will become immediately effective without requiring a demonstration of good cause.
A technical amendment involves designating the subsection relating to clinical trial diversity action plans as subsection (aa).
FDA Modernization Act 3.0
This bill requires the Food and Drug Administration (FDA) to publish an interim final rule implementing a provision of the Consolidated Appropriations Act of 2023 that authorized the use of certain alternatives to animal testing to support investigational use of a new drug.
The rule must replace references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research throughout the FDA’s regulations governing investigational new drug applications, and may make other changes to the regulations as appropriate.
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
