In the nature of a substitute.

This amendment, which may be cited as the FDA Modernization Act 3.0, aims to require the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to publish an interim final rule regarding nonclinical testing methods.

The amendment seeks to change the bill by adding the following:

• Updating Regulations: It requires the replacement of references to animal tests, data, studies, models, and research with references to nonclinical tests, data, studies, models, and research within specific sections of title 21, Code of Federal Regulations.

• Adding Definitions: It requires adding the definition of nonclinical test from section 505(z) of the Federal Food, Drug, and Cosmetic Act to specific sections of title 21, Code of Federal Regulations.

• Timeline and Effectiveness: The interim final rule must be published no later than 1 year after the Act is enacted and shall become immediately effective without requiring a demonstration of good cause.

• Technical Adjustment: It amends section 505 of the Federal Food, Drug, and Cosmetic Act by redesignating the second subsection (z), which relates to clinical trial diversity action plans, as subsection (aa).