H.R.2821

FDA Modernization Act 3.0 requires the FDA to update regulations to replace animal testing references with nonclinical testing references.

FDA Modernization Act 3.0 mandates the Secretary of Health and Human Services, through the Commissioner of Food and Drugs, to publish a final rule updating nonclinical testing methods. The rule will amend sections of title 21, Code of Federal Regulations, to replace references to animal tests with nonclinical tests. It also adds the definition of "nonclinical test" to specified sections. The interim final rule will become effective immediately without requiring the Secretary to demonstrate good cause.