OPENING THE RECORD
OPENING THE RECORD
H.R. 2821 · 119TH CONGRESS
This has not become law. Both chambers must pass the same text before sending it to the president. How a bill becomes law.
CONGRESSIONAL RESEARCH SERVICE
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.
The rule must be published within one year of the bill’s enactment, and must take immediate effect as an interim final rule.
Written by the Congressional Research Service for this version of the bill. Later versions may differ. Read at Congress.gov.