Sponsors (10)
The bill provides clearer, statutory definitions and immediate regulatory certainty for nonclinical versus clinical data—helping developers and patients reduce ambiguity and speed processes—but does so by skipping regular notice-and-comment and introducing short-term compliance and implementation risks that could affect study classification and safety until guidance is issued.
Patients (including those with chronic conditions), scientists/researchers, and hospitals/health systems gain clearer regulatory definitions that distinguish nonclinical (preclinical) data from clinical data, reducing ambiguity in drug development and helping streamline submissions and compliance.
Scientists/researchers and sponsor organizations receive near-term regulatory certainty because the rule is implemented immediately as an interim final rule, helping ongoing development programs proceed without protracted delay.
Patients and researchers could face unforeseen impacts on study categorization and requirements because narrowing or redefining terms (e.g., replacing 'animal' with 'nonclinical') may create implementation confusion until further guidance clarifies scope.
Scientists/researchers and patients lose an opportunity for public input because the immediate effectiveness of the interim final rule removes the usual notice-and-comment period for stakeholder feedback on important regulatory language changes.
Hospitals, health systems, and sponsor organizations may incur short-term compliance costs to update submissions, standard operating procedures, and training to reflect the new terminology and expectations.
Based on analysis of 2 sections of legislative text.
Requires FDA to publish an interim final rule within 1 year replacing general references to tests and 'animal' in specified CFR sections with 'nonclinical tests...' and to add the statutory definition, effective immediately.
Introduced February 3, 2025 by Cory Anthony Booker · Last progress December 17, 2025
Requires the Department of Health and Human Services, through the FDA Commissioner, to issue an interim final rule within one year that updates specified parts of Title 21 of the Code of Federal Regulations to replace broad references to tests, data, studies, models, and research (including the word "animal") with the term "nonclinical tests, data, studies, models, and research," and to add the statutory definition of "nonclinical test" into several CFR provisions. The rule must be made immediately effective upon publication without the agency having to show "good cause" under the Administrative Procedure Act. It also makes a technical redesignation of an existing statutory subsection in 21 U.S.C. 355.