Sponsors (10)
Directs FDA to update specified CFR sections to replace generic references with the statutory term "nonclinical tests, data, studies, models, and research" and to add the statutory definition, via an immediately effective interim final rule published within 1 year.
Official title: Require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to publish a final rule relating to nonclinical testing methods.
Introduced February 3, 2025 by Cory Anthony Booker · Last progress December 17, 2025
The bill provides clearer, near-term regulatory definitions that can speed and simplify drug development administrative processes, but does so by implementing an immediately effective rule that reduces stakeholder input and creates short-term compliance and implementation risks.
Patients, drug sponsors, and researchers will see clearer regulatory distinctions between nonclinical (preclinical) and clinical data, reducing ambiguity in development pathways and improving regulatory predictability.
Drug sponsors, researchers, and health systems can streamline submissions and compliance because the bill inserts a statutory definition into key CFR provisions, reducing administrative friction and potential back-and-forth with regulators.
Scientists, researchers, hospitals, and affected patients gain near-term regulatory certainty because the interim final rule is immediately effective, allowing ongoing development programs to operate under the new definition without delay.
Scientists, researchers, hospitals, and patients lose the normal notice-and-comment opportunity because the interim final rule is immediately effective, reducing public and stakeholder input on how the new regulatory language is interpreted.
Hospitals, sponsors, and research institutions may incur short-term compliance costs to update submissions, standard operating procedures, and training to reflect the new terminology, increasing operational expenses.
Patients and researchers may face implementation confusion because narrowing or redefining terms (e.g., replacing 'animal' with 'nonclinical') could change how studies are categorized or required, potentially affecting oversight until further guidance clarifies scope.
Based on analysis of 2 sections of legislative text.
Requires the FDA to update selected drug and biologic regulations to replace broad references to tests and research (and the word “animal”) with the statutory term “nonclinical tests, data, studies, models, and research,” and to add the statutory definition of “nonclinical test” into several parts of Title 21 CFR. The Department of Health and Human Services must publish an immediately effective interim final rule within 1 year of enactment; the bill also makes a small technical redesignation in the statute to move an existing clinical trial diversity provision to a different subsection.