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HHS/FDA RIN: 0910-AJ27 Publication ID: 2026 
Title: ●Nonclinical Testing Terminology 
Abstract:

This rule adds the definition of nonclinical test to the definitions sections of its drug and biological product regulations and substitutes nonclinical for animal in phrases like animal test and makes other comparable or conforming amendments in certain safety and reporting sections of its regulations. The rule also substitutes nonclinical for preclinical and in vitro for consistency in terminology.  These amendments align with recent amendments to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and remove an outdated emphasis on the use of animal safety testing.  These changes may also foster the development and use of scientifically valid new testing methodologies, potentially improving predictive accuracy while replacing, reducing, or refining animal use. The rule adds no new requirements.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Other 
CFR Citation: 21 CFR 312.3    21 CFR 312.22 and 312.23    21 CFR 312.32 and 312.33    21 CFR 312.82    21 CFR 312.86    21 CFR 312.88    21 CFR 314.3    21 CFR 314.50    21 CFR 314.81    21 CFR 314.93    21 CFR 315.2    21 CFR 315.6    21 CFR 330.10    21 CFR 361.1    21 CFR 601.31    21 CFR 601.35    21 CFR 601.70   
Legal Authority: 21 U.S.C. 301 et seq.    42 U.S.C. 201 et seq.    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2026 
Direct Final Rule  12/00/2026 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Shena Arellano
Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Office of the Commissioner, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-8353
Email: shena.arellano@fda.hhs.gov