Policy Analyst

0910-AJ27 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Nonclinical Testing Terminology

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with recent amendments to the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and remove an outdated emphasis on the use of animal safety testing.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.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No No Other 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 21 U.S.C. 301 et seq. 42 U.S.C. 201 et seq. 21 U.S.C. 371 No NPRM 12/00/2026 Direct Final Rule 12/00/2026 No No None No No No No Shena Arellano Policy Analyst 0910 Food and Drug Administration FDA 301 796-8353 shena.arellano@fda.hhs.gov Office of the Commissioner, 10903 New Hampshire Avenue, Silver Spring MD 20993