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HHS/FDA RIN: 0910-AJ01 Publication ID: Fall 2024 
Title: ●Good Laboratory Practice for Nonclinical Laboratory Studies 
Abstract:

The Food and Drug Administration (FDA) is proposing to: (1) Amend the regulations for Good Laboratory Practice (21 CFR part 58) to require a modern quality system for conducting nonclinical laboratory studies when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA; (2) to provide an opportunity for a hearing prior to disqualification of certain persons involved in the conduct of a nonclinical laboratory study (21 CFR part 16); and (3) to simultaneously withdraw the 2016 proposed rule.

 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 16    21 CFR 58   
Legal Authority: 21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2025 
Regulatory Flexibility Analysis Required: YES  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Ann Marie Metayer
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 32, Room 4375,
Silver Spring, MD 20993
Phone:301 796-3324
Email: ann.metayer@fda.hhs.gov