View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
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:
|
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 |