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HHS/FDA RIN: 0910-AG47 Publication ID: Spring 2010 
Title: ●Good Laboratory Practice for Nonclinical Laboratory Studies 
Abstract: The Food and Drug Administration (FDA) is seeking comment on whether to amend the regulation governing good laboratory practices (GLPs) (21 CFR part 58--Good Laboratory Practice for Nonclinical Laboratory Studies). The GLP regulation was finalized in December 1978 and prescribes GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for FDA-regulated products. Since this regulation was published, clinical studies have changed markedly. To help ensure the integrity of data in nonclinical studies submitted to FDA, the agency is proposing that nonclinical facilities/laboratories follow a risk-based GLP quality system. While many of the requirements of the existing regulation are consistent with a GLP quality system, FDA is proposing modifications to incorporate all basic elements needed for a GLP quality system consistent with internationally recognized quality systems. FDA believes that implementation of a GLP quality system would institute a risk-based approach, reduce regulatory burden, and encourage science-based technology. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 58 (revision)   
Legal Authority: 21 USC 342    21 USC 346 and 346a    21 USC 348    21 USC 351 to 353    21 USC 355    ...   
Legal Deadline:  None
Action Date FR Cite
ANPRM  06/00/2010    
ANPRM Comment Period End  09/00/2010    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
C.T. Viswanathan
Associate Director, Division of Scientific Investigations, Office of Compliance
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 5346, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3394
Fax:301 847-8748