This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR
       Search

View Rule

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

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
Timetable:
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
Email: ct.viswanathan@fda.hhs.gov

 
About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us