[Federal Register: February 4, 2003 (Volume 68, Number 23)]
[Notices]               
[Page 5645]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04fe03-56]                         


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


[Docket No. 00D-1540]


 
Withdrawal of Draft Guidance for Industry on Electronic Records; 
Electronic Signatures, Electronic Copies of Electronic Records


AGENCY: Food and Drug Administration, HHS.


ACTION: Notice; withdrawal.


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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of a draft guidance entitled ``Guidance for Industry, 21 CFR 
Part 11; Electronic Records; Electronic Signatures, Electronic Copies 
of Electronic Records.''


DATES: February 4, 2003.


FOR FURTHER INFORMATION CONTACT: Randall L. Woods, Center for Drug 
Evaluation and Research (HFD-324), Food and Drug Administration, Metro 
Park North I, 7520 Standish Pl., rm. 265, Rockville, MD 20855, 301-827-
0065.


SUPPLEMENTARY INFORMATION:


I. Background


    On August 21, 2002, FDA announced that it was undertaking a new 
initiative to enhance FDA's current good manufacturing practice program 
(the CGMP initiative). This new initiative will focus FDA's resources 
and regulatory attention on those aspects of manufacturing that pose 
the greatest risk, ensure that FDA's work does not impede innovation, 
and enhance the consistency of FDA's regulatory approach among the 
various components. More information on FDA's announcement of this new 
initiative can be found on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=www.fda.gov/bbs/topics/NEWS/2002/NEW00829.html
, or a copy of the press release (Ref. 1) may be 
seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Please reference the docket number found in brackets in the heading of 
this document.
    Under the new initiative, primary responsibility for implementing 
part 11 (21 CFR Part 11); Electronic Records; Electronic Signatures has 
shifted to the Center for Drug Evaluation and Research, with continued 
involvement from other Centers and the Office of Regulatory Affairs.
    On November 12, 2002 (67 FR 68674), the agency issued a draft 
guidance for industry entitled ``Guidance for Industry, 21 CFR Part 11; 
Electronic Records; Electronic Signatures, Electronic Copies of 
Electronic Records.'' The agency wishes to limit the time spent by 
industry reviewing and commenting on the guidance, which may no longer 
represent FDA's approach under the CGMP initiative. The agency may 
decide to reissue the draft guidance once it has reviewed it under the 
CGMP initiative.


II. Reference


    The following reference is on display at the Dockets Management 
Branch (see section I of this document) and may be seen by interested 
parties between 9 a.m. and 4 p.m., Monday through Friday.
    1. U.S. Food and Drug Administration press release, ``FDA 
Unveils New Initiative To Enhance Pharmaceutical Good Manufacturing 
Practices,'' August 21, 2002.


    Dated: January 28, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2602 Filed 2-3-03; 8:45 am]

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