[Federal Register: February 25, 2003 (Volume 68, Number 37)]
[Notices]               
[Page 8775-8776]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe03-64]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 03D-0060, 99D-1458, 00D-1538, 00D-1543, 00D-1542, and 00D-
1539]

 
Draft Guidance for Industry on ``Part 11, Electronic Records, 
Electronic Signatures--Scope and Application;'' Availability of Draft 
Guidance and Withdrawal of Draft Part 11 Guidance Documents and a 
Compliance Policy Guide

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; availability; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Part 11, 
Electronic Records; Electronic Signatures--Scope and Application.'' 
This draft guidance explains FDA's current thinking regarding the 
requirements and application of part 11 (21 CFR part 11). As an 
outgrowth of its current good manufacturing practice (CGMP) initiative 
for human and animal drugs and biologics, FDA is embarking on a re-
examination of part 11 as it applies to all FDA regulated products. We 
may revise provisions of part 11 as a result of that reexamination. The 
draft guidance explains that while this re-examination is under way, we 
intend to exercise enforcement discretion with respect to certain part 
11 requirements. We are also announcing the withdrawal of Compliance 
Policy Guide (CPG) 7153.17 and previously published part 11 draft 
guidance documents on validation, glossary of terms, time stamps, and 
maintenance of electronic records.

DATES: Submit written or electronic comments on the draft guidance by 
April 28, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, or to the Division of Compliance Policy 
(HFC-230), Office

[[Page 8776]]

of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
in processing your requests. Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 

Submit electronic comments to http://www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.

FOR FURTHER INFORMATION CONTACT: Joseph C. Famulare, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-8940, part11@cder.fda.gov; 

or David Doleski, Center for Biologics Evaluation and Research (HFM-
676), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-3031, doleski@cber.fda.gov; or John Murray, Center 

for Devices and Radiological Health (HFZ-340), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
4659, jfm@cdrh.fda.gov; or Vernon D. Toelle, Center for Veterinary 

Medicine (HFV-234), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0312, vtoelle@cvm.fda.gov; or JoAnn Ziyad, 

Center for Food Safety and Applied Nutrition (HFS-206), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 
202-418-3116, jziyad@cfsan.fda.gov; or Scott MacIntire, Office of 

Regulatory Affairs (HFC-240), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857-1706, 301-827-0386, 
smacinti@ora.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In March 1997, FDA issued final regulations (part 11) that provided 
criteria for acceptance by FDA, under certain circumstances, of 
electronic records, electronic signatures, and handwritten signatures 
executed to electronic records as equivalent to paper records and 
handwritten signatures executed on paper (62 FR 13430, March 20, 1997). 
These regulations, which apply to all FDA program areas, were intended 
to permit the widest possible use of electronic technology, consistent 
with FDA's responsibility to protect the public health.
    Since part 11 became effective in August 1997, significant 
discussions have ensued between industry, contractors, and the agency 
concerning the interpretation and implementation of the rule. Concerns 
have been raised that some interpretations of the part 11 requirements 
would: (1) Unnecessarily restrict the use of electronic technology in a 
manner that is inconsistent with FDA's stated intent in issuing the 
rule, (2) significantly increase the costs of compliance to an extent 
that was not contemplated at the time the rule was drafted, and (3) 
discourage innovation and technological advances without providing a 
significant public health benefit. These concerns have been raised 
particularly in the areas of part 11 requirements for validation, audit 
trails, record retention, record copying, and legacy systems.
    This document provides guidance to persons who, in fulfillment of a 
requirement in a statute or another part of FDA's regulations to 
maintain records or submit information to FDA, have chosen to maintain 
the records or submit designated information electronically and, as a 
result, have become subject to part 11.
    This draft guidance announces that we intend to exercise 
enforcement discretion with respect to the validation, audit trail, 
record retention, and record copying requirements of part 11. However, 
records must still be maintained or submitted in accordance with the 
underlying predicate rules. We also intend to exercise enforcement 
discretion and will not normally take regulatory action to enforce part 
11 with regard to systems that were operational before August 20, 1997, 
the effective date of part 11 (commonly known as existing or legacy 
systems) while we are reexamining part 11.
    It is important to note that FDA's exercise of enforcement 
discretion as described in this guidance is limited to the specified 
part 11 requirements. We intend to enforce all other provisions of part 
11 including, but not limited to, certain controls for closed systems 
in Sec.  11.10, the corresponding controls for open systems (Sec.  
11.30), and requirements related to electronic signatures (e.g., 
Sec. Sec.  11.50, 11.70, 11.100, 11.200, and 11.300). We expect 
continued compliance with these provisions, and we will continue to 
enforce them.
    In the Federal Register of February 4, 2003 (68 FR 5645), we 
announced the withdrawal of the draft guidance entitled ``Guidance for 
Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, 
Electronic Copies of Electronic Records'' because we wished to limit 
the time spent by industry reviewing and commenting on the guidance, 
which might not have been representative of FDA's approach under the 
CGMP initiative.
    At this time, we are also announcing the withdrawal of CPG 7153.17 
and previously published part 11 draft guidance documents on 
validation, glossary of terms, time stamps, and maintenance of 
electronic records. FDA has determined that it might cause confusion to 
leave standing these other draft guidances on part 11 and CPG 7153.17. 
FDA received valuable public comment on the draft guidances and plans 
to use that information to inform the agency's future decisionmaking 
with respect to part 11.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
if finalized, will represent the agency's current thinking on ``Part 
11, Electronic Records, Electronic Signatures--Scope and Application.'' 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Submit 
a single copy of electronic comments to http://www.fda.gov/dockets/
ecomments
 or two hard copies of any written comments, except that 

individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
draft guidance and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/ora 

at http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/ora 
under ``Compliance References,'' or http://www.fda.gov/ohrms/dockets/
default.htm.



    Dated: February 19, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4312 Filed 2-20-03; 8:45 am]

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