[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Draft Guidance for Industry on ``Part 11, Electronic Records,
Electronic Signatures--Scope and Application;'' Availability of Draft
Guidance and Withdrawal of Draft Part 11 Guidance Documents and a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availability of a draft guidance for industry entitled ``Part 11,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This draft guidance explains FDA's current thinking regarding the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draft guidance explains that while this re-examination is under way, we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Policy Guide (CPG) 7153.17 and previously published part 11 draft
guidance documents on validation, glossary of terms, time stamps, and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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 Submit written comments on the draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug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]
BILLING CODE 4160-01-S