[Federal Register: September 5, 2003 (Volume 68, Number 172)]
[Notices]
[Page 52779-52781]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se03-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2003D-0060]
Guidance for Industry on ``Part 11, Electronic Records;
Electronic Signatures--Scope and Application;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Part 11, Electronic
Records; Electronic Signatures--Scope and Application.'' The guidance
explains FDA's current thinking regarding the requirements and
application of part 11 (21 CFR part 11). FDA has begun to re-examine
part 11 as it applies to all FDA regulated products. This guidance
explains that we will narrowly interpret the scope of part 11. While
the re-examination of part 11 is under way, we intend to exercise
enforcement discretion with respect to certain part 11 requirements.
With respect to systems that were operational before August 20, 1997,
the effective date of the final rule establishing part 11, we intend to
exercise enforcement discretion with respect to all part 11
requirements under certain circumstances.
DATES: Submit written or electronic comments on agency guidances at
any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and
[[Page 52780]]
Research, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD 20857. Send one self-addressed adhesive label to assist that office
in processing your requests. Submit written comments on the guidance to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Joseph C. Famulare, Center for Drug
Evaluation and Research (HFD-320), Food and Drug Administration, 11919
Rockville Pike, Rockville, MD 20852, 301-827-8940, or
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
FDA is announcing the availability of a guidance for industry
entitled ``Part 11, Electronic Records; Electronic Signatures--Scope
and Application.'' The guidance explains FDA's current thinking
regarding the requirements and application of part 11.
In March 1997, FDA issued final part 11 regulations 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.
After part 11 became effective in August 1997, significant
discussions ensued among industry, contractors, and the agency
concerning the scope, interpretation, and implementation of the
regulations. Concerns have been raised that some interpretations of the
part 11 requirements would have the following effects: (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.
As an outgrowth of its current good manufacturing practice (CGMP)
initiative for human and animal drugs and biologics, FDA has begun to
re-examine part 11 as it applies to all FDA regulated products. We may
revise provisions of part 11 as a result of that examination. This
guidance explains that we will narrowly interpret the scope of part 11.
While the re-examination of part 11 is under way, we intend to exercise
enforcement discretion with respect to certain part 11 requirements.
However, with respect to legacy systems we intend to exercise
enforcement discretion with respect to all part 11 requirements under
certain circumstances. As announced on February 25, 2003, in the
Federal Register document announcing the availability of the draft
version of this guidance (68 FR 8775), we have withdrawn Compliance
Policy Guide 7153.17 and previously published part 11 draft guidance
documents on validation, glossary of terms, time stamps, and
maintenance of electronic records. Also, in the Federal Register of
February 4, 2003 (68 FR 5645), we announced the withdrawal of the
previously published part 11 draft guidance on electronic copies of
electronic records.
FDA received a number of comments when it issued the February 2003
draft version of this guidance. We have considered the comments on the
draft carefully and have made some changes to address those comments.
Among other things, we have revised the guidance by making the
following changes:
1. Emphasize that part 11 remains in effect and that enforcement
discretion applies only to certain requirements or circumstances as
identified in the guidance;
2. Clarify the term `enforcement discretion';
3. Explain that time stamps should be clearly referenced;
4. Remove the National Institute of Standards and Technology risk
management guide as a reference and add the ISO 14971 risk management
guide as a reference;
5. State that the FDA currently has no plans to re-issue the
withdrawn part 11 draft guidance documents; and
6. Clarify the meaning of `part 11 legacy system.'
This guidance provides recommendations 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 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. We also intend
to exercise enforcement discretion and do not intend to recommend or
take enforcement action to enforce any part 11 requirements 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 re-examining part 11. However, records must still be maintained or
submitted in accordance with the underlying predicate rules.
It is important to note that FDA's exercise of enforcement
discretion as described in this guidance is limited to specified part
11 requirements (setting aside legacy systems, as to which the extent
of enforcement discretion, under certain circumstances, will be more
broad). 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. Where the
interpretation of part 11 in this guidance differs from the
interpretation in the preamble to part 11, the interpretation in this
guidance will apply.
This level 1 guidance is being issued consistent with FDA's good
guidance
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practices regulation (21 CFR 10.115). The guidance represents 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 Division of Dockets Management
(see ADDRESSES) written or electronic comments on the guidance at any
time. Two paper copies of mailed comments are to be submitted, 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 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 document at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default.htm
Dated: August 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-22574 Filed 9-03-03; 10:00 am]
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