[Federal Register Volume 68, Number 172 (Friday, September 5, 2003)]
[Notices]
[Pages 52779-52781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22574]


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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://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 
[email protected]; 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, [email protected]; or 
John Murray, Center for Devices and Radiological Health (HFZ-340), Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 
301-594-4659, [email protected]; or Vernon D. Toelle, Center for 
Veterinary Medicine (HFV-234), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0312, [email protected]; 
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, [email protected]; or Scott MacIntire, 
Office of Regulatory Affairs (HFC-240), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857-1706, 301-827-0386, 
[email protected].

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

[[Page 52781]]

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://www.fda.gov/cder/guidance/index.htm or 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]
BILLING CODE 4160-01-S