[Federal Register Volume 67, Number 218 (Tuesday, November 12, 2002)]
[Notices]
[Pages 68674-68675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28551]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1540]


Draft Guidance for Industry on Electronic Records; Electronic 
Signatures, Electronic Copies of Electronic Records; 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availability of a draft guidance for industry entitled ``Guidance for 
Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, 
Electronic Copies of Electronic Records.'' This draft guidance 
describes the agency's current thinking on issues pertaining to 
furnishing FDA with electronic copies of electronic records that are 
subject to part 11. Part 11 requires persons to employ procedures and 
controls for records subject to part 11 that include the ability to 
generate electronic copies of electronic records that are accurate, 
complete, and suitable for FDA inspection, review, and copying. This 
requirement helps ensure that electronic records and electronic 
signatures are trustworthy, reliable, and compatible with FDA's public 
health responsibilities.

DATES: Submit written or electronic comments on the draft guidance by 
February 10, 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Compliance Information and Quality 
Assurance (HFC-240), Office of Enforcement, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive labels to assist 
that office in processing your requests.
    Submit written comments on the draft guidance document to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, room 1061, Rockville, MD 20852. 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INFORMATION section for electronic access to the draft guidance 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: Paul J. Motise, Office of Enforcement 
(HFC-240), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-0383, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Guidance for Industry, 21 CFR part 11; Electronic Records; Electronic 
Signatures, Electronic Copies of Electronic Records.'' In the Federal 
Register of March 20, 1997 (62 FR 13430), FDA published a regulation 
providing criteria under which the agency considers electronic records 
and electronic signatures to be trustworthy, reliable, and generally 
equivalent to paper records and handwritten signatures executed on 
paper (``part 11''). The preamble to part 11 (21 CFR part 11) stated 
that the agency anticipated issuing supplemental guidance documents and 
would afford all interested parties the opportunity to

[[Page 68675]]

comment on draft guidance documents. Therefore, FDA is making this 
draft guidance available for public comment.
    The draft guidance addresses issues pertaining to providing FDA 
with electronic copies of electronic records subject to part 11 that 
are accurate, complete, and suitable for FDA inspection, review, and 
copying. Part 11 requires persons to be able to furnish FDA with 
electronic copies of electronic records that are subject to part 11. 
This draft guidance is intended to assist people who must meet this 
requirement; it may also assist FDA staff who apply part 11 to persons 
subject to the regulation. However, this draft guidance is not intended 
to address issues related to electronic records that are submitted to 
FDA but that are not required to be maintained.
    The draft guidance provides specific information on key principles 
and practices on electronic copies of electronic records, and it 
addresses some frequently asked questions. However, it is not intended 
to cover every aspect of generating electronic copies of electronic 
records that are accurate, complete, and suitable for FDA inspection, 
review and copying.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). This draft 
guidance, when finalized, will represent the agency's current thinking 
on providing FDA with electronic copies of electronic records. 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. Two 
copies of any nonelectronic 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. A copy 
of 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 document at 
http://www.fda.gov/ohrms/dockets/dockets/dockets.htm.

    Dated: October 28, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28551 Filed 11-8-02; 8:45 am]
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