[Federal Register Volume 67, Number 172 (Thursday, September 5, 2002)]
[Notices]
[Pages 56848-56849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1539]


Draft Guidance for Industry, Electronic Records; Electronic 
Signatures, Maintenance 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availability of a draft guidance for industry entitled ``Guidance for 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, 
Maintenance of Electronic Records.'' The draft guidance describes the 
agency's current thinking on issues pertaining to maintaining 
electronic records to 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DATES: Submit written or electronic comments on the draft guidance by 
December 4, 2002. 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Compliance Information and Quality 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 label 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draft guidance document to the Dockets Management Branch (HFA-305), 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, rm. 1060, 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access to the draft guidance document.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    FDA is announcing the availability of a draft guidance entitled 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, Maintenance 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 (21 CFR part 11)). The preamble to part 11 stated that 
the agency anticipated issuing supplemental guidance documents and 
would afford all interested parties the opportunity to comment on draft 
guidance documents.
    The draft guidance addresses issues pertaining to the maintenance 
of electronic records. Part 11 establishes requirements for such 
maintenance, and the draft guidance is intended to assist people who 
must meet these requirements; it may also assist FDA staff who apply 
part 11 to persons subject to the regulation.
    The draft guidance provides specific information on key principles 
and practices, and it addresses some frequently asked questions. It 
also describes two examples of approaches to maintaining electronic 
records. However, this draft guidance is not intended to cover 
everything about maintaining electronic records, and it does not apply 
to electronic records that are submitted to FDA, but that submitters 
are not required to maintain.
    By direct reference, this draft guidance incorporates definitions 
of terms contained in a companion draft guidance entitled ``Guidance 
for Industry, 21 CFR Part 11; Electronic Records; Electronic 
Signatures, Glossary of Terms'' that published in the Federal Register 
of September 24, 2001 (66 FR 48886).
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulations (21 CFR 10.115). This draft 
guidance, when finalized, will represent the agency's current thinking 
on maintaining electronic records in electronic form. 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.

[[Page 56849]]

II. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) 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/ora/compliance_ref/part11/default.htm.

    Dated: August 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22634 Filed 9-4-02; 8:45 am]
BILLING CODE 4160-01-S