[Federal Register: September 5, 2002 (Volume 67, Number 172)]
[Notices]
[Page 56848-56849]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se02-64]
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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Draft Guidance for Industry, Electronic Records; Electronic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availability of a draft guidance for industry entitled ``Guidance for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 The draft guidance describes the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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Compliance Information and Quality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draft guidance document to the Dockets Management Branch (HFA-305),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access to the draft guidance document.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: pmotise@ora.fda.gov.
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FDA is announcing the availability of a draft guidance entitled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