[Federal Register: September 24, 2001 (Volume 66, Number 185)]
[Notices]
[Page 48886-48887]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se01-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1543]
Draft Guidance for Industry; Electronic Records; Electronic
Signatures, Glossary of Terms; 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availability of a draft guidance entitled ``Guidance for Industry, 21
CFR Part 11; Electronic Records; Electronic Signatures, Glossary of
Terms.'' The draft guidance defines terms that will be used in FDA's
guidances that describe the agency's current thinking on principles and
procedures for creating, modifying, maintaining, archiving, retrieving,
and transmitting electronic records and electronic signatures in order
to ensure that electronic records
[[Page 48887]]
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DATES: Submit written or electronic comments on the draft guidance by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 24, 2001. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance entitled ``Guidance for Industry, 21 CFR Part 11; Electronic
Records; Electronic Signatures, Glossary of Terms'' 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 Submit written comments on the draft guidance to the Dockets
Management Branch (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section for electronic access to the draft guidance.
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FDA is announcing the availability of a draft guidance entitled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, Glossary of Terms.'' 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.
Therefore, FDA is making this draft guidance available for public
comment.
The draft guidance defines terms that will be used in other FDA
guidance documents about part 11. FDA believes that rather than repeat
definitions in multiple guidances it would be more efficient to
consolidate them in one common document. The glossary of terms is
intended to assist people who must meet part 11 requirements; it may
also assist FDA staff who apply part 11 to persons subject to the
regulation.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a companion draft document entitled ``Guidance for
Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures,
Validation'' and is offering the opportunity to comment on it, as well.
By direct reference, the companion draft document incorporates
definitions contained in the draft glossary of terms.
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 terms and their definitions as used in guidance documents about
electronic records and electronic signatures in the context of part 11.
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
(address above) written or electronic comments on the draft guidance.
Two copies of any 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ora/compliance_ref/Part11.
Dated: August 23, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-23699 Filed 9-21-01; 8:45 am]
BILLING CODE 4160-01-S