[Federal Register: March 20, 2002 (Volume 67, Number 54)]
[Notices]
[Page 12999]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20mr02-101]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1542]
Draft Guidance for Industry on Electronic Records; Electronic
Signatures, Time Stamps; 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availability of a draft guidance for industry entitled ``Guidance for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,
Time Stamps.'' The draft guidance describes the agency's current
thinking on issues pertaining to the use of computer generated time
stamps in computer systems subject to part 11 (21 CFR part 11)
requirements, to ensure that electronic records and electronic
signatures are trustworthy, reliable, and compatible with FDA's public
health responsibilities. The use of the computer generated time stamps
is a requirement of part 11 of title 21 of the Code of Federal
Regulations.
DATES: Submit written or electronic comments on the draft guidance by
June 18, 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Compliance Information and Quality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draft guidance document to the Dockets Management Branch (HFA-305),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access to the draft guidance document.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FDA is announcing the availability of a draft guidance entitled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, Time Stamps.'' 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 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 computer
generated time stamps in computer systems used to create, modify,
maintain, archive, retrieve, or transmit electronic records and
electronic signatures subject to part 11. Part 11 requires persons
subject to the regulation to implement time stamps in audit trails and
signature manifestations, and the 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.
The draft guidance provides specific information on key principles
and practices, and it addresses some frequently asked questions.
However, it is not intended to cover every aspect of time stamps.
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 computer generated time stamps used in computer systems subject to
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://www.fda.gov/ora/compliance_ref/Part11/default.htm.
Dated: March 12, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6623 Filed 3-19-02; 8:45 am]
BILLING CODE 4160-01-S