[Federal Register Volume 67, Number 54 (Wednesday, March 20, 2002)]
[Notices]
[Page 12999]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-6623]


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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Draft Guidance for Industry on Electronic Records; Electronic 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availability of a draft guidance for industry entitled ``Guidance for 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 The draft guidance describes the agency's current 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Compliance Information and Quality 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draft guidance document to the Dockets Management Branch (HFA-305), 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access to the draft guidance document.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    FDA is announcing the availability of a draft guidance entitled 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]
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