[Federal Register Volume 66, Number 185 (Monday, September 24, 2001)]
[Notices]
[Pages 48886-48887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-23699]


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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Draft Guidance for Industry; Electronic Records; Electronic 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availability of a draft guidance entitled ``Guidance for Industry, 21 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 The draft guidance defines terms that will be used in FDA's 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``Guidance for Industry, 21 CFR Part 11; Electronic 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 Submit written comments on the draft guidance to the Dockets 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://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section for electronic access to the draft guidance.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: [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    FDA is announcing the availability of a draft guidance entitled 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, 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://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]
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