[Federal Register: November 12, 2002 (Volume 67, Number 218)]

[Notices]               

[Page 68674-68675]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr12no02-101]                         



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DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



[Docket No. 00D-1540]



 

Draft Guidance for Industry on Electronic Records; Electronic 

Signatures, Electronic Copies 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availability of a draft guidance for industry entitled ``Guidance for 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, 

Electronic Copies of Electronic Records.'' This draft guidance 

describes the agency's current thinking on issues pertaining to 

furnishing FDA with electronic copies of electronic records that are 

subject to part 11. Part 11 requires persons to employ procedures and 

controls for records subject to part 11 that include the ability to 

generate electronic copies of electronic records that are accurate, 

complete, and suitable for FDA inspection, review, and copying. This 

requirement helps 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DATES: Submit written or electronic comments on the draft guidance by 

February 10, 2003. 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 labels 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    Submit written comments on the draft guidance document to the 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, room 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INFORMATION section for electronic access to the draft guidance 

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, Electronic Copies 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''). The preamble to part 11 (21 CFR part 11) stated 

that the agency anticipated issuing supplemental guidance documents and 

would afford all interested parties the opportunity to



[[Page 68675]]



comment on draft guidance documents. Therefore, FDA is making this 

draft guidance available for public comment.

    The draft guidance addresses issues pertaining to providing FDA 

with electronic copies of electronic records subject to part 11 that 

are accurate, complete, and suitable for FDA inspection, review, and 

copying. Part 11 requires persons to be able to furnish FDA with 

electronic copies of electronic records that are subject to part 11. 

This 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. However, this draft guidance is not intended 

to address issues related to electronic records that are submitted to 

FDA but that are not required to be maintained.

    The draft guidance provides specific information on key principles 

and practices on electronic copies of electronic records, and it 

addresses some frequently asked questions. However, it is not intended 

to cover every aspect of generating electronic copies of electronic 

records that are accurate, complete, and suitable for FDA inspection, 

review and copying.

    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 providing FDA with electronic copies of electronic records. 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 (see 

ADDRESSES) 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/ohrms/dockets/dockets/dockets.htm.



    Dated: October 28, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 02-28551 Filed 11-8-02; 8:45 am]



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