[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Proposed Rules]
[Pages 8669-8670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4026]



Food and Drug Administration

21 CFR Part 11

[Docket No. 00N-0358]

Technical Implementation of Electronic Records and Electronic 
Signatures; Public Meeting and Request for Presentation Abstracts

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of a meeting.


SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting on industry's experience in implementing the technical 
provisions of regulations on electronic records and electronic 
signatures, and requesting abstracts of presentations persons would 
like to give at the meeting. FDA and the Parenteral Drug Association 
(PDA) are co-sponsoring this event. However, participation is not 
limited to the pharmaceutical industry; all interested persons, from 
all FDA regulated industries, are invited to participate. The purpose 
of the meeting is to exchange information on the range of experiences 
persons subject to these regulations have had in implementing the 
rule's technical provisions and available products and services that 
enable implementation of those requirements. This will neither be a 
forum to discuss the merits of the rule, nor a tutorial on the 
regulation; meeting attendees should have a basic understanding of 
these regulations. Information presented at the event will assist FDA 
in developing future industry guidance documents with respect to these 

DATES: The meeting is scheduled for Monday and Tuesday, June 19 and 20, 
2000, from 8:30 a.m. to 5 p.m. Abstracts of proposed presentations must 
be received by March 19, 2000. Handouts and related presentation 
materials for accepted abstracts must be received by May 19, 2000. 
Submit written comments by May 19, 2000.

ADDRESSES: The meeting will be held at the Wyndham Franklin Plaza 
Hotel, 17th and Race Sts., Philadelphia, PA 19103.
    Send meeting registration requests, abstracts of proposed 
presentations and materials for accepted abstracts to the Angie 
Fischer, PDA, 7500 Old Georgetown Rd., suite 620, Bethesda, MD 20814. 
Material may be sent by electronic mail to PDA at fischer@pda.org.
    You may view documents related to this event at the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

    For general information:
    Steven M. Solomon, Office of Enforcement, Office of Regulatory 
Affairs (HFC-240), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0386, FAX: 301-827-0343, e-mail: 
    For information about registration for the public meeting: Angie 
Fischer, Program Director, PDA, 7500 Old Georgetown Rd., suite 620, 
Bethesda, MD 20814, 301-986-0293 x129; FAX 301-986-0296; e-mail: 


I. Introduction

    In the Federal Register of March 20, 1997 (62 FR 13430), FDA (we) 
issued a final rulemaking for part 11 (21 CFR part 11), electronic 
records and electronic signatures. The rule went into

[[Page 8670]]

effect on August 20, 1997. Part 11 is intended to create criteria for 
electronic recordkeeping technologies while preserving the agency's 
ability to protect and promote the public health (e.g., by facilitating 
timely review and approval of safe and effective new medical products, 
conducting efficient audits of required records, and when necessary 
pursuing regulatory actions). Part 11 applies to all FDA program areas, 
but does not mandate electronic recordkeeping. Part 11 describes the 
technical and procedural requirements that must be met if a person 
chooses to maintain records electronically and use electronic 
signatures. Part 11 applies to those records and signatures required by 
FDA predicate rules, as well as signatures that are not required, but 
appear in required records.
    Part 11 was developed in concert with industry over a period of 6 
years. Virtually all of the rule's requirements had been suggested by 
industry comments to a July 21, 1992, advance notice of proposed 
rulemaking (57 FR 32185). In response to comments to an August 31, 
1994, proposed rule (59 FR 45160), the agency refined and reduced many 
of the proposed requirements in order to minimize the burden of 
compliance. The final rule's provisions are consistent with an emerging 
body of Federal and State law as well as commercial standards and 

II. Scope of Meeting

    The scope of the meeting will be limited to implementation of part 
11's technical requirements. This forum will focus on how persons 
subject to the rule are finding and using available enabling 
technologies. We are mindful of the rapid pace at which such 
technologies are changing and emerging, and the importance of keeping 
up with products and services that help ensure that electronic records 
remain trustworthy, reliable, and compatible with FDA's public health 
protection responsibilities.
    Part 11 affords persons substantial flexibility in selecting 
enabling technologies that meet their respective needs, yet facilitate 
compliance with the rule. However, the agency is aware that some 
persons have found it challenging to keep up with available 
technologies and adapt them to older electronic recordkeeping systems. 
We expect this conference to help those persons and provide the agency 
with additional information we will use to develop future part 11 
guidance documents.
    We emphasize that this meeting is open to all FDA regulated 
industries (foods, cosmetics, pharmaceuticals, biologics, veterinary, 
and medical devices) as well as suppliers of computer technologies and 
services designed for use with electronic records. Attendees will have 
opportunity to ask questions of presenters.
    We encourage all interested professional and trade groups to 
support this event by advising their members about it and encouraging 
their participation. Such groups should contact the PDA regarding any 
additional assistance they would like to provide.
    We invite interested persons to give brief presentations about 
their experiences in implementing one or more of part 11's technical 
provisions. Likewise, we invite persons who provide enabling 
technologies specific to those requirements to give presentations 
addressing how they have been and can be applied to FDA regulated 
industries. In all cases, presentations must not exceed 20 minutes. Of 
particular interest would be presentations regarding modifications to 
electronic recordkeeping systems that were in use before August 20, 
1997, (so called legacy systems). Here are some examples of relevant 
    Electronic Records Creation: Methods of ensuring proper sequencing 
of electronic record entries and construction, use of technology to 
ensure validity of data input and operational instructions, and 
transaction controls to ensure that records are generated from the 
right data sources.
    Electronic Record Integrity and Reliability: Use of secure 
electronic audit trails that independently provide transaction date and 
time stamping of operator entries and actions that create, modify or 
delete electronic records; use of encryption and digital signatures in 
support of electronic record integrity and authenticity.
    Electronic Signatures: Use of biometric and digital signature 
technologies; linking electronic signatures to electronic records.
    Archiving Electronic Records: Methods of preserving electronic 
records, including content, structure, context, audit trail and other 
security attributes; migration from one file format and computing 
platform to another; ensuring accessibility by end users and FDA, 
especially when archiving to an environment different from the one in 
which the records were initially created.

III. Requests to Make Presentations, and Registration

    If you would like to make a presentation at this meeting, send a 
brief abstract (no longer than one page), along with the speaker's 
name, affiliation, title, postal address, fax and phone numbers, and 
electronic mail address to PDA (address above).
    If you elect to send your abstract and speaker information by 
electronic mail, send the material in Adobe(r) PDF (portable document 
format), or ASCII (American Standard Code for Information Interchange) 
format to fischer@pda.org.
    Abstracts of proposed presentations, along with speaker 
information, must be received by March 19, 2000. FDA and PDA will 
jointly determine which abstracts to accept, and authors will be 
notified. Presentation handouts and related materials for accepted 
abstracts must be received by May 19, 2000. (Speakers who miss this 
deadline but wish to give meeting attendees copies of their material 
should bring sufficient copies with them at the time of the meeting.)
    To register for the meeting, contact the PDA at the address above. 
Also, see the association's Internet site at http://www.pda.org. If you 
need special accommodations due to disability, please inform the PDA 
contact person above when you register.

IV. Public Docket

    You may review the documents related to this meeting in the Dockets 
Management Branch (address above), between 9 a.m. and 4 p.m., Monday 
through Friday. These documents include the co-sponsorship agreement 
between FDA and PDA for this event, presentation abstracts and speaker 
information materials, and presentation handouts upon completion of the 

V. Comments

    Interested persons, including those unable to attend or speak at 
the meeting, may send us comments regarding their experiences in 
implementing part 11's technical provisions, and their products or 
services that help people meet those requirements. Send paper comments 
on or before May 19, 2000, to the Dockets Management Branch (address 
above). You may also send comments electronically to the Dockets 
Management Branch via the Internet at http://www.fda.gov/ohrms/dockets.

    Dated: February 14, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-4026 Filed 2-18-00; 8:45 am]