[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]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
regulations.
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 [email protected].
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 FURTHER INFORMATION CONTACT:
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:
[email protected].
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:
[email protected].
SUPPLEMENTARY INFORMATION:
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
practices.
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
topics:
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 [email protected].
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
meeting.
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]
BILLING CODE 4160-01-F