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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA HOLDING PUBLIC MEETING ON ELECTRONIC RECORDS AND SIGNATURES

FDA Veterinarian Newsletter March/April 2000 Volume XV, No II

The Food and Drug Administration (FDA) and the Parenteral Drug Association (PDA) are cosponsoring a public meeting on industry experience in implementing the technical provisions of Title 21, Part 11, of the Code of Federal Regulations (CFR), Electronic Records; Electronic Signatures. All interested persons are invited to participate in the meeting that will be held June 19 and 20, 2000, at the Wyndham Franklin Plaza Hotel, 17th and Race Streets, Philadelphia, PA 19103, 215-448-2000.

The purpose of the meeting is to exchange information on (1) the range of experiences persons subject to Part 11 have had in implementing the rule's technical provisions, and (2) available products and services that enable implementation of those requirements. This will not be a forum to discuss the merits of the rule, nor a tutorial on the regulation; meeting attendees should have a basic understanding of Part 11. Information presented at the event will assist FDA in developing future industry guidance documents with respect to Part 11.

FDA invites interested persons to give brief presentations about their experiences in implementing one or more of Part 11's technical provisions. Likewise, the Agency invites 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.)

Individuals who would like to make a presentation at this meeting should 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:

Parenteral Drug Association
Attn: Ms. Angie Fischer, Program Director
7500 Old Georgetown Road, Suite 620
Bethesda, MD 20814

Abstracts of proposed presentations must be received by March 19, 2000. FDA and PDA will jointly review the abstracts, and authors will be notified accordingly. Handouts and related presentation materials for accepted abstracts must be received by May 19, 2000.

Interested parties who wish to send their abstract and speaker information by electronic mail should send the material in Adobe® PDF (Portable Document Format), or ASCII (American Standard Code for Information Interchange) format to fischer@pda.org.

To register for the meeting, contact the PDA at the above address. Also, see the association's Internet site at http://www.pda.org. If you need special accommodations due to disability, please inform the above PDA contact person when you register.

Interested persons, including those unable to attend or speak at the meeting, may submit comments regarding their experiences in implementing Part 11's technical provisions, and their products or services that help people meet those requirements. Paper comments should be sent on or before May 19, 2000 to: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Additional general information may be obtained from: Dr. Steven Solomon, Office of Enforcement, Office of Regulatory Affairs (HFC-240), FDA, 5600 Fishers Lane, Rockville, MD 20857, phone: 301-827-0386, fax: 301-827-0343, e-mail: ssolomon@ora.fda.gov.

A notice of the FDA/PDA cosponsored event now is on the FDA Internet site at URL: http://www.fda.gov/oc/meetings/interp11.html.