[Federal Register Volume 59, Number 39 (Monday, February 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-4412]


[Federal Register: February 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Videoconferencing Facility; 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 videoconferencing facility. The videoconferencing 
facility was established to improve communications between the agency 
and interested parties. The facility will be used for a variety of 
purposes, including meetings, with the public and regulated industries, 
internal FDA meetings, and training. The facility will be used to 
supplement face-to-face meetings and allow broader participation in 
discussions with FDA.

FOR FURTHER INFORMATION CONTACT: Angela M. Youngblood, Center for Drug 
Evaluation and Research (HFD-50), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-0724.

SUPPLEMENTARY INFORMATION: FDA has established a videoconferencing 
facility for general use by FDA. The facility, which became operational 
on June 1, 1993, is located in rm. 13B-37 in the Parklawn Bldg., 5600 
Fishers Lane, Rockville, MD 20857. The facility has a capacity for 25 
to 30 people and can be used to conduct videoconferences with FDA. The 
establishment of the facility culminates a 3-year project by FDA and 
the Pharmaceutical Manufacturers Association to improve communications 
between the agency and interested parties.
    The agency does not intend to restrict the use of the 
videoconferencing facility to any specific purpose. The facility can be 
used to expedite meetings with the public and regulated industries, or 
to facilitate training and internal FDA meetings. In addition to 
improving communications, FDA believes that the facility may even 
shorten FDA review times for applications because the facility can be 
used to facilitate prompt resolution of specific issues. 
Videoconferencing will also facilitate broader participation by 
industry staff in FDA meetings and make meetings more productive.

Policies and Procedures for Use

    FDA has established videoconferencing as an optional means of 
communicating with FDA. The decision on whether to conduct a face-to-
face meeting or videoconference, or a combination of meetings and 
videoconferences, must be agreed to by both the agency and the 
interested party. Use of the videoconferencing facility is not intended 
to limit, in any way, either face-to-face, telephone, written, or any 
other type of interaction involving FDA personnel. In fact, 
videoconferences can be used to supplement face-to-face meetings and 
enable more persons outside the Rockville, MD area to participate in 
discussions with FDA.
    All existing confidentiality rules that apply to face-to-face 
meetings also apply to videoconferences. The transmission signal 
between the videoconferencing sites is conducted through cables and is 
scrambled to provide security. Ordinarily, there will be no videotaping 
of videoconferences, but videotaping may be permitted if all parties 
agree to videotaping before the videoconference is held. FDA will not 
permit videoconferences to be broadcasted, however, because some 
information presented at such meetings may be confidential or otherwise 
protected from disclosure.
    All current FDA procedures for conducting meetings will apply to 
videoconferences. Because some participants may not always be in view 
of the camera, FDA recommends that each videoconference begin by 
introducing or identifying all participants.
    FDA will schedule videoconferences in response to a specific 
request. The request should be made to the contact person listed above. 
FDA recommends that parties request a videoconference at least several 
weeks in advance, and there is no time limit on how far in advance a 
videoconference may be scheduled.
    Scheduling will be done on a first-come, first-served basis. FDA 
will consider the geographical location of the parties when scheduling 
a videoconference; thus, for example, FDA will schedule morning 
meetings with parties in the Eastern United States, and schedule 
afternoon meetings with parties in the Western United States. The 
agency does not intend to establish prereserved blocks of time for 
parties in the Western United States.
    Once a videoconference has been scheduled, the agency will not 
reschedule the videoconference except in emergencies. This policy is in 
consideration of the substantial amount of scheduling and preparation 
involved in setting up a videoconference. Additionally, 
videoconferencing should be reserved for meetings that are likely to 
run at least 30 minutes. If a videoconference extends beyond its 
scheduled time, the videoconference may be extended, provided the 
facility is still available.
    The agenda and all materials planned to be presented during a 
videoconference should be sent to the Project Management Officer, 
Consumer Safety Officer, or appropriate official (in nonindustry-
related meetings) at least 14 days before the scheduled 
videoconference. The materials will be used as reference or backup 
material and will help assure high quality communication.
    During the videoconferencing facility's first year of operation, 
FDA will maintain a log on the use of the facility to determine the 
demand and variety of uses for the facility and to determine how much 
use is for internal FDA purposes or for FDA and nongovernmental 
entities. In addition, FDA will provide a questionnaire to participants 
to obtain their opinions on the value of the videoconferencing 
facility.
    Persons interested in obtaining information concerning the policies 
and procedures, which are continuing to evolve at this time, for using 
FDA's videoconferencing facility, as well as a listing of public 
videoconferencing rooms, should notify the contact person listed above.

    Dated: February 17, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-4412 Filed 2-25-94; 8:45 am]
BILLING CODE 4160-01-F