[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
