[Federal Register Volume 62, Number 13 (Tuesday, January 21, 1997)]
[Notices]
[Pages 3047-3048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1337]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). This
notice also summarizes the procedures for the meeting and methods by
which interested persons may participate in open public hearings before
FDA's advisory committees.
FDA has established an Advisory Committee Information Hotline (the
hotline) using a voice-mail telephone system. The hotline provides the
public with access to the most current information on FDA advisory
committee meetings. The advisory committee hotline, which will
disseminate current information and information updates, can be
accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory
committee is assigned a 5-digit number. This 5-digit number will appear
in each individual notice of meeting. The hotline will enable the
public to obtain information about a particular advisory committee by
using the committee's 5-digit number. Information in the hotline is
preliminary and may change before a meeting is actually held. The
hotline will be updated when such changes are made.
MEETING: The following advisory committee meeting is announced:
Dental Products Panel of the Medical Devices Advisory Committee
Date, time, and place. February 12, 1997, 9 a.m., Gaithersburg
Marriott Washingtonian Center, Ballroom, 9751 Washingtonian Blvd.,
Gaithersburg, MD. A limited number of overnight accommodations have
been reserved at the hotel. Attendees requiring overnight
accommodations may contact the hotel at 301-590-0044 and reference the
FDA Dental Products Panel meeting block. Reservations may be confirmed
at the group rate based on availability. Attendees with a disability
requiring special accommodations should contact Christie Wyatt, KRA
Corp., 301-495-1591, ext. 267. The availability of appropriate
accommodations cannot be assured unless prior notification is received.
Type of meeting and contact person. Open public hearing for the
reclassification of over-the-counter (OTC) denture cushions or pads, 9
a.m. to 9:30 a.m., unless public participation does not last that long;
open committee discussion, 9:30 a.m. to 11:30 a.m.; open public hearing
for the reclassification of temporary mandibular condyle implant
prostheses, 11:30 a.m. to 12 m., unless public participation does not
last that long; open committee discussion, 12 m. to 5:30 p.m.; Pamela
D. Scott, Center for Devices and Radiological Health (HFZ-480), Food
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-443-8879, or FDA Advisory Committee Information Hotline, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), Dental Products Panel,
code 12518. Please call the hotline for information concerning any
possible changes.
General function of the committee. The committee reviews and
evaluates data on the safety and effectiveness of marketed and
investigational devices and makes recommendations for their regulation.
Agenda--Open public hearing. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Those desiring to make formal presentations should
notify the contact person before February 5, 1997, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time required to make their comments.
Open committee discussion. The committee will discuss two petitions
for the reclassification of OTC denture cushions or pads that are
prefabricated or noncustom made disposable devices intended to improve
the fit of loose or uncomfortable dentures. (This does not include OTC
denture cushions or pads made of wax-impregnated cotton cloth that are
to be applied to the base or inner surface of a denture and are to be
discarded following 1 day's use; this device is presently class I). The
committee will also discuss a petition for the reclassification of
mandibular condyle implant prostheses for temporary use in the
treatment of patients following tumor resection.
FDA public advisory committee meetings may have as many as four
separable portions: (1) An open public hearing, (2) an open committee
discussion, (3) a closed presentation of data, and (4) a closed
committee deliberation. Every advisory committee meeting shall have an
open public hearing portion. Whether or not it also includes any of the
other three portions will depend upon the specific meeting involved.
There are no closed portions for the meetings announced in this notice.
The dates and times reserved for the open portions of each committee
meeting are listed above.
The open public hearing portion of the meeting(s) shall be at least
1 hour long unless public participation does not last that long. It is
emphasized, however, that the 1 hour time limit for an open public
hearing represents a minimum rather than a maximum time for public
participation, and an open public hearing may last for whatever longer
period the committee chairperson determines will facilitate the
committee's work.
Public hearings are subject to FDA's guideline (subpart C of 21 CFR
part 10) concerning the policy and procedures for electronic media
coverage of FDA's public administrative proceedings, including hearings
before public advisory committees under 21 CFR part 14. Under 21 CFR
10.205, representatives of the electronic media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants.
Meetings of advisory committees shall be conducted, insofar as is
practical, in accordance with the agenda published in this Federal
Register notice. Changes in the agenda will be announced at the
beginning of the open portion of a meeting.
Any interested person who wishes to be assured of the right to make
an oral presentation at the open public hearing portion of a meeting
shall inform the
[[Page 3048]]
contact person listed above, either orally or in writing, prior to the
meeting. Any person attending the hearing who does not in advance of
the meeting request an opportunity to speak will be allowed to make an
oral presentation at the hearing's conclusion, if time permits, at the
chairperson's discretion.
The agenda, the questions to be addressed by the committee, and a
current list of committee members will be available at the meeting
location on the day of the meeting.
Transcripts of the open portion of the meeting may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857,
approximately 15 working days after the meeting, at a cost of 10 cents
per page. The transcript may be viewed at the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857, approximately 15 working days after the meeting,
between the hours of 9 a.m. and 4 p.m., Monday through Friday. Summary
minutes of the open portion of the meeting may be requested in writing
from the Freedom of Information Office (address above) beginning
approximately 90 days after the meeting.
This notice is issued under section 10(a)(1) and (a)(2) of the
Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations
(21 CFR part 14) on advisory committees.
Dated: January 13, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-1337 Filed 1-17-97; 8:45 am]
BILLING CODE 4160-01-F