[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]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

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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