[Federal Register Volume 65, Number 189 (Thursday, September 28, 2000)]
[Notices]
[Pages 58278-58279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24999]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Dental Products Panel of the Medical Devices Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Dental Products Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 6, 2000, 8:30 
a.m. to 5:30 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: Pamela D. Scott, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12518. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for a glenoid fossa prosthesis that 
is used alone to reconstruct the temporomandibular joint (TMJ). The 
committee will also discuss and make recommendations on the labeling 
for a total TMJ prosthesis.
    Procedure: On October 6, 2000, from 9 a.m. to 5:30 p.m., the 
meeting is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Written submissions may be made to the contact person by 
September 28, 2000. Oral presentations from the public will be 
scheduled between approximately 9:15 a.m. and 9:45 a.m. on October 6, 
2000. Near the end of committee deliberations, a 30-minute open public 
session will be conducted for interested persons to address issues 
specific to the submission before the committee. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 28, 
2000, 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 
requested to make their presentation.
    Closed Committee Deliberations: On October 6, 2000, from 8:30 a.m. 
to 9 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)) regarding dental device issues.

[[Page 58279]]

    FDA regrets that it was unable to publish this notice 15 days prior 
to the October 6, 2000, Dental Products Panel of the Medical Devices 
Advisory Committee meeting. Because the agency believes there is some 
urgency to bring this issue to public discussion and qualified members 
of the Dental Products Panel of the Medical Devices Advisory Committee 
were available at this time, the Commissioner of Food and Drugs 
concluded that it was in the public interest to hold this meeting even 
if there was not sufficient time for the customary 15-day public 
notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 20, 2000.
Bernard A. Schwetz,
Acting Deputy Commissioner.
[FR Doc. 00-24999 Filed 9-26-00; 8:45 am]
BILLING CODE 4160-01-F