[Federal Register Volume 64, Number 80 (Tuesday, April 27, 1999)]
[Notices]
[Pages 22615-22616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10509]


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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 May 10, 1999, 10:30 a.m. 
to 6:30 p.m., and May 11, 1999, 8 a.m. to 3 p.m.
    Location: Holiday Inn, Walker-Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, 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: On May 10, 1999, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
a total temporomandibular joint (TMJ) prosthesis, which consists of the 
glenoid fossa prosthesis and the mandibular condyle prosthesis, for 
reconstruction of the TMJ. On May 11, 1999, the committee will discuss, 
make recommendations, and vote on a PMA that includes both a total TMJ 
prosthesis and a glenoid fossa prosthesis that can be used alone 
without the mandibular condyle prosthesis to reconstruct the TMJ. These 
PMA's were received in response to the final rule issued in the Federal 
Register of December 30, 1998 (63 FR 71743), requiring the filing of a 
PMA or a notice of completion of a

[[Page 22616]]

product development protocol for the total TMJ prosthesis (21 CFR 
872.3940), the glenoid fossa prosthesis (21 CFR 872.3950), the 
mandibular condyle prosthesis (for permanent reconstruction; 21 CFR 
872.3960), and the interarticular disc prosthesis (21 CFR 872.3970) 
under section 515(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e(b)).
    Procedure: On May 10, 1999, from 10:30 a.m. to 5:30 p.m., and May 
11, 1999, from 8 a.m. to 3 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 May 5, 1999. Oral presentations 
from the public will be scheduled between approximately 11:15 a.m. and 
11:45 a.m. on May 10, 1999, and between approximately 8:15 a.m. and 
8:45 a.m. on May 11, 1999. Near the end of the committee deliberations 
on each day, 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 May 5, 1999, 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 May 10, 1999, from 5:30 p.m. to 
6:30 p.m., the meeting will be closed to permit discussion of trade 
secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)) 
regarding dental device issues.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the May 10 and 11, 1999, Dental Products Panel of the Medical 
Devices Advisory Committee meeting. Because the agency believes there 
is some urgency to bring these issues to public discussion and 
qualified members of the Dental Products Panel of the Medical Devices 
Advisory Committee were available at this time, the Commissioner 
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: April 20, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-10509 Filed 4-26-99; 8:45 am]
BILLING CODE 4160-01-F