[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
