[Federal Register Volume 62, Number 244 (Friday, December 19, 1997)]
[Notices]
[Page 66635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33096]
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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). The meeting will
be open 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 regulatory issues.
Date and Time: The meeting will be held on January 12, 1998, 10:15
a.m. to 5 p.m., and January 13, 1998, 8 a.m. to 5 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: On January 12, 1998, the committee will discuss and vote on
a premarket approval application for a bone filling and augmentation
device for periodontal use. On January 13, 1998, the committee will
discuss and make recommendations to FDA regarding the reclassification
of subgroups of endosseous dental implant devices. The following
subgroups of endosseous implants will be included: Coated and uncoated
root form implants, coated and uncoated blade-type implants, temporary
implants, and implants with special enhanced retention features.
Procedure: 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 December 29,
1997. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. and 11:30 a.m. on January 12, 1998, and
between approximately 8:10 a.m. and 9:10 a.m. on January 13, 1998. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
January 5, 1998, 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: December 12, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-33096 Filed 12-18-97; 8:45 am]
BILLING CODE 4160-01-F
