[Federal Register: August 1, 2002 (Volume 67, Number 148)]
[Notices]
[Page 49945-49946]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au02-67]
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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 August 22, 2002, from 8
a.m. to 6 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: The committee will discuss, make recommendations, and vote
on a premarket approval application for a total temporomandibular joint
prosthesis for reconstruction of the temporomandibular joint.
Background information, including the agenda and questions for the
committee, will be available to the public one business day before the
meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html.
Material for the August 22, 2002, meeting will be posted on August 21,
2002.
Procedure: On August 22, 2002, from 8 a.m. to 5 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
August 5, 2002. Oral presentations from the public will be scheduled
between approximately 8:15 a.m. and 8:45 a.m. Near the end of the
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 August 19, 2002, 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 August 22, 2002, from 5 p.m. to
6 p.m., the meeting will be closed to permit FDA staff to present to
the committee trade secret and/or confidential commercial information
regarding dental device issues. This portion of the meeting will be
closed to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams,
Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days
in advance of the meeting.
[[Page 49946]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 25, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-19374 Filed 7-31-02; 8:45 am]
BILLING CODE 4160-01-S