[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Notices]
[Page 39879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19945]
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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 4, 1998, 10:30
a.m. to 6:30 p.m., and August 5, 1998, 8 a.m. to 3 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 August 4, 1998, the committee will discuss: (1)
Previously unclassified devices for use in the diagnosis and/or
treatment of temporomandibular joint dysfunction and oral-facial pain,
(2) devices that FDA believes may fall within a present device
classification and those devices that do not fall within a present
device classification and thus remain unclassified, and (3)
classification of the devices that remain unclassified. On August 5,
1998, the committee will continue discussion of the classification of
devices for use in the diagnosis and/or treatment of temporomandibular
joint dysfunction and oral-facial pain that remain unclassified. The
list of those devices that FDA believes may fall within a present
device classification and those devices that do not fall within a
present device classification and thus remain unclassified will be
placed on the FDA web site at ``http://www.fda.gov/cdrh/
degenint.html''.
Procedure: On August 4, 1998, from 10:30 a.m. to 5:30 p.m. and on
August 5, 1998, 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 July 31, 1998. Oral
presentations from the public will be scheduled between approximately
1:30 p.m. and 2:30 p.m. on August 4, 1998, and between approximately
8:10 a.m. and 8:40 a.m. on August 5, 1998. Near the end of committee
deliberations, a 30-minute open public session will be conducted for
interested persons to address issues specific to the classification
before the committee. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before July 31, 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.
Closed Committee Deliberations: On August 4, 1998, from 5:30 p.m.
to 6:30 p.m., the meeting will be closed to permit discussion of trade
secret and/or confidential information regarding dental device issues
(5 U.S.C. 552b(c)(4)). The meeting will discuss classified device
issues.
FDA regrets that it was unable to publish this notice 15 days prior
to the August 4 and 5, 1998, 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. I11Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 21, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-19945 Filed 7-22-98; 11:41 am]
BILLING CODE 4160-01-F
