[Federal Register: April 28, 2003 (Volume 68, Number 81)]
[Notices]
[Page 22391]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap03-67]
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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 May 22, 2003, from 9:30
a.m. to 4:30 p.m.
Location: Gaithersburg Holiday Inn, Walker/Whetstone Rooms, Two
Montgomery Village Ave., Gaithersburg, MD.
Contact Person: Michael E. Adjodha, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, via e-mail at mea@cdrh.fda.gov,
or by phone: 301-827-5283, ext. 123. Please call the FDA Advisory
Committee Information Line at 800-741-8138 (301-443-0572 in the
Washington, DC area), code 12518, for updated information on this
meeting.
Agenda: The committee will discuss, make recommendations, and vote
on a petition to reclassify tricalcium phosphate granules for dental
bone repair (21 CFR 872.3930) from class III to class II (special
controls). Background information, including the agenda and questions
for the committee, will be available to the public 1 business day
before the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html.
Material will be posted on May 21, 2003.
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 May 7, 2003.
Oral presentations from the public will be scheduled for approximately
60 minutes at the beginning of committee deliberations. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before May 7, 2003,
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 22, 2003, from 4 p.m. to
4:30 p.m., the meeting will be closed to the public to permit FDA to
present to the committee trade secret and/or confidential commercial
information regarding pending and future agency issues (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, 301-594-1283, ext. 113, at least 7 days in
advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 21, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-10299 Filed 4-25-03; 8:45 am]
BILLING CODE 4160-01-S