[Federal Register: June 18, 2004 (Volume 69, Number 117)]
[Notices]
[Page 34176]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jn04-125]
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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 July 13, 2004, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom Salons
A and B, 620 Perry Pkwy., 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, 301-827-5283, ext. 123, e-mail:
mea@cdrh.fda.gov, or FDA Advisory Committee Information Line 800-741-
8138 (301-443-0572 in the Washington, DC area), code 3014512518. 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 bone grafting material, which
contains a wound-healing and revascularization agent, for treatment of
dental osseous defects. 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/panel/index.html.
Material will be posted on July 12, 2004.
Procedure: On July 13, 2004, from 8:30 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
July 1, 2004. Oral presentations from the public will be scheduled for
approximately 30 minutes at the beginning of committee deliberations
and for approximately 30 minutes near the end of the deliberations.
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before
July 1, 2004, 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 July 13, 2004, from 8 a.m. to
8:30 a.m., the meeting will be closed 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: June 14, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-13726 Filed 6-17-04; 8:45 am]
BILLING CODE 4160-01-S