[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