[Federal Register: October 23, 2003 (Volume 68, Number 205)]
[Notices]               
[Page 60702]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc03-53]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
General and Plastic Surgery Devices 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). The meeting will 
be open to the public.
    Name of Committee: General and Plastic Surgery Devices 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 November 21, 2003, from 
8 a.m. to 5 p.m.
    Location: Gaithersburg Holiday Inn, Walker/Whetstone Rooms, Two 
Montgomery Village Ave., Gaithersburg, MD.
    Contact Person: David Krause, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12519. Please call the Information Line or access the 
Internet address of http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html for up-to-
date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on two premarket approval applications (PMAs) for injectable devices 
intended to restore soft tissue facial contours such as nasolabial 
folds. Background information for each PMA, 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.
 The material for this meeting will be posted on November 
20, 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 November 7, 
2003. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 8:30 a.m., 11:30 a.m. and 11:45 a.m., 1:15 
p.m. and 1:30 p.m., and 4 p.m. and 4:15 p.m. Time allotted for oral 
public presentations may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 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.
    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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 16, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-26696 Filed 10-22-03; 8:45 am]

BILLING CODE 4160-01-S