[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://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://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