[Federal Register: September 5, 2003 (Volume 68, Number 172)]
[Notices]
[Page 52775-52776]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se03-66]
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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 October 14, 2003, from 8
a.m. to 10 p.m., and October 15, 2003, from 7:30 a.m. to 5 p.m.
Location: Gaithersburg Marriott, Grand Ballroom, 9751 Washingtonian
Blvd., 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 at 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: On October 14 and 15, 2003, the committee will discuss,
make recommendations, and vote on a premarket approval application for
Silicone Gel-Filled Breast Prostheses. Background information,
including the agenda and questions for the committee, will be available
to the public on October 10, 2003, 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
.
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 September 30,
2003. Oral presentations from the public will be scheduled on October
14, 2003, between approximately 8 a.m. and 12 noon, and on October 15,
2003, between approximately 7:30 a.m. and 11:30 a.m. Time allotted for
each presentation is limited. Those desiring to make formal
[[Page 52776]]
oral presentations should notify the contact person before September
30, 2003, and submit a brief statement of the general nature of the
comments they wish to present, and the names and addresses of proposed
participants.
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: August 29, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-22580 Filed 9-4-03; 8:45 am]
BILLING CODE 4160-01-S