[Federal Register: March 5, 2004 (Volume 69, Number 44)]
[Notices]
[Page 10457]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr04-81]
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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 March 25, 2004, from 8
a.m. to 5 p.m.
Location: Hilton Washington, DC North/Gaithersburg, Ballroom Salons
A, B, C, and D, 620 Perry Pkwy., 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 3014512519. 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 a premarket approval application (PMA) for an injectable device
intended for use in the correction of lipoatrophy of the face in human
immunodeficiency virus (HIV) positive patients. Background information
for this 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 March 24, 2004.
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 March 15,
2004. On March 25, 2004, oral presentations from the public will be
scheduled for approximately 1 hour at the beginning of committee
deliberations and for approximately 1 hour near the end of the
committee deliberations. Time allotted for oral public presentations
may be limited. Those desiring to make formal oral presentations should
notify the contact person before March 15, 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.
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 Shirley Meeks,
Conference Management Staff, at 301-594-1283, ext. 105, 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: March 1, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-4983 Filed 3-4-04; 8:45 am]
BILLING CODE 4160-01-S