[Federal Register Volume 73, Number 198 (Friday, October 10, 2008)]
[Notices]
[Pages 60300-60301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24163]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0038]
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 18, 2008, from
8:30 a.m. to 5 p.m., and November 19, 2008, from 8 a.m. to 12:30 p.m.
Location: Marriott Gaithersburg Washingtonian Center, Salons C and
D, 9751 Washingtonian Blvd., Gaithersburg, MD.
Contact Person: Lisa M. Lim, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240-276-3555, 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 for up-to-date
information on this meeting. A notice in the Federal Register about
last minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the agency's Web site
and call the appropriate advisory committee hot line/phone line to
learn about possible modifications before coming to the meeting.
Agenda: On November 18, 2008, the committee will receive an update
on safety information collected on dermal fillers in the commercial
setting, discuss current premarket and postmarket approved study
designs, and make recommendations on general issues concerning the
study of various dermal fillers. In addition, the committee will
discuss the design of clinical trials for future premarket submissions
seeking approval of dermal fillers for new intended uses.
On November 19, 2008, the committee will discuss and make
recommendations on general issues related to the clinical trials of
cosmetic devices. Specifically, the committee will make recommendations
on how to quantify the effects of devices with various types of energy
sources, such as light-based products, light-based combination devices,
ultrasound devices (including focused ultrasound devices), massagers
combined with other energy modalities, cryogenic energy devices,
radiofrequency ablation devices, and microwave systems, on dermatologic
conditions.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
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 on or before
November 10, 2008. Oral presentations from the public will be scheduled
between approximately 9 a.m. and 10 a.m., and between 1:15 p.m. and
2:15 p.m. on November 18, 2008, and between approximately 8:15 a.m. and
9:15 a.m. on November 19, 2008. Those desiring to make formal oral
presentations should notify the contact person 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
on or before October 31, 2008. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by November
3, 2008.
[[Page 60301]]
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 240-276-8932 at least 7 days in advance
of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee
meetings.
Dated: October 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24163 Filed 10-9-08; 8:45 am]
BILLING CODE 4160-01-S