[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