[Federal Register Volume 71, Number 142 (Tuesday, July 25, 2006)]
[Notices]
[Pages 42097-42098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11775]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed 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 August 24, 2006, from 8 
a.m. to 5 p.m., and on August 25, 2006, from 9 a.m. to 5 p.m.
    Location: 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 3014512519. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On August 24, 2006, 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 HIV (human immunodeficiency virus) positive patients and 
a second PMA for the same device intended for use as a filler material 
to restore soft tissue facial contours such as nasolabial folds. On 
August 25, 2006, the committee will discuss and make recommendations on 
the reclassification, to Class II, of a Class III medical device: 
Cyanoacrylate tissue adhesive. Background information for this meeting, 
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/panel (click on ``Upcoming CDRH Advisory Panel/
Committee Meetings''). Material for the August 24 and 25 sessions will 
be posted on August 23, 2006.
    Procedure: On August 24, 2006, from 8 a.m. to 5 p.m., and on August 
25, 2006, from 9:30 a.m. to 5 p.m., the meeting is open to the public. 
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 August 10, 2006. On 
August 24, 2006, oral presentations from the public will be scheduled 
between approximately 8:30 a.m. and 9 a.m., approximately 11:45 a.m. 
and 12:15 p.m., approximately 1:45 p.m. and 2:15 p.m., and 
approximately 3:45 p.m. and 4:15 p.m. On August 25, 2006, oral 
presentations from the public will be scheduled between approximately 
11 a.m. and 12 noon. Time allotted for each presentation may be 
limited. 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

[[Page 42098]]

names and addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
August 10, 2006.
    Closed Committee Deliberations: On August 25, 2006, from 9 a.m. to 
9:30 a.m., the meeting will be closed to permit FDA to present to the 
committee trade secret and/or confidential commercial information (5 
U.S.C. 552b(c)(4)) relating to pending issues and applications.
    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 301-827-7291, 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: July 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11775 Filed 7-24-06; 8:45 am]
BILLING CODE 4160-01-S