[Federal Register Volume 73, Number 57 (Monday, March 24, 2008)]
[Notices]
[Page 15530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5810]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Ophthalmic 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: Ophthalmic 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 April 24 and 25, 2008,
from 8:30 a.m. to 5 p.m.
Location: Gaithersburg Holiday Inn, Ballroom, 2 Montgomery Village
Ave., Gaithersburg, MD.
Contact Person: Karen F. Warburton, Center for Devices and
Radiological Health, Food and Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 240-276-4238, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), code 3014512396. 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 April 24, 2008, the committee will discuss, make
recommendations, and vote on a premarket approval application,
sponsored by VisionCare Technologies, Inc., for an implantable
miniature telescope (IMT). The IMT, a visual prosthetic device, is
indicated for monocular implant in patients with stable, moderate to
profound central vision impairment due to bilateral central scotomas
associated with end-stage macular degeneration with geographic atrophy
or disciform scar, foveal involvement, and cataract. On April 25, 2008,
the committee will discuss general issues concerning the post market
experience with phakic intraocular lenses and laser-assisted in situ
keratomileusis (LASIK).
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
April 15, 2008. Oral presentations from the public will be scheduled on
April 24, 2008, between approximately 9:30 a.m. and 10 a.m. and between
approximately 3:30 p.m. and 4 p.m.; and on April 25, 2008, between
approximately 10 a.m. and 11:15 a.m. and between approximately 3 p.m.
and 4 p.m. 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
April 7, 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 April 8, 2008.
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 14, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-5810 Filed 3-21-08; 8:45 am]
BILLING CODE 4160-01-S