[Federal Register: June 20, 2006 (Volume 71, Number 118)]
[Page 35435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Ophthalmic 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: 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 July 14, 2006, from 8 
a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Montgomery 
Ballroom, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Sara M. Thornton, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2053 x 127, 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.
    Agenda: The committee will hear a presentation on FDA's Critical 
Path Initiative and a presentation by the Office of Surveillance and 
Biometrics, Center for Devices and Radiological Health, outlining their 
responsibility for the review of postmarket study design. Subsequently, 
the committee will discuss, make recommendations, and vote on a 
premarket approval application for an implantable miniature telescope 
(IMT). The IMT\TM\ is a visual prosthetic device which, when combined 
with the optics of the cornea, constitutes a telephoto lens and is 
indicated for use in patients with bilateral, stable macular 
degeneration and other bilateral, stable untreatable central vision 
disorders. Background information, 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/panel 

(click on ``Upcoming CDRH Advisory Committee/Panel Meetings'').
    Procedure: On July 14, 2006, from 8:45 a.m. to 6 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 July 5, 2006. Oral presentations from the public will be 
scheduled between approximately 9:45 a.m. and 10:15 a.m., and between 
approximately 3:30 p.m. and 4 p.m. 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 names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before July 
5, 2006.
    Closed Committee Deliberations: On July 14, 2006, from 8 a.m. to 
8:45 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)). This information is relevant to pending and future device 
submissions for vitreoretinal, surgical and diagnostic devices, 
intraocular and corneal implants, and contact lenses.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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: June 12, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-9601 Filed 6-19-06; 8:45 am]