[Federal Register: June 20, 2006 (Volume 71, Number 118)]
[Notices]
[Page 35435]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn06-45]
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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). 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
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: June 12, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-9601 Filed 6-19-06; 8:45 am]
BILLING CODE 4160-01-S