[Federal Register Volume 79, Number 91 (Monday, May 12, 2014)]
[Notices]
[Page 26973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10803]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
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 June 6, 2014, from 8
a.m. to 6 p.m.
Location: Hilton Washington, DC North/Gaithersburg, salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone
number is 301-977-8900.
Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 1552, Silver Spring, MD 20993, 301-796-5290,
[email protected], or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: On June 6, 2014, the committee will discuss, make
recommendations, and vote on information related to the premarket
approval application for the KAMRA Inlay (Model ACI 7000) (KAMRA Inlay)
submitted by applicant AcuFocus, Inc. The KAMRA Inlay is a permanent
corneal implant that is placed intrastromally in a corneal pocket or
under a corneal flap. The opaque annulus of the inlay reduces the
aperture of the eye, which improves near vision by providing an
increased depth of focus in the implanted eye. The proposed indication
for use states that the KAMRA Inlay is indicated for the improvement of
near and intermediate vision in presbyopic patients who require near or
intermediate correction. The KAMRA Inlay is intended to be placed
intrastromally in the cornea, on the visual axis, by way of a
femtosecond laser-created pocket using a spot/line separation of 6x6
microns ([micro]) or less. The KAMRA Inlay should be placed at a depth
equal to or greater than 180 [micro].
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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
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 May
30, 2014. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on June 6, 2014. Those individuals
interested in making 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 May 21, 2014. 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 May 27, 2014.
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 James Clark at
[email protected] or 301-796-5293 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: May 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10803 Filed 5-9-14; 8:45 am]
BILLING CODE 4160-01-P