[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11796-11797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04522]
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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. The meeting of the Ophthalmic Devices Panel
Advisory Committee scheduled for February 14, 2014, was postponed due
to unanticipated weather conditions and rescheduled for March 14, 2014.
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 March 14, 2014, from 8
a.m. to 6 p.m. This meeting is being rescheduled because of a postponed
meeting announced in the Federal Register of December 24, 2013 (78 FR
77688), originally scheduled for February 14, 2014.
Location: Hilton Washington, DC/North, 620 Perry Pkwy.,
Gaithersburg, MD 20877. The hotel's phone 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. 1544, Silver Spring, MD 20933, 301-796-5920,
[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 March 14, 2014, the committee will discuss, make
recommendations, and vote on information regarding the premarket
approval application for the Visian Toric Implantable Collamer Lens
(TICL) sponsored by STAAR Surgical Company. ``Visian TICL proposed
indications for use:
For adults 21-45 years of age;
For correction of myopic astigmatism in adults with
spherical equivalent ranging from -3.0D to <=-15.0D with cylinder of
1.0D to 4.0D;
For the reduction of myopic astigmatism in adults with
spherical equivalent ranging from greater than -15.0D to -20.0D with
cylinder 1.0D to 4.0D;
With an anterior chamber depth (ACD) of 3.0 mm or greater,
when measured from the corneal endothelium to the anterior surface of
the crystalline lens and a stable refractive history (within 0.5
Diopter for 1 year prior to implantation); and
The Visian TICL is intended for placement in the posterior
chamber (ciliary sulcus) of the phakic eye.''
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
[[Page 11797]]
submissions may be made to the contact person on or before March 7,
2014. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on March 14, 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 February 27, 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 March 3, 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 AnnMarie Williams at
[email protected] or 301-796-5966, 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: February 25, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-04522 Filed 2-28-14; 8:45 am]
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