[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77688-77689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30579]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-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 February 14, 2014, from
8 a.m. to 6 p.m.
Location: Gaithersburg Marriott Washingtonian Center, Salons A, B,
C and D, 9751 Washingtonian Blvd., Gaithersburg, MD 20878.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm.1609, Silver Spring, MD 20993, [email protected], 301-796-
6313, 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 February 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
[[Page 77689]]
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
February 7, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on February 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
January 30, 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 February 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: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-30579 Filed 12-23-13; 8:45 am]
BILLING CODE 4160-01-P