Document ID: FDA-2014-N-0314-0001
Agency: fda
Document Type: Notice
Title: Ophthalmic Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting
Posted Date: 2014-04-14T04:00Z

[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20889-20890]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-08217]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0314]

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 May 13, 2014, from 8 
a.m. to 6 p.m.
    Location: Holiday Inn Express/Highlands Conference Center, Oak I 
and II Conference Rooms, 20260 Goldenrod Lane, Germantown, MD 20876. 
The hotel's phone number is 301-605-1434.
    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, 
Natasha.Facey@fda.hhs.gov, 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 May 13, 2014, the committee will discuss and make 
recommendations regarding the guidance documents for contact lenses and 
contact lens accessories. The guidance for contact lenses entitled 
``Premarket Notification [510(k)] Guidance Document for Class II Daily 
Wear Contact Lenses'' and can be found at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080928.htm. The guidance for contact lens accessories entitled 
``Premarket Notification [510(k)] Guidance Document for Contact Lens 
Care Products'' and can be found at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080218.pdf. The discussion will include topics such as 
microbiological and chemical pre-clinical testing, revision of pre-
clinical test requirements to address patient non-compliance, 
modification of rigid gas permeable lens care regimens, and labeling 
for these devices.
    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.

[[Page 20890]]

    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 
6, 2014. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on May 13, 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 April 25, 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 April 29, 2014.
    FDA is opening a docket for public comment on this document. The 
docket number is FDA-2014-N-0314. The docket will close on May 23, 
2014. Interested persons are encouraged to use the docket to submit 
electronic or written comments regarding this meeting. Comments 
received on or before May 6, 2014, will be provided to the committee. 
Comments received after that date will be taken into consideration by 
the Agency. Submit electronic comments on this meeting to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be seen in the 
Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.
    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 
James.Clark@fda.hhs.gov 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: April 7, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-08217 Filed 4-11-14; 8:45 am]
BILLING CODE 4160-01-P