[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20889-20890]
From the Federal Register Online via the Government Publishing 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,
[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 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
[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: 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