Document ID: FDA-2015-N-0001-0006
Agency: fda
Document Type: Notice
Title: Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2015-01-28T05:00Z

[Federal Register Volume 80, Number 18 (Wednesday, January 28, 2015)]
[Notices]
[Page 4578]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01534]

[[Page 4578]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory 
Committee and 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 Committees: Dermatologic and Ophthalmic Drugs Advisory 
Committee and 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 24, 2015, 
from 8 a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 
20993-0002. Answers to commonly asked questions including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Moon Hee V. Choi, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 31, Rm. 2147, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 
301-847-8533, email: DODAC@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: The committees will discuss new drug application (NDA) 
203324, for riboflavin ophthalmic solutions with UV-A irradiation, 
submitted by Avedro, Inc. The combination products are used in 
corneal collagen cross-linking and proposed to be indicated for the 
treatment of progressive keratoconus or corneal ectasia following 
refractive surgery.
    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 
February 9, 2015. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. 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, 2015. 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 2, 2015.
    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 Moon Hee V. Choi 
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: January 23, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-01534 Filed 1-27-15; 8:45 am]
BILLING CODE 4164-01-P