
[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Page 71349]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29682]



[[Page 71349]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0805]


Dermatologic and Ophthalmic Drugs 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: Dermatologic and Ophthalmic Drugs 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 27, 2012, from 
9 a.m. to 5 p.m.
    Addresses: FDA is opening a docket for public comment on this 
meeting. The docket number is FDA-2011-N-0805. The docket will open for 
public comment on November 17, 2011. The docket will close on March 5, 
2012. Interested persons may submit electronic or written comments 
regarding this meeting. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. All comments received will be posted 
without change, including any personal information provided. Submit a 
single copy of electronic comments or a paper copy of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this meeting notice. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday. Comments received on or before February 10, 2012, will 
be provided to the committee before the meeting.
    Location: Hilton Washington DC/Silver Spring (scheduled to be 
renamed in January 2012 to DoubleTree by Hilton Hotel Washington DC/
Silver Spring), 8727 Colesville Rd., Silver Spring, MD. The hotel phone 
number is (301) 589-5200.
    Contact Person: Yvette Waples, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, rm. 2417, 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), and follow the prompts to the desired center or product area. 
Please call the Information Line for up-to-date information on this 
meeting. 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 and 
call the appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: The committee will be asked to comment on the following 
topics related to the use of ophthalmic drug products (products 
intended for use in the eye): (1) Appropriate types of clinical 
evidence for developing anti-inflammatory drugs for the treatment of 
postoperative inflammation and reduction of ocular (eye) pain in 
patients who have undergone ocular surgery. This will include a 
discussion of the definition and scope of this indication as well as 
the types of clinical trials needed to support approval; and (2) 
appropriateness of marketing a single bottle of ophthalmic product for 
use in both eyes for postsurgical indications as it relates to the 
potential risk for infection. FDA's Center for Drug Evaluation and 
Research would like the advisory committee to provide advice on the 
potential risk and approaches to mitigating that risk, including limits 
to fill size where appropriate.
    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 link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
All electronic and written submissions submitted to the Docket (see the 
ADDRESSES section of this document) on or before February 10, 2012, 
will be provided to the committee. Oral presentations from the public 
will be scheduled between approximately 11 a.m. and 12 noon. 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 2, 2012. 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, 
2012.
    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 Yvette Waples 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: November 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29682 Filed 11-16-11; 8:45 am]
BILLING CODE 4160-01-P


