[Federal Register Volume 77, Number 27 (Thursday, February 9, 2012)]
[Notices]
[Pages 6804-6805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2927]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Advisory Committee for Reproductive Health Drugs; 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: Advisory Committee for Reproductive Health 
Drugs.
    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 April 5, 2012, from 8 
a.m. to 4:30 p.m.
    Location: FDA White Oak Campus, Building 31, the Great Room, White 
Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver 
Spring, MD 20993-0002. Information regarding special accommodations due 
to a disability, visitor parking and transportation may be accessed at 
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You'', click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Kalyani Bhatt, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., WO31-
2417, Silver Spring, MD 20993-0002, 301-796-9001, Fax: 301-847-8533, 
email: [email protected], 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 discuss the benefits and risks of 
mirabegron (YM178), under new drug application (NDA) 202611, submitted 
by Astellas Pharma Global Development Inc., for the proposed indication 
of treatment of overactive bladder (OAB) with symptoms of urge urinary 
incontinence, urgency, and urinary frequency. Mirabegron is a beta-3-
adrenoceptor (AR) agonist and is a new molecular entity. The benefit/
risk discussion will focus on the adequacy of the demonstration of 
efficacy and safety in the treatment of OAB.
    FDA intends to make background material available to the public no 
later than two 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. 
Written

[[Page 6805]]

submissions may be made to the contact person on or before March 22, 
2012. 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 March 14, 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 March 15, 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 Kalyani Bhatt 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: February 3, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-2927 Filed 2-8-12; 8:45 am]
BILLING CODE 4160-01-P