[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Pages 734-735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-31675]


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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 March 4, 2013, from 8 
a.m. to 5 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 
20993-

[[Page 735]]

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., Bldg. 
31, Rm. 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). 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 http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee link, or call the advisory committee information 
line to learn about possible modifications before coming to the 
meeting.
    Agenda: On March 4, 2013, during the morning session, the committee 
will discuss new drug application (NDA) 022506, gabapentin 600 
milligram (mg) tablets, submitted by Depomed, Inc., for the proposed 
indication of treatment of moderate to severe vasomotor symptoms due to 
menopause.
    During the afternoon session, the committee will discuss NDA 
204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven 
Therapeutics, LLC, for the proposed indication of treatment of moderate 
to severe vasomotor symptoms associated with menopause.
    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 15, 2013. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 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 
February 7, 2013. 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 
sessions, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing sessions. The contact person will notify 
interested persons regarding their request to speak by February 8, 
2013.
    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: December 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31675 Filed 1-3-13; 8:45 am]
BILLING CODE 4160-01-P