Document ID: FDA-2014-N-0001-0058
Agency: fda
Document Type: Notice
Title: Joint Meeting of the Bone, Reproductive and Urologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee; Notice of Meeting
Posted Date: 2014-07-21T04:00Z

[Federal Register Volume 79, Number 139 (Monday, July 21, 2014)]
[Notices]
[Pages 42338-42339]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17081]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Joint Meeting of the Bone, Reproductive and Urologic Drugs 
Advisory Committee and the Drug Safety and Risk Management 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: Bone, Reproductive and Urologic Drugs Advisory 
Committee and the Drug Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 18, 2014, from 
8 a.m. to 1 p.m.
    Location: College Park Marriott Hotel and Conference Center, 3501 
University Blvd. East, Hyattsville, MD 20783. The hotel's telephone 
number is 301-985-7300.
    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: BRUDAC@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

[[Page 42339]]

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) 
206089 (oral testosterone undecanoate tablets), submitted by Clarus 
Therapeutics, for the proposed indication of testosterone replacement 
therapy in males for conditions associated with a deficiency or absence 
of endogenous testosterone: Primary hypogonadism (congenital or 
acquired) and hypogonadotropic hypogonadism (congenital or acquired).
    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 
September 3, 2014. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:45 a.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 August 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 August 26, 2014.
    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: July 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17081 Filed 7-18-14; 8:45 am]
BILLING CODE 4164-01-P