[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Notices]
[Page 82310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-33561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Cardiovascular and Renal 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: Cardiovascular and Renal 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 23, 2012, from 
8 a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727 
Colesville Rd., Silver Spring, MD 20910. The hotel's telephone number 
is (301) 589-5200.
    Contact Person: Kristina Toliver, 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), 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 new drug application (NDA) 
203202, proposed trade name NORTHERA (droxidopa capsules), submitted by 
Chelsea Therapeutics, Inc., for the treatment of symptomatic neurogenic 
orthostatic hypotension in patients with primary autonomic failure 
(Parkinson's Disease, Multiple System Atrophy, and Pure Autonomic 
Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic 
Autonomic Neuropathy.
    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. 
Written submissions may be made to the contact person on or before 
February 8, 2012. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 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 31, 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 1, 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 Kristina Toliver 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 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-33561 Filed 12-29-11; 8:45 am]
BILLING CODE 4130-01-P