[Federal Register Volume 75, Number 233 (Monday, December 6, 2010)]
[Notices]
[Pages 75681-75682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-30501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 January 20, 2011, from 8 
a.m. to 5 p.m. and on January 21, 2011, from 8 a.m. to 12 p.m.
    Location: FDA White Oak Campus, Building 31 Conference Center, the 
Great Room (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 ``White Oak Conference Center Parking 
and Transportation Information for FDA Advisory Committee Meetings''. 
Please note that visitors to the White Oak Campus must have a valid 
driver's license or other picture ID, and must enter through Building 
1.
    Contact Person: Diem-Kieu Ngo, 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, e-mail: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512543. 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: On January 20, 2011, the committee will discuss new drug 
application (NDA) 202-008, florbetapir F 18 injection, sponsored by 
Avid Radiopharmaceuticals, Inc., proposed for use in positron emission 
tomography (PET) imaging of [beta]-amyloid (beta-amyloid) aggregates in 
the brain to help rule out Alzheimer's disease.
    On January 21, 2011, the committee will discuss NDA 201-277, 
gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, 
proposed for use in diagnostic magnetic resonance imaging (MRI) in 
adults and children (2 years of age and older) to detect and visualize 
areas with disrupted blood brain barrier (BBB) and/or abnormal 
vascularity (abnormal blood supply and circulation) of the central 
nervous system. The BBB is an area consisting of specialized cells that 
restrict passage of certain molecules from the bloodstream into the 
brain.
    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 
January 5, 2011.

[[Page 75682]]

Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. on January 20, 2011, and between 
approximately 10 a.m. and 11 a.m. on January 21, 2011. 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 
December 27, 2010. 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 December 28, 
2010.
    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 Diem-Kieu Ngo 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 1, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-30501 Filed 12-3-10; 8:45 am]
BILLING CODE 4160-01-P