Document ID: FDA-2010-N-0001-0106
Agency: fda
Document Type: Notice
Title: Peripheral and Central Nervous System Drugs Advisory Committee and Drug Safety and Risk Management AdvisoryCommittee; Meeting
Posted Date: 2010-09-16T04:00Z

[Federal Register: September 16, 2010 (Volume 75, Number 179)]
[Notices]               
[Page 56548-56549]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se10-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Joint Meeting of the Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 November 3, 2010, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The Ballrooms, 
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
    Contact Person: Diem-Kieu Ngo, Center for Drug Evaluation and 
Research, Food and Drug

[[Page 56549]]

Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver 
Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, email: 
diem.ngo@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), codes 
3014512543 and 3014512535. 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 November 3, 2010, the committees will discuss a number 
of safety concerns with intravenous administration of the anti-seizure 
drugs phenytoin and fosphenytoin, including the condition known as 
Purple Glove Syndrome, and recommend what regulatory actions, if any, 
are necessary to diminish the risks.
    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 
October 20, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those desiring to make 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 October 12, 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 October 
13, 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: September 10, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-23044 Filed 9-15-10; 8:45 am]
BILLING CODE 4160-01-S