Document ID: FDA-2008-N-0038-0068
Agency: fda
Document Type: Notice
Title: Anti-Infective Drugs Advisory Committee; Notice of Meeting
Posted Date: 2008-10-10T04:00Z

[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Notices]               
[Page 60299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc08-81]                         

[[Page 60299]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
Anti-Infective 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: Anti-Infective 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 December 3, 2008, from 8 
a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers 
Lane, Rockville, MD.
    Contact Person: Janie Kim, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 301-827-
7001, fax: 301-827-6776, e-mail: Janie.kim@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512530. 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) 22-
268, artemether 20 milligrams (mg)/lumefantrine 120 mg, sponsored by 
Novartis Pharmaceuticals Corp., for the proposed indication of 
treatment of acute, uncomplicated malaria infection due to Plasmodium 
falciparum or mixed infections including P. falciparum.
    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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and 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 
November 18, 2008. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12:30 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 November 7, 2008. 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 November 10, 2008.
    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 Janie Kim 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/oc/advisory/
default.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: October 3, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24197 Filed 10-9-08; 8:45 am]

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