[Federal Register Volume 73, Number 200 (Wednesday, October 15, 2008)]
[Notices]
[Pages 61136-61137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24354]


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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 November 18, 2008, from 
8 a.m. to 5 p.m., November 19, 2008, from 8 a.m. to 5:30 p.m. and on 
November 20, 2008, from 8 a.m. to 12 noon.
    Location: Holiday Inn/College Park, The Ballroom, 10000 Baltimore 
Ave., College Park, MD. The hotel telephone number is 301-345-6700.
    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: <a href="/cdn-cgi/l/email-protection#3a505b54535f145153577a5c5e5b14525249145d554c"><span class="__cf_email__" data-cfemail="39535857505c17525054795f5d581751514a175e564f">[email protected]</span></a>, 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: On November 18, 2008, the committee will discuss the 
justification of the non-inferiority margin for complicated skin and 
skin structure infections. On November 19, 2008, the committee will 
discuss: (1) New drug application (NDA) 022-110, telavancin powder for 
reconstitution and intravenous administration, Theravance, Inc., 
proposed for the treatment of complicated skin and skin structure 
infection, and (2) NDA 022-153, oritavancin, Targanta Therapeutics 
Corp., proposed for the treatment of complicated skin and skin 
structure infection. On November 20, 2008, the committee will discuss 
NDA 022-269, iclaprim, Arpida AG, proposed for the treatment of 
complicated skin and skin structure infection.
    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 4, 2008. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 1:15 p.m. on November 18, 2008, between 
approximately 11:30 a.m. to

[[Page 61137]]

11:45 a.m. and 4:15 p.m. to 4:30 p.m. on November 19, 2008, and between 
approximately 10:15 a.m. to 10:30 a.m. on November 20, 2008. 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 24, 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 October 28, 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 6, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24354 Filed 10-14-08; 8:45 am]
BILLING CODE 4160-01-S


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