[Federal Register: July 25, 2006 (Volume 71, Number 142)]
[Page 42096-42097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 September 11 and 12, 
2006, from 8 a.m. to 5 p.m.
    Location: Hilton-Gaithersburg, Salons A, B, and C, 620 Perry Pkwy, 
Gaithersburg, MD.
    Contact Person: Sohail Mosaddegh, 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: sohail.mosaddegh@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. The 
background material will become available no later than the day before 
the meeting and will be posted on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
 under the heading ``Anti-Infective Drugs 

Advisory Committee (AIDAC).'' (Click on the year 2006 and scroll down 
to AIDAC meetings.)
    Agenda: On September 11, 2006, the committee will discuss new drug 
applications (NDAs) 21-931, garenoxacin mesylate tablets, 400 
milligrams (mg) and 600 mg, and NDA 21-932, intravenous garenoxacin 
mesylate, 400 mg (200 milliliters (mL) of 2 mg/mL) and 600 mg (300 mL 
of 2 mg/mL), proposed trade name GENINAX, submitted by Schering Corp., 
for the proposed treatment indications of acute bacterial exacerbation 
of chronic bronchitis, acute bacterial sinusitis, community-acquired 
pneumonia, complicated and uncomplicated skin and skin structure 
infections, and complicated intra-abdominal infections. On September 
12, 2006, the committee will discuss supplemental new drug application 
(sNDA) 21-158/S-006, Factive (gemifloxacin mesylate) Tablets, submitted 
by Oscient Pharmaceuticals Corp., for the proposed treatment of acute 
bacterial sinusitis.
    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 
August 25, 2006. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2 p.m. on September 11, 2006, and 
between approximately 1 p.m. and 1:30 p.m. on September 12, 2006. Time 
allotted for each presentation may be limited. 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 August 25, 2006.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Sohail Mosaddegh 
(see Contact Person) at least 7 days in advance of the meeting.

[[Page 42097]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-11772 Filed 7-24-06; 8:45 am]