[Federal Register: July 25, 2006 (Volume 71, Number 142)]
[Notices]
[Page 42096-42097]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy06-51]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 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
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 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]
BILLING CODE 4160-01-S