[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Page 66545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Joint Meeting of the Anti-Infective Drugs Advisory Committee and 
the Drug Safety and Risk Management Advisory Committee; Notice of 

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 Committees: Anti-Infective 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 December 14, 2006, from 
8 a.m. to 6 p.m. and on December 15, 2006, from 8 a.m. to 5 p.m.
    Location: Crowne Plaza/Silver Spring, The Ballrooms, 8777 Georgia 
Ave., Silver Spring, MD. The hotel telephone number is 301-589-0800.
    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), codes 3014512530 or 3014512535. Please 
call the Information Line for up-to-date information on this meeting.
    Agenda: On both days, the committee will discuss the overall 
benefit to risk considerations for the approved product KETEK 
(telithromycin), new drug application (NDA) 21-144, with the current 
indications of: Acute bacterial exacerbations of chronic bronchitis, 
acute bacterial sinusitis, and community acquired pneumonia, 
manufactured by Sanofi-Aventis.
    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 headings Anti-

Infective Drugs Advisory Committee or Drug Safety and Risk Management 
Advisory Committee. (Click on the year 2006 and scroll down to the 
above named committee meetings.)
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committees. 
Written submissions may be made to the contact person on or before 
November 30, 2006. Oral presentations from the public will be scheduled 
between approximately 10 a.m. to 11 a.m. on December 15, 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 November 30, 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 at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 8, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-19249 Filed 11-14-06; 8:45 am]