[Federal Register: November 15, 2006 (Volume 71, Number 220)]
[Notices]
[Page 66545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15no06-78]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Anti-Infective Drugs Advisory Committee and
the Drug Safety and Risk Management 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 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
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 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]
BILLING CODE 4160-01-S