[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Page 9764]
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 Pediatric 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 
Pediatric 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 April 12, 2007, from 
8:30 a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers 
Lane, Rockville, 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), codes 3014512530 or 8732310001. Please 
call the Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss clinical trial designs for 
products that seek indications for the prevention and/or treatment of 
disease caused by Shiga toxin-producing bacteria. FDA intends to make 
background material available to the public no later than 1 business 
day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
, click on the year 2007 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 
March 29, 2007. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. 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 March 21, 2007. 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 March 22, 
    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: February 26, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-3720 Filed 3-2-07; 8:45 am]