[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Page 5724-5725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Vaccines and Related Biological Products 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: Vaccines and Related Biological Products 
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 February 27, 2007, from 
8 a.m. to 5:30 p.m. and on February 28, 2007, from 8 a.m. to 4:15 p.m.
    Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry 
Pkwy., Gaithersburg, MD 20877.
    Contact Person: Christine Walsh or Denise Royster, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 301-451-2391. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On February 27, 2007, in the morning session, the committee 
will hear presentations and make recommendations on the safety and 
effectiveness of an H5N1 inactivated

[[Page 5725]]

influenza vaccine manufactured by Sanofi Pasteur. In the afternoon, the 
committee will hear presentations and have discussions on clinical 
development of influenza vaccines for pre-pandemic uses. On February 
28, 2007, in the morning, the committee will hear presentations and 
make recommendations on strain selections for the influenza virus 
vaccine for the 2007-2008 season. In the afternoon, the committee will 
hear presentations and have discussions on circulating lineages of 
influenza type B virus.
    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 
    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 
February 13, 2007. Oral presentations from the public will be scheduled 
between approximately 10:45 and 11:15 a.m. and 2:45 and 3:15 p.m. on 
February 27, 2007, and between approximately 10:40 and 11:10 a.m. and 
2:50 and 3:20 p.m. on February 28, 2007. 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 February 5, 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 February 
6, 2007.
    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 Christine Walsh or 
Denise Royster 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 1, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-1899 Filed 2-6-07; 8:45 am]