[Federal Register: April 16, 2007 (Volume 72, Number 72)]
[Page 19003-19004]
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). At least one 
portion of the meeting will be closed 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 May 16, 2007, from 9 
a.m. to 4:30 p.m. and on May 17, 2007, from 8 a.m. to 1 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 3014512391. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On May 16, 2007, in the morning session, the committee will 
hear presentations and make recommendations on the safety and 
effectiveness of influenza virus vaccine live (FluMist) in a pediatric 
population less than 59 months of age, manufactured by MedImmune 
Vaccines, Inc. In the afternoon, the committee will hear an overview of 
the function of the Laboratory of Bacterial Polysaccharides and the 
Laboratory of Enteric & Sexually Transmitted Diseases, Division of 
Bacterial Parasitic and Allergenic Products, Office of Vaccines 
Research and Review, CBER and in closed session will discuss the report 
of the November 29, 2006, laboratory site visit. On May 17, 2007, the 
committee will hear presentations and make recommendations on the 
safety and immunogenicity of a live vaccinia virus smallpox vaccine 
(ACAM2000) manufactured by Acambis, Inc.
    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: On May 16, 2007, from 9 a.m. to 3:50 p.m. and on May 17, 
2007, from 8 a.m. to 1 p.m., the meeting is open to the public. 
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 May 2, 2007. Oral 
presentations from the public will be scheduled between approximately 
11:45 a.m. to 12:15 p.m. and 3:20 p.m. to 3:50 p.m. on May 16, 2007, 
and between approximately 11:15 a.m. to 11:45 a.m. on May 17, 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 April 24, 2007. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to

[[Page 19004]]

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 April 25, 2007.
    Closed Committee Deliberations: On May 16, 2007 from 3:50 p.m. to 
4:30 p.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the review of 
internal research programs in the Office of Bacterial Parasitic and 
Allergenic Products, Office of Vaccines Research and Review, CBER.
    Person's 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: April 6, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-7090 Filed 4-13-07; 8:45 am]