[Federal Register: October 23, 2007 (Volume 72, Number 204)]
[Page 60022-60023]
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 by teleconference on 
November 14, 2007, from 1 p.m. to approximately 4:30 p.m.
    Location: National Institutes of Health, Building 29B, Conference 
Rooms A/B, Bethesda, MD. This meeting will be held by teleconference. 
The public is welcome to attend the meeting at the specified location 

[[Page 60023]]

a speaker phone will be provided. Public participation in the meeting 
is limited to the use of the speaker phone in the conference room. 
Important information about transportation and directions to the 
National Institutes of Health (NIH) campus, parking, and security 
procedures is available on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitor/index.htm.
 Visitors must show two forms of identification, one 

of which must be a government issued photo identification such as a 
Federal employee badge, driver's license, passport, green card, etc. If 
you are planning to drive to and park on the NIH campus, you must enter 
at the South Dr. entrance of the campus which is located on Wisconsin 
Ave. (the Medical Center Metro entrance), and allow extra time for 
vehicle inspection. Detailed information about security procedures is 
located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitorsecurity.htm. Due to the 

limited available parking, visitors are encouraged to use public 
    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. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On November 14, 2007, the committee will meet in open 
session to hear updates of the research programs in: (1) The Laboratory 
of Method Development, Division of Viral Products, Center for Biologics 
Evaluation and Research, FDA and (2) the Laboratory of Mycobacterial 
Diseases & Cellular Immunology, Division of Bacterial Parasitic & 
Allergenic Products, Center for Biologics Evaluation and Research, FDA.
    FDA intends to make background material available to the public no 
later than 2 business days 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 November 14, 2007, from 1 p.m. to approximately 3:30 
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 November 7, 2007. Oral presentations from the 
public will be scheduled between approximately 2:30 p.m. and 3:30 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 October 30, 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 October 31, 2007.
    Closed Committee Deliberations: On November 14, 2007, from 
approximately 3:30 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 reports of intramural research programs and make 
recommendations regarding personnel staffing decisions.
    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.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 


    Dated: October 17, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20854 Filed 10-22-07; 8:45 am]