Document ID: FDA-2008-N-0038-0082
Agency: fda
Document Type: Notice
Title: Vaccines and Related Biological Products Advisory Committee; Notice of Meeting
Posted Date: 2008-11-03T05:00Z

[Federal Register: November 3, 2008 (Volume 73, Number 213)]
[Notices]               
[Page 65386-65387]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no08-51]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee

[[Page 65387]]

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 November 20, 2008, from 
1 p.m. to approximately 4 p.m.
    Location: National Institutes of Health, Building 29B, Conference 
Room C. This meeting will be held by teleconference. The public is 
welcome to attend the meeting at the specified location where a 
speakerphone will be provided. Public participation in the meeting is 
limited to the use of the speakerphone in the conference room. 
Important information about transportation and directions to the NIH 
campus, parking, and security procedures is available on the Internet 
at 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. Detailed information about security 
procedures is located at http://www.nih.gov/about/visitorsecurity.htm. 
Due to the limited available parking, visitors are encouraged to use 
public transportation.
    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 20, 2008, the Committee will meet in open 
session to hear updates of the research program in the Laboratory of 
DNA Viruses, Division of Viral 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://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: On November 20, 2008, 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 13, 2008. 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 November 5, 2008. 
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 November 6, 2008.
    Closed Committee Deliberations: On November 20, 2008, from 
approximately 3:30 p.m. to 4 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 report of the intramural research program 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 
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 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://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee 
meetings.

    Dated: October 21, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26139 Filed 10-31-08; 8:45 am]

BILLING CODE 4160-01-S