Document ID: FDA-2010-N-0001-0085
Agency: fda
Document Type: Notice
Title: Vaccines and Related Biological Products Advisory Committee
Posted Date: 2010-08-06T04:00Z

[Federal Register: August 6, 2010 (Volume 75, Number 151)]
[Notices]               
[Page 47605-47606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au10-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

 
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 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 September 21, 2010, from 
2 p.m. to approximately 6 p.m.
    Location: National Institutes of Health (NIH), Building 29B/
Conference Room C. 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. (FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.) 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 September 21, 2010, the committee will meet in open 
session to hear updates of the research programs in the Laboratory of 
Respiratory & Special Pathogens, Division of Bacterial, Parasitic, & 
Allergenic Products; Laboratory of Hepatitis Viruses, and Laboratory of 
Vector Borne Virus Diseases, Division of Viral Products, Office of 
Vaccines Research and Review, 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/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    Procedure: On September 21, 2010, from 2 p.m. to approximately 5:10 
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 September 15, 2010. Oral presentations from the 
public will be scheduled between approximately 4:10 p.m. and 5:10 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 September 9, 2010. 
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,

[[Page 47606]]

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 September 10, 2010.
    Closed Committee Deliberations: On September 21, 2010, from 
approximately 5:10 p.m. to approximately 6 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 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 
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/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.

    Dated: August 3, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-19462 Filed 8-5-10; 8:45 am]
BILLING CODE 4160-01-S