Document ID: FDA-2009-N-0664-0070
Agency: fda
Document Type: Notice
Title: Meetings: Vaccines and Related Biological Products Advisory Committee
Posted Date: 2009-08-17T04:00Z

[Federal Register: August 17, 2009 (Volume 74, Number 157)]
[Notices]               
[Page 41449-41450]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au09-97]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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). 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 September 9, 2009, from 
8 a.m. to approximately 5 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. 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 9, 2009, in the morning, the committee will 
discuss and make recommendations on the safety and effectiveness in 
females of a vaccine manufactured by GlaxoSmithKline against Human 
Papillomavirus. In the afternoon, the committee will discuss and make 
recommendations on the safety and effectiveness of vaccinating males 
with Gardasil, a vaccine manufactured by Merck & Co. against Human 
Papillomavirus.
    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: 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 4, 2009. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12 noon and between approximately 
3:40 p.m. and 4:10 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 August 27, 2009. 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 September 
3, 2009.
    Persons attending FDA's advisory committee meetings are advised 
that the

[[Page 41450]]

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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 11, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-19639 Filed 8-14-09; 8:45 am]

BILLING CODE 4160-01-S