[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59729-59730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24253]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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 November 16, 2010, from 
9 a.m. to approximately 4 p.m. and on November 17, 2010, from 8:30 a.m. 
to approximately 1:15 p.m.
    Location: Hilton Silver Spring Hotel, Maryland Ballroom, 8727 
Colesville Rd., Silver Spring, MD 20910.
    Contact Person: Donald W. Jehn or Denise Royster, Food and Drug 
Administration, 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

[[Page 59730]]

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 16, 2010, the committee will meet in open 
session to review and discuss the pathway to licensure for protective 
antigen-based anthrax vaccines for a post-exposure prophylaxis 
indication using the animal rule. On November 17, 2010, the committee 
will meet in open session to review and discuss the effectiveness of 
vaccinating males and females with Gardasil manufactured by Merck & Co. 
for the prevention of anal dysplasia and anal cancer.
    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 November 16, 2010, from 9 a.m. until approximately 
11:45 a.m. and from 2 p.m. until approximately 4 p.m. and on November 
17, 2010, 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 10, 2010. Oral presentations from 
the public will be scheduled between approximately 2:15 p.m. and 2:45 
p.m. on November 16, 2010, and between approximately 11:45 a.m. and 
12:15 p.m. on November 17, 2010. 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 2, 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, 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 
3, 2010.
    Closed Committee Deliberations: On November 16, 2010, between 12 
p.m. and approximately 2 p.m., the meeting will be closed to permit 
discussion and review of trade secret and/or confidential commercial 
information (5 U.S.C. 552b(c)(4)). The committee will hear firms 
discuss protocols they propose to use for the pathway to licensure for 
protective antigen-based anthrax vaccines for a post-exposure 
prophylaxis indication using the animal rule.
    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 Donald W. Jehn 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: September 23, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-24253 Filed 9-27-10; 8:45 am]
BILLING CODE 4160-01-S