[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]
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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 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