[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Notices]
[Pages 53273-53274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24894]
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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). 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 18, 2009 from 8
a.m. to approximately 5:45 p.m. and on November 19, 2009 from 8 a.m. to
approximately 3:15 p.m.
Location: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD.
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,
[[Page 53274]]
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: In open session on November 18, 2009, the committee will
discuss and make recommendations on the safety and effectiveness of a
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein),
BLA 125324, and will hear an update on FDA's Influenza A (H1N1) 2009
monovalent vaccine activities; Postmarketing surveillance. On November
19, 2009, the committee will discuss and make recommendations on the
safety and effectiveness of an Influenza Vaccine, Purified Recombinant
Influenza Hemagglutinin, BLA STN125285.
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 18, 2009, from 8 a.m. to approximately 5:45
p.m. and on November 19, 2009, from approximately 9 a.m. to
approximately 3:15 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 16, 2009. Oral
presentations from the public will be scheduled between approximately
1:20 p.m. and 1:50 p.m. on November 18, 2009, and approximately 1:30
p.m. and 2 p.m. on November 19, 2009. 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 9, 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 November
10, 2009.
Closed Committee Deliberations: On November 19, 2009, from 8 a.m.
to approximately 9 a.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)).
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 9, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24894 Filed 10-15-09; 8:45 am]
BILLING CODE 4160-01-S