[Federal Register Volume 74, Number 199 (Friday, October 16, 2009)]
[Pages 53273-53274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24894]



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.


    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 
    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]