[Federal Register: April 16, 2007 (Volume 72, Number 72)]
[Notices]
[Page 19003-19004]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ap07-97]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 May 16, 2007, from 9
a.m. to 4:30 p.m. and on May 17, 2007, from 8 a.m. to 1 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.
Agenda: On May 16, 2007, in the morning session, the committee will
hear presentations and make recommendations on the safety and
effectiveness of influenza virus vaccine live (FluMist) in a pediatric
population less than 59 months of age, manufactured by MedImmune
Vaccines, Inc. In the afternoon, the committee will hear an overview of
the function of the Laboratory of Bacterial Polysaccharides and the
Laboratory of Enteric & Sexually Transmitted Diseases, Division of
Bacterial Parasitic and Allergenic Products, Office of Vaccines
Research and Review, CBER and in closed session will discuss the report
of the November 29, 2006, laboratory site visit. On May 17, 2007, the
committee will hear presentations and make recommendations on the
safety and immunogenicity of a live vaccinia virus smallpox vaccine
(ACAM2000) manufactured by Acambis, Inc.
FDA intends to make background material available to the public no
later than 1 business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and scroll down to the appropriate advisory committee
link.
Procedure: On May 16, 2007, from 9 a.m. to 3:50 p.m. and on May 17,
2007, from 8 a.m. to 1 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 May 2, 2007. Oral
presentations from the public will be scheduled between approximately
11:45 a.m. to 12:15 p.m. and 3:20 p.m. to 3:50 p.m. on May 16, 2007,
and between approximately 11:15 a.m. to 11:45 a.m. on May 17, 2007.
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 April 24, 2007. Time
allotted for each presentation may be limited. If the number of
registrants requesting to
[[Page 19004]]
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 April 25, 2007.
Closed Committee Deliberations: On May 16, 2007 from 3:50 p.m. to
4:30 p.m., the meeting will be closed to permit discussion where
disclosure would constitute a clearly unwarranted invasion of personal
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss the review of
internal research programs in the Office of Bacterial Parasitic and
Allergenic Products, Office of Vaccines Research and Review, CBER.
Person's 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 6, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-7090 Filed 4-13-07; 8:45 am]
BILLING CODE 4160-01-S