[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Notices]
[Page 968-969]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ja07-51]
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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 January 25, 2007, from 8
a.m. to 5 p.m.
Location: Doubletree Hotel, 8120 Wisconsin Ave., Bethesda, MD
20814.
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: In Session I, the committee will hear presentations and
make recommendations on the safety and immunogenicity of PENTACEL
(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid
Conjugate) Vaccine Combined (DTaP-IPV/Hib)), manufactured by Sanofi
Pasteur, Ltd. In Session II, the committee will hear an overview of the
research programs in the Office of Vaccines Research and Review, Center
for Biologics Evaluation and Research (CBER). In the closed session,
the committee will discuss the
[[Page 969]]
report of the Office of Vaccines Research and Review Office Site Visit
of May 19, 2006.
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/[fxsp0]ohrms/[fxsp0]dockets/[fxsp0]ac/
[fxsp0]acmenu.htm. Click on the year 2007 and scroll down to the
appropriate advisory committee link.
Procedure: On January 25, 2007, from 8 a.m. to 4:25 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 January 19, 2007. Oral presentations from the public will be
scheduled between approximately 11:15 a.m. to 11:45 a.m. and 3:55 p.m.
to 4:25 p.m. 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
January 11, 2007. 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 January 12,
2007.
Closed Committee Deliberations: On January 25, 2007, from 4:25 p.m.
to 5 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 report of
the May 19, 2006, review of internal research programs in the Office of
Vaccines Research and Review, Division of Viral Products and Division
of Bacterial, Parasitic, and Allergenic Products, CBER.
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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: January 3, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. 07-28 Filed 1-4-07; 8:45 am]
BILLING CODE 4160-01-S