[Federal Register: January 9, 2007 (Volume 72, Number 5)]
[Page 968-969]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

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 January 25, 2007, from 8 
a.m. to 5 p.m.
    Location: Doubletree Hotel, 8120 Wisconsin Ave., 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, 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, 
    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 
    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]