[Federal Register: August 30, 2005 (Volume 70, Number 167)]
[Notices]
[Page 51355-51356]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au05-47]
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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 via teleconference on
September 22, 2005 from 1:30 p.m. to 5 p.m.
Location: NIH campus, Food and Drug Administration Bldg. 29B,
Conference Room C, 8800 Rockville Pike, Bethesda, MD. This meeting will
be held by teleconference. The public is welcome to attend the meeting
at the above location. A speaker phone will be provided at the
specified location for public participation in this meeting. Important
information about transportation and directions to the NIH campus,
parking, and security procedures is available on the internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitor/index.htm.
Visitors must show two forms of
identification such as a Federal employee badge, driver's license,
passport, green card, etc. If you are planning to drive to and park on
the NIH campus, you must enter at the South Drive entrance of the
campus, which is located on Wisconsin Ave. (the medical center metro
entrance), and allow extra time for vehicle inspection. Detailed
information about security procedures is located at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking,
visitors are encouraged to use public transportation.
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: The committee will hear an overview of the research of the
Laboratory of Retroviruses and the Laboratory of Immunoregulation,
Division of Viral Products, and the Laboratory of Respiratory and
Special Pathogens and the Laboratory of Methods Development and Quality
Control, Division of Bacterial Parasitic and Allergenic Products,
Office of Vaccines Research and Review, Center for Biologics Evaluation
and Research (CBER), and in closed session will discuss the reports
from the Laboratory Site Visits of April 18 and 19, 2005, and June 16,
2005.
Procedure: On September 22, 2005, from 1:30 p.m. to 4 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 by
September 15, 2005. Oral presentations from the public will be
scheduled between approximately 3 p.m. to 4 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 15,
2005, 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.
Closed Committee Deliberations: On September 22, 2005, from 4 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 a 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 (see CONTACT PERSON) 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).
[[Page 51356]]
Dated: August 23, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-17181 Filed 8-29-05; 8:45 am]