[Federal Register: April 19, 2004 (Volume 69, Number 75)]
[Page 20941-20942]
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 via teleconference on May 
6, 2004, from 1:30 p.m. to 3:30 p.m.
    Location: National Institute of Health (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 speakerphone 
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), 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 on the Laboratory of 
DNA Viruses, Division of Viral Products, Office of Vaccines Research 
and Review, Center for Biologics and Research (CBER), and in closed 
session will discuss the report from the laboratory site visit of March 
4, 2004.
    Procedure: On May 6, 2004, from 1:30 p.m. to 3 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 April 29, 
2004. Oral presentations from the public will be scheduled between 
approximately 2 p.m. to 3 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before April 30, 2004, 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 
    Closed Committee Deliberations: On May 6, 2004, from 3 p.m. to 3:30 
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 a review of internal 
research programs in the Office of Vaccines Research and Review, 
Division of Viral 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).

[[Page 20942]]

    Dated: April 9, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-8721 Filed 4-16-04; 8:45 am]