[Federal Register Volume 67, Number 68 (Tuesday, April 9, 2002)]
[Notices]
[Page 17076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-8463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Anthrax Vaccines: Efficacy Testing and Surrogate Markers of 
Immunity; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), in cooperation with the Department of 
Defense (DoD), is announcing the following public workshop: ``Anthrax 
Vaccines: Efficacy Testing and Surrogate Markers of Immunity.'' The 
workshop will discuss possible strategies for the efficacy testing of 
investigational anthrax vaccines.
    Date and Time: The public workshop will be held on April 23, 2002, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Jay P. Sanford 
Auditorium on the campus of the Uniformed Services University of Health 
Sciences (USUHS), 4301 Jones Bridge Rd., Bethesda, MD 20814.
    Contact: Kerry Davis, Science Applications International Corp. 
(SAIC), 5340 Spectrum Dr., suite N, Frederick, MD 21703, 301-619-7078, 
FAX 301-698-6188, e-mail: [email protected].
    Registration: Preregistration is required and must be completed by 
April 12, 2002. Contact Kerry Davis (see ``Contact'' for address) for 
information about registration, including registration fees. Seating is 
limited.
    If you need special accommodations due to a disability, please 
contact Kerry Davis at least 7 days in advance of the meeting.
    Transcripts: You may request public workshop transcripts in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857. The 
transcripts will be available approximately 15 working days after the 
meeting at the cost of 10 cents per page. The public workshop 
transcript will also be available on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm

SUPPLEMENTARY INFORMATION: CBER, in cooperation with DoD, is holding a 
public workshop entitled ``Anthrax Vaccines: Efficacy Testing and 
Surrogate Markers of Immunity.'' The workshop will discuss: (1) 
Pathogenesis of Bacillus anthracis, (2) animal models of anthrax, (3) 
immunogenicity data available from human clinical trials of anthrax 
vaccines, and (4) identification of surrogate markers and possible 
strategies. The workshop's goal is to expedite the development of 
anthrax vaccines by providing additional information about efficacy 
testing of these vaccines.

    Dated: March 29, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-8463 Filed 4-8-02; 8:45 am]
BILLING CODE 4160-01-S