[Federal Register: August 31, 2004 (Volume 69, Number 168)]
[Page 53077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Animal Models and Correlates of Protection for Plague Vaccines; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.


    The Food and Drug Administration (FDA) is announcing the following 
public workshop: ``Animal Models and Correlates of Protection for 
Plague Vaccines.'' The purpose of this workshop is to provide a public 
forum to discuss the animal models that may be most appropriate for 
evaluating new plague vaccines; the critical immune responses that may 
correlate with protection against plague; and the kinds of experimental 
and clinical assays that will need to be developed to measure these 
critical immune responses both in animals and in humans. The workshop 
will develop information that may be critical to the design of the 
pivotal studies required to assess plague vaccine efficacy.
    Date and Time: This 1 1/2-day public workshop will be held on 
October 13, 2004, from 8:30 a.m. to 5 p.m., and October 14, 2004, from 
8:30 a.m. to 12 noon.
    Location: The workshop will be held at the Marriott Gaithersburg 
Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg, MD.
    The Marriott Gaithersburg Washingtonian Center is located 
approximately 30 minutes from Ronald Reagan Washington National and 
Washington Dulles International airports. Directions to the hotel can 
be found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://marriott.com/property/propertyPage/WASWG.

    Contact Person: Regarding the public workshop: Robert J. Watson, 
Science Applications International Corp., 5340 Spectrum Dr., suite N, 
Frederick, MD 21703, 301-228-3148, FAX: 301-698-5991, e-mail: 
    Regarding this document: Nathaniel L. Geary, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
    Registration: Registration is required; however, there is no 
registration fee for this public workshop. The deadline for 
registration is Wednesday, October 6, 2004. There will be no onsite 
registration. Information about the workshop and online registration 
can be found at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=https://www.seeuthere.com/event/m2c640-122589588204.

    If you need special accommodations due to a disability, please 
contact Robert Watson (see Contact Person) at least 7 days in advance 
of the workshop.

SUPPLEMENTARY INFORMATION: FDA's Center for Biologics Evaluation and 
Research; the National Institutes of Health, National Institute of 
Allergy and Infectious Diseases; and the Department of Health and Human 
Services, Office of Research Development and Coordination are 
sponsoring a public workshop. The workshop will be divided into 
interactive sessions in which leaders in the plague research field will 
present topics of particular relevance to plague vaccines. The sessions 
will include the following topics: (1) Introduction to the ``Animal 
Rule,'' (2) pathogenesis of plague, (3) plague vaccines and assessment 
of immune responses, (4) human disease and relevant animal models, and 
(5) implementation of the ``Animal Rule'' for plague vaccines. In 
addition, an expert panel will discuss the issues that will be critical 
for the development and eventual licensure of plague vaccines. The 
workshop's goal is to expedite the development and licensure of new 
plague vaccines by providing information critical to the development of 
the following: (1) Appropriate animal models, (2) immuno-assays, and 
(3) testing plans for vaccine evaluation.
    Transcripts: Transcripts of the workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the workshop at a cost of 10 cents 
per page. Additionally, the transcript will be placed on the FDA 
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: August 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19776 Filed 8-30-04; 8:45 am]