[Federal Register: August 31, 2004 (Volume 69, Number 168)]
[Notices]
[Page 53077]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au04-60]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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:
robert.j.watson@saic.com.
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]
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