[Federal Register Volume 72, Number 116 (Monday, June 18, 2007)]
[Notices]
[Pages 33508-33509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11613]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0225]


Anthrax Vaccines--Bridging Correlates of Protection in Animals to 
Immunogenicity in Humans; 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 a public 
workshop entitled ``Anthrax Vaccines--Bridging Correlates of Protection 
in Animals to Immunogenicity in Humans.'' The purpose of the public 
workshop is to discuss possible strategies for bridging animal efficacy 
data to human immunogenicity data for investigational anthrax vaccines.
    Date and Time: The public workshop will be held on November 8, 
2007, from 8:30 a.m. to 5 p.m. and November 9, 2007, from 8:30 a.m. to 
1 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD, 20877, 1-301-977-8900.
    Contact Person: Pier Minor, National Institutes of Health/Office of 
the Director, 6610 Rockledge Dr., Rm. 5WS6, Mail Stop Code 6604, 
Bethesda, MD 20892, 301-451-6809, FAX: 301-402-0659, e-mail: 
[email protected].
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, and fax number) to the 
contact person by October 19, 2007. There is no registration fee for 
the public workshop. Early registration is recommended because seating 
is limited. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Wenda Minor (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA's Center for Biologics Evaluation and 
Research, in cooperation with the National Institutes of Health and the 
Department of Health and Human Services' Office of Biomedical Advanced 
Research and Development Authority (BARDA) within the Office of the 
Assistant Secretary for Preparedness and Response, is holding this 
public workshop. The public workshop will include discussions on: (1) 
Background information on the ``Animal Rule'' (May 31, 2002, 67 FR 
37988), immunological correlates of protection, and the toxin 
neutralizing assay that will be used to assess anthrax vaccine 
immunogenicity in animals and humans; (2) animal protection data for 
anthrax vaccines given both pre- and post-exposure; and (3) human 
immunogenicity data for anthrax vaccines. The goal of the public 
workshop is to discuss ways to expedite the development of new anthrax 
vaccines by providing additional information about bridging animal 
protection data to human immunogenicity.

[[Page 33509]]

    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page. A transcript of the public workshop will be available 
on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: June 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11613 Filed 6-15-07; 8:45 am]
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