[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Notices]
[Page 60681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20981]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Immune Correlates of Protection Against Influenza A Viruses in 
Support of Pandemic Vaccine Development; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled `` Immune Correlates of Protection against Influenza 
A Viruses in Support of Pandemic Vaccine Development.'' The purpose of 
the public workshop is to identify the gaps in our knowledge and 
abilities in addressing the unique challenges encountered in the 
development and evaluation of vaccines intended to protect against 
pandemic influenza.
    Date and Time: The public workshop will be held on December 10, 
2007, from 8:30 a.m. to 5:30 p.m. and December 11, 2007, from 8 a.m. to 
5:15 p.m.
    Location: The public workshop will be held at the Hyatt Regency 
Bethesda, One Bethesda Metro Center, Bethesda, MD 20814. For 
directions, see the hotel Web site at: http://www.bethesda.hyatt.com or 
call the hotel at 301-657-1234.
    Contact Person: Maureen Hess, Center for Biologics Evaluation and 
Research (HFM-405), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-827-5113, FAX: 301-827-9781, e-mail: 
[email protected].
    Registration: E-mail or fax your registration information 
(including name, title, firm name, address, telephone, fax number and 
e-mail address) to the contact person by November 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 Ms. Maureen Hess (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's 
Division of Intramural Research within the National Institute of 
Allergy and Infectious Diseases and the World Health Organization, is 
holding this public workshop. The public workshop will include 
discussions on: (1) Current knowledge regarding correlates of 
protection against seasonal influenza, (2) immune responses to avian 
influenza infections and vaccines for novel influenza viruses in 
humans, (3) assays to evaluate vaccine immunogenicity, and (4) 
evaluation of avian influenza vaccine efficacy. The goals of the public 
workshop are to: (1) Identify the gaps in our knowledge and abilities 
in addressing the unique challenges encountered in the development and 
evaluation of vaccines intended to protect against pandemic influenza, 
and (2) facilitate implementation of a global research agenda to 
improve efficacy assessment of pandemic influenza vaccines.
    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: October 18, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20981 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S