E7-11613. 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.

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: [phone], e-mail: [e-mail].

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.

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.