[Federal Register Volume 68, Number 187 (Friday, September 26, 2003)]
[Notices]
[Page 55641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-24303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Counter Terrorism Products Regulated by the Center for Biologics 
Evaluation and Research: Effective Strategies to Assist in Product 
Development; 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 ``Counter Terrorism Products Regulated by the Center 
for Biologics Evaluation and Research: Effective Strategies to Assist 
in Product Development.'' The purpose of the public workshop is to 
provide a forum for discussing strategies to assist in the effective 
development of products regulated by the Center for Biologics 
Evaluation and Research (CBER) that may be used in counter terrorism 
efforts (e.g., vaccines, blood and blood products including 
immunoglobulins, gene therapies, and human cellular and tissue-based 
products).
    Date and Time: The workshop will be held on October 23, 2003, from 
8:30 a.m. to 5 p.m., and on October 24, 2003, from 8:30 a.m. to 5 p.m.
    Location: The workshop will be held at the Hyatt Regency Bethesda, 
One Bethesda Metro Center, Bethesda, MD.
    Contact Person: Gloria Blankenship, CBER (HFM-49), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-2000, 
FAX 301-827-3079, e-mail: [email protected].
    Registration: Mail, e-mail, or fax your registration information 
(including name, professional degree, title, e-mail address, firm name, 
address, telephone, and fax number) to Gloria Blankenship, (see Contact 
Person) by October 10, 2003. There is no registration fee for the 
public workshop. Because seating is limited, we recommend early 
registration. There will be no onsite registration.
    If you need special accommodations due to a disability, please 
contact Gloria Blankenship (see Contact Person) at least 7 days in 
advance.

SUPPLEMENTARY INFORMATION: The purpose of this public workshop is to 
provide a forum for sharing information and strategies to assist in the 
efficient and successful development of products regulated by CBER and 
used for counter terrorism efforts. CBER is interested in promoting a 
discussion of issues related to the development of counter terrorism 
products, including manufacturing and clinical issues, and other 
relevant issues. The workshop is intended to help sponsors address 
commonly asked questions and avoid common misunderstandings and to 
provide practical information on successful product development 
strategies.
    FDA invites participants to submit issues for discussion prior to 
the workshop. There will be an opportunity to raise additional 
questions and issues for discussion at the meeting. Mail or fax your 
issues and questions to Gloria Blankenship (see Contact Person) by 
October 10, 2003.
    FDA will post on CBER's Web site (http://www.fda.gov/cber/) the 
agenda for this meeting, when finalized.
    Transcripts: Please note that transcripts of the meeting will not 
be prepared.

    Dated: September 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-24303 Filed 9-25-03; 8:45 am]
BILLING CODE 4160-01-S