26 September 2003
Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html

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[Federal Register: September 26, 2003 (Volume 68, Number 187)]
[Notices]
[Page 55641]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se03-76]

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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: Blankenship@cber.fda.gov.
    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