[Federal Register Volume 70, Number 186 (Tuesday, September 27, 2005)]
[Notices]
[Pages 56471-56472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19195]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


International Conference on Harmonisation Workshop on Oncolytic 
Viruses; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``ICH Workshop on Oncolytic Viruses.'' The workshop 
will be held in conjunction with the International Conference on 
Harmonisation (ICH) expert working group and steering committee 
meetings in Chicago, IL. The objective of the workshop is to identify 
and discuss issues relevant to clinical development of oncolytic 
viruses including safety. The following viruses will be covered: 
Adenovirus, herpes simplex virus, reovirus, Newcastle disease virus, 
measles virus, and Sendai virus. Speakers will address selectivity, 
attenuation modes, shedding, clinical and viral safety, and proof of 
concept in support of the approach in animal and human setting.
    Date and Time: The workshop will be held on November 7, 2005, from 
8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Westin Michigan 
Avenue, 909 North Michigan Ave., Chicago, IL 60611.
    Contact Person: Daniel Takefman, Center for Biologics Evaluation 
and Research (HFM-720), Food and Drug Administration, Rockville, MD 
20852, 301-827-5102, e-mail: [email protected].
    Registration: Registrations are being collected by the 
Pharmaceutical Research and Manufacturers of America (PhRMA). Send 
registration information (including name, title, firm name, address, 
telephone, and fax number) to Liz Cross at PhRMA by FAX: 202-572-7797, 
or e-mail: [email protected], no later than Friday, October 14, 2005. 
The registration fee for this workshop is $450 for industry; $175 for 
academia and government participants. To register via the Internet go 
to http://

[[Page 56472]]

www.ich.org/cache/html/2238-272-1.html.
    The registration fee will be used to offset some expenses of 
hosting the workshop including speakers, meeting rooms, coffee breaks, 
and materials.
    If you need special accommodations due to a disability, please 
contact Liz Cross at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: ICH was established in 1990 as a joint 
regulatory/industry project to improve, through harmonization, the 
efficiency of the process for developing and registering new medicinal 
products in the European Union (EU), Japan, and the United States 
without compromising the regulatory obligations of safety and 
effectiveness.
    ICH's steering committee recognized that in the rapidly evolving 
area of gene therapy medicinal products, there is a need to continue to 
foster the exchange of information that may impact the regulation of 
such products. The Gene Therapy Discussion Group (GTDG) is leading 
these activities within ICH.
    Regulatory and industry representatives from the three ICH regions 
(EU, Japan, and the United States), and experts from the European Free 
Trade Association, Health Canada, and the World Health Organization 
participate in this group.
    The objectives of GTDG are to monitor emerging scientific issues 
and proactively set out principles that may have a beneficial impact on 
harmonizing regulation of gene therapy products.
    The current ICH process and structure can be found on the Internet 
at http://www.ich.org (FDA has verified the Web site address, but we 
are not responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register).
    The agenda and registration form for the public workshop are 
available on the Internet at http://www.ich.org/cache/html/2238-272-1.html (FDA has verified the Web site address, but we are not 
responsible for subsequent changes to the Web site after this document 
publishes in the Federal Register).
    The workshop agenda includes panel discussions in addition to 
invited presentations. A summary of the workshop will be available 
through ICH after the meeting.

    Dated: September 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19195 Filed 9-26-05; 8:45 am]
BILLING CODE 4160-01-S