
[Federal Register: July 18, 2008 (Volume 73, Number 139)]
[Notices]               
[Page 41362]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18jy08-95]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

 
Animal Models for the Treatment of Acute Radiation Syndrome; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research and Center for Drug Evaluation and Research, 
and the National Institutes of Health, National Institute of Allergy 
and Infectious Diseases, are announcing a public workshop entitled 
``Animal Models for the Treatment of Acute Radiation Syndrome (ARS).'' 
The purpose of the public workshop is to discuss issues that should be 
considered when developing animal models to assist in developing and 
demonstrating the efficacy of products intended for treatment of ARS.
    Date and Time: The public workshop will be held on September 17, 
2008, from 8:30 a.m. to 5:30 p.m., and on September 18, 2008, from 8:30 
a.m. to 1 p.m.
    Location: The public workshop will be held at the Hilton Hotel, 
Washington DC North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 
20877.
    Contact Person: Bernadette Kawaley, Center for Biologics Evaluation 
and Research (HFM-43), Food and Drug Administration, 1401 Rockville 
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-
3079; e-mail: CBERTraining@fda.hhs.gov (Subject line: Animal Models for 
ARS Workshop).
    Registration: Mail, fax, or e-mail your registration information 
(including name, title, firm name, address, telephone and fax numbers) 
to the contact person by August 25, 2008. There is no registration fee 
for the public workshop. Early registration is recommended because 
seating is limited. Registration on the day of the public workshop will 
be provided on a space available basis beginning at 8 a.m. If you need 
special accommodations due to a disability, please contact Bernadette 
Kawaley (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION:  There are no approved medical products with 
an indication for treatment of ARS. The public workshop will provide 
the opportunity to explore current research involving animal models for 
the development of treatments for ARS, and to determine what areas need 
further research. There will be feature presentations by experts from 
government, academia, and medicine. The first day of the workshop will 
include presentations on the effects of radiation and the management of 
patients with ARS, and a discussion of the application of the animal 
rule to therapies for ARS. Both days of the workshop will examine the 
challenges faced when using animal models to mimic radiation exposure 
scenarios and will include panel discussions that will focus on various 
animal models and their application to the different syndromes of ARS.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: July 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-16461 Filed 7-17-08; 8:45 am]

BILLING CODE 4160-01-S
