[Federal Register Volume 74, Number 158 (Tuesday, August 18, 2009)]
[Notices]
[Page 41734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


Development of Antiviral Products for Treatment of Smallpox and 
Related Poxvirus Infections; 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 regarding scientific issues in clinical development of 
antiviral drug products for treatment of smallpox and related poxvirus 
infections. This public workshop is intended to provide information for 
and gain perspective from health care providers, academia, and industry 
on various aspects of antiviral product development for smallpox and 
related poxvirus infections, including the status of clinical 
understanding of smallpox from pre-eradication experience, current 
epidemiology of naturally occurring poxvirus infections, potential 
effect of antiviral treatment for smallpox and related poxvirus 
infections, and issues pertaining to animal models for smallpox and 
related poxvirus infections. The input from this public workshop will 
help in developing topics for further discussion.
    Dates and Times: The public workshop will be held on September 1, 
2009, from 8:30 a.m. to 5:30 p.m. and on September 2, 2009, from 8 a.m. 
to 4 p.m.
    Location: The public workshop will be held at the Crowne Plaza 
Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910.
    Contact Person: Chris Moser or Lori Benner, Center for Drug 
Evaluation and Research, Food and Drug Administration, Office of 
Antimicrobial Products, New Hampshire Ave., Bldg. 22, rm. 6209, Silver 
Spring, MD 20993-0002, 301-796-1300.
    Registration: To register electronically, e-mail registration 
information (including name, title, firm name, address, telephone, and 
fax number) to [email protected] by August 24, 2009. Persons 
without access to the Internet can call 301-796-1300 to register. 
Registration is free for the public workshop, but interested parties 
are encouraged to register early because spaced is limited. Seating 
will be available on a first-come, first-served basis. Persons needing 
a sign language interpreter or other special accommodations should 
notify Christine Moser or Lori Benner (see Contact Person) at least 7 
days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop 
regarding antiviral drug development for smallpox and related poxvirus 
infections. This public workshop will focus on scientific 
considerations in the clinical development of products for treatment of 
smallpox and related poxvirus infections. This public workshop is 
intended to provide information regarding historical perspectives on 
smallpox and current perspectives on related poxvirus infections in 
humans. The workshop will explore approaches to assessing the potential 
effect of antiviral treatment for smallpox and related poxvirus 
infections. Issues pertaining to animal models for smallpox and related 
poxvirus infection and their relationship to disease in humans will be 
discussed at the workshop. In addition, the workshop will include 
perspectives of public health organizations on possible uses of an 
antiviral product for poxvirus infections.
    The agency encourages individuals, patient advocates, industry, 
consumer groups, health care professionals, researchers, and other 
interested persons to attend this public workshop.
    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 20 working days after the public workshop, at a cost of 
10 cents per page. Transcripts will also be available on the Internet 
at http://www.fda.gov/Drugs/NewsEvents/ucm169065.htm approximately 45 
days after the workshop.

    Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19781 Filed 8-17-09; 8:45 am]
BILLING CODE 4160-01-S