Document ID: FDA-2009-N-0664-0071
Agency: fda
Document Type: Notice
Title: Public Workshop: Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections
Posted Date: 2009-08-18T04:00Z

[Federal Register: August 18, 2009 (Volume 74, Number 158)]
[Notices]
[Page 41734]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18au09-63]

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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 SmallpoxWkshp@fda.hhs.gov 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