Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections; Public Workshop, 41734 [E9-19781]
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Federal Register / Vol. 74, No. 158 / Tuesday, August 18, 2009 / Notices
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VerDate Nov<24>2008
16:30 Aug 17, 2009
Jkt 217001
redelegations, provided they are
consistent with this reorganization.
Food and Drug Administration
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.
[Docket No. FDA–2009–N–0664]
SUPPLEMENTARY INFORMATION:
Dated: August 7, 2009.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. E9–19680 Filed 8–17–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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 https://
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
E:\FR\FM\18AUN1.SGM
18AUN1
]]>Agencies
[Federal Register Volume 74, Number 158 (Tuesday, August 18, 2009)]
[Notices]
[Page 41734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19781]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
