Animal Models for the Treatment of Acute Radiation Syndrome; Public Workshop, 41362 [E8-16461]
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Federal Register / Vol. 73, No. 139 / Friday, July 18, 2008 / Notices
decomposition. It does not create or
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Dated: June 30, 2008.
Margaret O’K. Glavin,
Associate Commissioner for Regulatory
Affairs.
[FR Doc. E8–16453 Filed 7–17–08; 8:45 am]
BILLING CODE 4160–01–S
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,
dwashington3 on PRODPC61 with NOTICES3
HHS.
ACTION:
Notice of public workshop.
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
VerDate Aug<31>2005
15:36 Jul 17, 2008
Jkt 214001
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; email: 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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
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
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0038]
Rapid Methods for Detecting
Mycoplasma Contamination in the
Manufacture of Vaccines, Including
Pandemic Influenza Vaccines, and
Other Biological Products; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Rapid Methods for Detecting
Mycoplasma Contamination in the
Manufacture of Vaccines, Including
Pandemic Influenza Vaccines, and
Other Biological Products.’’ The
purpose of the public workshop is to
provide a forum on recent scientific and
technical achievements in the
development of rapid methods for
mycoplasma testing during the
manufacture of vaccines and other
biological products. Such discussion
may help to assess how these methods
compare with currently used methods.
Expedited manufacture may be of
particular importance to public health
during an influenza pandemic.
Date and Time: The public workshop
will be held on September 22, 2008,
from 8:30 a.m. to 5 p.m., and September
23, 2008, from 8:30 a.m. to 12 noon.
Location: The public workshop will
be held at the Hilton 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,
Rockville, MD 20852–1448, 301–827–
2000, FAX: 301–827–3079, e-mail:
CBERTraining@fda.hhs.gov (Subject
line: Mycoplasma Workshop).
E:\FR\FM\18JYN1.SGM
18JYN1
]]>Agencies
[Federal Register Volume 73, Number 139 (Friday, July 18, 2008)]
[Notices]
[Page 41362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-16461]
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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.
-----------------------------------------------------------------------
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 https://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
