Memorandum of Understanding With the National Heart, Lung, and Blood Institute, a Part of the National Institutes of Health, 64340-64348 [E8-25738]
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64340
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
The sources of the previous data are
records of generic drug applications
over the past 10 years.
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: October 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–25741 Filed 10–28–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
scientific and clinical topics, questions,
and problems that may arise. This MOU
also provides the framework for sharing
of information.
[Docket No. FDA–2008–N–0043]
[FDA No. 225–07–1000]
DATES:
Memorandum of Understanding With
the National Heart, Lung, and Blood
Institute, a Part of the National
Institutes of Health
FOR FURTHER INFORMATION CONTACT:
Keith Wonnacott, Cellular Therapy
Branch (HFM–720), Center for Biologics
Evaluation and Research, Food and
Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852–
1448, 301–827–5102; or John W.
Thomas, Division of Blood Diseases and
Resources, National Heart, Lung, and
Blood Institute MSC 7950, 6701
Rockledge Dr., Rockledge II, rm. 9150,
Bethesda, MD 20892–7950, 301–435–
0065.
AGENCY:
The agreement became effective
September 11, 2008.
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA’s
Center for Biologics Evaluation and
Research (CBER) and the National Heart,
Lung, and Blood Institute (NHLBI), a
part of the National Institutes of Health
(NIH). This MOU outlines the terms of
collaboration between CBER and NHLBI
in areas of mutual concern for
protecting and improving the public
health. Specifically this MOU provides
for the implementation of a plan for
promoting better communication and
understanding of regulations, policies,
and statutory responsibilities, and to
serve as a forum for discussion of
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In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
BILLING CODE 4160–01–S
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64348
Federal Register / Vol. 73, No. 210 / Wednesday, October 29, 2008 / Notices
BILLING CODE 4160–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0043]
[FDA No. 225–08–6000]
Memorandum of Understanding With
the U.S. Army Medical Research
Institute of Infectious Diseases
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and
Drug Administration (FDA) is providing
notice of a memorandum of
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SUMMARY:
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understanding (MOU) with the U.S.
Army Research Institute of Infectious
Diseases (USAMRIID). This MOU
identifies the terms of collaboration
between FDA and USAMRIID in the
area of emergency preparedness.
Specifically this MOU provides for the
sharing of information and collaborative
activities related to biological threat
agents and diagnostics to detect such
biological threat agents in order to assist
both parties in more efficiently
preparing for and responding to
emergencies in which such diagnostic
tests may be used.
DATES: The agreement became effective
September 5, 2008.
FOR FURTHER INFORMATION CONTACT:
Nancy J. Pluhowski, Senior
Regulatory Health Scientist, Center
for Devices and Radiological Health
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(HFZ–001), Food and Drug
Administration, 9200 Corporate
Blvd., Rockville, MD 20850, 240–
276–3816, or
Dan Coffman, Business Plans and
Programs Office, USAMRIID, 1425
Porter St., Fort Detrick, MD 21702–
5011, 301–619–6886.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
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[FR Doc. E8–25738 Filed 10–28–08; 8:45 am]
]]>Agencies
[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Notices]
[Pages 64340-64348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25738]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0043]
[FDA No. 225-07-1000]
Memorandum of Understanding With the National Heart, Lung, and
Blood Institute, a Part of the National Institutes of Health
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is providing notice of
a memorandum of understanding (MOU) between FDA's Center for Biologics
Evaluation and Research (CBER) and the National Heart, Lung, and Blood
Institute (NHLBI), a part of the National Institutes of Health (NIH).
This MOU outlines the terms of collaboration between CBER and NHLBI in
areas of mutual concern for protecting and improving the public health.
Specifically this MOU provides for the implementation of a plan for
promoting better communication and understanding of regulations,
policies, and statutory responsibilities, and to serve as a forum for
discussion of scientific and clinical topics, questions, and problems
that may arise. This MOU also provides the framework for sharing of
information.
DATES: The agreement became effective September 11, 2008.
FOR FURTHER INFORMATION CONTACT: Keith Wonnacott, Cellular Therapy
Branch (HFM-720), Center for Biologics Evaluation and Research, Food
and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD
20852-1448, 301-827-5102; or John W. Thomas, Division of Blood Diseases
and Resources, National Heart, Lung, and Blood Institute MSC 7950, 6701
Rockledge Dr., Rockledge II, rm. 9150, Bethesda, MD 20892-7950, 301-
435-0065.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which
states that all written agreements and MOUs between FDA and others
shall be published in the Federal Register, the agency is publishing
notice of this MOU.
Dated: October 15, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
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[FR Doc. E8-25738 Filed 10-28-08; 8:45 am]
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