[Federal Register Volume 73, Number 210 (Wednesday, October 29, 2008)]
[Notices]
[Pages 64340-64348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-25738]


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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.

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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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