Food and Drug Administration, HHS.
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.
The agreement became effective September 11, 2008.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.Start Signature
Dated: October 15, 2008.
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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