[Federal Register Volume 73, Number 175 (Tuesday, September 9, 2008)]
[Notices]
[Pages 52385-52392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-20932]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0043]
[FDA No. 225-08-8001]


Memorandum of Understanding Between the Food and Drug 
Administration and the University of Pennsylvania

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 and the University of 
Pennsylvania (Penn). The purpose of this MOU is to establish terms of 
collaboration between FDA and Penn focused primarily but not 
exclusively, in the areas of translational therapeutics, diagnostics, 
bioinformatics, new clinical trial models, drug/device co-development, 
and pharmacoepidemiology. Beyond the collaborations in the traditional 
academic programs for training, research, and outreach, this MOU will 
also include collaborations with Penn extended partnerships such as the 
Institute for Translational Medicine and Therapeutics which includes 
the Children's Hospital of Philadelphia, the Wistar Institute, and the 
University of Sciences in Philadelphia.

DATES: The agreement became effective on July 24, 2008.

FOR FURTHER INFORMATION CONTACT:
    For FDA: Wendy R. Sanhai, Office of the Commissioner, Office of 
Scientific and Medical Programs (HF-18), Food and Drug

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Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7867.
    For Penn: Glenn N. Gaulton, PENN Medicine, University of 
Pennsylvania, 421 Curie Blvd., Philadelphia, PA 19104-6160, 215-898-
2874.

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: September 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
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[FR Doc. E8-20932 Filed 9-8-08; 8:45 am]
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