[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65745-65749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-5793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-07-8005]


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

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 Duke University. 
The purpose of this MOU is to establish the terms of collaboration 
between FDA and Duke, beginning with an initiative to strengthen Human 
Subjects Protection by reexamining and modernizing the conduct of 
clinical trials to ensure that design, execution, and analysis are of 
optimal quality. To this end, Duke will be the convener of a Public 
Private Partnership, to which FDA will be a founding partner, to 
systematically modernize the clinical trial process.

DATES: The agreement became effective September, 22, 2007.

FOR FURTHER INFORMATION CONTACT: Melissa Robb, Office of Critical Path 
Programs, Office of Scientific and Medical Programs, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1516.

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: November 16, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 07-5793 Filed 11-21-07; 8:45 am]
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