[Federal Register Volume 71, Number 199 (Monday, October 16, 2006)]
[Notices]
[Pages 60732-60739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-06-8404]


Memorandum of Understanding Between the Food and Drug 
Administration, and Duke University for the Cardiac Safety Research 
Consortium

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, on 
behalf of its Duke Clinical Research Institute (DCRI). FDA and Duke 
University agree to collaborate under the terms and conditions of this 
MOU, through steering committees and technical working groups, to 
develop strategic plans, set priorities, and leverage resources and 
expertise from multiple sources, including the private sector, toward 
the goals of identifying indicators of cardiovascular risk, predicting 
adverse cardiovascular events associated with therapeutic 
interventions, improving the clinical utility of biomarker technologies 
as diagnostic and assessment tolls that facilitate the development of 
safer and more effective cardiovascular therapies, diagnostic, and 
assessment tools. This collaboration between the Parties shall be known 
as the Cardiac Safety Research Consortium.

DATES: The agreement became effective August 15, 2006.

FOR FURTHER INFORMATION CONTACT:
    For FDA: Wendy R. Sanhai, Office of the Commissioner (HF-18), Food 
and Drug Administration, 5600 Fishers Lane, 14B-45, Rockville, MD 
20857, 301-827-7867, FAX: 301-443-9718, <a href="/cdn-cgi/l/email-protection#4f382a212b36613c2e21272e260f292b2e6127273c61282039"><span class="__cf_email__" data-cfemail="cbbcaea5afb2e5b8aaa5a3aaa28badafaae5a3a3b8e5aca4bd">[email protected]</span></a>.
    For Duke Clinical Research Institute: Christopher H. Cabell, 
Department of Medicine, Duke University School of Medicine, DUMC Box 
2705, Durham, NC 27705, 919-668-8611, FAX: 919-668-7066, 
<a href="/cdn-cgi/l/email-protection#d6b5bea4bfa5f8b5b7b4b3baba96b2a3bdb3f8b3b2a3"><span class="__cf_email__" data-cfemail="caa9a2b8a3b9e4a9aba8afa6a68aaebfa1afe4afaebf">[email protected]</span></a>.
    For Duke: Office of Research Administration, Duke University 
Medical Center, 2424 Erwin Rd., suite 1103, Durham, NC 27705, 919-684-
5175, FAX: 919-684-6278.

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 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 06-8708 Filed 10-13-06; 8:45 am]
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