06-8708. 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.

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: [phone], [e-mail].

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: [phone], [e-mail].

For Duke: Office of Research Administration, Duke University Medical Center, 2424 Erwin Rd., suite 1103, Durham, NC 27705, 919-684-5175, FAX: [phone].

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.