Skip to Content

Notice

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

A Notice by the Food and Drug Administration on 10/16/2006

Document Details

Information about this document as published in the Federal Register.

Printed version:
PDF
Publication Date:
10/16/2006
Agencies:
Food and Drug Administration
Dates:
The agreement became effective August 15, 2006.
Effective Date:
08/15/2006
Document Type:
Notice
Document Citation:
71 FR 60732
Page:
60732-60739 (8 pages)
Agency/Docket Number:
FDA 225-06-8404
Document Number:
06-8708
Document Details
Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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.

Start Further Info

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, wendy.sanhai@fda.hhs.gov.

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, chris.cabell@duke.edu.

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.

End Further Info End Preamble Start Supplemental Information

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.

Start Signature

Dated: October 6, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature Start Printed Page 60733

Start Printed Page 60734

Start Printed Page 60735

Start Printed Page 60736

Start Printed Page 60737

Start Printed Page 60738

Start Printed Page 60739

End Supplemental Information

BILLING CODE 4160-01-S

[FR Doc. 06-8708 Filed 10-13-06; 8:45 am]

BILLING CODE 4160-01-C

Published Document