07-5793. Memorandum of Understanding Between the Food and Drug Administration and Duke University

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. 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.