E8-20932. Memorandum of Understanding Between the Food and Drug Administration and the University of Pennsylvania

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 the University of Pennsylvania (Penn). The purpose of this MOU is to establish terms of collaboration between FDA and Penn focused primarily but not exclusively, in the areas of translational therapeutics, diagnostics, bioinformatics, new clinical trial models, drug/device co-development, and pharmacoepidemiology. Beyond the collaborations in the traditional academic programs for training, research, and outreach, this MOU will also include collaborations with Penn extended partnerships such as the Institute for Translational Medicine and Therapeutics which includes the Children's Hospital of Philadelphia, the Wistar Institute, and the University of Sciences in Philadelphia.

DATES:

The agreement became effective on July 24, 2008.

FOR FURTHER INFORMATION CONTACT:

For FDA: Wendy R. Sanhai, Office of the Commissioner, Office of Scientific and Medical Programs (HF-18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7867.

For Penn: Glenn N. Gaulton, PENN Medicine, University of Pennsylvania, 421 Curie Blvd., Philadelphia, PA 19104-6160, 215-898-2874.

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: September 2, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.