05-24100. Memorandum of Understanding Between the United States Food and Drug Administration and the C-Path Institute

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 the United States Food and Drug Administration and the C-Path Institute. The specific purpose of this MOU is to establish an overarching framework for collaboration between the parties. This framework will be based on mutually agreed upon programs and activities in the areas of applied scientific research and training/education to foster the development of new evaluation tools to inform medical product development. The parties shall each leverage its own expertise and resources to facilitate programs of shared interests across the diverse disciplines of therapeutics, biological sciences, engineering and medical devices in building applied research and training/education programs. The appropriate formal agreements will be executed as required by law for any activities that result from this collaboration.

DATES:

The agreement became effective October 14, 2005.

FOR FURTHER INFORMATION CONTACT:

For C-Path Institute: Raymond L. Woosley, The Critical Path Institute, 4280 N. Campbell Ave., #214, Tucson, AZ 85718, 520-547-3440, FAX: [phone], e-mail: [e-mail].

For The Food and Drug Administration: Mary I. Poos, Office of External Relations, Food and Drug Administration (HF-10), 5600 Fishers Lane, Rockville, MD 20857, 301-827-2825, FAX: [phone], e-mail: [e-mail].

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: December 7, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.