07-2106. Memorandum of Understanding Between the National Cancer Institute and the Food and Drug Administration

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 National Cancer Institute (NCI), part of the National Institutes of Health of the Department of Health and Human Services. The purpose of this MOU is to establish a formal collaboration between FDA and NCI regarding proteomics science and technology to accelerate proteomics technology development and application in clinical settings. FDA and NCI intend to collaborate in areas involving proteomics such as: Sample collection, preparation, storage and processing; bioinformatics and data analysis; discovery and validation of biomarkers; and surrogate biomarkers of cancer development and drug response, including standardization among technology platforms and assay standards development.

DATES:

The agreement became effective April 5, 2007.

FOR FURTHER INFORMATION CONTACT:

Francis Kalush, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0996, e-mail: [e-mail].

or Henry Rodriguez, Office of the Director, (MSC-2580), National Cancer Institute, 31 Center Dr., rm. 10A52, Bethesda, MD 20892, 301-496-1550.

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: April 20, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.