07-1921. 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 (NIH) of the Department of Health and Human Services (DHHS). The purpose of this MOU is to establish a formal collaboration between FDA and NCI regarding the creation of a common standards-based data repository to facilitate the electronic exchange and analysis of data from research studies on investigational drugs in a fully secure manner.

DATES:

The agreement became effective March 2, 2007.

FOR FURTHER INFORMATION CONTACT:

Randy Levin, Center for Drug Evaluation Research (HF-18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7784 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: April 5, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.