08-496. Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health

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 Institutes of Health (NIH). This MOU establishes the terms of collaboration between the two Federal agencies to develop a unified Federal approach to adverse event (AE) reporting. Specifically, FDA and NIH will collaborate in development of a project that will result in a web-based method for consumers, health professionals, investigators, sponsors, and other parties to electronically submit AE reports. The project includes the development of at least two products: (1) A Rational Questionnaire, an interactive help system that will assist reporters of information in determining what specific data need to be submitted and to whom, and (2) a prototype to test the feasibility of a central, Federal web-based portal to provide direct, seamless, online submission of adverse event reports to appropriate agencies.

DATES:

The agreement became effective September 27, 2007.

FOR FURTHER INFORMATION CONTACT:

Daryl Allis, OC/Office of Critical Path Programs, Food and Drug Administration, 5600 Fishers Lane (HF-18), Rockville, MD 20785, 301-827-7868.

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: January 28, 2008.

Jeffrey Shuren,

Assistant Commissioner for Policy.