Skip to Content

Notice

Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

Start Printed Page 6974

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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.

Start Signature

Dated: January 28, 2008.

Jeffrey Shuren,

Assistant Commissioner for Policy.

End Signature Start Printed Page 6975

Start Printed Page 6976

Start Printed Page 6977

Start Printed Page 6978

Start Printed Page 6979

Start Printed Page 6980

Start Printed Page 6981

Start Printed Page 6982 End Supplemental Information

BILLING CODE 4160-01-S

[FR Doc. 08-496 Filed 2-5-08; 8:45 am]

BILLING CODE 4160-01-C