

[Federal Register: February 6, 2008 (Volume 73, Number 25)]
[Notices]               
[Page 6973-6982]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe08-65]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA No. 225-07-8007]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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