73 FR 25 pgs. 6973-6982 - Memorandum of Understanding Between the Food and Drug Administration and the National Institutes of Health
Type: NOTICEVolume: 73Number: 25Pages: 6973 - 6982
Docket number: [FDA No. 225-07-8007]
FR document: [FR Doc. 08-496 Filed 2-5-08; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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.
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.
BILLING CODE 4160-01-S
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[FR Doc. 08-496 Filed 2-5-08; 8:45 am]
BILLING CODE 4160-01-C