[Federal Register Volume 71, Number 4 (Friday, January 6, 2006)]
[Notices]
[Pages 944-950]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-113]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-05-8007]


Implementation Plan for the Memorandum of Understanding Regarding 
the Sharing and Exchange of Information About Therapeutic Products 
Between the Food and Drug Administration Department of Health and Human 
Services of the United States of America and Health Products and Food 
Branch, Health Canada of Canada

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
an Implementation Plan (Implementation Plan) for the Memorandum of 
Understanding (MOU) Regarding the Sharing and Exchange of Information 
About Therapeutic Products Between the Food and Drug Administration 
Department of Health and Human Services of the United States of America 
and the Health Products and Food Branch, Health Canada of Canada. The 
purpose of the Implementation Plan is to establish the following: A 
governance structure for directing and monitoring the implementation of 
the MOU; clear process by which each party will undertake the exchange 
of otherwise not public information; and the process for setting and 
monitoring mutually agreed upon annual priorities for cooperation.

DATES: The Implementation Plan became effective December 1, 2005.

FOR FURTHER INFORMATION CONTACT: Matthew E. Eckel, Office of 
International Programs, (HFG-1), 5600 Fishers Lane, Rockville MD, 
20857, 301-827-4480, FAX: 301-480-0716.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(a) and (c), 
which states that all written agreements and understandings signed by 
FDA and other departments, agencies, and organizations shall be 
published in the Federal Register, except those agreements and 
memoranda of understanding between FDA and State or local government 
agencies that are cooperative work-sharing agreements, the agency is 
publishing notice of this Implementation Plan.

    Dated: December 30, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 06-113 Filed 1-5-06; 8:45 am]
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