06-113. 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 ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: [phone].

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.