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Staff Manual Guide 2830.1, Attachment A

MEMORANUM OF UNDERSTANDING 
BETWEEN THE 
(Insert Name of the Participating Party) 
AND THE 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
FOOD AND DRUG ADMINISTRATION

I. Purpose: Briefly state the specific purpose of the agreement.

II. Background: Describe why the agreement is needed or the opportunity it provides for international harmonization.

III. Substance of Agreement: Provide a comprehensive description of what is being agreed to and the specific responsibilities of each party.

IV. Name and Address of Participating Parties: Self-explanatory.

V. Liaison Officers:

A. For Participating Party:

Individual's Name:

Title:

Address:

Telephone Number:

B. For the Food and Drug Administration:

Same information as above.

VI. Period of Agreement: This agreement becomes effective upon acceptance by both parties. It may be modified by mutual written consent or terminated by either party upon a thirty-day advance written notice to the other party. The parties agree to evaluate the agreement at least once in a five-year period, at which time either party will have the option of continuing, modifying, or canceling the agreement.

 

APPROVED AND ACCEPTED FOR THE
(Name of Foreign Party)
APPROVED AND ACCEPTED FOR
FOOD AND DRUG ADMINISTRATION
By __________________________________ By __________________________________
Title ________________________________ Title ________________________________
Date ________________________________ Date ________________________________