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Staff Manual Guide 2830.1, Attachment B

MOU FORMAT-MULTIPLE COMMODITIES MEMORANUM OF UNDERSTANDING BETWEEN THE FOOD AND DRUG ADMINISTRATION U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES AND THE (Insert Name of the Counterpart Participating Party) (Insert Name of Country) Concerning (Insert Types) Products Exported to the United States of America

  1. PURPOSE: A Statement of the purposes of the MOU.
  2. DEFINITIONS: Definitions of terms used in the MOU.
  3. SUBSTANTIVE OBLIGATIONS: A comprehensive description of what each party agrees to do and the specific responsibilities of each party.
  4. TECHNICAL INFORMATION EXCHANGE: A listing of the types of the sharing of expertise, providing assistance, and exchanging information that will help ensure the quality and safety of the product(s) covered by the MOU.
  5. SAMPLE COLLECTION: A listing of references or location of sample schedules that FDA or the foreign government will use when auditing sample product(s) covered by the MOU.
  6. ANALYTICAL METHODOLOGY: A listing of the latest edition of references containing methods FDA will use, or equivalent procedures if agreed to by both parties, to determine the compliance of products(s) covered by the MOU.
  7. PARTICIPATING PARTIES: Name and Address of Participating Parties.
  8. LIAISON OFFICERS:
    1. For Participating Party:
      1. In the foreign country: Individual's Name: Title: Address: Telephone Number: FAX Number:
      2. At the foreign government's embassy:

        Same as above

    2. For the Food and Drug Administration:

      For the sponsoring Center: Same as above

  9. ADMINISTRATIVE PROCEDURES: Brief statements on any ways and means on which the parties have agreed in order to give instruction and guidance for the practical implementation and application of the MOU.
  10. PERIOD OF AGREEMENT: This MOU will enter into force upon signature by both parties and will continue for a period of five (5) years. The parties agree to evaluate the MOU sometime during the five-year period. It may be extended or amended by written agreement of the parties. It may be terminated by either party upon 30-days written notice to the other. FOR THE (NAME OF FOREIGN PARTICIPATING FOR THE FOOD AND DRUG ADMINISTRATION PARTY) OF (INSERT NAME OF COUNTRY) OF THE UNITED STATES OF AMERICA.

By __________________________________ By __________________________________

Title _______________________________ Title _______________________________

Date ________________________________ Date ________________________________


ATTACHMENT TO MULTIPLE COMMODITIES MOU.

  1. COMMODITY (Insert Name of Commodity)
  2. DEFINITIONS Definitions of terms used only in the attachment.
  3. SAMPLING SCHEDULE List the number of subs (and the weight of each sub) per lot that should be collected for each type of audit analysis.
  4. ANALYTICAL METHODOLOGY Cite the specific procedures that are to be used to analyze audit samples for each specified attribute. If necessary, include sample preparation guidelines.
  5. CRITERIA FOR CERTIFICATION List the criteria, by attribute, that should be used by the participating foreign party and will be used by FDA to determine if the commodity complies with the laws enforced by FDA.
  6. EFFECTIVE DATE The provisions of this attachment to the Memorandum of Understanding will become effective (insert number) days after this attachment has been accepted by the (insert name of participating foreign party) and the Food and Drug Administration as indicated below: FOR THE (NAME OF FOREIGN PARTICIPATING FOR THE FOOD AND DRUG ADMINISTRATION PARTY) OF (INSERT NAME OF COUNTRY).

    Name ________________________________ Name ________________________________

    Title _______________________________ Title _______________________________

    Acceptance Date _____________________ Acceptance Date _____________________

    Effective Date ______________________ Effective Date ______________________