[Federal Register Volume 61, Number 56 (Thursday, March 21, 1996)]
[Notices]
[Pages 11645-11646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6740]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[FDA-225-96-4001]


Memorandum of Cooperation Between the Food and Drug 
Administration, Mexico, and Canada

AGENCY: Food and Drug Administration, HHS.


[[Page 11646]]

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of cooperation (MOC) between the FDA, the Subsecretaria de 
Regulacion y Fomento Sanitario, Mexico, and the Health Protection 
Branch, Canada. The purpose of the MOC is to expand and strengthen 
communications among the three governments in the scientific and 
regulatory fields of health.

DATES: The agreement became effective October 30, 1995.

FOR FURTHER INFORMATION CONTACT: Marilyn E. Veek, Office of 
International Affairs (HFY-50), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-4480.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and memoranda of cooperation between 
FDA and others shall be published in the Federal Register, the agency 
is publishing notice of this memorandum of cooperation.


    Dated: March 11, 1996.
Gary J. Dykstra,
Acting Associate Commissioner for Regulatory Affairs.

Memorandum of Cooperation Between the Subsecretaria de Regulacion y 
Fomento Sanitario Secretaria de Salud (SSA) of the United Mexican 
States and the Food and Drug Administration (FDA), Department of Health 
and Human Services of the United States of America and the Health 
Protection Branch (HPB), Health Canada of Canada Regarding Cooperation 
in the Scientific and Regulatory Fields of Health

Preamble

    The Subsecretaria de Regulacion y Fomento Sanitario, the Food 
and Drug Administration and the Health Protection Branch seek to 
expand and strengthen communications among the three governments in 
the scientific and regulatory fields of health.

I. Purpose

    The Subsecretaria de Regulacion y Fomento Sanitario of the 
Secretaria de Salud (SSA) of the United Mexican States, the Food and 
Drug Administration (FDA) of the Department of Health and Human 
Services of the United States of America, and the Health Protection 
Branch (HPB) of the Department of Health of Canada affirm by this 
document their intention to strengthen existing mutual cooperation 
in the scientific and regulatory areas of regulated products, 
specifically foods (including dietary supplements), drugs (including 
biologics), cosmetics, medical devices, radiation-emitting 
electronic products, and related products. The parties intend to 
enhance, expand, and develop joint efforts to exchange information 
in health and in regulatory areas related to regulated products and 
prevention of health fraud related to the following areas:
    A. The exchange of information at the earliest feasible stages 
of investigations into the safety of regulated products.
    B. The exchange of information (including, for example, 
legislation, regulations, proposed amendments, guidelines, and 
technical documents such as evaluations of foreign suppliers of 
regulated products and enforcement decisions, including recalls or 
rejected shipments of products, and training material for regulatory 
officers) with respect to regulated products.
    C. Communication on evaluation of the safety and nutritional 
quality of food, of the safety, effectiveness, and quality of drugs 
(including biologics) and medical devices, of the chemical and 
microbiological safety of cosmetics. The activities are intended to 
include, for example, communications on clinical protocols, new 
product approvals, and withdrawal of marketing approval due to 
concerns about safety, lack of proof of effectiveness, 
bioequivalence problems, etc.
    D. The parties also intend to communicate on the evaluation of 
the chemical and microbiological safety of foods and cosmetics by 
exchanging information on chemical and microbiological analytical 
methods and criteria for safety evaluation.
    E. Exchange of information on areas where two or more of the 
countries regulatory requirements are equivalent, with a view to 
working toward the development of a common approach in determining 
compliance status. The participants also intend to discuss their 
standards with a view toward considering whether it would be 
appropriate to undertake harmonization activities.
    F. Strive through increased dialogue to achieve a common 
position in meetings of international organizations.
    G. Communicate concerning the development of research and 
monitoring protocols and projects (including, for example, such 
areas as epidemiology, dietary surveys and health hazard related 
issues) and pre- and post-market surveillance activities.
    H. Communicate concerning the development of programs to 
increase consumer protection related to health fraud.

II. Specific Plans

    As the need arises in areas described in Section I, the 
participants may develop and agree upon specific plans of 
cooperation which will be incorporated in written agreements or 
arrangements.

III. Source of Funding

    Each party to the Memorandum of Cooperation intends to fund its 
own activities subject to the availability of appropriated funds, 
personnel, and other resources. Any exchange of information or other 
activity under this Memorandum of Cooperation are to be performed in 
accordance with applicable laws and regulations.

IV. Participating Parties

    A. Subsecretaria de Regulacion y Fomento Sanitario, Secretaria 
de Salud, Lieja 7, 1er. Piso, Col. Juarez, 06696 Mexico, D.F.
    B. Food and Drug Administration, Department of Health and Human 
Services, 5600 Fishers Lane, Rockville, Maryland 20857.
    C. Health Protection Branch, Health Canada, Tunney's Pasture, 
Ottawa, Ontario K1A 0L7.

V. Liaison Officers

    A. Coordinador de Asesores, Subsecretaria de Regulacion and 
Fomento Sanitario, Lieja 7, 1er. Piso, Col. Juarez, 06696 Mexico, 
D.F., (525) 553-73-28 and (525) 553-6979; FAX (525) 553-69-96.
    B. Director, International Affairs Staff, Office of External 
Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, (301) 443-4480; FAX (301) 443-0235.
    C. Advisor to the Assistant Deputy Minister, Health Protection 
Branch, Health Canada, Tunney's Pasture, Ottawa, Ontario K1A 0L7, 
(613) 957-1804; FAX (613) 957-3954.

VI. Duration

    Cooperation under this memorandum will commence upon signature 
of all participants. This memorandum may be revised by mutual 
written consent of all participants. Cooperation under this 
memorandum may be terminated upon thirty days advance written notice 
to the other participants.

For the Food and Drug Administration of the United States of America

 Sharon Smith Holston
Title: Deputy Commissioner, External Affairs, FDA
Date: October 30, 1995
Place: Ottawa, Canada

For the Subsecretaria de Regulacion y Fomento Sanitario of the United 
Mexican States

 Rafael Camacho Solis
Title: Subsecretario de Regulacion y Fomento Sanitario
Date: 30/x/95
Place: Ottawa, Canada

For the Health Protection Branch of Canada

 Kent R. Foster
Title: ADM, HPB
Date: 30 October 1995
Place: Ottawa, Canada
[FR Doc. 96-6740 Filed 3-20-96; 8:45 am]
BILLING CODE 4160-01-F