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U.S. Department of Health and Human Services

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MOU 225-82-8000

Memorandum of Understanding

Between
The Centers for Disease Control 

and

The Food and Drug Administration

 

I. PURPOSE

The purpose of this agreement between the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), both agencies of the Department of Health and Human Services (HHS), is to provide a framework for orderly exchange of information and for coordination of actions of both agencies involving public health measures that impact on each other's missions. This agreement will set forth the responsibilities of each agency in epidemiologic investigations and related activities. It is understood that nothing in this agreement alters other agreements or relationships which already exist between CDC and FDA or precludes establishment of future agreements or relationships which would be mutually beneficial.

 

II. BACKGROUND

FDA is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act, the Radiation Control for Health and Safety Act, and certain sections of the Public Health Service Act. In fulfilling its responsibilities, FDA protects the public health of the nation by ensuring that foods, drugs, and medical devices are safe and labeled honestly and informatively. In addition, FDA monitors radiation emitting electronic products to assure safety.

 

CDC is responsible for the general advancement of the public health by the Public Health Service Act and the Occupational Health and Safety Act of 1970. Additional responsibilities are also given to CDC by the Clinical Laboratory Improvement Act of 1963 (42 U.S.C. 263a).

Each agency has a responsibility to contribute to the total effort of the Federal Government in those areas where it has recognized capability and experience.

III. SUBSTANCE OF AGREEMENT AND RESPONSIBILITIES
OF EACH AGENCY

 

A. CDC will:

1. Provide epidemiologic alert information promptly to FDA when there is a possible association with the use of foods, drugs, cosmetics, medical devices, biologic products, diagnostics, and any other products regulated by FDA. Information concerning the effectiveness of disease control measures (biologics, drugs, medical devices) will also be provided to FDA.

2. Supply laboratory data promptly to FDA whenever information concerning the safety or efficacy of articles regulated by FDA is generated by CDC laboratories in conjunction with pursuit of activities.

3. Provide technical advice in areas of recognized, expertise, whenever possible, on request of FDA.

4. Provide FDA with expert witnesses to support regulatory efforts, where possible and when requested.

5. Collaborate with FDA in all investigations of mutual concern. Primary responsibilities in each investigation will be determined on a case-by-case basis.

 

B. FDA will:

1. Provide alert information promptly to CDC concerning product-associated infections, and collaborate with CDC in establishing the epidemiologic relevance of products associated with disease.

2. Provide technical advice in areas of recognized expertise, whenever possible, on request of CDC.

3. Alert CDC promptly of all disease outbreaks encountered as part of its activities, whether or not these disease occurrences are related to FDA-regulated products.

4. Collaborate with CDC in all investigations of mutual concern. Primary responsibilities in each investigation will be determined on a case-by-case basis.

 

C. It is mutually agreed that:

1. Each agency will cooperate and coordinate with the other agency, to the maximum extent permitted by available resources, in activities that relate to joint interests.

2. Both agencies will participate in periodic joint meetings to promote better communication and understanding of regulations, policies, and statutory responsibilities, and to serve as a forum for questions and problems that may arise. Each agency will specify a person who will be responsible for coordinating the above activities, establishing agenda items for discussion, and for assuring that appropriate persons within each agency are involved in and/or informed of these discussions and maintaining a general scientific information exchange mechanism.

3. Each agency will consult with the other before issuing press or scientific releases or publications which importantly affect the actions and programs of the other agency.

4. Each agency will keep its customary records and make those related to the operation of this agreement available to the other agency. The agencies will exchange reports or papers before publication or delivery if that exchange will facilitate needed regulatory action.

5. When either agency is unable to carry out any of its responsibilities under this agreement, the other agency will be notified immediately.

6. Regulations or recommendations proposed by either agency that may have an impact on the other agency will be referred to that agency for review and comment before publication.

7. Each agency will designate central contact points where communications for the other agency dealing with matters covered by this agreement should be referred.

8. Each agency will make personnel, equipment, and facilities available to the other when necessary and feasible.

9. Nothing in this agreement modifies other existing agreements of memoranda of understanding, nor does it preclude entering into other agreements which may set forth procedures for special programs which can be handled more efficiently and expertly by other agreements.

 

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

A. Department of Health and Human Services,
Public Health Service,
Centers for Disease Control,
Atlanta, Ga. 30333.

 

B. Department of Health and Human Services,
Public Health Service
Food and Drug Administration
5600 Fishers Lane
Rockville, Md. 20857.

 

V. LIAISON OFFICERS

For the Centers for Disease Control:
Deputy Director,
Centers for Disease Control,
Currently William C. Watson, Jr.,
Atlanta, Ga. 30333.

 

B. For the Food and Drug Administration:
Deputy Commissioner,
Food and Drug Administration,
Currently Mark Novitch, M.D.
5600 Fishers Lane,
Rockville, Md. 20857.

 

VI. PERIOD OF AGREEMENT

This agreement becomes effective upon signature of both parties and will continue indefinitely. It may be modified by mutual consent or terminated by either party upon 120 days written notice.

Approved and Accepted
for the Centers for Disease Control

Signed by: William H. Foege, M.D.
Assistant Surgeon General
Director
Centers for Disease Control

Date: January 12, 1982

Approved and Accepted
for the Food and Drug Administration

Signed by: Arthur Hull Hayes, Jr., M.D.
Commissioner of Food and Drugs

Date: January 12, 1982