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MOU 225-83-6000

Memorandum of Understanding

Between
The National Center for Health Statistics 

and

The Food and Drug Administration

 

CHAPTER 55e – MOUs & IAG – FEDERAL

Subject: MOU with National Center for Health Statistics Regarding Exchange of Information (FDA 225-83-6000)

 

I. PURPOSE

This agreement establishes a mechanism for the regular exchange of information in areas of common interest and shared responsibility, and provides a procedure of fostering the development off collaborative projects.

 

II. BACKGROUND

The Food and Drug Administration (FDA) provides leadership among Federal agencies in protecting the public health of the Nation by insuring that foods are safe, pure, and wholesome: drugs, medical devices, and biological products are safe and effective; cosmetics are harmless: and that exposure to potentially injurious radiation in minimized.

To accomplish these functions, FDA:

1. Establish regulations governing the manufacture and distribution of products;

2. Monitors manufactures compliance with the statute and applicable regulations;

3. Evaluates the safety and effectiveness of new drugs and certain medical devices;

4. Conducts and supports special surveys and other research and analyses on nutrition, use of drug products, and exposure to radiation; and

5. Collaborates with, and provides assistance to other Federal Agencies; national, State, and local organizations; private establishments; and voluntary groups to facilitate, conduct, and expand programs to provide information and experience on reactions to drug use, exposure to x-rays, problems with medical devices, and hospital-based health hazards.

 

The National Center for Health Statistics (NCHS) provides national leadership in the areas of health statistics and epidemiology.

In carrying out its responsibilities, NCHS:

1. Collects, analyzes, and disseminates national health statistics on vital events and health characteristics of the population, the supply and utilization of health facilities and manpower; the operation of health systems services; health costs and expenditure; and environmental, social, and other health hazards.

2. Administers the cooperative health statistics program;

3. Stimulates and conducts basic and applied research in health data systems and statistical methodology;

4. Coordinates, to the maximum extent feasible, the overall health and epidemiological statistical activities of the agencies of the Public Health Service (PHS), and provides technical assistance in the planning, management, and evaluation of statistical programs of the PHS;

5. Maintains operational liaison with statistical units of other health agencies, public and private, and provides technical assistance within the limitations of staff resources;

6. Fosters research, consultation, and training programs in international statistical activities;

7. Participates with other Federal agencies in the development of National health statistics policy, and

8. Provides the Assistant Secretary for Health and the Surgeon General with consultation and advice on statistical matters.

 

III. SUBSTANCE OF AGREEMENT

The two agencies share common interest in the area of epidemiology, vital events, and statistical data collection and dissemination of information, particularly as it relates to radiation exposure, nutrition, hospital services, and dispensation of drugs.

Both agencies hold interests in exploring further additional avenues where mutually supportive activities can be collaborated in and pursued further.

 

In order to assure that these collaborations are pursued in a continuing and timely fashion, FDA and NCHS will meet once a quarter, or more frequently if needs arise, alternating meeting sites between the two agencies, and will share information, report on progress, and explore new areas for collaboration, Co-chairpersons will be designated by the Commissioner of Food and Drugs and the NCHS Director on an annual basis.

 

IV. NAME AND ADDRESS OF PARTICIPATING PARTIES

A. National Center for Health Statistics
Prince George's Plaza
3700 East-West Highway
Hyattsville, MD 20782

 

B. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

 

V. LIAISON OFFICERS

A. Director, Division of Health Examination Statistics
(currently Mr. Robert S. Murphy)
National Center for Health Statistics
Room 2-58, Center Building
Princes George's Plaza
3700 East-West Highway
Hyattsville, MD 20782
Telephone: (301) 436-7068

 

B. Assistant Director for Health Programs Research
(currently Evelyn W. Gordon Ph.D.)
Office of Radiological Health ( HFX-4)
National Center for Devices and Radiological Health
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-6220

 

VI. PERIOD OF AGREEMENT

This agreement becomes effective upon acceptance by both parties, and will continue indefinitely. It may be modified by mutual consent or terminated by either party upon a 30-day advance written notice to the other party.

Approved and Accepted
for the National Center for Health Statistics

Signed by: M. Feinleib, Director

Date: August 9, 1983

Approved and Accepted
for the Food and Drug Administration

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

Date: August 9, 1983