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MOU 225-82-7000

Memorandum of Understanding

Between
The Animal and Plant Health Inspection Service
United States Department of Agriculture 

and

The Food and Drug Administration
Department of Health and Human Services

 

I. PURPOSE

This agreement reflects the understanding between the Animal and Plant Health Inspection Service (APHIS) and the Food and Drug Administration (FDA) regarding responsibilities for regulating animal biological products as biologicals under the Virus, Serum, and Toxin Act of 1913 (VSTA) or as drugs under the Food, Drug, and Cosmetic Act (FDCA).

 

II. BACKGROUND

Animal biological products generally act through a specific immune process and are intended for use in the treatment (including prevention, diagnosis, or cure) of diseases in animals. Such products include but are not limited to vaccines, bacterins, sera, antisera, antitoxins, toxoids, allergens, diagnostic antigens prepared from, derived from, or prepared with microorganisms, or growth products of microorganisms, animal tissues, animal fluids, or other substances of natural or synthetic origin.

 

Animal biological products which are prepared or sold in places under exclusive federal jurisdiction or which are shipped interstate are subject to regulation under VSTA. When such products are not produced in an establishment licensed under VSTA but are nevertheless shipped interstate, shippers of such products are subject to sanctions under VSTA. Because animal biological products are "drugs" within the meaning of FDCA, FDA may regulate such products when VSTA does not apply or, as in the case of unlicensed biologicals in interstate commerce, if VSTA does not offer an appropriate remedy at law. Accordingly, FDA may exercise jurisdiction over animal biological products that, although not distributed in interstate commerce, are manufactured from components that are received in interstate commerce. Unlicensed animal biological products delivered for shipment in interstate commerce are also subject to seizure and injunction proceedings under FDCA.

 

III. SUBSTANCE OF AGREEMENT

A. REFERRAL AND EXCHANGE OF INFORMATION FOR PURPOSES OF INVESTIGATION OR APPROPRIATE LEGAL ACTION

For the purpose of coordinating investigation and enforcement and avoiding duplication of effort, FDA and USDA agree to provide each other with any information which may come to their attention regarding veterinary products and which may be germane to either agency’s enforcement functions under VSTA or FDCA. Such information shall be provided to the liaison officers of the agencies who are named in paragraph V of this agreement. In addition, the liaison officers shall provide information to each other regarding pending investigations and enforcement actions on a regular basis.

 

B. NEW PRODUCTS AND PRODUCTS WHICH RAISE DEFINITIONAL OR JURISDICTIONAL QUESTIONS

The development of genetic engineering technology, monoclonal antibodies, and the preparation of synthetic vaccines has introduced a new generation of biological products for use in the treatment of disease in animals. Aspects of these new products may differ significantly from prior products. For example, the immunological and physiological responses to the products may differ. Thus, the procedures used in the past by APHIS and FDA for determining which administrative agency would have responsibility in regulating a given biological product may no longer clearly fit or apply to these new products.

 

Therefore, APHIS and FDA agree to establish and maintain a standing committee of not less then three persons from each agency to address the status of such new products as well as to consider regulatory responsibilities over them. The standing committee shall meet at least once each year and at such other times as it may be called into session at the request of either agency’s liaison officer or designee. Interested persons may contact the liaison officer of either agency regarding the regulatory status of new products or other products which raise questions of jurisdictional or a definitional nature. The committee’s decisions regarding such questions will be subject to both policy and legal reviews by each agency. This agreement is intended to change neither the regulatory responsibilities of the agencies nor the classification of products already licensed, approved, or otherwise regulated by the agencies. Changes may be agreed upon by both parties for orderly and effective regulation.

 

IV. NAME AND ADDRESS OF PARTICIPATING AGENCIES

Animal and Plant Health Inspection Service,
U.S. Department of Agriculture,
12th St. and Independence Ave. SW.,
Washington, D.C. 20250.

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

 

V. LIAISON OFFICERS

Individuals in the following positions are designated as the liaison officers for the purposes of this agreement and shall be the primary points of contact regarding any matters relevant to the agreement.

 

A. For the Animal and Plant Inspection Service:

Senior Staff Veterinarian,
(currently R. J. Price, D.V.M.),
Veterinary Biologics Staff,
Animal and Plant Health Inspection Service,
301-436-9245.

 

B. For the Food and Drug Administration:

Associate Director for Surveillance and Compliance,
(currently Max L. Crandall, D.V.M.),
Bureau of Veterinary Medicine,
Food and Drug Administration,
301-443-3400.

 

VI. PERIOD OF AGREEMENT

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

Approved and Accepted
for the Animal and Plant Health Inspection Service

Signed by:

Date: May 7, 1982

Approved and Accepted
for the Food and Drug Administration

Signed by: Joseph P. Hile
Associate Commissioner for Regulatory Affairs

Date: April 21, 1982