[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR103.3]

[Page 574-575]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 103--EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING--Table of Contents
 
Sec. 103.3  Shipment of experimental biological products.

    Except as provided in this section, no person shall ship or deliver 
for shipment in or from the United States, the District of Columbia, or 
any Territory

[[Page 575]]

of the United States any unlicensed biological product for experimental 
use in animals. For the benefit of license applicants and to permit and 
encourage research, a person may be authorized by the Administrator to 
ship unlicensed biological products for the purpose of evaluating such 
experimental products by treating limited numbers of animals, Provided, 
that, the Administrator determines that the conditions under which the 
experiment is to be conducted are adequate to prevent the spread of 
disease and approves the procedures set forth in the request for such 
authorization. Special restrictions or tests may be imposed, especially 
in the case of products containing live organisms, when they are deemed 
necessary or advisable by the Administrator. A request for authorization 
to ship an unlicensed biological product for experimental study and 
evaluation shall be accompanied by the following:
    (a) One copy of a permit or letter of permission from the proper 
State or foreign animal health authorities of each State or foreign 
country involved.
    (b) Two copies of a tentative list of the names of the proposed 
recipients and quantity of experimental product that is to be shipped to 
each individual. In the event of subsequent changes, additional 
information shall be furnished when such facts are known;
    (c) Two copies of a description of the product, recommendations for 
use, and results of preliminary research work;
    (d) Three copies of labels or label sketches which show the name or 
identification of the product and bear a statement, ``Notice! For 
Experimental Use Only--Not For Sale,'' or equivalent. The U.S. 
Veterinary License legend shall not appear on such labels; and
    (e) Two copies of a proposed general plan covering the methods and 
procedures for evaluating the product and for maintaining records of the 
quantities of experimental product prepared, shipped and used. At the 
conclusion of field studies, results shall be obtained, summarized, and 
submitted to the Animal and Plant Health Inspection Service.
    (f) Data acceptable to the Administrator demonstrating that use of 
the experimental biological product in meat animals is not likely to 
result in the presence of any unwholesome condition in the edible parts 
of animals subsequently presented for slaughter.
    (g) A statement from the research investigator or research sponsor 
agreeing to furnish, upon the Administrator's request, additional 
information concerning each group of meat animals involved prior to 
movement of these animals from the premises where the test is to be 
conducted. Such information shall include the owner's name and address; 
number, species, class and location of animals involved; date shipment 
is anticipated; along with name and address of consignee, buyer, 
commission firm or abattoir.
    (h) Any information the Administrator may require in order to assess 
the product's impact on the environment.

[26 FR 7726, Aug. 18, 1961, as amended at 30 FR 11848, Sept. 16, 1965; 
52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991]