[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR104.4]

[Page 534-535]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 104--PERMITS FOR BIOLOGICAL PRODUCTS--Table of Contents
 
Sec. 104.4  Products for research and evaluation.

    (a) An application for a U.S. Veterinary Biological Product Permit 
to import a biological product for research and evaluation shall be 
accompanied by a brief description of such product, methods of 
propagating antigens including composition of medium, species of animals 
or cell cultures involved, degree of inactivation or attenuation, 
recommendations for use, and the proposed plan of evaluation. The 
applicant shall also provide any information the Administrator may 
require in order to assess the product's impact on the environment.
    (b)(1) A permit to import a biological product for research and 
evaluation shall not be issued unless the scientific capabilities of the 
investigator are determined to be adequate to safeguard domestic animals 
and protect public health, interest, or safety from any deleterious 
effects which might result from use of such product. Special 
restrictions or tests may be specified as part of the permit when they 
are deemed necessary or advisable by the Administrator.
    (2) No person shall ship a product imported under this section for 
research and evaluation anywhere in or from the United States unless 
authorized by the Administrator in accordance with the provisions of 
Sec. 103.3 of this subchapter.

[[Page 535]]

    (c) A biological product shall not be imported for Research and 
Evaluation which is not packaged and labeled in accordance with 
Sec. 112.9 of this subchapter.
    (d) When a licensed product has been exported from the United 
States, a permit may be issued to the producer for a small quantity of 
such product for in vitro Research and Evaluation tests: Provided, That, 
the importation of such product will not endanger the livestock or 
poultry of this country.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 
52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991]