[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR102.3]

[Page 624]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 102_LICENSES FOR BIOLOGICAL PRODUCTS--Table of Contents
 
Sec. 102.3  License applications.

    (a) U.S. Veterinary Biologics Establishment License. (1) The 
operator of each establishment of the kind specified in Sec. 102.2 
shall make written application to the Administrator for a license. Blank 
forms of application will be furnished upon request to Animal and Plant 
Health Inspection Service.
    (2) When a person conducts more than one establishment, a separate 
application shall be made for each establishment.
    (3) Whenever subsidiaries are to operate in an establishment for 
which license application is made, the applicant shall apply for 
permission for such subsidiaries to operate in the establishment and 
furnish therewith a complete statement regarding the relationship 
between the applicant and the subsidiaries.
    (4) Facilities documents, prepared as prescribed in part 108 of this 
subchapter, shall accompany the application for license unless 
previously filed with Animal and Plant Health Inspection Service.
    (5) Each application for a U.S. Veterinary Biologics Establishment 
License shall be accompanied by an application for one or more U.S. 
Veterinary Biological Product Licenses and the supporting documents 
required by paragraph (b)(2) of this section.
    (6) A new application shall be made when a change of ownership, 
operation, or location of an establishment occurs; or prior to the 
expiration of a U.S. Veterinary Biologics Establishment License issued 
for an interim period of time.
    (b) U.S. Veterinary Biological Product License. (1) The licensee of 
each establishment or applicant for an establishment license shall make 
written application to the Administrator for a U.S. Veterinary 
Biological Product License for each biological product to be prepared in 
the licensed establishment.
    (2) Each application for a U.S. Veterinary Biological Product 
License shall be supported by:
    (i) At least four copies of an Outline of Production prepared in 
accordance with Sec. Sec. 114.8 and 114.9 of this subchapter; and
    (ii) At least three copies of test reports and research data 
sufficient to establish purity, safety, potency, and efficacy of the 
product; and
    (iii) Legends prepared as prescribed in Sec. 108.5 of this 
subchapter designating which facilities are to be used in the 
preparation of each fraction; and
    (iv) Labels in finished form or sketches prepared as prescribed in 
Sec. 112.5 of this subchapter, together with information regarding all 
claims to be made on labels and in advertising matter to be used in 
connection with or related to the biological product.

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

[39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 
49 FR 21043, May 18, 1984; 50 FR 50763, Dec. 12, 1985; 56 FR 66783, Dec. 
26, 1991]