[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.9]

[Page 594-595]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 113--STANDARD REQUIREMENTS--Table of Contents
 
Sec. 113.9  New potency test.

    A potency test written into the filed Outline of Production for a 
product

[[Page 595]]

shall be considered confidential information by Animal and Plant Health 
Inspection Service until at least two additional product licenses are 
issued for the product or unless use of the test is authorized by the 
licensee, in which case, such potency test may be published as part of 
the Standard Requirement for the product.
    (a) Until a potency test is published as part of the Standard 
Requirement for the product, reference to such a test shall be made in 
the filed Outline of Production and the test shall be conducted.
    (b) When a potency test has been published as part of the Standard 
Requirement, such test shall be conducted unless the product is 
specifically exempted as provided in Sec. 113.4.

[40 FR 14084, Mar. 28, 1975, as amended at 56 FR 66784, Dec. 26, 1991]