[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR116.5]

[Page 748-749]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 116_RECORDS AND REPORTS--Table of Contents
 
Sec. 116.5  Reports.

    (a) When required by the Administrator, reports containing accurate 
and complete information concerning biological products, including but 
not limited to, product development and preparation, and market 
suspensions and

[[Page 749]]

recalls, shall be prepared and submitted to the Animal and Plant Health 
Inspection Service by the licensee, permittee, or foreign manufacturer 
(whose products are being imported or offered for importation). Unless 
otherwise authorized by the Administrator, records necessary to make 
such reports shall be maintained in each establishment.
    (b) If, at any time, there are indications that raise questions 
regarding the purity, safety, potency, or efficacy of a product, or if 
it appears that there may be a problem regarding the preparation, 
testing, or distribution of a product, the licensee, permittee, or 
foreign manufacturer must immediately notify the Animal and Plant Health 
Inspection Service concerning the circumstances and the action taken, if 
any. Notification may be made by mail to Director, Center for Veterinary 
Biologics, Inspection and Compliance, 510 South 17th Street, Suite 104, 
Ames, IA 50010-8197; by electronic mail to cvb@usda.gov; by fax to (515) 
232-7120; or by telephone to (515) 232-5785.

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

[61 FR 52874, Oct. 9, 1996, as amended at 64 FR 43045, Aug. 9, 1999]