TITLE 9 - ANIMALS AND ANIMAL PRODUCTS

CHAPTER I - ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE

SUBCHAPTER E - VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS

PART 116 - RECORDS AND REPORTS

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 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 500108197; by electronic mail to cvb@usda.gov; by fax to (515) 2327120; or by telephone to (515) 2325785. (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]