Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection; Correction

The Food and Drug Administration (FDA) is correcting a final rule that was published in the Federal Register of July 10, 1996 (61 FR 36290), that amended the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) held by Boehringer Ingelheim Animal Health, Inc. The regulation inadvertently failed to specify that only Boehringer Ingelheim's oxytetracycline injection is approved for subcutaneous use in cattle. In addition, the preamble failed to provide that the supplemental approval was granted 3 years marketing exclusivity for the new use. This document corrects these errors. EFFECTIVE DATE: July 10, 1996. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1643.