[Federal Register Volume 62, Number 56 (Monday, March 24, 1997)] [Rules and Regulations] [Page 13825] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-7277] [[Page 13825]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. ----------------------------------------------------------------------- SUMMARY: 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. SUPPLEMENTARY INFORMATION: In the Federal Register of July 10, 1996 (61 FR 36290), FDA published the approval of Boehringer Ingelheim Animal Health, Inc.'s supplemental ANADA 200-008 that provides for subcutaneous use of oxytetracycline injection in addition to the approved intravenous and intramuscular use in beef and nonlactating dairy cattle. The approval document inadvertently failed to specify that only Boehringer Ingelheim's oxytetracycline injection is approved for subcutaneous use in cattle. Accordingly, the agency is correcting 21 CFR 522.1660(c)(1)(iii) as set forth below. In addition, the document did not state that under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), as in effect on May 22, 1996, the date of approval, this approval for food-producing animals qualifies for 3 years of marketing exclusivity beginning May 22, 1996, because the supplement contains reports of new clinical or field investigations other than bioequivalence, or residue studies, and in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) essential to the approval of the supplement and conducted or sponsored by the applicant. Sec. 522.1660 [Corrected] 2. In FR Doc. 96-17541, appearing on page 36290 in the Federal Register of Wednesday, July 10, 1996, the following correction is made. On page 36291, in the first column, in line 2, amendment ``2.'' is corrected to read as follows: 2. Section 522.1660 Oxytetracycline injection is amended in paragraph (c)(1)(iii) by removing the first sentence and adding two sentences in its place, to read as follows: Sec. 522.1660 Oxytetracycline injection. * * * * * (c) * * * (1) * * * (iii) Administer intramuscularly or intravenously at the 3 to 5 milligrams level, intramuscularly at the 9 milligrams level. Sponsor 000010, may also administer subcutaneously at the 3 to 5 milligrams and 9 milligrams levels. * * * * * * * * Dated: March 13, 1997. Robert C. Livingston, Director, Office of New Animal Drug Evaluation Center for Veterinary Medicine [FR Doc. 97-7277 Filed 3-21-97; 8:45 am] BILLING CODE 4160-01-F