[Federal Register Volume 62, Number 98 (Wednesday, May 21, 1997)] [Rules and Regulations] [Pages 27692-27693] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-13268] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation and Injectable Dosage Form New Animal Drugs; Oxytetracycline Injection AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer Animal Health. The supplemental NADA provides for subcutaneous use of oxytetracycline injection in addition to intramuscular and intravenous use in beef cattle and nonlactating dairy cattle, and calves including preruminating (veal) calves. EFFECTIVE DATE: May 21, 1997. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1644. SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 10017, filed supplemental NADA 113-232 that provides for use of LiquamycinLA-200 (oxytetracycline injection) for subcutaneous in addition to intramuscular and intravenous treatment of beef cattle, nonlactating dairy cattle, and calves including preruminating (veal) calves. The supplemental NADA is approved as of April 23, 1997, and the regulations are amended in Sec. 522.1660 (21 CFR 522.1660) to reflect the approval. The basis of approval is discussed in the freedom of information summary. Section 522.1660(c) is redesignated as paragraph (d) and new paragraph (c) is added to provide for more uniform regulations and future expansion. Also Sec. 522.1660 is amended in new paragraph (d)(1) to add the phrase ``and calves including preruminating (veal) calves'' after the phrase ``nonlactating cattle'' in the title and an additional sentence following the text of newly redesignated paragraph (d)(1)(iii) to provide for subcutaneous use for this sponsor. Furthermore, Sec. 522.1660 is amended to correct several typographical errors. The errors are: In Sec. 522.1660(d)(1)(ii), Haemophilis is misspelled, Staphylococcus is not capitalized, and in Sec. 522.1660(d)(2)(ii), multocida is misspelled. In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval for food-producing animals qualifies for 3 years of marketing exclusivity beginning April 23, 1997, because the supplement contains substantial evidence of effectiveness of the drug involved, any studies of animal safety or, in the case of food-producing animals, human food safety studies (other than bioequivalence or residue studies) required for approval of the supplement and conducted or sponsored by the applicant. Exclusivity applies only to the subcutaneous route of administration. The agency has determined under 21 CFR 25.24(d)(1)(i) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjects in 21 CFR Part 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 2. Section 522.1660 is amended by redesignating paragraph (c) as (d) and reserving paragraph (c), in newly redesignated paragraph (d)(1) by revising the heading, in newly redesignated paragraph (d)(1)(ii) by removing the word ``Hemophilis'' and adding in its place ``Haemophilis'' and by removing the word ``staphylococcus'' and adding in its place ``Staphylococcus'', in newly redesignated paragraph (d)(2)(ii) by removing the word ``multicida'' and adding in its place ``multocida'', and by adding a new sentence at the end of newly redesignated paragraph (d)(1)(iii) to read as follows: Sec. 522.1660 Oxytetracycline injection. * * * * * (c) [Reserved] (d) * * * (1) Beef cattle, nonlactating dairy cattle and calves including preruminating (veal) calves. * * * (iii) * * * For sponsor 000069, use subcutaneously with a maximum of 10 milliliters per injection site in adult cattle as well as intramuscularly and intravenously. * * * * * [[Page 27693]] Dated: May 7, 1997. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 97-13268 Filed 5-20-97; 8:45 am] BILLING CODE 4160-01-F