[Federal Register Volume 62, Number 83 (Wednesday, April 30, 1997)] [Rules and Regulations] [Page 23356] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-11079] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Soluble Powder 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 an abbreviated new animal drug application (ANADA) filed by the Pennfield Oil Co. The ANADA provides for the use of a generic oxytetracycline hydrochloride soluble powder for the drinking water of cattle, swine, sheep, chickens, and turkeys. EFFECTIVE DATE: April 30, 1997. FOR FURTHER INFORMATION CONTACT: Dianne T. McRae, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1623. SUPPLEMENTARY INFORMATION: Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68137, filed ANADA 200-026, which provides for use of 102.4- gram (g) oxytetracycline hydrochloride per 4.78-ounce (135.5-g) packet for making medicated drinking water for cattle, swine, sheep, chickens, and turkeys for control and treatment of bacterial infections caused by oxytetracycline susceptible organisms. ANADA 200-026 for Pennfield Oil Co.'s oxytetracycline hydrochloride water soluble powder is approved as a generic copy of Pfizer's NADA 8-622 Terramycin-343 (oxytetracycline hydrochloride) soluble powder. The ANADA is approved as of March 13, 1997, and the regulations are amended in 21 CFR 520.1660d by adding new paragraphs (a)(8) and (b)(6) to reflect the approval. The basis for approval is discussed in the freedom of information summary. 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. 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 520 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 520 is amended as follows: PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 2. Section 520.1660d is amended by adding new paragraphs (a)(8) and (b)(6) to read as follows: Sec. 520.1660d Oxytetracycline hydrochloride soluble powder. (a) * * * (8) Each 135.5-gram packet (4.78 ounce) contains 102.4 grams of OTC HCl. (b) * * * (6) No. 053389 for use of OTC HCl concentrations in paragraph (a)(8) of this section in chickens, turkeys, swine, cattle, and sheep. * * * * * Dated: April 2, 1997. Michael J. Blackwell, Deputy Director, Center for Veterinary Medicine. [FR Doc. 97-11079 Filed 4-29-97; 8:45 am] BILLING CODE 4160-01-F