[Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)] [Rules and Regulations] [Pages 8372-8373] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-4514] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Melengestrol Acetate, Monensin, and Tylosin 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 Pharmacia & Upjohn Co. The supplement provides for the use of separately approved Type A medicated articles containing melengestrol acetate (dry form only), monensin, and tylosin to manufacture certain combination drug, dry, meal Type B medicated feeds for use in making Type C medicated feeds. The feeds are for heifers fed in confinement for slaughter for increased rate of weight gain, improved feed efficiency, suppression of estrus, and reduced incidence of liver abscesses. EFFECTIVE DATE: February 25, 1997. FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center For Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1638. SUPPLEMENTARY INFORMATION: Pharmacia & Upjohn, 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed supplemental NADA 138-792, which provides for combining separately approved melengestrol acetate (MGA) (dry form only), monensin sodium, and tylosin phosphate Type A medicated articles to manufacture dry, meal Type B medicated feeds used to make Type C medicated feeds for heifers fed in confinement for slaughter for increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduced incidence of liver abscesses. The supplement is approved as of December 17, 1996, and 21 CFR 558.342 is amended in paragraph (c)(5)(iii)(C) to reflect the approval. Approval of this supplement which provides for use of a different physical [[Page 8373]] form of Type B feed did not require reevaluation of the safety or effectiveness data supporting the NADA or the submission of any new data. Therefore, a freedom of information summary is not required. 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 approval does not qualify for marketing exclusivity because the supplement does not contain substantial evidence of the 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. The agency has determined under 21 CFR 25.24(d)(1)(ii) 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 558 Animal drugs, Animal feeds. 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 558 is amended as follows: PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: Secs. 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b, 371). Sec. 558.342 [Amended] 2. Section 558.342 Melengestrol acetate is amended in paragraph (c)(5)(ii)(C) by removing the word ``pelleted''. Dated: January 31, 1997. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 97-4514 Filed 2-24-97; 8:45 am] BILLING CODE 4160-01-F