[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)] [Rules and Regulations] [Pages 41191-41192] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-20535] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Melengestrol Acetate and Oxytetracycline 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 two original new animal drug applications (NADA's) filed by Pharmacia & Upjohn Co. The NADA's provide for the use of separately approved Type A medicated articles containing melengestrol acetate (dry and liquid form) and oxytetracycline (dry form) to make dry combination drug Type C medicated feeds. The Type C medicated 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: August 3, 1998. 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 Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199, filed original NADA's 46-718 and 46-719 that provide for combining separately approved melengestrol acetate (MGA) (dry and liquid form) and oxytetracycline (dry form) Type A medicated articles to make dry 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 NADA's are approved as of May 6, 1998, and 21 CFR 558.342(d)(8) and 558.450(d)(3)(iii) are added to reflect the approvals. 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. FDA has determined under 21 CFR 25.33(a)(2) 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: 21 U.S.C. 360b, 371. 2. Section 558.342 is amended by adding paragraph (d)(8) to read as follows: Sec. 558.342 Melengestrol acetate. * * * * * (d) * * * (8) Amount. Melengestrol acetate, 0.25 to 0.5 milligram per head per day, plus oxytetracycline, 75 milligrams per head per day. (i) Indications for use. For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), and reduction of liver condemnation due to liver abscesses. (ii) Limitations. Heifers fed in confinement for slaughter. Add at the rate of 0.5 to 2.0 pounds per head per day a medicated feed (liquid or dry) containing 0.125 to 1.0 milligram of melengestrol acetate per pound to a feed containing 6 to 10 grams of oxytetracycline per ton; or add at the rate of 0.5 to 2.0 pounds per head per day a dry medicated feed containing 0.125 to 1.0 milligram of melengestrol acetate plus 37.5 to 150 milligrams of oxytetracycline per pound to provide 0.25 to 0.5 milligram of melengestrol acetate and 75 milligrams of oxytetracycline per head per day. Liquid melengestrol acetate may not be mixed [[Page 41192]] with oxytetracycline in a common liquid feed supplement. Melengestrol acetate as provided by 000009, oxytetracycline by 000069, in Sec. 510.600(c) of this chapter. 3. Section 558.450 is amended by adding paragraph (d)(3)(iii) to read as follows: Sec. 558.450 Oxytetracycline. * * * * * (d) * * * (3) * * * (iii) Melengestrol acetate as in Sec. 558.342. Dated: June 30, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 98-20535 Filed 7-31-98; 8:45 am] BILLING CODE 4160-01-F