[Federal Register Volume 63, Number 74 (Friday, April 17, 1998)] [Rules and Regulations] [Pages 19184-19185] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-10251] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Bacitracin Zinc; Technical Amendment AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendment. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulation for use of bacitracin zinc Type A medicated articles to make Type C medicated feeds [[Page 19185]] in combination with other drugs to include certain other drugs that have been approved elsewhere in the animal drug regulations. This action is being taken to ensure the accuracy and consistency of the regulation because the cross-references were not updated at the time the combination drug uses were approved. EFFECTIVE DATE: April 17, 1998. FOR FURTHER INFORMATION CONTACT: David L. Gordon, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1739. SUPPLEMENTARY INFORMATION: In Sec. 558.78(d)(3) (21 CFR 558.78(d)(3)) FDA codified a list of combinations in which bacitracin zinc is approved for use with certain drugs that have been approved elsewhere in 21 CFR part 558. Several cross-references to approved combination drug uses were not included in that list. Section 558.78(d)(3) is amended to add those cross-references. 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 558.78 is amended by revising paragraph (d)(3) to read as follows: Sec. 558.78 Bacitracin zinc. * * * * * (d) * * * (3) Bacitracin zinc may be used as approved in combination as follows: (i) Amprolium as in Sec. 558.55. (ii) Amprolium and roxarsone as in Sec. 558.55. (iii) Amprolium and ethopabate as in Sec. 558.58. (iv) Amprolium and ethopabate with roxarsone as in Sec. 558.58. (v) Carbarsone as in Sec. 558.120. (vi) Clopidol as in Sec. 558.175. (vii) Clopidol and roxarsone as in Sec. 558.175. (viii) Decoquinate as in Sec. 558.195. (ix) Decoquinate and roxarsone as in Sec. 558.195. (x) Hygromycin B as in Sec. 558.274. (xi) Hygromycin B and penicillin as in Sec. 558.274. (xii) Lasalocid sodium and roxarsone as in Sec. 558.311. (xiii) Monensin as in Sec. 558.355. (xiv) Monensin and roxarsone as in Sec. 558.355. (xv) Robenidine as in Sec. 558.515. (xvi) Salinomycin as in Sec. 558.550. (xvii) Salinomycin and roxarsone as in Sec. 558.550. (xviii) Zoalene as in Sec. 558.680. (xix) Zoalene and arsanilic acid as in Sec. 558.680. (xx) Zoalene and roxarsone as in Sec. 558.680. Dated: March 31, 1998. Andrew J. Beaulieu, Deputy Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 98-10251 Filed 4-16-98; 8:45 am] BILLING CODE 4160-01-F