[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.415] [Page 449-450] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents Subpart B--Specific New Animal Drugs for Use in Animal Feeds Sec. 558.415 Novobiocin. (a) Approvals. Type A medicated articles: 25 grams of activity per pound to 000009 in Sec. 510.600(c) of this chapter. Type B medicated feeds: 17.5 grams per pound to 000009 in Sec. 510.600(c) of this chapter. (b) Related tolerances. See Sec. 556.460 of this chapter. (c) Conditions of use. It is used in animal feeds as follows: (1) Chickens--(i) Amount. Novobiocin, 6-7 mgs. per lb. body weight per day. (a) Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. (b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter. (ii) Amount. Novobiocin, 10-14 mgs. per lb. body weight per day. (a) Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin. (b) Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter. (2) Turkeys--(i) Amount. Novobiocin, 4-5 mgs. per lb. body weight per day. (a) Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. (b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying turkeys; feed 5 to 7 days; withdraw 4 days before slaughter. (ii) Amount. Novobiocin, 5-8 mgs. per lb. body weight per day. (a) Indications for use. Aid in the control of recurring outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin following initial treatment with 7-8 mgs. per pound body weight per day. (b) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per [[Page 450]] ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter. (iii) Amount. Novobiocin, 7-8 mgs. per lb. body weight per day. (a) Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infection susceptible to novobiocin; treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin. (b) Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter. (3) Mink--(i) Amount. 20 mgs. per lb. body weight per day. (ii) Indications for use. For treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms. (iii) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; feed for 7 days. (4) Ducks--(i) Amount. Novobiocin, 350 grams per ton. (ii) Indications for use. Control of infectious serositis and fowl cholera in ducks caused by Pasteurella anatipestifer and P. multocida, susceptible to novobiocin. (iii) Limitations. Administer, as sole ration, for 5 to 7 days, continue medication for 14 days if necessary, repeat if reinfection occurs; discontinue use at least 3 days before slaughter; not for use in laying ducks. [40 FR 13959, Mar. 27, 1975, as amended at 45 FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, 1986; 52 FR 36402, Sept. 29, 1987]