[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: 21CFR558.366] [Page 445-448] 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. 558.366 Nicarbazin. (a) Specifications. Type A medicated articles containing 25 percent nicarbazin. [[Page 446]] (b) Approvals. See Nos. 000986, 060728, and 066104 in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section. (c) Related tolerances. See Sec. 556.445 of this chapter. (d) Conditons of use. It is used in chicken feed as follows: ---------------------------------------------------------------------------------------------------------------- Combination in grams Nicarbazin in grams per ton per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- 27 to 45.................... Narasin 27 to 45....... Broiler chickens; Sec. 000986 prevention of 558.363(d)(1)(iii). coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, E. mivati.. Narasin 27 to 45 and Broiler chickens; Feed continuously as 000986 bacitracin methylene prevention of sole ration. Withdraw disalicylate 4 to 50. coccidiosis caused by 5 days before Eimeria tenella, E. slaughter. Do not necatrix, E. allow turkeys, acervulina, E. horses, or other maxima, E. brunetti, equines access to E. mivati; for formulations increased rate of containing narasin. weight gain and Ingestion of narasin improved feed by these species has efficiency. been fatal. Do not feed to laying hens. Narasin and nicarbazin as provided by 000986, bacitracin methylene disalicylate by 046573. Narasin 27 to 45 and Broiler chickens: For Feed continuously as 046573 bacitracin methylene prevention of sole ration. Do not disalicylate 50.. coccidiosis caused by feed to laying hens. Eimeria tenella, E. Withdraw 5 days necatrix, E. before slaughter. Do acervulina, E. not allow turkeys, maxima, E. brunetti, horses or other and E. mivati; as an equines access to aid in the prevention formulations of necrotic enteritis containing narasin. caused or complicated Ingestion of narasin by Clostridium spp. by these species has or other organisms been fatal. Narasin susceptible to and nicarbazin as bacitracin.. provided by No. 000986, bacitracin methylene disalicylate by No. 046573 in Sec. 510.600(c) of this chapter.. Narasin 27 to 45 and Broiler chickens: For To control necrotic 046573 bacitracin methylene prevention of enteritis, start disalicylate 100 to coccidiosis caused by medication at first 200.. Eimeria tenella, E. clinical signs of necatrix, E. disease; vary dosage acervulina, E. based on the severity maxima, E. brunetti, of infection; and E. mivati; as an administer aid in the control of continuously for 5 to necrotic enteritis 7 days or as long as caused or complicated clinical signs by Clostridium spp. persist, then reduce or other organisms bacitracin to susceptible to prevention level (50 bacitracin.. g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow turkeys, horses or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and nicarbazin as provided by No. 000986, bacitracin methylene disalicylate by No. 046573 in Sec. 510.600(c) of this chapter.. Narasin 27 to 45, Broiler chickens; Feed continuously as 046573 bacitracin methylene prevention of sole ration. Withdraw disalicylate 50, and coccidiosis caused by 5 days before roxarsone 22.7 to Eimeria tenella, E. slaughter. Do not 45.4.. necatrix, E. allow turkeys, horses acervulina, E. or other equines maxima, E. brunetti, access to and E. mivati, as an formulations aid in the prevention containing narasin. of necrotic enteritis Ingestion of narasin caused or complicated by these species has by Clostridium spp. been fatal. Do not or other organisms feed to laying hens. susceptible to Use as sole source of bacitracin, for organic arsenic. increased rate of Narasin and weight gain, improved nicarbazin as feed efficiency, and provided by 000986, improved bacitracin methylene pigmentation.. disalicylate and roxarsone by 046573.. [[Page 447]] Narasin 27 to 45 and Broiler chickens; Feed continuously as 000986 Lincomycin 2 to 4. prevention of sole ration. Withdraw coccidiosis caused by 5 days before Eimeria tenella, E. slaughter. Do not necatrix, E. allow turkeys, acervulina, E. horses, or other maxima, E. brunetti, equines access to E. mivati; for formulations increased rate of containing narasin. weight gain and Ingestion of narasin improved feed by these species has efficiency. been fatal. Do not feed to laying hens. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Narasin and nicarbazin as provided by 000986, lincomycin by 000009. Narasin 27 to 45 and Broiler chickens; for Feed continuously as 000986 roxarsone 22.7 to prevention of sole ration. Use as 45.4.. coccidiosis caused by sole source of Eimeria tenella, E. organic arsenic. necatrix, E. Withdraw 5 days acervulina, E. before slaughter. Do maxima, E. brunetti, not allow turkeys, and E. mivati; for horses or other increased rate of equines access to weight gain, improved formulations feed efficiency, and containing narasin. improved Ingestion of narasin pigmentation.. by these species has been fatal. Do not feed to laying hens. Use as sole source of organic arsenic. Narasin and nicarbazin as provided by 000986, roxarsone by 046573.. 113.5 (0.0125 pct).......... ....................... Chickens; aid in Feed continuously as 000986 preventing outbreaks sole ration from time 060728 of cecal (Eimeria chicks are placed on 066104 tenella) and litter until past the intestinal (E. time when coccidiosis acervulina, E. is ordinarily a maxima, E. necatrix, hazard; do not use as and E. brunetti) a treatment for coccidiosis. coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. Bacitracin methylene Broiler chickens; aid ......do.............. 060728 disalicylate 30. in preventing 066104 outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight gain and improved feed efficiency. Bacitracin zinc 4 to Broiler chickens; aid For broiler chickens 066104 50.. in preventing only. Feed outbreaks of cecal continuously as sole (Eimeria tenella) and ration from time intestinal (E. chicks are placed on acervulina, E. litter until past the maxima, E. necatrix, time when coccidiosis and E. brunetti) is ordinarily a coccidiosis, and for hazard. Discontinue increased rate of medication 4 days weight gain and before marketing the improved feed birds for human efficiency.. consumption to allow for elimination of the drug from edible tissue. Do not feed to laying hens in production. Nicarbazin as provided by 066104, bacitracin zinc by 046573.. [[Page 448]] Bambermycins 1 to 2.... Broiler chickens; aid Feed continuously as 057926 in preventing sole ration from time outbreaks of cecal chicks are placed on (Eimeria tenella) and litter until past the intestinal (E. time when coccidiosis acervulina, E. is ordinarily a maxima, E. necatrix, hazard; do not use as and E. brunetti) a treatment for coccidiosis, for coccidiosis; do not increased rate of use in flushing weight gain and mashes; do not feed improved feed to laying hens; efficiency.. withdraw 4 days before slaughter. Nicarbazin as provided by 066104.. Lincomycin 2 (0.00044 Broiler chickens; aid Feed continuously as 060728 pct). in preventing sole ration from time 066104 outbreaks of secal chicks are placed on (Eimeria tenella) and litter until past the intestinal (E. time when coccidiosis acervulina, E. is ordinarily a maxima, E. necatrix, hazard; do not use as and E. brunetti) a treatment for coccidiosis; for coccidiosis; do not increased rate of use in flushing weight gain.. mashes; do not feed to laying hens; withdraw 4 days before slaughter.. Roxarsone 22.7 ......do.............. Feed continuously as 060728 (0.0025).. sole ration from time 066104 chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; as sole source of organic arsenic; do not use a treatment for coccidiosis; do not use in flushing mashes; do not feed to laying hens; withdraw 5 days before slaughter. Roxarsone 22.7 (0.0025) ......do.............. ......do.............. 060728 plus lincomycin 2 066104 (0.0004).. ---------------------------------------------------------------------------------------------------------------- [42 FR 56729, Oct. 28, 1977; 43 FR 1942, Jan. 13, 1978, as amended at 44 FR 40887, July 13, 1979; 50 FR 13562, Apr. 5, 1985; 51 FR 7399, Mar. 3, 1986; 54 FR 1928, Jan. 18, 1989; 60 FR 29483, June 5, 1995; 61 FR 1832, Jan. 24, 1996; 61 FR 14021, Mar. 29, 1996; 61 FR 14483, Apr. 2, 1996; 62 FR 29011, May 29, 1997; 63 FR 13124, Mar. 18, 1998; 63 FR 57248, Oct. 27, 1998; 64 FR 4966, Feb. 2, 1999; 64 FR 18574, Apr. 15, 1999; 64 FR 20164, Apr. 26, 1999; 64 FR 49384, Sept. 13, 1999; 65 FR 11889, Mar. 7, 2000; 66 FR 46706, Sept. 7, 2001; 66 FR 47962, Sept. 17, 2001; 66 FR 63500, Dec. 7, 2001; 67 FR 30327, May 6, 2002]