[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR558.366]

[Page 439-441]
 
                        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) Type A medicated articles: 25 percent to 000986, 060728, and 
063271 in Sec. 510.600(c) of this chapter for use as indicated in the 
table in paragraph (c) of this section.
    (b) Related tolerances. See Sec. 556.445 of this chapter.
    (c) 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,        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..
                              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.

[[Page 440]]


                              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      063271
                                                        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                                     063271
                                                        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       063271
                               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 063271,
                                                                                bacitracin zinc by
                                                                                063238..
                              Bambermycins 1 to 2....  Broiler chickens; aid   Feed continuously as       012799
                                                        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 063271..
                              Lincomycin 2 (0.00044    Broiler chickens; aid   Feed continuously as       060728
                               pct).                    in preventing           sole ration from time     063271
                                                        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..

[[Page 441]]


                              Roxarsone 22.7           ......do..............  Feed continuously as       060728
                               (0.0025)..                                       sole ration from time     063271
                                                                                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                                                          063271
                               (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]