21 C.F.R. § 558.311   Lasalocid.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds

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§ 558.311   Lasalocid.

(a) Specifications. A minimum of 90 percent of lasalocid activity is derived from lasalocid A.

(b) Approvals. Type A medicated articles approved for sponsors identified in §510.600(c) of this chapter for use as in paragraph (e) of this section as follows:

(1) 3.0, 3.3, 3.8, 4.0, 4.3, 4.4, 5.0, 5.1, 5.5, 5.7, 6.0, 6.3, 6.7, 7.2, 7.5, 8.0, 8.3, 10.0, 12.5, 15, 20, and 50 percent activity to No. 046573 for use as in paragraphs (e)(1) (i), (ii), (iii), (iv), and (x) of this section.

(2) 15 percent activity to No. 066104 as provided by No. 046573 for use as in paragraph (e)(1)(v) of this section.

(3) 15, 20, 33.1, and 50 percent activity to No. 046573 for use in cattle feeds as in paragraphs (e)(1)(vi), (vii), (ix), (xi), (xii), and (xv) of this section, and for use in sheep as in paragraph (e)(1)(viii) of this section.

(4) 15 percent activity to No. 046573 for use in Type C rabbit feeds as in paragraph (e)(1)(xvi) of this section and for use in ruminant free-choice Type C feeds as in paragraphs (e)(2), (e)(3), and (e)(4) of this section.

(5) 15 percent activity to 021930 (Type A article provided by 046573) for use in free-choice vitamin-mineral Type C cattle feeds as in paragraph (e)(1)(xi).

(6) 20 percent activity as a liquid Type A article to No. 046573 for use in cattle feeds as in paragraphs (e)(1)(vi), (e)(1)(vii), (e)(1)(ix), (e)(1)(xi), (e)(1)(xii), and (e)(3) of this section, and for use in sheep feeds as in paragraph (e)(1)(viii) of this section.

(7) 20 percent activity to No. 046573 for use as follows:

(i) Chukar partridges as in paragraph (e)(1)(xiii).

(ii) Turkeys as in paragraph (e)(1)(xiv).

(iii) Rabbits as in paragraph (e)(1)(xvi).

(8) 15 percent activity to No. 017800 for use as in paragraph (e)(1)(xviii) of this section.

(9) 15 percent activity to No. 068287 for use in free-choice protein blocks for cattle as in paragraphs (e)(1)(xix) of this section.

(c) Related tolerance. See §556.347 of this chapter.

(d) Special considerations. (1) Type C cattle and sheep feeds may be manufactured from lasalocid liquid Type B feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows:

(i) For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for no less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.

(ii) For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.

(2) A physically stable lasalocid liquid feed will not be subject to the requirements for mixing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) sufficient to maintain a viscosity of not less than 300 centipoises per second for 3 months.

(3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the manufacturer may secure approval of a positionally stable liquid feed by:

(i) Either filing a new animal drug application for the product or establishing a master file containing data to support the stability of its product;

(ii) Authorizing the agency to reference and rely upon the data in the master file to support approval of a supplemental new animal drug application to establish physical stability; and

(iii) Requesting the sponsor of an approved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the manufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug application will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufacture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing directions different from the standard directions established in paragraph (d)(1) of this section may also follow this procedure.

(4) If adequate information is submitted to show that a particular liquid feed containing lasalocid is stable outside the pH of 4.0 to 8.0, the pH restriction described in paragraphs (d)(1) and (d)(2) of this section may be waived.

(5) Required label statements:

(i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undiluted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established.

(iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

(6) Lasalocid Type A medicated articles containing lasalocid dried fermentation residue are for use in cattle and sheep feed only.

(7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(1)(xii) and (e)(1)(xviii) of this section must be the subject of an approved NADA or supplemental NADA as provided in §510.455 of this chapter.

(e)(1) Conditions of use. It is used as follows:

 ----------------------------------------------------------------------------------------------------------------   Lasalocid sodium activity in    Combination in grams          grams per ton                   per ton          Indications for use        Limitations       Sponsor----------------------------------------------------------------------------------------------------------------(i) 68 (0.0075 pct) to 113         ....................  For the prevention of    For broiler or          046573 (0.0125 pct).                                            coccidiosis caused by    fryer chickens                                                          Eimeria tenella, E.      only; feed                                                          necatrix, E.             continuously as                                                          acervulina, E.           the sole ration.                                                          brunetti, E. mivati,                                                          and E. maxima.(ii) 68 (0.0075 pct) to 113        Roxarsone 45.4        Broiler or fryer         For broiler or          046573 (0.0125 pct).                      (0.005 pct).          chickens; for the        fryer chickens                                                          prevention of            only; feed                                                          coccidiosis caused by    continuously as                                                          Eimeria tenella, E.      the sole ration;                                                          necatrix, E.             as sole source of                                                          acervulina, E.           organic arsenic;                                                          brunetti, E. mivati,     withdraw 5 d                                                          and E. maxima and as     before slaughter;                                                          an aid in the            roxarsone provided                                                          reduction of lesions     by Nos. 046573 and                                                          due to E. tenella.       011526 in §                                                                                   510.600(c) of this                                                                                   chapter.                                   Roxarsone 45.4 plus   For prevention of        For broiler             046573                                    bambermycins 1        coccidiosis caused by    chickens only;                                    (0.00011 pct).        Eimeria tenella, E.      feed continuously                                                          necatrix, E.             as sole ration;                                                          acervulina, E.           withdraw 5 days                                                          brunetti, E. mivati,     before slaughter;                                                          and E. maxima; as an     roxarsone provided                                                          aid in the reduction     by Nos. 046573 and                                                          of lesions due to E.     011526 in §                                                          tenella; and for         510.600(c) of this                                                          increased rate of        chapter,                                                          weight gain.             bambermycins                                                                                   provided by No.                                                                                   016592.                                   Bambermycins 1 to 2.  Broiler chickens: For    Feed continuously       016592                                                          prevention of            as sole ration.                                                          coccidiosis caused by    Bambermycins                                                          Eimeria tenella, E.      provided by No.                                                          necatrix, E.             016592 in §                                                          acervulina, E.           510.600(c) of this                                                          brunetti, E. mivati,     chapter..                                                          and E. maxima; and for                                                          increased rate of                                                          weight gain and                                                          improved feed                                                          efficiency..                                   Roxarsone 45.4 plus   For prevention of        For broiler             046573                                    lincomycin 2.0.       coccidiosis caused by    chickens only;                                                          Eimeria tenella, E.      feed continuously                                                          necatrix, E.             as sole ration;                                                          acervulina, E.           withdraw 5 days                                                          brunetti, E. mivati,     before slaughter;                                                          and E. maxima; as an     roxarsone provided                                                          aid in the reduction     by Nos. 046573 and                                                          of lesions due to E.     011526 in §                                                          tenella; and for         510.600(c) of this                                                          increased rate of        chapter,                                                          weight gain and          lincomycin                                                          improved feed            provided by No.                                                          efficiency.              000009.                                   Roxarsone 45.4 plus   For prevention of        For broiler or          046573                                    bacitracin 10 to 25.  coccidiosis caused by    fryer chickens                                                          Eimeria tenella, E.      only; feed                                                          necatrix, E.             continuously as                                                          acervulina, E.           the sole ration;                                                          brunetti, E. mivati,     withdraw 5 days                                                          and E. maxima; as an     before slaughter;                                                          aid in the reduction     roxarsone provided                                                          of lesions due to E.     by Nos. 046573 and                                                          tenella; and for         011526 in §                                                          increased rate of        510.600(c) of this                                                          weight gain.             chapter,                                                                                   bacitracin                                                                                   methylene                                                                                   disalicylate                                                                                   provided by No.                                                                                   046573 in §                                                                                   510.600(c) of this                                                                                   chapter.                                   Roxarsone 45.4 plus   For prevention of        For broiler             046573                                    bacitracin 10 or 30.  coccidiosis caused by    chickens only;                                                          E. tenella, E.           feed continuously                                                          necatrix, E.             as sole ration;                                                          acervulina, E.           withdraw 5 days                                                          brunetti, E. mivati      before slaughter;                                                          and E. maxima; as an     roxarsone provided                                                          aid in the reduction     by Nos. 046573 and                                                          of lesions due to E.     011526 in §                                                          tenella; and for         510.600(c) of this                                                          increased rate of        chapter,                                                          weight gain (10 grams    bacitracin zinc                                                          per ton) or improved     provided by No.                                                          feed efficiency (30      000004.                                                          grams per ton).                                   Roxarsone 45.5 plus   Prevention of            Feed continuously       046573                                    bacitracin            coccidiosis caused by    as sole ration; as                                    methylene             Eimeria necatrix, E.     sole source of                                    disalicylate 50.      tenella, E.              organic arsenic;                                                          acervulina, E.           withdraw 5 days                                                          brunetti; E. mivati,     before slaughter.                                                          and E. maxima;                                                          reduction of lesions                                                          due to E. tenella;                                                          prevention of necrotic                                                          enteritis caused or                                                          complicated by                                                          Clostridium spp. or                                                          other susceptible                                                          organisms.(iii) 68 (0.0075 pct)............  Lincomycin 2          Broiler or fryer         For broiler and         046573                                    (0.00022 pct).        chickens; for the        fryer chickens                                                          prevention of            only; feed                                                          coccidiosis caused by    continuously as                                                          Eimeria mivati, E.       sole ration;                                                          brunetti, E. tenella,    withdraw 5 d                                                          E. acervulina, E.        before slaughter;                                                          maxima, and E.           Type C feed must                                                          necatrix; for            be used within 4                                                          increased rate of        weeks of                                                          weight gain and          manufacture; as                                                          improved feed            lincomycin                                                          efficiency.              hydrochloride                                                                                   monohydrate.(iv) 68 (0.0075 percent).........  Bacitracin 10 to 50.  For prevention of        For broiler or          046573                                                          coccidiosis caused by    fryer chickens                                                          Eimeria tenella, E.      only; feed                                                          necatrix, E.             continuously as                                                          acervulina, E.           the sole ration;                                                          brunetti, E. mivati,     bacitracin                                                          and E. maxima, and for   methylene                                                          increased rate of        disalicylate                                                          weight gain and          provided by No.                                                          improved feed            046573 in §                                                          efficiency.              510.600(c) of this                                                                                   chapter.(v) 68 (0.0075 pct) to 113         Virginiamycin 20....  For prevention of        For broiler and         046573 (0.0125 pct).                                            coccidiosis caused by    fryer chickens                                                          Eimeria tenella E.       only; feed                                                          necatrix, E.             continuously as                                                          acervulina, E.           sole ration; do                                                          brunetti, E. mivati,     not feed to laying                                                          and E. maxima, and for   chickens;                                                          increased rate of        lasalocid sodium                                                          weight gain and          provided by No.                                                          improved feed            046573 in §                                                          efficiency.              510.600(c) of this                                                                                   chapter.(vi) 10 (0.0011 pct) to 30         ....................  Cattle; for improved     In Type C feeds;        046573 (0.0033 pct).                                            feed efficiency.         for cattle fed in                                                                                   confinement for                                                                                   slaughter only;                                                                                   feed continuously                                                                                   in complete feed                                                                                   to provide not                                                                                   less than 100 mg                                                                                   nor more than 360                                                                                   mg of lasalocid                                                                                   sodium activity                                                                                   per head per day.                                   Oxytetracycline 7.5.  Cattle: for improved     In Type C feeds,        046573                                                          feed efficiency and      for beef cattle                                                          reduction of incidence   fed in confinement                                                          and severity of liver    for slaughter;                                                          abscesses.               feed continuously                                                                                   at 100 to 360 mg/                                                                                   head/day lasalocid                                                                                   and 75 mg/head/day                                                                                   oxytetracycline.                                                                                   As monoalkyl (C8-                                                                                   C18) trimethyl                                                                                   ammonium                                                                                   oxytetracycline.(vii) 25 (0.0027 pct) to 30        ....................  Cattle; for improved     In Type C feeds;        046573 (0.0033 pct).                                            feed efficiency and      for cattle fed in                                                          increased rate of        confinement for                                                          weight gain.             slaughter only;                                                                                   feed continuously                                                                                   in complete feed                                                                                   to provide not                                                                                   less than 250 mg                                                                                   nor more than 360                                                                                   mg of lasalocid                                                                                   sodium activity                                                                                   per head per day.                                   Oxytetracycline 7.5.  Cattle: for improved     In Type C feeds,        046573                                                          feed efficiency,         for beef cattle                                                          increased rate of        fed in confinement                                                          weight gain, and         for slaughter;                                                          reduction of incidence   feed continuously                                                          and severity of liver    at 250 to 360 mg/                                                          abscesses.               head/day lasalocid                                                                                   and 75 mg/head/day                                                                                   oxytetracycline.                                                                                   As monoalkyl (C8-                                                                                   C18) trimethyl                                                                                   ammonium                                                                                   oxytetracycline.(viii) 20 (0.0022 pct) to 30       ....................  Sheep; for the           In Type C feeds;        046573 (0.0033 pct).                                            prevention of            for sheep                                                          coccidiosis caused by    maintained in                                                          Eimeria ovina, E.        confinement; feed                                                          crandallis, E.           continuously in                                                          ovinoidalis (E.          complete feed to                                                          ninakohlyakimovae), E.   provide not less                                                          parva, and E.            than 15 mg nor                                                          intricata.               more than 70 mg of                                                                                   lasalocid sodium                                                                                   activity per head                                                                                   per day depending                                                                                   on body weight.(ix).............................  ....................  Pasture cattle           Feed continuously       046573                                                          (slaughter, stocker,     at a rate of not                                                          feeder cattle, and       less than 60 mg or                                                          dairy and beef           more than 300 mg                                                          replacement heifers):    of lasalocid per                                                          for increased rate of    head per day when                                                          weight gain. Intakes     on pasture; the                                                          of lasalocid in excess   drug must be                                                          of 200 mg/head/day       contained in at                                                          have not been shown to   least 1 pound of                                                          be more effective than   feed..                                                          200 mg/head/day..(x) 68 (0.0075 pct) to 113         Bacitracin 4 to 50..  Broiler chickens; for    For broiler             046573 (0.0125 pct).                                            prevention of            chickens only;                                                          coccidiosis caused by    feed continuously                                                          Eimeria tenella, E.      as the sole                                                          necatrix, E.             ration; bacitracin                                                          acervulina, E.           methylene                                                          brunetti, E. mivati,     disalicylate                                                          and E. maxima; and for   provided by No.                                                          improved feed            046573 in §                                                          efficiency.              510.600(c) of this                                                                                   chapter.(xi) 68 (0.0075 pct) to 113        Bacitracin zinc 4 to  Broiler chickens. For    Feed continuously       046573 (0.0125 pct).                      50.                   prevention of            as sole ration.                                                          coccidiosis caused by    Bacitracin zinc                                                          Eimeria tenella, E.      and lasalocid                                                          necatrix, E.             sodium as provided                                                          acervulina, E.           by No. 046573 in                                                          brunetti, E. mivati,     § 510.600(c)                                                          and E. maxima, and for   of this chapter..                                                          increased rate of                                                          weight gain and                                                          improved feed                                                          efficiency..(xii)............................  ....................  Pasture cattle           Feed continuously       046573                                                          (slaughter, stocker,     on a free-choice                                                          feeder cattle, and       basis at a rate of                                                          dairy and beef           not less than 60                                                          replacement heifers):    mg or more than                                                          For increased rate of    300 mg of                                                          weight gain. Intakes     lasalocid per head                                                          of lasalocid in excess   per day..                                                          of 200 mg/head/day                                                          have not been shown to                                                          be more effective than                                                          200 mg/head/day..(xiii)...........................  ....................  Cattle; for control of   For cattle; hand        046573                                                          coccidiosis caused by    feed at a rate of                                                          Eimeria bovis and        1 mg of lasalocid                                                          Eimeria zuernii.         per 2.2 pounds                                                                                   body weight per                                                                                   day to cattle                                                                                   weighing up to 800                                                                                   pounds with a                                                                                   maximum of 360 mg                                                                                   of lasalocid per                                                                                   head per day.(xiv) 113 (0.0125 pct)...........  ....................  Chukar partridges; for   Feed continuously       046573                                                          prevention of            as sole ration up                                                          coccidiosis caused by    to 8 weeks of age.                                                          Eimeria legionensis.(xv) 68 (0.0075 pct) to 113        ....................  Growing turkeys; for     Feed continuously       046573 (0.0125 pct).                                            prevention of            as sole ration.                                                          coccidiosis caused by                                                          E. meleagrimitis, E.                                                          gallopavonis, and E.                                                          adenoeides..                                   Bacitracin 4 to 50..  Growing turkeys; for     Feed continuously       046573                                                          prevention of            as sole ration.                                                          coccidiosis caused by                                                          E. meleagrimitis, E.                                                          gallopavonis, and E.                                                          adenoeides; for                                                          increased rate of                                                          weight gain and                                                          improved feed                                                          efficiency..                                   Bacitracin methylene  Growing turkeys; for     Feed continuously       046573                                    disalicylate 4 to     prevention of            as sole ration.                                    50.                   coccidiosis caused by    Bacitracin                                                          E. meleagrimitis, E.     methylene                                                          gallopavonis, and E.     disalicylate as                                                          adenoeides; for          provided by No.                                                          increased rate of        046573 in §                                                          weight gain and          510.600(c) of this                                                          improved feed            chapter..                                                          efficiency..                                   Virginiamycin 10 to   Growing turkeys; for     Feed continuously       046573                                    20.                   prevention of            as sole ration. As                                                          coccidiosis caused by    lasalocid sodium                                                          E. meleagrimitis, E.     provided by 063238                                                          gallopavonis, and E.     and virginiamycin                                                          adenoeides, and for      provided by                                                          increased rate of        066104..                                                          weight gain and                                                          improved feed                                                          efficiency..(xvi)............................  ....................  Replacement calves; for  In milk replacer        046573                                                          control of coccidiosis   powder; hand feed                                                          caused by E. bovis and   at a rate of 1 mg                                                          E. zuernii..             of lasalocid per                                                                                   2.2 lb body weight                                                                                   per day; include                                                                                   on labeling                                                                                   warning: ``A                                                                                   withdrawal period                                                                                   has not been                                                                                   established for                                                                                   lasalocid in pre-                                                                                   ruminating calves.                                                                                   Do not use in                                                                                   calves to be                                                                                   processed for                                                                                   veal''.(xvii) 113 (0.0125 pct)..........  ....................  Rabbits; for prevention  Feed continuously       046573                                                          of coccidiosis caused    as sole ration up                                                          by Eimeria stiedae.      to 6 1/2 weeks of                                                                                   age.(xviii) 1440.....................  ....................  Pasture cattle           Feed continuously       021930                                                          (slaughter, stocker,     on a free-choice       017800                                                          feeder cattle, and       basis at a rate of                                                          dairy and beef           not less than 60                                                          replacement heifers):    mg nor more than                                                          For increased rate of    200 mg of                                                          weight gain..            lasalocid per head                                                                                   per day..(xix) 300........................  ....................  Pasture cattle           Feed continuously       068287                                                          (slaughter, stocker,     on a free-choice                                                          feeder cattle, and       basis at a rate of                                                          dairy and beef           not less than 60                                                          replacement heifers):    mg nor more than                                                          for increased rate of    200 mg of                                                          weight gain..            lasalocid per head                                                                                   per day..(xx) 10 to 30....................  Chlortetracycline 25  1. Cattle fed in         Feed continuously       046573                                    to 100.               confinement for          in complete feed                                                          slaughter: For           at a rate of 350                                                          improved feed            mg                                                          efficiency; and for      chlortetracycline                                                          control of bacterial     and not less than                                                          pneumonia associated     100 mg nor more                                                          with shipping fever      than 360 mg of                                                          complex caused by        lasalocid sodium                                                          Pasteurella spp.         activity per head                                                          susceptible to           per day..                                                          chlortetracycline..                                   ....................  2. Cattle under 700      Feed continuously       046573                                                          pounds fed in            in complete feed                                                          confinement for          at a rate of 350                                                          slaughter: For           mg                                                          improved feed            chlortetracycline                                                          efficiency; and for      and not less than                                                          control of active        100 mg nor more                                                          infection of             than 360 mg of                                                          anaplasmosis caused by   lasalocid sodium                                                          Anaplasma marginale      activity per head                                                          susceptible to           per day..                                                          chlortetracycline..(xxi) 10 to 30...................  Chlortetracycline     Cattle fed in            Feed continuously       046573                                    500 to 2000.          confinement for          in complete feed                                                          slaughter: For           for not more than                                                          improved feed            5 days to provide                                                          efficiency; and for      10 mg                                                          treatment of bacterial   chlortetracycline                                                          enteritis caused by E.   per lb body weight                                                          coli and bacterial       per day and not                                                          pneumonia caused by P.   less than 100 mg                                                          multocida organisms      nor more than 360                                                          susceptible to           mg of lasalocid                                                          chlortetracycline..      sodium activity                                                                                   per head per day..(xxii) 25 to 30..................  Chlortetracycline 25  1. Cattle fed in         Feed continuously       046573                                    to 42.2.              confinement for          in complete feed                                                          slaughter: For           at a rate of 350                                                          increased rate of        mg                                                          weight gain and          chlortetracycline                                                          improved feed            and not less than                                                          efficiency; and for      250 mg nor more                                                          control of bacterial     than 360 mg of                                                          pneumonia associated     lasalocid sodium                                                          with shipping fever      activity per head                                                          complex caused by        per day..                                                          Pasteurella spp.                                                          susceptible to                                                          chlortetracycline..                                   ....................  2. Cattle under 700      Feed continuously       046573                                                          pounds fed in            in complete feed                                                          confinement for          at a rate of 350                                                          slaughter: For           mg                                                          increased rate of        chlortetracycline                                                          weight gain and          and not less than                                                          improved feed            250 mg nor more                                                          efficiency; and for      than 360 mg of                                                          control of active        lasalocid sodium                                                          infection of             activity per head                                                          anaplasmosis caused by   per day..                                                          Anaplasma marginale                                                          susceptible to                                                          chlortetracycline..(xxiii) 25 to 30.................  Chlortetracycline     Cattle fed in            Feed continuously       046573                                    500 to 1200.          confinement for          in complete feed                                                          slaughter: For           for not more than                                                          increased rate of        5 days to provide                                                          weight gain and          10 mg                                                          improved feed            chlortetracycline                                                          efficiency; and for      per lb body weight                                                          treatment of bacterial   per day and not                                                          enteritis caused by E.   less than 250 mg                                                          coli and bacterial       nor more than 360                                                          pneumonia caused by P.   mg of lasalocid                                                          multocida organisms      sodium activity                                                          susceptible to           per head per day..                                                          chlortetracycline..(xxiv) 30 to 181.8...............  Chlortetracycline 25  1. Beef cattle under     Hand feed               046573                                    to 2800.              700 pounds: For          continuously at a                                                          control of coccidiosis   rate of 350 mg                                                          caused by Eimeria        chlortetracycline                                                          bovis and E. zuernii;    per head per day                                                          and for control of       and 1 mg lasalocid                                                          active infection of      per 2.2 lb body                                                          anaplasmosis caused by   weight per day                                                          Anaplasma marginale      with a maximum of                                                          susceptible to           360 mg lasalocid                                                          chlortetracycline..      per head per day..                                   ....................  2. Beef cattle up to     Hand feed               046573                                                          800 pounds: For          continuously at a                                                          control of coccidiosis   rate of 350 mg                                                          caused by Eimeria        chlortetracycline                                                          bovis and E. zuernii;    per head per day                                                          and for control of       and 1 mg lasalocid                                                          bacterial pneumonia      per 2.2 lb body                                                          associated with          weight per day                                                          shipping fever complex   with a maximum of                                                          caused by Pasteurella    360 mg lasalocid                                                          spp. susceptible to      per head per day..                                                          chlortetracycline..(xxv) 30 to 181.8................  Chlortetracycline     Cattle up to 800         Hand feed               046573                                    500 to 4000.          pounds: For control of   continuously for                                                          coccidiosis caused by    not more than 5                                                          Eimeria bovis and E.     days to provide 10                                                          zuernii; and for         mg                                                          treatment of bacterial   chlortetracycline                                                          enteritis caused by E.   per lb body weight                                                          coli and bacterial       per day and 1 mg                                                          pneumonia caused by P.   lasalocid per 2.2                                                          multocida organisms      lb body weight per                                                          susceptible to           day with a maximum                                                          chlortetracycline..      of 360 mg                                                                                   lasalocid per head                                                                                   per day..(xxvi) 30 to 600.................  Chlortetracycline 25  1. Pasture cattle        Hand feed               046573                                    to 700.               (slaughter, stocker,     continuously at a                                                          feeder cattle, and       rate of 350 mg                                                          beef replacement         chlortetracycline                                                          heifers): for            and not less than                                                          increased rate of        60 mg or more than                                                          weight gain; and for     300 mg lasalocid                                                          control of bacterial     per head daily in                                                          pneumonia associated     at least 1 lb of                                                          with shipping fever      feed. Intakes of                                                          complex caused by        lasalocid in                                                          Pasteurella spp.         excess of 200 mg/                                                          susceptible to           head/day have not                                                          chlortetracycline..      been shown to be                                                                                   more effective                                                                                   than 200 mg/head/                                                                                   day..                                   ....................  2. Pasture cattle under  Hand feed               046573                                                          700 pounds (slaughter,   continuously at a                                                          stocker, feeder          rate of 350 mg                                                          cattle, and beef         chlortetracycline                                                          replacement heifers):    and not less than                                                          for increased rate of    60 mg or more than                                                          weight gain; and for     300 mg lasalocid                                                          control of active        per head daily in                                                          infection of             at least 1 lb of                                                          anaplasmosis caused by   feed. Intakes of                                                          Anaplasma marginale      lasalocid in                                                          susceptible to           excess of 200 mg/                                                          chlortetracycline..      head/day have not                                                                                   been shown to be                                                                                   more effective                                                                                   than 200 mg/head/                                                                                   day..(xxvii) 30 to 600................  Chlortetracycline 25  Pasture cattle over 700  Hand feed               046573                                    to 1100.              pounds (slaughter,       continuously at a                                                          stocker, feeder          rate of 0.5 mg                                                          cattle, and beef         chlortetracycline                                                          replacement heifers):    per lb body weight                                                          For increased rate of    per day and not                                                          weight gain; and for     less than 60 mg or                                                          control of control of    more than 300 mg                                                          active infection of      lasalocid per head                                                          anaplasmosis caused by   daily in at least                                                          Anaplasma marginale      1 lb of feed.                                                          susceptible to           Intakes of                                                          chlortetracycline..      lasalocid in                                                                                   excess of 200 mg/                                                                                   head/day have not                                                                                   been shown to be                                                                                   more effective                                                                                   than 200 mg/head/                                                                                   day..(xxviii) 30 to 600...............  Chlortetracycline     Pasture cattle           Hand feed               046573                                    500 to 4000..         (slaughter, stocker,     continuously for                                                          feeder cattle, and       not more than 5                                                          dairy and beef           days to provide 10                                                          replacement heifers):    mg                                                          For increased rate of    chlortetracycline                                                          weight gain; and for     per lb body weight                                                          treatment of bacterial   per day and not                                                          enteritis caused by E.   less than 60 mg or                                                          coli and bacterial       more than 300 mg                                                          pneumonia caused by P.   lasalocid per head                                                          multocida organisms      daily in at least                                                          susceptible to           1 lb of feed.                                                          chlortetracycline..      Intakes of                                                                                   lasalocid in                                                                                   excess of 200 mg/                                                                                   head/day have not                                                                                   been shown to be                                                                                   more effective                                                                                   than 200 mg/head/                                                                                   day..----------------------------------------------------------------------------------------------------------------

(2) It is used as a free-choice mineral Type C feed as follows:

(i) Specifications.

 ------------------------------------------------------------------------            Ingredient               Percent    International feed No.------------------------------------------------------------------------Defluorinated Phosphate (20.5          35.9   6-01-080 percent Calcium, 18.5 percent Phosphorus).Sodium Chloride (Salt)............     20.0   6-04-152Calcium Carbonate (38 percent          18.0   6-01-069 Calcium).Cottonseed Meal...................     10.0   5-01-621Potassium Chloride................      3.0   6-03-755Selenium Premix (0.02 percent           3.0   .......................... Selenium) \1\.Dried Cane Molasses...............      2.5   4-04-695Magnesium Sulfate.................      1.7   6-02-758Vitamin Premix \1\................      1.4   ..........................Magnesium Oxide...................      1.2   6-02-756Potassium Sulfate.................      1.2   6-06-098Trace Mineral Premix \1\..........      1.04  ..........................Bovatec Premix (68 grams per            1.06  .......................... pound).------------------------------------------------------------------------\1\ Content of this vitamin and trace mineral premixes may be varied;  however, they should be comparable to those used by the firm for other  free-choice feeds. Formulation modifications require FDA approval  prior to marketing. Selenium must comply with § 573.920 of this  chapter. Ethylenediamine dihydroiodide (EDDI) should comply with FDA  Compliance Policy Guide Sec. 651.100 (CPG 7125.18).

(ii) Amount. 1,440 grams per ton (0.16 percent).

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers); feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(3) It is used as a ruminant free-choice liquid Type C feed as follows:

(i) Specifications.

 ------------------------------------------------------------------------            Ingredient               Percent     International feed No.------------------------------------------------------------------------Cane Molasses....................      55.167  4-13-241Condensed Molasses Fermentation        24.0    N/A Solubles.50% Urea Solution (23% N)........      12.0    N/AAmmonium Polyphosphate Solution..       1.0    6-08-42Phosphoric Acid (54%)............       3.0    6-03-707Xanthan Gum......................       0.05   8-15-818Water............................       4.0    N/ATrace Mineral Mix \1\............       0.5    N/AVitamin Premix \1\...............       0.2    N/ABovatec Liquid 20 (90.8 gm/lb)          0.083  N/A \2\.------------------------------------------------------------------------\1\ Content of vitamin and trace mineral premixes may be varied;  however, they should be comparable to those used for other free-choice  liquid feeds. Formulation modifications require FDA approval prior to  marketing. Selenium must comply with § 573.920 of this chapter.  EDDI should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG  7125.18).\2\ To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of  Bovatec Liquid 20 (90.8 gm/lb). If dry Bovatec-68 (68 gm/lb) is used,  use 2.206 lbs per ton (0.111%), replacing molasses.

(ii) Amount. 150 grams per ton (.017 percent).

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day.

(v) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(4) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

 ------------------------------------------------------------------------            Ingredient               Percent    International feed No.------------------------------------------------------------------------Monocalcium Phosphate (21% P).....    57.70   6-01-082Salt..............................    17.55   6-04-152Distillers Dried Grains w/Solubles     5.40   5-28-236Dried Cane Molasses (46% Sugars)..     5.20   4-04-695Potassium Chloride................     4.90   6-03-755Trace Mineral/Vitamin Premix\1\...     3.35   ..........................Calcium Carbonate (38% Ca)........     2.95   6-01-069Mineral Oil.......................     1.05   8-03-123Magnesium Oxide (58% Mg)..........     1.00   6-02-756Iron Oxide (52% Fe)...............     0.10   6-02-431Lasalocid Type A Medicated Article     0.80   .......................... (68 g per pound).------------------------------------------------------------------------\1\ Content of vitamin and trace mineral premixes may be varied.  However, they should be comparable to those used for other free-choice  loose mineral feeds. Formulation modifications require FDA approval  prior to marketing. Selenium must comply with § 573.920 of this  chapter. EDDI should comply with FDA Compliance Policy Guides Sec.  651.100 (CPG 7125.18).

(ii) Amount. 1,088 grams per ton.

(iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day.

(v) Sponsor. See No. 046573 in §510.600(c) of this chapter.

(5) Additional combinations. Lasalocid may be used in accordance with the provisions of this section in combination as follows:

(i) Melengestrol acetate alone or in combination with tylosin in accordance with §558.342.

(ii) [Reserved]

[41 FR 44382, Oct. 8, 1976]

Editorial Note:  For Federal Register citations affecting §558.311, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

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