[Federal Register Volume 65, Number 163 (Tuesday, August 22, 2000)]
[Rules and Regulations]
[Pages 50914-50917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-21412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene 
Disalicylate, Robenidine Hydrochloride, and Roxarsone

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) filed by Alpharma, Inc. The NADA provides for use of approved 
bacitracin methylene disalicylate (BMD), robenidine hydrochloride, and 
roxarsone Type A medicated articles to make three-way combination Type 
C medicated broiler chicken feeds used for prevention of coccidiosis; 
as an aid in the prevention and control of necrotic enteritis; and for 
increased rate of weight gain, improved feed efficiency, and improved 
pigmentation.

DATES: This rule is effective August 22, 2000.

FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for 
Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-1600.

SUPPLEMENTARY INFORMATION: Alpharma, Inc., One Executive Dr., P.O. Box 
1399, Fort Lee, NJ 07024, filed NADA 141-155 that provides for use of 
BMD (10, 25, 30, 40, 50, 60, or 75 grams per pound (g/lb) 
BMD), ROBENZ (30 g/lb robenidine hydrochloride), and 3-
NITRO (45.4, 90, 227, or 360 g/lb roxarsone) Type A medicated 
articles to make three-way combination Type C medicated feeds 
containing 30 g/ton robenidine hydrochloride, 22.7 to 45.4 g/ton 
roxarsone, and 50 or 100 to 200 g/ton BMD for use in broiler chickens.
    The combination Type C medicated feeds containing 50 g/ton BMD are 
used for prevention of coccidiosis caused by Eimeria tenella, E. 
necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; for 
increased rate of weight gain, improved feed efficiency, and improved 
pigmentation in broiler chickens; and as an aid in the prevention of 
necrotic enteritis caused or complicated by Clostridium spp. or other 
organisms susceptible to bacitracin. The combination Type C medicated 
feeds containing 100 to 200 g/ton BMD are used for prevention of 
coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. 
brunetti, E. mivati, and E. maxima; for increased rate of weight gain, 
improved feed efficiency, and improved pigmentation in broiler 
chickens; and as an aid in the control of necrotic enteritis caused or 
complicated by Clostridium spp. or other organisms susceptible to 
bacitracin. The NADA is approved as of July 3, 2000, and the 
regulations are amended in Secs. 558.76 and 558.515 (21 CFR 558.76 and 
558.515) to reflect the approval. The basis of approval is discussed in 
the freedom of information summary.
    Section 558.76 is also amended editorially to consolidate the 
cross-references for approved combinations in paragraph (d)(3) and list 
them in alphabetical order. Section 558.515 is amended editorially to 
display the conditions of use in paragraph (d) in a table format.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(2) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

    1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.

    2. Section 558.76 is amended by revising paragraph (d)(3) to read 
as follows:

[[Page 50915]]

Sec. 558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) Bacitracin methylene disalicylate may also be used with:
    (i) Amprolium as in Sec. 558.55.
    (ii) Amprolium and ethopabate as in Sec. 558.58.
    (iii) Carbarsone (not USP) as in Sec. 558.120.
    (iv) Decoquinate alone and with roxarsone as in Sec. 558.195.
    (v) Fenbendazole as in Sec. 558.258.
    (vi) Halofuginone hydrobromide alone and with roxarsone as in 
Sec. 558.265.
    (vii) Hygromycin B as in Sec. 588.274.
    (viii) Ivermectin as in Sec. 558.300.
    (ix) Lasalocid sodium alone and with roxarsone as in Sec. 558.311.
    (x) Monensin alone and with roxarsone as in Sec. 588.355.
    (xi) Narasin alone and with roxarsone as in Sec. 558.363.
    (xii) Nicarbazin alone and with narasin and roxarsone as in 
Sec. 558.366.
    (xiii) Nitarsone as in Sec. 558.369.
    (xiv) Robenidine alone and with roxarsone as in Sec. 558.515.
    (xv) Salinomycin alone and with roxarsone as in Sec. 558.550.
    (xvi) Semduramicin alone and with roxarsone as in Sec. 558.555.
    (xvii) Zoalene alone and with arsanilic acid as in Sec. 558.680.
    3. Section 558.515 is amended by revising paragraphs (c) and (d) to 
read as follows:


Sec. 558.515  Robenidine hydrochloride.

* * * * *
    (c) Related tolerances. See Sec. 556.580 of this chapter.
    (d) Conditions of use. It is used in feed for chickens as follows:

 
------------------------------------------------------------------------
   Robenidine
 hydrochloride    Combination   Indications for   Limitations    Sponsor
  in grams/ton   in  grams/ton        use
------------------------------------------------------------------------
30 (0.0033 pct)                 For broiler and  Feed           063238
                                 fryer            continuously
                                 chickens: As     as sole
                                 an aid in the    ration. Do
                                 prevention of    not feed to
                                 coccidiosis      layers.
                                 caused by E.     Withdraw 5
                                 mivati, E.       days prior
                                 brunetti, E.     to
                                 tenella, E.      slaughter.
                                 acervulina, E.
                                 maxima, and E.
                                 necatrix.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously
                  bacitracin     chickens: As     as sole
                  methylene      an aid in the    ration. Do
                  disalicylate   prevention of    not feed to
                  ) 4 to 30      coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 increased rate
                                 of weight
                                 gain.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously
                  bacitracin     chickens: As     as sole
                  methylene      an aid in the    ration. Do
                  disalicylate   prevention of    not feed to
                  ) 27 to 50     coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 improved feed
                                 efficiency.
                 Bacitracin     For broiler      Feed           046573
                  (as            chickens: As     continuously
                  bacitracin     an aid in the    as sole
                  methylene      prevention of    ration. Use
                  disalicylate   coccidiosis      as the sole
                  ) 50 and       caused by E.     source of
                  roxarsone      mivati, E.       organic
                  22.7 to 45.4   brunetti, E.     arsenic;
                                 tenella, E.      poultry
                                 acervulina, E.   should have
                                 maxima, and E.   access to
                                 necatrix. As     water at all
                                 an aid in the    times; drug
                                 prevention of    overdose or
                                 necrotic         lack of
                                 enteritis        water intake
                                 caused or        may result
                                 complicated by   in leg
                                 Clostridium      weakness or
                                 spp. or other    paralysis.
                                 organisms        Do not feed
                                 susceptible to   to laying
                                 bacitracin.      chickens.
                                 For increased    Withdraw 5
                                 rate of weight   days prior
                                 gain, improved   to
                                 feed             slaughter.
                                 efficiency,
                                 and improved
                                 pigmentation.

[[Page 50916]]

 
                 Bacitracin     For broiler      To control     046573
                  (as            chickens: As     necrotic
                  bacitracin     an aid in the    enteritis,
                  methylene      prevention of    start
                  disalicylate   coccidiosis      medication
                  ) 100 to 200   caused by E.     at first
                  and            mivati, E.       clinical
                  roxarsone      brunetti, E.     signs of
                  22.7 to 45.4   tenella, E.      disease;
                                 acervulina, E.   vary
                                 maxima, and E.   bacitracin
                                 necatrix. As     dosage based
                                 an aid in the    on the
                                 control of       severity of
                                 necrotic         infection;
                                 enteritis        administer
                                 caused or        continuously
                                 complicated by   for 5 to 7
                                 Clostridium      days or as
                                 spp. or other    long as
                                 organisms        clinical
                                 susceptible to   signs
                                 bacitracin.      persist,
                                 For increased    then reduce
                                 rate of weight   bacitracin
                                 gain, improved   to
                                 feed             prevention
                                 efficiency,      level (50 g/
                                 and improved     ton). Use as
                                 pigmentation.    the sole
                                                  source of
                                                  organic
                                                  arsenic;
                                                  poultry
                                                  should have
                                                  access to
                                                  water at all
                                                  times; drug
                                                  overdose or
                                                  lack of
                                                  water intake
                                                  may result
                                                  in leg
                                                  weakness or
                                                  paralysis.
                                                  Do not feed
                                                  to laying
                                                  chickens.
                                                  Withdraw 5
                                                  days prior
                                                  to
                                                  slaughter.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously  063238
                  bacitracin     chickens: As     as sole
                  zinc) 4 to     an aid in the    ration. Do
                  30             prevention of    not feed to
                                 coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 increased rate
                                 of weight
                                 gain.
                 Bacitracin     For broiler and  Feed           046573
                  (as            fryer            continuously  063238
                  bacitracin     chickens: As     as sole
                  zinc) 27 to    an aid in the    ration. Do
                  50             prevention of    not feed to
                                 coccidiosis      laying
                                 caused by E.     chickens.
                                 mivati, E.       Withdraw 5
                                 brunetti, E.     days prior
                                 tenella, E.      to
                                 acervulina, E.   slaughter.
                                 maxima, and E.
                                 necatrix. For
                                 improved feed
                                 efficiency.
                 Chlortetracyc  For broiler and  Feed
                  line 100 to    fryer            continuously
                  200            chickens: As     as sole
                                 an aid in the    ration up to
                                 prevention of    14 days. Do
                                 coccidiosis      not feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. For    days prior
                                 control of       to
                                 infectious       slaughter.
                                 synovitis
                                 caused by
                                 Mycoplasma
                                 synoviae
                                 susceptible to
                                 chlortetracycl
                                 ine.
                 Chlortetracyc  For broiler and  Feed
                  line 200 to    fryer            continuously
                  400            chickens: As     as sole
                                 an aid in the    ration up to
                                 prevention of    14 days. Do
                                 coccidiosis      not feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. For    days prior
                                 control of       to
                                 chronic          slaughter.
                                 respiratory
                                 disease (CRD)
                                 and air sac
                                 infection
                                 caused by M.
                                 gallisepticum
                                 and E. coli
                                 susceptible to
                                 chlortetracycl
                                 ine.
                 Chlortetracyc  For broiler and  Feed           063238
                  line 500       fryer            continuously
                                 chickens: As     as sole
                                 an aid in the    ration up to
                                 prevention of    5 days. Do
                                 coccidiosis      not feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. As     days prior
                                 an aid in the    to
                                 reduction of     slaughter.
                                 mortality due
                                 to E. coli
                                 susceptible to
                                 chlortetracycl
                                 ine.

[[Page 50917]]

 
                 Lincomycin 2   For broiler and  Feed           000009
                                 fryer            continuously
                                 chickens: As     as the sole
                                 an aid in the    ration. Do
                                 prevention of    not feed to
                                 coccidiosis      laying hens.
                                 caused by E.     Withdraw 5
                                 mivati, E.       days before
                                 brunetti, E.     slaughter.
                                 tenella, E.
                                 acervulina, E.
                                 maxima, and E.
                                 necatrix. For
                                 increase in
                                 rate of weight
                                 gain and
                                 improved feed
                                 efficiency.
                 Oxytetracycli  For broiler      Feed           000069
                  ne 400         chickens: As     continuously
                                 an aid in the    for 7 to 14
                                 prevention of    days. Do not
                                 coccidiosis      feed to
                                 caused by E.     chickens
                                 mivati, E.       producing
                                 brunetti, E.     eggs for
                                 tenella, E.      human
                                 acervulina, E.   consumption.
                                 maxima, and E.   Withdraw 5
                                 necatrix. For    days before
                                 control of CRD   slaughter.
                                 and air sac
                                 infection
                                 caused by
                                 Mycoplasma
                                 gallisepticum
                                 and E. coli
                                 susceptible to
                                 oxytetracyclin
                                 e.
                 Roxarsone      For broiler and  Feed           046573
                  22.5 to 45.4   fryer            continuously
                  (0.005         chickens: As     as the sole
                  percent)       an aid in the    ration. Use
                                 prevention of    as sole
                                 coccidiosis      source of
                                 caused by E.     organic
                                 mivati, E.       arsenic. Do
                                 brunetti, E.     not feed to
                                 tenella, E.      layers.
                                 acervulina, E.   Withdraw 5
                                 maxima, and E.   days prior
                                 necatrix. For    to
                                 increased rate   slaughter.
                                 of weight
                                 gain.
------------------------------------------------------------------------


    Dated: July 25, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-21412 Filed 8-21-00; 8:45 am]
BILLING CODE 4160-01-F