[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10976-10985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02617]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

[Docket No. FDA-2014-N-0002]


Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug 
Applications for Combination Drug Medicated Feeds Containing an 
Arsenical Drug

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect the withdrawal of approval of 69 new animal 
drug applications (NADAs) and 22 abbreviated new animal drug 
applications (ANADAs) for use of arsanilic acid, carbarsone, or 
roxarsone Type A medicated articles to manufacture combination drug 
Type B and Type C medicated feeds. This action is being taken at the 
sponsor's request because the products are no longer manufactured or 
marketed. FDA is also amending the animal drug regulations to remove 
entries describing conditions of use for combination drug medicated 
feeds for which no NADA is approved. This action is being taken to 
improve the accuracy of the regulations.

DATES: This rule is effective March 10, 2014.

FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary 
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9079, [email protected].

SUPPLEMENTARY INFORMATION: Recently, the Agency provided notice of the 
withdrawal of approval of NADAs for Type A medicated articles 
containing

[[Page 10977]]

arsanilic acid, carbarsone, and roxarsone and revoked applicable 
regulations for their conditions of use to manufacture single-
ingredient medicated feeds in 21 CFR part 558 New Animal Drugs For Use 
in Animal Feeds (78 FR 70062, Nov. 22, 2013; 78 FR 69992, Nov. 22, 
2013; 78 FR 70566, Nov. 26, 2013; 78 FR 70496, Nov. 26, 2013).
    Subsequently, the following six sponsors of NADAs and ANADAs 
permitting use of arsanilic acid, carbarsone, or roxarsone Type A 
medicated articles to manufacture combination drug Type B and Type C 
medicated feeds requested that FDA withdraw approval of their 
applications because these combination medicated feeds are no longer 
manufactured or marketed.
     Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has 
requested that FDA withdraw approval of the following 39 NADAs and 11 
ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
040-435..................  3-NITRO (roxarsone)/DECCOX (decoquinate).
041-178..................  Roxarsone/AMPROL Plus (amprolium and
                            ethopabate)/LINCOMIX (lincomycin).
041-984..................  Roxarsone/ROFENAID (sulfadimethoxine/
                            ormetoprim).
091-326..................  3-NITRO (roxarsone)/DECCOX (decoquinate)/
                            ALBAC (bacitracin zinc).
092-522..................  Roxarsone/COBAN (monensin)/LINCOMIX
                            (lincomycin).
095-546..................  Roxarsone/ROBENZ (robenidine).
102-485..................  3-NITRO (roxarsone)/AVATEC (lasalocid).
105-758..................  3-NITRO (roxarsone)/AMPROL HI-E (amprolium
                            and ethopabate)/BACIFERM (bacitracin zinc).
112-661..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            LINCOMIX (lincomycin).
112-687..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            FLAVOMYCIN (bambermycins).
116-082..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/BMD
                            (bacitracin MD).
116-088..................  3-NITRO (roxarsone)/COBAN (monensin)/BMD
                            (bacitracin MD).
123-154..................  3-NITRO (roxarsone)/BACIFERM (bacitracin
                            zinc)/COBAN (monensin).
126-052..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            BACIFERM (bacitracin zinc).
131-894..................  3-NITRO (roxarsone)/AVATEC (lasalocid)/
                            bacitracin MD.
132-447..................  Roxarsone/BIO-COX (salinomycin).
134-185..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            FLAVOMYCIN (bambermycins).
135-321..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD
                            (bacitracin MD).
137-536..................  3-NITRO (roxarsone)/BIO-COX/ALBAC (bacitracin
                            zinc).
138-703..................  3-NITRO (roxarsone)/COBAN (monensin)/ALBAC
                            (bacitracin zinc).
139-190..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            BACIFERM (bacitracin zinc).
140-581..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            LINCOMIX (lincomycin).
140-852..................  3-NITRO (roxarsone)/MONTEBAN/BMD (bacitracin
                            MD).
140-867..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            AUREOMYCIN (chlortetracycline).
141-100..................  3-NITRO (roxarsone)/DECCOX (decoquinate)/BMD
                            (bacitracin MD).
141-112..................  3-NITRO (roxarsone)/MAXIBAN (narasin and
                            nicarbazin)/BMD (bacitracin MD).
141-121..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD
                            (bacitracin MD).
141-131..................  3-NITRO (roxarsone)/ZOAMIX (zoalene)/BMD
                            (bacitracin MD).
141-135..................  3-NITRO (roxarsone)/BIO-COX (salinomycin).
141-138..................  3-NITRO (roxarsone)/COBAN (monensin)/BMD
                            (bacitracin MD).
141-139..................  3-NITRO (roxarsone)/COBAN (monensin).
141-142..................  3-NITRO (roxarsone)/AMPROL (amprolium)/BMD
                            (bacitracin MD).
141-155..................  3-NITRO (roxarsone)/ROBENZ (robenidine)/BMD
                            (bacitracin MD).
141-157..................  3-NITRO (roxarsone)/STENOROL (halofuginone).
141-223..................  3-NITRO (roxarsone)/CLINACOX (diclazuril).
141-293..................  3-NITRO (roxarsone)/AVATEC (lasalocid).
200-206..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            DECCOX (decoquinate).
200-207..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            COYDEN 25 (clopidol).
200-208..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AVATEC (lasalocid).
200-209..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            SACOX (salinomycin).
200-214..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AMPROL HI-E (amprolium and ethopabate).
200-211..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            COBAN (monensin).
200-215..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            BIO-COX (salinomycin).
200-217..................  3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/
                            AMPROL HI-E (amprolium and ethopabate).
200-259..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            CHLORMAX (chlortetracycline).
200-260..................  3-NITRO (roxarsone)/BIO-COX (salinomycin)/
                            CHLORMAX (chlortetracycline).
038-879..................  CARB-O-SEP (carbarsone)/ZOAMIX (zoalene).
039-646..................  CARB-O-GAIN (carbarsone)/BMD (bacitracin MD).
136-484..................  CARB-O-SEP (carbarsone)/BACIFERM (bacitracin
                            zinc).
200-203..................  CARB-O-SEP (carbarsone)/ALBAC (bacitracin
                            zinc).
------------------------------------------------------------------------

     Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 
Sofia, Bulgaria, has requested that FDA withdraw approval of the 
following 16 NADAs and 8 ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
013-461..................  3-NITRO (roxarsone)/AMPROL Plus (amprolium
                            and ethopabate).
040-264..................  3-NITRO (roxarsone)/COYDEN 25 (clopidol).
041-541..................  3-NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD
                            (bacitracin MD).
044-016..................  Roxarsone + bacitracin Zinc/COYDEN 25
                            (clopidol).

[[Page 10978]]

 
049-179..................  Roxarsone/AMPROL HI-E (amprolium and
                            ethopabate).
049-180..................  Roxarsone/AMPROL HI-E (amprolium and
                            ethopabate)/BMD (bacitracin MD).
095-547..................  3-NITRO (roxarsone)/AMPROL HI-E (amprolium
                            and ethopabate)/FLAVOMYCIN (bambermycins).
095-548..................  3-NITRO (roxarsone)/AMPROL (amprolium)/
                            FLAVOMYCIN (bambermycins).
095-549..................  3-NITRO (roxarsone)/AMPROL (amprolium)/
                            FLAVOMYCIN (bambermycins).
098-341..................  3-NITRO (roxarsone)/COBAN (monensin)/
                            FLAVOMYCIN (bambermycins).
101-628..................  3-NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/
                            zoalene.
140-533..................  3-NITRO (roxarsone)/STENOROL (halofuginone)/
                            BMD (bacitracin MD).
140-843..................  3-NITRO (roxarsone)/MONTEBAN (narasin)/
                            FLAVOMYCIN (bambermycins).
141-190..................  3-NITRO (roxarsone)/LINICOX (diclazuril)/BMD
                            (bacitracin MD).
200-080..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            FLAVOMYCIN (bambermycins).
200-081..................  3-NITRO (roxarsone)/SACOX (salinomycin)/BMD
                            (bacitracin MD).
200-086..................  3-NITRO (roxarsone)/SACOX (salinomycin)/ALBAC
                            (bacitracin zinc).
200-090..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            LINCOMIX (lincomycin).
200-091..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            AUREOMYCIN (chlortetracycline).
200-094..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            STAFAC (virginiamycin).
200-097..................  3-NITRO (roxarsone)/SACOX (salinomycin).
200-143..................  3-NITRO (roxarsone)/SACOX (salinomycin)/
                            BACIFERM (bacitracin zinc).
118-507..................  CARB-O-SEP (carbarsone)/AMPROL (amprolium).
130-661..................  CARB-O-SEP (carbarsone)/FLAVOMYCIN
                            (bambermycins).
------------------------------------------------------------------------

     Phibro Animal Health Corp., GlenPointe Centre East, 3d 
floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 has 
requested that FDA withdraw approval of the following seven NADAs and 
two ANADAs:

------------------------------------------------------------------------
        NADA/ANADA                  Ingredient new animal drugs
------------------------------------------------------------------------
107-997..................  Roxarsone/NICARB (nicarbazin)/LINCOMIX
                            (lincomycin).
108-115..................  Roxarsone/NICARB (nicarbazin).
120-724..................  3-NITRO (roxarsone)/STAFAC (virginiamycin)/
                            COBAN (monensin).
138-953..................  3-NITRO (roxarsone)/STAFAC (virginiamycin)/
                            BIO-COX (salinomycin).
141-058..................  3-NITRO (roxarsone)/AVIAX (semduramycin)/BMD
                            (bacitracin MD).
141-066..................  3-NITRO (roxarsone)/AVIAX (semduramycin).
141-226..................  Roxarsone/AVIAX (semduramycin)/STAFAC
                            (virginiamycin).
200-170..................  3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/
                            LINCOMIX (lincomycin).
200-172..................  3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin).
------------------------------------------------------------------------

     Elanco Animal Health, A Division of Eli Lilly & Co., Lilly 
Corporate Center, Indianapolis, IN 46285 has requested that FDA 
withdraw approval of the following four NADAs:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
041-500..................  3-NITRO (roxarsone)/COBAN (monensin).
049-464..................  Roxarsone/monensin/bacitracin.
140-445..................  Roxarsone/MONTEBAN (narasin).
141-113..................  3-NITRO (roxarsone)/MAXIBAN (narasin and
                            nicarbazin).
------------------------------------------------------------------------

     Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 
24, Ireland, has requested that FDA withdraw approval of the following 
three NADAs:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
038-241..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin)/zoalene.
038-242..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin)/amprolium + ethopabate.
038-624..................  PRO-GEN (arsanilic acid)/ERYTHRO
                            (erythromycin).
------------------------------------------------------------------------

     Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144 
has requested that FDA withdraw approval of the following ANADA:

------------------------------------------------------------------------
           NADA                     Ingredient new animal drugs
------------------------------------------------------------------------
200-355..................  3-NITRO (roxarsone)/PENNCHLOR
                            (chlortetracycline)/BIO-COX (salinomycin).
------------------------------------------------------------------------


[[Page 10979]]

    Elsewhere in this issue of the Federal Register, FDA gave notice 
that approval of these NADAs and ANADAs, and all supplements and 
amendments thereto, is withdrawn, effective March 10, 2014. As provided 
in the regulatory text of this document, the animal drug regulations 
are amended to reflect these voluntary withdrawals of approval.
    In addition, FDA has noticed that certain sections in part 558 
contain entries describing conditions of use for combination drug 
medicated feeds for which no NADA is approved. These errors were 
introduced by the Agency during the 1976 recodification of certain food 
additive regulations (41 FR 10984, March 15, 1976). That rule did not 
identify whether particular regulations were the subject of an approved 
NADA and consequently resulted in codification of certain conditions of 
use for which there is no approved NADA. At this time, the Agency is 
amending the regulations to remove entries that describe conditions of 
use for combination drug medicated feeds for which no NADA is approved. 
This action is being taken to improve the accuracy of the regulations.
    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

21 CFR Parts 556

    Animal drugs, Food.

21 CFR Parts 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 parts 556 and 
558 are amended as follows:

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
1. The authority citation for 21 CFR part 556 continues to read as 
follows:

    Authority: 21 U.S.C. 342, 360b, 371.

0
2. Revise Sec.  556.60 to read as follows:


Sec.  556.60  Arsenic.

    (a) [Reserved]
    (b) Tolerances. The tolerances for total residue of combined 
arsenic (calculated as As) are:
    (1) Turkeys--(i) Muscle and eggs: 0.5 parts per million (ppm).
    (ii) Other edible tissues: 2 ppm.
    (2) [Reserved]
    (c) Related conditions of use. See Sec.  558.369 of this chapter.

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

0
3. The authority citation for 21 CFR part 558 continues to read as 
follows:

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


Sec.  558.4  [Amended]

0
4. In Sec.  558.4, in paragraph (d), in the ``Category II'' table:
0
a. Remove the entries for ``Arsanilate acid'', ``Carbarsone'', and 
``Sulfaquinoxaline'';
0
b. Remove the row entries under ``Nitarsone'' for ``Sulfanitran'' and 
``Roxarsone''.
0
c. Remove the four entries for ``Roxarsone'' and their respective 
following row entries; and
0
d. In the fourth entry for ``Sulfamethazine,'' remove its three 
following row entries for ``Aklomide'' and two following row entries 
for ``Roxarsone''.

0
5. In Sec.  558.55, revise paragraphs (d)(1) through (3) and add 
paragraph (d)(4) to read as follows:


Sec.  558.55  Amprolium.

* * * * *
    (d) * * *
    (1) Cattle. It is used as follows:

----------------------------------------------------------------------------------------------------------------
      Amprolium in grams per ton              Indications for use                Limitations            Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 11, 350; to provide 5      Calves: As an aid in the        Top-dress on or mix in the        016592
 milligrams per kilogram of body         prevention of coccidiosis       daily ration. Feed for 21
 weight per day.                         caused by Eimeria bovis and     days when experience
                                         E. zuernii.                     indicates that coccidiosis
                                                                         is likely to be a hazard, as
                                                                         the sole source of
                                                                         amprolium. Withdraw 24 hours
                                                                         before slaughter. A
                                                                         withdrawal period has not
                                                                         been established for this
                                                                         product in preruminating
                                                                         calves. Do not use in calves
                                                                         to be processed for veal.
(ii) 113.5 to 11, 350; to provide 10    Calves: As an aid in the        Top-dress on or mix in the        016592
 milligrams per kilogram of body         treatment of coccidiosis        daily ration. Feed for 5
 weight per day.                         caused by Eimeria bovis and     days as the sole source of
                                         E. zuernii.                     amprolium. Withdraw 24 hours
                                                                         before slaughter. A
                                                                         withdrawal period has not
                                                                         been established for this
                                                                         product in preruminating
                                                                         calves. Do not use in calves
                                                                         to be processed for veal.
----------------------------------------------------------------------------------------------------------------

    (2) Chickens. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5..............  ..................  Replacement chickens:    Feed continuously until     016592
                                                      For development of       onset of production as
                                                      active immunity to       follows:
                                                      coccidiosis.
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                                Up to 5 weeks of age  From 5 to 8 weeks of   Over 8 weeks of age
                                               ----------------------          age         ---------------------
              Growing conditions                                     ----------------------
                                                 Amprolium in grams    Amprolium in grams    Amprolium in grams
                                                       per ton               per ton               per ton
----------------------------------------------------------------------------------------------------------------
Severe exposure to coccidiosis................                 113.5            72.6-113.5            36.3-113.5
                                                           (0.0125%)      (0.008%-0.0125%)      (0.004%-0.0125%)
Moderate exposure to coccidiosis..............            72.6-113.5            54.5-113.5            36.3-113.5

[[Page 10980]]

 
                                                    (0.008%-0.0125%)      (0.006%-0.0125%)      (0.004%-0.0125%)
Slight exposure to coccidiosis................            36.3-113.5            36.3-113.5            36.3-113.5
                                                    (0.004%-0.0125%)      (0.004%-0.0125%)      (0.004%-0.0125%)
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(ii) 36.3 to 113.5.............  Bacitracin          Replacement chickens:    Feed according to           054771
                                  methylene           For development of       subtable in item (i).
                                  disalicylate 4 to   active immunity to       Bacitracin methylene
                                  50.                 coccidiosis; and for     disalicylate as
                                                      increased rate of        provided by No. 054771
                                                      weight gain and          in Sec.   510.600(c)
                                                      improved feed            of this chapter.
                                                      efficiency.
(iii) 72.6 to 113.5............  ..................  Broiler chickens: For    Feed continuously as        016592
                                                      prevention of            the sole ration; as
                                                      coccidiosis caused by    sole source of
                                                      Eimeria tenella only.    amprolium.
(iv) 72.6 to 113.5.............  Bambermycins 1 to   Broiler chickens: For    Feed continuously as        016592
                                  2.                  prevention of            the sole ration; as
                                                      coccidiosis caused by    sole source of
                                                      Eimeria tenella only;    amprolium.
                                                      and for increased rate   Bambermycins as
                                                      of weight gain and       provided by No. 016592
                                                      improved feed            in Sec.   510.600(c)
                                                      efficiency.              of this chapter.
(v) 113.5......................  ..................  1. Laying chickens: For  Feed continuously as        016592
                                                      prevention of            the sole ration; as
                                                      coccidiosis.             the sole source of
                                                                               amprolium.
                                                     2. Laying chickens: For  Feed for 2 weeks.......
                                                      treatment of
                                                      coccidiosis in
                                                      moderate outbreaks.
(vi) 113.5 to 227..............  ..................  1. Replacement           Feed continuously from      016592
                                                      chickens: For            day-old until onset of
                                                      prevention of            production; as the
                                                      coccidiosis where        sole source of
                                                      immunity to              amprolium.
                                                      coccidiosis is not
                                                      desired.
                                                     2. Broiler chickens:     Feed continuously as
                                                      For prevention of        the sole ration; as
                                                      coccidiosis where        sole source of
                                                      immunity to              amprolium.
                                                      coccidiosis is not
                                                      desired.
(vii) 113.5 to 227.............  Bambermycins 1 to   Broiler chickens: For    Feed continuously as        016592
                                  2.                  prevention of            the sole ration; as
                                                      coccidiosis where        sole source of
                                                      immunity to              amprolium.
                                                      coccidiosis is not       Bambermycins as
                                                      desired; and for         provided by No. 016592
                                                      increased rate of        in Sec.   510.600(c)
                                                      weight gain and          of this chapter.
                                                      improved feed
                                                      efficiency.
(viii) 227.....................  ..................  Laying chickens: For     Feed for 2 weeks.......     016592
                                                      treatment of
                                                      coccidiosis in severe
                                                      outbreaks..
----------------------------------------------------------------------------------------------------------------

    (3) Turkeys. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5......................  Bambermycins 1 to   Growing turkeys: For     Feed continuously as        016592
                                  4.                  prevention of            the sole source of
                                                      coccidiosis; and for     amprolium;
                                                      increased rate of        bambermycins as
                                                      weight gain and          provided by No. 016592
                                                      improved feed            in Sec.   510.600(c)
                                                      efficiency.              of this chapter.
(ii) 113.5 to 227..............  ..................  Turkeys: For prevention  Feed continuously as        016592
                                                      of coccidiosis.          the sole ration; as
                                                                               sole source of
                                                                               amprolium.
----------------------------------------------------------------------------------------------------------------

    (4) Pheasants. It is used as follows:

----------------------------------------------------------------------------------------------------------------
                                   Combination in
   Amprolium in grams per ton       grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 159........................  ..................  Growing pheasants: For   Feed continuously as        016592
                                                      the prevention of        sole ration. Use as
                                                      coccidiosis caused by    sole source of
                                                      Eimeria colchici, E.     amprolium.
                                                      duodenalis, and E.
                                                      phasiani.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------


0
6. In Sec.  558.58, revise paragraph (e) to read as follows:


Sec.  558.58  Amprolium and ethopabate.

* * * * *
    (e) Conditions of use. It is used in chicken feed as follows:

[[Page 10981]]



----------------------------------------------------------------------------------------------------------------
  Amprolium and ethopabate in      Combination in
         grams per ton              grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(1) Amprolium 113.5 and          ..................  Broiler chickens: As an  Feed continuously as        016592
 ethopabate 3.6.                                      aid in the prevention    sole ration; as sole
                                                      of coccidiosis.          source of amprolium.
                                                                               Not for laying
                                                                               chickens.
(2) Amprolium 113.5 and          Lincomycin 2 to 4.  Broiler chickens: As an  Feed continuously as        054771
 ethopabate 3.6.                                      aid in the prevention    sole ration; as sole
                                                      of coccidiosis; for      source of amprolium.
                                                      increased rate of        Not for laying
                                                      weight gain and          chickens.
                                                      improved feed           Lincomycin as provided
                                                      efficiency.              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                               chapter.
(3) Amprolium 113.5 and          ..................  Broiler chickens and     Feed continuously as        016592
 ethopabate 36.3.                                     replacement chickens:    sole ration; as sole
                                                      where immunity to        source of amprolium.
                                                      coccidiosis is not       Not for chickens over
                                                      desired: As an aid in    16 weeks of age.
                                                      the prevention of
                                                      coccidiosis where
                                                      severe exposure to
                                                      coccidiosis from
                                                      Eimeria acervulina, E.
                                                      maxima, and E.
                                                      brunetti is likely to
                                                      occur.
(4) Amprolium 113.5 and          Bacitracin 4 to 50  1. Broiler chickens and  Feed as the sole ration     016592
 ethopabate 36.3.                                     replacement chickens:    from the time chickens
                                                      where immunity to        are placed on litter
                                                      coccidiosis is not       until past the time
                                                      desired; to aid in       when coccidiosis is
                                                      prevention of            ordinarily a hazard.
                                                      coccidiosis where        Not for chickens over
                                                      severe exposure to       16 weeks of age; do
                                                      coccidiosis from         not feed to laying
                                                      Eimeria acervulina, E.   chickens; as sole
                                                      maxima, and E.           source of amprolium;
                                                      brunetti is likely to    not for use as a
                                                      occur; for increased     treatment for
                                                      rate of weight gain in   outbreaks of
                                                      broiler chickens         coccidiosis.
                                                      raised in floor pens.    Bacitracin as
                                                                               bacitracin methylene
                                                                               disalicylate as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(5) Amprolium 113.5 and          Bacitracin 4 to 50  2. Broiler chickens: As  Feed as the sole ration     054771
 ethopabate 36.3.                                     an aid in prevention     from the time chickens
                                                      of coccidiosis where     are placed on litter
                                                      severe exposure to       until market weight.
                                                      coccidiosis from         Not for chickens over
                                                      Eimeria acervulina, E.   16 weeks of age; do
                                                      maxima, and E.           not feed to laying
                                                      brunetti is likely to    chickens; as sole
                                                      occur; for improved      source of amprolium;
                                                      feed efficiency.         not for use as a
                                                                               treatment for
                                                                               coccidiosis.
                                                                               Bacitracin zinc as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(6) Amprolium 113.5 and          Bambermycins 1 to   Broiler chickens: As an  Feed continuously as        016592
 ethopabate 3.6.                  3.                  aid in the prevention    the sole ration; as
                                                      of coccidiosis where     sole source of
                                                      severe exposure to       amprolium.
                                                      coccidiosis from        Bambermycins as
                                                      Eimeria acervulina, E.   provided by No. 016592
                                                      maxima, and E.           in Sec.   510.600(c)
                                                      brunetti is likely to    of this chapter.
                                                      occur; for increased
                                                      rate of weight gain,
                                                      improved feed
                                                      efficiency.
(7) Amprolium 113.5 and          Virginiamycin 15..  Broiler chickens; as an  Feed continuously as        066104
 ethopabate 36.3.                                     aid in the prevention    the sole ration; as
                                                      of coccidiosis where     sole source of
                                                      severe exposure to       amprolium. Do not feed
                                                      coccidiosis from         to laying chickens.
                                                      Eimeria acervulina, E.   Not for chickens over
                                                      maxima, and E.           16 weeks of age.
                                                      brunetti is likely to   Virginiamycin as
                                                      occur; for increased     provided by No. 066104
                                                      rate of weight gain      in Sec.   510.600(c)
                                                      and improved feed        of this chapter.
                                                      efficiency.
(8) Amprolium 113.5 and          Virginiamycin 5 to  Broiler chickens; as an  Feed continuously as        066104
 ethopabate 36.3.                 15.                 aid in the prevention    the sole ration; as
                                                      of coccidiosis where     sole source of
                                                      severe exposure to       amprolium. Do not feed
                                                      coccidiosis from         to laying chickens.
                                                      Eimeria acervulina, E.   Not for chickens over
                                                      maxima, and E.           16 weeks of age.
                                                      brunetti is likely to   Virginiamycin as
                                                      occur; for increased     provided by No. 066104
                                                      rate of weight gain.     in Sec.   510.600(c)
                                                                               of this chapter.
(9) Amprolium 227 and            ..................  For broiler chickens     Not for laying chickens     016592
 ethopabate 3.6.                                      and replacement
                                                      chickens where
                                                      immunity to
                                                      coccidiosis is not
                                                      desired; prevention of
                                                      coccidiosis.
(10) Amprolium 227 and           Chlortetracycline   For chickens where       Do not feed to chickens     054771
 ethopabate 3.6.                  100 to 200.         immunity to              producing eggs for
                                                      coccidiosis is not       human consumption.
                                                      desired; prevention of   Feed for 7 to 14 days.
                                                      coccidiosis; control
                                                      of infectious
                                                      synovitis caused by
                                                      Mycoplasma synoviae
                                                      susceptible to
                                                      chlortetracycline.
(11) Amprolium 227 and           Chlortetracycline   For chickens where       In low calcium feed         054771
 ethopabate 3.6.                  200 to 400.         immunity to              containing 0.8%
                                                      coccidiosis is not       dietary calcium and
                                                      desired; prevention of   1.5% sodium sulfate;
                                                      coccidiosis; control     feed continuously as
                                                      of chronic respiratory   sole ration for 7 to
                                                      disease (CRD) and air    14 days; do not feed
                                                      sac infection caused     to chickens producing
                                                      by M. gallisepticum      eggs for human
                                                      and E. coli              consumption.
                                                      susceptible to
                                                      chlortetracycline.
----------------------------------------------------------------------------------------------------------------


[[Page 10982]]

Sec.  558.62  [Removed]

0
7. Remove Sec.  558.62.

0
8. In Sec.  558.76, revise paragraph (d)(3) to read as follows:


Sec.  558.76  Bacitracin methylene disalicylate.

* * * * *
    (d) * * *
    (3) Bacitracin methylene disalicylate may also be used in 
combination with:
    (i) Amprolium as in Sec.  558.55.
    (ii) Amprolium and ethopabate as in Sec.  558.58.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Diclazuril as in Sec.  558.198.
    (v) Fenbendazole as in Sec.  588.258.
    (vi) Halofuginone as in Sec.  558.265.
    (vii) Hygromycin B as in Sec.  588.274.
    (viii) Ivermectin as in Sec.  558.300.
    (ix) Lasalocid sodium as in Sec.  558.311.
    (x) Monensin as in Sec.  588.355.
    (xi) Narasin as in Sec.  558.363.
    (xii) Nicarbazin alone and with narasin as in Sec.  558.366.
    (xiii) Nitarsone as in Sec.  558.369.
    (xiv) Robenidine as in Sec.  558.515.
    (xv) Salinomycin as in Sec.  558.550.
    (xvi) Semduramicin as in Sec.  558.555.
    (xvii) Zoalene as in Sec.  558.680.

0
9. In Sec.  558.78, revise paragraph (d)(3) to read as follows:


Sec.  558.78  Bacitracin zinc.

* * * * *
    (d) * * *
    (3) Bacitracin zinc may also be used in combination with:
    (i) Amprolium and ethopabate as in Sec.  558.58.
    (ii) Clopidol as in Sec.  558.175.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Lasalocid as in Sec.  558.311.
    (v) Monensin as in Sec.  558.355.
    (vi) Naracin as in Sec.  558.363.
    (vii) Nitarsone as in Sec.  558.369.
    (viii) Robenidine as in Sec.  558.515.
    (ix) Salinomycin as in Sec.  558.550.
0
10. In Sec.  558.95, revise paragraph (d)(5) to read as follows:


Sec.  558.95  Bambermycins.

* * * * *
    (d) * * *
    (5) Bambermycins may also be used in combination with:
    (i) Amprolium as in Sec.  558.55.
    (ii) Amprolium and ethopabate as in Sec.  558.58.
    (iii) Clopidal as in Sec.  558.175.
    (iv) Diclazuril as in Sec.  558.198.
    (v) Halofuginone as in Sec.  558.265.
    (vi) Lasalocid as in Sec.  558.311.
    (vii) Monensin as in Sec.  558.355.
    (viii) Narasin alone or with nicarbazin as in Sec.  558.363.
    (ix) Nicarbazin as in Sec.  558.366.
    (x) Salinomycin as in Sec.  558.550.
    (xi) Zoalene as in Sec.  558.680.


Sec.  558.120  [Removed]

0
11. Remove Sec.  558.120.

0
12. In Sec.  558.128, revise paragraph (e)(7) to read as follows:


Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (7) Chlortetracycline may also be used in combination with:
    (i) Amprolium and ethopabate as in Sec.  558.58.
    (ii) Bacitracin methylene disalicylate as in Sec.  558.76.
    (iii) Clopidol as in Sec.  558.175.
    (iv) Decoquinate as in Sec.  558.195.
    (v) Hygromycin B as in Sec.  558.274.
    (vi) Laidlomycin as in Sec.  558.305.
    (vii) Lasalocid as in Sec.  558.311.
    (viii) Monensin as in Sec.  558.355.
    (ix) Robenidine as in Sec.  558.515.
    (x) Salinomycin as in Sec.  558.550.
    (xi) Tiamulin as in Sec.  558.600.


Sec.  558.175  [Amended]

0
13. In Sec.  558.175, remove paragraphs (d)(3) and (8); and redesignate 
paragraphs (d)(4) through (7) as paragraphs (d)(3) through (6), 
respectively, and paragraphs (d)(9) through (11) as paragraphs (d)(7) 
through (9), respectively.


Sec.  558.195  [Amended]

0
14. In Sec.  558.195, remove paragraphs (e)(1)(iv) and (v) and 
redesignate paragraphs (e)(1)(vi) through (ix) as paragraphs (e)(1)(iv) 
through (vii), respectively.


Sec.  558.198  [Amended]

0
15. In Sec.  558.198, remove paragraphs (d)(1)(iii), (iv), and (vi) and 
redesignate paragraphs (d)(1)(v), (vii), and (viii) as paragraphs 
(d)(1)(iii), (iv), and (v), respectively.

0
16. In Sec.  558.248, remove paragraph (d)(3); and revise the section 
heading to read as follows:


Sec.  558.248  Erythromycin.

* * * * *

0
17. In Sec.  558.265, remove and reserve paragraphs (d)(1)(v) and 
(viii) and (d)(3)(ii) and revise the section heading to read as 
follows:


Sec.  558.265  Halofuginone.

* * * * *

0
18. Revise Sec.  558.274 to read as follows:


Sec.  558.274  Hygromycin B.

    (a) Approvals. See sponsor numbers in Sec.  510.600(c) of this 
chapter for Type A medicated articles or Type B medicated feeds as 
follow:
    (1) No. 000986: 2.4 and 8 grams per pound (g/lb).
    (2) Nos. 012286 and 051311: 2.4 g/lb.
    (3) No. 017790: 0.6 g/lb.
    (4) No. 054771: 0.6 and 1.6 g/lb.
    (b) Related tolerances. See Sec.  556.330 of this chapter.
    (c) Conditions of use. It is used in feed as follows:
    (1) Chickens--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
 Hygromycin B in grams per ton      grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 8 to 12....................  ..................  Chickens: For control    Withdraw 3 days before      000986
                                                      of infestation of        slaughter.                 012286
                                                      large roundworms                                    017790
                                                      (Ascaris galli), cecal                              054771
                                                      worms (Heterakis
                                                      gallinae), and
                                                      capillary worms
                                                      (Capillaria obsignata).
(ii) 8 to 12...................  Tylosin 4 to 50...  Chickens: For control    Withdraw 3 days before      000986
                                                      of infestations of       slaughter. Tylosin as
                                                      large roundworms         tylosin phosphate as
                                                      (Ascaris galli), cecal   provided by No. 000986
                                                      worms (Heterakis         in Sec.   510.600 of
                                                      gallinae), and           this chapter.
                                                      capillary worms
                                                      (Capillaria
                                                      obsignata); growth
                                                      promotion and feed
                                                      efficiency.
----------------------------------------------------------------------------------------------------------------

    (2) Swine--

[[Page 10983]]



----------------------------------------------------------------------------------------------------------------
                                   Combination in
 Hygromycin B in grams per ton      grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 12.........................  ..................  Swine: For control of    Withdraw 15 days before     000986
                                                      infestation of large     slaughter.                 012286
                                                      roundworms (Ascaris                                 017790
                                                      suis), nodular worms                                054771
                                                      (Oesophagostomum
                                                      dentatum), and
                                                      whipworms (Trichuris
                                                      suis).
(ii) 12........................  Tylosin 10 to 100.  Swine: For control of    Feed continuously as        000986
                                                      infestations of large    follows: Animal weight
                                                      roundworms (Ascaris      (lbs.):
                                                      suis), nodular worms     Up to 40 . . . 20 to
                                                      (Oesophagostomum         100 \1\.
                                                      dentatum), and           41 to 100 . . . 20 to
                                                      whipworms (Trichuris     40 \1\.
                                                      suis); growth            101 to market weight .
                                                      promotion and feed       . . 10 to 20 \1\.
                                                      efficiency.             Withdraw 15 days before
                                                                               slaughter. Tylosin as
                                                                               tylosin phosphate as
                                                                               provided by No. 000986
                                                                               in Sec.   510.600 of
                                                                               this chapter.
----------------------------------------------------------------------------------------------------------------
\1\ Amount of Tylosin (g/t).


0
19. In Sec.  558.311:
0
a. In paragraph (e)(1)(ii), remove the entries for:
0
i.Roxarsone 45.4 (0.005 pct);
0
ii. Roxarsone 45.4 plus bambermycins 1 (0.00011 pct);
0
iii. Roxarsone 45.4 plus lincomycin 2.0;
0
iv. Roxarsone 45.4 plus bacitracin 10 to 25;
0
v. Roxarsone 45.4 plus bacitracin 10 or 30; and
0
vi. Roxarsone 45.4 plus bacitracin methylene disalicylate 50'';
0
b. In paragraph (e)(1)(xv), remove the entry for ``Roxarsone 22.7 to 
45.4''; and
0
c. Revise paragraph (e)(5).
    The revision reads as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (5) Lasalocid may also be used in combination with:
    (i) Melengestrol acetate alone or in combination with tylosin as in 
Sec.  558.342.
    (ii) [Reserved]

0
20. In Sec.  558.325, revise paragraph (d)(3) to read as follows:


Sec.  558.325  Lincomycin.

* * * * *
    (d) * * *
    (3) Lincomycin may also be used in combination with:
    (i) Amprolium and ethopabate as in Sec.  558.58.
    (ii) Clopidol as in Sec.  558.175.
    (iii) Decoquinate as in Sec.  558.195.
    (iv) Fenbendazole as in Sec.  588.258.
    (v) Halofuginone as in Sec.  558.265.
    (vi) Ivermectin as in Sec.  558.300.
    (vii) Lasalocid sodium as in Sec.  558.311.
    (viii) Monensin as in Sec.  588.355.
    (ix) Nicarbazin alone and with narasin as in Sec.  558.366.
    (x) Pyrantel as in Sec.  558.485.
    (xi) Robenidine as in Sec.  558.515.
    (xii) Salinomycin as in Sec.  558.550.
    (xiii) Zoalene as in Sec.  558.680.

0
21. In Sec.  558.340, revise the section heading to read as follows:


Sec.  558.340  Maduramicin.

* * * * *


Sec.  558.355  [Amended]

0
22. In Sec.  558.355:
0
a. Remove and reserve paragraphs (f)(1)(ii), (vii), (x), (xi), (xii), 
(xv), (xvi), (xvii), (xviii), (xix), (xx), (xxiii), (xxvi), and 
(xxvii);
0
b. Remove and reserve paragraphs (f)(4)(vi) and (vii); and
0
c. Remove the second instance of a paragraph designated (f)(4)(iv) 
(following (f)(4)(vii).


Sec.  558.363  [Amended]

0
23. In Sec.  558.363:
0
a. Remove and reserve paragraphs (a)(2), (a)(5) and (a)(6);
0
b. Remove paragraphs (d)(1)(ii), (v), (vii), (viii), and (ix) and 
(d)(3)(iii) and (iv); and
0
c. Redesignate paragraphs (d)(1)(iii) and (iv) as paragraphs (d)(1)(ii) 
and (iii), paragraph (d)(1)(vi) as paragraph (d)(1)(iv), and paragraphs 
(d)(1)(x) and (xi) as paragraphs (d)(1)(v) and (vi).


Sec.  558.366  [Amended]

0
24. In the table in Sec.  558.366(d):
0
a. In the ``Nicarbazin in grams per ton'' column, following the entry 
for ``27 to 45'', remove the row entries for:
0
i. Narasin 27 to 45, bacitracin methylene disalicylate 50, and 
roxarsone 22.7 to 45.4; and
0
ii. Narasin 27 to 45 and roxarsone 22.7 to 45.4;
0
b. In the ``Nicarbazin in grams per ton'' column, following the entry 
for ``90.8 to 181.6 (0.01 to 0.02 pct)'', remove the row entry for 
``Bacitracin methylene disalicylate 4 to 50 and roxarsone 22.7 to 
45.4''; and
0
c. In the ``Nicarbazin in grams per ton'' column, following the entry 
for ``113.5 (0.0125 pct)'', remove the row entries for:
0
i. Roxarsone 22.7 (0.0025); and
0
ii. Roxarsone 22.7 (0.0025) plus lincomycin 2 (0.0004).''


Sec.  558.460  [Amended]

0
25. In Sec.  558.460, remove and reserve paragraph (d)(2).

0
26. In Sec.  558.515, in paragraph (d), remove the entries for 
``Bacitracin (as bacitracin methylene disalicylate) 50 and roxarsone 
22.7 to 45.4'', ``Bacitracin (as bacitracin methylene disalicylate) 100 
to 200 and roxarsone 22.7 to 45.4'', and ``Roxarsone 22.5 to 45.4 
(0.005 percent)''; and revise the section heading to read as follows:


Sec.  558.515  Robenidine.

* * * * *


Sec.  558.530  [Removed]

0
27. Remove Sec.  558.530.


Sec.  558.550  [Amended]

0
28. In Sec.  558.550, remove and reserve paragraphs (d)(1)(ii), (iv), 
(v), (viii), (ix), (xii), (xiv), (xv), (xvii), (xviii), (xix), and 
(xxiv) and (d)(3)(iv), (vi), and (vii).


Sec.  558.555  [Amended]

0
29. In Sec.  558.555, remove paragraphs (d)(3), (d)(4), and (d)(8); and 
redesignate paragraphs (d)(5), (d)(6), and (d)(7) as paragraphs (d)(3), 
(d)(4), and (d)(5), respectively.


Sec.  558.575  [Amended]

0
30. In Sec.  558.575, remove and reserve paragraph (d)(1)(ii).

0
31. In Sec.  558.680, revise paragraph (d) to read as follows:


Sec.  558.680  Zoalene.

* * * * *
    (d) Conditions of use--(1) Chickens--

[[Page 10984]]



----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Zoalene in grams/ton          grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 36.3 to 113.5..............  ..................  Replacement chickens:    Grower ration not to be     054771
                                                      For development of       fed to birds over 14
                                                      active immunity to       weeks of age; as
                                                      coccidiosis.             follows:
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                                                  Starter ration Grams   Grower ration Grams per
                      Growing conditions                                per ton                    ton
----------------------------------------------------------------------------------------------------------------
Severe exposure...............................................          113.5 (0.0125%)               75.4-113.5
                                                                                               (0.0083%-0.0125%)
Light to moderate exposure....................................               75.4-113.5                36.3-75.4
                                                                      (0.0083%-0.0125%)         (0.004%-0.0083%)
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Zoalene in grams/ton          grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(ii) 36.3-113.5................  Bacitracin          Replacement chickens:    Feed continuously as        054771
                                  methylene           For development of       sole ration as in
                                  disalicylate 4 to   active immunity to       subtable in item (i).
                                  50.                 coccidiosis; and for     Grower ration not to
                                                      increased rate of        be fed to birds over
                                                      weight gain and          14 weeks of age.
                                                      improved feed            Bacitracin methylene
                                                      efficiency.              disalicylate as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(iii) 36.3-113.5...............  Bacitracin          Replacement chickens:    Feed continuously as        054771
                                  methylene           For development of       sole ration as in
                                  disalicylate 50.    active immunity to       subtable in item (i).
                                                      coccidiosis; and as an   Grower ration not to
                                                      aid in the prevention    be fed to birds over
                                                      of necrotic enteritis    14 weeks of age.
                                                      caused or complicated    Bacitracin methylene
                                                      by Clostridium spp. or   disalicylate as
                                                      other organisms          provided by No. 054771
                                                      susceptible to           in Sec.   510.600(c)
                                                      bacitracin.              of this chapter.
(iv) 36.3-113.5................  Bacitracin          Replacement chickens:    Feed continuously as        054771
                                  methylene           For development of       sole ration as in
                                  disalicylate 100    active immunity to       subtable in item (i).
                                  to 200.             coccidiosis; and as an   To control necrotic
                                                      aid in the control of    enteritis, start
                                                      necrotic enteritis       medication at first
                                                      caused or complicated    clinical signs of
                                                      by Clostridium spp. or   disease; vary
                                                      other organisms          bacitracin dosage
                                                      susceptible to           based on the severity
                                                      bacitracin.              of infection;
                                                                               administer
                                                                               continuously for 5 to
                                                                               7 days or as long as
                                                                               clinical signs
                                                                               persist, then reduce
                                                                               bacitracin to
                                                                               prevention level (50 g/
                                                                               ton). Bacitracin
                                                                               methylene disalicylate
                                                                               as provided by No.
                                                                               054771 in Sec.
                                                                               510.600(c) of this
                                                                               chapter.
(v) 113.5......................  ..................  Broiler chickens: For    Feed continuously as        054771
                                                      prevention and control   sole ration.
                                                      of coccidiosis.
(vi) 113.5.....................  Bacitracin          Broiler chickens: As an  Feed continuously as        054771
                                  methylene           aid in the prevention    sole ration.
                                  disalicylate 4 to   and control of           Bacitracin methylene
                                  50.                 coccidiosis; and for     disalicylate as
                                                      increased rate of        provided by No. 054771
                                                      weight gain and          in Sec.   510.600(c)
                                                      improved feed            of this chapter.
                                                      efficiency.
(vii) 113.5....................  Bacitracin          Broiler chickens: For    Feed continuously as        054771
                                  methylene           prevention and control   sole ration.
                                  disalicylate 50.    of coccidiosis; and as   Bacitracin methylene
                                                      an aid in the            disalicylate as
                                                      prevention of necrotic   provided by No. 054771
                                                      enteritis caused or      in Sec.   510.600(c)
                                                      complicated by           of this chapter.
                                                      Clostridium spp. or
                                                      other organisms
                                                      susceptible to
                                                      bacitracin.
(viii) 113.5...................  Bacitracin          Broiler chickens: For    Feed continuously as        054771
                                  methylene           prevention and control   sole ration. To
                                  disalicylate 100    of coccidiosis; and as   control necrotic
                                  to 200.             an aid in the control    enteritis, start
                                                      of necrotic enteritis    medication at first
                                                      caused or complicated    clinical signs of
                                                      by Clostridium spp. or   disease; vary
                                                      other organisms          bacitracin dosage
                                                      susceptible to           based on the severity
                                                      bacitracin.              of infection;
                                                                               administer
                                                                               continuously for 5 to
                                                                               7 days or as long as
                                                                               clinical signs
                                                                               persist, then reduce
                                                                               bacitracin to
                                                                               prevention level (50 g/
                                                                               ton).
                                                                              Bacitracin methylene
                                                                               disalicylate as
                                                                               provided by No. 054771
                                                                               in Sec.   510.600(c)
                                                                               of this chapter.
(ix) 113.5.....................  Bambermycins 1....  Broiler chickens: As an  Feed continuously as        016592
                                                      aid in the prevention    sole ration. Do not
                                                      and control of           feed to chickens over
                                                      coccidiosis; and for     14 weeks of age.
                                                      increased rate of        Bambermycins as
                                                      weight gain and          provided by No. 016592
                                                      improved feed            in Sec.   510.600(c)
                                                      efficiency.              of this chapter.
(x) 113.5......................  Lincomycin 2......  Broiler chickens: As an  Feed continuously as        054771
                                                      aid in the prevention    sole ration. Do not
                                                      and control of           feed to laying
                                                      coccidiosis; and for     chickens. As
                                                      increased rate of        lincomycin
                                                      weight gain and          hydrochloride
                                                      improved feed            monohydrate provided
                                                      efficiency.              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                               chapter.
----------------------------------------------------------------------------------------------------------------


[[Page 10985]]

    (2) Turkeys--

----------------------------------------------------------------------------------------------------------------
                                   Combination in
      Zoalene in grams/ton          grams per ton      Indications for use          Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 113.5 to 170.3.............  ..................  Growing turkeys: For     Feed continuously as        054771
                                                      prevention and control   sole ration. For
                                                      of coccidiosis.          turkeys grown for meat
                                                                               purposes only. Do not
                                                                               feed to laying birds.
(ii) 113.5 to 170.3............  Bacitracin          Growing turkeys: For     Feed continuously as        054771
                                  methylene           prevention and control   sole ration until 14
                                  disalicylate 4 to   of coccidiosis; and      to 16 weeks of age.
                                  50.                 for increased rate of    For turkeys grown for
                                                      weight gain and          meat purposes only. Do
                                                      improved feed            not feed to laying
                                                      efficiency.              birds.
----------------------------------------------------------------------------------------------------------------


    Dated: February 3, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-02617 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P