[Federal Register Volume 71, Number 93 (Monday, May 15, 2006)]
[Rules and Regulations]
[Pages 27954-27959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4505]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 25 approved new 
animal drug applications (NADAs) and 16 approved abbreviated new animal 
drug applications (ANADAs) for Type A medicated articles and feed use 
combinations from Intervet, Inc., to Huvepharma AD.

DATES: This rule is effective May 15, 2006.

FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, has informed FDA that it has transferred 
ownership of, and all rights and interest in, the following 25 approved 
NADAs and 16 approved ANADAs for Type A medicated articles and feed use 
combinations to Huvepharma AD, 33 James Boucher Blvd., Sophia 1407, 
Bulgaria:

------------------------------------------------------------------------
        Application No.                       Trade Name(s)
------------------------------------------------------------------------
NADA 044-759                     FLAVOMYCIN (bambermycins) Type A
                                  medicated article
------------------------------------------------------------------------
NADA 095-543                     AMPROL HI-E / FLAVOMYCIN
------------------------------------------------------------------------
NADA 095-547                     AMPROL HI-E / FLAVOMYCIN / 3-NITRO
------------------------------------------------------------------------
NADA 095-548                     AMPROL / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
NADA 095-549                     AMPROL PLUS / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
NADA 098-340                     FLAVOMYCIN / MONENSIN
------------------------------------------------------------------------
NADA 098-341                     FLAVOMYCIN / 3-NITRO / COBAN
------------------------------------------------------------------------
NADA 101-628                     FLAVOMYCIN / 3-NITRO / ZOALENE
------------------------------------------------------------------------
NADA 101-629                     FLAVOMYCIN / ZOALENE
------------------------------------------------------------------------
NADA 130-185                     FLAVOMYCIN / AMPROLIUM
------------------------------------------------------------------------
NADA 130-661                     FLAVOMYCIN / CARB-O-SEP
------------------------------------------------------------------------
NADA 130-951                     STENOROL (halofuginone hydrobromide)
------------------------------------------------------------------------

[[Page 27955]]

 
NADA 137-483                     FLAVOMYCIN / STENOROL
------------------------------------------------------------------------
NADA 139-473                     STENOROL / STAFAC
------------------------------------------------------------------------
NADA 140-339                     FLAVOMYCIN / NICARB
------------------------------------------------------------------------
NADA 140-340                     STENOROL / LINCOMIX
------------------------------------------------------------------------
NADA 140-533                     STENOROL / 3-NITRO / BMD
------------------------------------------------------------------------
NADA 140-584                     STENOROL / BMD
------------------------------------------------------------------------
NADA 140-824                     STENOROL Type A medicated article
------------------------------------------------------------------------
NADA 140-843                     MONTEBAN / FLAVOMYCIN / 3-NITRO
------------------------------------------------------------------------
NADA 140-845                     FLAVOMYCIN / MONTEBAN
------------------------------------------------------------------------
NADA 140-918                     STENOROL / FLAVOMYCIN
------------------------------------------------------------------------
NADA 140-919                     STENOROL / BMD
------------------------------------------------------------------------
NADA 141-034                     GAINPRO (bambermycins) Type A medicated
                                  article
------------------------------------------------------------------------
NADA 141-129                     AVATEC / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-075                    SACOX (salinomycin sodium) Type A
                                  medicated article
------------------------------------------------------------------------
ANADA 200-080                    SACOX / 3-NITRO / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-081                    SACOX / 3-NITRO / BMD
------------------------------------------------------------------------
ANADA 200-082                    SACOX / BMD
------------------------------------------------------------------------
ANADA 200-083                    SACOX / FLAVOMYCIN
------------------------------------------------------------------------
ANADA 200-086                    SACOX / ALBAC / 3-NITRO
------------------------------------------------------------------------
ANADA 200-089                    SACOX / BACIFERM
------------------------------------------------------------------------
ANADA 200-090                    SACOX / LINCOMIX / 3-NITRO
------------------------------------------------------------------------
ANADA 200-091                    SACOX / 3-NITRO / AUREOMYCIN
------------------------------------------------------------------------
ANADA 200-092                    SACOX / STAFAC
------------------------------------------------------------------------
ANADA 200-093                    SACOX / LINCOMIX
------------------------------------------------------------------------
ANADA 200-094                    SACOX / STAFAC / 3-NITRO
------------------------------------------------------------------------
ANADA 200-095                    SACOX / AUREOMYCIN
------------------------------------------------------------------------
ANADA 200-096                    SACOX / TERRAMYCIN
------------------------------------------------------------------------
ANADA 200-097                    SACOX / 3-NITRO
------------------------------------------------------------------------
ANADA 200-143                    SACOX / 3-NITRO / BACIFERM
------------------------------------------------------------------------
------------------------------------------------------------------------

    Accordingly, the agency is amending the regulations in 21 CFR 
558.55, 558.58, 558.95, 558.120, 558.265, 558.311, 558.355, 558.363, 
558.366, 558.450, 558.550, and 558.680 to reflect the transfer of 
ownership and a current format.
    In addition, Huvepharma AD has not been previously listed in the 
animal drug regulations as a sponsor of an approved application. At 
this time, 21 CFR 510.600(c) is being amended to add entries for the 
firm.
    Also, FDA has found that the April 1, 2005, edition of Title 21, 
parts 500 to 599 of the Code of Federal Regulations (CFR) does not 
accurately reflect the use limitations for amprolium in single-
ingredient, medicated broiler chicken feeds. The existing entry 
erroneously includes limitations normally associated with the use of 
arsenicals in feed. At this time, the regulations are being amended in 
Sec.  558.55 to correct this error. FDA is also taking this opportunity 
to consolidate entries for similar combination medicated feeds in the 
same section of part 558, and to eliminate duplicate entries. These 
actions are being taken to improve the accuracy and readability 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 Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 558

    Animal drugs, Animal feeds.

0
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 510 and 
558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.


0
2. In Sec.  510.600, in the table in paragraph (c)(1) alphabetically 
add an entry for ``Huvepharma AD''; and in the table in paragraph 
(c)(2) numerically add an entry for ``016592'' to read as follows:


Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of 
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
          Firm name and address                  Drug labeler code
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
Huvepharma AD, 33 James Boucher Blvd.,     016592
 Sophia 1407, Bulgaria
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
      Drug labeler code                  Firm name and address
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------
016592                         Huvepharma AD, 33 James Boucher Blvd.,
                                Sophia 1407, Bulgaria
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

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.  558.55  [Amended]

0
4. Amend Sec.  558.55 as follows:
0
a. In the table in paragraph (d)(2)(ii), in the ``Limitations'' column 
in the entry for ``Amprolium 72.6 to 113.5 grams per ton'', remove the 
first sentence;
0
b. In the table in paragraph (d)(2)(iii), in the ``Limitations'' column 
in the entry for ``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1 
(0.0025% to 0.00375%)'', remove ``057926'' and add in its place 
``016592''; and in the ``Sponsor'' column add ``016592'' and
0
c. In the table in paragraph (d)(2)(iii), in the ``Limitations'' column 
and ``Sponsor'' column in the entry for

[[Page 27956]]

``Bambermycins 1 to 4'', remove ``057926'' and add in its place 
``016592''.

0
5. Amend Sec.  558.58 as follows:
0
a. Revise paragraph (a);
0
b. Redesignate paragraphs (b), (c), and (d) as paragraphs (c), (d), and 
(e);
0
c. Add new paragraph (b);
0
d. In the table in newly redesignated paragraph (e)(1)(i), add an entry 
for ``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1'';
0
e. In the table in newly redesignated paragraph (e)(1)(ii), in the 
``Limitations'' column in the entries for ``Bambermycins 2 to 3 plus 
roxarsone 22.8 to 34.1'', remove ``057926'' and add in its place 
``016592''; and in the ``Sponsor'' column add ``016592''; and
0
f. In the table in newly redesignated paragraph (e)(1)(iii), in the 
``Limitations'' column in the entries for ``Bambermycins 1 to 3'' and 
``Bambermycins 1 to 3 plus roxarsone 22.8 to 34.1'', remove ``057926'' 
and add in its place ``016592''; and in the ``Sponsor'' column add 
``016592''.
    The revisions and additions read as follows:


Sec.  558.58  Amprolium and ethopabate.

    (a) Specifications. Type A medicated articles containing:
    (1) 25 percent amprolium and 8 percent ethopabate or 5 percent 
amprolium and 1.6 percent ethopabate;
    (2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent 
amprolium and 0.16 percent ethopabate.
    (b) Approvals. See No. 050604 in Sec.  510.600(c) of this chapter.
* * * * *
    (e) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
     Amprolium and
  ethopabate in grams   Combination in grams     Indications for use            Limitations            Sponsor
        per ton                per ton
----------------------------------------------------------------------------------------------------------------
(i) Amprolium 113.5     * *                    * *                       *                                     *
 (0.0125%) and
 ethopabate 3.6
 (0.0004%).
----------------------------------------------------------------------------------------------------------------
                        Bambermycins, 1 to    Broiler chickens: As an   Feed continuously as the          016592
                         3; plus roxarsone,    aid in the prevention     sole ration; as sole
                         22.8 to 34.1          of coccidiosis; and for   source of amprolium and
                                               increased rate of         organic arsenic; withdraw
                                               weight gain, improved     5 d before slaughter;
                                               feed efficiency, and      roxarsone provided by No.
                                               improved pigmentation.    046573, bambermycins by
                                                                         No. 016592 in Sec.
                                                                         510.600(c) of this
                                                                         chapter.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
6. Amend Sec.  558.95 as follows:
0
a. In paragraphs (a)(1), (a)(2), and (a)(5), remove ``057926'' and add 
in its place ``016592'';
0
b. Remove and reserve paragraph (d)(1)(ii);
0
c. Remove paragraphs (d)(1)(iii) through (d)(1)(xiv) and paragraphs 
(d)(3)(iii) and (d)(3)(iv); and
0
d. Revise paragraph (d)(5).
    The revision reads as follows:


Sec.  558.95  Bambermycins.

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

0
7. In Sec.  558.120, add paragraph (d)(1)(iv) and remove paragraph 
(d)(2)(iii) to read as follows:


Sec.  558.120  Carbarsone (not U.S.P.).

* * * * *
    (d) * * *
    (1) * * *
    (iv) Grams per ton. 227 carbarsone, plus 1 or 4 grams per ton 
bambermycins.
    (a) Indications for use. As an aid in the prevention of blackhead; 
and for increased rate of weight gain (4 grams per ton bambermycins) or 
improved feed efficiency (1 gram per ton bambermycins).
    (b) Limitations. Feed continuously 2 weeks before blackhead is 
expected and continue as long as prevention is needed. Withdraw 5 days 
before slaughter. As sole source of organic arsenic. Bambermycins 
provided by No. 046573 in Sec.  510.600(c) of this chapter.
* * * * *

0
8. In Sec.  558.265, revise paragraph (a); redesignate paragraphs (b) 
and (c) as paragraphs (c) and (d); and add new paragraph (b) to read as 
follows:


Sec.  558.265  Halofuginone hydrobromide.

    (a) Specifications. Type A medicated articles containing 6 grams of 
halofuginone hydrobromide per kilogram.
    (b) Approvals. See No. 016592 in Sec.  510.600(c) of this chapter.
* * * * *

0
9. Amend Sec.  558.311 as follows:
0
a. In the table in paragraph (e)(1)(ii) in the entry in the 
``Combination in grams per ton'' column for ``Roxarsone 45.4 plus 
bambermycins 1'', in the ``Limitations'' column remove ``012799'' and 
add in its place ``016592'';
0
b. In the table in paragraph (e)(1)(ii) following the entry in the 
``Combination in grams per ton'' column for ``Roxarsone 45.4 plus 
bambermycins 1'', add an entry for ``Bambermycins 1 to 2''; and
0
c. Remove and reserve paragraph (e)(5)(ii).
    The addition reads as follows:


Sec.  558.311  Lasalocid.

* * * * *
    (e) * * *
    (1) * * *

[[Page 27957]]



----------------------------------------------------------------------------------------------------------------
   Lasalocid in     Combination in grams
  grams per ton            per ton                Indications for use              Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
(ii) 68 (0.0075     * *                     * *                               *                      ...........
 pct) to 113
 (0.0125 pct).
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                   Bambermycins 1 to 2     Broiler chickens: For prevention  Feed continuously as         016592
                                            of coccidiosis caused by          sole ration.
                                            Eimeria tenella, E. necatrix,     Bambermycins provided
                                            E. acervulina, E. brunetti, E.    by No. 016592 in Sec.
                                            mivati, and E. maxima; and for      510.600(c) of this
                                            increased rate of weight gain     chapter.
                                            and improved feed efficiency.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *

0
10. In Sec.  558.355, in paragraphs (b)(10), (f)(2)(v)(b), and 
(f)(2)(vi)(b), remove ``057926'' and add in its place ``016592''; and 
revise paragraphs (f)(1)(vi), (f)(1)(vii), and (f)(1)(xvii) to read as 
follows:


Sec.  558.355  Monensin.

* * * * *
    (f) * * *
    (1) * * *
    (vi) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 
1 to 2 grams.
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; and as an aid in the prevention of 
coccidiosis caused by E. necatrix, E. tenella,E. acervulina, E. 
brunetti, E. mivati, and E. maxima.
    (b) Limitations. Feed continuously as sole ration; do not feed to 
laying chickens. Bambermycins provided by No. 016592 in Sec.  
510.600(c) of this chapter.
    (vii) Amount per ton. Monensin, 90 to 110 grams; plus bambermycins, 
1 gram; plus roxarsone, 22.7 to 45.4 grams
    (a) Indications for use. For increased rate of weight gain and 
improved feed efficiency; and as an aid in the prevention of 
coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. 
brunetti, E. mivati, and E. maxima.
    (b) Limitations. Feed continuously as sole ration; use as sole 
source of organic arsenic; withdraw 5 d before slaughter; do not feed 
to laying chickens. Bambermycins provided by No. 016592 in Sec.  
510.600(c) of this chapter; roxarsone provided by No. 046573.
* * * * *
    (xvii) Amount per ton. Bambermycins, 1 to 2 grams plus monensin, 90 
to 110 grams plus roxarsone, 22.7 to 45.4 grams.
    (a) Indications for use. For increased rate of weight gain; and as 
an aid in prevention of coccidiosis caused by E. necatrix, E. tenella, 
E. acervulina, E. brunetti, E. mivati, and E. maxima.
    (b) Limitations. Feed continuously as sole ration; use as sole 
source of organic arsenic; withdraw 5 d before slaughter; do not feed 
to laying chickens. Bambermycins provided by No. 016592 in Sec.  
510.600(c) of this chapter; roxarsone provided by No. 046573.
* * * * *

0
11. Amend Sec.  558.363 as follows:
0
a. In paragraphs (a)(4), (a)(5), and (d)(1)(vii)(B), remove ``057926'' 
and add in its place ``016592'';
0
b. In paragraph (d)(1)(iv)(B) add a new sentence at the end of the 
paragraph; and
0
c. Remove paragraph (d)(1)(xii).
    The addition reads as follows:


Sec.  558.363  Narasin.

* * * * *
    (d) * * *
    (1) * * *
    (iv) * * *
    (B) * * * Narasin as provided by No. 000986; bambermycins by No. 
016592 in Sec.  510.600(c) of this chapter.
* * * * *

0
12. In the table in paragraph (d) of Sec.  558.366, alphabetically add 
new entries for ``Narasin 27 to 45, and bambermycins 1 to 2'' and 
``Bambermycins 1 to 2'' to read as follows:


Sec.  558.366  Nicarbazin.

* * * * *
    (d) * * *

----------------------------------------------------------------------------------------------------------------
  Nicarbazin in     Combination in grams
  grams per ton           per ton            Indications for use              Limitations              Sponsor
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                   Narasin 27 to 45, and   * *                       * *                                       *
                    bacitracin methylene
                    disalicylate 50, and
                    roxarsone 22.7 to
                    45.4
----------------------------------------------------------------------------------------------------------------

[[Page 27958]]

 
                   Narasin 27 to 45, and  Broiler chickens: As an   Feed continuously as sole             000986
                    bambermycins 1 to 2    aid in preventing         ration from time chicks are
                                           outbreaks of cecal        placed on litter until past
                                           (Eimeria tenella) and     the time when coccidiosis is
                                           intestinal (E.            ordinarily a hazard; do not
                                           acervulina, E. maxima,    use as a treatment for
                                           E. necatrix, and E.       coccidiosis; do not use in
                                           brunetti) coccidiosis;    flushing mashes; do not feed
                                           and for increased rate    to laying hens; withdraw 4
                                           of weight gain and        days before slaughter.
                                           improved feed             Bambermycins provided by No.
                                           efficiency.               016592; nicarbazin and narasin
                                                                     by No. 066104 in Sec.
                                                                     510.600(c) of this chapter..
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
113.5 (0.0125      * *                     * *                       * *                                       *
 pct)
----------------------------------------------------------------------------------------------------------------
                   Bacitracin zinc 4 to    * *                       * *                                       *
                    50
----------------------------------------------------------------------------------------------------------------
                   Bambermycins 1 to 2    Broiler chickens: For     Feed continuously as sole             016592
                                           prevention of             ration. Bambermycins provided
                                           coccidiosis caused by     by No. 016592 in Sec.
                                           Eimeria tenella, E.       510.600(c) of this chapter.
                                           necatrix, E.
                                           acervulina, E.
                                           brunetti, E. mivati,
                                           and E. maxima; and for
                                           increased rate of
                                           weight gain and
                                           improved feed
                                           efficiency.
----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------


0
13. In the table in paragraph (d)(1)(vii) of Sec.  558.450, remove the 
entry for ``Salinomycin 40 to 60 g/ton''; and add paragraph (d)(3)(v) 
to read as follows:


Sec.  558.450  Oxytetracycline.

* * * * *
    (d) * * *
    (3) * * *
    (v) Salinomycin as in Sec.  558.550.

0
14. In Sec.  558.550, in paragraphs (d)(1)(xv)(c) and (d)(1)(xvi)(c), 
remove ``057926'' and add in its place ``016592''; add paragraphs 
(d)(1)(xxiii) and (d)(1)(xxiv); and revise paragraphs (b)(2) and (d)(4) 
to read as follows:


Sec.  558.550  Salinomycin.

* * * * *
    (b) * * *
    (2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii) 
through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), 
(d)(3)(i), and (d)(4) of this section.
* * * * *
    (d) * * *
    (1) * * *
    (xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus 
bambermycins, 1 to 3 grams.
    (a) Indications for use. Broiler chickens: For prevention of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, E. brunetti, and E. mivati; and for improved feed efficiency.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens; not approved for use with pellet binders; may be fatal 
if accidentally fed to adult turkeys or horses. Salinomycin as provided 
by Nos. 046573 and 016592; bambermycins by No. 016592 in Sec.  
510.600(c) of this chapter.
    (xxiv) Amount per ton. Salinomycin, 40 to 60 grams; plus 
bambermycins, 1 to 2 grams; plus roxarsone, 45.4 grams.
    (a) Indications for use. Broiler chickens: For prevention of 
coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. 
maxima, E. brunetti, and E. mivati, including some field strains of E. 
tenella that are more susceptible to roxarsone combined with 
salinomycin than salinomycin alone; and for improved feed efficiency.
    (b) Limitations. Feed continuously as sole ration. Do not feed to 
laying chickens; as sole source or organic arsenic; withdraw 5 days 
before slaughter; not approved for use with pellet binders; may be 
fatal if accidentally fed to adult turkeys or horses; Salinomycin as 
provided by Nos. 046573and 016592; bambermycins by No. 016592; 
roxarsone by No. 046573 in Sec.  510.600(c) of this chapter.
* * * * *
    (4) Chickens: It is used in chicken feed as follows:
    (i) Amount per ton. Salinomycin, 40 to 60 grams; plus 
oxytetracycline, 500 grams.
    (a) Indications for use. For prevention of coccidiosis caused by 
Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, 
and E. mivati; and for reduction of mortality due to air sacculitis 
(air-sac-infection) caused by Escherichia coli susceptible to 
oxytetracycline.
    (b) Limitations. Feed continuously for 5 days; do not feed to 
chickens producing eggs for human consumption; withdraw 24 hours before 
slaughter; in low calcium feeds withdraw 3 d before slaughter. 
Salinomycin as provided by Nos. 046573 and 016592; oxytetracycline as 
provided by No. 066104 in Sec.  510.600(c) of this chapter.
    (ii) [Reserved]

0
15. In Sec.  558.680, alphabetically add two entries to the table in 
paragraph (d)(1)(ii); and revise paragraph (d)(2) to read as follows:


Sec.  558.680  Zoalene.

* * * * *
    (d) * * *
    (1) * * *

[[Page 27959]]



------------------------------------------------------------------------
                     Combination
 Zoalene in grams    in grams per    Indications for      Limitations
      per ton            ton               use
------------------------------------------------------------------------
(ii) 113.5          * *             * *                 * * *
 (0.0125%).
------------------------------------------------------------------------
                    Bacitracin      * * *               * *
                     100 to 500
------------------------------------------------------------------------
                    Bambermycins   Broiler chickens:   Feed continuously
                     1              As an aid in the    as sole ration.
                                    prevention and      Do not feed to
                                    control of          chickens over 14
                                    coccidiosis; and    weeks of age.
                                    for increased       Bambermycins as
                                    rate of weight      provided by No.
                                    gain and improved   016592 in Sec.
                                    feed efficiency.    510.600(c) of
                                                        this chapter.
------------------------------------------------------------------------
                    Bambermycins   Broiler chickens:   Feed continuously
                     1 plus         As an aid in the    as sole ration.
                     roxarsone      prevention and      Do not feed to
                     22.7           control of          chickens over 14
                                    coccidiosis; and    weeks of age;
                                    for increased       feed as sole
                                    rate of weight      source of
                                    gain and improved   organic arsenic;
                                    feed efficiency.    withdraw 5 days
                                                        before
                                                        slaughter.
                                                        Bambermycins as
                                                        provided by No.
                                                        016592,
                                                        roxarsone by No.
                                                        046573 in Sec.
                                                        510.600(c) of
                                                        this chapter.
------------------------------------------------------------------------
                              * * * * * * *
------------------------------------------------------------------------

    (2) Zoalene may also be used in combination with roxarsone as in 
Sec.  558.530.

    Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-4505 Filed 5-12-06; 8:45 am]
BILLING CODE 4160-01-S