Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug, 10976-10985 [2014-02617]
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10976
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
NADA/ANADA
107–997
108–115
120–724
138–953
141–058
141–066
141–226
200–170
200–172
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Ingredient new animal drugs
Roxarsone/NICARB (nicarbazin)/LINCOMIX (lincomycin).
Roxarsone/NICARB (nicarbazin).
3–NITRO (roxarsone)/STAFAC (virginiamycin)/COBAN (monensin).
3–NITRO (roxarsone)/STAFAC (virginiamycin)/BIO–COX (salinomycin).
3–NITRO (roxarsone)/AVIAX (semduramycin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/AVIAX (semduramycin).
Roxarsone/AVIAX (semduramycin)/STAFAC (virginiamycin).
3–NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/LINCOMIX (lincomycin).
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
041–500
049–464
140–445
141–113
Ingredient new animal drugs
............
............
............
............
3–NITRO (roxarsone)/COBAN (monensin).
Roxarsone/monensin/bacitracin.
Roxarsone/MONTEBAN (narasin).
3–NITRO (roxarsone)/MAXIBAN (narasin and nicarbazin).
• Cross Vetpharm Group Ltd.,
Broomhill Road, Tallaght, Dublin 24,
Ireland, has requested that FDA
withdraw approval of the following
three NADAs:
NADA
Ingredient new animal drugs
038–241 ............
038–242 ............
038–624 ............
PRO–GEN (arsanilic acid)/ERYTHRO (erythromycin)/zoalene.
PRO–GEN (arsanilic acid)/ERYTHRO (erythromycin)/amprolium and ethopabate.
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:
ANADA
Ingredient new animal drugs
200–355 ............
3–NITRO (roxarsone)/PENNCHLOR (chlortetracycline)/BIO–COX (salinomycin).
TKELLEY on DSK3SPTVN1PROD with RULES
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with 21 CFR 514.116 Notice of
withdrawal of approval of application,
notice is given that approval of the
NADAs and ANADAs listed in this
document, and all supplements and
amendments thereto, is hereby
withdrawn, effective March 10, 2014.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: February 3, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–02616 Filed 2–26–14; 8:45 am]
BILLING CODE 4160–01–P
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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.
Final rule; technical
amendments.
ACTION:
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
SUMMARY:
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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,
john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Recently,
the Agency provided notice of the
withdrawal of approval of NADAs for
Type A medicated articles containing
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
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
NADA/ANADA
TKELLEY on DSK3SPTVN1PROD with RULES
040–435
041–178
041–984
091–326
092–522
095–546
102–485
105–758
112–661
112–687
116–082
116–088
123–154
126–052
131–894
132–447
134–185
135–321
137–536
138–703
139–190
140–581
140–852
140–867
141–100
141–112
141–121
141–131
141–135
141–138
141–139
141–142
141–155
141–157
141–223
141–293
200–206
200–207
200–208
200–209
200–214
200–211
200–215
200–217
200–259
200–260
038–879
039–646
136–484
200–203
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3–NITRO (roxarsone)/DECCOX (decoquinate).
Roxarsone/AMPROL Plus (amprolium and ethopabate)/LINCOMIX (lincomycin).
Roxarsone/ROFENAID (sulfadimethoxine/ormetoprim).
3–NITRO (roxarsone)/DECCOX (decoquinate)/ALBAC (bacitracin zinc).
Roxarsone/COBAN (monensin)/LINCOMIX (lincomycin).
Roxarsone/ROBENZ (robenidine).
3–NITRO (roxarsone)/AVATEC (lasalocid).
3–NITRO (roxarsone)/AMPROL HI–E (amprolium and ethopabate)/BACIFERM (bacitracin zinc).
3–NITRO (roxarsone)/AVATEC (lasalocid)/LINCOMIX (lincomycin).
3–NITRO (roxarsone)/AVATEC (lasalocid)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/AVATEC (lasalocid)/BMD (bacitracin MD).
3–NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/BACIFERM (bacitracin zinc)/COBAN (monensin).
3–NITRO (roxarsone)/AVATEC (lasalocid)/BACIFERM (bacitracin zinc).
3–NITRO (roxarsone)/AVATEC (lasalocid)/bacitracin MD.
Roxarsone/BIO–COX (salinomycin).
3–NITRO (roxarsone)/BIO–COX (salinomycin)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/BIO–COX (salinomycin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/BIO–COX/ALBAC (bacitracin zinc).
3–NITRO (roxarsone)/COBAN (monensin)/ALBAC (bacitracin zinc).
3–NITRO (roxarsone)/BIO–COX (salinomycin)/BACIFERM (bacitracin zinc).
3–NITRO (roxarsone)/BIO–COX (salinomycin)/LINCOMIX (lincomycin).
3–NITRO (roxarsone)/MONTEBAN/BMD (bacitracin MD).
3–NITRO (roxarsone)/BIO–COX (salinomycin)/AUREOMYCIN (chlortetracycline).
3–NITRO (roxarsone)/DECCOX (decoquinate)/BMD (bacitracin MD).
3–NITRO (roxarsone)/MAXIBAN (narasin and nicarbazin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/BIO–COX (salinomycin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/ZOAMIX (zoalene)/BMD (bacitracin MD).
3–NITRO (roxarsone)/BIO–COX (salinomycin).
3–NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/COBAN (monensin).
3–NITRO (roxarsone)/AMPROL (amprolium)/BMD (bacitracin MD).
3–NITRO (roxarsone)/ROBENZ (robenidine)/BMD (bacitracin MD).
3–NITRO (roxarsone)/STENOROL (halofuginone).
3–NITRO (roxarsone)/CLINACOX (diclazuril).
3–NITRO (roxarsone)/AVATEC (lasalocid).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/DECCOX (decoquinate).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/COYDEN 25 (clopidol).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/AVATEC (lasalocid).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/SACOX (salinomycin).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI–E (amprolium and ethopabate).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/COBAN (monensin).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/BIO–COX (salinomycin).
3–NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI–E (amprolium and ethopabate).
3–NITRO (roxarsone)/SACOX (salinomycin)/CHLORMAX (chlortetracycline).
3–NITRO (roxarsone)/BIO–COX (salinomycin)/CHLORMAX (chlortetracycline).
CARB–O–SEP (carbarsone)/ZOAMIX (zoalene).
CARB–O–GAIN (carbarsone)/BMD (bacitracin MD).
CARB–O–SEP (carbarsone)/BACIFERM (bacitracin zinc).
CARB–O–SEP (carbarsone)/ALBAC (bacitracin zinc).
withdraw approval of the following 16
NADAs and 8 ANADAs:
NADA/ANADA
013–461
040–264
041–541
044–016
............
............
............
............
VerDate Mar<15>2010
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:
Ingredient new animal drugs
• Huvepharma AD, 5th Floor, 3A
Nikolay Haitov Str., 1113 Sofia,
Bulgaria, has requested that FDA
Ingredient new animal drugs
3–NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).
3–NITRO (roxarsone)/COYDEN 25 (clopidol).
3–NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD (bacitracin MD).
Roxarsone + bacitracin Zinc/COYDEN 25 (clopidol).
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
NADA/ANADA
049–179
049–180
095–547
095–548
095–549
098–341
101–628
140–533
140–843
141–190
200–080
200–081
200–086
200–090
200–091
200–094
200–097
200–143
118–507
130–661
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Ingredient new animal drugs
Roxarsone/AMPROL HI–E (amprolium and ethopabate).
Roxarsone/AMPROL HI–E (amprolium and ethopabate)/BMD (bacitracin MD).
3–NITRO (roxarsone)/AMPROL HI–E (amprolium and ethopabate)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/COBAN (monensin)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/zoalene.
3–NITRO (roxarsone)/STENOROL (halofuginone)/BMD (bacitracin MD).
3–NITRO (roxarsone)/MONTEBAN (narasin)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/LINICOX (diclazuril)/BMD (bacitracin MD).
3–NITRO (roxarsone)/SACOX (salinomycin)/FLAVOMYCIN (bambermycins).
3–NITRO (roxarsone)/SACOX (salinomycin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/SACOX (salinomycin)/ALBAC (bacitracin zinc).
3–NITRO (roxarsone)/SACOX (salinomycin)/LINCOMIX (lincomycin).
3–NITRO (roxarsone)/SACOX (salinomycin)/AUREOMYCIN (chlortetracycline).
3–NITRO (roxarsone)/SACOX (salinomycin)/STAFAC (virginiamycin).
3–NITRO (roxarsone)/SACOX (salinomycin).
3–NITRO (roxarsone)/SACOX (salinomycin)/BACIFERM (bacitracin zinc).
CARB–O–SEP (carbarsone)/AMPROL (amprolium).
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
NADA/ANADA
107–997
108–115
120–724
138–953
141–058
141–066
141–226
200–170
200–172
............
............
............
............
............
............
............
............
............
Ingredient new animal drugs
Roxarsone/NICARB (nicarbazin)/LINCOMIX (lincomycin).
Roxarsone/NICARB (nicarbazin).
3–NITRO (roxarsone)/STAFAC (virginiamycin)/COBAN (monensin).
3–NITRO (roxarsone)/STAFAC (virginiamycin)/BIO–COX (salinomycin).
3–NITRO (roxarsone)/AVIAX (semduramycin)/BMD (bacitracin MD).
3–NITRO (roxarsone)/AVIAX (semduramycin).
Roxarsone/AVIAX (semduramycin)/STAFAC (virginiamycin).
3–NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/LINCOMIX (lincomycin).
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
041–500
049–464
140–445
141–113
Ingredient new animal drugs
............
............
............
............
3–NITRO (roxarsone)/COBAN (monensin).
Roxarsone/monensin/bacitracin.
Roxarsone/MONTEBAN (narasin).
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
TKELLEY on DSK3SPTVN1PROD with RULES
038–241 ............
038–242 ............
038–624 ............
PRO–GEN (arsanilic acid)/ERYTHRO (erythromycin)/zoalene.
PRO–GEN (arsanilic acid)/ERYTHRO (erythromycin)/amprolium + ethopabate.
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 ............
VerDate Mar<15>2010
withdraw approval of the following
seven NADAs and two ANADAs:
3–NITRO (roxarsone)/PENNCHLOR (chlortetracycline)/BIO–COX (salinomycin).
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
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.
(c) Related conditions of use. See
§ 558.369 of this chapter.
List of Subjects
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
21 CFR Parts 556
Animal drugs, Food.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
1. The authority citation for 21 CFR
part 556 continues to read as follows:
■
Authority: 21 U.S.C. 342, 360b, 371.
■
2. Revise § 556.60 to read as follows:
§ 556.60
3. The authority citation for 21 CFR
part 558 continues to read as follows:
■
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:
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]
Authority: 21 U.S.C. 360b, 371.
§ 558.4
[Amended]
4. In § 558.4, in paragraph (d), in the
‘‘Category II’’ table:
■ a. Remove the entries for ‘‘Arsanilate
acid’’, ‘‘Carbarsone’’, and
‘‘Sulfaquinoxaline’’;
■ b. Remove the row entries under
‘‘Nitarsone’’ for ‘‘Sulfanitran’’ and
‘‘Roxarsone’’.
■ c. Remove the four entries for
‘‘Roxarsone’’ and their respective
following row entries; and
■ d. In the fourth entry for
‘‘Sulfamethazine,’’ remove its three
following row entries for ‘‘Aklomide’’
and two following row entries for
‘‘Roxarsone’’.
■ 5. In § 558.55, revise paragraphs (d)(1)
through (3) and add paragraph (d)(4) to
read as follows:
■
§ 558.55
*
Amprolium.
*
*
*
*
(d) * * *
(1) Cattle. It is used as follows:
Amprolium in grams per
ton
Indications for use
Limitations
(i) 113.5 to 11, 350; to
provide 5 milligrams per
kilogram of body weight
per day.
Calves: As an aid in the prevention of coccidiosis
caused by Eimeria bovis and E. zuernii.
(ii) 113.5 to 11, 350; to
provide 10 milligrams
per kilogram of body
weight per day.
Calves: As an aid in the treatment of coccidiosis
caused by Eimeria bovis and E. zuernii.
Top-dress on or mix in the daily ration. Feed for
21 days when experience 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.
Top-dress on or mix in the daily ration. Feed for 5
days 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.
Sponsor
016592
016592
(2) Chickens. It is used as follows:
Combination in
grams per ton
Indications for use
Limitations
(i) 36.3 to 113.5 .......
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Amprolium in grams
per ton
.................................
Replacement chickens: For development
of active immunity to coccidiosis.
Feed continuously until onset of production as follows:
Sponsor
016592
Up to 5 weeks of age
Over 8 weeks of age
Amprolium in grams
per ton
Growing conditions
From 5 to 8 weeks of
age
Amprolium in grams
per ton
Amprolium in grams
per ton
Severe exposure to coccidiosis ...............................................................
113.5
(0.0125%)
72.6–113.5
Moderate exposure to coccidiosis ...........................................................
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72.6–113.5
(0.008%–0.0125%)
54.5–113.5
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36.3–113.5
(0.004%–0.0125%)
36.3–113.5
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Up to 5 weeks of age
Over 8 weeks of age
Amprolium in grams
per ton
Growing conditions
From 5 to 8 weeks of
age
Amprolium in grams
per ton
Amprolium in grams
per ton
(0.008%–0.0125%)
36.3–113.5
(0.004%–0.0125%)
Slight exposure to coccidiosis .................................................................
Amprolium in grams
per ton
(ii) 36.3 to 113.5 ......
(iii) 72.6 to 113.5 .....
(iv) 72.6 to 113.5 .....
(v) 113.5 ..................
(vi) 113.5 to 227 ......
(vii) 113.5 to 227 .....
(viii) 227 ...................
Combination in
grams per ton
(0.006%–0.0125%)
36.3–113.5
(0.004%–0.0125%)
Indications for use
(0.004%–0.0125%)
36.3–113.5
(0.004%–0.0125%)
Limitations
Bacitracin methylene Replacement chickens: For development
disalicylate 4 to 50.
of active immunity to coccidiosis; and
for increased rate of weight gain and
improved feed efficiency.
................................. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only.
Bambermycins 1 to
Broiler chickens: For prevention of coc2.
cidiosis caused by Eimeria tenella only;
and for increased rate of weight gain
and improved feed efficiency.
................................. 1. Laying chickens: For prevention of
coccidiosis.
2. Laying chickens: For treatment of coccidiosis in moderate outbreaks.
................................. 1. Replacement chickens: For prevention
of coccidiosis where immunity to coccidiosis is not desired.
2. Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis
is not desired.
Bambermycins 1 to
Broiler chickens: For prevention of coc2.
cidiosis where immunity to coccidiosis
is not desired; and for increased rate of
weight gain and improved feed efficiency.
................................. Laying chickens: For treatment of coccidiosis in severe outbreaks..
Feed according to subtable in item (i).
Bacitracin methylene disalicylate as
provided by No. 054771 in § 510.600(c)
of this chapter.
Feed continuously as the sole ration; as
sole source of amprolium.
Feed continuously as the sole ration; as
sole
source
of
amprolium.
Bambermycins as provided by No.
016592 in § 510.600(c) of this chapter.
Feed continuously as the sole ration; as
the sole source of amprolium.
Feed for 2 weeks.
Sponsor
054771
016592
016592
016592
Feed continuously from day-old until
onset of production; as the sole source
of amprolium.
Feed continuously as the sole ration; as
sole source of amprolium.
016592
Feed continuously as the sole ration; as
sole
source
of
amprolium.
Bambermycins as provided by No.
016592 in § 510.600(c) of this chapter.
016592
Feed for 2 weeks ......................................
016592
(3) Turkeys. It is used as follows:
Amprolium in grams
per ton
Combination in
grams per ton
Indications for use
(i) 113.5 ...................
Bambermycins 1 to
4.
(ii) 113.5 to 227 .......
.................................
Limitations
Growing turkeys: For prevention of coccidiosis; and for increased rate of
weight gain and improved feed efficiency.
Turkeys: For prevention of coccidiosis .....
Feed continuously as the sole source of
amprolium; bambermycins as provided
by No. 016592 in § 510.600(c) of this
chapter.
Feed continuously as the sole ration; as
sole source of amprolium.
Sponsor
016592
016592
(4) Pheasants. It is used as follows:
Amprolium in grams
per ton
Combination in
grams per ton
Indications for use
Limitations
(i) 159 ......................
.................................
Growing pheasants: For the prevention of
coccidiosis caused by Eimeria colchici,
E. duodenalis, and E. phasiani.
Feed continuously as sole ration. Use as
sole source of amprolium.
Sponsor
016592
TKELLEY on DSK3SPTVN1PROD with RULES
(ii) [Reserved]
6. In § 558.58, revise paragraph (e) to
read as follows:
■
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*
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*
Amprolium and ethopabate.
*
Frm 00030
*
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*
Sfmt 4700
(e) Conditions of use. It is used in
chicken feed as follows:
E:\FR\FM\27FER1.SGM
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10981
Combination in
grams per ton
Indications for use
Limitations
(1) Amprolium 113.5
and ethopabate
3.6.
(2) Amprolium 113.5
and ethopabate
3.6.
.................................
Broiler chickens: As an aid in the prevention of coccidiosis.
Lincomycin 2 to 4 ....
Broiler chickens: As an aid in the prevention of coccidiosis; for increased rate of
weight gain and improved feed efficiency.
.................................
(4) Amprolium 113.5
and ethopabate
36.3.
Bacitracin 4 to 50 ....
Broiler chickens and replacement chickens: where immunity to coccidiosis is
not desired: As an aid in the prevention
of coccidiosis where severe exposure
to coccidiosis from Eimeria acervulina,
E. maxima, and E. brunetti is likely to
occur.
1. Broiler chickens and replacement
chickens: where immunity to coccidiosis is not desired; to aid in prevention
of coccidiosis where severe exposure
to coccidiosis from Eimeria acervulina,
E. maxima, and E. brunetti is likely to
occur; for increased rate of weight gain
in broiler chickens raised in floor pens.
Feed continuously as sole ration; as sole
source of amprolium. Not for laying
chickens.
Feed continuously as sole ration; as sole
source of amprolium. Not for laying
chickens.
Lincomycin as provided by No. 054771 in
§ 510.600(c) of this chapter.
Feed continuously as sole ration; as sole
source of amprolium. Not for chickens
over 16 weeks of age.
016592
(3) Amprolium 113.5
and ethopabate
36.3.
Bacitracin 4 to 50 ....
2. Broiler chickens: As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria
acervulina, E. maxima, and E. brunetti
is likely to occur; for improved feed efficiency.
(6) Amprolium 113.5
and ethopabate
3.6.
Bambermycins 1 to
3.
(7) Amprolium 113.5
and ethopabate
36.3.
Virginiamycin 15 ......
Feed continuously as the sole ration; as
sole source of amprolium. Do not feed
to laying chickens. Not for chickens
over 16 weeks of age.
Virginiamycin as provided by No. 066104
in § 510.600(c) of this chapter.
066104
(8) Amprolium 113.5
and ethopabate
36.3.
Virginiamycin 5 to
15.
.................................
Feed continuously as the sole ration; as
sole source of amprolium. Do not feed
to laying chickens. Not for chickens
over 16 weeks of age.
Virginiamycin as provided by No. 066104
in § 510.600(c) of this chapter.
Not for laying chickens .............................
066104
(9) Amprolium 227
and ethopabate
3.6.
(10) Amprolium 227
and ethopabate
3.6.
Broiler chickens: As an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria
acervulina, E. maxima, and E. brunetti
is likely to occur; for increased rate of
weight gain, improved feed efficiency.
Broiler chickens; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria
acervulina, E. maxima, and E. brunetti
is likely to occur; for increased rate of
weight gain and improved feed efficiency.
Broiler chickens; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria
acervulina, E. maxima, and E. brunetti
is likely to occur; for increased rate of
weight gain.
For broiler chickens and replacement
chickens where immunity to coccidiosis
is not desired; prevention of coccidiosis.
For chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infectious synovitis
caused by Mycoplasma synoviae susceptible to chlortetracycline.
For chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of chronic respiratory
disease (CRD) and air sac infection
caused by M. gallisepticum and E. coli
susceptible to chlortetracycline.
Feed as the sole ration from the time
chickens are placed on litter until past
the time when coccidiosis is ordinarily
a hazard. Not for chickens over 16
weeks of age; do not feed to laying
chickens; as sole source of amprolium;
not for use as a treatment for outbreaks of coccidiosis. Bacitracin as
bacitracin methylene disalicylate as
provided by No. 054771 in § 510.600(c)
of this chapter.
Feed as the sole ration from the time
chickens are placed on litter until market weight. Not for chickens over 16
weeks of age; do not feed to laying
chickens; as sole source of amprolium;
not for use as a treatment for coccidiosis. Bacitracin zinc as provided by No.
054771 in § 510.600(c) of this chapter.
Feed continuously as the sole ration; as
sole source of amprolium.
Bambermycins as provided by No.
016592 in § 510.600(c) of this chapter.
016592
(5) Amprolium 113.5
and ethopabate
36.3.
TKELLEY on DSK3SPTVN1PROD with RULES
Amprolium and
ethopabate in grams
per ton
Do not feed to chickens producing eggs
for human consumption. Feed for 7 to
14 days.
054771
In low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate;
feed continuously as sole ration for 7 to
14 days; do not feed to chickens producing eggs for human consumption.
054771
(11) Amprolium 227
and ethopabate
3.6.
VerDate Mar<15>2010
Chlortetracycline
100 to 200.
Chlortetracycline
200 to 400.
16:18 Feb 26, 2014
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054771
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054771
016592
016592
10982
§ 558.62
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
[Removed]
§ 558.95
7. Remove § 558.62.
■ 8. In § 558.76, revise paragraph (d)(3)
to read as follows:
■
§ 558.76
Bacitracin methylene disalicylate.
*
*
*
*
*
(d) * * *
(3) Bacitracin methylene disalicylate
may also be used in combination with:
(i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in
§ 558.58.
(iii) Decoquinate as in § 558.195.
(iv) Diclazuril as in § 558.198.
(v) Fenbendazole as in § 588.258.
(vi) Halofuginone as in § 558.265.
(vii) Hygromycin B as in § 588.274.
(viii) Ivermectin as in § 558.300.
(ix) Lasalocid sodium as in § 558.311.
(x) Monensin as in § 588.355.
(xi) Narasin as in § 558.363.
(xii) Nicarbazin alone and with
narasin as in § 558.366.
(xiii) Nitarsone as in § 558.369.
(xiv) Robenidine as in § 558.515.
(xv) Salinomycin as in § 558.550.
(xvi) Semduramicin as in § 558.555.
(xvii) Zoalene as in § 558.680.
■ 9. In § 558.78, revise paragraph (d)(3)
to read as follows:
§ 558.78
Bacitracin zinc.
*
*
*
*
*
(d) * * *
(3) Bacitracin zinc may also be used
in combination with:
(i) Amprolium and ethopabate as in
§ 558.58.
(ii) Clopidol as in § 558.175.
(iii) Decoquinate as in § 558.195.
(iv) Lasalocid as in § 558.311.
(v) Monensin as in § 558.355.
(vi) Naracin as in § 558.363.
(vii) Nitarsone as in § 558.369.
(viii) Robenidine as in § 558.515.
(ix) Salinomycin as in § 558.550.
■ 10. In § 558.95, revise paragraph (d)(5)
to read as follows:
Bambermycins.
*
*
*
*
*
(d) * * *
(5) Bambermycins may also be used in
combination with:
(i) Amprolium as in § 558.55.
(ii) Amprolium and ethopabate as in
§ 558.58.
(iii) Clopidal as in § 558.175.
(iv) Diclazuril as in § 558.198.
(v) Halofuginone as in § 558.265.
(vi) Lasalocid as in § 558.311.
(vii) Monensin as in § 558.355.
(viii) Narasin alone or with nicarbazin
as in § 558.363.
(ix) Nicarbazin as in § 558.366.
(x) Salinomycin as in § 558.550.
(xi) Zoalene as in § 558.680.
§ 558.120
[Removed]
11. Remove § 558.120.
12. In § 558.128, revise paragraph
(e)(7) to read as follows:
through (11) as paragraphs (d)(7)
through (9), respectively.
§ 558.195
[Amended]
14. In § 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.
■
§ 558.198
[Amended]
15. In § 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.
■ 16. In § 558.248, remove paragraph
(d)(3); and revise the section heading to
read as follows:
■
■
§ 558.248
■
*
§ 558.128
Chlortetracycline.
*
*
*
*
*
(e) * * *
(7) Chlortetracycline may also be used
in combination with:
(i) Amprolium and ethopabate as in
§ 558.58.
(ii) Bacitracin methylene disalicylate
as in § 558.76.
(iii) Clopidol as in § 558.175.
(iv) Decoquinate as in § 558.195.
(v) Hygromycin B as in § 558.274.
(vi) Laidlomycin as in § 558.305.
(vii) Lasalocid as in § 558.311.
(viii) Monensin as in § 558.355.
(ix) Robenidine as in § 558.515.
(x) Salinomycin as in § 558.550.
(xi) Tiamulin as in § 558.600.
§ 558.175
[Amended]
13. In § 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)
■
Erythromycin.
*
*
*
*
■ 17. In § 558.265, remove and reserve
paragraphs (d)(1)(v) and (viii) and
(d)(3)(ii) and revise the section heading
to read as follows:
§ 558.265
Halofuginone.
*
*
*
*
*
■ 18. Revise § 558.274 to read as
follows:
§ 558.274
Hygromycin B.
(a) Approvals. See sponsor numbers
in § 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 § 556.330
of this chapter.
(c) Conditions of use. It is used in feed
as follows:
(1) Chickens—
Combination in
grams per ton
Indications for use
Limitations
(i) 8 to 12 .................
.................................
Tylosin 4 to 50 ........
Chickens: For control of infestation of
large roundworms (Ascaris galli), cecal
worms (Heterakis gallinae), and capillary worms (Capillaria obsignata).
Chickens: For control of infestations of
large roundworms (Ascaris galli), cecal
worms (Heterakis gallinae), and capillary worms (Capillaria obsignata);
growth promotion and feed efficiency.
Withdraw 3 days before slaughter ............
(ii) 8 to 12 ................
TKELLEY on DSK3SPTVN1PROD with RULES
Hygromycin B in
grams per ton
Withdraw 3 days before slaughter.
Tylosin as tylosin phosphate as provided by No. 000986 in § 510.600 of
this chapter.
(2) Swine—
VerDate Mar<15>2010
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27FER1
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000986
012286
017790
054771
000986
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
Hygromycin B in
grams per ton
Combination in
grams per ton
Indications for use
Limitations
(i) 12 ........................
.................................
Withdraw 15 days before slaughter ..........
(ii) 12 .......................
Tylosin 10 to 100 ....
Swine: For control of infestation of large
roundworms (Ascaris suis), nodular
worms (Oesophagostomum dentatum),
and whipworms (Trichuris suis).
Swine: For control of infestations of large
roundworms (Ascaris suis), nodular
worms (Oesophagostomum dentatum),
and whipworms (Trichuris suis); growth
promotion and feed efficiency.
1 Amount
19. In § 558.311:
a. In paragraph (e)(1)(ii), remove the
entries for:
■ i.Roxarsone 45.4 (0.005 pct);
■ ii. Roxarsone 45.4 plus bambermycins
1 (0.00011 pct);
■ iii. Roxarsone 45.4 plus lincomycin
2.0;
■ iv. Roxarsone 45.4 plus bacitracin 10
to 25;
■ v. Roxarsone 45.4 plus bacitracin 10
or 30; and
■ vi. Roxarsone 45.4 plus bacitracin
methylene disalicylate 50’’;
■ b. In paragraph (e)(1)(xv), remove the
entry for ‘‘Roxarsone 22.7 to 45.4’’; and
■ c. Revise paragraph (e)(5).
The revision reads as follows:
*
*
*
*
(e) * * *
(5) Lasalocid may also be used in
combination with:
(i) Melengestrol acetate alone or in
combination with tylosin as in
§ 558.342.
(ii) [Reserved]
■ 20. In § 558.325, revise paragraph
(d)(3) to read as follows:
16:18 Feb 26, 2014
§ 558.340
Maduramicin.
*
*
*
§ 558.355
Jkt 232001
*
*
000986
012286
017790
054771
000986
22. In § 558.355:
a. Remove and reserve paragraphs
(f)(1)(ii), (vii), (x), (xi), (xii), (xv), (xvi),
(xvii), (xviii), (xix), (xx), (xxiii), (xxvi),
and (xxvii);
■ b. Remove and reserve paragraphs
(f)(4)(vi) and (vii); and
■ c. Remove the second instance of a
paragraph designated (f)(4)(iv)
(following (f)(4)(vii).
■
■
§ 558.366
[Amended]
[Amended]
24. In the table in § 558.366(d):
a. In the ‘‘Nicarbazin in grams per
ton’’ column, following the entry for ‘‘27
to 45’’, remove the row entries for:
■ i. Narasin 27 to 45, bacitracin
methylene disalicylate 50, and
roxarsone 22.7 to 45.4; and
■ ii. Narasin 27 to 45 and roxarsone 22.7
to 45.4;
■ 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
■ c. In the ‘‘Nicarbazin in grams per
ton’’ column, following the entry for
■
■
PO 00000
Frm 00033
Fmt 4700
‘‘113.5 (0.0125 pct)’’, remove the row
entries for:
■ i. Roxarsone 22.7 (0.0025); and
■ ii. Roxarsone 22.7 (0.0025) plus
lincomycin 2 (0.0004).’’
§ 558.460
[Amended]
23. In § 558.363:
a. Remove and reserve paragraphs
(a)(2), (a)(5) and (a)(6);
■ b. Remove paragraphs (d)(1)(ii), (v),
(vii), (viii), and (ix) and (d)(3)(iii) and
(iv); and
■ 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).
*
*
*
*
(d) * * *
(3) Lincomycin may also be used in
combination with:
(i) Amprolium and ethopabate as in
§ 558.58.
(ii) Clopidol as in § 558.175.
(iii) Decoquinate as in § 558.195.
(iv) Fenbendazole as in § 588.258.
(v) Halofuginone as in § 558.265.
(vi) Ivermectin as in § 558.300.
(vii) Lasalocid sodium as in § 558.311.
(viii) Monensin as in § 588.355.
(ix) Nicarbazin alone and with narasin
as in § 558.366.
(x) Pyrantel as in § 558.485.
(xi) Robenidine as in § 558.515.
(xii) Salinomycin as in § 558.550.
VerDate Mar<15>2010
(xiii) Zoalene as in § 558.680.
21. In § 558.340, revise the section
heading to read as follows:
■
■
Lincomycin.
*
TKELLEY on DSK3SPTVN1PROD with RULES
Feed continuously as follows: Animal
weight (lbs.):
Up to 40 . . . 20 to 100 1
41 to 100 . . . 20 to 40 1
101 to market weight . . . 10 to 20 1
Withdraw 15 days before slaughter.
Tylosin as tylosin phosphate as provided by No. 000986 in § 510.600 of
this chapter.
■
§ 558.363
Lasalocid.
*
§ 558.325
Sponsor
of Tylosin (g/t).
■
■
§ 558.311
10983
Sfmt 4700
[Amended]
25. In § 558.460, remove and reserve
paragraph (d)(2).
■
26. In § 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:
■
§ 558.515
Robenidine.
*
*
*
§ 558.530
■
*
*
[Removed]
27. Remove § 558.530.
§ 558.550
[Amended]
28. In § 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).
■
§ 558.555
[Amended]
29. In § 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.
■
§ 558.575
[Amended]
30. In § 558.575, remove and reserve
paragraph (d)(1)(ii).
■
31. In § 558.680, revise paragraph (d)
to read as follows:
■
§ 558.680
*
Zoalene.
*
*
*
*
(d) Conditions of use—(1) Chickens—
E:\FR\FM\27FER1.SGM
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Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
Zoalene in grams/ton
Combination in
grams per ton
Indications for use
Limitations
(i) 36.3 to 113.5 .......
.................................
Replacement chickens: For development
of active immunity to coccidiosis.
Grower ration not to be fed to birds over
14 weeks of age; as follows:
Starter ration
Grams per ton
Growing conditions
Severe exposure ......................................................................................................................
113.5 (0.0125%)
Light to moderate exposure .....................................................................................................
75.4–113.5
(0.0083%–0.0125%)
Zoalene in grams/ton
Combination in
grams per ton
Indications for use
Bacitracin methylene Replacement chickens: For development
disalicylate 4 to 50.
of active immunity to coccidiosis; and
for increased rate of weight gain and
improved feed efficiency.
(iii) 36.3–113.5 ........
Bacitracin methylene
disalicylate 50.
(iv) 36.3–113.5 ........
Bacitracin methylene
disalicylate 100 to
200.
(v) 113.5 ..................
.................................
(vii) 113.5 ................
(viii) 113.5 ................
Broiler chickens: For prevention and control of coccidiosis.
Bacitracin methylene Broiler chickens: As an aid in the prevendisalicylate 4 to 50.
tion and control of coccidiosis; and for
increased rate of weight gain and improved feed efficiency.
Bacitracin methylene Broiler chickens: For prevention and condisalicylate 50.
trol of coccidiosis; and as an aid in the
prevention of necrotic enteritis caused
or complicated by Clostridium spp. or
other organisms susceptible to bacitracin.
Bacitracin methylene Broiler chickens: For prevention and condisalicylate 100 to
trol of coccidiosis; and as an aid in the
200.
control of necrotic enteritis caused or
complicated by Clostridium spp. or
other organisms susceptible to bacitracin.
TKELLEY on DSK3SPTVN1PROD with RULES
(ix) 113.5 .................
Bambermycins 1 .....
(x) 113.5 ..................
Lincomycin 2 ...........
VerDate Mar<15>2010
Replacement chickens: For development
of active immunity to coccidiosis; and
as an aid in the prevention of necrotic
enteritis caused or complicated by
Clostridium spp. or other organisms
susceptible to bacitracin.
Replacement chickens: For development
of active immunity to coccidiosis; and
as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
16:18 Feb 26, 2014
Jkt 232001
Broiler chickens: As an aid in the prevention and control of coccidiosis; and for
increased rate of weight gain and improved feed efficiency.
Broiler chickens: As an aid in the prevention and control of coccidiosis; and for
increased rate of weight gain and improved feed efficiency.
PO 00000
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054771
Grower ration
Grams per ton
75.4–113.5
(0.0083%–0.0125%)
36.3–75.4
(0.004%–0.0083%)
Limitations
(ii) 36.3–113.5 .........
(vi) 113.5 .................
Sponsor
Sponsor
Feed continuously as sole ration as in
subtable in item (i). Grower ration not
to be fed to birds over 14 weeks of
age. Bacitracin methylene disalicylate
as provided by No. 054771 in
§ 510.600(c) of this chapter.
Feed continuously as sole ration as in
subtable in item (i). Grower ration not
to be fed to birds over 14 weeks of
age. Bacitracin methylene disalicylate
as provided by No. 054771 in
§ 510.600(c) of this chapter.
Feed continuously as sole ration as in
subtable in item (i). To control necrotic
enteritis, start medication at first clinical
signs of disease; vary bacitracin dosage based on the severity 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
§ 510.600(c) of this chapter.
Feed continuously as sole ration ..............
054771
Feed continuously as sole ration. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of
this chapter.
Feed continuously as sole ration. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of
this chapter.
054771
Feed continuously as sole ration. To control necrotic enteritis, start medication
at first clinical signs of disease; vary
bacitracin dosage based on the severity 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 § 510.600(c) of
this chapter.
Feed continuously as sole ration. Do not
feed to chickens over 14 weeks of age.
Bambermycins as provided by No.
016592 in § 510.600(c) of this chapter.
Feed continuously as sole ration. Do not
feed to laying chickens. As lincomycin
hydrochloride monohydrate provided by
No. 054771 in § 510.600(c) of this
chapter.
E:\FR\FM\27FER1.SGM
27FER1
054771
054771
054771
054771
054771
016592
054771
Federal Register / Vol. 79, No. 39 / Thursday, February 27, 2014 / Rules and Regulations
10985
(2) Turkeys—
Zoalene in grams/ton
Combination in
grams per ton
Indications for use
Limitations
(i) 113.5 to 170.3 .....
.................................
Growing turkeys: For prevention and control of coccidiosis.
(ii) 113.5 to 170.3 ....
Bacitracin methylene Growing turkeys: For prevention and condisalicylate 4 to 50.
trol of coccidiosis; and for increased
rate of weight gain and improved feed
efficiency.
Feed continuously as sole ration. For turkeys grown for meat purposes only. Do
not feed to laying birds.
Feed continuously as sole ration until 14
to 16 weeks of age. For turkeys grown
for meat purposes only. Do not feed to
laying 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
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–370]
Schedules of Controlled Substances:
Placement of Alfaxalone into Schedule
IV
Drug Enforcement
Administration, Department of Justice.
AGENCY:
ACTION:
Final rule.
With the issuance of this final
rule, the Administrator of the Drug
Enforcement Administration (DEA)
places the substance 5a-pregnan-3a-ol11,20-dione (alfaxalone), including its
salts, isomers, and salts of isomers, into
schedule IV of the Controlled
Substances Act (CSA). This scheduling
action is pursuant to the CSA which
requires that such actions be made on
the record after opportunity for a
hearing through formal rulemaking.
This action imposes the regulatory
controls and administrative, civil, and
criminal sanctions applicable to
schedule IV controlled substances on
persons who handle (manufacture,
distribute, dispense, import, export,
engage in research, conduct
instructional activities with, or possess)
or propose to handle alfaxalone and
substances containing alfaxalone.
SUMMARY:
TKELLEY on DSK3SPTVN1PROD with RULES
DATES:
Effective Date: March 31, 2014.
FOR FURTHER INFORMATION CONTACT:
Ruth A. Carter, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
16:18 Feb 26, 2014
Jkt 232001
Legal Authority
The DEA implements and enforces
titles II and III of the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, as amended. Titles II and III are
referred to as the ‘‘Controlled
Substances Act’’ and the ‘‘Controlled
Substances Import and Export Act,’’
respectively, and are collectively
referred to as the ‘‘Controlled
Substances Act’’ or the ‘‘CSA’’ for the
purpose of this action. 21 U.S.C. 801–
971. The DEA publishes the
implementing regulations for these
statutes in title 21 of the Code of Federal
Regulations (CFR), parts 1300 to 1321.
The CSA and its implementing
regulations are designed to prevent,
detect, and eliminate the diversion of
controlled substances and listed
chemicals into the illicit market while
providing for the legitimate medical,
scientific, research, and industrial needs
of the United States. Controlled
substances have the potential for abuse
and dependence and are controlled to
protect the public health and safety.
Under the CSA, controlled substances
are classified into one of five schedules
based upon their potential for abuse,
their currently accepted medical use,
and the degree of dependence the
substance may cause. 21 U.S.C. 812. The
initial schedules of controlled
substances established by Congress are
found at 21 U.S.C. 812(c), and the
current list of all scheduled substances
is published at 21 CFR part 1308.
Pursuant to 21 U.S.C. 811(a)(1), the
Attorney General may, by rule, ‘‘add to
such a schedule or transfer between
such schedules any drug or other
substance if he (A) finds that such drug
or other substance has a potential for
abuse, and (B) makes with respect to
such drug or other substance the
findings prescribed by [21 U.S.C. 812(b)]
for the schedule in which such drug is
to be placed . . ..’’ Pursuant to 28 CFR
0.100(b), the Attorney General has
delegated this scheduling authority to
the Administrator of the DEA. 28 CFR
0.104.
The CSA provides that scheduling of
any drug or other substance may be
PO 00000
Frm 00035
Fmt 4700
Sfmt 4700
Sponsor
054771
054771
initiated by the Attorney General (1) on
his own motion; (2) at the request of the
Secretary of the Department of Health
and Human Services (HHS),1 or (3) on
the petition of any interested party. 21
U.S.C. 811(a). This action is based on a
recommendation from the Assistant
Secretary of the HHS and on an
evaluation of all other relevant data by
the DEA. This action imposes the
regulatory controls and administrative,
civil, and criminal sanctions applicable
to schedule IV controlled substances on
persons who handle or propose to
handle alfaxalone.
Background
Alfaxalone (5a-pregnan-3a-ol-11,20dione, previously spelled
‘‘alphaxalone’’), a substance with
central nervous system (CNS)
depressant properties, is a neurosteroid
that is a derivative of 11-alpha-hydroxyprogesterone. On October 23, 2012, the
Food and Drug Administration (FDA)
published a final rule to approve a New
Animal Drug Application (NADA, 141–
342) for alfaxalone (Alfaxan®), as an
intravenous injectable anesthetic, for the
induction and maintenance of
anesthesia and for induction of
anesthesia followed by maintenance of
anesthesia with an inhalant anesthetic,
in cats and dogs (77 FR 64715).
Alfaxalone primarily acts as an agonist
at the gamma-aminobutyric acid
(GABA) receptor-channel complex, with
a mechanism of action at this site
similar to that of barbiturates like
phenobarbital (schedule IV) and
methohexital (schedule IV),
benzodiazepines such as diazepam
(schedule IV) and midazolam (schedule
IV), as well as the anesthetic agents
1 As set forth in a memorandum of understanding
entered into by the HHS, the Food and Drug
Administration (FDA), and the National Institute on
Drug Abuse (NIDA), the FDA acts as the lead agency
within the HHS in carrying out the Secretary’s
scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1995. In
addition, because the Secretary of the HHS has
delegated to the Assistant Secretary for Health of
the HHS the authority to make domestic drug
scheduling recommendations, for purposes of this
document, all subsequent references to ‘‘Secretary’’
have been replaced with ‘‘Assistant Secretary.’’
E:\FR\FM\27FER1.SGM
27FER1
]]>Agencies
[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10976-10985]
From the Federal Register Online via the Government Printing 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, john.bartkowiak@fda.hhs.gov.
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.
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[[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
