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

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Start Preamble

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.

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Recently, the Agency provided notice of the withdrawal of approval of NADAs for Type A medicated articles containing Start Printed Page 10977arsanilic 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/ANADAIngredient new animal drugs
040-4353-NITRO (roxarsone)/DECCOX (decoquinate).
041-178Roxarsone/AMPROL Plus (amprolium and ethopabate)/LINCOMIX (lincomycin).
041-984Roxarsone/ROFENAID (sulfadimethoxine/ormetoprim).
091-3263-NITRO (roxarsone)/DECCOX (decoquinate)/ALBAC (bacitracin zinc).
092-522Roxarsone/COBAN (monensin)/LINCOMIX (lincomycin).
095-546Roxarsone/ROBENZ (robenidine).
102-4853-NITRO (roxarsone)/AVATEC (lasalocid).
105-7583-NITRO (roxarsone)/AMPROL HI-E (amprolium and ethopabate)/BACIFERM (bacitracin zinc).
112-6613-NITRO (roxarsone)/AVATEC (lasalocid)/LINCOMIX (lincomycin).
112-6873-NITRO (roxarsone)/AVATEC (lasalocid)/FLAVOMYCIN (bambermycins).
116-0823-NITRO (roxarsone)/AVATEC (lasalocid)/BMD (bacitracin MD).
116-0883-NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD).
123-1543-NITRO (roxarsone)/BACIFERM (bacitracin zinc)/COBAN (monensin).
126-0523-NITRO (roxarsone)/AVATEC (lasalocid)/BACIFERM (bacitracin zinc).
131-8943-NITRO (roxarsone)/AVATEC (lasalocid)/bacitracin MD.
132-447Roxarsone/BIO-COX (salinomycin).
134-1853-NITRO (roxarsone)/BIO-COX (salinomycin)/FLAVOMYCIN (bambermycins).
135-3213-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD (bacitracin MD).
137-5363-NITRO (roxarsone)/BIO-COX/ALBAC (bacitracin zinc).
138-7033-NITRO (roxarsone)/COBAN (monensin)/ALBAC (bacitracin zinc).
139-1903-NITRO (roxarsone)/BIO-COX (salinomycin)/BACIFERM (bacitracin zinc).
140-5813-NITRO (roxarsone)/BIO-COX (salinomycin)/LINCOMIX (lincomycin).
140-8523-NITRO (roxarsone)/MONTEBAN/BMD (bacitracin MD).
140-8673-NITRO (roxarsone)/BIO-COX (salinomycin)/AUREOMYCIN (chlortetracycline).
141-1003-NITRO (roxarsone)/DECCOX (decoquinate)/BMD (bacitracin MD).
141-1123-NITRO (roxarsone)/MAXIBAN (narasin and nicarbazin)/BMD (bacitracin MD).
141-1213-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD (bacitracin MD).
141-1313-NITRO (roxarsone)/ZOAMIX (zoalene)/BMD (bacitracin MD).
141-1353-NITRO (roxarsone)/BIO-COX (salinomycin).
141-1383-NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD).
141-1393-NITRO (roxarsone)/COBAN (monensin).
141-1423-NITRO (roxarsone)/AMPROL (amprolium)/BMD (bacitracin MD).
141-1553-NITRO (roxarsone)/ROBENZ (robenidine)/BMD (bacitracin MD).
141-1573-NITRO (roxarsone)/STENOROL (halofuginone).
141-2233-NITRO (roxarsone)/CLINACOX (diclazuril).
141-2933-NITRO (roxarsone)/AVATEC (lasalocid).
200-2063-NITRO (roxarsone)/ALBAC (bacitracin zinc)/DECCOX (decoquinate).
200-2073-NITRO (roxarsone)/ALBAC (bacitracin zinc)/COYDEN 25 (clopidol).
200-2083-NITRO (roxarsone)/ALBAC (bacitracin zinc)/AVATEC (lasalocid).
200-2093-NITRO (roxarsone)/ALBAC (bacitracin zinc)/SACOX (salinomycin).
200-2143-NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI-E (amprolium and ethopabate).
200-2113-NITRO (roxarsone)/ALBAC (bacitracin zinc)/COBAN (monensin).
200-2153-NITRO (roxarsone)/ALBAC (bacitracin zinc)/BIO-COX (salinomycin).
200-2173-NITRO (roxarsone)/ALBAC (bacitracin zinc)/AMPROL HI-E (amprolium and ethopabate).
200-2593-NITRO (roxarsone)/SACOX (salinomycin)/CHLORMAX (chlortetracycline).
200-2603-NITRO (roxarsone)/BIO-COX (salinomycin)/CHLORMAX (chlortetracycline).
038-879CARB-O-SEP (carbarsone)/ZOAMIX (zoalene).
039-646CARB-O-GAIN (carbarsone)/BMD (bacitracin MD).
136-484CARB-O-SEP (carbarsone)/BACIFERM (bacitracin zinc).
200-203CARB-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/ANADAIngredient new animal drugs
013-4613-NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate).
040-2643-NITRO (roxarsone)/COYDEN 25 (clopidol).
041-5413-NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD (bacitracin MD).
044-016Roxarsone + bacitracin Zinc/COYDEN 25 (clopidol).
Start Printed Page 10978
049-179Roxarsone/AMPROL HI-E (amprolium and ethopabate).
049-180Roxarsone/AMPROL HI-E (amprolium and ethopabate)/BMD (bacitracin MD).
095-5473-NITRO (roxarsone)/AMPROL HI-E (amprolium and ethopabate)/FLAVOMYCIN (bambermycins).
095-5483-NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins).
095-5493-NITRO (roxarsone)/AMPROL (amprolium)/FLAVOMYCIN (bambermycins).
098-3413-NITRO (roxarsone)/COBAN (monensin)/FLAVOMYCIN (bambermycins).
101-6283-NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/zoalene.
140-5333-NITRO (roxarsone)/STENOROL (halofuginone)/BMD (bacitracin MD).
140-8433-NITRO (roxarsone)/MONTEBAN (narasin)/FLAVOMYCIN (bambermycins).
141-1903-NITRO (roxarsone)/LINICOX (diclazuril)/BMD (bacitracin MD).
200-0803-NITRO (roxarsone)/SACOX (salinomycin)/FLAVOMYCIN (bambermycins).
200-0813-NITRO (roxarsone)/SACOX (salinomycin)/BMD (bacitracin MD).
200-0863-NITRO (roxarsone)/SACOX (salinomycin)/ALBAC (bacitracin zinc).
200-0903-NITRO (roxarsone)/SACOX (salinomycin)/LINCOMIX (lincomycin).
200-0913-NITRO (roxarsone)/SACOX (salinomycin)/AUREOMYCIN (chlortetracycline).
200-0943-NITRO (roxarsone)/SACOX (salinomycin)/STAFAC (virginiamycin).
200-0973-NITRO (roxarsone)/SACOX (salinomycin).
200-1433-NITRO (roxarsone)/SACOX (salinomycin)/BACIFERM (bacitracin zinc).
118-507CARB-O-SEP (carbarsone)/AMPROL (amprolium).
130-661CARB-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/ANADAIngredient new animal drugs
107-997Roxarsone/NICARB (nicarbazin)/LINCOMIX (lincomycin).
108-115Roxarsone/NICARB (nicarbazin).
120-7243-NITRO (roxarsone)/STAFAC (virginiamycin)/COBAN (monensin).
138-9533-NITRO (roxarsone)/STAFAC (virginiamycin)/BIO-COX (salinomycin).
141-0583-NITRO (roxarsone)/AVIAX (semduramycin)/BMD (bacitracin MD).
141-0663-NITRO (roxarsone)/AVIAX (semduramycin).
141-226Roxarsone/AVIAX (semduramycin)/STAFAC (virginiamycin).
200-1703-NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/LINCOMIX (lincomycin).
200-1723-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:
NADAIngredient new animal drugs
041-5003-NITRO (roxarsone)/COBAN (monensin).
049-464Roxarsone/monensin/bacitracin.
140-445Roxarsone/MONTEBAN (narasin).
141-1133-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:
NADAIngredient new animal drugs
038-241PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin)/zoalene.
038-242PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin)/amprolium + ethopabate.
038-624PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin).
  • Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144 has requested that FDA withdraw approval of the following ANADA:
NADAIngredient new animal drugs
200-3553-NITRO (roxarsone)/PENNCHLOR (chlortetracycline)/BIO-COX (salinomycin).
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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.

Start List of Subjects

List of Subjects

21 CFR Parts 556

  • Animal drugs
  • Food

21 CFR Parts 558

  • Animal drugs
  • Animal feeds
End List of Subjects

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:

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

End Part Start Amendment Part

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

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

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2. Revise § 556.60 to read as follows:

End Amendment Part
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 § 558.369 of this chapter.

Start Part

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

End Part Start Amendment Part

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

End Amendment Part Start Authority

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

End Authority
[Amended]
Start Amendment Part

4. In § 558.4, in paragraph (d), in the “Category II” table:

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a. Remove the entries for “Arsanilate acid”, “Carbarsone”, and “Sulfaquinoxaline”;

End Amendment Part Start Amendment Part

b. Remove the row entries under “Nitarsone” for “Sulfanitran” and “Roxarsone”.

End Amendment Part Start Amendment Part

c. Remove the four entries for “Roxarsone” and their respective following row entries; and

End Amendment Part Start Amendment Part

d. In the fourth entry for “Sulfamethazine,” remove its three following row entries for “Aklomide” and two following row entries for “Roxarsone”.

End Amendment Part Start Amendment Part

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

End Amendment Part
Amprolium.
* * * * *

(d) * * *

(1) Cattle. It is used as follows:

Amprolium in grams per tonIndications for useLimitationsSponsor
(i) 113.5 to 11, 350; to provide 5 milligrams per kilogram of body weight per dayCalves: As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zuerniiTop-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 veal016592
(ii) 113.5 to 11, 350; to provide 10 milligrams per kilogram of body weight per dayCalves: As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zuerniiTop-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 veal016592

(2) Chickens. It is used as follows:

Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 36.3 to 113.5Replacement chickens: For development of active immunity to coccidiosisFeed continuously until onset of production as follows:016592
Growing conditionsUp to 5 weeks of ageFrom 5 to 8 weeks of ageOver 8 weeks of age
Amprolium in grams per tonAmprolium in grams per tonAmprolium in grams per ton
Severe exposure to coccidiosis113.572.6-113.536.3-113.5
(0.0125%)(0.008%-0.0125%)(0.004%-0.0125%)
Moderate exposure to coccidiosis72.6-113.554.5-113.536.3-113.5
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(0.008%-0.0125%)(0.006%-0.0125%)(0.004%-0.0125%)
Slight exposure to coccidiosis36.3-113.536.3-113.536.3-113.5
(0.004%-0.0125%)(0.004%-0.0125%)(0.004%-0.0125%)
Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(ii) 36.3 to 113.5Bacitracin methylene disalicylate 4 to 50Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed according to subtable in item (i). Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter054771
(iii) 72.6 to 113.5Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella onlyFeed continuously as the sole ration; as sole source of amprolium016592
(iv) 72.6 to 113.5Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter016592
(v) 113.51. Laying chickens: For prevention of coccidiosisFeed continuously as the sole ration; as the sole source of amprolium016592
2. Laying chickens: For treatment of coccidiosis in moderate outbreaksFeed for 2 weeks
(vi) 113.5 to 2271. Replacement chickens: For prevention of coccidiosis where immunity to coccidiosis is not desiredFeed continuously from day-old until onset of production; as the sole source of amprolium016592
2. Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desiredFeed continuously as the sole ration; as sole source of amprolium
(vii) 113.5 to 227Bambermycins 1 to 2Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter016592
(viii) 227Laying chickens: For treatment of coccidiosis in severe outbreaks.Feed for 2 weeks016592

(3) Turkeys. It is used as follows:

Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 113.5Bambermycins 1 to 4Growing turkeys: For prevention of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as the sole source of amprolium; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter016592
(ii) 113.5 to 227Turkeys: For prevention of coccidiosisFeed continuously as the sole ration; as sole source of amprolium016592

(4) Pheasants. It is used as follows:

Amprolium in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 159Growing pheasants: For the prevention of coccidiosis caused by Eimeria colchici, E. duodenalis, and E. phasianiFeed continuously as sole ration. Use as sole source of amprolium016592
(ii) [Reserved]
Start Amendment Part

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

End Amendment Part
Amprolium and ethopabate.
* * * * *

(e) Conditions of use. It is used in chicken feed as follows:Start Printed Page 10981

Amprolium and ethopabate in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(1) Amprolium 113.5 and ethopabate 3.6Broiler chickens: As an aid in the prevention of coccidiosisFeed continuously as sole ration; as sole source of amprolium. Not for laying chickens016592
(2) Amprolium 113.5 and ethopabate 3.6Lincomycin 2 to 4Broiler chickens: As an aid in the prevention of coccidiosis; for increased rate of weight gain and improved feed efficiencyFeed 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 chapter054771
(3) Amprolium 113.5 and ethopabate 36.3Broiler 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 occurFeed continuously as sole ration; as sole source of amprolium. Not for chickens over 16 weeks of age016592
(4) Amprolium 113.5 and ethopabate 36.3Bacitracin 4 to 501. 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 pensFeed 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 chapter016592
(5) Amprolium 113.5 and ethopabate 36.3Bacitracin 4 to 502. 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 efficiencyFeed 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 chapter054771
(6) Amprolium 113.5 and ethopabate 3.6Bambermycins 1 to 3Broiler 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 efficiencyFeed continuously as the sole ration; as sole source of amprolium Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter016592
(7) Amprolium 113.5 and ethopabate 36.3Virginiamycin 15Broiler 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 efficiencyFeed 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 chapter066104
(8) Amprolium 113.5 and ethopabate 36.3Virginiamycin 5 to 15Broiler 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 gainFeed 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 chapter066104
(9) Amprolium 227 and ethopabate 3.6For broiler chickens and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosisNot for laying chickens016592
(10) Amprolium 227 and ethopabate 3.6Chlortetracycline 100 to 200For chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracyclineDo not feed to chickens producing eggs for human consumption. Feed for 7 to 14 days054771
(11) Amprolium 227 and ethopabate 3.6Chlortetracycline 200 to 400For 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 chlortetracyclineIn 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 consumption054771
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[Removed]
Start Amendment Part

7. Remove § 558.62.

End Amendment Part Start Amendment Part

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

End Amendment Part
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.

Start Amendment Part

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

End Amendment Part
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.

Start Amendment Part

10. In § 558.95, revise paragraph (d)(5) to read as follows:

End Amendment Part
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.

[Removed]
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11. Remove § 558.120.

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

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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.

[Amended]
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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) through (11) as paragraphs (d)(7) through (9), respectively.

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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.

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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.

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

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Erythromycin.
* * * * *
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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:

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Halofuginone.
* * * * *
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18. Revise § 558.274 to read as follows:

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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

Hygromycin B in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 8 to 12Chickens: For control of infestation of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata)Withdraw 3 days before slaughter000986 012286 017790 054771
(ii) 8 to 12Tylosin 4 to 50Chickens: For control of infestations of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata); growth promotion and feed efficiencyWithdraw 3 days before slaughter. Tylosin as tylosin phosphate as provided by No. 000986 in § 510.600 of this chapter000986

(2) SwineStart Printed Page 10983

Hygromycin B in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 12Swine: For control of infestation of large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum), and whipworms (Trichuris suis)Withdraw 15 days before slaughter000986 012286 017790 054771
(ii) 12Tylosin 10 to 100Swine: For control of infestations of large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum), and whipworms (Trichuris suis); growth promotion and feed efficiencyFeed 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 chapter000986
1 Amount of Tylosin (g/t).
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19. In § 558.311:

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a. In paragraph (e)(1)(ii), remove the entries for:

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i.Roxarsone 45.4 (0.005 pct);

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ii. Roxarsone 45.4 plus bambermycins 1 (0.00011 pct);

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iii. Roxarsone 45.4 plus lincomycin 2.0;

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iv. Roxarsone 45.4 plus bacitracin 10 to 25;

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v. Roxarsone 45.4 plus bacitracin 10 or 30; and

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vi. Roxarsone 45.4 plus bacitracin methylene disalicylate 50”;

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b. In paragraph (e)(1)(xv), remove the entry for “Roxarsone 22.7 to 45.4”; and

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c. Revise paragraph (e)(5).

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The revision reads as follows:

Lasalocid.
* * * * *

(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]

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

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Lincomycin.
* * * * *

(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.

(xiii) Zoalene as in § 558.680.

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

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Maduramicin.
* * * * *
[Amended]
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22. In § 558.355:

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a. Remove and reserve paragraphs (f)(1)(ii), (vii), (x), (xi), (xii), (xv), (xvi), (xvii), (xviii), (xix), (xx), (xxiii), (xxvi), and (xxvii);

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b. Remove and reserve paragraphs (f)(4)(vi) and (vii); and

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c. Remove the second instance of a paragraph designated (f)(4)(iv) (following (f)(4)(vii).

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23. In § 558.363:

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a. Remove and reserve paragraphs (a)(2), (a)(5) and (a)(6);

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b. Remove paragraphs (d)(1)(ii), (v), (vii), (viii), and (ix) and (d)(3)(iii) and (iv); and

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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).

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[Amended]
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24. In the table in § 558.366(d):

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a. In the “Nicarbazin in grams per ton” column, following the entry for “27 to 45”, remove the row entries for:

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i. Narasin 27 to 45, bacitracin methylene disalicylate 50, and roxarsone 22.7 to 45.4; and

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ii. Narasin 27 to 45 and roxarsone 22.7 to 45.4;

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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

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c. In the “Nicarbazin in grams per ton” column, following the entry for “113.5 (0.0125 pct)”, remove the row entries for:

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i. Roxarsone 22.7 (0.0025); and

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ii. Roxarsone 22.7 (0.0025) plus lincomycin 2 (0.0004).”

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[Amended]
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25. In § 558.460, remove and reserve paragraph (d)(2).

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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:

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Robenidine.
* * * * *
[Removed]
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27. Remove § 558.530.

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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).

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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.

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[Amended]
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30. In § 558.575, remove and reserve paragraph (d)(1)(ii).

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

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Zoalene.
* * * * *

(d) Conditions of use—(1) ChickensStart Printed Page 10984

Zoalene in grams/tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 36.3 to 113.5Replacement chickens: For development of active immunity to coccidiosisGrower ration not to be fed to birds over 14 weeks of age; as follows:054771
Growing conditionsStarter ration Grams per tonGrower ration Grams per ton
Severe exposure113.5 (0.0125%)75.4-113.5 (0.0083%-0.0125%)
Light to moderate exposure75.4-113.5 (0.0083%-0.0125%)36.3-75.4 (0.004%-0.0083%)
Zoalene in grams/tonCombination in grams per tonIndications for useLimitationsSponsor
(ii) 36.3-113.5Bacitracin methylene disalicylate 4 to 50Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed 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 chapter054771
(iii) 36.3-113.5Bacitracin methylene disalicylate 50Replacement 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 bacitracinFeed 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 chapter054771
(iv) 36.3-113.5Bacitracin methylene disalicylate 100 to 200Replacement 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 bacitracinFeed 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 chapter054771
(v) 113.5Broiler chickens: For prevention and control of coccidiosisFeed continuously as sole ration054771
(vi) 113.5Bacitracin methylene disalicylate 4 to 50Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter054771
(vii) 113.5Bacitracin methylene disalicylate 50Broiler chickens: For prevention and control of coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed continuously as sole ration. Bacitracin methylene disalicylate as provided by No. 054771 in § 510.600(c) of this chapter054771
(viii) 113.5Bacitracin methylene disalicylate 100 to 200Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed 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 chapter054771
(ix) 113.5Bambermycins 1Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed 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 chapter016592
(x) 113.5Lincomycin 2Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Do not feed to laying chickens. As lincomycin hydrochloride monohydrate provided by No. 054771 in § 510.600(c) of this chapter054771
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(2) Turkeys

Zoalene in grams/tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 113.5 to 170.3Growing turkeys: For prevention and control of coccidiosisFeed continuously as sole ration. For turkeys grown for meat purposes only. Do not feed to laying birds054771
(ii) 113.5 to 170.3Bacitracin methylene disalicylate 4 to 50Growing turkeys: For prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration until 14 to 16 weeks of age. For turkeys grown for meat purposes only. Do not feed to laying birds054771
Start Signature

Dated: February 3, 2014.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

End Signature End Supplemental Information

[FR Doc. 2014-02617 Filed 2-26-14; 8:45 am]

BILLING CODE 4160-01-P