[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)] [Rules and Regulations] [Pages 10976-10985] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2014-02617] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 556 and 558 [Docket No. FDA-2014-N-0002] Zoetis Inc., et al.; Withdrawal of Approval of New Animal Drug Applications for Combination Drug Medicated Feeds Containing an Arsenical Drug AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of 69 new animal drug applications (NADAs) and 22 abbreviated new animal drug applications (ANADAs) for use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds. This action is being taken at the sponsor's request because the products are no longer manufactured or marketed. FDA is also amending the animal drug regulations to remove entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations. DATES: This rule is effective March 10, 2014. FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, [email protected]. SUPPLEMENTARY INFORMATION: Recently, the Agency provided notice of the withdrawal of approval of NADAs for Type A medicated articles containing [[Page 10977]] arsanilic acid, carbarsone, and roxarsone and revoked applicable regulations for their conditions of use to manufacture single- ingredient medicated feeds in 21 CFR part 558 New Animal Drugs For Use in Animal Feeds (78 FR 70062, Nov. 22, 2013; 78 FR 69992, Nov. 22, 2013; 78 FR 70566, Nov. 26, 2013; 78 FR 70496, Nov. 26, 2013). Subsequently, the following six sponsors of NADAs and ANADAs permitting use of arsanilic acid, carbarsone, or roxarsone Type A medicated articles to manufacture combination drug Type B and Type C medicated feeds requested that FDA withdraw approval of their applications because these combination medicated feeds are no longer manufactured or marketed.Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 has requested that FDA withdraw approval of the following 39 NADAs and 11 ANADAs: ------------------------------------------------------------------------ NADA/ANADA Ingredient new animal drugs ------------------------------------------------------------------------ 040-435.................. 3-NITRO (roxarsone)/DECCOX (decoquinate). 041-178.................. Roxarsone/AMPROL Plus (amprolium and ethopabate)/LINCOMIX (lincomycin). 041-984.................. Roxarsone/ROFENAID (sulfadimethoxine/ ormetoprim). 091-326.................. 3-NITRO (roxarsone)/DECCOX (decoquinate)/ ALBAC (bacitracin zinc). 092-522.................. Roxarsone/COBAN (monensin)/LINCOMIX (lincomycin). 095-546.................. Roxarsone/ROBENZ (robenidine). 102-485.................. 3-NITRO (roxarsone)/AVATEC (lasalocid). 105-758.................. 3-NITRO (roxarsone)/AMPROL HI-E (amprolium and ethopabate)/BACIFERM (bacitracin zinc). 112-661.................. 3-NITRO (roxarsone)/AVATEC (lasalocid)/ LINCOMIX (lincomycin). 112-687.................. 3-NITRO (roxarsone)/AVATEC (lasalocid)/ FLAVOMYCIN (bambermycins). 116-082.................. 3-NITRO (roxarsone)/AVATEC (lasalocid)/BMD (bacitracin MD). 116-088.................. 3-NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD). 123-154.................. 3-NITRO (roxarsone)/BACIFERM (bacitracin zinc)/COBAN (monensin). 126-052.................. 3-NITRO (roxarsone)/AVATEC (lasalocid)/ BACIFERM (bacitracin zinc). 131-894.................. 3-NITRO (roxarsone)/AVATEC (lasalocid)/ bacitracin MD. 132-447.................. Roxarsone/BIO-COX (salinomycin). 134-185.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin)/ FLAVOMYCIN (bambermycins). 135-321.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD (bacitracin MD). 137-536.................. 3-NITRO (roxarsone)/BIO-COX/ALBAC (bacitracin zinc). 138-703.................. 3-NITRO (roxarsone)/COBAN (monensin)/ALBAC (bacitracin zinc). 139-190.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin)/ BACIFERM (bacitracin zinc). 140-581.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin)/ LINCOMIX (lincomycin). 140-852.................. 3-NITRO (roxarsone)/MONTEBAN/BMD (bacitracin MD). 140-867.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin)/ AUREOMYCIN (chlortetracycline). 141-100.................. 3-NITRO (roxarsone)/DECCOX (decoquinate)/BMD (bacitracin MD). 141-112.................. 3-NITRO (roxarsone)/MAXIBAN (narasin and nicarbazin)/BMD (bacitracin MD). 141-121.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin)/BMD (bacitracin MD). 141-131.................. 3-NITRO (roxarsone)/ZOAMIX (zoalene)/BMD (bacitracin MD). 141-135.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin). 141-138.................. 3-NITRO (roxarsone)/COBAN (monensin)/BMD (bacitracin MD). 141-139.................. 3-NITRO (roxarsone)/COBAN (monensin). 141-142.................. 3-NITRO (roxarsone)/AMPROL (amprolium)/BMD (bacitracin MD). 141-155.................. 3-NITRO (roxarsone)/ROBENZ (robenidine)/BMD (bacitracin MD). 141-157.................. 3-NITRO (roxarsone)/STENOROL (halofuginone). 141-223.................. 3-NITRO (roxarsone)/CLINACOX (diclazuril). 141-293.................. 3-NITRO (roxarsone)/AVATEC (lasalocid). 200-206.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ DECCOX (decoquinate). 200-207.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ COYDEN 25 (clopidol). 200-208.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ AVATEC (lasalocid). 200-209.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ SACOX (salinomycin). 200-214.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ AMPROL HI-E (amprolium and ethopabate). 200-211.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ COBAN (monensin). 200-215.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ BIO-COX (salinomycin). 200-217.................. 3-NITRO (roxarsone)/ALBAC (bacitracin zinc)/ AMPROL HI-E (amprolium and ethopabate). 200-259.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/ CHLORMAX (chlortetracycline). 200-260.................. 3-NITRO (roxarsone)/BIO-COX (salinomycin)/ CHLORMAX (chlortetracycline). 038-879.................. CARB-O-SEP (carbarsone)/ZOAMIX (zoalene). 039-646.................. CARB-O-GAIN (carbarsone)/BMD (bacitracin MD). 136-484.................. CARB-O-SEP (carbarsone)/BACIFERM (bacitracin zinc). 200-203.................. CARB-O-SEP (carbarsone)/ALBAC (bacitracin zinc). ------------------------------------------------------------------------ Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria, has requested that FDA withdraw approval of the following 16 NADAs and 8 ANADAs: ------------------------------------------------------------------------ NADA/ANADA Ingredient new animal drugs ------------------------------------------------------------------------ 013-461.................. 3-NITRO (roxarsone)/AMPROL Plus (amprolium and ethopabate). 040-264.................. 3-NITRO (roxarsone)/COYDEN 25 (clopidol). 041-541.................. 3-NITRO (roxarsone)/COYDEN 25 (clopidol)/BMD (bacitracin MD). 044-016.................. Roxarsone + bacitracin Zinc/COYDEN 25 (clopidol). [[Page 10978]] 049-179.................. Roxarsone/AMPROL HI-E (amprolium and ethopabate). 049-180.................. Roxarsone/AMPROL HI-E (amprolium and ethopabate)/BMD (bacitracin MD). 095-547.................. 3-NITRO (roxarsone)/AMPROL HI-E (amprolium and ethopabate)/FLAVOMYCIN (bambermycins). 095-548.................. 3-NITRO (roxarsone)/AMPROL (amprolium)/ FLAVOMYCIN (bambermycins). 095-549.................. 3-NITRO (roxarsone)/AMPROL (amprolium)/ FLAVOMYCIN (bambermycins). 098-341.................. 3-NITRO (roxarsone)/COBAN (monensin)/ FLAVOMYCIN (bambermycins). 101-628.................. 3-NITRO (roxarsone)/FLAVOMYCIN (bambermycins)/ zoalene. 140-533.................. 3-NITRO (roxarsone)/STENOROL (halofuginone)/ BMD (bacitracin MD). 140-843.................. 3-NITRO (roxarsone)/MONTEBAN (narasin)/ FLAVOMYCIN (bambermycins). 141-190.................. 3-NITRO (roxarsone)/LINICOX (diclazuril)/BMD (bacitracin MD). 200-080.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/ FLAVOMYCIN (bambermycins). 200-081.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/BMD (bacitracin MD). 200-086.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/ALBAC (bacitracin zinc). 200-090.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/ LINCOMIX (lincomycin). 200-091.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/ AUREOMYCIN (chlortetracycline). 200-094.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/ STAFAC (virginiamycin). 200-097.................. 3-NITRO (roxarsone)/SACOX (salinomycin). 200-143.................. 3-NITRO (roxarsone)/SACOX (salinomycin)/ BACIFERM (bacitracin zinc). 118-507.................. CARB-O-SEP (carbarsone)/AMPROL (amprolium). 130-661.................. CARB-O-SEP (carbarsone)/FLAVOMYCIN (bambermycins). ------------------------------------------------------------------------ Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., suite 21, Teaneck, NJ 07666 has requested that FDA withdraw approval of the following seven NADAs and two ANADAs: ------------------------------------------------------------------------ NADA/ANADA Ingredient new animal drugs ------------------------------------------------------------------------ 107-997.................. Roxarsone/NICARB (nicarbazin)/LINCOMIX (lincomycin). 108-115.................. Roxarsone/NICARB (nicarbazin). 120-724.................. 3-NITRO (roxarsone)/STAFAC (virginiamycin)/ COBAN (monensin). 138-953.................. 3-NITRO (roxarsone)/STAFAC (virginiamycin)/ BIO-COX (salinomycin). 141-058.................. 3-NITRO (roxarsone)/AVIAX (semduramycin)/BMD (bacitracin MD). 141-066.................. 3-NITRO (roxarsone)/AVIAX (semduramycin). 141-226.................. Roxarsone/AVIAX (semduramycin)/STAFAC (virginiamycin). 200-170.................. 3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin)/ LINCOMIX (lincomycin). 200-172.................. 3-NITRO (roxarsone)/NICARMIX 25 (nicarbazin). ------------------------------------------------------------------------ Elanco Animal Health, A Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has requested that FDA withdraw approval of the following four NADAs: ------------------------------------------------------------------------ NADA Ingredient new animal drugs ------------------------------------------------------------------------ 041-500.................. 3-NITRO (roxarsone)/COBAN (monensin). 049-464.................. Roxarsone/monensin/bacitracin. 140-445.................. Roxarsone/MONTEBAN (narasin). 141-113.................. 3-NITRO (roxarsone)/MAXIBAN (narasin and nicarbazin). ------------------------------------------------------------------------ Cross Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland, has requested that FDA withdraw approval of the following three NADAs: ------------------------------------------------------------------------ NADA Ingredient new animal drugs ------------------------------------------------------------------------ 038-241.................. PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin)/zoalene. 038-242.................. PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin)/amprolium + ethopabate. 038-624.................. PRO-GEN (arsanilic acid)/ERYTHRO (erythromycin). ------------------------------------------------------------------------ Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144 has requested that FDA withdraw approval of the following ANADA: ------------------------------------------------------------------------ NADA Ingredient new animal drugs ------------------------------------------------------------------------ 200-355.................. 3-NITRO (roxarsone)/PENNCHLOR (chlortetracycline)/BIO-COX (salinomycin). ------------------------------------------------------------------------ [[Page 10979]] Elsewhere in this issue of the Federal Register, FDA gave notice that approval of these NADAs and ANADAs, and all supplements and amendments thereto, is withdrawn, effective March 10, 2014. As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these voluntary withdrawals of approval. In addition, FDA has noticed that certain sections in part 558 contain entries describing conditions of use for combination drug medicated feeds for which no NADA is approved. These errors were introduced by the Agency during the 1976 recodification of certain food additive regulations (41 FR 10984, March 15, 1976). That rule did not identify whether particular regulations were the subject of an approved NADA and consequently resulted in codification of certain conditions of use for which there is no approved NADA. At this time, the Agency is amending the regulations to remove entries that describe conditions of use for combination drug medicated feeds for which no NADA is approved. This action is being taken to improve the accuracy of the regulations. This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. List of Subjects 21 CFR Parts 556 Animal drugs, Food. 21 CFR Parts 558 Animal drugs, Animal feeds. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 556 and 558 are amended as follows: PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 0 1. The authority citation for 21 CFR part 556 continues to read as follows: Authority: 21 U.S.C. 342, 360b, 371. 0 2. Revise Sec. 556.60 to read as follows: Sec. 556.60 Arsenic. (a) [Reserved] (b) Tolerances. The tolerances for total residue of combined arsenic (calculated as As) are: (1) Turkeys--(i) Muscle and eggs: 0.5 parts per million (ppm). (ii) Other edible tissues: 2 ppm. (2) [Reserved] (c) Related conditions of use. See Sec. 558.369 of this chapter. PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 0 3. The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. Sec. 558.4 [Amended] 0 4. In Sec. 558.4, in paragraph (d), in the ``Category II'' table: 0 a. Remove the entries for ``Arsanilate acid'', ``Carbarsone'', and ``Sulfaquinoxaline''; 0 b. Remove the row entries under ``Nitarsone'' for ``Sulfanitran'' and ``Roxarsone''. 0 c. Remove the four entries for ``Roxarsone'' and their respective following row entries; and 0 d. In the fourth entry for ``Sulfamethazine,'' remove its three following row entries for ``Aklomide'' and two following row entries for ``Roxarsone''. 0 5. In Sec. 558.55, revise paragraphs (d)(1) through (3) and add paragraph (d)(4) to read as follows: Sec. 558.55 Amprolium. * * * * * (d) * * * (1) Cattle. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Amprolium in grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 113.5 to 11, 350; to provide 5 Calves: As an aid in the Top-dress on or mix in the 016592 milligrams per kilogram of body prevention of coccidiosis daily ration. Feed for 21 weight per day. caused by Eimeria bovis and days when experience E. zuernii. indicates that coccidiosis is likely to be a hazard, as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (ii) 113.5 to 11, 350; to provide 10 Calves: As an aid in the Top-dress on or mix in the 016592 milligrams per kilogram of body treatment of coccidiosis daily ration. Feed for 5 weight per day. caused by Eimeria bovis and days as the sole source of E. zuernii. amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. ---------------------------------------------------------------------------------------------------------------- (2) Chickens. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Combination in Amprolium in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 36.3 to 113.5.............. .................. Replacement chickens: Feed continuously until 016592 For development of onset of production as active immunity to follows: coccidiosis. ---------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- Up to 5 weeks of age From 5 to 8 weeks of Over 8 weeks of age ---------------------- age --------------------- Growing conditions ---------------------- Amprolium in grams Amprolium in grams Amprolium in grams per ton per ton per ton ---------------------------------------------------------------------------------------------------------------- Severe exposure to coccidiosis................ 113.5 72.6-113.5 36.3-113.5 (0.0125%) (0.008%-0.0125%) (0.004%-0.0125%) Moderate exposure to coccidiosis.............. 72.6-113.5 54.5-113.5 36.3-113.5 [[Page 10980]] (0.008%-0.0125%) (0.006%-0.0125%) (0.004%-0.0125%) Slight exposure to coccidiosis................ 36.3-113.5 36.3-113.5 36.3-113.5 (0.004%-0.0125%) (0.004%-0.0125%) (0.004%-0.0125%) ---------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- Combination in Amprolium in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (ii) 36.3 to 113.5............. Bacitracin Replacement chickens: Feed according to 054771 methylene For development of subtable in item (i). disalicylate 4 to active immunity to Bacitracin methylene 50. coccidiosis; and for disalicylate as increased rate of provided by No. 054771 weight gain and in Sec. 510.600(c) improved feed of this chapter. efficiency. (iii) 72.6 to 113.5............ .................. Broiler chickens: For Feed continuously as 016592 prevention of the sole ration; as coccidiosis caused by sole source of Eimeria tenella only. amprolium. (iv) 72.6 to 113.5............. Bambermycins 1 to Broiler chickens: For Feed continuously as 016592 2. prevention of the sole ration; as coccidiosis caused by sole source of Eimeria tenella only; amprolium. and for increased rate Bambermycins as of weight gain and provided by No. 016592 improved feed in Sec. 510.600(c) efficiency. of this chapter. (v) 113.5...................... .................. 1. Laying chickens: For Feed continuously as 016592 prevention of the sole ration; as coccidiosis. the sole source of amprolium. 2. Laying chickens: For Feed for 2 weeks....... treatment of coccidiosis in moderate outbreaks. (vi) 113.5 to 227.............. .................. 1. Replacement Feed continuously from 016592 chickens: For day-old until onset of prevention of production; as the coccidiosis where sole source of immunity to amprolium. coccidiosis is not desired. 2. Broiler chickens: Feed continuously as For prevention of the sole ration; as coccidiosis where sole source of immunity to amprolium. coccidiosis is not desired. (vii) 113.5 to 227............. Bambermycins 1 to Broiler chickens: For Feed continuously as 016592 2. prevention of the sole ration; as coccidiosis where sole source of immunity to amprolium. coccidiosis is not Bambermycins as desired; and for provided by No. 016592 increased rate of in Sec. 510.600(c) weight gain and of this chapter. improved feed efficiency. (viii) 227..................... .................. Laying chickens: For Feed for 2 weeks....... 016592 treatment of coccidiosis in severe outbreaks.. ---------------------------------------------------------------------------------------------------------------- (3) Turkeys. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Combination in Amprolium in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 113.5...................... Bambermycins 1 to Growing turkeys: For Feed continuously as 016592 4. prevention of the sole source of coccidiosis; and for amprolium; increased rate of bambermycins as weight gain and provided by No. 016592 improved feed in Sec. 510.600(c) efficiency. of this chapter. (ii) 113.5 to 227.............. .................. Turkeys: For prevention Feed continuously as 016592 of coccidiosis. the sole ration; as sole source of amprolium. ---------------------------------------------------------------------------------------------------------------- (4) Pheasants. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Combination in Amprolium in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 159........................ .................. Growing pheasants: For Feed continuously as 016592 the prevention of sole ration. Use as coccidiosis caused by sole source of Eimeria colchici, E. amprolium. duodenalis, and E. phasiani. (ii) [Reserved] ---------------------------------------------------------------------------------------------------------------- 0 6. In Sec. 558.58, revise paragraph (e) to read as follows: Sec. 558.58 Amprolium and ethopabate. * * * * * (e) Conditions of use. It is used in chicken feed as follows: [[Page 10981]] ---------------------------------------------------------------------------------------------------------------- Amprolium and ethopabate in Combination in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (1) Amprolium 113.5 and .................. Broiler chickens: As an Feed continuously as 016592 ethopabate 3.6. aid in the prevention sole ration; as sole of coccidiosis. source of amprolium. Not for laying chickens. (2) Amprolium 113.5 and Lincomycin 2 to 4. Broiler chickens: As an Feed continuously as 054771 ethopabate 3.6. aid in the prevention sole ration; as sole of coccidiosis; for source of amprolium. increased rate of Not for laying weight gain and chickens. improved feed Lincomycin as provided efficiency. by No. 054771 in Sec. 510.600(c) of this chapter. (3) Amprolium 113.5 and .................. Broiler chickens and Feed continuously as 016592 ethopabate 36.3. replacement chickens: sole ration; as sole where immunity to source of amprolium. coccidiosis is not Not for chickens over desired: As an aid in 16 weeks of age. the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. (4) Amprolium 113.5 and Bacitracin 4 to 50 1. Broiler chickens and Feed as the sole ration 016592 ethopabate 36.3. replacement chickens: from the time chickens where immunity to are placed on litter coccidiosis is not until past the time desired; to aid in when coccidiosis is prevention of ordinarily a hazard. coccidiosis where Not for chickens over severe exposure to 16 weeks of age; do coccidiosis from not feed to laying Eimeria acervulina, E. chickens; as sole maxima, and E. source of amprolium; brunetti is likely to not for use as a occur; for increased treatment for rate of weight gain in outbreaks of broiler chickens coccidiosis. raised in floor pens. Bacitracin as bacitracin methylene disalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (5) Amprolium 113.5 and Bacitracin 4 to 50 2. Broiler chickens: As Feed as the sole ration 054771 ethopabate 36.3. an aid in prevention from the time chickens of coccidiosis where are placed on litter severe exposure to until market weight. coccidiosis from Not for chickens over Eimeria acervulina, E. 16 weeks of age; do maxima, and E. not feed to laying brunetti is likely to chickens; as sole occur; for improved source of amprolium; feed efficiency. not for use as a treatment for coccidiosis. Bacitracin zinc as provided by No. 054771 in Sec. 510.600(c) of this chapter. (6) Amprolium 113.5 and Bambermycins 1 to Broiler chickens: As an Feed continuously as 016592 ethopabate 3.6. 3. aid in the prevention the sole ration; as of coccidiosis where sole source of severe exposure to amprolium. coccidiosis from Bambermycins as Eimeria acervulina, E. provided by No. 016592 maxima, and E. in Sec. 510.600(c) brunetti is likely to of this chapter. occur; for increased rate of weight gain, improved feed efficiency. (7) Amprolium 113.5 and Virginiamycin 15.. Broiler chickens; as an Feed continuously as 066104 ethopabate 36.3. aid in the prevention the sole ration; as of coccidiosis where sole source of severe exposure to amprolium. Do not feed coccidiosis from to laying chickens. Eimeria acervulina, E. Not for chickens over maxima, and E. 16 weeks of age. brunetti is likely to Virginiamycin as occur; for increased provided by No. 066104 rate of weight gain in Sec. 510.600(c) and improved feed of this chapter. efficiency. (8) Amprolium 113.5 and Virginiamycin 5 to Broiler chickens; as an Feed continuously as 066104 ethopabate 36.3. 15. aid in the prevention the sole ration; as of coccidiosis where sole source of severe exposure to amprolium. Do not feed coccidiosis from to laying chickens. Eimeria acervulina, E. Not for chickens over maxima, and E. 16 weeks of age. brunetti is likely to Virginiamycin as occur; for increased provided by No. 066104 rate of weight gain. in Sec. 510.600(c) of this chapter. (9) Amprolium 227 and .................. For broiler chickens Not for laying chickens 016592 ethopabate 3.6. and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis. (10) Amprolium 227 and Chlortetracycline For chickens where Do not feed to chickens 054771 ethopabate 3.6. 100 to 200. immunity to producing eggs for coccidiosis is not human consumption. desired; prevention of Feed for 7 to 14 days. coccidiosis; control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. (11) Amprolium 227 and Chlortetracycline For chickens where In low calcium feed 054771 ethopabate 3.6. 200 to 400. immunity to containing 0.8% coccidiosis is not dietary calcium and desired; prevention of 1.5% sodium sulfate; coccidiosis; control feed continuously as of chronic respiratory sole ration for 7 to disease (CRD) and air 14 days; do not feed sac infection caused to chickens producing by M. gallisepticum eggs for human and E. coli consumption. susceptible to chlortetracycline. ---------------------------------------------------------------------------------------------------------------- [[Page 10982]] Sec. 558.62 [Removed] 0 7. Remove Sec. 558.62. 0 8. In Sec. 558.76, revise paragraph (d)(3) to read as follows: Sec. 558.76 Bacitracin methylene disalicylate. * * * * * (d) * * * (3) Bacitracin methylene disalicylate may also be used in combination with: (i) Amprolium as in Sec. 558.55. (ii) Amprolium and ethopabate as in Sec. 558.58. (iii) Decoquinate as in Sec. 558.195. (iv) Diclazuril as in Sec. 558.198. (v) Fenbendazole as in Sec. 588.258. (vi) Halofuginone as in Sec. 558.265. (vii) Hygromycin B as in Sec. 588.274. (viii) Ivermectin as in Sec. 558.300. (ix) Lasalocid sodium as in Sec. 558.311. (x) Monensin as in Sec. 588.355. (xi) Narasin as in Sec. 558.363. (xii) Nicarbazin alone and with narasin as in Sec. 558.366. (xiii) Nitarsone as in Sec. 558.369. (xiv) Robenidine as in Sec. 558.515. (xv) Salinomycin as in Sec. 558.550. (xvi) Semduramicin as in Sec. 558.555. (xvii) Zoalene as in Sec. 558.680. 0 9. In Sec. 558.78, revise paragraph (d)(3) to read as follows: Sec. 558.78 Bacitracin zinc. * * * * * (d) * * * (3) Bacitracin zinc may also be used in combination with: (i) Amprolium and ethopabate as in Sec. 558.58. (ii) Clopidol as in Sec. 558.175. (iii) Decoquinate as in Sec. 558.195. (iv) Lasalocid as in Sec. 558.311. (v) Monensin as in Sec. 558.355. (vi) Naracin as in Sec. 558.363. (vii) Nitarsone as in Sec. 558.369. (viii) Robenidine as in Sec. 558.515. (ix) Salinomycin as in Sec. 558.550. 0 10. In Sec. 558.95, revise paragraph (d)(5) to read as follows: Sec. 558.95 Bambermycins. * * * * * (d) * * * (5) Bambermycins may also be used in combination with: (i) Amprolium as in Sec. 558.55. (ii) Amprolium and ethopabate as in Sec. 558.58. (iii) Clopidal as in Sec. 558.175. (iv) Diclazuril as in Sec. 558.198. (v) Halofuginone as in Sec. 558.265. (vi) Lasalocid as in Sec. 558.311. (vii) Monensin as in Sec. 558.355. (viii) Narasin alone or with nicarbazin as in Sec. 558.363. (ix) Nicarbazin as in Sec. 558.366. (x) Salinomycin as in Sec. 558.550. (xi) Zoalene as in Sec. 558.680. Sec. 558.120 [Removed] 0 11. Remove Sec. 558.120. 0 12. In Sec. 558.128, revise paragraph (e)(7) to read as follows: Sec. 558.128 Chlortetracycline. * * * * * (e) * * * (7) Chlortetracycline may also be used in combination with: (i) Amprolium and ethopabate as in Sec. 558.58. (ii) Bacitracin methylene disalicylate as in Sec. 558.76. (iii) Clopidol as in Sec. 558.175. (iv) Decoquinate as in Sec. 558.195. (v) Hygromycin B as in Sec. 558.274. (vi) Laidlomycin as in Sec. 558.305. (vii) Lasalocid as in Sec. 558.311. (viii) Monensin as in Sec. 558.355. (ix) Robenidine as in Sec. 558.515. (x) Salinomycin as in Sec. 558.550. (xi) Tiamulin as in Sec. 558.600. Sec. 558.175 [Amended] 0 13. In Sec. 558.175, remove paragraphs (d)(3) and (8); and redesignate paragraphs (d)(4) through (7) as paragraphs (d)(3) through (6), respectively, and paragraphs (d)(9) through (11) as paragraphs (d)(7) through (9), respectively. Sec. 558.195 [Amended] 0 14. In Sec. 558.195, remove paragraphs (e)(1)(iv) and (v) and redesignate paragraphs (e)(1)(vi) through (ix) as paragraphs (e)(1)(iv) through (vii), respectively. Sec. 558.198 [Amended] 0 15. In Sec. 558.198, remove paragraphs (d)(1)(iii), (iv), and (vi) and redesignate paragraphs (d)(1)(v), (vii), and (viii) as paragraphs (d)(1)(iii), (iv), and (v), respectively. 0 16. In Sec. 558.248, remove paragraph (d)(3); and revise the section heading to read as follows: Sec. 558.248 Erythromycin. * * * * * 0 17. In Sec. 558.265, remove and reserve paragraphs (d)(1)(v) and (viii) and (d)(3)(ii) and revise the section heading to read as follows: Sec. 558.265 Halofuginone. * * * * * 0 18. Revise Sec. 558.274 to read as follows: Sec. 558.274 Hygromycin B. (a) Approvals. See sponsor numbers in Sec. 510.600(c) of this chapter for Type A medicated articles or Type B medicated feeds as follow: (1) No. 000986: 2.4 and 8 grams per pound (g/lb). (2) Nos. 012286 and 051311: 2.4 g/lb. (3) No. 017790: 0.6 g/lb. (4) No. 054771: 0.6 and 1.6 g/lb. (b) Related tolerances. See Sec. 556.330 of this chapter. (c) Conditions of use. It is used in feed as follows: (1) Chickens-- ---------------------------------------------------------------------------------------------------------------- Combination in Hygromycin B in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 8 to 12.................... .................. Chickens: For control Withdraw 3 days before 000986 of infestation of slaughter. 012286 large roundworms 017790 (Ascaris galli), cecal 054771 worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). (ii) 8 to 12................... Tylosin 4 to 50... Chickens: For control Withdraw 3 days before 000986 of infestations of slaughter. Tylosin as large roundworms tylosin phosphate as (Ascaris galli), cecal provided by No. 000986 worms (Heterakis in Sec. 510.600 of gallinae), and this chapter. capillary worms (Capillaria obsignata); growth promotion and feed efficiency. ---------------------------------------------------------------------------------------------------------------- (2) Swine-- [[Page 10983]] ---------------------------------------------------------------------------------------------------------------- Combination in Hygromycin B in grams per ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 12......................... .................. Swine: For control of Withdraw 15 days before 000986 infestation of large slaughter. 012286 roundworms (Ascaris 017790 suis), nodular worms 054771 (Oesophagostomum dentatum), and whipworms (Trichuris suis). (ii) 12........................ Tylosin 10 to 100. Swine: For control of Feed continuously as 000986 infestations of large follows: Animal weight roundworms (Ascaris (lbs.): suis), nodular worms Up to 40 . . . 20 to (Oesophagostomum 100 \1\. dentatum), and 41 to 100 . . . 20 to whipworms (Trichuris 40 \1\. suis); growth 101 to market weight . promotion and feed . . 10 to 20 \1\. efficiency. Withdraw 15 days before slaughter. Tylosin as tylosin phosphate as provided by No. 000986 in Sec. 510.600 of this chapter. ---------------------------------------------------------------------------------------------------------------- \1\ Amount of Tylosin (g/t). 0 19. In Sec. 558.311: 0 a. In paragraph (e)(1)(ii), remove the entries for: 0 i.Roxarsone 45.4 (0.005 pct); 0 ii. Roxarsone 45.4 plus bambermycins 1 (0.00011 pct); 0 iii. Roxarsone 45.4 plus lincomycin 2.0; 0 iv. Roxarsone 45.4 plus bacitracin 10 to 25; 0 v. Roxarsone 45.4 plus bacitracin 10 or 30; and 0 vi. Roxarsone 45.4 plus bacitracin methylene disalicylate 50''; 0 b. In paragraph (e)(1)(xv), remove the entry for ``Roxarsone 22.7 to 45.4''; and 0 c. Revise paragraph (e)(5). The revision reads as follows: Sec. 558.311 Lasalocid. * * * * * (e) * * * (5) Lasalocid may also be used in combination with: (i) Melengestrol acetate alone or in combination with tylosin as in Sec. 558.342. (ii) [Reserved] 0 20. In Sec. 558.325, revise paragraph (d)(3) to read as follows: Sec. 558.325 Lincomycin. * * * * * (d) * * * (3) Lincomycin may also be used in combination with: (i) Amprolium and ethopabate as in Sec. 558.58. (ii) Clopidol as in Sec. 558.175. (iii) Decoquinate as in Sec. 558.195. (iv) Fenbendazole as in Sec. 588.258. (v) Halofuginone as in Sec. 558.265. (vi) Ivermectin as in Sec. 558.300. (vii) Lasalocid sodium as in Sec. 558.311. (viii) Monensin as in Sec. 588.355. (ix) Nicarbazin alone and with narasin as in Sec. 558.366. (x) Pyrantel as in Sec. 558.485. (xi) Robenidine as in Sec. 558.515. (xii) Salinomycin as in Sec. 558.550. (xiii) Zoalene as in Sec. 558.680. 0 21. In Sec. 558.340, revise the section heading to read as follows: Sec. 558.340 Maduramicin. * * * * * Sec. 558.355 [Amended] 0 22. In Sec. 558.355: 0 a. Remove and reserve paragraphs (f)(1)(ii), (vii), (x), (xi), (xii), (xv), (xvi), (xvii), (xviii), (xix), (xx), (xxiii), (xxvi), and (xxvii); 0 b. Remove and reserve paragraphs (f)(4)(vi) and (vii); and 0 c. Remove the second instance of a paragraph designated (f)(4)(iv) (following (f)(4)(vii). Sec. 558.363 [Amended] 0 23. In Sec. 558.363: 0 a. Remove and reserve paragraphs (a)(2), (a)(5) and (a)(6); 0 b. Remove paragraphs (d)(1)(ii), (v), (vii), (viii), and (ix) and (d)(3)(iii) and (iv); and 0 c. Redesignate paragraphs (d)(1)(iii) and (iv) as paragraphs (d)(1)(ii) and (iii), paragraph (d)(1)(vi) as paragraph (d)(1)(iv), and paragraphs (d)(1)(x) and (xi) as paragraphs (d)(1)(v) and (vi). Sec. 558.366 [Amended] 0 24. In the table in Sec. 558.366(d): 0 a. In the ``Nicarbazin in grams per ton'' column, following the entry for ``27 to 45'', remove the row entries for: 0 i. Narasin 27 to 45, bacitracin methylene disalicylate 50, and roxarsone 22.7 to 45.4; and 0 ii. Narasin 27 to 45 and roxarsone 22.7 to 45.4; 0 b. In the ``Nicarbazin in grams per ton'' column, following the entry for ``90.8 to 181.6 (0.01 to 0.02 pct)'', remove the row entry for ``Bacitracin methylene disalicylate 4 to 50 and roxarsone 22.7 to 45.4''; and 0 c. In the ``Nicarbazin in grams per ton'' column, following the entry for ``113.5 (0.0125 pct)'', remove the row entries for: 0 i. Roxarsone 22.7 (0.0025); and 0 ii. Roxarsone 22.7 (0.0025) plus lincomycin 2 (0.0004).'' Sec. 558.460 [Amended] 0 25. In Sec. 558.460, remove and reserve paragraph (d)(2). 0 26. In Sec. 558.515, in paragraph (d), remove the entries for ``Bacitracin (as bacitracin methylene disalicylate) 50 and roxarsone 22.7 to 45.4'', ``Bacitracin (as bacitracin methylene disalicylate) 100 to 200 and roxarsone 22.7 to 45.4'', and ``Roxarsone 22.5 to 45.4 (0.005 percent)''; and revise the section heading to read as follows: Sec. 558.515 Robenidine. * * * * * Sec. 558.530 [Removed] 0 27. Remove Sec. 558.530. Sec. 558.550 [Amended] 0 28. In Sec. 558.550, remove and reserve paragraphs (d)(1)(ii), (iv), (v), (viii), (ix), (xii), (xiv), (xv), (xvii), (xviii), (xix), and (xxiv) and (d)(3)(iv), (vi), and (vii). Sec. 558.555 [Amended] 0 29. In Sec. 558.555, remove paragraphs (d)(3), (d)(4), and (d)(8); and redesignate paragraphs (d)(5), (d)(6), and (d)(7) as paragraphs (d)(3), (d)(4), and (d)(5), respectively. Sec. 558.575 [Amended] 0 30. In Sec. 558.575, remove and reserve paragraph (d)(1)(ii). 0 31. In Sec. 558.680, revise paragraph (d) to read as follows: Sec. 558.680 Zoalene. * * * * * (d) Conditions of use--(1) Chickens-- [[Page 10984]] ---------------------------------------------------------------------------------------------------------------- Combination in Zoalene in grams/ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 36.3 to 113.5.............. .................. Replacement chickens: Grower ration not to be 054771 For development of fed to birds over 14 active immunity to weeks of age; as coccidiosis. follows: ---------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- Starter ration Grams Grower ration Grams per Growing conditions per ton ton ---------------------------------------------------------------------------------------------------------------- Severe exposure............................................... 113.5 (0.0125%) 75.4-113.5 (0.0083%-0.0125%) Light to moderate exposure.................................... 75.4-113.5 36.3-75.4 (0.0083%-0.0125%) (0.004%-0.0083%) ---------------------------------------------------------------------------------------------------------------- ---------------------------------------------------------------------------------------------------------------- Combination in Zoalene in grams/ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (ii) 36.3-113.5................ Bacitracin Replacement chickens: Feed continuously as 054771 methylene For development of sole ration as in disalicylate 4 to active immunity to subtable in item (i). 50. coccidiosis; and for Grower ration not to increased rate of be fed to birds over weight gain and 14 weeks of age. improved feed Bacitracin methylene efficiency. disalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (iii) 36.3-113.5............... Bacitracin Replacement chickens: Feed continuously as 054771 methylene For development of sole ration as in disalicylate 50. active immunity to subtable in item (i). coccidiosis; and as an Grower ration not to aid in the prevention be fed to birds over of necrotic enteritis 14 weeks of age. caused or complicated Bacitracin methylene by Clostridium spp. or disalicylate as other organisms provided by No. 054771 susceptible to in Sec. 510.600(c) bacitracin. of this chapter. (iv) 36.3-113.5................ Bacitracin Replacement chickens: Feed continuously as 054771 methylene For development of sole ration as in disalicylate 100 active immunity to subtable in item (i). to 200. coccidiosis; and as an To control necrotic aid in the control of enteritis, start necrotic enteritis medication at first caused or complicated clinical signs of by Clostridium spp. or disease; vary other organisms bacitracin dosage susceptible to based on the severity bacitracin. of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ ton). Bacitracin methylene disalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (v) 113.5...................... .................. Broiler chickens: For Feed continuously as 054771 prevention and control sole ration. of coccidiosis. (vi) 113.5..................... Bacitracin Broiler chickens: As an Feed continuously as 054771 methylene aid in the prevention sole ration. disalicylate 4 to and control of Bacitracin methylene 50. coccidiosis; and for disalicylate as increased rate of provided by No. 054771 weight gain and in Sec. 510.600(c) improved feed of this chapter. efficiency. (vii) 113.5.................... Bacitracin Broiler chickens: For Feed continuously as 054771 methylene prevention and control sole ration. disalicylate 50. of coccidiosis; and as Bacitracin methylene an aid in the disalicylate as prevention of necrotic provided by No. 054771 enteritis caused or in Sec. 510.600(c) complicated by of this chapter. Clostridium spp. or other organisms susceptible to bacitracin. (viii) 113.5................... Bacitracin Broiler chickens: For Feed continuously as 054771 methylene prevention and control sole ration. To disalicylate 100 of coccidiosis; and as control necrotic to 200. an aid in the control enteritis, start of necrotic enteritis medication at first caused or complicated clinical signs of by Clostridium spp. or disease; vary other organisms bacitracin dosage susceptible to based on the severity bacitracin. of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ ton). Bacitracin methylene disalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter. (ix) 113.5..................... Bambermycins 1.... Broiler chickens: As an Feed continuously as 016592 aid in the prevention sole ration. Do not and control of feed to chickens over coccidiosis; and for 14 weeks of age. increased rate of Bambermycins as weight gain and provided by No. 016592 improved feed in Sec. 510.600(c) efficiency. of this chapter. (x) 113.5...................... Lincomycin 2...... Broiler chickens: As an Feed continuously as 054771 aid in the prevention sole ration. Do not and control of feed to laying coccidiosis; and for chickens. As increased rate of lincomycin weight gain and hydrochloride improved feed monohydrate provided efficiency. by No. 054771 in Sec. 510.600(c) of this chapter. ---------------------------------------------------------------------------------------------------------------- [[Page 10985]] (2) Turkeys-- ---------------------------------------------------------------------------------------------------------------- Combination in Zoalene in grams/ton grams per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 113.5 to 170.3............. .................. Growing turkeys: For Feed continuously as 054771 prevention and control sole ration. For of coccidiosis. turkeys grown for meat purposes only. Do not feed to laying birds. (ii) 113.5 to 170.3............ Bacitracin Growing turkeys: For Feed continuously as 054771 methylene prevention and control sole ration until 14 disalicylate 4 to of coccidiosis; and to 16 weeks of age. 50. for increased rate of For turkeys grown for weight gain and meat purposes only. Do improved feed not feed to laying efficiency. birds. ---------------------------------------------------------------------------------------------------------------- Dated: February 3, 2014. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. 2014-02617 Filed 2-26-14; 8:45 am] BILLING CODE 4160-01-P