21 CFR - § 558.3-558.680 - New Animal Drugs for Use in Animal Feeds

420 21 CFR Ch. I (4–1–23 Edition) § 556.760 (2) Chickens. Edible tissues (excluding eggs): Not required. (3) Swine. (i) Kidney, skin, and fat: 0.4 ppm. (ii) Liver: 0.3 ppm. (iii) Muscle: 0.1 ppm. (c) Related conditions of use. See § 558.635 of this chapter. [84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020] § 556.760 Zeranol. (a) Acceptable daily intake (ADI). The ADI for total residue of zeranol is 1.25 μg/kg of body weight per day. (b) Tolerances. The tolerances for zeranol are: (1) Cattle. Edible tissues (excluding milk): Not required. (2) Sheep. Edible tissues (excluding milk): 20 ppb. (c) Related conditions of use. See § 522.2680 of this chapter. § 556.765 Zilpaterol. (a) Acceptable daily intake (ADI). The ADI for total residue of zilpaterol is 0.083 μg/kg of body weight per day. (b) Tolerances. The tolerance for zilpaterol freebase (marker residue) is: (1) Cattle. (i) Liver (target tissue): 12 ppb. (ii) Muscle: 10 ppb. (2) [Reserved] (c) Related conditions of use. See § 558.665 of this chapter. [84 FR 32993, July 11, 2019, as amended at 85 FR 18121, Apr. 1, 2020] § 556.770 Zoalene. (a) [Reserved] (b) Tolerances. The tolerances for zoalene and its metabolite 3-amino-5 nitro-o-toluamide are: (1) Chickens. (i) Liver and kidney: 6 ppm. (ii) Muscle: 3 ppm. (iii) Fat: 2 ppm. (2) Turkeys. Liver and muscle: 3 ppm. (c) Related conditions of use. See § 558.680 of this chapter. PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS Subpart A—General Provisions Sec. 558.3 Definitions and general considerations applicable to this part. 558.4 Requirement of a medicated feed mill license. 558.5 Requirements for liquid medicated feed. 558.6 Veterinary feed directive drugs. Subpart B—Specific New Animal Drugs For Use in Animal Feeds 558.55 Amprolium. 558.58 Amprolium and ethopabate. 558.59 Apramycin. 558.68 Avilamycin. 558.76 Bacitracin methylenedisalicylate. 558.78 Bacitracin zinc. 558.95 Bambermycins. 558.115 Carbadox. 558.128 Chlortetracycline. 558.140 Chlortetracycline and sulfamethazine. 558.175 Clopidol. 558.185 Coumaphos. 558.195 Decoquinate. 558.198 Dichlorvos. 558.205 Diclazuril. 558.235 Efrotomycin. 558.248 Erythromycin. 558.254 Famphur. 558.258 Fenbendazole. 558.261 Florfenicol. 558.265 Halofuginone hydrobromide. 558.274 Hygromycin B. 558.295 Iodinated casein. 558.300 Ivermectin. 558.305 Laidlomycin. 558.311 Lasalocid. 558.325 Lincomycin. 558.330 Lubabegron. 558.340 Maduramicin. 558.342 Melengestrol. 558.348 Mibolerone. 558.355 Monensin. 558.360 Morantel. 558.363 Narasin. 558.364 Narasin and nicarbazin. 558.365 Neomycin sulfate. 558.366 Nicarbazin. 558.415 Novobiocin. 558.430 Nystatin. 558.450 Oxytetracycline. 558.455 Oxytetracycline and neomycin. 558.464 Poloxalene. 558.470 Polyoxyethylene. 558.485 Pyrantel. 558.500 Ractopamine. 558.515 Robenidine. 558.550 Salinomycin. 558.555 Semduramicin. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00430 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 421 Food and Drug Administration, HHS § 558.3 558.575 Sulfadimethoxine and ormetoprim. 558.582 Sulfamerazine. 558.586 Sulfaquinoxaline. 558.600 Thiabendazole. 558.612 Tiamulin. 558.618 Tilmicosin. 558.625 Tylosin. 558.630 Tylosin and sulfamethazine. 558.633 Tylvalosin. 558.635 Virginiamycin. 558.665 Zilpaterol. 558.680 Zoalene. AUTHORITY: 21 U.S.C. 354, 360b, 360ccc, 360ccc–1, 371. SOURCE: 40 FR 13959, Mar. 27, 1975, unless otherwise noted. Subpart A—General Provisions § 558.3 Definitions and general consid erations applicable to this part. (a) Regulations in this part provide for approved uses of drugs and com binations of drugs in animal feeds. Ap proved combinations of such drugs are specifically identified or incorporated by cross-reference. Unless specifically provided for by the regulations, a com bination of two or more drugs is not approved. (b) The following definitions apply to terms used in this part: (1) New animal drugs approved for use in animal feed are placed in two categories as follows: (i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species. (ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regu lated on a ‘‘no-residue’’ basis or with a zero tolerance because of carcinogenic concern regardless of whether a with drawal period is required in any spe cies. (2) A ‘‘Type A medicated article’’ is intended solely for use in the manufac ture of another Type A medicated arti cle or a Type B or Type C medicated feed. It consists of a new animal drug(s), with or without carrier (e.g., calcium carbonate, rice hull, corn, glu ten) with or without inactive ingredi ents. The manufacture of a Type A medicated article requires an applica tion approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter. (3) A ‘‘Type B medicated feed’’ is in tended solely for the manufacture of other medicated feeds (Type B or Type C). It contains a substantial quantity of nutrients including vitamins and/or minerals and/or other nutritional in gredients in an amount not less than 25 percent of the weight. It is manufac tured by diluting a Type A medicated article or another Type B medicated feed. The maximum concentration of animal drug(s) in a Type B medicated feed is 200 times the highest continuous use level for Category I drugs and 100 times the highest continuous use level for Category II drugs. The term ‘‘high est continuous use level’’ means the highest dosage at which the drug is ap proved for continuous use (14 days or more), or, if the drug is not approved for continuous use, it means the high est level used for disease prevention or control. If the drug is approved for multiple species at different use levels, the highest approved level of use would govern under this definition. The man ufacture of a Type B medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter. (4) A ‘‘Type C medicated feed’’ is in tended as the complete feed for the ani mal or may be fed ‘‘top dressed’’ (added on top of usual ration) on or offered ‘‘free-choice’’ (e.g., supplement) in con junction with other animal feed. It contains a substantial quantity of nu trients including vitamins, minerals, and/or other nutritional ingredients. It is manufactured by diluting a Type A medicated article or a Type B medi cated feed. A Type C medicated feed may be further diluted to produce an other Type C medicated feed. The man ufacture of a Type C medicated feed from a Category II, Type A medicated article requires a medicated feed mill license application approved under § 515.20 of this chapter. (5) A Type B or Type C medicated feed manufactured from a drug compo nent (bulk or ‘‘drum-run’’ (dried crude fermentation product)) requires an ap plication approved under § 514.105 of this chapter or an index listing granted under § 516.151 of this chapter. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00431 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 422 21 CFR Ch. I (4–1–23 Edition) § 558.4 (6) A ‘‘veterinary feed directive (VFD) drug’’ is a drug intended for use in or on animal feed which is limited by an approved application filed pursu ant to section 512(b) of the Federal Food, Drug, and Cosmetic Act, a condi tionally approved application filed pur suant to section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional super vision of a licensed veterinarian. Use of animal feed bearing or containing a VFD drug must be authorized by a law ful veterinary feed directive. (7) A ‘‘veterinary feed directive’’ is a written (nonverbal) statement issued by a licensed veterinarian in the course of the veterinarian’s professional prac tice that orders the use of a VFD drug or combination VFD drug in or on an animal feed. This written statement authorizes the client (the owner of the animal or animals or other caretaker) to obtain and use animal feed bearing or containing a VFD drug or combina tion VFD drug to treat the client’s ani mals only in accordance with the con ditions for use approved, conditionally approved, or indexed by the Food and Drug Administration. (8) A ‘‘medicated feed’’ means a Type B medicated feed as defined in para graph (b)(3) of this section or a Type C medicated feed as defined in paragraph (b)(4) of this section. (9) For the purposes of this part, a ‘‘distributor’’ means any person who distributes a medicated feed containing a VFD drug to another person. Such other person may be another dis tributor or the client-recipient of a VFD. (10) An ‘‘animal production facility’’ is a location where animals are raised for any purpose, but does not include the specific location where medicated feed is made. (11) An ‘‘acknowledgment letter’’ is a written (nonverbal) communication provided to a distributor (consignor) from another distributor (consignee). An acknowledgment letter must be provided either in hardcopy or through electronic media and must affirm: (i) That the distributor will not ship such VFD feed to an animal production facility that does not have a VFD, (ii) That the distributor will not ship such VFD feed to another distributor without receiving a similar written ac knowledgment letter, and (iii) That the distributor has com plied with the distributor notification requirements of § 558.6(c)(5). (12) A ‘‘combination veterinary feed directive (VFD) drug’’ is a combination new animal drug (as defined in § 514.4(c)(1)(i) of this chapter) intended for use in or on animal feed which is limited by an approved application filed under section 512(b) of the Federal Food, Drug, and Cosmetic Act, a condi tionally approved application filed under section 571 of the Federal Food, Drug, and Cosmetic Act, or an index listing under section 572 of the Federal Food, Drug, and Cosmetic Act to use under the professional supervision of a licensed veterinarian, and at least one of the new animal drugs in the com bination is a VFD drug. Use of animal feed bearing or containing a combina tion VFD drug must be authorized by a lawful VFD. (13) ‘‘Major species’’ means cattle, horses, swine, chickens, turkeys, dogs, and cats. (14) ‘‘Minor species’’ means animals, other than humans, that are not major species. [51 FR 7392, Mar. 3, 1986, as amended at 52 FR 2682, Jan. 26, 1987; 54 FR 51386, Dec. 15, 1989; 56 FR 19268, Apr. 26, 1991; 64 FR 63206, Nov. 19, 1999; 65 FR 76929, Dec. 8, 2000; 72 FR 69130, Dec. 6, 2007; 80 FR 31733, June 3, 2015; 81 FR 57800, Aug. 24, 2016] § 558.4 Requirement of a medicated feed mill license. (a) A feed manufacturing facility must possess a medicated feed mill li cense in order to manufacture a Type B or Type C medicated feed from a Cat egory II, Type A medicated article. (b) The manufacture of the following types of feed are exempt from the re quired license, unless otherwise speci fied: (1) Type B or Type C medicated feed using Category I, Type A medicated ar ticles or Category I, Type B or Type C medicated feeds; and (2) Type B or Type C medicated feed using Category II, Type B or Type C medicated feeds. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00432 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 423 Food and Drug Administration, HHS § 558.4 (c) The use of Type B and Type C medicated feeds shall also conform to the conditions of use provided for in subpart B of this part. (d) This paragraph identifies each drug by category, the maximum level of drug in Type B medicated feeds, and the assay limits for the drug in Type A medicated articles and Type B and Type C medicated feeds, as follows: CATEGORY I Drug Assay limits percent 1 Type A Type B maximum (200x) Assay limits percent 1 Type B/C 2 Amprolium with Ethopabate ......... 94–114 22.75 g/lb (5.0%) ........................ 80–120. Avilamycin .................................... 90–110 7.3 g/lb (1.6%) ............................ 80–110. Bacitracin methylenedisalicylate .. 85–115 25.0 g/lb (5.5%) ........................... 70–130. Bacitracin zinc .............................. 84–115 5.0 g/lb (1.1%) ............................ 70–130. Bambermycins .............................. 90–110 800 g/ton (0.09%) ....................... 80–120/70–130. Chlortetracycline ........................... 85–115 40.0 g/lb (8.8%) .......................... 80–115/70–130. Coumaphos .................................. 95–115 6.0 g/lb (1.3%) ............................ 80–120. Decoquinate ................................. 90–105 2.72 g/lb (0.6%) ........................... 80–120. Dichlorvos ..................................... 100–115 33.0 g/lb (7.3%) .......................... 90–120/80–130. Diclazuril ....................................... 90–110 182 g/t (0.02%) ........................... 85–115/70–120. Efrotomycin ................................... 94–113 1.45 g/lb (0.32%) ........................ 80–120. Iodinated casein ........................... 85–115 20.0 g/lb (4.4%) .......................... 75–125. Laidlomycin propionate potassium 90–110 1 g/lb (0.22%) ............................. 90–115/85–115. Lasalocid ...................................... 95–115 40.0 g/lb (8.8%) ........................... Type B (cattle and sheep): 80–120; Type C (all): 75–125. Lincomycin .................................... 90–115 20.0 g/lb (4.4%) ........................... 80–130. Lubabegron .................................. 87–107 908 g/ton ..................................... 85–115/80–120. Melengestrol acetate .................... 90–110 10.0 g/ton (0.0011%) .................. 70–120. Monensin ...................................... 85–115 40.0 g/lb (8.8%) .......................... Chickens, turkeys, and quail: 75–125; Cattle: 5–10 g/ton 80–120; Cattle: 10– 30 g/ton 85–115; Goats: 20 g/ton 85– 115; Liq. feed: 80–120. Narasin ......................................... 90–110 9.0 g/lb (1.98%) .......................... 85–115/75–125. Nicarbazin (granular) ............. 90–110 9.0 g/lb (1.98%) .......................... 85–115/75–125. Narasin ......................................... 90–110 9.0 g/lb (1.98%) .......................... 85–115/75–125. Nystatin ......................................... 85–125 5.0 g/lb (1.1%) ............................ 75–125. Oxytetracycline ............................. 90–120 20.0 g/lb (4.4%) .......................... 75–125/65–135. Poloxalene .................................... 90–110 54.48 g/lb (12.0%) ...................... Liq. feed: 85–115. Ractopamine ................................ 85–105 2.46 g/lb (0.54%) ......................... 80–110/75–125. Salinomycin .................................. 90–110 6.0 g/lb (1.3%) ............................ 80–120. Semduramicin (as semduramicin sodium). 90–110 2.27 g/lb (0.50%) ......................... 80–110 Semduramicin (as semduramicin sodium biomass). 90–110 2.27 g/lb (0.50%) ......................... 80–120 Tylosin .......................................... 80–120 10.0 g/lb (2.2%) .......................... 75–125. Tylvalosin ...................................... 90–110 3.86 g/lb ...................................... 85–115. Virginiamycin ................................ 85–115 10.0 g/lb (2.2%) .......................... 70–130. Zoalene ......................................... 92–104 11.35 g/lb (2.5%) ........................ 85–115. 1 Percent of labeled amount. 2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make Type C medicated feed. CATEGORY II Drug Assay limits percent 1 Type A Type B maximum (100x) Assay limits percent 1 Type B/C 2 Amprolium .................................... 94–114 11.35 g/lb (2.5%) ......................... 80–120. Apramycin ..................................... 88–112 7.5 g/lb (1.65%) .......................... 80–120. Carbadox ...................................... 90–110 2.5 g/lb (0.55%) .......................... 75–125. Clopidol ......................................... 94–106 11.4 g/lb (2.5%) .......................... 90–115/80–120. Erythromycin ................................. 85–115 4.625 g/lb (1.02%) ....................... 75–125. Famphur ....................................... 100–110 5.5 g/lb (1.21%) .......................... 90–115/80–120. Fenbendazole ............................... 93–113 8.87 g/lb (1.96%) ........................ 75–125. Florfenicol ..................................... 90–110 9.1 g/lb (2.0%) ............................ Swine feed: 85–115 Catfish feed: 80–110. Salmonid feed: 80–110. Halofuginone hydrobromide ......... 90–115 272.0 g/ton (.03%) ...................... 75–125. Hygromycin B ............................... 90–110 1,200 g/ton (0.13%) .................... 75–125. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00433 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 424 21 CFR Ch. I (4–1–23 Edition) § 558.5 CATEGORY II—Continued Drug Assay limits percent 1 Type A Type B maximum (100x) Assay limits percent 1 Type B/C 2 Ivermectin ..................................... 95–105 1,180 g/ton (0.13%) .................... 80–110. Maduramicin ammonium .............. 90–110 545 g/ton (.06%) ......................... 80–120. Morantel tartrate ........................... 90–110 66.0 g/lb (14.52%) ....................... 85–115. Neomycin ...................................... 80–120 20 g/lb (4.4%) .............................. 70–125. Oxytetracycline ............................. 80–120 20 g/lb (4.4%) .............................. 65–135. Neomycin sulfate ................... 80–120 100 g/lb (22.0%) .......................... 70–125. Nicarbazin (granular) .................... 90–110 5.675 g/lb (1.25%) ....................... 85–115/75–125. Nicarbazin (powder) ..................... 96–104 9.08 g/lb (2.00%) ........................ 85–115/80–120. Novobiocin .................................... 85–115 17.5 g/lb (3.85%) ........................ 80–120. Pyrantel tartrate ............................ 90–110 36 g/lb (7.9%) .............................. 75–125. Robenidine ................................... 95–115 1.5 g/lb (0.33%) ........................... 80–120. Sulfadimethoxine .......................... 90–110 Poultry: 5.675 g/lb ....................... Fish: 85.1 g/lb ............................. 80–115/75–125. Ormetoprim ........................... 90–110 Poultry: 3.405 g/lb ....................... Fish: 17.0 g/lb ............................. 80–115. Sulfamerazine ............................... 85–115 18.6 g/lb (4.0%) ........................... 85–115. Sulfamethazine ............................. 85–115 10.0 g/lb (2.2%) .......................... 80–120. Chlortetracycline .................... 85–115 10.0 g/lb (2.2%) .......................... 85–125/70–130. Sulfamethazine ............................. 85–115 10.0 g/lb (2.2%) .......................... 80–120. Tylosin ................................... 80–120 10.0 g/lb (2.2%) .......................... 75–125. Sulfaquinoxaline ........................... 98–106 11.2 g/lb (2.5%) .......................... 85–115. Thiabendazole .............................. 94–106 45.4 g/lb (10.0%) ........................ >7% 85–115; <7% 90–110. Tiamulin hydrogen fumarate ........ 90–115 10 g/lb ......................................... 90–115/70–130. Tilmicosin ...................................... 90–110 37.9 g/lb (8.35%) ......................... Swine Type B/C feed: 85–115. Cattle Type B feed: 85–115. Cattle Type C feed: 80–110. Zilpaterol ....................................... 90–110 680 g/t (0.075%) ......................... 80–110/75–115. 1 Percent of labeled amount. 2 Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two range limit, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed. These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B medicated feed with lower assay limits to make a Type C medicated feed. (e) When drugs from both categories are in combination, the Category II re quirements will apply to the combina tion drug product. [51 FR 7392, Mar. 3, 1986] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.4, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.5 Requirements for liquid medi cated feed. (a) What types of liquid medicated feeds are covered by this section? This section covers the following types of liquid medicated feed: (1) Type B feed that is intended for further manufacture of other medi cated feeds (§ 558.3(b)(3)) or: (2) Type C feed that is intended for the following: (i) Further manufacture of another Type C feed, or (ii) Top-dressing (adding on top of the usual ration) (§ 558.3(b)(4)). (b) How is liquid free-choice medicated feed regulated? Liquid free-choice medi cated feed is covered by this section and by § 510.455. (c) What is required for new animal drugs intended for use in liquid feed? Any new animal drug intended for use in liquid feed must be approved for such use under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) or index listed under section 572 of the act. Such approvals under section 512 of the act must be: (1) An original NADA, (2) A supplemental NADA, or (3) An abbreviated NADA. (d) What are the approval requirements under section 512 of the act for new ani mal drugs intended for use in liquid feed? An approval under section 512 of the act for a new animal drug intended for use in liquid feed must contain the fol lowing information: (1) Data, or a reference to data in a master file (MF), that shows the rel evant ranges of conditions under which the drug will be chemically stable in VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00434 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 425 Food and Drug Administration, HHS § 558.6 liquid feed under field use conditions; and (2) Data, or a reference to data in an MF, that shows that the drug is phys ically stable in liquid feed under field conditions; or (3) Feed labeling with recirculation or agitation directions as follows: (i) For liquid feeds stored in recircu lating tank systems: Recirculate im mediately prior to use for not less than 10 minutes, moving not less than 1 per cent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in me chanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 min utes, creating a turbulence at the bot tom of the tank that is visible at the top. Agitate daily as described even when not used. (e) How are chemical and physical sta bility data to be submitted? The data must be submitted as follows: (1) Directly in the NADA, (2) By a sponsor, or (3) To an MF that a sponsor may then reference in its NADA with written consent of the MF holder. (f) What will be stated in the published approval for a new animal drug intended for use in liquid feed? The approval of a new animal drug intended for use in liquid feed as published in this sub chapter will include the following re quirements: (1) The formula and/or specifications of the liquid medicated feed, where the owner of this information requests such publication; and/or (2) A statement that the approval has been granted for a proprietary formula and/or specifications. (g) When is a medicated feed mill license required for the manufacture of a liquid medicated feed? An approved medicated feed mill license is required for the manufacture of the following types of feeds: (1) All liquid medicated feeds that contain a Category II drug, and (2) Liquid medicated feeds that con tain a Category I drug and use a propri etary formula and/or specifications. (h) What measures are in place to pre vent certain drugs, approved for use in animal feed or drinking water but not in liquid medicated feed, from being diverted to use in liquid feeds? Any product con taining any form of bacitracin, oxytet racycline, or chlortetracycline, in tended for oral administration via ani mal feed and/or drinking water, and not approved for use in a liquid medi cated feed must include in its labeling the following statement: ‘‘FOR USE IN ONLY. NOT FOR USE IN LIQUID MEDICATED FEEDS.’’ The blank may be filled in with the words: ‘‘DRY FEEDS’’, ‘‘DRINKING WATER’’, or ‘‘DRY FEEDS AND DRINKING WATER’’. (i) Can the labeling provisions of para graph (h) of this section be waived, and how can I apply for a waiver? (1) The la beling provisions of paragraph (h) of this section may be waived if there is evidence to indicate that it is unlikely a new animal drug would be used in the manufacture of a liquid medicated feed. (2) To obtain a waiver, you must sub mit a letter requesting a waiver to the Office of New Animal Drug Evaluation (HFV–100), Center for Veterinary Medi cine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. (3) The letter must include a copy of the product label; a description of the formulation; and information to estab lish that the physical, chemical, or other properties of the new animal drug are such that diversion to use in liquid medicated feed is unlikely. (j) What else do I need to know about the labeling provisions of paragraph (h) of this section? The labeling provisions of paragraph (h) of this section may be implemented without prior approval as provided for in § 514.8(c)(3) of this chap ter. [69 FR 30197, May 27, 2004, as amended at 71 FR 74785, Dec. 13, 2006; 72 FR 69131, Dec. 6, 2007] § 558.6 Veterinary feed directive drugs. (a) General requirements related to vet erinary feed directive (VFD) drugs. (1) Animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combination VFD feed) may be fed to animals only by or upon a lawful VFD issued by a licensed vet erinarian. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00435 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 426 21 CFR Ch. I (4–1–23 Edition) § 558.6 (2) A VFD feed or combination VFD feed must not be fed to animals after the expiration date on the VFD. (3) Use and labeling of a VFD drug or a combination VFD drug in feed is lim ited to the approved, conditionally ap proved, or indexed conditions of use. Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted. (4) All involved parties (the veteri narian, the distributor, and the client) must retain a copy of the VFD for 2 years. The veterinarian must retain the original VFD in its original form (electronic or hardcopy). The dis tributor and client copies may be kept as an electronic copy or hardcopy. (5) All involved parties must make the VFD and any other records speci fied in this section available for inspec tion and copying by FDA upon request. (6) All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD drugs or combination VFD drugs must promi nently and conspicuously display the following cautionary statement: ‘‘Cau tion: Federal law restricts medicated feed containing this veterinary feed di rective (VFD) drug to use by or on the order of a licensed veterinarian.’’ (b) Responsibilities of the veterinarian issuing the VFD. (1) In order for a VFD to be lawful, the veterinarian issuing the VFD must: (i) Be licensed to practice veterinary medicine; and (ii) Be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice re quirements, including issuing the VFD in the context of a veterinarian-client patient relationship (VCPR) as defined by the State. If applicable VCPR re quirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter. (2) The veterinarian must only issue a VFD that is in compliance with the conditions for use approved, condi tionally approved, or indexed for the VFD drug or combination VFD drug. (3) The veterinarian must ensure that the following information is fully and accurately included on the VFD: (i) The veterinarian’s name, address, and telephone number; (ii) The client’s name, business or home address, and telephone number; (iii) The premises at which the ani mals specified in the VFD are located; (iv) The date of VFD issuance; (v) The expiration date of the VFD. This date must not extend beyond the expiration date specified in the ap proval, conditional approval, or index listing, if such date is specified. In cases where the expiration date is not specified in the approval, conditional approval, or index listing, the expira tion date of the VFD must not exceed 6 months after the date of issuance; (vi) The name of the VFD drug(s); (vii) The species and production class of animals to be fed the VFD feed; (viii) The approximate number of animals to be fed the VFD feed by the expiration date of the VFD. The ap proximate number of animals is the po tential number of animals of the spe cies and production class identified on the VFD that will be fed the VFD feed or combination VFD feed at the speci fied premises by the expiration date of the VFD; (ix) The indication for which the VFD is issued; (x) The level of VFD drug in the VFD feed and duration of use; (xi) The withdrawal time, special in structions, and cautionary statements necessary for use of the drug in con formance with the approval; (xii) The number of reorders (refills) authorized, if permitted by the drug approval, conditional approval, or index listing. In cases where reorders (refills) are not specified on the label ing for an approved, conditionally ap proved, or index listed VFD drug, reor ders (refills) are not permitted; (xiii) The statement: ‘‘Use of feed containing this veterinary feed direc tive (VFD) drug in a manner other than as directed on the labeling (extralabel use) is not permitted.’’; (xiv) An affirmation of intent for combination VFD drugs as described in paragraph (6) of this section; and (xv) The veterinarian’s electronic or written signature. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00436 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 427 Food and Drug Administration, HHS § 558.6 (4) The veterinarian may, at his or her discretion, enter the following in formation on the VFD to more specifi cally identify the animals authorized to be treated/fed the VFD feed: (i) A more specific description of the location of animals (e.g., by site, pen, barn, stall, tank, or other descriptor that the veterinarian deems appro priate); (ii) The approximate age range of the animals; (iii) The approximate weight range of the animals; and (iv) Any other information the vet erinarian deems appropriate to identify the animals specified in the VFD. (5) For VFDs intended to authorize the use of an approved, conditionally approved, or indexed combination VFD drug that includes more than one VFD drug, the veterinarian must include the drug-specific information required in paragraphs (b)(3)(vi), (ix), (x), and (xi) of this section for each VFD drug in the combination. (6) The veterinarian may restrict VFD authorization to only include the VFD drug(s) cited on the VFD or may expand such authorization to allow the use of the cited VFD drug(s) along with one or more over-the-counter (OTC) animal drugs in an approved, condi tionally approved, or indexed combina tion VFD drug. The veterinarian must affirm his or her intent regarding com bination VFD drugs by including one of the following statements on the VFD: (i) ‘‘This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drug(s) in combination with any other animal drugs.’’ (ii) ‘‘This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, condi tionally approved, or indexed combina tion(s) in medicated feed that contains the VFD drug(s) as a component.’’ [List specific approved, conditionally ap proved, or indexed combination medi cated feeds following this statement.] (iii) ‘‘This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally ap proved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.’’ (7) The veterinarian must issue a written (nonverbal) VFD. (8) The veterinarian must send a copy of the VFD to the distributor via hardcopy, facsimile (fax), or electroni cally. If in hardcopy, the veterinarian must send the copy of the VFD to the distributor either directly or through the client. (9) The veterinarian must provide a copy of the VFD to the client. (c) Responsibilities of any person who distributes an animal feed containing a VFD drug or a combination VFD drug. (1) The distributor is permitted to fill a VFD only if the VFD contains all the information required in paragraph (b)(3) of this section. (2) The distributor is permitted to distribute an animal feed containing a VFD drug or combination VFD drug only if it complies with the terms of the VFD and is manufactured and la beled in conformity with the approved, conditionally approved, or indexed con ditions of use for such drug. (3) The distributor must keep records of the receipt and distribution of all medicated animal feed containing a VFD drug for 2 years. (4) In addition to other applicable recordkeeping requirements found in this section, if the distributor manu factures the animal feed bearing or containing the VFD drug, the dis tributor must also keep VFD feed man ufacturing records for 1 year in accord ance with part 225 of this chapter. Such records must be made available for in spection and copying by FDA upon re quest. (5) A distributor of animal feed con taining a VFD drug must notify FDA prior to the first time it distributes animal feed containing a VFD drug. The notification is required one time per distributor and must include the following information: (i) The distributor’s complete name and business address; (ii) The distributor’s signature or the signature of the distributor’s author ized agent; and (iii) The date the notification was signed. (6) A distributor must also notify FDA within 30 days of any change in ownership, business name, or business address. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00437 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 428 21 CFR Ch. I (4–1–23 Edition) § 558.55 (7) The notifications cited in para graphs (c)(5) and (6) of this section must be submitted to the Food and Drug Administration, Center for Vet erinary Medicine, Division of Animal Feeds (HFV–220), 12225 Wilkins Ave., Rockville, MD 20852, Fax: 240–453–6882, or email (via attachment): MedicatedFeedsTeamMail@fda.hhs.gov. (8) A distributor is permitted to dis tribute a VFD feed to another dis tributor only if the originating dis tributor (consignor) first obtains a written (nonverbal) acknowledgment letter, as defined in § 558.3(b)(11), from the receiving distributor (consignee) before the feed is shipped. Consignor distributors must retain a copy of each consignee distributor’s acknowledg ment letter for 2 years. [80 FR 31733, June 3, 2015; 80 FR 35841, June 23, 2015, as amended at 85 FR 50784, Aug. 18, 2020] Subpart B—Specific New Animal Drugs for Use in Animal Feeds § 558.55 Amprolium. (a) Specifications. Type A medicated article containing 25 percent amprolium. (b) Sponsor. No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.50 of this chapter. (d) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite. (e) Conditions of use—(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 milligrams per kilogram of body weight per day. Calves: As an aid in the prevention of coc cidiosis 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. 016592 (ii) 113.5 to 11, 350; to provide 10 milli grams per kilogram of body weight per day. Calves: As an aid in the treatment of coc cidiosis caused by Eimeria bovis and E. zuernii. 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. 016592 (2) Chickens. It is used as follows: Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 36.3 to 113.5 ...... ................................. Replacement chickens: For devel opment of active immunity to coccidiosis. Feed continuously until onset of production as follows: 016592 Growing conditions Up to 5 weeks of age From 5 to 8 weeks of age Over 8 weeks of age Amprolium in grams per ton Amprolium in grams per ton Amprolium in grams 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 (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%) VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00438 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 429 Food and Drug Administration, HHS § 558.55 Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (ii) 36.3 to 113.5 ..... Bacitracin methylenedisalicy late 4 to 50. Replacement chickens: For devel opment of active immunity to coccidiosis; and for increased rate of weight gain and im proved feed efficiency. Feed according to subtable in item (i). Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 72.6 to 113.5 .... ................................. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only. Feed continuously as the sole ra tion; as sole source of amprolium. 016592 (iv) 72.6 to 113.5 .... Bambermycins 1 to 2. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella only; and for in creased rate of weight gain and improved feed efficiency. Feed continuously as the sole ra tion; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 016592 (v) 113.5 ................. ................................. 1. Laying chickens: For preven tion of coccidiosis. Feed continuously as the sole ra tion; as the sole source of amprolium. 016592 2. Laying chickens: For treatment of coccidiosis in moderate out breaks. Feed for 2 weeks. (vi) 113.5 to 227 ..... ................................. 1. Replacement chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired. Feed continuously from day-old until onset of production; as the sole source of amprolium. 016592 2. Broiler chickens: For preven tion of coccidiosis where immu nity to coccidiosis is not desired. Feed continuously as the sole ra tion; as sole source of amprolium. (vii) 113.5 to 227 .... Bambermycins 1 to 2. Broiler chickens: For prevention of coccidiosis where immunity to coccidiosis is not desired; and for increased rate of weight gain and improved feed effi ciency. Feed continuously as the sole ra tion; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 016592 (viii) 227 .................. ................................. Laying chickens: For treatment of coccidiosis in severe outbreaks.. 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 Limitations Sponsor (i) 113.5 .................. Bambermycins 1 to 4. Growing turkeys: For prevention of coccidiosis; and for in creased rate of weight gain and improved feed efficiency. Feed continuously as the sole source of amprolium; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 016592 (ii) 113.5 to 227 ...... ................................. Turkeys: For prevention of coc cidiosis. Feed continuously as the sole ra tion; as sole source of amprolium. 016592 (4) Pheasants. It is used as follows: Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 159 ..................... ................................. Growing pheasants: For the pre vention of coccidiosis caused by Eimeria colchici, E. duodenalis, and E. phasiani. Feed continuously as sole ration. Use as sole source of amprolium. 016592 (ii) [Reserved] (5) Permitted combinations. Amprolium may also be used in combination with: (i) Virginiamycin as in § 558.635. (ii) [Reserved] [41 FR 10985, Mar. 15, 1976] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.55, see the List of CFR VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00439 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 430 21 CFR Ch. I (4–1–23 Edition) § 558.58 Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.58 Amprolium and ethopabate. (a) Specifications. Type A medicated articles containing: (1) 25 percent amprolium and 8 per cent ethopabate or 5 percent amprolium and 1.6 percent ethopabate; (2) 25 percent amprolium and 0.8 per cent ethopabate or 5 percent amprolium and 0.16 percent ethopabate. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.50 and 556.260 of this chapter. (d) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite. (e) Conditions of use. It is used in chicken feed as follows: Amprolium and ethopabate in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (1) Amprolium 113.5 and ethopabate 3.6. ................................. Broiler chickens: As an aid in the prevention of coccidiosis. Feed continuously as sole ration; as sole source of amprolium. Not for laying chickens. 016592 (2) Amprolium 113.5 and ethopabate 36.3. ................................. Broiler chickens and replacement chickens: where immunity to coccidiosis is not desired: As an aid in the prevention of coc cidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. 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 ... 1. Broiler chickens and replace ment chickens: where immunity to coccidiosis is not desired; to aid in prevention of coccidiosis where severe exposure to coc cidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; for in creased rate of weight gain in broiler chickens raised in floor pens. Feed as the sole ration from the time chickens are placed on lit ter until past the time when coccidiosis is ordinarily a haz ard. 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 coc cidiosis. Bacitracin as bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 016592 (4) 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 effi ciency. Feed as the sole ration from the time chickens are placed on lit ter 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. 054771 (5) Amprolium 113.5 and ethopabate 36.6. Bambermycins 1 to 3. 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 effi ciency. Feed continuously as the sole ra tion; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 016592 (6) Amprolium 227 and ethopabate 3.6. ................................. For broiler chickens and replace ment chickens where immunity to coccidiosis is not desired; prevention of coccidiosis. Not for laying chickens ................. 016592 (f) Amprolium and ethopabate may also be used in combination with: (1)–(2) [Reserved] (3) Chlortetracycline as in § 558.128. [41 FR 10990, Mar. 15, 1976] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.58, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00440 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 431 Food and Drug Administration, HHS § 558.68 § 558.59 Apramycin. (a) Specifications. Type A articles con taining 75 grams apramycin (as apramycin sulfate) per pound. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.52 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for apramycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for apramycin shall not be refilled. (e) Conditions of use in swine— Apramycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (1) 150 ............................... ........................ For control of porcine colibacillosis (weanling pig scours) caused by sus ceptible strains of Escherichia coli. Feed as the sole ration for 14 consecutive days. Withdraw 28 days be fore slaughter. 058198 (2) [Reserved]. [81 FR 94995, Dec. 27, 2016, as amended at 87 FR 10970, Feb. 28, 2022] § 558.68 Avilamycin. (a) Specifications. Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.60 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for avilamycin medicated feeds must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled. (e) Conditions of use. Administer in feed as follows: (1) Chickens— Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 13.6 to 40.9 ...... ........................ Broiler chickens: For the preven tion of mortality caused by ne crotic enteritis associated with Clostridium perfringens in broiler chickens. Feed as the sole ration for 21 con secutive days. To assure re sponsible antimicrobial drug use in broiler chickens, treatment ad ministration must begin on or before 18 days of age. 058198 (ii) 13.6 to 40.9 ..... Monensin, 90 to 110 Broiler chickens: For the preven tion of mortality caused by ne crotic enteritis associated with Clostridium perfringens; and as an aid in the prevention of coc cidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.. Feed as the sole ration for 21 con secutive days. To assure re sponsible antimicrobial drug use in broiler chickens, treatment ad ministration must begin on or before 18 days of age. See § 558.355(d) of this chapter. Monensin as provided by No. 058198 in § 510.600(c) of this chapter.. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00441 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 432 21 CFR Ch. I (4–1–23 Edition) § 558.68 Avilamycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (iii) 13.6 to 40.9 .... Narasin, 54 to 90 Broiler chickens: For the preven tion of mortality caused by ne crotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma.. Feed as the sole ration for 21 con secutive days to chickens that are at risk of developing, but not yet showing clinical signs of, ne crotic enteritis associated with Clostridium perfringens. To as sure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Inges tion of narasin by these species has been fatal. Narasin as pro vided by No. 058198 in § 510.600(c) of this chapter.. 058198 (iv) 13.6 to 40.9 .... Narasin, 27 to 45 plus nicarbazin, 27 to 45 Broiler chickens: For the preven tion of mortality caused by ne crotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma. Feed as the sole ration for 21 con secutive days to chickens that are at risk of developing, but not yet showing clinical signs of, ne crotic enteritis associated with Clostridium perfringens. Avilamycin has not been dem onstrated to be effective in broil er chickens showing clinical signs of necrotic enteritis prior to the start of medication. To as sure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow adult tur keys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to chickens producing eggs for human consumption. Narasin and nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter. 058198 (v) 13.6 to 40.9 ..... Salinomycin sodium, 40 to 60 Broiler chickens: For the preven tion of mortality caused by ne crotic enteritis associated with Clostridium perfringens; and for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxi ma, E. brunetti, and E. mivati.. Feed as the sole ration for 21 con secutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis asso ciated with Clostridium perfringens. Not approved for use with pellet binders. To as sure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effec tive in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. Do not feed to laying hens pro ducing eggs for human con sumption. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592 in § 510.600(c) of this chapter.. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00442 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 433 Food and Drug Administration, HHS § 558.76 (2) Swine— Avilamycin in grams/ton Combinationin grams/ton Indications for use Limitations Sponsor (i) 73 ..................... ........................ Weaned pigs less than 14 weeks of age: For the reduction in inci dence and overall severity of di arrhea in the presence of patho genic Escherichia coli in groups of weaned pigs. Feed as the sole ration for 21 con secutive days. To assure re sponsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older. 058198 (ii) [Reserved]. [80 FR 61297, Oct. 13, 2015, as amended at 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 48703, July 26, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR 11509, Feb. 24, 2017; 83 FR 14587, Apr. 5, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 33001, July 11, 2019; 85 FR 4209, Jan. 24, 2020; 85 FR 45308, July 28, 2020; 86 FR 13188, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021] § 558.76 Bacitracin methylenedisalicylate. (a) Specifications. (1) Type A medi cated articles containing feed grade bacitracin methylenedisalicylate equivalent to 10, 25, 30, 40, 50, 60, or 75 grams bacitracin per pound. (2) Type A medicated article con taining feed grade bacitracin methylenedisalicylate equivalent to 50 grams bacitracin per pound. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) No. 054771 for use of products in paragraph (a)(1) of this section as in paragraph (d) of this section. (2) No. 069254 for use of product in paragraph (a)(2) of this section as in paragraph (d) of this section. (c) Related tolerances. See § 556.70 of this chapter. (d) Conditions of use—(1) Chickens— Bacitracin in grams per ton Indications for use Limitations Sponsor (i) 4 to 50 ....................... Broiler and replacement chickens: For in creased rate of weight gain and im proved feed efficiency. Feed continuously as sole ration .............. 054771 069254 (ii) 10 to 25 .................... Laying hens: For increased egg produc tion and improved feed efficiency. Feed continuously as sole ration for the first 7 months of egg production. 054771 (iii) 50 ............................. Broiler and replacement chickens: As an aid in the prevention of necrotic enter itis caused or complicated by Clos tridium spp. or other organisms suscep tible to bacitracin. Feed continuously as sole ration .............. 054771 (iv) 50 ............................. Broiler and replacement chickens: For the prevention of mortality caused by ne crotic enteritis associated with Clos tridium perfringens. Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. 069254 (v) 100 to 200 ................ Broiler and replacement chickens: As an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration. Start at first clinical signs of disease. Vary dos age based on severity of infection. Ad minister continuously for 5 to 7 days or as long as clinical signs persist, then reduce medication to prevention level (50 grams/ton). 054771 (2) Turkeys— Bacitracin in grams per ton Indications for use Limitations Sponsor (i) 4 to 50 ....................... Growing turkeys: For increased rate of weight gain and improved feed effi ciency. Feed continuously as sole ration .............. 054771 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00443 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 434 21 CFR Ch. I (4–1–23 Edition) § 558.76 Bacitracin in grams per ton Indications for use Limitations Sponsor (ii) 200 ............................ Growing turkeys: As an aid in the control of transmissible enteritis complicated by organisms susceptible to bacitracin methylenedisalicylate. Feed continuously as the sole ration ........ 054771 (3) Swine— Bacitracin in grams per ton Indications for use Limitations Sponsor (i) 10 to 30 ..................... Growing and finishing swine: For in creased rate of weight gain and im proved feed efficiency. .................................................................... 054771 (ii) 250 ............................ Growing and finishing swine: For control of swine dysentery (bloody scours) as sociated with Brachyspira hyodysenteriae in pigs up to 250 lbs body weight. Feed as the sole ration. Feed 250 grams per ton of complete feed on premises with a history of swine dysentery, but where signs of the disease have not yet occurred or following an approved treatment of the disease condition. Di agnosis should be confirmed by a vet erinarian a when results are not satis factory. 054771 (iii) 250 ........................... Pregnant sows: For control of clostridial enteritis caused by Clostridium perfringens in suckling piglets. As the sole ration. Feed to sows from 14 days before through 21 days after farrowing on premises with a history of clostridial scours. Diagnosis should be confirmed by a veterinarian when re sults are not satisfactory. 054771 (4) Cattle— Bacitracin amount Indications for use Limitations Sponsor (i) 70 mg per head per day. Beef steers and heifers fed in confine ment for slaughter: For reduction in the number of liver condemnations due to abscesses. Administer continuously throughout the feeding period. 054771 069254 (ii) 250 mg per head per day. Beef steers and heifers fed in confine ment for slaughter: For reduction in the number of liver condemnations due to abscesses. Administer continuously for 5 days then discontinue for subsequent 25 days, re peat the pattern during the feeding pe riod. 054771 069254 (5) Game birds— Bacitracin in grams per ton Indications for use Limitations Sponsor (i) 4 to 50 ....................... Growing pheasants: For increased rate of weight gain and improved feed effi ciency. Feed continuously as sole ration .............. 054771 069254 (ii) 5 to 20 ...................... Growing quail: For increased rate of weight gain and improved feed effi ciency in quail not over 5 weeks of age. Feed continuously as sole ration to quail not over 5 weeks of age. 054771 069254 (iii) 200 ........................... Growing quail: For the prevention of ul cerative enteritis in growing quail due to Clostridium colinum susceptible to baci tracin methylenedisalicylate. Feed continuously as the sole ration ........ 054771 (6) Bacitracin methylenedisalicylate may also be used in combination with: (i) Amprolium as in § 558.55. (ii) Amprolium and ethopabate as in § 558.58. (iii) Chlortetracycline as in § 558.128. (iv) Clopidol as in § 558.175. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00444 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 435 Food and Drug Administration, HHS § 558.95 (v) Decoquinate as in § 558.195. (vi) Diclazuril as in § 558.198. (vii) Fenbendazole as in § 558.258. (viii) Halofuginone as in § 558.265. (ix) Ivermectin as in § 558.300. (x) Lasalocid as in § 558.311. (xi) Monensin as in § 558.355. (xii) Narasin as in § 558.363. (xiii) Narasin and nicarbazin as in § 558.364. (xiv) Nicarbazin as in § 558.366. (xv) Robenidine as in § 558.515. (xvi) Salinomycin as in § 558.550. (xvii) Semduramicin as in § 558.555. (xviii) Zoalene as in § 558.680. [41 FR 10993, Mar. 15, 1976] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.76, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.78 Bacitracin zinc. (a) Specifications. Type A medicated articles containing bacitracin zinc equivalent to 10, 25, 40, or 50 grams per pound bacitracin. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.70 of this chapter. (d) Conditions of use. (1) It is used as follows: Bacitracin zinc in grams per ton Combinations in grams per ton Indications for use Limitations Sponsor (i) 4 to 50 ................... ............................. Chickens: for increased rate of weight gain and improved feed efficiency. Growing chickens ....................... 054771 (ii) 4 to 50 .................. ............................. Turkeys and pheasants: for in creased rate of weight gain and improved feed efficiency. Growing turkeys and pheasants 054771 (iii) 5 to 20 ................. .................................. Quail; for increased rate of weight gain and improved feed efficiency. Growing quail; feed as the Type C feed to starting quail through 5 weeks of age. 054771 (iv) 10 to 25 ............... .................................. Laying chickens; improved feed efficiency and increased egg production. ..................................................... 054771 (v) 10 to 50 ................ .................................. Swine; increased rate of weight gain and improved feed effi ciency. Growing and finishing swine ...... 054771 (vi) 20 ........................ .................................. Growing-finishing swine; in creased rate of weight gain. In Type C feed ........................... 054771 (vii) 20 to 40 .............. .................................. Growing-finishing swine; im proved feed efficiency. ......do ......................................... 054771 (2) It is used in feed for growing cat tle at 35 to 70 milligrams per head per day as follows: (i) To aid in stimulating growth and improving feed efficiency. (ii) For increased rate of weight gain and improved feed efficiency; see spon sor 054771. (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) Nicarbazin as in § 558.366. (viii) Robenidine as in § 558.515. (ix) Salinomycin as in § 558.550. [41 FR 10994, Mar. 15, 1976] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.78, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.95 Bambermycins. (a) Specifications. Type A medicated articles containing 2, 4, or 10 grams bambermycins per pound. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) No. 016592: 2, 4, and 10 grams per pound for use as in paragraphs (e)(1) through (4) of this section. (2) No. 012286: 2 grams for use as in paragraph (e)(2) of this section and 0.4 and 2 grams per pound for use as in paragraph (e)(3) of this section. (c) Related tolerances. See § 556.75 of this chapter. (d) Special considerations. (1) Bambermycins liquid Type B feeds may VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00445 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 436 21 CFR Ch. I (4–1–23 Edition) § 558.95 be manufactured from dry bambermycins Type A articles. The liquid Type B feeds must have a pH of 3.8 to 7.5, moisture content of 30 to 45 percent. (2) The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liq uid Type B feed is 1 week after date of manufacture. (e) Conditions of use—(1) Chickens. Use in medicated feed as follows: Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 1 to 2 ................................. Broiler chickens: For increased rate of weight gain and im proved feed efficiency. Feed continuously as the sole ration. 016592. (ii) [Reserved]. (2) Turkeys. Use in medicated feed as follows: Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 1 to 2 ................................. Growing turkeys: For improved feed efficiency. Feed continuously as the sole ration. 012286, 016592. (ii) 2 ........................................ Growing turkeys: For in creased rate of weight gain and improved feed efficiency. Feed continuously as the sole ration. 012286, 016592. (3) Swine. Use in medicated feed as follows: Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 2 ......................................... Growing-finishing swine: For increased rate of weight gain and improved feed effi ciency. Feed continuously as the sole ration. 012286, 016592. (ii) 2 to 4 ................................ Growing-finishing swine: For increased rate of weight. Feed continuously as the sole ration. 012286, 016592. (4) Cattle. Bambermycins in grams/ton Indications for use Limitations Sponsor (i) 1 to 4 ................................. Growing beef steers and heif ers fed in confinement for slaughter: For increased rate of weight gain and im proved feed efficiency. Feed continuously at a rate of 10 to 20 milligrams per head per day. 016592. (ii) 2 to 80 .............................. Growing beef steers and heif ers on pasture (stocker, feeder, and slaughter), and replacement beef and dairy heifers on pasture: For in creased rate of weight gain. Feed continuously on a hand fed basis at a rate of 10 to 40 milligrams per head per day in 1 to 10 pounds of supplemental Type C medi cated feed. 016592. (iii) Used as a free-choice Type C medicated loose-mineral feed for pas ture cattle (slaughter, stocker, and feeder cattle; and beef replacement heifers) as follows: (a) Specifications. Ingredient International Feed No. Percent Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ...................... 6–01–080 ...................... 42.50 Sodium chloride (salt) .................................................................................... 6–04–152 ...................... 20.10 Calcium carbonate (38% calcium) ................................................................. 6–01–069 ...................... 15.24 Corn distillers dried grains w/solubles ........................................................... 5–28–236 ...................... 9.57 Magnesium oxide ........................................................................................... 6–02–756 ...................... 5.15 Vitamin and trace mineral premix * ............................................................... ......... ............................. 3.72 Mineral oil ...................................................................................................... ......... ............................. 1.00 Yeast (primary dehydrated yeast) ................................................................. 7–05–533 ...................... 0.75 Bambermycins Type A article (10 g/lb) ......................................................... ......... ............................. 0.60 Iron oxide ....................................................................................................... 6–02–431 ...................... 0.50 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00446 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 437 Food and Drug Administration, HHS § 558.95 Ingredient International Feed No. Percent Magnesium sulfate (67%) .............................................................................. 6–02–758 ...................... 0.32 Selenium premix (270 mg/lb) * ...................................................................... ......... ............................. 0.21 Copper sulfate ............................................................................................... 6–01–720 ...................... 0.18 Potassium sulfate (0.33%) ............................................................................. 6–06–098 ...................... 0.16 *Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (b) Amount per ton. 120 grams. (c)Indications for use. For increased rate of weight gain. (d) Limitations. For free-choice feed ing to pasture cattle (slaughter, stock er, and feeder cattle; and beef replace ment heifers). Feed a nonmedicated commercial mineral product for 6 weeks to stabilize consumption be tween 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day. (iv) Use free-choice Type C medicated feeds for pasture cattle (slaughter, stocker, and feeder cattle; and beef re placement heifers) as follows: (a) Amount. Feed continuously to pro vide 10 to 40 milligrams of bambermycins per head per day. (b) Indications for use. For increased rate of weight gain. (c) Limitations. Each use in a free choice Type C medicated feed must be the subject of an approved new animal drug application (NADA) or supple mental NADA as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/ head/day. (v) Used as a free-choice Type C medicated loose mineral feed for pas ture cattle (slaughter, stocker, and feeder cattle; and dairy and beef re placement heifers) as follows: (A) Specifications. Ingredient International Feed No. Percent Deflorinated phosphate (20.5% calcium, 18.5% phosphorus) ...................... 6–01–080 ...................... 42.50 Sodium chloride (salt) .................................................................................... 6–04–152 ...................... 20.10 Calcium carbonate (38% calcium) ................................................................. 6–01–069 ...................... 15.45 Corn distillers dried grains w/solubles ........................................................... 5–28–236 ...................... 9.57 Magnesium oxide ........................................................................................... 6–02–756 ...................... 5.15 Vitamin and trace mineral premix * ................................................................ ........................................ 3.72 Mineral oil ...................................................................................................... ........................................ 1.00 Yeast (primary dehydrated yeast) ................................................................. 7–05–533 ...................... 0.75 Bambermycins Type A article (10 g/lb) ......................................................... ........................................ 0.60 Iron oxide ....................................................................................................... 6–02–431 ...................... 0.50 Magnesium sulfate (67%) .............................................................................. 6–02–758 ...................... 0.32 Copper sulfate ............................................................................................... 6–01–720 ...................... 0.18 Potassium sulfate (0.33%) ............................................................................. 6–06–098 ...................... 0.16 * Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free choice feeds. Formulation modifications require FDA approval prior to marketing. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (B) Amount per ton. 120 grams. (C) Indications for use. For increased rate of weight gain. (D) Limitations. For free-choice feed ing to pasture cattle (slaughter, stock er, and feeder cattle; and dairy and beef replacement heifers). Feed a non-medi cated commercial mineral product for 6 weeks to stabilize consumption be tween 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day. (5) Combinations. Bambermycins may also be used in combination with: (i) Amprolium as in § 558.55. (ii) Amprolium and ethopabate as in § 558.58. (iii) Clopidol as in § 558.175. (iv) Diclazuril as in § 558.198. (v) Halofuginone as in § 558.265. (vi) Lasalocid as in § 558.311. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00447 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 438 21 CFR Ch. I (4–1–23 Edition) § 558.115 (vii) Monensin as in § 558.355. (viii) Narasin as in § 558.363. (ix) Narasin and nicarbazin as in § 558.364. (x) Nicarbazin as in § 558.366. (xi) Salinomycin as in § 558.550. (xii) Zoalene as in § 558.680. [40 FR 13959, Mar. 27, 1975] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.95, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.115 Carbadox. (a) Approvals. Type A medicated arti cles: 2.2. percent (10 grams per pound) to 066104 in § 510.600(c) of this chapter. (b) Related tolerances. See § 556.100 of this chapter. (c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite. (d) Conditions of use. It is used for swine as follows: (1) Amount per ton. 10–25 grams (0.0011–0.00275 percent). (i) Indications for use. For increase in rate of weight gain and improvement of feed efficiency. (ii) Limitations. Not for use in preg nant swine or swine intended for breed ing purposes. Do not feed to swine within 42 days of slaughter. (2) Amount per ton. 50 grams (0.0055 percent). (i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dys entery); control of bacterial swine en teritis (salmonellosis or necrotic enter itis caused by Salmonella choleraesuis); increased rate of weight gain and im proved feed efficiency. (ii) Limitations. Not for use in preg nant swine or swine intended for breed ing purposes. Do not feed to swine within 42 days of slaughter. (3) Amount per ton. Carbadox 50 grams (0.0055 percent) plus pyrantel tartrate, 96 grams (0.0106 percent). (i) Indications for use. For control of swine dysentery (vibrionic dysentery, bloody scours, or hemorrhagic dys entery); control of bacterial swine en teritis (salmonellosis or necrotic enter itis caused by Salmonella choleraesuis); aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum) infections. (ii) Limitations. Do not feed to swine over 75 pounds; do not feed within 10 weeks of slaughter; consult a veteri narian before feeding to severely de bilitated animals; feed continuously as sole ration. Do not use in complete feeds containing less than 15 percent crude protein. (4) Carbadox may also be used in combination with oxytetracycline as in § 558.450. [40 FR 13959, Mar. 27, 1975, as amended at 40 FR 45164, Oct. 1, 1975; 40 FR 57798, Dec. 12, 1975; 42 FR 761, Jan. 4, 1977; 51 FR 7396, Mar. 3, 1986; 63 FR 59216, Nov. 3, 1998; 66 FR 47963, Sept. 17, 2001; 69 FR 51173, Aug. 18, 2004; 82 FR 21691, May 10, 2017] § 558.128 Chlortetracycline. (a) Specifications. Type A medicated articles containing either chlortetra cycline calcium complex equivalent to chlortetracycline hydrochloride, or for products intended for use in milk re placer, chlortetracycline hydro chloride. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type A medi cated article. (2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article. (3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article. (c) Related tolerances. See § 556.150 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled. (3) In milk replacers or starter feed; include on labeling the warning: ‘‘A withdrawal period has not been estab lished for this product in preruminating calves. Do not use in calves to be processed for veal.’’ (4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(vi) of this VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00448 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 439 Food and Drug Administration, HHS § 558.128 section must conform to § 510.455 of this chapter. (5) When manufactured for use as in paragraph (e)(5)(iii) of this section, in clude on labeling the warning: ‘‘Psit tacosis, avian chlamydiosis, or orni thosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.’’ (e) Conditions of use—(1) Chickens. It is used as follows: Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ton .... .................................. Chickens: For control of infec tious synovitis caused by Mycoplasma synoviae suscep tible to chlortetracycline. Feed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption. 054771 066104 069254 (ii) 100 to 200 g/ton ... Clopidol, 113.5 ........ Broiler and replacement chick ens: As an aid in the preven tion of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for control of infectious synovitis caused by M. synoviae sus ceptible to chlortetracycline. Feed continuously as the sole ration from the time chicks are placed in floor pens for 7 to 14 days. Do not feed to chick ens over 16 weeks of age. Do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; clopidol as provided by No. 016592 in § 510.600(c) of this chapter. 016592 (iii) 100 to 200 g/ton .. Decoquinate, 27.2 ... Chickens: For prevention of coc cidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for control of infectious synovitis caused by M, synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 days. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption. Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iv) 100 g/ton ............. Robenidine, 30 ........ Broiler and fryer chickens: As an aid in the prevention of coc cidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the con trol of chronic respiratory dis ease (CRD) caused by Myco plasma gallisepticum suscep tible to chlortetracycline; and as an aid in the control of in fectious synovitis caused by M. synoviae susceptible to chlortetracycline. Feed continuously as sole ra tion. Do not use this product in feeds conta. Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (v) 200 to 400 g/ton ... .................................. Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli suscep tible to chlortetracycline. Feed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption. 054771 066104 069254 (vi) 200 g/ton ............. Amprolium, 227 and ethopabate, 3.6. For chickens where immunity to coccidiosis is not desired: For prevention of coccidiosis; and for treatment of chronic res piratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline. Use in low calcium feed con taining 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. Chlor tetracycline as provided by No. 054771; amprolium and ethopabate as provided by No. 016592 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00449 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 440 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (vii) 200 g/ton ............ Decoquinate, 27.2 ... Broilers: As an aid in the pre vention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, and E. brunetti; and for the treatment of chronic respiratory disease (air sac in fection) and the prevention of synovitis. Feed continuously as the sole ration for no more than 8 weeks. Use in low calcium feed containing 0.8% dietary calcium. Bentonite should not be used in decoquinate feeds. Do not feed to chickens pro ducing eggs for human con sumption. Chlortetracycline and decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (viii) 200 g/ton ............ Robenidine 30 ......... Broiler and fryer chickens: As an aid in the prevention of coc cidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the con trol of chronic respiratory dis ease (CRD) caused by M. gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlor tetracycline. Feed continuously as sole ra tion. Do not use this product in feeds containing bentonite. Do not feed to chickens pro ducing eggs for human con sumption. Withdraw 5 days prior to slaughter. Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (ix) 500 g/ton ............. .................................. Chickens: For the reduction of mortality due to E. coli infec tions susceptible to chlortetra cycline. 1. Feed for 5 days. To sponsor No. 054771 under NADA 048– 761 and No. 069254 under ANADA 200–510: zero with drawal time. 054771 069254 2. Feed for 5 days; withdraw 24 hours prior to slaughter. Do not feed to chickens producing eggs for human consumption. 054771 066104 069254 (x) 500 g/ton .............. Monensin, 90 to 110 Chickens: As an aid in the re duction of mortality due to E. coli infections susceptible to chlortetracycline; and as an aid in the prevention of coc cidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Feed for 5 days as the sole ra tion. Do not feed to laying chickens. Not to be fed con tinuously for more than 5 days. Do not feed to chickens over 16 weeks of age. With draw 24 hours before slaugh ter. See § 558.355(d) of this chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in § 510.600(c) of this chapter. 054771 069254 (xi) 500 g/ton ............. Robenidine, 30 ........ Broiler and fryer chickens: As an aid in the prevention of coc cidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the reduction of mortality due to E. coli susceptible to chlor tetracycline. Feed continuously as sole ration for up to 5 days. Do not use this product in feeds con taining bentonite. Do not feed to chickens producing eggs for human consumption. With draw 5 days prior to slaughter. Chlortetracycline and robenidine as provided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00450 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 441 Food and Drug Administration, HHS ยง 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xii) 500 g/ton ............ Salinomycin, 40 to 60. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and as an aid in the re duction of mortality due to E. coli susceptible to chlortetra cycline. For use in low calcium feeds containing 0.8% calcium. Not approved for use with pellet binders. Not to be fed continu ously for more than 5 days. Do not feed to laying chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlor tetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in ยง 510.600(c) of this chapter. 016592 054771 069254 (2) Turkeys. It is used as follows: Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 200 g/ton ............... .................................. Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlor tetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. 054771 066104 069254 (ii) 400 g/ton .............. .................................. 1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis suscep tible to chlortetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. 054771 066104 069254 ............................... .................................. 2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline. ..................................................... 054771 066104 069254 (iii) 25 mg/lb of body weight. .................................. Turkeys: For control of compli cating bacterial organisms as sociated with bluecomb (trans missible enteritis; coronaviral enteritis) susceptible to chlor tetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. 054771 066104 069254 (3) Swine. It is used as follows: Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 50 to 100 g/ton ...... .................................. Swine: For reducing the inci dence of cervical lymphade nitis (jowl abscesses) caused by Group E Streptococci sus ceptible to chlortetracycline. ..................................................... 054771 066104 069254 (ii) 400 g/ton .............. .................................. Breeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 days. 054771 066104 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00451 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 442 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (iii) 10 mg/lb of body weight. .................................. Swine: For treatment of bacterial enteritis caused by Esch erichia coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida suscep tible to chlortetracycline; for the control of porcine prolif erative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for spon sor No. 069254 in § 510.600(c) of this chapter. 054771 066104 069254 (iv) 10 mg/lb of body weight. Bacitracin methylenedisalicyl ate, 10 to 30. Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlor tetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetra cycline; and for increased rate of weight gain and improved feed efficiency. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Chlortetra cycline and bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 (v) 10 mg/lb of body weight. Bacitracin methylenedisalicyl ate, 10 to 30. Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlor tetracycline; and for increased rate of weight gain and im proved feed efficiency. Feed chlortetracycline at ap proximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed for not more than 14 days. Withdraw 5 d prior to slaugh ter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetra cycline provided by Nos. 054771 and 069254 in § 510.600(c) of this chapter. 054771 069254 (vi) 10 mg/lb of body weight. Tiamulin hydrogen fumarate, 35. For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sen sitive to chlortetracycline and treatment of bacterial pneu monia caused by P. multocida sensitive to chlortetracycline. Feed chlortetracycline at ap proximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed continuously as the sole ration for 14 days. Withdraw medi cated feed 2 days before slaughter. Tiamulin as pro vided by Nos. 058198 or 069254 in § 510.600(c) of this chapter. 058198 069254 (4) Cattle. It is used as follows: Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) to provide 70 mg/head/ day. ................................ Growing cattle (over 400 lb): For reduction of liver con demnation due to liver ab scesses. Feed to provide chlortetra cycline at the rate of 70 mg per animal daily. A with drawal period has not been established in pre-rumi nating calves. Do not use in calves to be processed for veal. 054771 066104 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00452 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 443 Food and Drug Administration, HHS ยง 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (ii) 5.83 to 14 g/ton to pro vide 70 mg/head/day. Melengestrol ace tate, 0.25 to 2 g/ ton to provide 0.25 to 0.5 mg melengestrol ac etate per head per day. Growing beef heifers fed in confinement for slaughter (over 400 lb): For reduction of the incidence of liver ab scesses, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed con taining 5.83 to 14 g/ton chlortetracycline. Chlortetra cycline and melengestrol as provided by No. 054771 in ยง 510.600(c) of this chapter. 054771 (iii) 7 to 17.5 g/ton .............. Monensin, 5 to 40 Growing beef steers and heif ers fed in confinement for slaughter over 400 lb: For reduction of the incidence of liver abscesses and for im proved feed efficiency. Feed as the sole ration to pro vide 70 mg chlortetracycline per head per day and 50 to 480 mg monensin per head per day. No additional im provement in feed efficiency has been shown from feed ing monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in ยง 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00453 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 444 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (iv) 7 to 17.5 g/ton .............. Monensin, 10 to 40 Growing beef steers and heif ers fed in confinement for slaughter over 400 lb: For reduction of the incidence of liver abscesses and for pre vention and control of coc cidiosis due to Eimeria bovis and Eimeria zuernii. Feed as the sole ration to pro vide 70 mg chlortetracycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to pro vide, depending upon sever ity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in § 510.600(c) of this chapter. 069254 (v) to provide 0.5 mg/lb of body weight daily. ................................ Beef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline. Feed to provide chlortetra cycline at the rate of 0.5 mg per pound of body weight daily. Withdraw 48 hours prior to slaughter. To spon sor Nos. 054771 and 069254: Zero withdrawal time. 054771 066104 069254 (vi) 33.33 to 50 g/ton to provide 0.5 mg/lb of body weight per day. Melengestrol ace tate, 0.5 to 2 g/ ton to provide 0.5 mg melengestrol acetate per head per day. Replacement beef heifers over 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline and for suppression of estrus (heat). Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed con taining 33.33 to 50 g/ton chlortetracycline. Feeding a Type C top-dress medicated feed containing melengestrol acetate shall not exceed 24 days. Chlor tetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00454 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 445 Food and Drug Administration, HHS § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (vii) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily. Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline; and for increased rate of weight gain. Feed continuously on a hand fed basis 0.5 mg chlortetra cycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in ex cess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is re quired. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (viii) 25 to 1,100 g/ton to provide 0.5 mg/lb of body weight daily. Lasalocid, 30 to 600; melengestrol ac etate, 0.5 to 2 g/ ton to provide 0.5 mg/head/day melengestrol ac etate. Replacement beef heifers on pasture over 700 pounds: For control of active infec tion of anaplasmosis caused by Anaplasma marginale susceptible to chlortetra cycline, increased rate of weight gain, and suppres sion of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 1,100 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 0.5 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00455 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 446 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (ix) 33.33 to 66.67 g/ton ..... Monensin, 5 to 40 Growing beef steers and heif ers fed in confinement for slaughter over 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline and for improved feed effi ciency. Feed as the sole ration to pro vide 0.5 mg chlortetracycline per lb. body weight per day and 50 to 480 mg monensin per head per day. No addi tional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in § 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00456 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 447 Food and Drug Administration, HHS ยง 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (x) 33.33 to 66.67 g/ton ...... Monensin, 10 to 40 Growing beef steers and heif ers fed in confinement for slaughter over 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Feed as the sole ration to pro vide 0.5 mg chlortetracycline per lb. body weight per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in ยง 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00457 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 448 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xi) 50 to 117 g/ton ............. Monensin, 7.14 to 40. Growing beef steers and heif ers fed in confinement for slaughter under 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline and for improved feed effi ciency. Feed as the sole ration to pro vide 350 mg chlortetra cycline per head per day and 50 to 480 mg monensin per head per day. No addi tional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in § 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00458 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 449 Food and Drug Administration, HHS ยง 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xii) 50 to 117 g/ton ............ Monensin, 10 to 40 Growing beef steers and heif ers fed in confinement for slaughter under 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Feed as the sole ration to pro vide 350 mg chlortetra cycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in ยง 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00459 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 450 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xiii) 50 to 117 g/ton ........... Monensin, 7.14 to 40. Growing beef steers and heif ers fed in confinement for slaughter: For the control of bacterial pneumonia associ ated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for improved feed efficiency. Feed as the sole ration to pro vide 350 mg chlortetra cycline per head per day and 50 to 480 mg monensin per head per day. No addi tional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in § 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00460 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 451 Food and Drug Administration, HHS § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xiv) 50 to 117 g/ton ........... Monensin, 10 to 40 Growing beef steers and heif ers fed in confinement for slaughter: For the control of bacterial pneumonia associ ated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Feed as the sole ration to pro vide 350 mg chlortetra cycline per head per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 480 mg monensin per head per day. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in § 510.600(c) of this chapter. 069254 (xv) to provide 0.5 to 2.0 mg/lb of body weight daily. ................................ Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline. In Type C free-choice cattle feeds such as feed blocks or salt-mineral mixes manu factured from approved Type A articles. See para graph (d)(4) of this section. 054771 (xvi) to provide 10 mg/lb of body weight daily. ................................ Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. To sponsor No. 054771 (NADAs 048–761 and 046–699) and to spon sor No. 069254 (ANADA 200–510): May be mixed in the cattle’s daily ration or administered as a top-dress. In feed including milk re placers withdraw 10 days prior to slaughter. To spon sor Nos. 054771 and 069254: Zero withdrawal time. See paragraph (d)(3) of this section. 054771 066104 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00461 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 452 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xvii) to provide 10 mg/lb of body weight daily. ................................ Calves (up to 250 lb): For the treatment of bacterial enter itis caused by Escherichia coli susceptible to chlortetra cycline. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. 054771 066104 069254 (xviii) 400 to 2,000 g/ton .... Monensin, 5 to 40 Growing beef steers and heif ers fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida sus ceptible to chlortetracycline; for improved feed efficiency. Feed as the sole ration to pro vide 10 mg chlortetracycline per lb. body weight per day. Treat for not more than 5 days, then continue feeding monensin Type C medi cated feed alone. No addi tional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 mg monensin per head per day). For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in § 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00462 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 453 Food and Drug Administration, HHS ยง 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xix) 400 to 2,000 g/ton ...... Monensin, 5 to 40 Growing beef steers and heif ers: For treatment of bac terial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida sus ceptible to chlortetracycline; and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Feed as the sole ration to pro vide 10 mg chlortetracycline per lb. body weight per day and 0.14 to 0.42 mg monensin per lb. body weight per day to provide, depending upon severity of the coccidiosis challenge, up to 480 mg monensin per head per day. Treat for not more than 5 days, then con tinue feeding monensin Type C medicated feed alone. For use in dry feeds only. Not for use in liquid feed supplements. Do not allow horses or other equines access to feed con taining monensin. Ingestion of monensin by horses has been fatal. Monensin medi cated cattle and goat feeds are safe for use in cattle and goats only. Consump tion by unapproved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in ยง 510.600(c) of this chapter. 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00463 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 454 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xx) 400 to 2,000 g/ton ....... Monensin, 10 to 200. Beef calves 2 months of age and older: For treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida sus ceptible to chlortetracycline; and for the prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuernii. Feed as the sole ration to pro vide 10 mg chlortetracycline per lb. body weight per day and 0.14 to 1.00 mg monensin per lb. body weight per day to provide, depending upon severity of coccidiosis challenge, up to 200 mg of monensin per head per day. Feed for not more than 5 days, then con tinue to feed monensin Type C medicated feed alone. For use in dry feeds only. Not for use in liquid feed supple ments. Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unap proved species may result in toxic reactions. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin over dosing. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Monensin as provided by No. 058198, chlortetra cycline by No. 069254 in § 510.600(c) of this chapter. 069254 (xxi) 500 to 2,000 g/ton to provide 10 mg/lb of body weight daily. Laidlomycin, 5 ....... Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline; and for in creased rate of weight gain and improved feed effi ciency. Feed continuously at a rate of 30 to 75 mg laidlomycin pro pionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00464 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 455 Food and Drug Administration, HHS § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xxii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily. Laidlomycin, 5 to 10. Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline; and for im proved feed efficiency. Feed continuously at a rate of 30 to 75 mg laidlomycin pro pionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxiii) 500 to 2,000 to pro vide 10 mg/lb of body weight daily. Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline; and for im proved feed efficiency. Feed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (xxiv) 500 to 1,200 g/ton to provide 10 mg/lb of body weight daily. Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline; and for in creased rate of weight gain and improved feed effi ciency. Feed continuously in complete feed to provide 10 mg chlor tetracycline per lb body weight and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00465 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 456 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xxv) 500 to 4,000 to pro vide 10 mg/lb of body weight daily. Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heif ers): For treatment of bac terial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline; and for in creased rate of weight gain. Feed continuously on a hand fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pas ture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is re quired. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (xxvi) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 600: Melengestrol ac etate, 0.5 to 2 g/ ton to provide 0.5 mg/head/day melengestrol ac etate. Replacement dairy heifers on pasture less than 20 months of age and replacement beef heifers on pasture: For treatment of bacterial enter itis caused by Escherichia coli and bacterial pneu monia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline, increased rate of weight gain, and suppres sion of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 10 mg chlortetracycline per lb body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed for not more than 5 days. After completing feed ing of this combination, con tinue feeding a Type C top dress medicated feed con taining melengestrol acetate alone for a total time not ex ceeding 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chap ter. 054771 (xxvii) 500 to 4,000 g/ton ... ................................ Calves, beef and nonlactating dairy cattle: For the treat ment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. Hand feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 046– 699: 24-hour withdrawal pe riod. To sponsor No. 054771 under NADA 048– 761 and No. 069254 under ANADA 200–510: Zero with drawal period. 054771 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00466 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 457 Food and Drug Administration, HHS ยง 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xxviii) 500 to 4,000 g/ton ... Decoquinate, 12.9 to 90.8. Calves, beef and non-lactating dairy cattle: For the treat ment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms sus ceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii. Feed at a rate of 1g chlortetra cycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coc cidiosis. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in ยง 510.600(c) of this chapter. 054771 069254 (xxiv) 500 to 4,000 to pro vide 10 mg per pound of body weight. Melengestrol ace tate, 0.25 to 2 g/ ton to provide 0.25 to 0.5 mg melengestrol ac etate per head per day. Growing beef heifers fed in confinement for slaughter: For the treatment of bac terial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline, increased rate of weight gain, improved feed efficiency, and sup pression of estrus (heat). Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed con taining 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feed ing a Type C top-dress medicated feed containing melengestrol acetate alone. Chlortetracycline and melengestrol as provided by No. 054771 in ยง 510.600(c) of this chapter. 054771 (xxx) 500 to 4,000 to pro vide 10 mg per pound of body weight. Melengestrol ace tate, 0.5 to 2 g/ ton to provide 0.5 mg melengestrol acetate per head per day. Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bac terial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline, and for sup pression of estrus (heat). Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed con taining 500 to 4,000 g/ton chlortetracycline for not more than 5 days. After completing feeding of this combination, continue feed ing a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceed ing 24 days. Use in dairy heifers less than 20 months of age may cause drug resi dues in milk and/or in calves born to these cows. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. Chlortetra cycline and melengestrol as provided by No. 054771 in ยง 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00467 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 458 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xxxi) 4,000 to 20,000 g/ton ................................ Calves, beef and nonlactating dairy cattle: For the treat ment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms sus ceptible to chlortetracycline. Administer as a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. 054771 069254 (xxxii) 4,000 to 20,000 g/ton Decoquinate, 90.8 to 535.7. Calves, beef and non-lactating dairy cattle: For the treat ment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms sus ceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii. Feed at a rate of 1g chlortetra cycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coc cidiosis. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (xxxiii) 4,000 to 20,000 g/ ton to provide 10 mg/lb of body weight per day. Melengestrol ace tate, 0.25 to 2 g/ ton to provide 0.25 to 0.5 mg melengestrol ac etate per head per day. Growing beef heifers fed in confinement for slaughter: For the treatment of bac terial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline, and for in creased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). Top dress 0.5 to 2 pounds of this medicated feed con taining both drugs onto or mix at feeding with a non medicated feed for not more than 5 days. After com pleting feeding of this com bination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00468 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 459 Food and Drug Administration, HHS § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xxxiv) 4,000 to 20,000 g/ ton to provide 10 mg/lb of body weight per day. Melengestrol ace tate, 0.5 to 2 g/ ton to provide 0.5 mg melengestrol acetate per head per day. Replacement dairy heifers less than 20 months of age and replacement beef heifers: For the treatment of bac terial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline, and for sup pression of estrus (heat). Top dress 0.5 to 2 pounds of this medicated feed con taining both drugs onto or mix at feeding with a non medicated feed for not more than 5 days. After com pleting feeding of this com bination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone for a total time not exceed ing 24 days. Use in dairy heifers less than 20 months of age may cause drug resi dues in milk and/or in calves born to these cows. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. Chlortetra cycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxxv) to provide 350 mg/ head/day. ................................ Beef cattle: For control of bac terial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetra cycline. Feed to provide chlortetra cycline at the rate of 350 mg per animal daily. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046– 699 and 049–287, No. 066104 under NADA 092– 286, and No. 069254 under NADA 048–480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048–761 and No. 069254 under NADA 138–935 and ANADA 200– 510: Zero withdrawal period. 054771 066104 069254 (xxxvi) to provide 350 mg/ head/day. ................................ Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline. Feed to provide chlortetra cycline at the rate of 350 mg per animal daily. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. Withdrawal periods: To sponsor No. 054771 under NADAs 046– 699 and 049–287, No. 066104 under NADA 092– 286, and No. 069254 under NADA 048–480: Withdraw 48 hours prior to slaughter. To sponsor No. 054771 under NADA 048–761 and No. 069254 under NADA 138–935 and ANADA 200– 510: Zero withdrawal period. 054771 066104 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00469 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 460 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xxxvii) 50 to 350 g/ton to provide 350 mg/head/day. Melengestrol ace tate, 0.5 to 2 g/ ton to provide 0.5 mg melengestrol acetate per head per day. Replacement beef heifers under 700 lb: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline and for suppression of estrus (heat). Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed con taining 50 to 350 g/ton chlortetracycline for up to 24 days of feeding. Do not ex ceed 24 days of feeding. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xxxviii) 20 to 350 g/ton ...... ................................ Beef cattle and replacement dairy heifers: For control of bacterial pneumonia associ ated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. Feed to provide chlortetra cycline at the rate of 350 mg per head per day. This drug is not approved for use in female dairy cattle 20 months of age or older, in cluding dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048– 761 and No. 069254 under ANADA 200–510: Zero with drawal period. 054771 069254 (xxxix) 20 to 350 g/ton to provide 350 mg/head/day. Melengestrol ace tate, 0.25 to 2 g/ ton to provide 0.25 to 0.5 mg melengestrol ac etate per head per day. Growing beef heifers fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetra cycline, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). Melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with the Type C medicated feed con taining 20 to 350 g/ton chlortetracycline. Chlortetra cycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xl) 20 to 350 g/ton to pro vide 350 mg/head/day. Melengestrol ace tate, 0.5 to 2 g/ ton to provide 0.5 mg melengestrol acetate per head per day. Replacement dairy heifers less than 20 months of age and replacement beef heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetra cycline and suppression of estrus (heat). Melengestrol acetate Type C top-dress medicated feed must be top dressed or mixed at feeding with the Type C medicated feed con taining 20 to 350 g/ton chlortetracycline. Use in dairy heifers less than 20 months of age may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. Chlortetracycline and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00470 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 461 Food and Drug Administration, HHS § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xli) 23.3 to 58.3 g/ton to provide 350 mg/head/day. Laidlomycin, 5 ....... Cattle fed in confinement for slaughter: For control of bacterial pneumonia associ ated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight gain and improved feed effi ciency. Feed continuously at a rate of 30 to 75 mg laidlomycin pro pionate potassium per head per day. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xlii) 14.6 to 116.7 g/ton to provide 350 mg/head/day. Laidlomycin, 5 to 10. Cattle fed in confinement for slaughter: For control of bacterial pneumonia associ ated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiency. Feed continuously at a rate of 30 to 75 mg laidlomycin pro pionate potassium per head per day. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xliii) 25 to 42.2 g/ton to provide 350 mg/head/day. Lasalocid, 25 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infec tion of anaplasmosis caused by Anaplasma marginale susceptible to chlortetra cycline; and for increased rate of weight gain and im proved feed efficiency. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (xliv) 25 to 42.2 g/ton to provide 350 mg/head/day. Lasalocid, 25 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associ ated with shipping fever complex caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline; and for in creased rate of weight gain and improved feed effi ciency. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00471 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 462 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xlv) 25 to 100 g/ton to pro vide 350 mg/head/day. Lasalocid, 10 to 30 Cattle under 700 pounds fed in confinement for slaughter: For control of active infec tion of anaplasmosis caused by Anaplasma marginale susceptible to chlortetra cycline; and for improved feed efficiency. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (xlvi) 25 to 100 g/ton to pro vide 350 mg/head/day. Lasalocid, 10 to 30 Cattle fed in confinement for slaughter: For control of bacterial pneumonia associ ated with shipping fever complex caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline; and for im proved feed efficiency. Feed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (xlvii) 25 to 700 to provide 350 g/head/day. Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heif ers): For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella multocida organisms sus ceptible to chlortetracycline; and for increased rate of weight gain. Feed continuously on a hand fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pas ture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is re quired. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00472 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 463 Food and Drug Administration, HHS § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (xlviii) 25 to 700 g/ton to provide 350 mg/head/day. Lasalocid, 30 to 600; melengestrol ac etate, 0.5 to 2 g/ ton to provide 0.5 mg/head/day melengestrol ac etate. Replacement beef heifers on pasture: For control of bac terial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetra cycline, increased rate of weight gain, and suppres sion of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetra cycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not ex ceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chap ter. 054771 (xliv) 25 to 700 to provide 350 mg/head/day. Lasalocid, 30 to 600. Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline; and for increased rate of weight gain. Feed continuously on a hand fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pas ture cattle have not been shown to be more effective than 200 mg lasalocid/head/ day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is re quired. A withdrawal period has not been established for this product in pre-rumi nating calves. Do not use in calves to be processed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (l) 25 to 700 g/ton to pro vide 350 mg/head/day. Lasalocid, 30 to 600; melengestrol ac etate, 0.5 to 2 g/ ton to provide 0.5 mg/head/day melengestrol ac etate. Replacement beef heifers on pasture under 700 pounds: For control of active infec tion of anaplasmosis caused by Anaplasma marginale susceptible to chlortetra cycline, increased rate of weight gain, and suppres sion of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 700 g/ ton of chlortetracycline and 30 to 600 g/ton lasalocid to provide 350 mg chlortetra cycline per head daily and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Do not ex ceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chap ter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00473 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 464 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (li) 25 to 2,800 to provide 350 mg/head/day. Lasalocid, 30 to 181.8. Beef cattle weighing under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline; and for the control of coc cidiosis caused by Eimeria bovis and E. zuernii. Hand feed continuously at a rate of 350 mg chlortetra cycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 (lii) 25 to 2,800 g/ton to provide 350 mg/head/day. Lasalocid, 30 to 181.8; melengestrol ac etate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/ head/day melengestrol ac etate. Growing beef heifers fed in confinement for slaughter under 700 pounds: For con trol of active infection of anaplasmosis caused by Anaplasma marginale sus ceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, im proved feed efficiency, and suppression of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head per day and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetra cycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (liii) 25 to 2,800 to provide 350 mg/head/day. Lasalocid, 30 to 181.8. Beef cattle weighing up to 800 pounds: For control of bac terial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetra cycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuernii. Hand feed continuously at a rate of 350 mg chlortetra cycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00474 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 465 Food and Drug Administration, HHS § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (liv) 25 to 2,800 g/ton to provide 350 mg/head/day. Lasalocid, 30 to 181.8; melengestrol ac etate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/ head/day melengestrol ac etate. Growing beef heifers fed in confinement for slaughter up to 800 pounds: For control of bacterial pneumonia as sociated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chap ter. 054771 (lv) 25 to 2,800 g/ton to provide 350 mg/head/day. Lasalocid, 30 to 181.8; melengestrol ac etate, 0.5 to 2 g/ ton to provide 0.5 mg/head/day melengestrol ac etate. Replacement beef heifers up to 800 pounds: For control of bacterial pneumonia as sociated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppression of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 25 to 2,800 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 350 mg chlortetracycline per head daily and 1 mg lasalocid per 2.2 lb. of body weight daily with a maximum of 360 mg lasalocid per head per day. Do not exceed 24 days of feeding. See § 558.311(d) of this chapter. Chlortetra cycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (lvi) 500 to 4,000 to provide 10 mg/head/day. Lasalocid, 30 to 181.8. Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by Escherichia coli and bac terial pneumonia caused by Pasteurella multocida sus ceptible to chlortetracycline; and for the control of coc cidiosis caused by Eimeria bovis and E. zuernii. Hand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cat tle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines ac cess to feeds containing lasalocid. No withdrawal pe riod is required. A with drawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be proc essed for veal. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00475 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 466 21 CFR Ch. I (4–1–23 Edition) § 558.128 Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (lvii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 181.8; melengestrol ac etate, 0.25 to 2 g/ton to provide 0.25 to 0.5 mg/ head/day melengestrol ac etate. Growing beef heifers fed in confinement for slaughter up to 800 pounds: For the treatment of bacterial enter itis caused by Escherichia coli and bacterial pneu monia caused by Pasteurella multocida orga nisms susceptible to chlor tetracycline, control of coc cidiosis caused by Eimeria bovis and E. zuernii, in creased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days of feeding. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol ac etate alone. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 (lviii) 500 to 4,000 g/ton to provide 10 mg/lb of body weight daily. Lasalocid, 30 to 181.8; melengestrol ac etate, 0.5 to 2 g/ ton to provide 0.5 mg/head/day melengestrol ac etate. Replacement dairy heifers up to 800 pounds and less than 20 months of age and re placement beef heifers up to 800 pounds: For the treat ment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms sus ceptible to chlortetracycline, control of coccidiosis caused by Eimeria bovis and E. zuernii, and suppres sion of estrus (heat). The melengestrol acetate Type C top-dress medicated feed must be top dressed onto or mixed at feeding with a Type C medicated feed containing 500 to 4,000 g/ton of chlortetracycline and 30 to 181.8 g/ton lasalocid to provide 10 mg chlortetracycline per lb of body weight per day and 1 mg lasalocid per 2.2 lb of body weight per day with a maximum of 360 mg lasalocid per head per day for not more than 5 days. After completing feeding of this combination, continue feeding a Type C top-dress medicated feed containing melengestrol acetate alone. See § 558.311(d) of this chapter. Chlortetracycline, lasalocid, and melengestrol as provided by No. 054771 in § 510.600(c) of this chap ter. 054771 (5) Minor species. It is used as follows: Chlortetracycline amount Indications for use Limitations Sponsor (i) 80 mg/head/day ............. Breeding sheep; reducing the inci dence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline. ............................................................... 054771 066104 069254 (ii) 200 to 400 g/ton ............ Ducks: For the control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetra cycline. Feed in complete ration to provide from 8 to 28 mg/lb of body weight per day, depending upon age and sever ity of disease, for not more than 21 days. Do not feed to ducks pro ducing eggs for human consumption. 054771 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00476 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 467 Food and Drug Administration, HHS § 558.140 Chlortetracycline amount Indications for use Limitations Sponsor (iii) 10 mg/g of finished feed daily. Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 days. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. See paragraph (d)(5) of this section. 054771 069254 (6) It is used as a free-choice, loose mineral Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Dicalcium Phos phate .................. 46.20 6–26–335 Sodium Chloride (Salt) .................. 15.00 6–04–152 Magnesium Oxide 10.67 6–02–756 Cottonseed Meal ... 10.00 5–01–625 Trace Mineral/Vita min Premix 1 ....... 3.80 Calcium Carbonate 3.50 6–01–069 Dried Cane Molas ses ..................... 3.00 4–04–695 Potassium Chloride 2.00 6–03–755 Mineral Oil ............. 2.00 8–03–123 Iron Oxide .............. 0.50 6–02–431 Chlortetracycline Type A medi cated article (90 gram/lb) .............. 3.33 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). (ii) Amount. 6,000 grams per ton. (iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetra cycline. (iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day. (v) Sponsors. See Nos. 054771 and 069254 in § 510.600(c) of this chapter. [81 FR 94995, Dec. 27, 2016, as amended at 82 FR 21691, May 10, 2017; 82 FR 43485, Sept. 18, 2017; 83 FR 13636, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8975, Mar. 13, 2019; 84 FR 39185, Aug. 9, 2019; 86 FR 13189, Mar. 8, 2021; 86 FR 14822, Mar. 19, 2021; 86 FR 17064, Apr. 1, 2021; 86 FR 57999, Oct. 20, 2021; 86 FR 61686, Nov. 8, 2021; 87 FR 58963, Sept. 29, 2022; 87 FR 76422, Dec. 14, 2022; 88 FR 14901, Mar. 10, 2023] § 558.140 Chlortetracycline and sulfamethazine. (a) Specifications. Type A medicated articles containing: (1) 35 grams (g) per pound (/lb) each, chlortetracycline and sulfamethazine. (2) 40 g/lb each, chlortetracycline and sulfamethazine. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) No. 054771 for use of product de scribed in paragraph (a)(1) as in para graph (e)(1) of this section. (2) No. 069254 for use of product de scribed in paragraph (a)(1) as in para graph (e)(1)(i) of this section. (3) Nos. 054771 and 069254 for use of product described in paragraph (a)(2) as in paragraph (e)(2) of this section. (c) Related tolerances. See §§ 556.150 and 556.670 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for chlortetracycline and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline and sulfamethazine shall not be refilled. (e) Conditions of use—(1) Cattle— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00477 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 468 21 CFR Ch. I (4–1–23 Edition) § 558.140 Chlortetra cycline and sulfamethazine amount each Combina tion in grams/ton Indications for use Limitations Sponsors (i) To provide 350 milli grams per head per day. ................ Beef cattle: As an aid in the maintenance of weight gains in the pres ence of respiratory dis ease such as shipping fever. Feed for 28 days. Withdraw 7 days prior to slaughter. A with drawal period has not been es tablished for this product in pre ruminating calves. Do not use in calves to be processed for veal. 054771 069254 (ii) 35 to 105 g/ ton, each. Lasalocid, 10 to 30. Beef steers and heifers fed in confinement for slaughter: As an aid in the maintenance of weight gains in the pres ence of respiratory dis ease such as shipping fever, and for improved feed efficiency. Feed continuously for 28 days to provide 350 mg chlortetra cycline, 350 mg sulfamethazine, and 100 to 300 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A with drawal period has not been es tablished for this product in pre ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 35 to 42.2 g/ton, each. Lasalocid, 25 to 30. Beef steers and heifers fed in confinement for slaughter: As an aid in the maintenance of weight gains in the pres ence of respiratory dis ease such as shipping fever, and for improved feed efficiency and in creased rate of weight gain. Feed continuously for 28 days to provide 350 mg chlortetra cycline, 350 mg sulfamethazine, and 250 to 300 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. Withdraw 7 days prior to slaughter. A with drawal period has not been es tablished for this product in pre ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00478 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 469 Food and Drug Administration, HHS § 558.175 Chlortetra cycline and sulfamethazine amount each Combina tion in grams/ton Indications for use Limitations Sponsors (iv) 35 to 700 g/ ton, each. Lasalocid, 30 to 181.8. Beef cattle up to 800 lb: As an aid in the mainte nance of weight gains in the presence of res piratory disease such as shipping fever, and for control of coccidiosis caused by Eimeria bovis and E. zuernii. Hand feed continuously for 28 days to provide 350 mg chlor tetracycline, 350 mg sulfamethazine, and 1 mg lasalocid per 2.2 lb body weight per day up to a maximum of 360 mg lasalocid per head per day. Do not allow horses or other equines access to Type C feeds containing lasalocid as in gestion may be fatal. Safety of lasalocid for use in unapproved species has not been estab lished. Withdraw 7 days prior to slaughter. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (2) Swine— Chlortetracycline and sulfamethazine amount Indications for use Limitations Sponsors (i) 100 g/ton of feed each, chlortetracycline and sulfamethazine. Swine: For reduction of the incidence of cervical ab scesses; treatment of bac terial swine enteritis (sal monellosis or necrotic en teritis caused by Sal monella choleraesuis and vibrionic dysentery); pre vention of these diseases during times of stress; and maintenance of weight gains in the presence of atrophic rhinitis. Feed as the sole ration. With draw 15 days prior to slaughter. 054771 069254 (ii) [Reserved] [79 FR 37622, July 2, 2014, as amended at 80 FR 13231, Mar. 13, 2015; 81 FR 63054, Sept. 14, 2016; 81 FR 95004, Dec. 27, 2016; 82 FR 21691, May 10, 2017; 84 FR 12495, Apr. 2, 2019; 86 FR 13189, Mar. 8, 2021; 86 FR 14822, Mar. 19, 2021] § 558.175 Clopidol. (a) Specifications. Type A medicated article containing 25 percent clopidol. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.160 of this chapter. (d) Conditions of use—(1) Chickens— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00479 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 470 21 CFR Ch. I (4–1–23 Edition) § 558.175 Clopidol in grams per ton Combination in grams per ton Indications for use Limitations Sponsors (i) 113.5 ............. ................................. Broiler chickens and re-placement chickens intended for use as caged layers: As an aid in the pre vention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.. Do not feed to chickens over 16 weeks of age. 016592 (ii) 113.5 ............ Bacitracin methylenedisalicy late, 4 to 50. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain.. Feed continuously as the sole ration from the time chicks are placed in floor pens until slaughter. Do not feed to chickens over 16 weeks of age; bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 016592 (iii) 113.5 ........... Bacitracin zinc, 5 to 25. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency.. Feed continuously as sole ra tion; bacitracin zinc as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 016592 (iv) 113.5 ........... Bambermycins, 1 to 2. Broiler chickens: As an aid in preven tion of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiency.. Feed continuously as the sole ration. Do not feed to chick ens over 16 weeks of age. 016592 (v) 227 ............... ................................. Broiler and replacement chickens in tended for use as caged layers: As an aid in the prevention of coccidi osis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.. Feed continuously as the sole ration; feed up to 16 weeks of age if intended for use as caged layers; withdraw 5 days before slaughter if given at the level of 0.025 percent in feed or reduce level to 0.0125 percent 5 days before slaughter. 016592 (vi) 227 .............. Bambermycins, 1 to 2. Broiler chickens: As an aid in preven tion of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for increased rate of weight gain and improved feed efficiency.. Feed continuously as sole ra tion until 5 days before slaughter. Withdraw 5 days before slaughter or feed 113.5 g/ton clopidol and 1 to 2 g/ton bambermycins during those 5 days before slaugh ter. Do not feed to chickens over 16 weeks of age. 016592 (2) Turkeys— Clopidol in grams per ton Combination in grams per ton Indications for use Limitations Sponsors (i) 113.5 or 227 ................................. Turkeys: As an aid in the prevention of leucocytozoonosis caused by Leucocytozoon smithi.. For turkeys grown for meat purposes only; feed continu ously as the sole ration at 0.0125 or 0.025 percent clopidol depending on man agement practices, degree of exposure, and amount of feed eaten; withdraw 5 days before slaughter. 016592 (ii) [Reserved] (3) Combinations. Clopidol may also be used in combination with: (i) Chlortetracycline as in § 558.128. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00480 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 471 Food and Drug Administration, HHS § 558.195 (ii) Lincomycin as in § 558.325. [68 FR 17882, Apr. 14, 2003, as amended at 72 FR 60551, Oct. 25, 2007; 74 FR 61028, Nov. 23, 2009; 79 FR 10965, 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016; 84 FR 12495, Apr. 2, 2019; 86 FR 14822, Mar. 19, 2021] § 558.185 Coumaphos. (a) Specifications. Type A medicated articles containing 1.12, 2.0, 11.2, or 50 percent coumaphos. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.168 of this chapter. (d) Special considerations. (1) Labeling shall bear the following warning: The active ingredient coumaphos is a cho linesterase inhibitor. Do not use this product on animals simultaneously or within a few days before or after treat ment with, or exposure to, cholin esterase-inhibiting drugs, pesticides, or chemicals. (2) See § 500.25 of this chapter. (e) Conditions of use in laying chickens. Coumaphos in grams per ton Indications for use Limitations Sponsor (1) 27.2 (0.003 percent) .................... Laying chickens: For control of cap illary worm (Capillaria obsignata) and as an aid in control of com mon round worm (Ascaridia galli) and cecal worm (Heterakis gallinae). Feed continuously as the sole ra tion for 14 days. If reinfection oc curs, treatment may be repeated, but not sooner than 3 weeks after the end of the previous treatment. Do not feed to chickens within 10 days of vaccination or other con ditions of stress.. 058198 (2) 36.3 (0.004 percent) .................... Replacement pullets: For control of capillary worm (Capillaria obsignata) and as an aid in con trol of common round worm (Ascaridia galli) and cecal worm (Heterakis gallinae). Feed continuously as the sole ra tion for from 10 to 14 days. Do not feed to chickens under 8 weeks of age or within 10 days of vaccination or other conditions of stress. If birds are maintained on contaminated litter or exposed to infected birds, a second 10- to 14-day treatment is rec ommended, but not sooner than 3 weeks after the end of the pre vious treatment. If reinfection oc curs after production begins, re peat treatment as recommended for laying flocks.. 058198 [86 FR 14822, Mar. 19, 2021] § 558.195 Decoquinate. (a) Specifications. Type A medicated article containing 6 percent decoquinate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.170 of this chapter. (d) Special considerations. (1) Ben tonite should not be used in decoquinate feeds. (2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section. (3) Type C cattle feeds may be manu factured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises. (e) Conditions of use. It is used as fol lows: (1) Chickens— Decoquinate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 27.2 ............... Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti. Do not feed to laying hens pro ducing eggs for human con sumption. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00481 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 472 21 CFR Ch. I (4–1–23 Edition) § 558.195 Decoquinate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (ii) 27.2 .............. Bacitracin methylenedisalicy late, 4 to 50. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for increased rate of weight gain and improved feed effi ciency. Feed continuously as sole ra tion; do not feed to laying chickens. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 27.2 ............. Bacitracin zinc, 10 to 50. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti. Feed continuously as sole ra tion; do not feed to laying chickens. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (2) Cattle— Decoquinate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12.9 to 90.8 .. Cattle (including ruminating and non ruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E. zuernii. Feed Type C feed or milk re placer to provide 22.7 milli grams (mg) per 100 pounds (lb) of body weight (0.5 mg/ kg) per day. Feed at least 28 days during periods of expo sure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for human consumption. See paragraph (d)(3) of this section. 054771 (ii) 12.9 to 90.8 Monensin, 5 to 30 ... Cattle fed in confinement for slaugh ter: For prevention of coccidiosis caused by Eimeria bovis and E. zuernii; and for improved feed effi ciency. Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb of body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of ex posure to coccidiosis or when it is likely to be a haz ard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(9)(i). Monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592, 054771 (iii) 90.9 to 535.7 Cattle (including ruminating and non ruminating calves and veal calves): For prevention of coccidiosis caused by Eimeria bovis and E. zuernii. Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of expo sure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section. 054771 (3) Minor species— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00482 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 473 Food and Drug Administration, HHS § 558.198 Decoquinate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12.9 to 90.8 .. ................................. 1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, and E. bakuensis. Feed Type C feed or milk re placer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of expo sure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for human consumption. 054771 ...................... ............................. 2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni and E. ninakohlyakimovae. Feed Type C feed or milk re placer at a rate to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of expo sure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for human consumption. (ii) 90.9 to 535.7 ................................. 1. Young sheep: For the prevention of coccidiosis caused by Eimeria ovinoidalis, E. crandallis, E. parva, and E. bakuensis. Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a haz ard. Do not feed to sheep producing milk for human consumption. 054771 ...................... ............................. 2. Young goats: For the prevention of coccidiosis caused by Eimeria christenseni and E. ninakohlyakimovae. Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg per 100 lb of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a haz ard. Do not feed to goats producing milk for human consumption. .................... (4) Decoquinate may also be used in combination with: (i)–(ii) [Reserved] (iii) Chlortetracycline as in § 558.128. (iv) Lincomycin as in § 558.325. [67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005; 78 FR 25183, Apr. 30, 2013; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 79 FR 17860, Mar. 31, 2014; 80 FR 13231, Mar. 13, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 22525, Apr. 18, 2016; 81 FR 67152, Sept. 30, 2016; 81 FR 95004, Dec. 27, 2016; 83 FR 48947, Sept. 28, 2018; 84 FR 12496, Apr. 2, 2019; 85 FR 18121, Apr. 1, 2020; 86 FR 14822, Mar. 19, 2021] § 558.198 Dichlorvos. (a) Specifications. Each pound of Type A medicated article containing 3.1 or 9.6 percent dichlorvos. (b) Sponsor. See No. 054628 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.180 of this chapter. (d) Special considerations. (1) Dichlorvos is to be included in meal or mash or mixed with feed in crumble form only after the crumble feed has been manufactured. Do not mix in feeds to be pelleted nor with pelleted feed. Do not soak the feed or admin ister as wet mash. Feed must be dry when administered. Do not use in ani mals other than swine. Do not allow fowl access to feed containing this VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00483 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 474 21 CFR Ch. I (4–1–23 Edition) § 558.205 preparation or to feces from treated animals. (2) Dichlorvos is a cholinesterase in hibitor. Do not use this product in ani mals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. If human or animal poisoning should occur, immediately consult a physician or a veterinarian. Atropine is anti dotal. (3) Labeling for Type A articles and Type B feeds must include a statement that containers or materials used in packaging such Type A articles and Type B feeds are not to be reused and all such packaging materials must be destroyed after the product has been used. (e) Conditions of use. It is used in swine feed as follows: Dichlorvos grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 348 ................ Swine up to 70 pounds body weight: For the removal and control of ma ture, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp.), large roundworm (Ascaris suum) and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.. Feed as sole ration for 2 con secutive days. For swine from 70 pounds to market weight, feed as sole ration at the rate of 8.4 pounds of feed per head until the medi cated feed has been con sumed. For boars, open or bred gilts, and sows, feed as sole ration at the rate of 4.2 pounds per head per day for 2 consecutive days.. 054628 (ii) 479 ............... Boars, open or bred gilts, and sows: For the removal and control of ma ture, immature, and/or fourth-stage larvae of the whipworm (Trichuris suis), nodular worm (Oesophagostomum sp.), large roundworm (Ascaris suum) and the thick stomach worm (Ascarops strongylina) of the gastrointestinal tract.. Feed as sole ration at the rate of 6 pounds per head for one feeding.. 054628 (iii) 334 to 500 ... Pregnant swine: An aid in improving litter production efficiency by in creasing pigs born alive, birth weights, survival to market, and rate of weight gain. Treatment also removes and controls mature, im mature and/or fourth stage larvae of whipworm (Trichuris suis), nod ular worm (Oesophagostomum spp.) large roundworm (Ascaris suum), and the thick stomach worm (Ascarops strongylina) occur ring in the gastrointestinal tract of the sow or gilt.. Mix into a gestation feed to provide 1,000 milligrams per head daily during last 30 days of gestation.. 054628 [84 FR 12497, Apr. 2, 2019] § 558.205 Diclazuril. (a) Specifications. Type A medicated article containing 0.2 percent diclazuril. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.185 of this chapter. (d) Conditions of use—(1) Chickens. For chickens it is used as follows: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00484 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 475 Food and Drug Administration, HHS ยง 558.205 Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor (i) 0.91 ..................... .............................. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is ef fective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. 058198 (ii) 0.91 ..................... Bacitracin methylenedisali cylate, 4 to 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima, and for increased rate of weight gain and improved feed effi ciency. Because diclazuril is effec tive against E. maxima later in its life cycle, subclinical intestinal le sions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bac itracin methylenedisalicylate pro vided by No. 054771 in ยง 510.600(c) of this chap ter. 058198 (iii) 0.91 .................... Bambermycins, 1 to 2. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima, and for increased rate of weight gain and improved feed effi ciency. Because diclazuril is effec tive against E. maxima later in its life cycle, subclinical intestinal le sions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Bambermycins provided by No. 016592 in ยง 510.600(c) of this chap ter. 058198 (2) Turkeys. For turkeys it is used as follows: Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor (i) 0.91 ..................... .............................. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis. Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consump tion. 058198 (ii) 0.91 ..................... Bacitracin methylenedisali cylate, 4 to 50. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency. Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consump tion. Bacitracin methylenedisalicylate as provided by No. 054771 in ยง 510.600(c) of this chapter. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00485 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 476 21 CFR Ch. I (4–1–23 Edition) § 558.235 Diclazuril grams/ton Combination grams/ton Indications for use Limitations Sponsor (iii) 0.91 .................... Bambermycins 1 to 2. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for improved feed efficiency. Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consump tion. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 058198 (iv) 0.91 .................... Bambermycins 2 .. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency. Feed continuously as the sole ration. Do not feed to breeding turkeys. Do not feed to birds producing eggs for human consump tion. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 058198 (3) Diclazuril may also be used in combination with virginiamycin as in § 558.635. [64 FR 35923, July 2, 1999, as amended at 65 FR 50134, Aug. 17, 2000; 66 FR 47962, 47963, Sept. 17, 2001; 66 FR 62917, Dec. 4, 2001; 67 FR 34830, May 16, 2002; 67 FR 47257, July 18, 2002; 67 FR 48549, July 25, 2002; 69 FR 9947, Mar. 3, 2004; 72 FR 60552, Oct. 25, 2007; 79 FR 10982, Feb. 27, 2014; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95004, Dec. 27, 2016. Redesignated and amended at 84 FR 12497, 12498, Apr. 2, 2019; 87 FR 10970, Feb. 28, 2022] § 558.235 Efrotomycin. (a) Specifications. Type A medicated articles containing 14.5 grams efrotomycin per pound. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.224 of this chapter. (d) Conditions of use in swine— Efrotomycin in grams/ton Indications for use Limitations Sponsor (1) 3.6 ................................ Swine: For improved feed efficiency ........ Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds. 000010 (2) 3.6 to 14.5 ................... Swine: For increased rate of weight gain Feed continuously as sole ration. Not to be used in swine weighing more than 250 pounds. 000010 [57 FR 38442, Aug. 25, 1992, as amended at 62 FR 63271, Nov. 28, 1997; 84 FR 33001, July 11, 2019; 84 FR 39185, Aug. 9, 2019; 85 FR 45309, July 28, 2020] § 558.248 Erythromycin. (a) Specifications. Type A medicated articles containing 92.5 grams per pound erythromycin (as the thiocyanate salt). (b) Sponsor. See No. 061133 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.230 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for erythromycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for erythromycin shall not be refilled. (e) Conditions of use—(1) Chickens— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00486 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 477 Food and Drug Administration, HHS § 558.258 Erythromycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 ................ ................................ Chickens: As an aid in the preven tion of chronic respiratory disease during periods of stress. Feed for 2 days before stress and 3 to 6 days after stress. Withdraw 24 hours before slaughter. 061623 (ii) 92.5 ............... ................................ Chickens: As an aid in the preven tion of infectious coryza. Feed for 7 to 14 days. With draw 24 hours before slaughter. 061623 (iii) 185 ............... ................................ Chickens: As an aid in the preven tion and reduction of lesions and in lowering severity of chronic respiratory disease (CRD). Feed for 5 to 8 days. With draw 48 hours before slaughter. Do not use in birds producing eggs for food. 061623 (2) Turkeys— Erythromycin thiocyanate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 92.5 ................ ................................ Turkeys: As an aid in the prevention of chronic respiratory disease during periods of stress. Feed for 2 days before stress and 3 to 6 days after stress. 061623 (ii) 185 ................ ................................ Turkeys: As an aid in the prevention and reduction of lesions and in lowering severity of chronic res piratory disease (CRD). Feed for 5 to 8 days. Do not use in birds producing eggs for food. 061623 [41 FR 10999, Mar. 15, 1976, as amended at 45 FR 56799, Aug. 26, 1980; 49 FR 31281, Aug. 6, 1984; 51 FR 7397, Mar. 3, 1986; 52 FR 2684, Jan. 26, 1987; 54 FR 12189, Mar. 24, 1989; 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 79 FR 10982, Feb. 27, 2014; 81 FR 36790, June 8, 2016; 81 FR 95004, Dec. 27, 2016; 84 FR 8975, Mar. 13, 2019] § 558.254 Famphur. (a) Specifications. Type A medicated articles containing 13.2 or 33.3 percent famphur. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.273 of this chapter. (d) Special considerations. Famphur is a cholinesterase inhibitor. Do not use this product in animals simultaneously or within a few days before or after treatment with or exposure to cholin esterase-inhibiting drugs, pesticides, or chemicals. (e) Conditions of use. It is used in cat tle feed as follows: Famphur amount Indications for use Limitations Sponsor (1) To provide 1.1 milligrams per pound (mg/lb) body weight per day. Beef cattle and nonlactating dairy cattle: For control of grubs and as an aid in control of sucking lice. Feed for 30 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter. 000061 (2) To provide 2.3 mg/lb body weight per day. Beef cattle and nonlactating dairy cattle: For control of grubs. Feed for 10 days. Withdraw from dry dairy cows and heifers 21 days prior to freshening. Withdraw 4 days prior to slaughter. 000061 [84 FR 39185, Aug. 9, 2019, as amended at 87 FR 17947, Mar. 29, 2022] § 558.258 Fenbendazole. (a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/lb) fenbendazole. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.275 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use—(1) VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00487 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 478 21 CFR Ch. I (4–1–23 Edition) § 558.258 Amount fenbendazole in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 14.5 ................ .................................. Growing turkeys: For the treatment and control of gastrointestinal worms: roundworms, adults and lar vae (Ascaridia dissimilis); cecal worms, adults and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Black head). Feed continuously as the sole ration for 6 days. For growing turkeys only. 000061 (ii) [Reserved] ..... .................................. ............................................................. ................................................... ................ (2) Swine. Fenbendazole grams per ton Combination grams per ton Indications for use Limitations Sponsor (i) 10 to 300 ...... ................................. Swine: For the treatment and control of Lungworms: adult (Metastrongylus apri and M. pudendotectus); Gastrointestinal worms: adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); and Kidney worms: adult and larvae (Stephanurus dentatus). Feed as the sole ration to pro vide 9 mg/kg of body weight (4.08 mg/lb) over a period of 3 to 12 consecutive days. Swine must not be slaugh tered for human consump tion within 4 days following last treatment with this drug product. 000061 (ii) 10 to 300 (to provide 9 mg/ kg of body weight). Bacitracin methylenedisalicy late, 10 to 30. Growing/finishing swine: For the re moval and control of adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nod ular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus); and for increased rate of weight gain and improved feed effi ciency. Feed as the sole ration. Under conditions of continued ex posure to parasites, retreat ment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00488 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 479 Food and Drug Administration, HHS § 558.258 Fenbendazole grams per ton Combination grams per ton Indications for use Limitations Sponsor (iii) 10 to 300 (to provide 9 mg/ kg of body weight). Bacitracin methylenedisalicy late, 250. 1. Growing/finishing swine: For the removal and control of adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nod ular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus); and for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where signs of dis ease have not yet occurred; or fol lowing an approved treatment of the disease condition. 1. Growing/finishing swine: Feed as sole ration. Not for use in growing and finishing swine that weigh more than 250 lbs. Diagnosis of swine dysentery should be con firmed by a veterinarian when results are not satis factory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 2. Pregnant sows: For the removal and control of adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nod ular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus); for control of clostridial enteritis in suckling pigs caused by Clostridium perfringens. 2. Pregnant sows: Feed as sole ration. Diagnosis of clostridial enteritis should be confirmed by a veterinarian when results are not satis factory. Under conditions of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. (3) Cattle. Fenbendazole grams per ton Indications for use Limitations Sponsor (i) 200 to 1,000 ............. Dairy and beef cattle: For the treat ment and control of: Lungworms: adult (Dictyocaulus viviparus); Stom ach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); In testinal worms (adult and fourth stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small in testinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Feed as the sole ration for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A with drawal period has not been established for this product in pre-ruminating calves. 000061 (ii) [Reserved] ............... .............................................................. ...................................................................... ........................ VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00489 Fmt 8010 Sfmt 8016 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 480 21 CFR Ch. I (4–1–23 Edition) § 558.258 (iii) Top dress medicated feed—(A) Proprietary formulas. The following feed can be manufactured only per an approved proprietary formula and specifications: Fenbendazole concentration Indications for use Limitations Sponsor (1) 2.27 g/lb ............. Beef and dairy cattle: For the treatment and control of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intes tinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Feed as a top dress for 1 day to provide 5 mg/kg body weight (2.27 mg/lb). Milk taken during treatment and for 60 hours after the last treatment must not be used for human consumption. Cat tle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. 000061 (2) [Reserved] ......... .................................................................. .................................................................. .............................. (B) [Reserved] (iv) Free-choice medicated feeds—(A) Proprietary formulas (21 CFR 510.455(e)(2)). The following feeds can be manufactured only per an approved proprietary for mula and specifications: Fenbendazole concentration Indications for use Limitations Sponsor (1) 12,100 g/ton mineral. Beef cattle on pasture: For the treatment and control of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intes tinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Feed free-choice at the rate of 0.0375 lb per 100 pounds of body weight over a 3- to 6-day period to provide a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cat tle. Beef cattle must not be slaugh tered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A with drawal period has not been estab lished for this product in pre-rumi nating calves. 000061 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00490 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 481 Food and Drug Administration, HHS ยง 558.258 Fenbendazole concentration Indications for use Limitations Sponsor (2) 2.27 g/lb mineral Beef cattle on pasture: For the treatment and control of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread-necked intes tinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Feed free-choice at the rate of 0.10 lb (1.6 oz) per 100 pounds of body weight over a 3- to 6-day period, to deliver a total of 2.27 mg fenbendazole per pound of body weight. Not for use in dairy cattle. Beef cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. 000061 (3) 750 mg/lb of pro tein block (to pro vide 5 mg/kg body weight (2.27 mg/ lb)). Beef cattle: For the treatment and con trol of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage lar vae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Feed free choice at a rate of 0.1 pound of block per 100 pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consump tion within 16 days following last treat ment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been es tablished for this product in pre-rumi nating calves. 000061 (4) 750 mg/lb of mo lasses block (to provide 5 mg/kg body weight (2.27 mg/lb)). Beef cattle: For the treatment and con trol of: Lungworms: adult (Dictyocaulus viviparus); Stomach worms: adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage lar vae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): hookworms (Bunostomum phlebotomum), thread necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). Feed free choice at a rate of 0.1 pound of block per 100 pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consump tion within 11 days following last treat ment with this drug product. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been es tablished for this product in pre-rumi nating calves. 000061 (B) Published formulas (ยง 510.455(e)(1) of this chapter). The following feeds can be manufactured only per one of the for mulas and specifications published below: (1) Amount. 5 mg/kg body weight (2.27 mg/lb), including the following formu lations: Ingredient 1 Percent International Feed No. (i) Free-choice, dry Type C feed: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00491 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 482 21 CFR Ch. I (4–1–23 Edition) § 558.258 Ingredient 1 Percent International Feed No. Salt (sodium chloride) ...... 59.00 6–04–152 Monosodium phosphate ... 31.16 6–04–288 Dried cane mo lasses .......... 3.12 4–04–695 Zinc sulfate ..... 0.76 6–05–556 Copper sulfate 0.45 6–01–720 Fenbendazole 20% Type A article .......... 5.51 n/a (ii) Free-choice, dry Type C feed: Salt (sodium chloride) ...... 35.93 6–04–152 Dicalcium phosphate (18.5% P) .... 32.44 6–00–080 Calcium car bonate (38% Ca) .............. 15.93 6–01–069 Magnesium oxide (56% Mg) .............. 10.14 6–02–756 Zinc sulfate ..... 1.47 6–05–556 Mineral oil ....... 1.00 8–03–123 Dried cane mo lasses (46% sugars) ........ 0.98 4–04–695 Potassium io dide ............. 0.01 6–03–759 Fenbendazole 20% Type A article .......... 2.10 n/a (iii) Free-choice, liq uid Type C feed 2: Cane molas ses 3 ............ 80.902 4–13–251 Water .............. 9.36 n/a Urea solution, 55% ............. 7.05 5–05–707 Phosphoric acid 75% (feed grade) 2.00 6–03–707 Ingredient 1 Percent International Feed No. Xantham gum 0.20 8–15–818 Trace min erals 4 .......... 0.20 n/a Vitamin pre mix 4 ............ 0.01 n/a Fenbendazole 20% Type A article .......... 0.278 n/a 1 Formulation modifications require FDA approval prior to marketing. Selenium is not approved for use in the liquid, free-choice formulations described in paragraph (e)(3)(iv)(B) of this section. Free-choice cattle feeds containing selenium must comply with published regulations (see 21 CFR 573.920). 2 The labeling for the liquid free-choice Type C medicated feed must bear an expiration date of 12 weeks after the date of manufacture. 3 The percentage of cane molasses and water in the formu lation may be adjusted as needed to bring the brix value of the molasses to the industry standard of 79.5 brix. 4 The contents of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the manufacturer for other free-choice cattle feeds. (2) Indications for use. As in paragraph (e)(3)(i) of this section. (3) Limitations. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3- to 6-day pe riod. Milk taken during treatment and for 60 hours after the last treatment must not be used for human consump tion. Cattle must not be slaughtered for human consumption within 13 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. (4) Horses. Fenbendazole grams per ton Indications for use Limitations Sponsor (i) 4,540 ................ 5 mg/kg body weight (2.27 mg/lb) for the control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris, Triodontophorus spp.), small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp.), and pinworms (Oxyuris equi); 10 mg/kg body weight (4.54 mg/lb) for the control of ascarids (Parascaris equorum). Feed at the rate of 0.1 lb of feed per 100 lb of body weight to provide 2.27 mg fenbendazole/lb of body weight in a 1 day treatment or 0.2 lb of feed per 100 lb of body weight to provide 4.54 mg fenbendazole/lb of body weight in a 1 day treatment. All horses must be eating normally to ensure that each animal con sumes an adequate amount of the medi cated feed. Do not use in horses in tended for human consumption. 000061 (ii) [Reserved] ...... ....................................................................... ....................................................................... ........................ (5) Zoo and wildlife animals. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00492 Fmt 8010 Sfmt 8016 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 483 Food and Drug Administration, HHS § 558.261 Species/Class Fenbendazole grams per ton Indications for use Limitations Sponsor (i) Feral swine (Sus scrofa):. 90 to 325 ................ For the treatment and control of kid ney worm (Stephanurus dentatus), roundworm (Ascaris suum), nodular worm (Oesophagostomum dentatum). Use as a complete feed at a rate to provide 3 mg/kg/day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Re treatment may be required in 6 weeks. Do not use 14 days before or during the hunting season. 000061 (ii) Ruminants (subfamily Antilopinae, Hippotraginae, Caprinae). 50 to 300 ................ For the treatment and control of small stomach worm (Trichostrongylus spp.), thread necked intestinal worm (Nematodirus spp.), barberpole worm (Haemonchus spp.), whipworm (Trichuris spp.). Use as a complete feed at a rate to provide 2.5 mg/kg/ day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Re treatment may be required in 6 weeks. Do not use 14 days before or during the hunting season. 000061 (iii) Rocky moun tain bighorn sheep (Ovis c. canadensis). 375 to 1,000 ........... For the treatment and control of Protostrongylus spp.. Use as a complete feed at a rate to provide 10 mg/kg/ day for 3 consecutive days. Prior withdrawal of feed or water is not necessary. Re treatment may be required in 6 weeks. Do not use 14 days before or during the hunting season. 000061 (6) Fenbendazole may also be used in combination with: (i) [Reserved] (ii) Lincomycin as in § 558.325. [66 FR 58935, Nov. 26, 2001, as amended at 68 FR 34534, June 10, 2003; 72 FR 66046, Nov. 27, 2007; 73 FR 58873, Oct. 8, 2008; 74 FR 61517, Nov. 25, 2009; 79 FR 13545, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 86 FR 14822, Mar. 19, 2021; 87 FR 58964, Sept. 29, 2022; 88 FR 14904, Mar. 10, 2023] § 558.261 Florfenicol. (a) Specifications. Type A medicated articles containing florfenicol in the following concentrations: (1) 40 grams per kilogram for use as in paragraph (e)(1) of this section. (2) 500 grams per kilogram for use as in paragraph (e)(2) of this section. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.283 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for florfenicol medicated feeds: (i) For swine must not exceed 90 days from the date of issuance. (ii) For fish must not exceed 6 months from the date of issuance. (3) VFDs for florfenicol shall not be refilled. (4) Type A medicated articles and medicated feeds intended for use in fish shall bear the following: ‘‘Not for use in animals intended for breeding pur poses. The effects of florfenicol on re productive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degenera tion and atrophy.’’ (e) Conditions of use—(1) Swine— Florfenicol in grams/ton of feed Indications for use Limitations 182 .................................. For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.. Feed continuously as a sole ration for 5 con secutive days. The safety of florfenicol on swine reproductive performance, pregnancy, and lactation have not been determined. Feeds containing florfenicol must be withdrawn 13 days prior to slaughter. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00493 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 484 21 CFR Ch. I (4–1–23 Edition) § 558.261 (2) Fish— Florfenicol in grams/ton of feed Indications for use Limitations (i) 182 to 2,724 ................ Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri. Feed as a sole ration for 10 consecutive days to deliver 10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose related decrease in hematopoietic/ lymphopoietic tissue may occur. The time re quired for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. (ii) 182 to 1,816 ............... Freshwater-reared salmonids: For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furun culosis associated with Aeromonas salmonicida. Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed vet erinarian before initiating a further course of therapy. The effects of florfenicol on reproduc tive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. (iii) 182 to 2,724 .............. Freshwater-reared finfish: For the control of mor tality due to columnaris disease associated with Flavobacterium columnare. Feed as a sole ration for 10 consecutive days to deliver 10 to 15 mg florfenicol per kg of fish for freshwater-reared warmwater finfish and other freshwater-reared finfish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For cat fish, a dose-related decrease in hematopoietic/ lymphopoietic tissue may occur. The time re quired for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. (iv) 273 to 2,724 .............. Freshwater-reared warmwater finfish: For the control of mortality due to streptococcal septi cemia associated with Streptococcus iniae. Feed as a sole ration for 10 consecutive days to deliver 15 mg florfenicol per kg of fish. Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veteri narian before initiating a further course of ther apy. For catfish, a dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/ lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on repro ductive performance have not been deter mined. Feeds containing florfenicol must be withdrawn 15 days prior to slaughter. [70 FR 70047, Nov. 21, 2005, as amended at 71 FR 70304, Dec. 4, 2006; 72 FR 19798, Apr. 20, 2007; 72 FR 65885, Nov. 26, 2007; 77 FR 32012, May 31, 2012; 79 FR 18159, Apr. 1, 2014; 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 67152, Sept. 30, 2016; 86 FR 14822, Mar. 19, 2021; 87 FR 10971, Feb. 28, 2022] VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00494 Fmt 8010 Sfmt 8016 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 485 Food and Drug Administration, HHS § 558.265 § 558.265 Halofuginone. (a) Specifications. Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilo gram. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.308 of this chapter. (d) Conditions of use. It is used in feed as follows: (1) Chickens— Halofuginone in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 2.72 ................ .................................. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxi ma. Feed continuously as sole ra tion. Do not feed to layers. Withdraw 4 days before slaughter. 016592 (ii) 2.72 ............... Bacitracin methylenedisalicyl ate, 10 to 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxi ma; for improved feed efficiency. Feed continuously as sole ra tion. Do not feed to layers. Withdraw 5 days before slaughter. 016592 (iii) 2.72 ............... Bambermycins, 1 to 2. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E, acervulina, E. brunetti, E. mivati, and E. maxi ma; for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ra tion. Do not feed to layers. Withdraw 5 days before slaughter. 016592 (iv) 2.72 .............. .................................. Replacement broiler breeder chickens and replacement cage laying chick ens: For the prevention of coccidi osis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati/E. mitis, and E. brunetti. Feed continuously as sole ra tion to replacement cage lay ing chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter. 016592 (2) Turkeys— Halofuginone in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 1.36 to 2.72 .... .................................. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis. Feed continuously as sole ra tion. Withdraw 7 days before slaughter. Do not feed to lay ers or water fowl. 016592 (ii) 1.36 to 2.72 ... Bacitracin methylenedisalicyl ate, 10 to 50. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain. Feed continuously as sole ra tion. Withdraw 7 days before slaughter. Do not feed to lay ing chickens or water fowl. 016592 (iii) 1.36 to 2.72 .. Bambermycins, 2 ..... Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain. Feed continuously as sole ra tion. Withdraw 7 days before slaughter. Do not feed to lay ing chickens or waterfowl. 016592 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00495 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 486 21 CFR Ch. I (4–1–23 Edition) § 558.274 (3) Halofuginone may also be used in combination with: (i) Lincomycin as in § 558.325. (ii) [Reserved] [50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 27, 2014; 84 FR 8975, Mar. 13, 2019] § 558.274 Hygromycin B. (a) Specifications. Type A medicated articles containing 2.4 or 8 grams hygromycin B per pound (g/lb). (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter for as fol lows: (c) Related tolerances. See § 556.330 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for hygromycin B medicated feeds must not exceed 6 months from the date of issuance. VFDs for hygromycin B shall not be refilled. (e) Conditions of use. It is used in feed as follows: (1) Chickens— Hygromycin B grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (i) 8 to 12 ................... .................................. Chickens: For control of infec tions of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and cap illary worms (Capillaria obsignata). Use in complete feed. Withdraw 3 days before slaughter. 058198 (ii) [Reserved] (2) Swine— Hygromycin B grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (i) 12 .......................... .................................. Swine: For control of infections of large roundworms (A. suis), nodular worms (O. dentatum), and whipworms (Trichuris suis). In market hogs, use in complete feed for 8 weeks during the growing period. Withdraw 15 days before slaughter. 058198 (ii) [Reserved] [81 FR 95005, Dec. 27, 2016] § 558.295 Iodinated casein. (a) Specifications. Type A medicated article containing iodinated casein. (b) Sponsor. See No. 017762 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Ducks— Amount in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 .................... Growing ducks: For increased rate of weight gain. ................................................................... 017762 (ii) [Reserved] (2) Dairy cows— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00496 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 487 Food and Drug Administration, HHS § 558.300 Amount in grams/pound Indications for use Limitations Sponsor (1) 0.5 to 1.5 per 100 lb of body weight. Dairy cows: For increased milk produc tion. This drug is effective for limited periods of time, and the effectiveness is limited to the declining phase of lactation. Ad ministration must be accompanied with increased feed intake. Administration may increase heat sensitivity of the animal. 017762 (2) [Reserved] [85 FR 45309, July 28, 2020, as amended at 86 FR 14823, Mar. 19, 2021] § 558.300 Ivermectin. (a) Specifications. Type A medicated article containing 2.72 grams ivermectin per pound (g/lb). (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.344 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use in swine. It is used in feed as follows: Ivermectin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (1) 1.8 ................. Weaned, growing-finishing swine: For treatment and control of gastro intestinal roundworms (Ascaris suum, adults and fourth-stage lar vae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). Feed as the only feed for 7 consecutive days to provide 0.1 milligrams per kilograms (mg/kg) of body weight per day. Withdraw 5 days before slaughter. 000010 (2) 1.8 ................. Bacitracin methylenedisalicyl ate, 10 to 30. Weaned, growing-finishing swine: For treatment and control of gastro intestinal roundworms (Ascaris suum, adults and fourth-stage lar vae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabieivar. suis); and for increased rate of weight gain and improved feed efficiency. Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. 000010 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00497 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 488 21 CFR Ch. I (4–1–23 Edition) § 558.300 Ivermectin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (3) 1.8 ................. Bacitracin methylenedisalicyl ate, 250. Weaned, growing-finishing swine: For treatment and control of gastro intestinal roundworms (Ascaris suum, adults and fourth-stage lar vae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for control of swine dysentery associated with Treponema hyodysenteriae on premises with a history of swine dysentery, but where symptoms have not yet occurred, or following an approved treatment of disease condition. Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. 000010 (4) 1.8 to 11.8 .... Adult and breeding swine: For treat ment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage lar vae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. 000010 (5) 1.8 to 11.8 .... Bacitracin methylenedisalicyl ate, 250. Pregnant sows: For treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage lar vae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis); and for control of clostridial enteritis caused by Clostridium perfringens in suckling piglets. Feed as the only feed for 7 consecutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. Feed bacitracin methylenedisalicylate Type C medicated feed to sows from 14 days before through 21 days after farrowing on prem ises with a history of clostridial scours. 000010 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00498 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 489 Food and Drug Administration, HHS ยง 558.305 Ivermectin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (6) 18.2 to 120 ... Adult and breeding swine: For treat ment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage lar vae; Oesophagostomum spp., adults and fourth-stage larvae); kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae); lungworms (Metastrongylus spp., adults); threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation); lice (Haematopinus suis); and mange mites (Sarcoptes scabiei var. suis). Top dress on daily ration for in dividual treatment for 7 con secutive days to provide 0.1 mg/kg of body weight per day. Withdraw 5 days before slaughter. 000010 [72 FR 37437, July 10, 2007, as amended at 81 FR 17609, Mar. 30, 2016; 81 FR 95005, Dec. 27, 2016; 84 FR 12499, Apr. 2, 2019; 84 FR 39185, Aug. 9, 2019] ยง 558.305 Laidlomycin. (a) Specifications. Type A medicated articles containing 50 grams laidlomycin propionate potassium per pound. (b) Sponsor. See No. 054771 in ยง 510.600(c) of this chapter. (c) Tolerances. See ยง 556.346 of this chapter. (d) Special considerations. (1) Laidlomycin liquid Type B feeds may be manufactured from dry laidlomycin Type A articles. The liquid Type B feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear ap propriate mixing directions as follows: (i) For liquid feeds stored in recircu lating tank systems: Recirculate im mediately prior to use for no less than 10 minutes, moving not less than 1 per cent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in me chanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 min utes, creating a turbulence at the bot tom of the tank that is visible at the top. Agitate daily as described even when not used. (2) The expiration date for the liquid Type B feed is 21 days after date of manufacture. The expiration date for the dry Type C feed made from the liq uid Type B feed is 7 days after date of manufacture. (3) Labeling for all Type B feeds (liq uid and dry) and Type C feeds con taining laidlomycin shall bear the fol lowing statements: (i) Do not allow horses or other equines access to feeds containing laidlomycin propionate potassium. (ii) The safety of laidlomycin propio nate potassium in unapproved species has not been established. (iii) Not for use in animals intended for breeding. (e) Conditions of use. It is used in cat tle being fed in confinement for slaugh ter as follows: Laidlomycin in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (1) 5 .................... ............................. For improved feed efficiency and in creased rate of weight gain.. Feed continuously in a Type C feed at a rate of 30 to 75 mg/ head/day.. 054771 (2) 5 to 10 .......... ............................. For improved feed efficiency. ............. Feed continuously in a Type C feed at a rate of 30 to 150 milligrams/head/day.. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00499 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 490 21 CFR Ch. I (4–1–23 Edition) § 558.311 (f) Laidlomycin may also be used in combination with chlortetracycline as in § 558.128. [59 FR 18297, Apr. 18, 1994, as amended at 60 FR 53509, Oct. 16, 1995; 62 FR 9929, Mar. 5, 1997; 63 FR 27845, May 21, 1998; 66 FR 46706, Sept. 7, 2001; 68 FR 13839, Mar. 21, 2003; 68 FR 42590, July 18, 2003; 69 FR 30198, May 27, 2004; 79 FR 13545, Mar. 11, 2014; 81 FR 95005, Dec. 27, 2016; 86 FR 14823, Mar. 19, 2021] § 558.311 Lasalocid. (a) Specifications. Each pound of Type A medicated article contains 68 grams (15 percent), 90.7 grams (20 percent), or 150 grams (33.1 percent) lasalocid as lasalocid sodium activity. A minimum of 90 percent of lasalocid activity is de rived from lasalocid A. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerance. See § 556.347 of this chapter. (d) Special considerations. (1) Type C cattle and sheep feeds may be manufac tured from lasalocid liquid Type B feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows: (i) For liquid feeds stored in recircu lating tank systems: Recirculate im mediately prior to use for no less than 10 minutes, moving not less than 1 per cent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in me chanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 min utes, creating a turbulence at the bot tom of the tank that is visible at the top. Agitate daily as described even when not used. (2) A physically stable lasalocid liq uid feed will not be subject to the re quirements for mixing directions pre scribed in paragraph (d)(1) of this sec tion provided it has a pH of 4.0 to 8.0 and contains a suspending agent(s) suf ficient to maintain a viscosity of not less than 300 centipoises per second for 3 months. (3) If a manufacturer is unable to meet the requirements of paragraph (d)(1) or (d)(2) of this section, the man ufacturer may secure approval of a positionally stable liquid feed by: (i) Either filing a new animal drug application for the product or estab lishing a master file containing data to support the stability of its product; (ii) Authorizing the agency to ref erence and rely upon the data in the master file to support approval of a supplemental new animal drug applica tion to establish physical stability; and (iii) Requesting the sponsor of an ap proved new animal drug application to file a supplement to provide for use of its lasalocid Type A article in the man ufacture of the liquid feed specified in the appropriate master file. If the data demonstrate the stability of the liquid feed described in the master file, the supplemental new animal drug applica tion will be approved. The approval will provide a basis for the individual liquid feed manufacturer to manufac ture under a medicated feed license the liquid mediated feed described in the master file. A manufacturer who seeks to market a physically unstable lasalocid liquid feed with mixing direc tions different from the standard direc tions established in paragraph (d)(1) of this section may also follow this proce dure. (4) If adequate information is sub mitted to show that a particular liquid feed containing lasalocid is stable out side the pH of 4.0 to 8.0, the pH restric tion described in paragraphs (d)(1) and (d)(2) of this section may be waived. (5) Required label statements: (i) For liquid Type B feed (cattle and sheep): Mix thoroughly with grain and/ or roughage prior to feeding. Feeding undiluted, mixing errors, or inadequate mixing (recirculation or agitation) may result in an excess lasalocid con centration which could be fatal to cat tle and sheep. Do not allow horses or other equines access to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in unapproved species has not been established. (ii) For Type A articles or Type B feeds (cattle and sheep): Feeding undi luted or mixing errors may result in an excess lasalocid concentration which could be fatal to cattle and sheep. Do not allow horses or other equines ac cess to Type A articles or Type B feeds containing lasalocid as ingestion may be fatal. Safety of lasalocid for use in VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00500 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 491 Food and Drug Administration, HHS § 558.311 unapproved species has not been estab lished. (iii) For Type A articles, Type B or Type C feeds (cattle): A withdrawal pe riod has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (6) Lasalocid Type A medicated arti cles containing lasalocid dried fer mentation residue are for use in cattle and sheep feed only. (7) Each use in a free-choice Type C cattle feed as in paragraphs (e)(3)(vi) through (e)(3)(viii) of this section must be the subject of an approved NADA or supplemental NADA as provided in § 510.455 of this chapter. (e) Conditions of use. It is used as fol lows: (1) The conditions of use for chickens are: Lasalocid in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 68 to 113 ...... ................................. Broiler or fryer chickens: For preven tion of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima.. Feed continuously as the sole ration.. 054771 (ii) 68 ................. Bacitracin methylenedisalicy late, 10 to 50. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxi ma; and for increased rate of weight gain and improved feed effi ciency.. Feed continuously as the sole ration. Bacitracin methylenedisalicylate pro vided by No. 054771 in § 510.600(c) of this chapter.. 054771 (iii) 68 to 113 ..... Bacitracin methylenedisalicy late, 4 to 50. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxi ma; and for improved feed effi ciency.. Feed continuously as the sole ration. Bacitracin methylenedisalicylate pro vided by No. 054771 in § 510.600(c) of this chapter.. 054771 (iv) 68 to 113 .... Bacitracin zinc, 4 to 50. Broiler chickens. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxi ma; and for increased rate of weight gain and improved feed effi ciency.. Feed continuously as the sole ration. Bacitracin zinc pro vided by No. 054771 in § 510.600(c) of this chapter.. 054771 (v) 68 to 113 ..... Bambermycins, 1 to 2. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxi ma; and for increased rate of weight gain and improved feed effi ciency.. Feed continuously as sole ra tion. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter.. 016592 (2) The conditions of use for turkeys are: Lasalocid in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 68 to 113 ...... ................................. Growing turkeys; For prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides.. Feed continuously as sole ra tion.. 054771 (ii) 68 to 113 ..... Bacitracin methylenedisalicy late, 4 to 50. Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides; and for increased rate of weight gain and improved feed efficiency.. Feed continuously as the sole ration. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) in this chapter.. 054771 (iii) 68 to 113 ..... Bacitracin zinc, 4 to 50. Growing turkeys: For prevention of coccidiosis caused by E. meleagrimitis, E. gallopavonis, and E. adenoeides; and for increased rate of weight gain and improved feed efficiency.. Feed continuously as the sole ration. Bacitracin zinc as provided by No. 054771 in § 510.600(c) in this chapter.. 054771 (3) The conditions of use for cattle are— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00501 Fmt 8010 Sfmt 8016 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 492 21 CFR Ch. I (4–1–23 Edition) § 558.311 Lasalocid amount Indications for use Limitations Sponsor (i) 10 to 30 grams/ton of feed. Cattle fed in confinement for slaughter: For improved feed ef ficiency.. Feed continuously in complete feed to provide not less than 100 milligrams (mg) nor more than 360 mg of lasalocid sodium activity per head per day.. 054771 (ii) 25 to 30 grams/ton of feed. Cattle fed in confinement for slaughter: For improved feed ef ficiency and increased rate of weight gain.. Feed continuously in complete feed to provide not less than 250 mg nor more than 360 mg of lasalocid sodium activity per head per day.. 054771 (iii) Not less than 60 mg or more than 300 mg of lasalocid per head per day. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain.. Feed continuously at a rate of not less than 60 mg or more than 300 mg of lasalocid per head per day when on pasture. The drug must be contained in at least 1 pound of feed. Daily intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day.. 054771 (iv) 1 mg lasalocid per 2.2 pounds (lb) body weight per day. Cattle up to 800 lb: For control of coccidiosis caused by Eimeria bovis and E. zuernii.. Hand feed continuously at a rate of 1 mg of lasalocid per 2.2 lb body weight per day to provide not more than 360 mg of lasalocid per head per day.. 054771 (v) 1 mg lasalocid per 2.2 lb body weight per day. Replacement calves: For control of coccidiosis caused by E. bovis and E. zuernii.. In milk replacer powder, hand feed at a rate of 1 mg of lasalocid per 2.2 lb body weight per day. A withdrawal period has not been established for lasalocid in pre-ruminating calves. Do not use in calves to be proc essed for veal.. 054771 (vi) 1,440 grams/ton ............ Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain.. As a free-choice Type C medicated loose mineral, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.. 012286 (vii) 1,440 grams/ton ........... Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain.. As a free-choice Type C medicated mineral block, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.. 017800 (viii) 300 grams/ton ............. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain.. As a free-choice Type C medicated protein block, feed continuously at a rate of not less than 60 mg nor more than 200 mg of lasalocid per head per day.. 067949 (ix) 60 to 300 mg of lasalocid per head per day. Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replacement beef and dairy heifers on pasture: For increased rate of weight gain. Feed continuously as a Type C free-choice medicated feed at a rate of 60 to 300 mg of lasalocid per head per day. Daily intakes of lasalocid in excess of 200 mg/head/day have not been shown to be more effective than 200 mg/head/day. 054771 (4) The conditions of use for minor species are: Lasalocid in grams/ton Indications for use Limitations Sponsor (i) 20 to 30 ........................... Sheep maintained in confinement: For prevention of coccidiosis caused by Eimeria ovina, E. crandallis, E. ovinoidalis (E. ninakohlyakimovae), E. parva, and E. intricata.. Feed continuously in complete feed to provide not less than 15 milligrams (mg) nor more than 70 mg of lasalocid sodium activity per head per day depending on body weight.. 054771 (ii) 113 ................................. Chukar partridges: For prevention of coccidiosis caused by E. legionensis.. Feed continuously as sole ration up to 8 weeks of age.. 054771 (iii) 113 ................................ Rabbits: For prevention of coccidi osis caused by E. stiedae.. Feed continuously as sole ration up to 6 1/2 weeks of age. 054771 (5) It is used as a free-choice mineral Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Defluorinated phosphate (20.5% Ca, 18.5% P) .......................................................................... 35 .9 6–01–080 Sodium chloride (salt) ................................................................................................................. 20 .0 6–04–152 Calcium carbonate (38% Ca) ...................................................................................................... 18 .0 6–01–069 Cottonseed meal ......................................................................................................................... 10 .0 5–01–621 Potassium chloride ...................................................................................................................... 3 .0 6–03–755 Selenium premix (0.02 percent Se)1 ........................................................................................... 3 .0 Dried cane molasses (46% sugars) ............................................................................................ 2 .5 4–04–695 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00502 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 493 Food and Drug Administration, HHS § 558.311 Ingredient Percent International feed No. Magnesium sulfate ...................................................................................................................... 1 .7 6–02–758 Vitamin premix1 ........................................................................................................................... 1 .4 Magnesium oxide (58% Mg) ....................................................................................................... 1 .2 6–02–756 Potassium sulfate ........................................................................................................................ 1 .2 6–06–098 Trace mineral premix1 ................................................................................................................. 1 .04 Lasalocid Type A medicated article (68 g/lb)2 ............................................................................ 1 .06 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). 2 To provide 1,440 g lasalocid per ton, use 21.2 lbs (1.06%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 15.88 lbs per ton (0.794%), adding molasses. (ii) Amount. 1,440 grams per ton. (iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/ day have not been shown to be more ef fective than 200 mg/head/day. (iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers); feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day. (v) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (6) It is used as a ruminant free choice liquid Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Cane molasses ........................................................................................................................ 55 .167 4–13–241 Condensed molasses fermentation solubles .......................................................................... 24 .0 50% Urea Solution (23% N) .................................................................................................... 12 .0 Ammonium polyphosphate solution ........................................................................................ 1 .0 6–08–42 Phosphoric acid (54%) ............................................................................................................ 3 .0 6–03–707 Xanthan gum ........................................................................................................................... 0 .05 8–15–818 Water ....................................................................................................................................... 4 .0 Trace mineral premix1 ............................................................................................................. 0 .5 Vitamin premix1 ....................................................................................................................... 0 .2 Lasalocid liquid Type A medicated article (90.7 g/lb)2 ........................................................... 0 .083 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). 2 To provide 150 gm lasalocid per ton, use 1.652 lb (0.083%) of a lasalocid liquid Type A medicated article containing 90.7 g/ lb. If using a dry lasalocid Type A medicated article containing 68 g/lb, use, use 2.206 lbs per ton (0.111%), replacing molasses. If using a dry lasalocid Type A medicated article containing 90.7 g/lb, use 1.652 lbs per ton (0.083%), adding molasses. (ii) Amount. 150 grams per ton. (iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): for increased rate of weight gain. Intakes of lasalocid in excess of 200 mg/head/ day have not been shown to be more ef fective than 200 mg/head/day. (iv) Limitations. For pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers). Feed continuously on a free-choice basis at a rate of 60 to 300 milligrams lasalocid per head per day. (v) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (7) It is used as a free-choice, loose mineral Type C feed as follows: (i) Specifications. Ingredient Percent International feed No. Monocalcium phosphate (21% P) ............................................................................................... 57 .70 6–01–082 Salt .............................................................................................................................................. 17 .55 6–04–152 Distillers dried grains w/ solubles ................................................................................................ 5 .40 5–28–236 Dried cane molasses (46% Sugars) ........................................................................................... 5 .20 4–04–695 Potassium chloride ...................................................................................................................... 4 .90 6–03–755 Trace mineral/vitamin premix1 .................................................................................................... 3 .35 Calcium carbonate (38% Ca) ...................................................................................................... 2 .95 6–01–069 Mineral oil .................................................................................................................................... 1 .05 8–03–123 Magnesium oxide (58% Mg) ....................................................................................................... 1 .00 6–02–756 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00503 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 494 21 CFR Ch. I (4–1–23 Edition) § 558.325 Ingredient Percent International feed No. Iron oxide (52% Fe) .................................................................................................................... 0 .10 6–02–431 Lasalocid Type A medicated article (68 g/lb)2 ............................................................................ 0 .80 1 Content of the vitamin and trace mineral premixes may be varied; however, they should be comparable to those used by the firm for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). 2 To provide 1,088 g lasalocid per ton, use 16 lbs (0.80%) of a lasalocid Type A medicated article containing 68 g/lb. If using a lasalocid Type A medicated article containing 90.7 g/lb, use 12 lbs per ton (0.6%), adding molasses. (ii) Amount. 1,088 grams per ton. (iii) Indications for use. Pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers): For increased rate of weight gain. In takes of lasalocid in excess of 200 mg/ head/day have not been shown to be more effective than 200 mg/head/day. (iv) Limitations. Feed continuously on a free-choice basis at a rate of 60 to 300 mg lasalocid per head per day. (v) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (8) Lasalocid may also be used in combination with: (i) Chlortetracycline as in § 558.128. (ii) Chlortetracycline and sulfa methazine as in § 558.140. (iii) Lincomycin as in § 558.325. (iv) Melengestrol as in § 558.342. (v) Oxytetracycline as in § 558.450. (vi) Tylosin alone or in combination with melengestrol acetate as in § 558.625. (vii) Virginiamycin as in § 558.635. [41 FR 44382, Oct. 8, 1976] EDITORIAL NOTES: 1. For FEDERAL REGISTER citations affecting § 558.311, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. 2. At 79 FR 13545, Mar. 11, 2014, § 558.311 was amended; however, the amendment could not be incorporated because of the inaccurate amendatory instruction. § 558.325 Lincomycin. (a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydro chloride) per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.360 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for lincomycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for lincomycin shall not be refilled. (3) Labeling of Type A medicated ar ticles and Type B and Type C medi cated feeds containing lincomycin shall bear the following: (i) ‘‘CAUTION: Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.’’ (ii) [Reserved] (4) Labeling of medicated feeds con taining lincomycin intended for use in swine shall bear the following: (i) ‘‘CAUTION: Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment de velop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irri table behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.’’ (ii) ‘‘CAUTION: The effects of linco mycin on swine reproductive perform ance, pregnancy, and lactation have not been determined.’’ (e) Conditions of use—(1) Chickens— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00504 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 495 Food and Drug Administration, HHS § 558.325 Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 2 .............. ................................... Broilers: For the control of necrot ic enteritis caused or com plicated by Clostridium spp. or other organisms susceptible to lincomycin. Feed as the sole ration. Not for use in layers, breeders, or tur keys. 054771 (ii) [Re served] (iii) 2 ............ Clopidol, 113.5 ......... Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the prevention of cecal and in testinal coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Feed as the sole ration to broiler chickens. Do not feed to chick ens over 16 weeks of age. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants ac cess to feeds containing linco mycin. Ingestion by these spe cies may result in severe gas trointestinal effects. Clopidol as provided by No. 016592 in § 510.600 of this chapter. 054771 (iv) 2 ............ Decoquinate, 27.2 .... Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the pre vention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. Feed as the sole ration. Do not use in feeds containing ben tonite. Not for use in laying hens, breeding chickens, or tur keys. Do not allow rabbits, ham sters, guinea pigs, horses, or ruminants access to feeds con taining lincomycin. Ingestion by these species may result in se vere gastrointestinal effects. Decoquinate as provided by No. 054771 in § 510.600 of this chapter. 054771 (v) 2 ............. Halofuginone 2.72 .... Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and the preven tion of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. Feed continuously as sole ration. Withdraw 4 days before slaugh ter. Do not feed to laying chick ens or waterfowl. Halofuginone hydrobromide as provided by No. 016592 in § 510.600 of this chapter. 016592 (vi) 2 ............ Lasalocid, 68 to 113 Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the pre vention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E maxima. Feed as the sole ration. Type C feed must be used within 4 weeks of manufacture. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants ac cess to feeds containing linco mycin. Ingestion by these spe cies may result in severe gas trointestinal effects. Lasalocid as provided by No. 054771 in § 510.600 of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00505 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 496 21 CFR Ch. I (4–1–23 Edition) § 558.325 Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (vii) 2 ........... Monensin, 90 to 110 Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma. Feed as the sole ration. Must be thoroughly mixed in feeds be fore use. Do not feed undiluted. Not for use in laying hens, breeding chickens, or turkeys. Do not allow horses, or other equines, mature turkeys, or guinea fowl access to feed con taining monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants ac cess to feeds containing linco mycin. Ingestion by these spe cies may result in severe gas trointestinal effects. Monensin as provided by No. 058198 in § 510.600 of this chapter. 054771 (viii) 2 ........... Robenidine hydro chloride, 30. Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and as an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. Feed as the sole ration. Do not use in feeds containing ben tonite. Do not feed to laying hens producing eggs for human consumption. Not for use in lay ing hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Withdraw 5 days prior to slaughter. Type C feed con taining robenidine hydrochloride must be fed within 50 days from the date of manufacture. Robenidine hydrochloride as provided by No. 054771 in § 510.600 of this chapter. 054771 (ix) 2 ............ Salinomycin, 40 to 60 Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin, and for the pre vention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E maxima, E. brunetti, and E. mivati. Feed as the sole ration to broiler chickens. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Salinomycin as provided by No. 054771 in § 510.600 of this chapter. 05477 (x) 2 ............. Zoalene, 113.5 ......... Broiler chickens: For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin; and for the pre vention and control of coccidi osis. Feed as the sole ration from the time chicks are placed in floor pens until slaughtered for meat. Not for use in laying hens, breeding chickens, or turkeys. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds con taining lincomycin. Ingestion by these species may result in se vere gastrointestinal effects. Zoalene as provided by No. 054771 in § 510.600 of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00506 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 497 Food and Drug Administration, HHS § 558.325 (2) Swine— Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 40 ............ ................................... For control of swine dysentery and the control of porcine prolif erative enteropathies (ileitis) caused by Lawsonia intracellularis. Feed as sole ration. For use in swine on premises with a his tory of swine dysentery but where symptoms have not yet occurred, or following use of lin comycin at 100 grams (g)/ton for the treatment of swine dys entery and the control of por cine proliferative enteropathies (ileitis). 054771 (ii) 40 ........... Fenbendazole, 10 to 80. For control of swine dysentery in animals on premises with a his tory of swine dysentery, but where symptoms have not yet occurred; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and lar vae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—in testinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Lincomycin as pro vided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter. 000061 (iii) 40 .......... Pyrantel, 96 .............. For control of swine dysentery on premises with a history of swine dysentery, but where symptoms have not yet occurred; as an aid in the prevention of migra tion and establishment of large roundworm (Ascaris suum) in fections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infec tions. Feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Linco mycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (iv) 40 .......... Pyrantel, 96 .............. For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections. Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as pro vided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (v) 40 or 100 Pyrantel, 96 .............. For the treatment and/or control of swine dysentery; as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) in fections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infec tions. For treatment of swine dysentery, feed 100 grams of lincomycin and 96 grams of pyrantel tar trate per ton of complete feed for 3 weeks or until clinical signs of the disease disappear, following with 40 grams of linco mycin and 96 grams of pyrantel tartrate per ton of complete feed as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00507 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 498 21 CFR Ch. I (4–1–23 Edition) § 558.325 Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (vi) 40 .......... Pyrantel, 800 ............ For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections. Feed as a single therapeutic treat ment at a rate of 1 lb of feed per 40 lb of body weight for ani mals up to 200 lb and 5 lb of feed per head for animals over 200 lb. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. See para graph (d) of this section. Linco mycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (vii) 100 ....... ................................... For treatment of swine dysentery and the control of porcine prolif erative enteropathies (ileitis) caused by Lawsonia intracellularis. Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. 054771 (viii) 100 ....... Fenbendazole, 10 to 80. For the treatment of swine dys entery; and for the removal of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and lar vae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—in testinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter. 000061 (ix) 100 ........ Pyrantel, 96 .............. For the treatment of swine dys entery; as an aid in the preven tion of migration and establish ment of large roundworm (Ascaris suum) infections; and as an aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infec tions. Feed as the sole ration for 3 weeks or until clinical signs of the disease disappear. Not to be fed to swine that weigh more than 250 pounds. Withdraw 6 days prior to slaughter. Linco mycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (x) 100 ......... Pyrantel, 96 .............. For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) infections. Feed for 3 days as the sole ration. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as pro vided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (xi) 100 ........ Pyrantel, 800 ............ For the treatment and/or control of swine dysentery; for removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum spp.) infections. Feed as a single therapeutic treat ment. Not to be fed to swine that weigh more than 250 pounds. Withdraw 24 hours prior to slaughter. Lincomycin as provided by No. 054771; pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (xii) 100 to 200. ................................... For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae. Feed as sole ration for 21 days .... 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00508 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 499 Food and Drug Administration, HHS § 558.330 Lincomycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (xiii) 200 ....... Fenbendazole, 10 to 80. For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and for the re moval of: Adult stage lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages—liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum); adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages—in testinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). Feed as sole ration to provide a total dose of 9 mg fenbendazole/kg of body weight within 3 to 12 days. Do not feed to swine that weigh more than 250 pounds. Do not use within 6 days of slaughter. Lincomycin as provided by No. 054771; fenbendazole as provided by No. 000061 in § 510.600(c) of this chapter. 000061 (xiv) 200 ...... Pyrantel, 96 .............. For reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) in fections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infec tions. Feed as the sole ration for 21 days. Not for use in swine that weigh more than 250 pounds. Withdraw 6 days before slaugh ter. Lincomycin as provided by No. 054771; pyrantel as pro vided by No. 066104 in § 510.600(c) of this chapter. 054771 [81 FR 95005, Dec. 27, 2016, as amended at 82 FR 12170, Mar. 1, 2017; 82 FR 21691, May 10, 2017; 83 FR 13637, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8976, Mar. 13, 2019; 84 FR 12501, Apr. 2, 2019; 84 FR 39185, Aug. 9, 2019; 86 FR 14824, Mar. 19, 2021] § 558.330 Lubabegron. (a) Specifications. Each pound of Type A medicated article contains 4.54 grams (10 grams per kilogram) or 22.7 grams (50 grams per kilogram) of lubabegron as lubabegron fumarate. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.370 of this chapter. (d) Conditions of use. (1) It is used in cattle feed as follows: Lubabegron fu marate in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (i) 1.25 to 4.54 .. ................................. Beef steers and heifers fed in con finement for slaughter: For re duction of ammonia gas emis sions per pound of live weight and hot carcass weight during the last 14 to 91 days on feed. Feed continuously as the sole ra tion to provide 13 to 90 mg lubabegron/head/day during the last 14 to 91 days on feed. A decrease in dry matter in take may be noticed in some animals receiving lubabegron. Not approved for use in breed ing animals because safety and effectiveness have not been evaluated in these ani mals. Do not allow horses or other equines access to feed containing lubabegron. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00509 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 500 21 CFR Ch. I (4–1–23 Edition) § 558.330 Lubabegron fu marate in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (ii) 1.25 to 4.54 Monensin, 5 to 40 ... Beef steers and heifers fed in con finement for slaughter: For re duction of ammonia gas emis sions per pound of live weight and hot carcass weight and for improved feed efficiency during the last 14 to 91 days on feed. Feed continuously as the sole ra tion to provide 13 to 90 mg lubabegron/head/day and 50 to 480 mg monensin/head/day during the last 14 to 91 days on feed. No additional im provement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A de crease in dry matter intake may be noticed in some ani mals receiving lubabegron. Lubabegron has not been ap proved for use in breeding ani mals because safety and ef fectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed con taining lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cat tle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic re actions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin rec ommended in the feeding di rections, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cat tle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this prod uct for preruminating calves. Do not use in calves to be processed for veal. 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00510 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 501 Food and Drug Administration, HHS § 558.340 Lubabegron fu marate in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (iii) 1.25 to 4.54 Monensin, 10 to 40 Beef steers and heifers fed in con finement for slaughter: For re duction of ammonia gas emis sions per pound of live weight and hot carcass weight; and for prevention and control of coccidi osis due to Eimeria bovis and E. zuernii during the last 14 to 91 days on feed. Feed continuously as the sole ra tion to provide 13 to 90 mg lubabegron/head/day and 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, during the last 14 to 91 days on feed. A decrease in dry matter intake may be noticed in some animals re ceiving lubabegron. Lubabegron has not been ap proved for use in breeding ani mals because safety and ef fectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed con taining lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cat tle and goat feeds are safe for use in cattle and goats only. Consumption by unapproved species may result in toxic re actions. Feeding undiluted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin rec ommended in the feeding di rections, as reduced average daily gains may result. If feed refusals containing monensin are fed to other groups of cat tle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing. A withdrawal period has not been established for this prod uct for preruminating calves. Do not use in calves to be processed for veal. 016592 058198 (2) Lubabegron may also be used in combination with: (i) Tylosin as in § 558.625. (ii) [Reserved] [84 FR 12501, Apr. 2, 2019, as amended at 84 FR 53311, Oct. 7, 2019; 88 FR 14905, Mar. 10, 2023] § 558.340 Maduramicin. (a) Specifications. Type A medicated articles containing 4.54 grams maduramicin per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Tolerances. See § 556.375 of this chapter. (d) Conditions of use in chickens— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00511 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 502 21 CFR Ch. I (4–1–23 Edition) § 558.342 Amount in grams/ton Indications for use Limitations Sponsor (1) 4.54 to 5.45 ................. Broiler chickens: For prevention of coc cidiosis caused by Eimeria acervulina, E. tenella, E. brunetti, E. maxima, E. necatrix, and E. mivati. Feed continuously as sole ration. For broiler chickens only. Do not feed to laying hens. Withdraw 5 days before slaughter. 054771 (2) [Reserved] [85 FR 45310, July 28, 2020] § 558.342 Melengestrol. (a) Specifications. (1) Dry Type A medicated articles containing 100 or 200 milligrams (mg) melengestrol acetate per pound. (2) Liquid Type A medicated article containing 500 mg melengestrol acetate per pound. (b) Sponsor. See sponsors in § 510.600(c) of this chapter for use as in paragraph (e) of this section. (c) Related tolerances. See § 556.380 of this chapter. (d) Special considerations. (1) Type B or C medicated feeds may be manufac tured from melengestrol acetate liquid Type A articles or Type B or C medi cated feeds which have a pH of 4.0 to 8.0 and bear appropriate mixing directions as follows: (i) For liquid feeds stored in recircu lating tank systems: Recirculate im mediately prior to use for no less than 10 minutes, moving not less than 1 per cent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in me chanical, air, or other agitation type tank systems: Agitate immediately prior to use for not less than 10 min utes, creating a turbulence at the bot tom of the tank that is visible at the top. Agitate daily as described even when not used. (2) A physically stable melengestrol acetate liquid Type B or C feed will not be subject to the requirements for mix ing directions prescribed in paragraph (d)(1) of this section provided it has a pH of 4.0 to 8.0 and contains a sus pending agent(s) sufficient to maintain a viscosity of not less than 300 centi poises per second for 3 months. (3) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and lasalocid must be labeled in accordance with § 558.311(d). (4) Liquid or dry combination Type B or C medicated feeds containing melengestrol acetate and monensin must be labeled in accordance with § 558.355(d). (5) Liquid combination Type B or C medicated feeds containing melengestrol acetate and tylosin must be manufactured in accordance with § 558.625(d). (6) Liquid melengestrol acetate may not be mixed with oxytetracycline in a common liquid feed supplement. (e) Conditions of use—(1) Cattle. Melengestrol acetate in mg/head/day Combination in grams/ton Indications for use Limitations Sponsor (i) 0.25 to 0.5 ...... ............................... Heifers fed in confinement for slaugh ter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat).. Administer 0.5 to 2.0 pounds (lb)/head/day of medicated feed containing 0.125 to 1.0 mg melengestrol acetate/lb to provide 0.25 to 0.5 mg melengestrol acetate/head/ day.. 016592 054771 058198 (ii) 0.5 ................. .................................. Heifers intended for breeding: For suppression of estrus (heat). Administer 0.5 to 2.0 lb/head/ day of Type C feed con taining 0.25 to 1.0 mg melengestrol acetate/lb to provide 0.5 mg melengestrol acetate/head/day. Do not ex ceed 24 days of feeding. 016592 054771 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00512 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 503 Food and Drug Administration, HHS § 558.355 Melengestrol acetate in mg/head/day Combination in grams/ton Indications for use Limitations Sponsor (iii) 0.25 to 0.5 .... Lasalocid, 10 to 30 .. Heifers fed in confinement for slaugh ter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for control of coccidiosis caused by Eimeria bovis and Eimeria zuernii. Add at the rate of 0.5 to 2.0 lb/ head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed con taining 10 to 30 g of lasalocid per ton to provide 0.25 to 0.5 mg melengestrol acetate and 100 to 360 milligrams of lasalocid per head/day. See § 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771, 058198 (iv) 0.25 to 0.5 .... Monensin, 10 to 40 .. Heifers fed in confinement for slaugh ter: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat); and for the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Add at the rate of 0.5 to 2.0 lb/ head/day a medicated feed (liquid or dry) containing 0.125 to 1.0 mg melengestrol acetate/lb to a feed con taining 10 to 40 g of monensin per ton to provide 0.25 to 0.5 mg melengestrol acetate/head/day and 0.14 to 0.42 mg monensin/lb body weight, depending on sever ity of coccidiosis challenge, up to 480 mg monensin/ head/day. See § 558.355(d) of this chapter. Monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016952, 054771, or 058198 in § 510.600(c) of this chapter. 016592 045771 058198 (2) Melengestrol may also be used in combination with: (i) Oxytetracycline as in § 558.450. (ii) Ractopamine as in § 558.500. (iii) Tylosin as in § 558.625. (iv) Zilpaterol as in § 558.665. [42 FR 28535, June 3, 1977] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.342, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.348 Mibolerone. (a) Specifications. Each 6.5 ounce can contains 30 or 60 micrograms (μg) of mibolerone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) Amount. 30 μg for animals weighing up to 25 pounds; 60 μg for animals weigh ing 26 to 50 pounds; 120 μg for animals weighing 51 to 100 pounds; 180 μg for animals weighing over 100 pounds, or German Shepherds or German Shep herd mix weighing 30 to 80 pounds. Ad minister daily at least 30 days before expected initiation of heat and con tinue as long as desired, but for not more than 12 months. (2) Indications for use. For the preven tion of estrus (heat) in adult female dogs not intended primarily for breed ing purposes. (3) Limitations. Mibolerone should not be used in bitches before first estrous period or in purebred Bedlington ter riers. It is not intended for animals being used primarily for breeding pur poses. Use orally in adult female dogs only. Federal law restricts this drug to use by or on the order of a licensed vet erinarian. [85 FR 45310, July 28, 2020] § 558.355 Monensin. (a) Specifications. Type A medicated articles containing 45, 60, 90.7, or 110 grams monensin, USP, per pound. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00513 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 504 21 CFR Ch. I (4–1–23 Edition) § 558.355 (1) No. 058198 for use as in paragraph (f) of this section. (2) No. 016592 for use of a Type A medicated article containing 90.7 grams monensin, USP, per pound as in paragraphs (f)(3), (f)(4)(v), and (f)(6) of this section. (c) Related tolerances. See § 556.420 of this chapter. (d) Special considerations. (1) Type C chicken feed containing monensin as the mycelial cake shall bear an expira tion date of 90 days after its date of manufacture. (2)–(3) [Reserved] (4) Liquid Type B feeds shall bear an expiration date of 8 weeks after its date of manufacture. (5) All Type A medicated articles containing monensin shall bear the fol lowing warning statement: When mix ing and handling monensin Type A medicated articles, use protective clothing, impervious gloves, and a dust mask. Operators should wash thor oughly with soap and water after han dling. If accidental eye contact occurs, immediately rinse thoroughly with water. (6) All formulations containing monensin shall bear the following cau tion statement: Do not allow horses or other equines access to feed containing monensin. Ingestion of monensin by horses has been fatal. (7) Type A medicated articles con taining monensin intended for use in cattle and goats shall bear, in addition to the caution statement in paragraph (d)(6) of this section, the following statements: (i) Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unap proved species may result in toxic re actions. (ii) Feeding undiluted or mixing er rors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. (iii) Must be thoroughly mixed in feeds before use. (iv) Do not feed undiluted. (v) Do not exceed the levels of monensin recommended in the feeding directions, as reduced average daily gains may result. (vi) Do not feed to lactating goats. (vii) If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of refusals fed should be taken into consideration to prevent monensin overdosing (see paragraphs (d)(10)(i) and (d)(10)(ii) of this section). (viii) A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. (ix) You may notice the following: Reduced voluntary feed intake in dairy cows fed monensin. This reduction in creases with higher doses of monensin fed. Rule out monensin as the cause of reduced feed intake before attributing to other causes such as illness, feed management, or the environment. Re duced milk fat percentage in dairy cows fed monensin. This reduction in creases with higher doses of monensin fed. Increased incidence of cystic ova ries and metritis in dairy cows fed monensin. Reduced conception rates, increased services per animal, and ex tended days open and corresponding calving intervals in dairy cows fed monensin. Have a comprehensive and ongoing nutritional, reproductive, and herd health program in place when feeding monensin to dairy cows. (x) Inadequate mixing (recirculation or agitation) of monensin liquid Type B or Type C medicated feeds has resulted in increased monensin concentration which has been fatal to cattle and could be fatal to goats. (8) Type A medicated articles con taining monensin intended for use in chickens, turkeys, and quail shall bear the following statements: (i) Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. (ii) Must be thoroughly mixed in feeds before use. (iii) Do not feed undiluted. (iv) Do not feed to laying chickens. (v) Do not feed to chickens over 16 weeks of age. (vi) Not for broiler breeder replace ment chickens. (vii) Some strains of turkey coccidia may be monensin tolerant or resistant. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00514 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 505 Food and Drug Administration, HHS § 558.355 Monensin may interfere with develop ment of immunity to turkey coccidi osis. (viii) In the absence of coccidiosis in broiler chickens the use of monensin with no withdrawal period may limit feed intake resulting in reduced weight gain. (9) Type B feeds containing monensin shall bear the statements specified in the following paragraphs of this sec tion when intended for use in: (i) Cattle (as described in paragraphs (f)(3)(i) through (iii), (vi), and (vii) and (f)(4)(i) through (vi) of this section). See paragraphs (d)(6) and (d)(7)(i) through (v), (vii), and (viii) of this section. (ii) Dairy cows (as described in para graphs (f)(3)(iv) and (v) of this section). See paragraphs (d)(6) and (d)(7)(i) through (iv), (vii), (viii), and (ix) of this section. (iii) Goats: See paragraphs (d)(6) and (d)(7)(i) through (d)(7)(vi) of this sec tion. (iv) Chickens: See paragraphs (d)(8)(i) through (d)(8)(vi), and (d)(8)(viii) of this section. (v) Turkeys: See paragraphs (d)(8)(i), (d)(8)(ii), (d)(8)(iii), and (d)(8)(vii) of this section. (vi) Quail: See paragraphs (d)(8)(i), (d)(8)(ii), and (d)(8)(iii) of this section. (10) Type C feeds containing monensin shall bear the statements specified in the following paragraphs of this section when intended for use in: (i) Cattle (as described in paragraphs (f)(3)(i) through (iii), (vi), and (vii) and (f)(4)(i) through (vi) of this section). See paragraphs (d)(6) and (d)(7)(i), (v), (vii), and (viii) of this section. Paragraph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chapter. (ii) Dairy cows (as described in para graphs (f)(3)(iv) and (v) of this section). See paragraphs (d)(6) and (d)(7)(i), (vii), (viii), and (ix) of this section. Para graph (d)(7)(vii) of this section does not apply to free-choice Type C medicated feeds as defined in § 510.455 of this chap ter. (iii) Goats: See paragraphs (d)(6), (d)(7)(i), (d)(7)(v), and (d)(7)(vi) of this section. (iv) Chickens: See paragraphs (d)(8)(i), (d)(8)(iv), (d)(8)(v), (d)(8)(vi), and (d)(8)(viii) of this section. (v) Turkeys: See paragraphs (d)(8)(i) and (d)(8)(vii) of this section. (vi) Quail: See paragraph (d)(8)(i) of this section. (11) Type B and Type C liquid feeds requiring recirculation or agitation that contain monensin and are in tended for use in cattle (including dairy cows) and goats shall bear the caution statement specified in para graph (d)(7)(x) of this section. (12) Mixing directions for liquid feeds requiring recirculation or agitation: (i) For liquid feeds stored in recircu lating tank systems: Recirculate im mediately prior to use for not less than 10 minutes, moving not less than 1 per cent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in me chanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 min utes, creating a turbulence at the bot tom of the tank that is visible at the top. Agitate daily as described even when not used. (e) [Reserved] (f) Conditions of use. It is used as fol lows: (1) Chickens— Monensin in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (i) 90 to 110. .............................. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Feed continuously as the sole ration. In the absence of coccidiosis, the use of monensin with no with drawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. 058198 (ii) 90 to 110. .............................. Layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Feed continuously as the sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to lay ing chickens. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00515 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 506 21 CFR Ch. I (4–1–23 Edition) § 558.355 Monensin in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (iii) 90 to 110. Bacitracin methylenedisali cylate, 4 to 50. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no with drawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iv) 90 to 110. Bacitracin methylenedisali cylate, 4 to 50. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Feed as the sole ration throughout the feeding period. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coc cidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake result ing in reduced weight gain. Not for broiler breeder replacement chick ens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter. 069254 (v) 90 to 110. Bacitracin methylenedisali cylate, 4 to 50. Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the preven tion of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Feed as the sole ration throughout the feeding period. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter. 069254 (vi) 90 to 110. Bacitracin methylenedisali cylate, 4 to 50. Layer replacement chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for in creased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to lay ing chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. 054771 (vii) 90 to 110. Bacitracin methylenedisali cylate, 5 to 25. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no with drawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00516 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 507 Food and Drug Administration, HHS § 558.355 Monensin in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (viii) 90 to 110. Bacitracin methylenedisali cylate, 50. Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the pre vention of mortality caused by ne crotic enteritis associated with Clostridium perfringens. Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. In the absence of coc cidiosis in broiler chickens, the use of monensin with no withdrawal period may limit feed intake result ing in reduced weight gain. Not for broiler breeder replacement chick ens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter. 069254 (ix) 90 to 110. Bacitracin methylenedisali cylate, 50. Laying hen replacement chickens and layer breeder replacement chickens: As an aid in the preven tion of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for the pre vention of mortality caused by ne crotic enteritis associated with Clostridium perfringens. Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Not for broiler breeder replacement chickens. Monensin provided by No. 058198, bacitracin methylenedisalicylate provided by No. 069254 in § 510.600(c) of this chapter. 069254 (x) 90 to 110. Bacitracin methylenedisali cylate, 50. Broiler and layer replacement chick ens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency, and as an aid in the prevention of necrotic enteritis caused or com plicated by Clostridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration. Do not feed to chickens over 16 weeks of age. Do not feed to lay ing chickens. Monensin sodium provided by No. 058198, bacitracin methylenedisalicylate provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xi) 90 to 110. Bacitracin zinc, 4 to 50. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no with drawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. 054771 (xii) 90 to 110. Bacitracin zinc, 10 Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no with drawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00517 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 508 21 CFR Ch. I (4–1–23 Edition) § 558.355 Monensin in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (xiii) 90 to 110. Bacitracin zinc, 10 to 30. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for improved feed efficiency. Feed continuously as sole ration. In the absence of coccidiosis, the use of monensin with no with drawal period may limit feed intake resulting in reduced weight gain. Do not feed to laying chickens. Bacitracin zinc provided by No. 054771 in § 510.600(c) of this chapter. 058198 (xiv) 90 to 110. Bambermycins, 1 to 2. Broiler chickens: As an aid in the prevention of coccidiosis caused by E. necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. Do not feed to laying chickens. Bambermycins provided by No. 016592 in § 510.600(c) of this chapter. 016592, 058198 (2) Turkeys— Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 54 to 90 .............................. Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis. For growing turkeys only. Feed con tinuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with devel opment of immunity to turkey coc cidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. 058198 (ii) 54 to 90. Bacitracin methylenedisali cylate, 4 to 50. Growing turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency. Feed continuously as the sole ration. The optimum level depends upon the severity of coccidiosis expo sure. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may inter fere with development of immunity to turkey coccidiosis. Bacitracin methylenedisalicylate as provided by No. 054771 or 069254 in § 510.600(c) of this chapter. 058198 069254 (iii) 54 to 90. Bacitracin methylenedisali cylate, 200. Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and as an aid in the control of transmissible enter itis complicated by organisms sus ceptible to bacitracin methylenedisalicylate. For growing turkeys only. Feed con tinuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with devel opment of immunity to turkey coc cidiosis. Do not allow horses, other equines, mature turkeys, or guinea fowl access to feed containing monensin. Ingestion of monensin by horses and guinea fowl has been fatal. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00518 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 509 Food and Drug Administration, HHS § 558.355 Monensin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (iv) 54 to 90. Bambermycins, 1 to 2. Growing turkeys: For the prevention of coccidiosis in turkeys caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for im proved feed efficiency. For growing turkeys only. Feed con tinuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with devel opment of immunity to turkey coc cidiosis. Bambermycins as pro vided by No. 016592 in § 510.600(c) of this chapter. 058198 (v) 54 to 90. Bambermycins, 2 Growing turkeys: For the prevention of coccidiosis caused by E. adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency. For growing turkeys only. Feed con tinuously as sole ration. Some strains of turkey coccidia may be monensin tolerant or resistant. Monensin may interfere with devel opment of immunity to turkey coc cidiosis. Bambermycins as pro vided by No. 016592 in § 510.600(c) of this chapter. 058198 (3) Cattle— Monensin in grams/ton Indications for use Limitations Sponsor (i) 5 to 40 ....................... Growing beef steers and heifers fed in confinement for slaughter: For im proved feed efficiency. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No addi tional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 grams per ton (360 milligrams per head per day). See special labeling considerations in paragraph (d) of this section. 016592 058198 (ii) 10 to 40 .................... Growing beef steers and heifers fed in confinement for slaughter: For preven tion and control of coccidiosis due to Eimeria bovis and E. zuernii. Feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, de pending upon the severity of challenge, up to maximum of 480 milligrams per head per day. See special labeling considerations in paragraph (d) of this section. 016592 058198 (iii) 10 to 200 ................. Calves excluding veal calves: For pre vention and control of coccidiosis due to Eimeria bovis and E. zuernii. Feed at a rate of 0.14 to 1.0 milligram monensin per pound of body weight per day, depending upon the severity of challenge, up to maximum of 200 milligrams per head per day. See spe cial labeling considerations in para graph (d) of this section. 016592 058198 (iv) 11 to 22 ................... Dairy cows: For increased milk produc tion efficiency (production of market able solids-corrected milk per unit of feed intake). Feed continuously to dry and lactating dairy cows in a total mixed ration (‘‘complete feed’’). See special labeling considerations in paragraph (d) of this section. 016592 058198 (v) 11 to 400 .................. Dairy cows: For increased milk produc tion efficiency (production of market able solids-corrected milk per unit of feed intake). Feed continuously to dry and lactating dairy cows in a component feeding system (including top dress). The Type C medicated feed must be fed in a minimum of 1 lb of feed to provide 185 to 660 mg/head/day monensin to lac tating cows or 115 to 410 mg/head/day monensin to dry cows. See special la beling considerations in paragraph (d) of this section. 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00519 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 510 21 CFR Ch. I (4–1–23 Edition) § 558.355 Monensin in grams/ton Indications for use Limitations Sponsor (vi) 15 to 400 ................. Growing beef steers and heifers on pas ture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. For increased rate of weight gain, feed at a rate of 50 to 200 milligrams monensin per head per day in not less than 1 pound of feed or, after the 5th day, feed at a rate of 400 milligrams per head per day every other day in not less than 2 pounds of feed. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, de pending on severity of challenge, up to 200 milligrams per head per day. Dur ing first 5 days of feeding, cattle should receive no more than 100 milligrams per day in not less than 1 pound of feed. See special labeling consider ations in paragraph (d) of this section. 016592 058198 (vii) 25 to 400 ................ Beef cows: For improved feed efficiency when receiving supplemental feed, and for the prevention and control of coc cidiosis due to Eimeria bovis and E. zuernii. Feed as supplemental feed, either hand fed in a minimum of 1 pound of feed or mixed in a total ration. For improved feed efficiency, feed continuously at a rate of 50 to 200 milligrams monensin per head per day. For prevention and control of coccidiosis, feed at a rate of 0.14 to 0.42 milligram per pound of body weight per day, depending upon severity of challenge, up to a maximum of 200 milligrams per head per day. During first 5 days of feeding, cattle should receive no more than 100 milli grams per head per day in not less than 1 pound of feed. See special la beling considerations in paragraph (d) of this section. 016592 058198 (4) Free-choice cattle feeds— Monensin amount Indications for use Limitations Sponsor (i) 150 milli grams per pound of protein mineral block (0.033%). Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) and replace ment beef heifers on pasture: For increased rate of weight gain, and for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii in pasture cattle which may require supplemental feed. Provide 50 to 200 milligrams of monensin (0.34 to 1.33 pounds of block) per head per day, at least 1 block per 10 to 12 head of cattle. Roughage must be available at all times. Do not allow animals access to other protein blocks, salt or mineral, while being fed this product. See paragraph (d)(10)(i) of this section. 012286 (ii) 175 milli grams per pound of protein mineral block (0.038%). Growing beef steers and heifers on pasture (stocker, feeder, and slaughter): For in creased rate of weight gain. Provide 40 to 200 milligrams of monensin (0.25 to 1.13 pounds or 4 to 18 ounces of block) per head per day, at least 1 block per 4 head of cattle. Do not allow cattle access to salt or mineral while being fed this prod uct. Ingestion by cattle of monensin at levels of 600 milligrams per head per day and higher has been fatal. See paragraph (d)(10)(i) of this section. 017800 (iii) 400 milli grams per pound of protein mineral block (0.088%). Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For in creased rate of weight gain. Provide 80 to 200 milligrams of monensin (0.2 to 0.5 pounds of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or min erals containing salt. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. 067949 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00520 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 511 Food and Drug Administration, HHS § 558.355 Monensin amount Indications for use Limitations Sponsor (iv) 400 mg per pound of block (0.088%). Pasture cattle (slaughter, stocker, feeder, and dairy and beef replacement heifers): For in creased rate of weight gain. Provide 50 to 200 mg of monensin (2 to 8 ounces of block) per head per day, at least 1 block per 5 head of cattle. Feed blocks continuously. Do not feed salt or mineral supplements in addition to the blocks. Inges tion by cattle of monensin at levels of 600 mg per head per day and higher has been fatal. The effectiveness of this block in cull cows and bulls has not been established. See paragraph (d)(10)(i) of this section. 086113 (v) 1,620 grams per ton of min eral gran ules as specified in para graph (f)(4)(v)(A) of this section. Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) or in a dry lot and replacement beef and dairy heifers: For increased rate of weight gain, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Feed at a rate of 50 to 200 milligrams per head per day. During the first 5 days of feeding, cattle should receive no more than 100 milligrams per day. Do not feed addi tional salt or minerals. Do not mix with grain or other feeds. Monensin is toxic to cattle when consumed at higher than approved levels. Stressed and/or feed- and/or water deprived cattle should be adapted to the pasture and to unmedicated mineral supple ment before using the monensin mineral supplement. 016592 058198 (A) Specifications. Use as free-choice Type C medicated feed formulated as min eral granules as follows: Ingredient Percent International feed No. Monocalcium phosphate (21% phosphorus, 15% calcium) .................................................................. 29.49 6–01–082 Sodium chloride (salt) ........................................................................................................................... 24.37 6–04–152 Dried cane molasses ............................................................................................................................. 20.0 4–04–695 Ground limestone (33% calcium) or calcium carbonate (38% calcium) ............................................... 13.75 6–02–632 Cane molasses ...................................................................................................................................... 3.0 4–04–696 Processed grain by-products (as approved by AAFCO) ...................................................................... 5.0 Vitamin/trace mineral premix 1 .............................................................................................................. 2.5 Monensin Type A article, 90.7 grams per pound ................................................................................. 0.89 Antidusting oil ........................................................................................................................................ 1.0 1 Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide should comply with FDA Compliance Policy Guide Sec. 651.100 (CPG 7125.18). (B) [Reserved] (5) Bobwhite quail— Monensin in grams/ton Indications for use Limitations Sponsor (i) 73 ........... Growing bobwhite quail: For the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae. Feed continuously in complete feed at a rate of 50 to 480 milligrams of monensin per head per day. No additional improvement in feed efficiency has been shown from feed ing monensin at levels greater than 30 grams per ton (360 milligrams per head per day). 058198 (ii) [Re served]. ........................................................................... ........................................................................... ........................ (6) Goats— Monensin in grams/ton Indications for use Limitations Sponsor (i) 20 ........... Goats maintained in confinement: For the pre vention of coccidiosis caused by Eimeria crandallis, E. christenseni, and E. ninakohlyakimovae. Feed continuously. Do not feed to lactating goats. See paragraph (d)(11) of this section for provisions for monensin liquid Type C goat feeds. 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00521 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 512 21 CFR Ch. I (4–1–23 Edition) § 558.360 Monensin in grams/ton Indications for use Limitations Sponsor (ii) [Re served]. ........................................................................... ........................................................................... ........................ (7) Monensin may also be used in combination with: (i) Avilamycin as in § 558.68. (ii) Chlortetracycline as in § 558.128. (iii) Decoquinate as in § 558.195. (iv) Lubabegron as in § 558.330. (v) Lincomycin as in § 558.325. (vi) Melengestrol acetate as in § 558.342. (vii) Oxytetracycline as in § 558.450. (viii) Ractopamine as in § 558.500. (ix) Tilmicosin as in § 558.618. (x) Tylosin as in § 558.625. (xi) Virginiamycin as in § 558.635. (xii) Zilpaterol alone or in combina tion as in § 558.665. [40 FR 13959, Mar. 27, 1975] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.355, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.360 Morantel. (a) Specifications. Each pound of Type A medicated article contains 88 grams morantel tartrate. (b) Sponsor. See No. 066104 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.425 of this chapter. (d) Special considerations. (1) Do not use in Type B or Type C medicated feeds containing bentonite. (2) Consult your veterinarian before using in severely debilitated animals and for assistance in the diagnosis, treatment, and control of parasitism. (e) Conditions of use. It is used in feed as follows: Morantel tartrate in grams/ton Indications for use Limitations Sponsor (1) 0.44 to 4.4 grams of morantel tartrate per pound of feed. Cattle: For removal and control of mature gastrointestinal nematode infections of cattle including stomach worms (Haemonchus spp., Ostertagia spp., Trichostrongylus spp.), worms of the small intestine (Cooperia spp., Trichostrongylus spp., Nematodirus spp.), and worms of the large intestine (Oesophagostomum radiatum). Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat cattle with in 14 days of slaughter. 066104 (2) 0.44 to 4.4 grams of morantel tartrate per pound of feed. Goats: For removal and control of mature gastrointestinal nematode infections of goats including Haemonchus contortus, Ostertagia (Teladorsagia) circumcincta, and Trichostrongylus axei. Feed as a single therapeutic treatment at 0.44 gram of morantel tartrate per 100 pounds of body weight. Fresh water should be available at all times. When medicated feed is consumed, resume normal feeding. Conditions of constant worm exposure may require retreatment in 2 to 4 weeks. Do not treat goats with in 30 days of slaughter. 066104 [84 FR 39185, Aug. 9, 2019] § 558.363 Narasin. (a) Specifications. Type A medicated articles containing 36, 45, 54, 72, or 90 grams narasin per pound. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Tolerances. See § 556.428 of this chapter. (d) Special considerations. An expira tion date of 2 months (8 weeks) is re quired for narasin Type C medicated swine feeds. (e) Conditions of use. It is used as fol lows: (1) Chickens— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00522 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 513 Food and Drug Administration, HHS § 558.363 Narasin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 54 to 90 .......... .................................. Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines ac cess to narasin formulations. Ingestion of narasin by these species has been fatal. 058198 (ii) 54 to 72 ......... Bacitracin methylenedisalicyl ate, 10 to 50. Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma, and for increased rate of weight gain and improved feed effi ciency. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines ac cess to narasin formulations. Ingestion of narasin by these species has been fatal. Baci tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 54 to 72 ........ Bacitracin zinc, 4 to 50. Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma, and for increased rate of weight gain and improved feed effi ciency. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines ac cess to narasin formulations. Ingestion of narasin by these species has been fatal. Baci tracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iv) 54 to 72 ........ Bambermycins, 1 to 2. Broiler chickens: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma, and for increased rate of weight gain and improved feed effi ciency. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines ac cess to narasin formulations. Ingestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 016592 (2) Swine— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00523 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 514 21 CFR Ch. I (4–1–23 Edition) § 558.364 Narasin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 13.6 to 27.2 .... .................................. Growing-finishing swine: For in creased rate of weight gain when fed for at least 4 weeks. Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals be cause safety and effective ness have not been evalu ated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse re actions may occur. If signs of toxicity occur, discontinue use. 058198 (ii) 18.1 to 27.2 ... .................................. Growing-finishing swine: For in creased rate of weight gain and im proved feed efficiency when fed for at least 4 weeks. Feed continuously for at least 4 weeks to swine during the growing-finishing period as the sole ration. No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 13.6 g/ ton. Effectiveness has not been demonstrated when fed for durations less than 4 weeks. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals be cause safety and effective ness have not been evalu ated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse re actions may occur. If signs of toxicity occur, discontinue use. 058198 (3) Narasin single-ingredient Type A medicated articles may also be used in combination with: (i) Avilamycin as in § 558.68. (ii) [Reserved] [83 FR 64741, Dec. 18, 2018, as amended at 86 FR 14825, Mar. 19, 2021] § 558.364 Narasin and nicarbazin. (a) Specifications. A fixed-ratio, com bination drug Type A medicated article containing 36 grams narasin and 36 grams nicarbazin per pound. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Tolerances. See §§ 556.428 and 556.445 of this chapter. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00524 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 515 Food and Drug Administration, HHS § 558.364 (d) Conditions of use. It is used as fol lows: (1) Chickens— Narasin and nicarbazin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 27 to 45 of each drug. .................................. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult tur keys, horses, or other equines access to formula tions containing narasin. In gestion of narasin by these species has been fatal. The two drugs can be combined only at a 1:1 ratio for the 27 to 45 grams per ton range. Only granular nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter may be used in the combina tion. 058198 (ii) 27 to 45 of each drug. Bacitracin methylenedisalicyl ate, 4 to 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma, and for increased rate of weight gain and improved feed effi ciency. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult tur keys, horses, or other equines access to formula tions containing narasin. In gestion of narasin by these species has been fatal. With draw 5 days before slaugh ter. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 058198 (iii) 27 to 45 of each drug. Bacitracin methylenedisalicyl ate, 4 to 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma, and for increased rate of weight gain and improved feed effi ciency. Feed as the sole ration throughout the feeding pe riod. For broiler chickens only. Do not feed to laying hens. Do not allow adult tur keys, horses, or other equines access to formula tions containing narasin. In gestion of narasin by these species has been fatal. Baci tracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter. 069254 (iv) 27 to 45 of each drug. Bacitracin methylenedisalicyl ate, 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the preven tion of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bac itracin. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult tur keys, horses, or other equines access to formula tions containing narasin. In gestion of narasin by these species has been fatal. With draw 5 days before slaugh ter. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00525 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 516 21 CFR Ch. I (4–1–23 Edition) § 558.365 Narasin and nicarbazin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (v) 27 to 45 of each drug. Bacitracin methylenedisalicyl ate, 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxi ma, and for the prevention of mor tality caused by necrotic enteritis associated with Clostridium perfringens. Feed as the sole ration for 28 to 35 days, starting from the time chicks are placed for brooding. For broiler chickens only. Do not feed to laying hens. Do not allow adult tur keys, horses, or other equines access to formula tions containing narasin. In gestion of narasin by these species has been fatal. Baci tracin methylenedisalicylate as provided by No. 069254 in § 510.600(c) of this chapter. 069254 (vi) 27 to 45 of each drug. Bacitracin methylenedisalicyl ate, 100 to 200. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or com plicated by Clostridium spp. or other organisms susceptible to bac itracin. To control necrotic enteritis, start medication at first clin ical signs of disease; vary dosage based on the severity of infection; administer con tinuously for 5 to 7 days or as long as clinical signs per sist, then reduce bacitracin to prevention level (50 g/ton). Do not feed to laying hens. Withdraw 5 days before slaughter. Do not allow tur keys, horses, or other equines access to formula tions containing narasin. In gestion of narasin by these species has been fatal. Baci tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (vii) 27 to 45 of each drug. Bambermycins, 1 to 2. Broiler chickens: As an aid in pre venting outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ra tion from time chicks are placed on litter until past the time when coccidiosis is ordi narily a hazard. Do not use as a treatment for coccidi osis. Do not feed to laying hens. Withdraw 5 days be fore slaughter. Do not allow turkeys, horses, or other equines access to formula tions containing narasin. In gestion of narasin by these species has been fatal. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 058198 (2) Narasin and nicarbazin fixed ratio, combination drug Type A medi cated articles may also be used in com bination with: (i) Avilamycin as in § 558.68. (ii) Virginiamycin as in § 558.635. [83 FR 64742, Dec. 18, 2018, as amended at 84 FR 8981, Mar. 13, 2019; 88 FR 14907, Mar. 10, 2023; 88 FR 16550, Mar. 20, 2023] § 558.365 Neomycin sulfate. (a) Specifications. Type A medicated article containing 325 grams neomycin sulfate per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.430 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00526 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 517 Food and Drug Administration, HHS ยง 558.365 drug to use by or on the order of a li censed veterinarian. See ยง 558.6 for addi tional requirements. (2) The expiration date of VFDs for neomycin medicated feeds must not ex ceed 6 months from the date of issuance. VFDs for neomycin shall not be refilled. (e) Conditions of use. Neomycin sul fate is used as follows: Neomycin Sulfate Combination Indications for Use Limitations Sponsor (1) 250 to 2,250 grams per ton (g/t) of dry type C feed.. ...................... Cattle, swine, sheep, and goats. For treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli suscep tible to neomycin.. To provide 10 milligrams (mg) of neomycin sulfate per pound of body weight per day for a maximum of 14 days. The concentration of neomycin sulfate required in medicated feed must be ad justed to compensate for var iation in age and weight of animal, the nature and sever ity of disease signs, and en vironmental temperature and humidity, each of which af fects feed consumption. If symptoms persist after using for 2 or 3 days, consult a vet erinarian. Treatment should continue 24 to 48 hours be yond remission of disease symptoms. Discontinue treat ment prior to slaughter as fol lows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been estab lished for use in preruminating calves. Do not use in calves to be proc essed for veal. A milk discard time has not been estab lished for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in dry feeds only. Not for use in liquid feed sup plements.. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00527 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 518 21 CFR Ch. I (4–1–23 Edition) § 558.366 Neomycin Sulfate Combination Indications for Use Limitations Sponsor (2) 400 to 2,000 g/t of type C milk replacer.. .......................... Do. ....................................................... To provide 10 mg of neomycin sulfate per pound of body weight per day for a max imum of 14 days. Amount consumed will vary depend ing on animal’s consumption and weight. If symptoms per sist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remis sion of disease symptoms. Discontinue treatment prior to slaughter as follows: Cattle 1 day, swine 3 days, sheep 2 days, and goats 3 days. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be proc essed for veal. A milk discard time has not been estab lished for use in lactating dairy cattle or lactating dairy goats. Do not use in female dairy cattle 20 months of age or older or female dairy goats 12 months of age or older. For use in milk replacers only.. 054771 [64 FR 70576, Dec. 17, 1999, as amended at 65 FR 45881, July 26, 2000; 79 FR 13545, Mar. 11, 2014; 81 FR 95009, Dec. 27, 2016. Redesignated at 83 FR 64742, Dec. 18, 2018] § 558.366 Nicarbazin. (a) Specifications. Type A medicated articles containing 25 percent nicarbazin. (b) Sponsors. See Nos. 058198, 060728, and 066104 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.445 of this chapter. (d) Conditions of use. It is used as fol lows: (1) Chickens— Nicarbazin in grams per ton Combination in grams per ton Indications for use Limitations Spon sor (i) 90.8 to 181.6 ..... .......................... Chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coc cidiosis. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00528 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 519 Food and Drug Administration, HHS ยง 558.366 Nicarbazin in grams per ton Combination in grams per ton Indications for use Limitations Spon sor (ii) 90.8 to 181.6 .... Bacitracin methylenedis alicylate, 4 to 50. Broiler chickens: As an aid in preventing out breaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxi ma, E. necatrix, and E. brunetti) coccidi osis, and for in creased rate of weight gain and improved feed efficiency. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; baci tracin methylenedisalicylate as provided by No. 054771 in ยง 510.600(c) of this chapter. 054771 (iii) 90.8 to 181.6 .... Bacitracin methylenedis alicylate, 30. Broiler chickens; As an aid in preventing out breaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxi ma, E. necatrix, and E. brunetti) coccidi osis, and for in creased rate of weight gain and improved feed efficiency. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; bacitracin methylenedisalicylate as pro vided by No. 054771 in ยง 510.600(c) of this chapter. 066104 (iv) 90.8 to 181.6 ... Bacitracin methylenedis alicylate 50. Broiler chickens: As an aid in preventing out breaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxi ma, E. necatrix, and E. brunetti) coccidi osis, and as an aid in the prevention of ne crotic enteritis caused or complicated by Clostridium spp. or other organisms sus ceptible to bacitracin. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for outbreaks of coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter for use levels at or below 113.5 g/ton. Withdraw 5 days before slaughter for use levels above 113.5 g/ton. Nicarbazin as provided by No. 066104; baci tracin methylenedisalicylate as provided by No. 054771 in ยง 510.600(c) of this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00529 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 520 21 CFR Ch. I (4–1–23 Edition) § 558.366 Nicarbazin in grams per ton Combination in grams per ton Indications for use Limitations Spon sor (v) 113.5 ................. .......................... Chickens: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coc cidiosis. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. 058198 060728 (vi) 113.5 ................ Bacitracin methylenedis alicylate, 30. Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coc cidiosis, and for in creased rate of weight gain and improved feed efficiency. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as pro vided by No. 066104; baci tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 060728 (vii) 113.5 ............... Bacitracin zinc, 4 to 50. Broiler chickens; aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coc cidiosis, and for in creased rate of weight gain and improved feed efficiency. For broiler chickens only. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in flush ing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as provided by No. 066104, bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. 054771 066104 (viii) 113.5 .............. Bambermycins, 1 to 2. Broiler chickens: As an aid in preventing out breaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxi ma, E. necatrix, and E. brunetti) coccidi osis, and for in creased rate of weight gain and improved feed efficiency. Feed continuously as sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; do not use as a treatment for coccidiosis. Do not use in flushing mashes. Do not feed to laying hens. Withdraw 4 days before slaughter. Nicarbazin as pro vided by No. 066104; bambermycins as provided by No. 016592 in § 510.600(c) of this chapter. 016592 (2) Nicarbazin single-ingredient Type A medicated articles may also be used in combination with: (i) [Reserved] (ii) Virginiamycin as in § 558.635. [83 FR 64743, Dec. 18, 2018, as amended at 86 FR 14825, Mar. 19, 2021; 88 FR 14907, Mar. 10, 2023] VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00530 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 521 Food and Drug Administration, HHS § 558.430 § 558.415 Novobiocin. (a) Specifications. Type A medicated article containing 25 grams of novobiocin activity per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.460 of this chapter. (d) Conditions of use. It is used in ani mal feeds as follows: (1) Chickens— Novobiocin amount Indications for use Limitations Sponsor (i) To provide 6 to 7 milli grams per pound (mg/lb) of body weight per day. Chickens: As an aid in the treatment of breast blisters associated with staphy lococcal infections susceptible to novobiocin. Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter. 054771 (ii) To provide 10 to 14 mg/lb of body weight per day. Chickens: For the treatment of staphy lococcal synovitis and generalized staphylococcal infections susceptible to novobiocin. Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter. 054771 (2) Turkeys— Novobiocin amount Indications for use Limitations Sponsor (i) To provide 4 to 5 mg/lb of body weight per day. Turkeys: As an aid in the treatment of breast blisters associated with staphy lococcal infections susceptible to novobiocin. Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. With draw 4 days before slaughter. 054771 (ii) To provide 5 to 8 mg/lb of body weight per day. Turkeys: As an aid in the control of re curring outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin following initial treatment with 7 to 8 mg/lb of body weight per day. Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. With draw 4 days before slaughter. 054771 (iii) To provide 7 to 8 mg/lb of body weight per day. Turkeys: For the treatment of staphy lococcal synovitis and generalized staphylococcal infections susceptible to novobiocin; and treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida sus ceptible to novobiocin. Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. With draw 4 days before slaughter. 054771 (3) Minor species— Novobiocin amount Indications for use Limitations Sponsor (i) 350 grams per ton. Ducks: For the control of infectious sero sitis and fowl cholera in ducks caused by Pasteurella anatipestifer and P. multocida, susceptible to novobiocin. Administer as the sole ration for 5 to 7 days. Continue medication for 14 days if necessary. Repeat if reinfection oc curs. Discontinue use at least 3 days before slaughter. Not for use in laying ducks. 054771 (ii) To provide 20 mg/lb of body weight per day. Mink: For the treatment of generalized infections, abscesses, or urinary infec tions caused by staphylococcal or other novobiocin sensitive organisms. Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 7 days. 054771 [40 FR 13959, Mar. 27, 1975, as amended at 45 FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, Mar. 11, 2014; 84 FR 12501, Apr. 2, 2019] § 558.430 Nystatin. (a) Specifications. Type A medicated article containing 20 grams of nystatin activity per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00531 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 522 21 CFR Ch. I (4–1–23 Edition) § 558.450 (c) Related tolerances. See § 556.470 of this chapter. (d) Conditions of use— Amount in grams/ton Indications for use Limitations Sponsor (1) 50 ................................. Growing and laying chickens and growing turkeys: As an aid in the control of crop mycosis and mycotic diarrhea (Candida albicans). ................................................................... 054771 (2) 100 ............................... Growing and laying chickens and growing turkeys: For the treatment of crop my cosis and mycotic diarrhea (Candida albicans). To be fed for 7 to 10 days ....................... 054771 [41 FR 11002, Mar. 15, 1976, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 53 FR 40729, Oct. 18, 1988; 55 FR 8461, Mar. 8, 1990; 57 FR 8578, Mar. 11, 1992; 79 FR 13545, Mar. 11, 2014; 85 FR 45310, July 28, 2020] § 558.450 Oxytetracycline. (a) Specifications. Each pound of Type A medicated article contains: (1) Oxytetracycline (from oxytetra cycline quaternary salt) equivalent to 50 or 100 grams oxytetracycline hydro chloride; or oxytetracycline (from oxy tetracycline dihydrate base) equivalent to 10, 30, 50, 100, or 200 grams oxytetra cycline hydrochloride. (2) Oxytetracycline (from oxytetra cycline dihydrate base) equivalent to 50, 100, or 200 grams oxytetracycline hydrochloride; or 100 grams oxytetra cycline hydrochloride. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) No. 066104: Type A medicated arti cles as in paragraph (a)(1) of this sec tion. (2) No. 069254: Type A medicated arti cles as in paragraph (a)(2) of this sec tion. (c) Related tolerances. See § 556.500 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for oxytetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for oxytetracycline shall not be refilled. (3) In accordance with § 558.5, labeling shall bear the statement: ‘‘For use in dry animal feed only. Not for use in liq uid feed supplements.’’ (e) Conditions of use—(1) Chickens— Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 100 to 200 g/ ton. ................................. Chickens: For control of infec tious synovitis caused by Mycoplasma synoviae and control of fowl cholera caused by Pasteurella multocida sus ceptible to oxytetracycline. Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period. 066104 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00532 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 523 Food and Drug Administration, HHS § 558.450 Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (ii) 200 g/ton ........ Monensin, 90 to 110 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of complicated chronic res piratory disease (CRD or air sac infection) caused by Mycoplasma gallisepticum and Escherichia coli. Feed continuously as the sole ration. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed con taining less than 0.55% die tary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chap ter Oxytetracycline as pro vided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. 066104 (iii) 400 g/ton ....... ................................. Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetracycline. Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Zero-day withdrawal period. 066104 069254 (iv) 400 g/ton ....... Robenidine, 30 ....... Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli susceptible to oxytetra cycline. Feed continuously for 7 to 14 days. Do not feed to chickens producing eggs for human consumption. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 5 days before slaughter. Oxytetracycline as provided by No. 066104; robenidine as provided by No. 054771 in § 510.600(c) of this chapter. 066104 (v) 500 g/ton ....... ................................. Chickens: For reduction of mor tality due to air sacculitis (air sac infection) caused by E. coli susceptible to oxytetra cycline. Feed continuously for 5 days. Do not feed to chickens pro ducing eggs for human con sumption. Do not use in feed containing less than 0.55% di etary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. 066104 069254 (vi) 500 g/ton ....... Monensin, 90 to 100 Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mortality due to air-sacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline. Feed for 5 days as the sole ra tion. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not feed to chickens over 16 weeks of age. Do not use in feed con taining less than 0.55% die tary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 72 hours before slaughter. See § 558.355(d) of this chap ter. Oxytetracycline as pro vided by No. 066104; monensin as provided by No. 058198 in § 510.600(c) of this chapter. 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00533 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 524 21 CFR Ch. I (4–1–23 Edition) § 558.450 Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (vii) 500 g/ton ...... Salinomycin, 40 to 60. Chickens: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; and as an aid in the reduction of mor tality due to air-sacculitis (air sac infection) caused by E. coli sensitive to oxytetra cycline. Feed for 5 days as the sole ra tion. Treat at first clinical signs of the disease. Do not feed to laying chickens. Do not use in feed containing less than 0.55% dietary calcium. Use in such low calcium feeds may result in violative residues. Withdraw 24 hours before slaughter. Oxytetracycline as provided by No. 066104; salinomycin as provided by No. 016592 in § 510.600(c) of this chapter. 066104 016592 (2) Turkeys— Oxytetracycline amount Indications for use Limitations Sponsor (i) 100 g/ton ............... Turkeys: For control of hexamitiasis caused by Hexamita meleagridis sus ceptible to oxytetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. Zero-day with drawal period. 066104 069254 (ii) 200 g/ton .............. Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to oxytetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period. 066104 069254 (iii) 25 mg/lb of body weight daily. Turkeys: For control of complicating bac terial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxy tetracycline. Feed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption. For No. 066104, withdraw 5 days before slaughter. For No. 069254, zero-day withdrawal period. 066104 069254 (3) Swine— Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily. ................................. Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis sus ceptible to oxytetracycline and treatment of bacterial pneu monia caused by Pasteurella multocida susceptible to oxy tetracycline. Feed continuously for 7 to 14 days. 066104 069254 (ii) 10 mg/lb of body weight daily. ................................. Breeding swine: For control and treatment of leptospirosis (re ducing the incidence of abor tion and shedding of leptospirae) caused by Leptospira pomona suscep tible to oxytetracycline. Feed continuously for not more than 14 days. 066104 069254 (iii) 10 mg/lb of body weight daily. Carbadox, 10 to 25 Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis sus ceptible to oxytetracycline and treatment of bacterial pneu monia caused by Pasteurella multocida susceptible to oxy tetracycline; and for increased rate of weight gain and im proved feed efficiency. Feed continuously as the sole ration for 7 to 14 days. Not for use in pregnant swine or swine intended for breeding purposes. Do not mix in feeds containing bentonite. Do not feed to swine within 42 days of slaughter. Oxytetracycline and carbadox as provided by No. 066104 in § 510.600(c) of this chapter. 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00534 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 525 Food and Drug Administration, HHS § 558.450 (4) Cattle— Oxytetracycline amount Combination in grams/ton Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily. ................................. Calves and beef and nonlac tating dairy cattle: For treat ment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida susceptible to oxy tetracycline. Feed continuously for 7 to 14 days. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, with draw 5 days before slaughter. For No. 066104, zero-day withdrawal period. 066104 069254 (ii) 10 mg/lb of body weight daily. ................................. Calves: For treatment of bac terial enteritis caused by E. coli susceptible to oxytetra cycline. Feed continuously for 7 to 14 days in milk replacer or starter feed. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. For No. 069254, with draw 5 days before slaughter. For No. 066104, zero-day withdrawal period. 066104 069254 (iii) 75 mg/head/ day. ................................. Growing cattle (over 400 lb): For reduction of incidence of liver abscesses. Feed continuously. This drug product is not approved for use in female dairy cattle 20 months of age or older, in cluding dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 066104 069254 (iv) 75 mg/head/ day. Lasalocid 25 to 30 .. Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain and im proved feed efficiency. Feed continuously to provide 250 to 360 mg lasalocid and 75 mg of oxytetracycline per head per day. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (v) 75 mg/head/ day. Melengestrol ace tate, 0.25 to 2.0. Heifers fed in confinement for slaughter (over 400 lb): For reduction of incidence of liver abscesses; and for increased rate of weight gain, improved feed efficiency, and suppres sion of estrus (heat). Feed continuously to provide 0.25 to 0.5 mg of melengestrol acetate and 75 mg of oxytetracycline per head per day. Melengestrol as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (vi) 0.5 to 2.0 g/ head/day. ................................. Cattle: For prevention and treat ment of the early stages of shipping fever complex. Feed 3 to 5 days before and after arrival in feedlots. This drug product is not approved for use in female dairy cattle 20 months of age or older, in cluding dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. 066104 069254 (5) Minor species— Oxytetracycline amount Indications for use Limitations Sponsor (i) 10 mg/lb of body weight daily. Sheep: For treatment of bacterial enter itis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetracycline. Feed continuously for 7 to 14 days; withdraw 5 days before slaughter. 066104 069254 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00535 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 526 21 CFR Ch. I (4–1–23 Edition) § 558.455 Oxytetracycline amount Indications for use Limitations Sponsor (ii) 200 mg/colony as a dust (200 mg/oz) or syrup (200 mg/5 lb). Honey bees: For control of American foulbrood caused by Paenibacillus lar vae and European foulbrood caused by Melissococcus plutonius suscep tible to oxytetracycline. Apply every 4 to 5 days for a total of three applications. Remove at least 6 weeks prior to main honey flow. 066104 069254 (iii) 800 mg/colony as an extender patty (800 mg/patty). Honey bees: For control of American foulbrood caused by Paenibacillus lar vae and European foulbrood caused by Melissococcus plutonius suscep tible to oxytetracycline. Use as a single application. Remove at least 6 weeks prior to main honey flow. 066104 069254 (iv) 2.5 to 3.75 g/100 lb of fish/day. 1. Salmonids: For control of ulcer dis ease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by A. hydrophila, and pseudomonas dis ease. Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. 066104 2. Catfish: For control of bacterial hem orrhagic septicemia caused by A. hydrophila and pseudomonas disease. Administer in mixed ration for 10 days; do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed; do not administer when water tempera ture is below 16.7 °C (62 °F). 066104 (v) 3.75 g/100 lb of fish/ day. 1. Freshwater-reared salmonids: For control of mortality due to coldwater disease associated with Flavobacterium psychrophilum.. Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. 066104 2. Freshwater-reared Oncorhynchus mykiss: For control of mortality due to columnaris disease associated with Flavobacterium columnare.. Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. 066104 3. Freshwater-reared salmonids weigh ing up to 55 grams: For marking the skeletal tissue.. Feed for 10 days. Immediate release is permitted following last feeding of medicated feed. 066104 (vi) 11.35 g/100 lb of fish/ day. Pacific salmon not over 30 grams body weight: For marking of skeletal tissue. Administer medicated feed as the sole ration for 4 consecutive days. Do not liberate for at least 7 days following last feeding of medicated feed. 066104 (vii) 1 g/lb of medicated feed. Lobsters: For control of gaffkemia caused by Aerococcus viridans. Administer as sole ration for 5 consecu tive days; withdraw medicated feed 30 days before harvesting lobsters. 066104 [81 FR 95009, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 83 FR 48948, Sept. 28, 2018; 84 FR 12502, Apr. 2, 2019; 86 FR 14825, Mar. 19, 2021; 87 FR 10972, Feb. 28, 2022; 87 FR 76423, Dec. 14, 2022; 88 FR 14907, Mar. 10, 2023] § 558.455 Oxytetracycline and neomy cin. (a) Specifications. Type A medicated articles containing oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline hydrochloride and 50 g/ lb neomycin sulfate or oxytetracycline equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate. (b) Sponsors. See Nos. 066104 and 069254 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.430 and 556.500 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for oxytetracycline and neomycin medi cated feeds must not exceed 6 months from the date of issuance. VFDs for ox ytetracycline and neomycin shall not be refilled. (3) Cattle feeds shall bear the fol lowing warning statement: ‘‘Use of more than one product containing neo mycin or failure to follow withdrawal times may result in illegal drug resi dues.’’ (e) Indications for use—(1) Chickens. It is used in feed as follows: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00536 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 527 Food and Drug Administration, HHS ยง 558.455 Oxytetracycline and ne omycin sulfate amount in grams per ton of feed Indications for use Limitations Sponsors (i) 100 to 200 ................ Chickens: For control of infectious synovitis caused by Mycoplasma synoviae; control of fowl cholera caused by Pasteurella multocida susceptible to oxytetracycline.. Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feed, withdraw 3 d before slaughter.. 066104 069254 (ii) 400 .......................... Chickens: For control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Esch erichia coli susceptible to oxytetracycline.. Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption; in low calcium feeds, withdraw 3 d before slaughter.. 066104 069254 (iii) 500 ......................... Chickens: For reduction of mortality due to air sacculitis (air-sac- infection) caused by E. coli susceptible to oxytetracycline.. Feed continuously for 5 d; do not feed to chickens producing eggs for human con sumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter.. 066104 069254 (2) Turkeys. It is used in feed as follows: Oxytetracycline and ne omycin sulfate amount Indications for use Limitations Sponsors (i) 100 g/ton of feed ..... Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to oxytetracycline.. Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption.. 066104 069254 (ii) 200 g/ton of feed ..... Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to ox ytetracycline.. Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.. 066104 069254 (iii) To provide 25 milli grams per pound (mg/lb) of body weight daily.. Turkeys: For control of complicating bac terial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to oxy tetracycline.. Feed continuously for 7 to 14 d; withdraw 5 d before slaughter; do not feed to turkeys producing eggs for human consumption.. 066104 069254 (3) Swine. It is used in feed as follows: Oxytetracycline and neomycin sulfate amount Limitations Sponsors (i) To provide 10 mg/lb of body weight daily. Swine: For treatment of bacterial enteritis caused by E. coli and Salmonella choleraesuis and treatment of bacterial pneumonia caused by P. multocida suscep tible to oxytetracycline; treatment and control of colibacillosis (bac terial enteritis) caused by E. coli susceptible to neomycin. Feed continuously for 7 to 14 d; withdraw 5 d before slaughter. 066104 069254 (ii) To provide 10 mg/lb of body weight daily. Breeding swine: For control and treatment of leptospirosis (reduc ing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to oxytetracycline. Feed continuously for not more than 14 d; withdraw 5 d before slaugh ter. 066104 069254 (4) Cattle. It is used in feed as follows: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00537 Fmt 8010 Sfmt 8016 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 528 21 CFR Ch. I (4–1–23 Edition) § 558.455 Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors (i) To provide 10 mg/lb of body weight daily. Calves and beef and nonlactating dairy cattle: For treatment of bac terial enteritis caused by E. coli and bacterial pneumonia (ship ping fever complex) caused by P. multocida susceptible to oxytetra cycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. Feed continuously for 7 to 14 d; in feed or milk replacers. Treatment should continue 24 to 48 hours beyond remission of disease symptoms. A withdrawal period has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lac tating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d before slaughter. 066104 069254 (ii) To provide 10 mg/lb of body weight daily. Calves (up to 250 lb): For treatment of bacterial enteritis caused by E. coli susceptible to oxytetracycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. Feed continuously for 7 to 14 d; in milk replacers or starter feed. Treatment should continue 24 to 48 hours beyond remission of dis ease symptoms. A withdrawal pe riod has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. Withdraw 5 d be fore slaughter. 066104 069254 (iii) To provide 75 mg/head/day. Growing cattle (over 400 lb): For the reduction of the incidence of liver abscesses. Feed continuously ............................ 066104 069254 (iv) To provide 0.5 to 2.0 g/head/ day. Cattle: For prevention and treatment of the early stages of shipping fever complex. Feed 3 to 5 d before and after ar rival in feedlots. A withdrawal pe riod has not been established for use in preruminating calves. Do not use in calves to be processed for veal. A milk discard time has not been established for use in lactating dairy cattle. Do not use in female dairy cattle 20 months of age or older. 066104 069254 (5) S. It is used in feed as follows: Oxytetracycline and neomycin sulfate amount Indications for use Limitations Sponsors (i) To provide 10 mg/lb of body weight daily. Sheep: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to oxytetra cycline; treatment and control of colibacillosis (bacterial enteritis) caused by E. coli susceptible to neomycin. Feed continuously for 7 to 14 d. If symptoms persist after using for 2 or 3 days, consult a veterinarian. Treatment should continue 24 to 48 hours beyond remission of dis ease symptoms. Withdraw 5 d be fore slaughter. 66104, 069254 (ii) [Reserved]. [71 FR 16225, Mar. 31, 2006, as amended at 74 FR 40724, Aug. 13, 2009; 80 FR 13232, Mar. 13, 2015; 81 FR 95012, Dec. 27, 2016; 87 FR 76423, Dec. 14, 2022] VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00538 Fmt 8010 Sfmt 8016 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 529 Food and Drug Administration, HHS § 558.485 § 558.464 Poloxalene. (a) Specifications. Dry Type A medi cated articles containing 53 percent poloxalene or liquid Type A medicated articles containing 99.5 percent poloxalene. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.517 of this chapter. (d) Conditions of use. (1) For preven tion of legume (alfalfa, clover) and wheat pasture bloat in cattle. (2) Poloxalene dry Type A article and liquid Type A article must be thor oughly blended and evenly distributed in feed prior to use. This may be ac complished by adding the Type A arti cle to a small quantity of feed, mixing thoroughly, then adding this mixture to the remaining feed and again mixing thoroughly. Dosage is 1 gram of poloxalene per 100 pounds of body weight daily and continued during ex posure to bloat producing conditions. If bloating conditions are severe, the dose is doubled. Treatment should be start ed 2 to 3 days before exposure to bloat producing conditions. Repeat dosage if animals are exposed to bloat-producing conditions more than 12 hours after the last treatment. Do not exceed the high er dosage levels in any 24-hour period. [40 FR 39857, Aug. 29, 1975, as amended at 51 FR 7399, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 56 FR 50654, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 79 FR 13545, Mar. 11, 2014; 84 FR 33001, July 11, 2019] § 558.470 Polyoxyethylene. (a) Specifications. Each molasses based block contains 2.2 percent polyoxyethylene (23) lauryl ether. (b) Sponsor. See No. 067949 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Amount. 2 grams of polyoxyethylene (23) lauryl ether per 100 kilograms of body weight per day (1 pound of block per 500 kilo gram (1,100 pound) animal per day). Ini tially, provide one block per five head of cattle. Start treatment 10 to 14 days before exposure to bloat-producing pas tures. (2) Indications for use. For reduction of the incidence of bloat (alfalfa and clover) in pastured cattle. (3) Limitations. Administer free choice to beef cattle and nonlactating dairy cattle only. Do not allow cattle access to other sources of salt while being fed this product. Do not feed this product to animals without adequate forage/roughage consumption. [86 FR 14826, Mar. 19, 2021] § 558.485 Pyrantel. (a) Specifications. Type A medicated articles containing 48 or 80 grams per pound pyrantel tartrate. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as fol lows: (1) No. 066104: 48 and 80 grams per pound for use as in paragraph (e)(1) of this section. (2) Nos. 017135 and 054771: 48 grams per pound for use as in paragraph (e)(2) of this section. (c) Related tolerances. See § 556.560 of this chapter. (d) Special considerations. (1) See § 500.25 of this chapter. Consult a vet erinarian before using in severely de bilitated animals. (2) Do not mix in Type B or Type C medicated feeds containing bentonite. (e) Conditions of use—(1) Swine— Pyrantel grams/ton Indications for use Limitations Sponsor (i) 96 ................... Swine: As an aid in the preven tion of migration and estab lishment of large roundworm (Ascaris suum) infections; aid in the prevention of establish ment of nodular worm (Oesophagostomum) infec tions. Feed continuously as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter. 066104 (ii) 96 .................. Swine: For the removal and control of large roundworm (Ascaris suum) infections. Feed for 3 days as the sole ration in a Type C feed. Withdraw 24 hours prior to slaughter. 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00539 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 530 21 CFR Ch. I (4–1–23 Edition) § 558.500 Pyrantel grams/ton Indications for use Limitations Sponsor (iii) 800 ............... Swine: For the removal and control of large roundworm (Ascaris suum) and nodular worm (Oesophagostomum) in fections. Feed as the sole ration for a single therapeutic treatment in Type C feed at a rate of 1 lb of feed per 40 lb of body weight for animals up to 200 lb, and 5 lb of feed per head for animals 200 lb or over. Withdraw 24 hours prior to slaughter. 066104 (2) Horses— Pyrantel grams/ton Indications for use Limitations Sponsor To provide 1.2 mg/lb body weight. Prevention of Strongylus vulgaris larval infections; con trol of adult large strongyles (S. vulgaris, and S. edentatus), adult and 4th stage larvae small strongyles (Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., and Triodontophorus spp.), adult and 4th stage larvae pinworms (Oxyuris equi), and adult and 4th stage larvae ascarids (Parascaris equorum). Feed continuously. Administer either as a top-dress (not to exceed 20,000 g/ ton) or mixed in the horse’s daily grain ration (not to exceed 1,200 g/ton) dur ing the time that the animal is at risk of exposure to internal parasites. Do not use in horses intended for human consumption. Consult your veteri narian before using in severely debili tated animals and for assistance in the diagnosis, treatment, and control of parasitism. 017135 054771 (3) Pyrantel may also be used in com bination with: (i) Carbadox as in § 558.115. (ii) Lincomycin as in § 558.325. (iii) Tylosin as in § 558.625. [83 FR 48948, Sept. 28, 2018, as amended at 83 FR 64744, Dec. 18, 2018; 86 FR 14826, Mar. 19, 2021] § 558.500 Ractopamine. (a) Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 058198: Type A medicated arti cles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydro chloride. (2) Nos. 016592, 051311, and 054771: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride. (c) Related tolerances. See § 556.570 of this chapter. (d) Special considerations. (1) Labeling of Type B and Type C feeds shall bear the following: ‘‘Not for animals in tended for breeding.’’ (2) Labeling of Type B and Type C swine feeds shall bear the following: (i) ‘‘No increased benefit has been shown when ractopamine concentra tions in the diet are greater than 4.5 g/ ton.’’ (ii) ‘‘Ractopamine may increase the number of injured and/or fatigued pigs during marketing.’’ (3) Labeling of Type B and Type C tom turkey feeds shall bear the fol lowing: ‘‘No increased benefit has been shown when ractopamine concentra tions in the diet are greater than 4.6 g/ ton.’’ (4) Tylosin in combinations as tylosin phosphate. (5) Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liq uid Type B feeds must be maintained VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00540 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 531 Food and Drug Administration, HHS § 558.500 at a pH of 4.5 to 7.5 or, if in combina tion with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recircula tion or agitation: Recirculate imme diately prior to use for not less than 10 minutes, moving not less than 1 per cent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (e) Conditions of use—(1) Swine— Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 4.5 to 9.0 ........ .................................. For increased rate of weight gain, im proved feed efficiency, and in creased carcass leanness in fin ishing swine, weighing not less than 150 lbs, fed a complete ration con taining at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. Feed continuously as sole ra tion. 058198, 054771 (ii) [Reserved]. (2) Cattle. Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 8.2 to 24.6 ..... ................................ Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed. Feed continuously as sole ra tion during the last 28 to 42 days on feed. Not for ani mals intended for breeding. 016592 051311 054771 058198 (ii) 8.2 to 24.6 to provide 70 to 430 mg/head/ day. Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, de pending on se verity of coccidi osis challenge, up to 480 mg/ head/day. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and prevention and con trol of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed. Feed continuously as sole ra tion during the last 28 to 42 days on feed. Not for ani mals intended for breeding. See special labeling consid erations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 (iii) 9.8 to 24.6 .... ................................ Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness during the last 28 to 42 days on feed. Feed continuously as sole ra tion during the last 28 to 42 days on feed. Not for ani mals intended for breeding. 016592 051311 054771 058198 (iv) 9.8 to 24.6 to provide 90 to 430 mg/head/ day. Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, de pending on se verity of coccidi osis challenge, up to 480 mg/ head/day. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, increased carcass lean ness, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed. Feed continuously as sole ra tion during the last 28 to 42 days on feed. Not for ani mals intended for breeding. See special labeling consid erations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00541 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 532 21 CFR Ch. I (4–1–23 Edition) § 558.500 Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (v) 9.8 to 24.6 to provide 90 to 430 mg/head/ day. Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, de pending on se verity of coccidi osis challenge, up to 480 mg/ head/day, plus melengestrol ace tate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, increased carcass lean ness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) during the last 28 to 42 days on feed. Feed continuously as sole ra tion during the last 28 to 42 days on feed. Not for ani mals intended for breeding. See special labeling consid erations in §§ 558.342(d) and 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as provided by No. 016592 or 058198; melengestrol acetate as provided by No. 016592, 054771 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 (vi) Not to exceed 800; to provide 70 to 400 mg/ head/day. ................................ Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feed. Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continu ously during the last 28 to 42 days on feed. Not for animals intended for breed ing. 016592 051311 054771 058198 (vii) Not to ex ceed 800; to provide 70 to 400 mg/head/ day. Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, de pending on se verity of coccidi osis challenge, up to 480 mg/ head/day. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and prevention and con trol of coccidiosis due to Eimeria bovis and E. zuernii during the last 28 to 42 days on feed. Top dress ractopamine at a minimum of 1.0 lb/head/day of medicated feed continu ously during the last 28 to 42 days on feed. Not for animals intended for breed ing. See special labeling considerations in § 558.355(d) of this chapter. Ractopamine as provided by No. 016592, 054771, or 058198; monensin as pro vided by No. 016592 or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 (3) Turkeys— Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 4.6 to 11.8 (5 to 13 ppm). ............................. Finishing hen turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 7 to 14 days prior to slaughter.. Feed continuously as sole ra tion during the last 7 to 14 days prior to slaughter.. 058198 (ii) 4.6 to 11.8 (5 to 13 ppm). ............................. Finishing tom turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 14 days prior to slaughter.. Feed continuously as sole ra tion during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.. 058198 (iii) 4.6 to 11.8 (5 to 13 ppm). Monensin 54 to 90 ... Finishing hen turkeys: As in para graph (e)(3)(i) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.. Feed continuously as sole ra tion during the last 7 to 14 days prior to slaughter. See § 558.355(d).. 058198 (iv) 4.6 to 11.8 (5 to 13 ppm). Monensin 54 to 90 ... Finishing tom turkeys: As in para graph (e)(3)(ii) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.. Feed continuously as sole ra tion during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality. See § 558.355(d).. 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00542 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 533 Food and Drug Administration, HHS § 558.515 (4) Ractopamine may also be used in combination with tylosin in as in § 558.625. [67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006; 71 FR 67301, Nov. 21, 2006; 72 FR 10358, Mar. 8, 2007; 72 FR 41619, July 31, 2007; 72 FR 56897, Oct. 5, 2007; 72 FR 62571, Nov. 6, 2007; 72 FR 65667, Nov. 23, 2007; 72 FR 70777, Dec. 13, 2007; 73 FR 72715, Dec. 1, 2008; 73 FR 75323, Dec. 11, 2008; 74 FR 66914, Dec. 17, 2009; 75 FR 1276, Jan. 11, 2010; 75 FR 5888, Feb. 5, 2010; 75 FR 20917, Apr. 22, 2010; 75 FR 54018, Sept. 3, 2010; 77 FR 31724, May 30, 2012; 78 FR 63872, Oct. 25, 2013; 79 FR 13546, Mar. 11, 2014; 79 FR 37621, July 2, 2014; 79 FR 44278, July 31, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61298, Oct. 13, 2015; 81 FR 48703, July 26, 2016; 81 FR 95013, Dec. 27, 2016; 85 FR 18122, Apr. 1, 2020; 85 FR 45311, July 28, 2020; 86 FR 58013, Oct. 20, 2021; 87 FR 17947, Mar. 29, 2022] § 558.515 Robenidine. (a) Specifications. Type A medicated articles containing 30 grams per pound. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.580 of this chapter. (d) Special considerations. Type C feed containing robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use in Type B or Type C medicated feeds con taining bentonite. (e) Conditions of use. It is used in feed for chickens as follows: Robenidine hy drochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor 30 (0.0033 pct) ... ............................. Broiler chickens: As an aid in the pre vention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix.. Feed continuously as sole ra tion. Do not feed to chickens producing eggs for food. Withdraw 5 days prior to slaughter.. 054771 ........................ Bacitracin (as baci tracin methylenedisalicyl ate) 4 to 30. For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.. Feed continuously as sole ra tion. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.. 054771 ........................ Bacitracin (as baci tracin methylenedisalicyl ate) 27 to 50. For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.. Feed continuously as sole ra tion. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.. 054771 ........................ Bacitracin (as baci tracin methylenedisalicyl ate) 50. For broiler and fryer chickens: As an aid in the prevention of necrotic en teritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.. Feed continuously as sole ra tion. Do not feed to laying hens. Withdraw 5 days be fore slaughter.. 054771 ........................ Bacitracin (as baci tracin methylenedisalicyl ate) 100 to 200. For broiler and fryer chickens: As an aid in the control of necrotic enter itis caused or complicated by Clos tridium spp. or other organisms susceptible to bacitracin.. To control a necrotic enteritis outbreak, start medication at first clinical signs of disease; administer continuously for 5 to 7 days or as long as clin ical signs persist, then re duce bacitracin methylenedisalicylate to pre vention level (50 g/ton). Do not feed to laying hens. With draw 5 days before slaugh ter.. 054771 ........................ Bacitracin (as baci tracin zinc) 4 to 30. For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For increased rate of weight gain.. Feed continuously as sole ra tion. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.. 054771 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00543 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 534 21 CFR Ch. I (4–1–23 Edition) § 558.550 Robenidine hy drochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor ........................ Bacitracin (as baci tracin zinc) 27 to 50. For broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix. For improved feed efficiency.. Feed continuously as sole ra tion. Do not feed to laying chickens. Withdraw 5 days prior to slaughter.. 054771 054771 (f) Robenidine may also be used in combination with: (1) Chlortetracycline as in § 558.128. (2) Lincomycin as in § 558.325. (3) Oxytetracycline as in § 558.450. [40 FR 13959, Mar. 27, 1975] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.515, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.550 Salinomycin. (a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin sodium activity per pound. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use as in paragraph (e) of this section. (c) Related tolerances. See § 556.592 of this chapter. (d) Special considerations. Not ap proved for use with pellet binders. (e) Conditions of use. It is used as fol lows: (1) Chickens— Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 40 to 60 .......... .................................. Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Feed continuously as sole ra tion. Do not feed to birds pro ducing eggs for human con sumption. May be fatal if ac cidentally fed to adult turkeys or horses. 016592 (ii) 40 to 60 ......... Bacitracin methylenedisalicyl ate, 4 to 50. Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ra tion. Do not feed to laying chickens. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 016592 054771 (iii) 40 to 60 ........ Bacitracin methylenedisalicyl ate, 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the preven tion of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bac itracin. Feed continuously as sole ra tion. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) in this chapter. 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00544 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 535 Food and Drug Administration, HHS § 558.555 Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (iv) 40 to 60 ........ Bacitracin methylenedisalicyl ate, 100 to 200. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or com plicated by Clostridium spp. or other organisms susceptible to bac itracin. Feed continuously as sole ra tion. To control necrotic en teritis, start medication at first clinical signs of disease; vary dosage based on the severity of infection; administer con tinuously for 5 to 7 days or as long as clinical signs per sist, then reduce bacitracin to prevention level (50 grams per ton). Do not feed to lay ing chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as pro vided by No. 016592; baci tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) in this chapter. 054771 (v) 40 to 60 ......... Bacitracin zinc, 10 to 50. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain. Feed continuously as sole ra tion. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult tur keys or horses. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter. 016592 054771 (vi) 40 to 60 ........ Bambermycins, 1 to 3. Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed effi ciency. Feed continuously as sole ra tion. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter. 016592 (2) Game birds— Salinomycin in grams/ton Combination in grams per ton Indications for use Limitations Sponsor (i) 50 ................... .................................. Quail: For the prevention of coccidi osis caused by Eimeria dispersa and E. lettyae. Feed continuously as sole ra tion. Do not feed to birds pro ducing eggs for human con sumption. May be fatal if ac cidentally fed to adult turkeys or horses. 016592 (ii) [Reserved] ..... .................................. ............................................................. ................................................... ................ (3) Combinations. Salinomycin may also be used in combination with: (i) Avilamycin as in § 558.68. (ii) Chlortetracycline as in § 558.128. (iii) Lincomycin as in § 558.325. (iv) Oxytetracycline as in § 558.450. (v) Virginiamycin as in § 558.635. [48 FR 30616, July 5, 1983] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.550, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.555 Semduramicin. (a) Specifications. Type A medicated article containing: (1) 22.7 grams (g) per pound (lb) (50 g/ kilogram (kg)) semduramicin (as semduramicin sodium). (2) 22.7 g/lb (50 g/kg) semduramicin (as semduramicin sodium biomass). (b) Sponsor. See No. 066104 in § 510.600(c) of this chapter for use of product described in paragraph (a)(1) of this section as in paragraph (d) of this section; for use of product described in VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00545 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 536 21 CFR Ch. I (4–1–23 Edition) § 558.575 paragraph (a)(2) of this section as in paragraph (e) of this section. (c) Related tolerances. See § 556.597 of this chapter. (d) Conditions of use in chickens. It is used in chicken feed as follows: Semduramicin in grams per ton Combinations in grams per ton Indications for use Limitations Sponsor (1) 22.7 (25 ppm) Broiler chickens: For the pre vention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/E. mitis, E. necatrix, and E. tenella. Do not feed to laying hens. 066104 (2) 22.7 Bacitracin methylenedi salicylate 10 to 50 Broiler chickens: As in para graph (d)(1) of this section; for improved feed effi ciency. Feed continuously as sole ration. Do not feed to laying hens. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 066104 (e) Conditions of use in chickens. It is used in chicken feed as follows: Semduramicin in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (1) 22.7 (25 ppm) Broiler chickens: For the pre vention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis. Do not feed to laying hens. 066104 (2) [Reserved] (f) Semduramicin may also be used in combination with virginiamycin as in § 558.635. [59 FR 17477, Apr. 13, 1994, as amended at 60 FR 57928, Nov. 24, 1995; 61 FR 29481, June 11, 1996; 61 FR 43451, Aug. 23, 1996; 61 FR 66584, Dec. 18, 1996; 62 FR 66985, Dec. 23, 1997; 64 FR 48296, Sept. 3, 1999; 66 FR 47964, Sept. 17, 2001; 69 FR 13221, Mar. 22, 2004; 70 FR 41961, July 21, 2005; 73 FR 812, Jan. 4, 2008; 74 FR 41631, Aug. 18, 2009; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 17609, Mar. 30, 2016; 81 FR 95013, Dec. 27, 2016; 86 FR 14826, Mar. 19, 2021; 87 FR 17948, Mar. 29, 2022] § 558.575 Sulfadimethoxine and ormetoprim. (a) Specifications. Type A medicated articles containing either: (1) 25 percent sulfadimethoxine and 15 percent ormetoprim; or (2) 25 percent sulfadimethoxine and 5 percent ormetoprim. (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (1) No. 054771 for use of the product described in paragraph (a)(1) as in para graphs (e)(1), (e)(2)(i), and (e)(3)(i) through (iii) of this section. (2) No. 015331 for use of the product described in paragraph (a)(2) as in para graphs (e)(3)(iv) and (v) of this section. (c) Related tolerances. See §§ 556.490 and 556.640 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled. (e) Conditions of use. It is used in ani mal feeds as follows: (1) Chickens— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00546 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 537 Food and Drug Administration, HHS § 558.575 Sulfadimethoxine and ormetoprim grams/ton Indications for use Limitations Sponsors (i) Sulfadimethoxine, 113.5; ormetoprim, 68.1. Broiler chickens: As an aid in the pre vention of coccidiosis caused by all Eimeria species known to be patho genic to chickens, namely, E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bac terial infections due to Heterakis gallinarum (infectious coryza), Esch erichia coli (colibacillosis) and Pasteurella multocida (fowl cholera). Feed as sole ration. Withdraw 5 days before slaughter. 054771 (ii) Sulfadimethoxine, 113.5; ormetoprim, 68.1. Replacement chickens: As an aid in the prevention of coccidiosis caused by all Eimeria species known to be patho genic to chickens, namely, E. tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and bac terial infections due to Heterakis gallinarum (infectious coryza), Esch erichia coli (colibacillosis) and Pasteurella multocida (fowl cholera). Feed as sole ration. Do not feed to chickens over 16 weeks (112 days) of age. Withdraw 5 days before slaugh ter. 054771 (2) Turkeys— Sulfadimethoxine and ormetoprim grams/ton Indications for use Limitations Sponsors (i) Sulfadimethoxine, 56.75; ormetoprim, 34.05. Turkeys: As an aid in the prevention of coccidiosis caused by all Eimeria spe cies known to be pathogenic to tur keys, namely, E. adenoeides, E. gallopavonis, and E. meleagrimitis and bacterial infection due to Pasteurella multocida (fowl cholera). Do not feed to turkeys producing eggs for food. Withdraw 5 days before slaughter. 054771 (ii) [Reserved] (3) Minor species— Sulfadimethoxine and ormetoprim amount Indications for use Limitations Sponsors (i) Sulfadimethoxine, 227; ormetoprim, 136.2 grams/ton of feed. Ducks, including breeding ducks: As an aid in the control of bacterial infections due to Pasteurella multocida (fowl cholera). Feed as sole ration for 7 days. Medica tion should be started at the first signs of infection. Do not feed to ducks pro ducing eggs for food. Withdraw 5 days before slaughter. 054771 (ii) Sulfadimethoxine, 454; ormetoprim, 272.4 grams/ton of feed. Ducks: As an aid in the control of bac terial infections due to Escherichia coli, Riemerella anatipestifer, and se vere challenge of Pasteurella multocida (fowl cholera). Feed as a sole ration for 7 days. Medi cation should be started at the first signs of infection. Not for breeding ducks. Do not feed to ducks producing eggs for food. Withdraw 5 days before slaughter. (iii) Sulfadimethoxine, 113.5; ormetoprim, 68.1 grams/ton of feed. Chukar partridges: For prevention of coccidiosis caused by Eimeria kofoidi and E. legionensis. Feed continuously to young birds up to 8 weeks of age as sole ration. 054771 (iv) 630 to 3780 g/ton sulfadimethoxine and 126 to 756 g/ton ormetoprim to provide 50 milligrams (mg) of active ingredients per kilogram of body per day Salmonids: For the control of furuncu losis in salmonids (trout and salmon) caused by Aeromonas salmonicida strains susceptible to sulfadimethoxine and ormetoprim combination Administer for 5 consecutive days. With draw 42 days before release as stock er fish or slaughter 015331 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00547 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 538 21 CFR Ch. I (4–1–23 Edition) § 558.582 Sulfadimethoxine and ormetoprim amount Indications for use Limitations Sponsors (v) 630 to 3780 g/ton sulfadimethoxine and 126 to 756 g/ton ormetoprim to provide 50 mg of active ingredi ents per kilogram of body per day Catfish: For control of enteric septicemia of catfish caused by Edwardsiella ictaluri strains susceptible to sulfadimethoxine and ormetoprim com bination Administer for 5 consecutive days. With draw 3 days before slaughter or re lease as stocker fish 015331 [40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 95013, Dec. 27, 2016; 83 FR 13637, Mar. 30, 2018; 84 FR 12502, Apr. 2, 2019; 86 FR 14827, Mar. 19, 2021; 87 FR 76424, Dec. 14, 2022] § 558.582 Sulfamerazine. (a) Specifications. Type A medicated articles containing 99 percent sulfa merazine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.660 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for sulfamerazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfamerazine shall not be refilled. (e) Conditions of use. It is used in fish feed for as follows: Sulfamerazine grams/ton Combination in grams/ton Indications for use Limitations Sponsor (1) To deliver 10 grams of sulfa merazine per 100 pounds of fish per day. ................................. Rainbow trout, brook trout, and brown trout: For control of fu runculosis. Formulate to deliver 10 grams of sulfamerazine per 100 pounds of fish per day. Treat for not more than 14 days. Do not treat within 3 weeks of mar keting or stocking in stream open to fishing. 054771 (2) [Reserved]. [81 FR 95013, Dec. 27, 2016] § 558.586 Sulfaquinoxaline. (a) Specifications. Type A medicated articles containing 40 percent sulfaquinoxaline. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.685 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for sulfaquinoxaline medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfaquinoxaline shall not be refilled. (e) Conditions of use—(1) Chickens— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00548 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 539 Food and Drug Administration, HHS ยง 558.586 Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 0.015 percent ................................. As an aid in preventing out breaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti under average con ditions of exposure. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a haz ard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from inter current disease, other condi tions affecting drug intake, or variant strains of coccidia spe cies which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption. 016592 (ii) 0.0175 percent ................................. As an aid in preventing out breaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti where excessive exposure to coccidia is in creased due to overcrowding or other management factors. Feed continuously from the time birds are placed on litter and continue past the age when coccidiosis is ordinarily a haz ard. If death losses exceed 0.5 percent in a 2-day period, obtain a laboratory diagnosis. If coccidiosis is the cause, use the sulfaquinoxaline levels recommended for control of outbreaks, returning to the original dosage schedule after the outbreak has subsided. Losses may result from inter current disease, other condi tions affecting drug intake, or variant strains of coccidia spe cies which can contribute to the virulence of coccidiosis under field conditions. Do not treat chickens within 10 days of slaughter. Do not medicate chickens producing eggs for human consumption. 016592 (iii) 0.1 to 0.05 percent. ................................. As an aid in controlling out breaks of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, and E. brunetti. Feed at 0.1 percent level for first 48 to 72 hours. Skip 3 days; 0.05 percent for 2 days, skip 3 days; 0.05 percent for 2 days. If bloody droppings recur, give 0.05 percent for another 2 days. Do not treat chickens within 10 days of slaughter. Do not medicate chickens pro ducing eggs for human con sumption. 016592 (iv) 0.05 or 0.1 percent. ................................. As an aid in the control of acute fowl cholera caused by Pasteurella multocida suscep tible to sulfaquinoxaline and fowl typhoid caused by Sal monella gallinarum suscep tible to sulfaquinoxaline. Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. 016592 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00549 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 540 21 CFR Ch. I (4–1–23 Edition) § 558.600 (2) Turkeys— Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 0.0175 percent ................................. As an aid in preventing out breaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides. Feed continuously during time birds are closely confined. May be continued for a week to 10 days after flock is trans ferred to range to reduce dan ger of an outbreak following moving of the flock. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption. 016592 (ii) 0.05 percent ... ................................. As an aid in controlling out breaks of coccidiosis caused by Eimeria meleagrimitis and E. adenoeides. Feed for 2 days. Follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Again follow with 3 days on regular feed and 2 more days on 0.05 percent sulfaquinoxaline feed. Continue this schedule if nec essary until all signs of the outbreaks have subsided. Do not treat turkeys within 10 days of slaughter. Do not medicate turkeys producing eggs for human consumption. 016592 (iii) 0.05 or 0.1 percent. ................................. As an aid in the control of acute fowl cholera caused by Pasteurella multocida suscep tible to sulfaquinoxaline and fowl typhoid caused by Sal monella gallinarum suscep tible to sulfaquinoxaline. Feed 0.1 percent for 48 to 72 hours. Mortality should be brought under control. After medication, move birds to clean ground or to a clean house. If disease recurs, use 0.05 percent in feed again for 2 days. Do not treat chickens or turkeys within 10 days of slaughter for food. Do not medicate chickens or turkeys producing eggs for human consumption. 016592 (3) Rabbits— Sulfaquinoxaline in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 0.025 percent ................................. As an aid in preventing coccidi osis caused by Eimeria stiedae. Treatment to be started after weaning. Feed continuously for 30 days or feed medicated feed for 2 days out of every week until marketing. Do not treat within 10 days of slaugh ter. 016592 (ii) 0.1 percent ..... ................................. As an aid in controlling out breaks of coccidiosis caused by Eimeria stiedae. Feed for 2 weeks. Do not treat within 10 days of slaughter. 016592 [81 FR 95013, Dec. 27, 2016] § 558.600 Thiabendazole. (a) Specifications. Dry Type A medi cated articles containing 22, 44.1, 66.1, or 88.2 percent thiabendazole. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.730 of this chapter. (d) Special considerations. (1) The 66.1 percent Type A medicated article is solely for the manufacture of cane mo lasses liquid Type B feed, which is mixed in dry feeds. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00550 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 541 Food and Drug Administration, HHS § 558.600 (2) The 88.2 percent Type A medicated article is used solely for the manufac ture of an aqueous slurry for adding to a Type C dry cattle feed. (3) Do not use in Type B or Type C medicated feed containing bentonite. (e) Conditions of use. It is used in feed for animals as follows: (1) Swine— Thiabendazole in grams/ton Indications for use Limitations Sponsor (i) 45.4 to 908 (0.005 to 0.1 percent). Swine: As an aid in the prevention of in fections of large roundworms (genus Ascaris). Administer continuously in feed containing 0.05 to 0.1 percent thiabendazole per ton for 2 weeks followed by feed con taining 0.005 to 0.02 percent thiabendazole per ton for 8 to 14 weeks. Do not treat animals within 30 days of slaughter. 000010 (ii) [Reserved] (2) Cattle— Thiabendazole amount Indications for use Limitations Sponsor (i) 3 grams per 100 lb. body weight. For control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum). Use 3 grams per 100 lb. body weight at a single dose; may repeat once in 2 to 3 weeks. Do not treat animals within 3 days of slaughter. Milk taken from treat ed animals within 96 hours (8 milkings) after the latest treatment must not be used for food. 000010 (ii) 5 grams per 100 lb. body weight. For control of severe infections of gastro intestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Nematodirus spp., Oesophagostomum radiatum); control of infections of Cooperia spp. Use 5 grams per 100 lb. body weight at a single dose or divided into 3 equal doses, administered 1 dose each day, on succeeding days. May repeat once in 2 to 3 weeks. Do not treat animals within 3 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. 000010 (3) Minor species— Thiabendazole amount Indications for use Limitations Sponsor (i) 2 grams per 100 lb. body weight. Sheep and goats: For control of infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp.; Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.); also active against ova and larvae passed by sheep from 3 hours to 3 days after the feed is consumed (good activity against ova and larvae of T. colubriformis and axei, Ostertagia spp., Nematodirus spp., Strongyloides spp.; less effective against those of Haemonchus contortus and Oesophagostomum spp.). Use 2 grams per 100 lb. body weight at a single dose. Do not treat animals within 30 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. 050604 (ii) 3 grams per 100 lb. body weight. Goats: For control of severe infections of gastrointestinal roundworms (Trichostrongylus spp., Haemonchus spp., Ostertagia spp., Cooperia spp., Nematodirus spp., Bunostomum spp., Strongyloides spp., Chabertia spp., and Oesophagostomum spp.). Use 3 grams per 100 lb. body weight at a single dose. Do not treat animals within 30 days of slaughter. Milk taken from treated animals within 96 hours (8 milkings) after the latest treatment must not be used for food. 050604 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00551 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 542 21 CFR Ch. I (4–1–23 Edition) § 558.612 Thiabendazole amount Indications for use Limitations Sponsor (iii) 454 grams per ton of feed. Pheasants: For the treatment of gapeworms (Syngamus trachea). Feed continuously for 2 weeks (14 days). Do not use treated pheasants for food for 21 days after last day of treatment. Fertility, hatchability, and other repro ductive data are not available on use in breeding animals. 050604 [84 FR 39186, Aug. 9, 2019, as amended at 86 FR 14827, Mar. 19, 2021] § 558.612 Tiamulin. (a) Specifications. Type A article con taining 363.2 grams of tiamulin hydro gen fumarate per pound. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.732 of this chapter. (d) Special considerations. (1) Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. If signs of toxicity occur, discontinue use. (2) The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been deter mined. (3) Use as sole source of tiamulin. (e) Conditions of use—(1) Swine. It is used as follows: Tiamulin hydro gen fumarate in grams per ton Combination in grams per ton Indications for use Limitations Sponsor (i) 35 ................. ............................................ 1. For control of swine dysentery associated with Brachyspira (for merly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin. Feed continuously as sole ra tion on premises with a history of swine dysentery but where signs of disease have not yet occurred or following approved treat ment of disease. Withdraw 2 days before slaughter. 058198 2. For control of porcine prolif erative enteropathies (ileitis) as sociated with Lawsonia intracellularis. Feed continuously as the sole ration for not less than 10 days. Withdraw 2 days before slaughter. 058198 (ii) 200 .............. ............................................ For treatment of swine dysentery associated with Brachyspira (for merly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin. Feed continuously as the sole feed for 14 consecu tive days. Withdraw feed 7 days before slaughter. 058198 (2) Tiamulin may also be used in combination with chlortetracycline as in § 558.128. [67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, 2012; 79 FR 13546, Mar. 11, 2014. Redesignated and amended at 80 FR 13232, Mar. 13, 2015; 81 FR 95015, Dec. 27, 2016; 86 FR 14827, Mar. 19, 2021] § 558.618 Tilmicosin. (a) Specifications. Type A medicated article containing 90.7 grams (g) per pound tilmicosin as tilmicosin phos phate (200 g per kilogram). (b) Sponsor. See Nos. 016592 and 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.735 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) VFDs for tilmicosin phosphate shall not be refilled. (3) Labeling of tilmicosin Type B or Type C medicated feeds must bear the following warnings: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00552 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 543 Food and Drug Administration, HHS § 558.618 (i) Do not allow horses or other equines access to feeds containing tilmicosin. (ii) [Reserved] (4) Special considerations for use of tilmicosin medicated swine feeds in clude the following: (i) The expiration date of VFDs for tilmicosin must not exceed 90 days from the time of issuance. (ii) Labeling of tilmicosin Type B or Type C medicated feeds for swine must bear the following warning: ‘‘Do not use in any feeds containing bentonite. Bentonite in feeds may affect the effi cacy of tilmicosin.’’ (iii) Feed containing tilmicosin shall not be fed to pigs for more than 21 days during each phase of production with out ceasing administration for reevalu ation of antimicrobial use by a licensed veterinarian before reinitiating a fur ther course of therapy with an appro priate antimicrobial. (5) Special consideration for use of tilmicosin medicated cattle feeds in clude the following: (i) The expiration date of VFDs for cattle must not exceed 45 days from the time of issuance. (ii) Labeling of tilmicosin Type B or Type C medicated feeds for cattle must bear the following warning: ‘‘Do not use in any feeds containing bentonite, cottonseed meal, or cottonseed hulls. Bentonite, cottonseed meal, or cotton seed hulls in feeds may affect the effi cacy of tilmicosin.’’ (iii) To assure both food safety and responsible use in cattle, administra tion of feed containing tilmicosin to cattle experiencing an outbreak of BRD must be initiated during the first 45 days of the production period, shall not exceed a single 14-consecutive-day treatment, should not occur concur rent with or following administration of an injectable macrolide, and should not occur within 3 days following ad ministration of a nonmacrolide injectable BRD therapy. Tilmicosin medicated feed treatment has not been evaluated in cattle with severe clinical disease. Cattle with severe clinical ill ness should be evaluated for individual treatment with an alternative non macrolide therapy. (e) Conditions of use. It is used in feed as follows: (1) Swine— Tilmicosin phosphate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 181 to 363 ............. .................................... Swine: For the control of swine respiratory dis ease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida. Feed continuously as the sole ration for 21-day period, beginning ap proximately 7 days before an antici pated disease outbreak. The safety of tilmicosin has not been estab lished in male swine intended for breeding purposes. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this drug product. 058198, 016592 (ii) [Reserved] ............ .................................... ......................................... .............................................................. ................ (2) Cattle— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00553 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 544 21 CFR Ch. I (4–1–23 Edition) § 558.618 Tilmicosin phosphate in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 568 to 757 .............. .................................... Beef and nonlactating dairy cattle: For the control of bovine res piratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of beef and nonlactating dairy cat tle, where active BRD has been diagnosed in at least 10 percent of the animals in the group. Feed continuously for 14 days to pro vide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle in tended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. Cattle intended for human consumption must not be slaugh tered within 28 days of the last treat ment with this drug product. 058198, 016592 (ii) 568 to 757 ............. Monensin, 5 to 40 ..... Cattle fed in confine ment for slaughter: For improved feed ef ficiency; and for the control of bovine res piratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where ac tive BRD has been di agnosed in at least 10 percent of the animals in the group. Feed continuously for 14 days to pro vide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle in tended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaugh tered within 28 days of the last treat ment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chap ter. 016592 058198 (iii) 568 to 757 ............ Monensin, 10 to 40 ... Cattle fed in confine ment for slaughter: For prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for the control of BRD as sociated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in groups of cattle fed in confinement for slaughter, where ac tive BRD has been di agnosed in at least 10 percent of the animals in the group. Feed continuously for 14 days to pro vide 12.5 mg tilmicosin/kg of body weight/day. The safety of tilmicosin has not been established in cattle in tended for breeding purposes. This drug product is not approved for use in female dairy cattle 20 months of age or older. Use in these cattle may cause drug residues in milk. This drug product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in pre-ruminating calves. Cattle intended for human consumption must not be slaugh tered within 28 days of the last treat ment with this drug product. See § 558.355(d). Tilmicosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198 in § 510.600(c) of this chap ter. 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00554 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 545 Food and Drug Administration, HHS § 558.625 [61 FR 68148, Dec. 27, 1996; 62 FR 15391, Apr. 1, 1997, as amended at 64 FR 13679, Mar. 22, 1999; 65 FR 76930, Dec. 8, 2000; 67 FR 21997, May 2, 2002; 69 FR 78306, Dec. 30, 2004; 76 FR 76894, Dec. 9, 2011; 77 FR 60623, Oct. 4, 2012; 78 FR 19987, Apr. 3, 2013; 80 FR 61298, Oct. 13, 2015; 80 FR 76387, Dec. 9, 2015; 81 FR 48703, July 26, 2016; 81 FR 59135, Aug. 29, 2016; 81 FR 67153, Sept. 30, 2016; 85 FR 18123, Apr. 1, 2020; 86 FR 14827, Mar. 19, 2021] § 558.625 Tylosin. (a) Specifications. Type A medicated articles containing tylosin phosphate. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 016592: Type A medicated arti cles containing 40 or 100 grams per pound (g/lb). (2) No. 054771: Type A medicated arti cle containing 40 g/lb. (3) No. 058198: Type A medicated arti cles containing 10, 40, or 100 g/lb. (4) No. 066104: Type A medicated arti cles containing 20 or 40 g/lb. (c) Related tolerances. See § 556.746 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for tylosin medicated feeds must not ex ceed 6 months from the date of issuance. VFDs for tylosin shall not be refilled. (3) Type C medicated feeds for cattle may be manufactured from tylosin liq uid Type B medicated feeds which have a pH between 4.5 and 6.0 and which bear appropriate mixing directions as fol lows: (i) For liquid feeds stored in recircu lating tank systems: Recirculate im mediately prior to use for not less than 10 minutes, moving not less than 1 per cent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. (ii) For liquid feeds stored in me chanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 min utes, creating a turbulence at the bot tom of the tank that is visible at the top. Agitate daily as described even when not used. (4) Tylosin liquid Type B medicated feeds must bear an expiration date of 31 days after the date of manufacture. (5) Do not use tylosin liquid Type B medicated feeds in any liquid feed con taining sodium metabisulfite or in any finished feed (supplement, concentrate, or complete feed) containing in excess of 2 percent bentonite. (e) Conditions of use—(1) Swine— Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 40 or 100 ........ ................................. For control of swine dysentery associated with Brachyspira hyodysenteriae. Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Fol low with 40 grams per ton of complete feed until market weight. 016592 054771 058198 066104 (ii) 40 or 100 ....... Pyrantel, 96 ............ For control of swine dysentery associated with Brachyspira hyodysenteriae; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) in fections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Fol low with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (iii) 40 or 100 ...... ................................. For control of porcine prolif erative enteropathies (ileitis) associated with Lawsonia intracellularis. Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Fol low with 40 grams per ton of complete feed until market weight. 016592 054771 058198 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00555 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 546 21 CFR Ch. I (4–1–23 Edition) § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (iv) 40 or 100 ...... Pyrantel, 96 ............ For control of porcine prolif erative enteropathies (ileitis) associated with Lawsonia intracellularis; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) in fections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. Feed as the sole ration 100 g of tylosin per ton of complete feed for at least 3 weeks. Fol low with 40 grams per ton of complete feed until market weight. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (v) 40 or 100 ....... Ractopamine, 4.5 to 9.0. Finishing swine: For the control of swine dysentery associated with Brachyspira hyodysenteriae; for control of porcine proliferative enteropathies (ileitis) associ ated with Lawsonia intracellularis; and for in creased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine weighing not less than 150 lbs, fed a com plete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for at least 3 weeks, followed by 40 g/ton until mar ket weight. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter. 016592 054771 058198 (vi) 40 to 100 ...... ................................. For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water. Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chap ter. 016592 054771 058198 066104 (vii) 40 or 100 ..... Pyrantel, 96 ............ For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) in fections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) infections. Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chap ter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (viii) 40 to 100 ..... ................................. For the control of porcine prolif erative enteropathies (PPE, il eitis) associated with Lawsonia intracellularis imme diately after medicating with tylosin in drinking water. Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chap ter. 016592 054771 058198 066104 (ix) 40 or 100 ...... Pyrantel, 96 ............ For the control of porcine prolif erative enteropathies (PPE, il eitis) associated with Lawsonia intracellularis imme diately after medicating with tylosin in drinking water; and as an aid in the prevention of migration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) in fections. Administer as tylosin phosphate in feed continuously as the sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chap ter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00556 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 547 Food and Drug Administration, HHS § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (x) 40 to 100 ....... Ractopamine, 4.5 to 9.0. Finishing swine: For the treat ment and control of swine dysentery associated with Brachyspira hyodysenteriae, for control of porcine prolif erative enteropathies (PPE, il eitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass lean ness in finishing swine weigh ing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 40 to 100 grams of tylosin phosphate per ton of complete feed for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water for 3 to 10 days as in § 520.2640(d)(3) of this chapter. Tylosin phos phate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter. 016592 054771 058198 (xi) 100 ................ ................................. For reduction in severity of ef fects of atrophic rhinitis. Feed continuously as the sole ration. 016592 054771 058198 066104 (xii) 100 ............... Pyrantel, 96 ............ For reduction in severity of ef fects of atrophic rhinitis; aid as an aid in the prevention of mi gration and establishment of large roundworm (Ascaris suum) infections; aid in the prevention of establishment of nodular worm (Oesophagostomum spp.) in fections. Feed continuously as the sole ration. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. Tylosin phosphate and pyrantel as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (xiii) 100 .............. Ractopamine, 4.5 to 9.0. For the control of porcine prolif erative enteropathies (PPE, il eitis) associated with Lawsonia intracellularis; and for increased rate of weight gain, improved feed efficiency, and increased carcass lean ness in finishing swine weigh ing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter. Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter. Include 100 g/ton of tylosin for 3 weeks. Tylosin phosphate as provided by Nos. 058198 and 016592; ractopamine as provided by Nos. 058198 and 054771 in § 510.600(c) of this chapter. 016592 054771 058198 (2) Cattle— Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 8 to 10 ............ ................................. Beef cattle: For reduction of inci dence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes. Feed continuously as the sole ration to provide 60 to 90 mg/ head/day tylosin. 016592 054771 058198 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00557 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 548 21 CFR Ch. I (4–1–23 Edition) § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (ii) 8 to 10 ........... Lasalocid, 100 to 1440; plus melengestrol, 0.25 to 2.0. Heifers fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed ef ficiency, and suppression of estrus (heat). Feed continuously as sole ra tion. Feed to heifers at the rate of 0.5 to 2.0 pound(s) per head per day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate per head per day (specify one level), 100 to 360 mg lasalocid per head per day (specify one level), and 90 mg tylosin per head per day. This Type C product may be top dressed onto or mixed into a complete feed prior to feeding. Tylosin as provided by Nos. 016592 and 058198; lasalocid as provided by No. 054771; melengestrol as provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.342(d) in this chapter. 016592 054771 058198 (iii) 8 to 10 ........... Melengestrol, 0.25 to 2.0. Heifers fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; and for increased rate of weight gain, improved feed ef ficiency, and suppression of estrus (heat). Feed continuously as sole ra tion. Each pound contains 0.125 to 1.0 mg melengestrol acetate and 45 to 180 mg of tylosin. Feed to heifers at a rate of 0.5 to 2.0 pounds per head per day to provide 0.25 to 0.5 mg melengestrol ace tate and 60 to 90 mg tylosin per head per day. Prior to feeding, this Type C product must be top-dressed onto a complete feed or mixed into the amount of complete feed consumed by an animal per day. Tylosin provided by Nos. 016592 and 058198; melengestrol provided by Nos. 054771 and 058198 in § 510.600(c) of this chapter. See § 558.342(d) in this chap ter. 016592 054771 058198 (iv) 8 to 10 .......... Monensin, 5 to 40 .. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for improved feed efficiency. Feed continuously as sole ration to provide 50 to 480 monensin mg/head/day and 60 to 90 mg/head/day tylosin. A with drawal time has not been es tablished for pre-ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter. 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00558 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 549 Food and Drug Administration, HHS § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (v) 8 to 10 ........... Monensin, 10 to 40 Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for prevention of coccidiosis caused by Eimeria bovis and E zuernii. Feed continuously as sole ration to provide 0.14 to 0.42 mg monensin/lb body weight per day, depending on the sever ity of the coccidiosis chal lenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. A withdrawal time has not been established for pre ruminating calves. Do not use in calves to be processed for veal. Tylosin provided by Nos. 016592 or 058198; monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) in this chapter. 016592 058198 (vi) 8 to 10 .......... Monensin, 5 to 30 plus decoquinate, 13.6 to 22.7. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for the prevention of coccidi osis caused by Eimeria bovis and E. zuernii; and for im proved feed efficiency. Feed continuously as the sole ration to provide 22.7 mg of decoquinate per 100 lb body weight per day, 50 to 360 mg of monensin/head/day, and 60 to 90 mg of tylosin/head/day. Feed at least 28 days during period of exposure to coccidi osis or when it is likely to be a hazard. Do not feed to ani mals producing milk for food. Do not feed to lactating dairy cattle. A withdrawal time has not been established for pre ruminating calves. Do not use in calves to be processed for veal. Tylosin as provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; decoquinate as provided by No. 058198 in § 510.600(c) of this chapter. See §§ 558.311(d) and 558.355(d). 016592 054771 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00559 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 550 21 CFR Ch. I (4–1–23 Edition) § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (vii) 8 to 10 .......... Monensin, 5 to 40 plus lubabegron fumarate, 1.25 to 4.54. Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight; for reduction of inci dence of liver abscesses as sociated with Fusobacterium necrophorum and Arcanobacterium pyogenes, and for improved feed effi ciency during the last 14 to 91 days on feed. Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 50 to 480 mg monensin/head/day, and 60 to 90 mg tylosin/head/ day during the last 14 to 91 days on feed. No additional improvement in feed efficiency has been shown from feeding monensin at levels greater than 30 g/ton (360 mg monensin/head/day). A de crease in dry matter intake may be noticed in some ani mals receiving lubabegron. Lubabegron has not been ap proved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed con taining lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unap proved species may result in toxic reactions. Feeding undi luted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of re fusals fed should be taken into consideration to prevent monensin overdosing. A with drawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00560 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 551 Food and Drug Administration, HHS ยง 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (viii) 8 to 10 ......... Monensin, 10 to 40 plus lubabegron fumarate, 1.25 to 4.54. Beef steers and heifers fed in confinement for slaughter: For reduction of ammonia gas emissions per pound of live weight and hot carcass weight, for reduction of inci dence of liver abscesses as sociated with Fusobacterium necrophorum and Arcanobacterium pyogenes, and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii during the last 14 to 91 days on feed. Feed continuously as sole ration to provide 13 to 90 mg lubabegron/head/day, 0.14 to 0.42 mg monensin/lb body weight per day, depending upon severity of coccidiosis challenge, up to 480 mg/head/ day, and 60 to 90 mg tylosin/ head/day during the last 14 to 91 days on feed. A decrease in dry matter intake may be noticed in some animals re ceiving lubabegron. Lubabegron has not been ap proved for use in breeding animals because safety and effectiveness have not been evaluated in these animals. Do not allow horses or other equines access to feed con taining lubabegron and monensin. Ingestion of monensin by horses has been fatal. Monensin medicated cattle and goat feeds are safe for use in cattle and goats only. Consumption by unap proved species may result in toxic reactions. Feeding undi luted or mixing errors resulting in high concentrations of monensin has been fatal to cattle and could be fatal to goats. Must be thoroughly mixed in feeds before use. Do not exceed the levels of monensin recommended in the feeding directions, as re duced average daily gains may result. If feed refusals containing monensin are fed to other groups of cattle, the concentration of monensin in the refusals and amount of re fusals fed should be taken into consideration to prevent monensin overdosing. A with drawal period has not been established for this product for preruminating calves. Do not use in calves to be processed for veal. 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00561 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 552 21 CFR Ch. I (4–1–23 Edition) § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (ix) 8 to 10 .......... Monensin 10 to 40 plus melengestrol 0.25 to 2.0. Heifers fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat). Feed continuously as sole ration to heifers at a rate of 0.5 to 2 pounds per head per day to provide 0.25 to 0.5 mg/head/ day melengestrol acetate and 0.14 to 0.42 mg monensin/lb body weight per day, depend ing on the severity of the coc cidiosis challenge, up to 480 mg/head/day and 60 to 90 mg/head/day tylosin. The melengestrol acetate portion of this Type C medicated feed must be mixed into the com plete feed containing 10 to 40 g/ton monensin and 8 to 10 g/ ton tylosin at feeding into the amount of complete feed con sumed by an animal per day. A withdrawal time has not been established for pre-rumi nating calves. Do not use in calves to be processed for veal. See §§ 558.342(d) and 558.355(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; melengestrol pro vided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 (x) 8 to 10 ........... Monensin 10 to 40 plus ractopamine 8.2 to 24.6. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Feed continuously as sole ration to provide 70 to 430 mg/head/ day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/ day and 60 to 90 mg/head/ day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be proc essed for veal. See special la beling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin pro vided by No. 016592 or 058198; monensin as pro vided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00562 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 553 Food and Drug Administration, HHS § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (xi) 8 to 10 .......... Monensin 10 to 40 plus ractopamine, not to exceed 800. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Feed a minimum of 1.0 lb/head/ day ractopamine Type C top dress feed continuously to cattle fed in confinement for slaughter, to provide 70 to 400 mg/head/day ractopamine for the last 28 to 42 days on feed. Feed on top of a ration containing 10 to 40 g/ton monensin and 8 to 10 g/ton tylosin phosphate, to provide 0.14 to 0.42 mg monensin/lb body weight/day, depending on the severity of the coccidi osis challenge, up to 480 mg/ head/day and 60 to 90 mg/ head/day tylosin. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be proc essed for veal. See special la beling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin pro vided by No. 016592 or 058198; monensin as pro vided by No. 016592 or 058198; ractopamine provided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 (xii) 8 to 10 .......... Monensin 10 to 40 plus ractopamine 9.8 to 24.6. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 28 to 42 days on feed. Feed continuously as sole ration to provide 90 to 430 mg/head/ day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/ day and 60 to 90 mg/head/ day tylosin for the last 28 to 42 days on feed. A withdrawal time has not been established for pre-ruminating calves. Do not use in calves to be proc essed for veal. See special la beling considerations in §§ 558.355(d) and 558.500(d) of this chapter. Tylosin as pro vided by No. 016592 or 058198; monensin as pro vided by No. 016592 or 058198; ractopamine as pro vided by No. 016592, 054771, or 058198 in § 510.600(c) of this chapter. 016592 054771 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00563 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 554 21 CFR Ch. I (4–1–23 Edition) § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (xiii) 8 to 10 ......... Monensin, 10 to 40 plus ractopamine, 9.8 to 24.6, plus melengestrol, 0.125 to 1 mg/lb. Heifers fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E. zuernii; for in creased rate of weight gain, improved feed efficiency, and increased carcass leanness; and suppression of estrus (heat) in heifers fed in con finement for slaughter for the last 28 to 42 days on feed. Feed continuously as sole ration to provide 90 to 430 mg/head/ day ractopamine and 0.14 to 0.42 mg monensin/lb body weight per day, depending on the severity of the coccidiosis challenge, up to 480 mg/head/ day and 60 to 90 mg/head/ day tylosin for the last 28 to 42 days on feed. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). A withdrawal time has not been established for pre-rumi nating calves. Do not use in calves to be processed for veal. See special labeling con siderations in §§ 558.342(d), 558.355(d), and 558.500(d) of this chapter. Tylosin provided by No. 016592 or 058198; monensin as provided by No. 016592 or 058198; ractopamine as provided by No. 016592, 054771, or 058198; melengestrol acetate as provided by No. 016592 or 054771 in § 510.600(c) of this chapter. 016592 054771 058198 (xiv) 8 to 10 ......... Monensin, 10 to 40 plus zilpaterol, 6.8. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed. Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to pro vide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/ head/day tylosin. Do not use in veal calves. Withdrawal pe riod 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter. 000061 016592 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00564 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 555 Food and Drug Administration, HHS § 558.625 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (xv) 8 to 10 ......... Monensin, 10 to 40 plus zilpaterol, 6.8 to 24. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium pyogenes; for prevention and control of coccidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed. Feed this component feed con tinuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/ head/day tylosin. Do not use in veal calves. Withdrawal pe riod 3 days. Tylosin provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061 in § 510.600(c) of this chapter. See §§ 558.355(d) and 558.665(d) in this chapter. 000061 016592 (xvi) 8 to 10 ......... Monensin, 10 to 40 plus zilpaterol, 6.8 plus melengestrol, 0.125 to 1 mg/lb. Heifers fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coc cidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for sup pression of estrus (heat). Feed continuously as the sole ration to cattle during the last 20 to 40 days on feed to pro vide 60 to 90 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/ head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol pro vided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter. 000061 016592 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00565 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 556 21 CFR Ch. I (4–1–23 Edition) § 558.630 Tylosin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (xvii) 8 to 10 ........ Monensin, 10 to 40 plus zilpaterol, 6.8 to 24 plus melengestrol, 0.125 to 1 mg/lb. Heifers fed in confinement for slaughter: For reduction of in cidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; for prevention and control of coc cidiosis caused by Eimeria bovis and E zuernii; and for increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter for the last 20 to 40 days on feed; and for sup pression of estrus (heat). Feed this component feed con tinuously to cattle during the last 20 to 40 days on feed to provide 60 mg/head/day zilpaterol, 0.14 to 0.42 mg/lb body weight/day monensin, depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin, and 60 to 90 mg/ head/day tylosin. Feed melengestrol as a top dress or mixed with a complete ration at the rate of 0.5 to 2.0 pound/head/day (specify one level) to provide 0.25 to 0.5 mg melengestrol acetate/ head/day (specify one level). Do not use in veal calves. Withdrawal period 3 days. Tylosin as provided by Nos. 016592 or 058198; monensin as provided by No. 058198; zilpaterol as provided by No. 000061; melengestrol pro vided by Nos. 054771 or 058198 in § 510.600(c) of this chapter. See §§ 558.342(d), 558.355(d) and 558.665(d) in this chapter. 000061 016592 058198 [40 FR 13959, Mar. 27, 1975] EDITORIAL NOTE: For FEDERAL REGISTER ci tations affecting § 558.625, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov. § 558.630 Tylosin and sulfamethazine. (a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 5, 10, 20, or 40 grams each, per pound. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 058198 for use as in paragraph (e)(1) of this section. (2) No. 054771: 10 or 40 grams per pound each for use as in paragraph (e)(2) of this section. (c) Related tolerances. See §§ 556.670 and 556.746 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for tylosin and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin and sulfamethazine shall not be re filled. (3) Labeling shall bear the statement: ‘‘Do not use in medicated feeds con taining in excess of 2% bentonite.’’ (e) Conditions of use. It is used in feed for swine as follows: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00566 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 557 Food and Drug Administration, HHS § 558.635 Tylosin phosphate and sulfamethazine in grams/ton Combination in grams/ton Indications for use Limitations Sponsors (1) 100 each ....... ................................. For reduction in the severity of effects of atrophic rhinitis; low ering the incidence and sever ity of Bordetella bronchiseptica rhinitis; preven tion of swine dysentery asso ciated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); reducing the incidence of cer vical lymphadenitis (jowl ab scesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in con trolling jowl abscesses. Withdraw 15 days before swine are slaughtered. 058198 (2) 100 each ....... ................................. For reduction in the severity of effects of atrophic rhinitis; low ering the incidence and sever ity of Bordetella bronchiseptica rhinitis; preven tion of swine dysentery asso ciated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes). Withdraw 15 days before swine are slaughtered. 054771 [81 FR 95021, Dec. 27, 2016, as amended at 84 FR 33002, July 11, 2019] § 558.633 Tylvalosin. (a) Specifications. Type A medicated articles containing 77.12 grams tylvalosin per pound as tylvalosin tar trate. (b) Sponsor. See No. 066916 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.748 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) VFDs for tylvalosin shall not be refilled. (3) Crumbled Type C medicated feeds must bear an expiration date of 7 days after the date of manufacture. (e) Conditions of use. Tylvalosin in grams/ton Indications for use Limitations Sponsor (i) 38.6 Swine: For the control of porcine prolif erative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experi encing an outbreak of PPE. Feed continuously as the sole ration for 14 consecutive days. 066916 (ii) [Reserved] [81 FR 36790, June 8, 2016, as amended at 81 FR 67153, Sept. 30, 2016; 84 FR 12504, Apr. 2, 2019; 87 FR 17948, Mar. 29, 2022; 87 FR 58968, Sept. 29, 2022] § 558.635 Virginiamycin. (a) Specifications. Type A medicated articles containing 10, 20, 50, or 227 grams virginiamycin per pound. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00567 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 558 21 CFR Ch. I (4–1–23 Edition) § 558.635 (b) Sponsors. See No. 066104 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.750 of this chapter. (d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a li censed veterinarian. See § 558.6 for addi tional requirements. (2) The expiration date of VFDs for virginiamycin medicated feeds must not exceed 6 months from the date of issuance. VFDs for virginiamycin shall not be refilled. (3) Not for use in breeding swine over 120 pounds. (4) Dilute Type A article with at least 10 pounds of a feed ingredient prior to final mixing in 1 ton of Type C feed. (e) Conditions of use—(1) Chickens— Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (i) 20 .................... ................................. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin. Not for use in layers ................... 066104 (ii) 20 ................... Amprolium 72.6 to 113.5. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and for the prevention of coccidi osis caused by Eimeria tenella. For field conditions where only E. tenella is the major prob lem, feed continuously as the sole ration. Use as the sole source of amprolium. Do not use in feeds containing ben tonite. Not for use in laying chickens. Amprolium as pro vided by No. 016592 in § 510.600(c) of this chapter. 066104 (iii) 20 .................. Amprolium 113.5 to 227. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and for the prevention of coccidi osis where immunity to coc cidiosis is not desired. For most field conditions as they exist under modern manage ment practices, feed 113.5 g/ ton amprolium continuously. Where severe coccidiosis con ditions exist, feed 227 g/ton. Use as the sole source of amprolium. Do not use in feeds containing bentonite. Not for use in laying chickens. Amprolium as provided by No. 016592 in § 510.600(c) of this chapter. 066104 (iv) 20 .................. Diclazuril, 0.91 ........ Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and for the prevention of coccidi osis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Be cause diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in stud ies to reduce lesions scores and improve performance and health of birds challenged with E. maxima. Feed continuously as the sole ration. Do not feed to birds producing eggs for human consumption. Diclazuril as provided by No. 058198 in § 510.600(c) of this chapter. 058198 (v) 20 ................... Lasalocid 68 to 113 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and for the prevention of coccidi osis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima. Feed continuously as the sole ration. Do not feed to laying chickens. For broiler or fryer chickens only. Lasalocid as provided by No. 054771 in § 510.600(c) of this chapter. 066104 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00568 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 559 Food and Drug Administration, HHS § 558.635 Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsors (vi) 20 .................. Monensin 90 to 110 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and as an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. maxima, and E. mivati. Feed continuously as the sole ration. Do not feed to laying chickens. See § 558.355(d) in this chapter. Monensin as pro vided by No. 058198 in § 510.600(c) of this chapter. 066104 (vii) 20 ................. Narasin, 54 to 90 .... Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin and for the prevention of coccidi osis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Feed as the sole ration for broil er chickens. Do not feed to chickens producing eggs for human consumption. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Naracin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (viii) 20 ................ Narasin, 27 to 54 plus nicarbazin, 27 to 54. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin and for the prevention of coccidi osis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. Feed as the sole ration for broil er chickens. Do not feed to chickens producing eggs for human consumption. Nicarbazin medicated broilers may show reduced heat toler ance if exposed to high tem perature and high humidity. Provide adequate drinking water and ventilation during these periods. Do not allow adult turkeys, horses, or other equines access to narasin for mulations. Ingestion of narasin by these species has been fatal. Naracin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (ix) 20 .................. Salinomycin 40 to 60. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and for the prevention of coccidi osis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati. Feed continuously as the sole ration. Do not feed to chick ens over 16 weeks of age. Do not feed to laying chickens. Not approved for use with pel let binders. May be fatal if ac cidentally fed to adult turkeys or horses. Salinomycin as pro vided by No. 016592 in § 510.600(c) of this chapter. (x) 20 ................... Semduramicin 22.7 Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and for the prevention of coccidi osis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella. Feed continuously as the sole ration. Do not feed to laying hens. Semduramicin as pro vided by No. 066104 in § 510.600(c) of this chapter. 066104 (xi) 20 .................. Semduramicin (bio mass) 22.7. Broiler chickens: For prevention of necrotic enteritis caused by Clostridium perfringens sus ceptible to virginiamycin; and for the prevention of coccidi osis caused by Eimeria acervulina, E. brunetti, E. maxima, E mivati/mitis, E. necatrix, and E. tenella. Feed continuously as the sole ration. Withdraw 1 day before slaughter. Do not feed to lay ing hens. Semduramicin as provided by No. 066104 in § 510.600(c) of this chapter. 066104 (2) Swine— VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00569 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 560 21 CFR Ch. I (4–1–23 Edition) § 558.665 Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 25 .................... ................................. Growing-finishing swine: As an aid in control of dysentery in swine up to 120 pounds in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred. ..................................................... 066104 (ii) 50 or 100 ....... ................................. Growing-finishing swine: For treatment and control of swine dysentery in swine up to 120 pounds. Feed 100 grams per ton for 2 weeks, 50 grams per ton thereafter. 066104 (iii) 100 ................ ................................. Growing-finishing swine: For treatment of swine dysentery in nonbreeding swine over 120 pounds. Feed for 2 weeks ....................... 066104 (3) Cattle— Virginiamycin grams/ton Combination in grams/ton Indications for use Limitations Sponsor (i) 13.5 to 16.0 .... ................................. Cattle fed in confinement for slaughter: For reduction of in cidence of liver abscesses. Feed continuously as the sole ration to provide 85 to 240 milligrams per head per day. Not for use in animals in tended for breeding. 066104 (ii) [Reserved] [81 FR 95022, Dec. 27, 2016, as amended at 82 FR 11512, Feb. 24, 2017; 82 FR 21692, May 10, 2017; 85 FR 18125, Apr. 1, 2020; 87 FR 10972, Feb. 28, 2022; 88 FR 14908, Mar. 10, 2023] § 558.665 Zilpaterol. (a) Specifications. Type A medicated articles containing 21.77 grams (g) zilpaterol hydrochloride per pound. (b) Approvals. See No. 000061 in § 510.600(c) of this chapter. (c) Tolerances. See § 556.765 of this chapter. (d) Special considerations. (1) Labeling shall bear the following caution state ments: ‘‘Zilpaterol hydrochloride is not for use in animals intended for breed ing. Do not allow horses or other equines access to feed containing zilpaterol. Do not use in veal calves.’’ (2) Labeling of Type A medicated ar ticles and Type B medicated feeds used to manufacture complete Type C medi cated feeds shall bear the caution statement in paragraph (d)(3) of this section. (3) Labeling of complete Type C medicated feeds shall bear the fol lowing caution statements: ‘‘Not to be fed to cattle in excess of 90 mg zilpaterol/head/day in complete feed. If pen consumption of complete feed ex ceeds 26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be fed in complete feed.’’ (4) Type B Liquid Feeds can be manu factured containing 68 to 680 g zilpaterol hydrochloride/ton. The liquid Type B feeds must be maintained at a pH of 3.8 to 7.5. For liquid feeds stored in recirculating tank systems: Recircu late immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used. For liquid feeds stored in mechanical, air or other agi tation-type tank systems: Agitate im mediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used. (e) Conditions of use in cattle. It is ad ministered in feed as follows: VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00570 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 561 Food and Drug Administration, HHS § 558.665 Zilpaterol hydrochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (1) 6.8 ..................... ................................. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed. Feed continuously as the sole ra tion during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. 000061 (2) 6.8 ..................... Monensin 10 to 40 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Feed continuously as the sole ra tion during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depend ing on the severity of the coc cidiosis challenge, up to 480 mg/head/day monensin. With drawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter Monensin as pro vided by No. 058198 in § 510.600(c) of this chapter. 000061 058198 (3) 6.8 ..................... Melengestrol ace tate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat). Feed continuously as the sole ra tion during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. Melengestrol acetate as provided by Nos. 058198 or 054771 in § 510.600(c) of this chapter. 000061 058198 (4) 6.8 ..................... Monensin 10 to 40 plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat). Feed continuously as the sole ra tion during the last 20 to 40 days on feed to provide 60 to 90 mg zilpaterol hydrochloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depend ing on the severity of the coc cidiosis challenge, up to 480 mg/head/day monensin. With drawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 058198; melengestrol acetate as provided by Nos. 058198 or 054771 in § 510.600(c) of this chapter. 000061 058198 (5)–(6) [Reserved]. (7) 6.8 to 24 ............ ................................. Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed. Feed continuously during the last 20 to 40 days on feed to pro vide 60 mg zilpaterol hydro chloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. 000061 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00571 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 562 21 CFR Ch. I (4–1–23 Edition) § 558.680 Zilpaterol hydrochloride in grams/ton Combination in grams/ton Indications for use Limitations Sponsor (8) 6.8 to 24 ............ Monensin 10 to 40 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed; and for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii. Feed continuously during the last 20 to 40 days on feed to pro vide 60 mg zilpaterol hydro chloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.355(d) of this chapter. Monensin as provided by No. 058198 in § 510.600(c) of this chapter. 000061 (9) 6.8 to 24 ............ Melengestrol ace tate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed; and for suppression of estrus (heat). Feed continuously during the last 20 to 40 days on feed to pro vide 60 mg zilpaterol hydro chloride per head per day. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraph § 558.342(d) of this part. Melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. 000061 (10) 6.8 to 24 .......... Monensin 10 to 40, plus melengestrol acetate to provide 0.25 to 0.5 mg/ head/day. Heifers fed in confinement for slaughter: For increased rate of weight gain, improved feed effi ciency, and increased carcass leanness in cattle fed in con finement for slaughter during the last 20 to 40 days on feed; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat). Feed continuously during the last 20 to 40 days on feed to pro vide 60 mg zilpaterol hydro chloride per head per day and 0.14 to 0.42 mg monensin per pound of body weight per day depending on the severity of the coccidiosis challenge, up to 480 mg/head/day monensin. Withdrawal period: 3 days. See paragraph (d) of this section. See paragraphs §§ 558.342(d) and 558.355(d) of this chapter. Monensin as provided by No. 058198; melengestrol acetate as provided by No. 054771 in § 510.600(c) of this chapter. 000061 (f) Zilpaterol may also be used in combination with tylosin as in § 558.625. [71 FR 53006, Sept. 8, 2006, as amended at 72 FR 9245, Mar. 1, 2007; 72 FR 6019, Feb. 1, 2008; 73 FR 14385, Mar. 18, 2008; 73 FR 16755, Mar. 31, 2008; 73 FR 18959, Apr. 8, 2008; 73 FR 19432, Apr. 10, 2008; 74 FR 61517, Nov. 25, 2009; 75 FR 11451, Mar. 11, 2010; 77 FR 31724, May 30, 2012; 78 FR 42008, July 15, 2013; 78 FR 52852, Aug. 27, 2013; 80 FR 13232, Mar. 13, 2015; 80 FR 53460, Sept. 4, 2015; 81 FR 48703, July 26, 2016; 81 FR 95025, Dec. 27, 2016] § 558.680 Zoalene. (a) Specifications. Type A medicated article containing 25 percent zoalene. (b) Sponsors. See Nos. 054771 and 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.770 of this chapter. (d) Conditions of use—(1) Chickens— Zoalene in grams/ ton Combination in grams per ton Indications for use Limitations Sponsor (i) 36.3 to 113.5 ...... ................................. Replacement chickens: For devel opment of active immunity to coccidiosis. Feed continuously as sole ration. Grower ration not to be fed to birds over 14 weeks of age. Starter ration not to be fed to laying birds. 054771 058198 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00572 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 563 Food and Drug Administration, HHS § 558.680 Growing conditions Starter ration Grams per ton Grower ration Grams per ton Severe exposure ........................................................................................... 113.5 (0.0125%) 75.4–113.5 (0.0083%–0.0125%) Light to moderate exposure .......................................................................... 75.4–113.5 (0.0083%–0.0125%) 36.3–75.4 (0.004%–0.0083%) Zoalene in grams/ ton Combination in grams per ton Indications for use Limitations Sponsor (ii) 36.3–113.5 ......... Bacitracin methylenedisalicy late 4 to 50. Replacement chickens: For devel opment of active immunity to coccidiosis; and for increased rate of weight gain and im proved feed efficiency. Feed continuously as sole ration as in subtable in item (i). Grow er ration not to be fed to birds over 14 weeks of age. Baci tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (iii) 36.3 to 113.5 .... Bacitracin methylenedisalicy late, 50. Replacement chickens: For devel opment of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clos tridium spp. or other organisms susceptible to bacitracin. Feed continuously as the sole ra tion as in the subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 058198 (iv) 36.3 to 113.5 .... Bacitracin methylenedisalicy late, 100 to 200. Replacement chickens: For devel opment of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clos tridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration as in the subtable in item (i). To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dos age based on the severity of in fection; administer continuously for 5 to 7 days or as long as clinical signs persist, then re duce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 058198 (v) 113.5 ................. ................................. Broiler chickens: For prevention and control of coccidiosis. Feed continuously as sole ration. Not to be fed to laying birds. 054771 058198 (vi) 113.5 ................. Bacitracin methylenedisalicy late 4 to 50. Broiler chickens: As an aid in the prevention and control of coc cidiosis; and for increased rate of weight gain and improved feed efficiency. Feed continuously as sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 (vii) 113.5 ................ Bacitracin methylenedisalicy late, 50. Broiler 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 bacitracin. Feed continuously as the sole ra tion. Bacitracin methylenedisalicylate as pro vided by No. 054771 in § 510.600(c) of this chapter. 054771 058198 (viii) 113.5 ............... Bacitracin methylenedisalicy late,. 100 to 200 .............. Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of ne crotic enteritis caused or com plicated by Clostridium spp. or other organisms susceptible to bacitracin. Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary baci tracin dosage based on the se verity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to pre vention level (50 g/ton). Baci tracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter. 054771 058198 (ix) 113.5 ................. Bambermycins 1 ..... Broiler chickens: As an aid in the prevention and control of coc cidiosis; and for increased rate of weight gain and improved feed efficiency. 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. 016592 VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00573 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B 564 21 CFR Ch. I (4–1–23 Edition) Pt. 570 (2) Turkeys— Zoalene in grams/ ton Combination in grams/ton Indications for use Limitations Sponsor (i) 113.5 to 170.3 .... Growing turkeys: For prevention and control of coccidiosis. Feed continuously as sole ration. For turkeys grown for meat pur poses only. Not to be fed to laying birds. 054771 058198 (ii) 113.5 to 170.3 ... Bacitracin methylenedisalicy late, 4 to 50. Growing turkeys: For prevention and control of coccidiosis; and for increased rate of weight gain and improved feed effi ciency. Feed continuously as sole ration until 14 to 16 weeks of age. For turkeys grown for meat pur poses only. Not to be fed to laying birds. 054771 058198 (3) Zoalene may also be used in com bination with: (i)–(ii) [Reserved] (iii) Lincomycin as in § 558.325. [41 FR 11005, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR 27958, May 15, 2006; 76 FR 17027, Mar. 28, 2011; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 17610, Mar. 30, 2016; 81 FR 95025, Dec. 27, 2016; 82 FR 21693, May 10, 2017; 86 FR 14827, Mar. 19, 2021; 87 FR 17948, Mar. 29, 2022] PART 564 [RESERVED] PART 570—FOOD ADDITIVES Subpart A—General Provisions Sec. 570.3 Definitions. 570.6 Opinion letters on food additive sta tus. 570.13 Indirect food additives resulting from packaging materials prior sanctioned for animal feed and pet food. 570.14 Indirect food additives resulting from packaging materials for animal feed and pet food. 570.15 Adoption of regulation on initiative of Commissioner. 570.17 Exemption for investigational use and procedure for obtaining authoriza tion to market edible products from ex perimental animals. 570.18 Tolerances for related food additives. 570.19 Pesticide chemicals in processed foods. Subpart B—Food Additive Safety 570.20 General principles for evaluating the safety of food additives. 570.30 Eligibility for classification as gen erally recognized as safe (GRAS). 570.35 Affirmation of generally recognized as safe (GRAS) status. 570.38 Determination of food additive sta tus. Subparts C–D [Reserved] Subpart E—Generally Recognized as Safe (GRAS) Notice 570.203 Definitions. 570.205 Opportunity to submit a GRAS no tice. 570.210 How to send your GRAS notice to FDA. 570.215 Incorporation into a GRAS notice. 570.220 General requirements applicable to a GRAS notice. 570.225 Part 1 of a GRAS notice: Signed statements and certification. 570.230 Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect. 570.235 Part 3 of a GRAS notice: Target ani mal and human exposures. 570.240 Part 4 of a GRAS notice: Self-lim iting levels of use. 570.245 Part 5 of a GRAS notice: Experience based on common use in food before 1958. 570.250 Part 6 of a GRAS notice: Narrative. 570.255 Part 7 of a GRAS notice: List of sup porting data and information in your GRAS notice. 570.260 Steps you may take before FDA re sponds to your GRAS notice. 570.265 What FDA will do with a GRAS no tice. 570.275 Public disclosure of a GRAS notice. 570.280 Submission of a supplement. AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348, 371. SOURCE: 41 FR 38644, Sept. 10, 1976, unless otherwise noted. Subpart A—General Provisions § 570.3 Definitions. (a) Secretary means the Secretary of Health and Human Services. VerDate Sep<11>2014 16:35 May 05, 2023 Jkt 259076 PO 00000 Frm 00574 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT PC31aw or le y on L A P 50 LW 1R 2 w ith $ $ JO B