21 CFR 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 coccidiosis caused by Eimeria bovis and E. zuernii Top-dress on or mix in the daily ration. Feed for 21 days when experience indicates that coccidiosis is likely to be a hazard, as the sole source of amprolium. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal 016592

(ii) 113.5 to 11, 350; to provide 10 milligrams per kilogram of body weight per day Calves: As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zuernii Top-dress on or mix in the daily ration. Feed for 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 development 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%)

Amprolium in grams per ton Combination in grams per ton Indications for use Limitations Sponsor

(ii) 36.3 to 113.5 Bacitracin methylenedisalicylate 4 to 50 Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiency Feed according to subtable in item (i). Bacitracin methylenedisalicylate as provided 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 ration; 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 increased rate of weight gain and improved feed efficiency Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592

(v) 113.5 1. Laying chickens: For prevention of coccidiosis Feed continuously as the sole ration; as the sole source of amprolium 016592

2. Laying chickens: For treatment of coccidiosis in moderate outbreaks 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 prevention of coccidiosis where immunity to coccidiosis is not desired Feed continuously as the sole ration; 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 efficiency Feed continuously as the sole ration; as sole source of amprolium. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter 016592

(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 increased 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 coccidiosis Feed continuously as the sole ration; 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 prevention 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]