(a) Approvals. Type A medicated articles containing specified levels of narasin approved for sponsors identified in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section are as follows:
(1) To 000986: 36, 45, 54, 72, and 90 grams per pound, paragraph (d)(1)(i) of this section.
(2) [Reserved]
(3) To 000986: 36 grams per pound, with 36 grams per pound nicarbazin, paragraph (d)(1)(iii) of this section.
(4) To 016592: 36, 45, 54, 72, and 90 grams per pound, with 2 and 10 grams per pound bambermycins, paragraph (d)(1)(iv) of this section.
(5)-(6) [Reserved]
(7) To 054771: 36, 45, 54, 72, or 90 grams per pound, with 10, 25, 40, or 50 grams per pound bacitracin zinc, paragraph (d)(1)(x) of this section.
(8) To 000986: 45.4 grams per pound for use as in paragraph (d)(2) of this section.
(b) Tolerances. See Sec. 556.428 of this chapter.
(c) Special considerations. An expiration date of 2 months (8 weeks) is required for narasin Type C medicated swine feeds.
(d) Conditions of use. It is used as follows:
(1) Broiler chickens--(i) Amount per ton. Narasin, 54 to 90 grams.
(i) Amount per ton. Narasin, 54 to 90 grams.
(A) Indications for use. For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal.
(ii) Amount per ton. Narasin, 27 to 45 grams, plus nicarbazin, 27 to 45 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima.
(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these animals has been fatal. Withdraw 5 days before slaughter. The 2 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. 000986 in Sec. 510.600(c) of this chapter may be used in the combination.
(iii) Amount per ton. Narasin, 54 to 72 grams, plus bambermycins, 1 to 2 grams.
(A) Indications for use. For 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.
(B) Limitations. For broiler chickens only. Feed continuously as the sole ration. May be fatal if fed to adult turkeys, horses, or other equines. Narasin as provided by No. 000986; bambermycins by No. 016592 in Sec. 510.600(c) of this chapter.
(iv) Amount per ton. Narasin 54 to 72 grams, and bacitracin methylene disalicylate 10 to 50 grams.
(A) Indications for use. For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and E. tenella, for increased rate of weight gain, and for improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin methylene disalicylate by 046573 in Sec. 510.600(c) of this chapter.
(v) Amount per ton. Narasin, 54 to 72 grams and bacitracin zinc, 4 to 50 grams.
(A) Indications for use. For 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.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin as provided by 000986, bacitracin zinc by 046573 in Sec. 510.600(c) of this chapter.
(vi) Amount per ton. Narasin, 54 to 72 grams, plus tylosin, 4 to 50 grams.
(A) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain, and improved feed efficiency.
(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not allow adult turkeys, horses, or other equines access to formulations containing narasin. Ingestion of narasin by these species has been fatal. Narasin and tylosin as provided by 000986 in Sec. 510.600(c) of this chapter.
(2) Growing-finishing swine--(i) Amount per ton. Narasin, 13.6 to 27.2 grams.
(i) Amount per ton. Narasin, 13.6 to 27.2 grams.
(A) Indications for use. For increased rate of weight gain when fed for at least 4 weeks.
(B) Limitations. 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 because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.
(ii) Amount per ton. Narasin, 18.1 to 27.2 grams.
(A) Indications for use. For increased rate of weight gain and improved feed efficiency when fed for at least 4 weeks.
(B) Limitations. 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 because safety and effectiveness have not been evaluated in these animals. Swine being fed with narasin should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.
(3) Narasin may also be used for broilers in combination with:
(i) Nicarbazin with lincomycin as in Sec. 558.366.
(ii) Nicarbazin and bacitracin methylene disalicylate as in Sec. 558.366. [51 FR 29098, Aug. 14, 1986]
Editorial Notes: 1. For Federal Register citations affecting Sec. 558.363, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.
2. At 79 FR 13545, Mar. 11, 2014, Sec. 558.363 was amended; however, the amendment could not be incorporated due to inaccurate amendatory instruction.