21 CFR 558.555 - Semduramicin.

View all text of Subpart B [§ 558.55 - § 558.680]

§ 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 paragraph (a)(2) of this section as in paragraph (e) of this section.

(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 prevention 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 methylenedisalicylate 10 to 50	Broiler chickens: As in paragraph (d)(1) of this section; for improved feed efficiency.	Feed continuously as sole ration. Do not feed to laying hens. Bacitracin methylenedisalicylate as provided 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 prevention 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]