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21 CFR Ch. I (4–1–16 Edition)

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21 CFR Ch. I (4–1–16 Edition) § 520.905b 21 CFR Ch. I (4–1–16 Edition) (Dictyocaulus viviparus); stomach worm ment chickens intended to become (adults)—brown stomach worm breeding chickens, and for the treat- (Ostertagia ostertagi); stomach worms ment and control of adult A. galli and (adults and 4th-stage larvae)— Heterakis gallinarum in breeding chick- barberpole worm (Haemonchus contortus ens. and H. placei) and small stomach worm (iii) Limitations. Not for use in laying (Trichostongylus axei); intestinal worms hens and replacement chickens in- (adults and 4th-stage larvae)— tended to become laying hens. hookworm (Bunostonmum phlebotomum), [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. threadnecked intestinal worm 24, 1978. Redesignated at 44 FR 1375, Jan. 5, (Nematodirus helvetianus), small intes- 1979, and amended at 46 FR 29464, June 2, tinal worm (Cooperia punctata and C. 1981; 47 FR 15327, Apr. 9, 1982; 48 FR 42809, oncophora), bankrupt worm Sept. 20, 1983; 49 FR 1983, Jan. 17, 1984; 53 FR (Trichostrongylus colubriformis), and 40058, Oct. 13, 1988; 59 FR 26943, May 25, 1994; nodular worm (Oesophagostomum 61 FR 29478, June 11, 1996; 63 FR 63983, Nov. 18, 1998; 66 FR 47960, Sept. 17, 2001; 68 FR radiatum). 26205, May 15, 2003; 74 FR 17770, Apr. 17, 2009; (iii) Limitations. Cattle must not be 74 FR 61516, Nov. 25, 2009; 76 FR 17336, Mar. slaughtered within 8 days following 29, 2011; 80 FR 76386, Dec. 9, 2015] last treatment. A withdrawal period has not been established for this prod- § 520.905b Fenbendazole granules. uct in preruminating calves. Do not (a) Specifications. Each gram of gran- use in calves to be processed for veal. ules contains 222 milligrams (mg) (3) Beef cattle—(i) Amount. Administer fenbendazole. orally 10 mg/kg of body weight (2.3 mg/ (b) Sponsor. See No. 000061 in lb). Retreatment may be needed after 4 § 510.600(c) of this chapter. to 6 weeks. (c) Special considerations. See § 500.25 (ii) Indications for use. For the re- of this chapter. moval and control of stomach worm (d) Conditions of use—(1) Horses—(i) (4th stage inhibited larvae/type II Amount. 5 mg/kilogram (kg) for large ostertagiasis), Ostertagia ostertagi, and strongyles, small strongyles, and tapeworm, Moniezia benedeni. pinworms; 10 mg/kg for ascarids. (iii) Limitations. Cattle must not be (ii) Indications for use. For the control slaughtered within 8 days following of infections of large strongyles last treatment. A withdrawal period (Strongylus edentatus, S. equinus, S. has not been established for this prod- vulgaris), small strongyles, pinworms uct in preruminating calves. Do not (Oxyuris equi), and ascarids (Parascaris use in calves to be processed for veal. equorum). Federal law restricts this drug to use (iii) Limitations. Sprinkle the appro- by or on the order of a licensed veteri- priate amount of drug on a small narian. amount of the usual grain ration. Pre- (4) Goats—(i) Amount. Administer pare for each horse individually. With- orally 5 mg/kg of body weight (2.3 mg/ holding feed or water is not necessary. lb). Retreatment may be needed after 4 Retreat in 6 to 8 weeks if required. Do to 6 weeks. not use in horses intended for food. (ii) Indications for use. For the re- (2) Dogs—(i) Amount. 50 mg/kg daily moval and control of stomach worms for 3 consecutive days. (adults) Haemonchus contortus and (ii) Indications for use. For the treat- Teladorsagia circumcincta. ment and control of ascarids (Toxocara (iii) Limitations. Goats must not be canis, Toxascaris leonina), hookworms slaughtered for food within 6 days fol- (Ancylostoma caninum, Uncinaria lowing last treatment. Do not use in stenocephala), whipworms (Trichuris lactating goats. vulpis), and tapeworms (Taenia (5) Chickens—(i) Amount. Administer pisiformis). orally via drinking water at a daily (iii) Limitations. Mix the appropriate dose of 1 mg/kg body weight (0.454 mg/ amount of drug with a small amount of lb) for 5 consecutive days. the usual food; dry dog food may re- (ii) Indications for use. For the treat- quire slight moistening to facilitate ment and control of adult Ascaridia mixing. Medicated food must be fully galli in broiler chickens and replace- consumed. 188 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00198 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB Food and Drug Administration, HHS § 520.905d (3) Zoo and wildlife animals—(i) weight. Retreatment at intervals of 6 Amount. 10 mg/kg per day for 3 days. to 8 weeks may be required. (ii) Indications for use. For control of (B) For control of arteritis caused by internal parasites of Felidae and the fourth-stage larvae of S. vulgaris: Ursidae as follows: 4.6 mg/lb of body weight daily for 5 (A) Lion (Panthera leo) and Tiger days. Treatment should be initiated in (Panthera tigris): Ascarid (Toxocara cati, the spring and repeated in 6 months. Toxascaris leonina), Hookworm (C) For treatment of encysted (Ancylostoma spp.). mucosal cyathostome (small strongyle) (B) Cheetah (Acinonyx jubatus): Asca- larvae including early third-stage rid (Toxocara cati, Toxascaris leonina). (hypobiotic), late third-stage, and (C) Puma (Felis concolor), Panther fourth-stage larvae: 4.6 mg/lb of body (Panthera spp.), Leopard (Panthera weight daily for 5 consecutive days. pardus), Jaguar (Panthera onca): Asca- (D) Fenbendazole paste 10 percent rid (Toxocara cati, Toxascaris leonina), may be used concomitantly with ap- Hookworm (Ancylostoma spp.), Tape- worm (Taenia hydatigena, T. krabbei, T. proved forms of trichlorfon for the in- taeniaeformis). dications provided in paragraph (D) Black Bear (Ursus americanus): (e)(1)(i)(A) of this section and for treat- Ascarid (Baylisascaris transfuga, ing infections of stomach bots as pro- Toxascaris leonina), Hookworm vided in § 520.2520. (Ancylostoma caninum), Tapeworm (ii) Limitations. Do not use in horses (Taenia hydatigena, T. krabbei). intended for human consumption. (E) Polar Bear (Ursus maritimus) and (2) Cattle—(i) Amount. 2.3 mg/lb of Grizzly Bear (Ursus horribilis): Ascarid body weight. Retreatment may be (Baylisascaris transfuga, Toxascaris needed after 4 to 6 weeks. leonina). (ii) Indications for use. For the re- (iii) Limitations. Top dress or mix moval and control of lungworms with a small portion of food. Must be (Dictyocaulus viviparus), stomach fully consumed prior to feeding. Fed- worms (Haemonchus contortus, eral law restricts this drug to use by or Ostertagia ostertagi, Trichostrongylus on the order of a licensed veterinarian. axei), and intestinal worms Do not use 14 days before or during the (Bunostomum phlebotomum, Nematodirus hunting season. helvetianus, Cooperia punctata, C. [44 FR 1375, Jan. 5, 1979, as amended at 47 FR oncophora, Trichostrongylus 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 colubriformis, and Oesophagostomum FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, radiatum). 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, (iii) Limitations. Cattle must not be Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] slaughtered within 8 days following last treatment. A withdrawal period § 520.905c Fenbendazole paste. has not been established for this prod- (a) Specifications. Each gram of paste uct in preruminating calves. Do not contains 100 milligrams (mg) use in calves to be processed for veal. fenbendazole (10 percent). (b) Sponsor. See No. 000061 in [72 FR 24185, May 2, 2007, as amended at 74 § 510.600(c) of this chapter. FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011] (c) Related tolerances. See § 556.275 of this chapter. § 520.905d Fenbendazole powder. (d) Special considerations. See § 500.25 of this chapter. (a) Specifications. (1) Each 2-ounce (e) Conditions of use—(1) Horses—(i) packet contains 2.27 grams (4 percent) Indications for use and amounts—(A) For of fenbendazole plus other inert ingre- control of large strongyles (Strongylus dients. edentatus, S. equinus, S. vulgaris), small (2) Each 4-ounce packet contains 1.7 strongyles, pinworms (Oxyuris equi), grams (1.5 percent) of fenbendazole plus and ascarids (Parascaris equorum): 2.3 other inert ingredients. mg per pound (/lb) of body weight, or (b) Sponsors. (1) See No. 000061 in for foals and weanlings (less than 18 § 510.600(c) of this chapter for use of the months of age), 4.6 mg/lb of body 4-percent product. 189 VerDate Sep<11>2014 10:06 Apr 14, 2016 Jkt 238075 PO 00000 Frm 00199 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB.
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