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Food and Drug Administration, HHS § 520.905B Food and Drug Administration, HHS § 520.905b (b) Sponsor. See No. 000061 in has not been established for this prod- § 510.600(c) of this chapter. uct in preruminating calves. Do not (c) Related tolerances. See § 556.275 of use in calves to be processed for veal. this chapter. (3) Beef cattle—(i) Amount. Administer (d) Special considerations. (1) See orally 10 mg/kg of body weight (2.3 mg/ § 500.25 of this chapter. lb). Retreatment may be needed after 4 (2) Fenbendazole suspension 10 per- to 6 weeks. cent and approved forms of trichlorfon, (ii) Indications for use. For the re- when used concomitantly for treating moval and control of stomach worm the indications provided in paragraph (4th stage inhibited larvae/type II (e) of this section and for treating in- ostertagiasis), Ostertagia ostertagi, and fections of stomach bot as provided in tapeworm, Moniezia benedeni. § 520.2520, have been shown to be com- (iii) Limitations. Cattle must not be patible and not to interfere with one slaughtered within 8 days following another. last treatment. A withdrawal period (e) Conditions of use—(1) Horses—(i) has not been established for this prod- Amount. Administer orally 5 mg per uct in preruminating calves. Do not kilogram (/kg) (2.3 mg per pound (/lb)) use in calves to be processed for veal. for the control of large strongyles, Federal law restricts this drug to use small strongyles, and pinworms; 10 mg/ by or on the order of a licensed veteri- kg for the control of ascarids. narian. (ii) Indications for use. For the control (4) Goats—(i) Amount. Administer of large strongyles (Strongylus orally 5 mg/kg of body weight (2.3 mg/ edentatus, S. equinus, S. vulgaris), small lb). strongyles (Cyanthostomum spp., (ii) Indications for use. For the re- Cylicocyclus spp., Cylicostephanus spp., moval and control of stomach worms Triodontophorus spp.), pinworms (adults) Haemonchus contortus and (Oxyuris equi), and ascarids (Parascaris Teladorsagia circumcincta. equorum) in horses. (iii) Limitations. Retreatment may be (iii) Limitations. Administer by dose needed after 4 to 6 weeks. Goats must syringe or suitable plastic syringe. Do not be slaughtered for food within 6 not use in horses intended for human days following last treatment. Do not consumption. use in lactating goats. (2) Cattle including dairy cows of breed- [42 FR 59069, Nov. 15, 1977; 43 FR 12311, Mar. ing age—(i) Amount. Administer orally 5 24, 1978] mg/kg of body weight (2.3 mg/lb). Re- EDITORIAL NOTE: For FEDERAL REGISTER ci- treatment may be needed after 4 to 6 tations affecting § 520.905a, see the List of weeks. CFR Sections Affected, which appears in the (ii) Indications for use. For the re- Finding Aids section of the printed volume moval and control of lungworm and at www.fdsys.gov. (Dictyocaulus viviparus); stomach worm (adults)—brown stomach worm § 520.905b Fenbendazole granules. (Ostertagia ostertagi); stomach worms (a) Specifications. Each gram of gran- (adults and 4th-stage larvae)— ules contains 222 milligrams (mg) barberpole worm (Haemonchus contortus fenbendazole. and H. placei) and small stomach worm (b) Sponsor. See No. 000061 in (Trichostongylus axei); intestinal worms § 510.600(c) of this chapter. (adults and 4th-stage larvae)— (c) Special considerations. See § 500.25 hookworm (Bunostonmum phlebotomum), of this chapter. threadnecked intestinal worm (d) Conditions of use—(1) Horses—(i) (Nematodirus helvetianus), small intes- Amount. 5 mg/kilogram (kg) for large tinal worm (Cooperia punctata and C. strongyles, small strongyles, and oncophora), bankrupt worm pinworms; 10 mg/kg for ascarids. (Trichostrongylus colubriformis), and (ii) Indications for use. For the control nodular worm (Oesophagostomum of infections of large strongyles radiatum). (Strongylus edentatus, S. equinus, S. (iii) Limitations. Cattle must not be vulgaris), small strongyles, pinworms slaughtered within 8 days following (Oxyuris equi), and ascarids (Parascaris last treatment. A withdrawal period equorum). 159 VerDate Mar<15>2010 14:14 May 10, 2012 Jkt 226072 PO 00000 Frm 00169 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150 § 520.905c 21 CFR Ch. I (4–1–12 Edition) (iii) Limitations. Sprinkle the appro- Do not use 14 days before or during the priate amount of drug on a small hunting season. amount of the usual grain ration. Pre- [44 FR 1375, Jan. 5, 1979, as amended at 47 FR pare for each horse individually. With- 15327, Apr. 9, 1982; 48 FR 50528, Nov. 2, 1983; 59 holding feed or water is not necessary. FR 35252, July 11, 1994; 66 FR 47960, Sept. 17, Retreat in 6 to 8 weeks if required. Do 2001; 67 FR 47450, July 19, 2002; 71 FR 19429, not use in horses intended for food. Apr. 14, 2006; 74 FR 61516, Nov. 25, 2009] (2) Dogs—(i) Amount. 50 mg/kg daily § 520.905c Fenbendazole paste. for 3 consecutive days. (ii) Indications for use. For the treat- (a) Specifications. Each gram of paste contains 100 milligrams (mg) ment and control of ascarids (Toxocara fenbendazole (10 percent). canis, Toxascaris leonina), hookworms (b) Sponsor. See No. 000061 in ( Ancylostoma caninum, Uncinaria § 510.600(c) of this chapter. stenocephala), whipworms (Trichuris (c) Related tolerances. See § 556.275 of vulpis), and tapeworms (Taenia this chapter. pisiformis). (d) Special considerations. See § 500.25 (iii) Limitations. Mix the appropriate of this chapter. amount of drug with a small amount of (e) Conditions of use—(1) Horses—(i) the usual food; dry dog food may re- Indications for use and amounts—(A) For quire slight moistening to facilitate control of large strongyles (Strongylus mixing. Medicated food must be fully edentatus, S. equinus, S. vulgaris), small consumed. strongyles, pinworms (Oxyuris equi), (3) Zoo and wildlife animals—(i) and ascarids (Parascaris equorum): 2.3 Amount. 10 mg/kg per day for 3 days. mg per pound (/lb) of body weight, or (ii) Indications for use. For control of for foals and weanlings (less than 18 internal parasites of Felidae and months of age), 4.6 mg/lb of body Ursidae as follows: weight. Retreatment at intervals of 6 (A) Lion (Panthera leo) and Tiger to 8 weeks may be required. (B) For control of arteritis caused by (Panthera tigris): Ascarid (Toxocara cati, the fourth-stage larvae of S. vulgaris: Toxascaris leonina), Hookworm 4.6 mg/lb of body weight daily for 5 (Ancylostoma spp.). days. Treatment should be initiated in (B) Cheetah (Acinonyx jubatus): Asca- the spring and repeated in 6 months. rid (Toxocara cati, Toxascaris leonina). (C) For treatment of encysted (C) Puma (Felis concolor), Panther mucosal cyathostome (small strongyle) (Panthera spp.), Leopard (Panthera larvae including early third-stage pardus), Jaguar (Panthera onca): Asca- (hypobiotic), late third-stage, and rid (Toxocara cati, Toxascaris leonina), fourth-stage larvae: 4.6 mg/lb of body Hookworm (Ancylostoma spp.), Tape- weight daily for 5 consecutive days. worm (Taenia hydatigena, T. krabbei, T. (D) Fenbendazole paste 10 percent taeniaeformis). may be used concomitantly with ap- (D) Black Bear (Ursus americanus): proved forms of trichlorfon for the in- Ascarid (Baylisascaris transfuga, dications provided in paragraph Toxascaris leonina), Hookworm (e)(1)(i)(A) of this section and for treat- (Ancylostoma caninum), Tapeworm ing infections of stomach bots as pro- (Taenia hydatigena, T. krabbei). vided in § 520.2520. (ii) . Do not use in horses (E) Polar Bear (Ursus maritimus) and Limitations intended for human consumption. Grizzly Bear (Ursus horribilis): Ascarid (2) Cattle—(i) Amount. 2.3 mg/lb of (Baylisascaris transfuga, Toxascaris body weight. Retreatment may be leonina). needed after 4 to 6 weeks. (iii) Limitations. Top dress or mix (ii) Indications for use. For the re- with a small portion of food. Must be moval and control of lungworms fully consumed prior to feeding. Fed- (Dictyocaulus viviparus), stomach eral law restricts this drug to use by or worms (Haemonchus contortus, on the order of a licensed veterinarian. Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms (Bunostomum phlebotomum, Nematodirus 160 VerDate Mar<15>2010 14:14 May 10, 2012 Jkt 226072 PO 00000 Frm 00170 Fmt 8010 Sfmt 8010 Q:\21\21V6.TXT ofr150 PsN: PC150.
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