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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule; correction; technical amendment.

SUBJECT CATEGORY: New Animal Drugs for Use in Animal Feeds; Fenbendazole

DATES: This rule is effective November 26, 2001.

DOCUMENT SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to restore indications for fenbendazole medicated feeds for cattle that have been inadvertently deleted from the regulations. Changes to a table format are also being made. This action is being taken to correct these errors and to improve the accuracy of the regulations.

SUMMARY: Fenbendazole,

SUPPLEMENTAL INFORMATION

FDA has discovered that an error has become incorporated into the agency's regulation for part 558 (21 CFR part 558). A portion of the list of indications for fenbendazole medicated feeds for cattle was inadvertently deleted as a publication error beginning with the April 1, 1996, edition of the CFR. At this time, the regulations are being amended in Sec. 558.258 to correct this error, to format some portions of this section as a table, and to restructure other portions to more closely resemble similar regulations for free choice medicated feeds for cattle. Indications for the control of certain swine parasites, inadvertently removed in a previous revision of the regulations in the Federal Register of November 20, 1990 (55 FR 48230), are also being added. The entire text of Sec. 558.258 is being provided for the convenience of the reader.

Publication of this document constitutes final action on these changes under the Administrative Procedure Act (5 U.S.C. 553). Notice and public procedure are unnecessary because FDA is merely correcting nonsubstantive errors.

This rule does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because it is a rule of ``particular applicability.'' Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801808.
List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

PART 558NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.258 is revised to read as follows: Sec. 558.258 Fenbendazole.
(a) Specifications. Type A medicated articles: 4 percent (18.1 grams per pound (g/lb)), 8 percent (36.2 g/lb), and 20 percent (90.7 g/ lb) fenbendazole.
(b) Approvals. See No. 057926 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. 556.275 of this chapter. (d) Special considerations. See Sec. 500.25 of this chapter. (e) Conditions of use(1) Turkeys.
Amount fenbendazole in grams Combination in Indications for per ton grams per ton use Limitations Sponsor 14.5 (16 parts per million)... ................ Growing turkeys: Feed 057926 For the removal continuously as and control of the sole ration gastrointestinal for 6 days. For worms: round growing turkeys worms, adult and only. larvae
(Ascaridia dissimilis); cecal worms, adult and larvae (Heterakis gallinarum), an important vector of Histomonas meleagridis (Blackhead). (2) Swine.
[[Page 58936]]
Amount fenbendazole in grams per Combination in Indications for ton grams per ton use Limitations Sponsor (i) 10 to 300 (to provide 9 ................. For the removal Feed as sole 057926 milligrams per kilogram (mg/kg) and control of: ration. of body weight) given over a 3 Adult stage to 12day period. lungworms (Metastrongylus apri and M. pudendotectus); adult and larvae (L3, 4 stages liver, lung, intestinal forms) large roundworms (Ascaris suum); adult stage nodular worms (Oesophagostomum dentatum, O. quadrispinulatum) ; adult stage small stomach worms (Hyostrongylus rubidus); adult and larvae (L2, 3, 4 stages intestinal mucosal forms) whipworms (Trichuris suis); adult and larvae kidney worms (Stephanurus dentatus). (ii) 10 to 80 (to provide 9 mg/ Lincomycin 20..... As in paragraph Feed as sole 057926 kg of body weight). (e)(2)(i) of this ration. Do not section; for feed to swine increased rate of that weigh more gain in growing than 250 pounds finishing swine. (lbs); lincomycin as provided by 000009 in Sec. 510.600(c) of this chapter. (iii) 10 to 80 (to provide 9 mg/ Lincomycin 40..... As in paragraph Feed as sole 057926 kg of body weight). (e)(2)(i) of this ration. Do not section; for feed to swine control of swine that weigh more dysentery in than 250 lbs.; animals on lincomycin as premises with a provided by history of swine 000009 in Sec. dysentery, but 510.600(c) of where symptoms this chapter. have not yet occurred. (iv) 10 to 80 (to provide 9 mg/ Lincomycin 100.... As in paragraph Feed as sole 057926 kg of body weight). (e)(2)(i) of this ration. Do not section; for the use within 6 days treatment of of slaughter. Do swine dysentery. not feed to swine that weigh more than 250 lbs.; lincomycin as provided by 000009 inSec. 510.600(c) of this chapter. (v) 10 to 80 (to provide 9 mg/kg Lincomycin 200.... As in paragraph Feed as sole 057926 of body weight). (e)(2)(i) of this ration. Do not section; for use within 6 days reduction in the of slaughter. Do severity of swine not feed to swine mycoplasmal that weigh more pneumonia caused than 250 pound by Mycoplasma (lb); lincomycin hyopneumoniae. as provided by 000009 in Sec. 510.600(c) of this chapter. (vi) 10 to 300 (to provide 9 mg/ Bacitracin Growing/finishing Feed as sole 046573 kg of body weight). methylene swine: As in ration. Under disalicylate 10 paragraph conditions of to 30. (e)(2)(i) of this continued section; for exposure to increased rate of parasites, weight gain and retreatment may improved feed be needed after 4 efficiency. to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in Sec. 510.600(c) of this chapter. (vii) 10 to 300 (to provide 9 mg/ Bacitracin 1. Growing/ 1. Growing/ 046573 kg of body weight). methylene finishing swine: finishing swine: disalicylate 250. As in paragraph Feed as sole (e)(2)(i) of this ration. Not for section; for use in growing control of swine and finishing dysentery swine that weigh associated with more than 250 Treponema lbs. Diagnosis of hyodysenteriae on swine dysentery premises with a should be history of swine confirmed by a dysentery, but veterinarian when where signs of results are not disease have not satisfactory. yet occurred; or Under conditions following an of continued approved exposure to treatment of the parasites, disease condition. retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in Sec. 510.600(c) of this chapter. .............................. ................. 2. Pregnant sows: 2. Pregnant sows: As in paragraph Feed as sole (e)(2)(i) of this ration. Diagnosis section; for of clostridial control of enteritis should clostridial be confirmed by a enteritis in veterinarian when suckling pigs results are not caused by satisfactory. Clostridium Under conditions perfringens. of continued exposure to parasites, retreatment may be needed after 4 to 6 weeks. Bacitracin methylene disalicylate as provided by 046573 in Sec. 510.600(c) of this chapter. (3) Cattle(i) Conditions of use are as follows:
[[Page 58937]]
Amount fenbendazole in grams per Combination in grams
ton per ton Indications for use Limitations Sponsor (A) 5 mg/kg body weight (2.27 mg/ ................... For the removal and Feed as sole ration 057926 lb). control of for one day. Do lungworms not use within 13 (Dictyocaulus days of slaughter. viviparus); barberpole worms (Haemonchus contortus); brown stomach worms (Ostertagia ostertagi); small stomach worms (Trichostrongylus axei); hookworms (Bunostomum phlebotomum); threadnecked intestinal worms (Nematodirus helvetianus); small intestinal worms (Cooperia oncophora and C. punctata), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum). (B) 5 mg/kg body weight (2.27 mg/ ................... As in paragraph Formulate as 057926 lb) in a freechoice feed. (e)(3)(i)(A) of specified in this section. paragraph (e)(3)(ii) of this section. Feed a total of 5 mg of fenbendazole per kg (2.27 mg/lb) of body weight to cattle over a 3 to 6day period. Retreatment may be needed after 4 to 6 weeks. Do not slaughter within 13 days following last treatment. (ii) Formulate for use as a freechoice cattle feed as in paragraph (e)(3)(i)(B) of this section as follows:
International Ingredient\1\ Percent feed No.

(A) Ingredient:.................

Copper sulfate.............. 0.45 601720

Dried Cane Molasses......... 3.12 404695

Monosodium phosphate........ 31.16 604288

Salt (sodium chloride)...... 59.00 604152

Zinc sulfate................ 0.76 605556

Fenbendazole Type A article 5.51
(20%)..........................

(B) Ingredient:.................

Dicalcium phosphate......... 32.31 600080

Limestone................... 17.13 602632

Magnesium oxide............. 9.79 602756

Zinc sulfate................ 1.47 605556

Copper sulfate.............. 0.29 601720

Potassium iodide............ 0.0098 603759

Dried Cane Molasses......... 0.98 404695

Selenium.................... 0.0002

Salt........................ 35.93 604152

Fenbendazole Type A article 2.09
(20%)..........................
\1\The content of any added vitamin and trace mineral may be varied; however, they should be comparable to those used by the firm for other freechoice feeds. Formulation modifications require FDA approval prior to marketing. The amount of selenium must comply with published regulations.
(4) Zoo and wildlife animals.
Amount Indications for Species/Class fenbendazole use Limitations Sponsor (i) Feral swine (Sus scrofa).. 3 mg/kg/day for 3 For the removal Use as complete 057926 days.. and control of feed. Prior kidney worm withdrawal of (Stephanurus feed or water dentatus), is not roundworm necessary. (Ascaris suum), Retreatment may nodular worm be required in (Oesophagostomum 6 weeks. Do not dentatum). use 14 days before or during the hunting season. (ii) Ruminants (subfamily 2.5 mg/kg/day for For the removal Use as complete 057926 Antilopinae, Hippotraginae, 3 days.. and control of feed. Prior Caprinae). small stomach withdrawal of worm feed or water (Trichostrongylu is not s spp.), thread necessary. necked Retreatment may intestinal worm be required in (Nematodirus 6 weeks. Do not spp.), use 14 days barberpole worm before or (Haemonchus during the spp.), whipworm hunting season. (Trichuris spp.). [[Page 58938]]
(iii) Rocky mountain bighorn 10 mg/kg/day for For the removal Use as complete 057926 sheep (Ovis c. canadensis). 3 days.. and control of feed. Prior Protostrongylus withdrawal of spp. feed or water is not necessary. Retreatment may be required in 6 weeks. Do not use 14 days before or during the hunting season.

Dated: November 9, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 0129352 Filed 112301; 8:45 am] BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT George K. Haibel, Center for Veterinary Medicine (HFV6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 3018274567, email:
ghaibel@cvm.fda.gov.