Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations 28813

DEPARTMENT OF HEALTH AND animal drug applications (NADAs) and Medicine (HFV–100), Food and Drug HUMAN SERVICES 14 approved abbreviated new animal Administration, 7520 Standish Pl., drug applications (ANADAs) for oral Rockville, MD 20855, 240–276–8300, Food and Drug Administration dosage form new animal drug products [email protected]. from Pfizer, Inc., including its several 21 CFR Parts 510 and 520 subsidiaries and divisions, to Zoetis, SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 E. 42d St., New York, NY [Docket No. FDA–2014–N–0002] Inc. FDA is also amending the animal drug regulations to remove entries 10017, and its wholly owned Oral Dosage Form New Animal Drugs; describing conditions of use for new subsidiaries Alpharma, LLC; Fort Dodge Change of Sponsor animal drug products for which no Animal Health, Division of Wyeth; Fort NADA is approved, to make minor Dodge Animal Health, Division of AGENCY: Food and Drug Administration, corrections, and to reflect a current Wyeth Holdings Corp.; and its division, HHS. format. This is being done to increase Pharmacia & Upjohn Co., have informed ACTION: Final rule; technical the accuracy and readability of the FDA that they have transferred amendments. regulations. ownership of, and all rights and interest in, the 172 approved NADAs and 14 SUMMARY: The Food and Drug DATES: This rule is effective May 20, approved ANADAs in table 1 to Zoetis, Administration (FDA) is amending the 2014. Inc., 333 Portage St., Kalamazoo, MI animal drug regulations to reflect a FOR FURTHER INFORMATION CONTACT: change of sponsor for 172 approved new Steven D. Vaughn, Center for Veterinary 49007 as follows:

TABLE 1—NADAS AND ANADAS BEING TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC.

File No. Product name

006–707 ...... SULQUIN (sulfaquinoxaline) 6–50 Soluble Powder. 006–891 ...... SUL–Q–NOX (sulfaquinoxaline) Liquid 34%. 007–879 ...... TERRAMYCIN VET (oxytetracycline hydrochloride) Capsules. 007–981 ...... SOXISOL (sulfisoxazole) Tablets. 008–622 ...... TERRAMYCIN (oxytetracycline hydrochloride) Soluble Powder. 009–339 ...... CARAFEN (ammonium chloride and caramiphen edisylate) Cough Syrup. 009–392 ...... Primidone Tablets. 010–091 ...... MYLEPSIN (primidone) Tablets. 011–060 ...... TERRAMYCIN (oxytetracycline hydrochloride) Scour Tablets. 011–299 ...... PARVEX (piperazine and carbon disulfide) Suspension. 011–315 ...... NEOMIX 325 (neomycin sulfate) Soluble Powder. 011–403 ...... MEDROL (methylprednisolone) Tablets. 011–482 ...... VETAME (triflupromazine hydrochloride) Tablets. 011–582 ...... VETAMOX (acetazolamide sodium) Soluble Powder. 011–590 ...... PARVEX (piperazine and carbon disulfide) Bolus. 011–700 ...... CORTABA (methylprednisolone and acetylsalicylic acid) Tablets. 012–437 ...... TEMARIL–P (trimeprazine tartrate and prednisolone) Tablets. 012–656 ...... Promazine Granules. 012–956 ...... DYREX (trichlorfon) Bolus, Capsules, Granules, Tablets. 013–201 ...... DARBAZINE SPANSULE (prochlorperazine and isopropamide) Capsules. 013–248 ...... Freed No. 10 or 25 (trichlorfon and atropine). 013–957 ...... S.E.Z. (sulfaethoxypyridazine) for Drinking Water 6.25%. 014–366 ...... CYTOBIN (liothyronine sodium) Tablets. 015–102 ...... ALBON (sulfadimethoxine) Tablets. 015–126 ...... Spectinomycin Tablet and Injection. 015–154 ...... DYREX T.F. (trichlorfon, phenothiazine, and piperazine dihydrochloride) Powder. 015–160 ...... Sodium Sulfachloropyrazine Solution. 015–506 ...... WINSTROL–V (stanozolol) Tablets. 030–137 ...... MYLEPSIN (primidone) Tablets. 030–415 ...... FLUCORT (flumethasone) Tablets. 030–416 ...... MESULFIN (sulfamethizole and methenamine mandelate) Tablets. 031–205 ...... AGRIBON (sulfadimethoxine) 12.5% Drinking Water Solution. 031–448 ...... RHEAFORM (iodochlorhydroxyquin) Bolus. 031–553 ...... ESB 3 (sodium sulfachloropyrazine monohydrate) Solution and Soluble Powder. 031–715 ...... ALBON (sulfadimethoxine) Boluses. 031–914 ...... NEO–DARBAZINE SPANSULE (prochlorperazine, isopropamide, and neomycin sulfate) Capsule. 032–738 ...... PACITRAN (metoserpate hydrochloride). 032–946 ...... MAGNA TERRAMYCIN (oxytetracycline hydrochloride and carbomycin) Soluble Powder. 033–149 ...... PARVEX PLUS (piperazine, carbon disulfide, phenothiazine) Suspension. 033–342 ...... PROBAN (cythioate) Tablets 30 mg. 033–606 ...... PROBAN (cythioate) Oral Liquid. 033–653 ...... S.E.Z. (sulfaethoxypyridazine) Drinking Water Solution. 033–654 ...... S.E.Z. (sulfaethoxypyridazine) Oblets 15 G. 033–760 ...... BLOAT GUARD (poloxalene) Drench Concentrate. 033–887 ...... LINCOCIN (lincomycin hydrochloride) Tablets. 035–161 ...... TEMARIL–P SPANSULE (trimeprazine tartrate and prednisolone) Capsules. 035–650 ...... DYREX (trichlorfon and atropine) Powder. 038–160 ...... MAOLATE (chlorphenesin carbamate) Tablets. 039–356 ...... TRAMISOL (levamisole hydrochloride) Cattle Wormer Bolus.

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TABLE 1—NADAS AND ANADAS BEING TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC.—Continued

File No. Product name

039–357 ...... RIPERCOL L (levamisole hydrochloride) Soluble Drench Powder. 039–729 ...... THERABLOAT (poloxalene) Oral Liquid. 040–587 ...... LINCOCIN (lincomycin hydrochloride) Aquadrops. 041–629 ...... Spectinomycin Oral Liquid. 041–665 ...... TRANVET (propiopromazine hydrochloride) Chewable Tablets. 042–548 ...... AMFOROL (kanamycin sulfate, attapulgite, bismuth subcarbonate) Suspension. 042–740 ...... TRAMISOL (levamisole hydrochloride) Soluble Drench Powder for Sheep. 042–837 ...... TRAMISOL (levamisole hydrochloride) Sheep Wormer Oblets. 042–841 ...... AMFOROL (kanamycin sulfate, attapulgite, bismuth subcarbonate) Oral Tablets. 042–888 ...... BANMINTH/STRONGID (pyrantel tartrate) Pellets. 043–078 ...... CENTRINE (aminopentamide hydrogen sulfate) Oral Tablets. 043–785 ...... ALBON (sulfadimethoxine) Oral Suspension 5%. 045–513 ...... RIPERCOL L (levamisole hydrochloride) Soluble Powder. 045–515 ...... EQUIBUTE (phenylbutazone) Tablets 100 mg. 045–715 ...... ROBAXIN–V (methocarbamol) Tablets. 046–109 ...... L–S 50 (lincomycin hydrochloride and spectinomycin sulfate) Water Soluble Powder. 046–285 ...... AGRIBON (sulfadimethoxine) Soluble Powder. 047–033 ...... S.E.Z. (sulfaethoxypyridazine) C–R Oblets 15 Gm. 049–892 ...... SPANBOLET II (sulfamethazine). 055–013 ...... OMNIPEN (ampicillin anhydrous) Capsules 250 mg. 055–020 ...... AUREOMYCIN (chlortetracycline bisulfate) Soluble Powder. 055–032 ...... DICLOXIN (dicloxacillin sodium monohydrate) Capsules. 055–042 ...... AMPI–TAB (ampicillin trihydrate) Tablets. 055–047 ...... CHLOROMYCETIN (chloramphenicol palmitate) Oral Suspension. 055–051 ...... CHLOROMYCETIN (chloramphenicol) Tablets. 055–060 ...... Penicillin G Potassium, USP. 055–073 ...... PANMYCIN (tetracycline hydrochloride) Tablets. 055–074 ...... AMPI–BOL (ampicillin trihydrate) Boluses. 055–076 ...... ALBAPLEX (tetracycline hydrochloride novobiocin sodium) Tablets. 055–078 ...... AMOXI–TABS (amoxicillin trihydrate) Tablets. 055–080 ...... AMOXI–DOSER (amoxicillin trihydrate) Oral Suspension. 055–081 ...... AMOXI–TABS (amoxicillin trihydrate) Tablets. 055–085 ...... AMOXI–DROP (amoxicillin trihydrate) Oral Suspension. 055–087 ...... AMOXI–BOL (amoxicillin trihydrate) Boluses. 055–088 ...... AMOXI–SOL (amoxicillin trihydrate) Soluble Powder. 055–099 ...... CLAVAMOX (amoxicillin trihydrate and clavulanate potassium) Tablets. 055–101 ...... CLAVAMOX (amoxicillin trihydrate and clavulanate potassium) Drops. 065–004 ...... PANMYCIN 500 (tetracycline hydrochloride) Bolus. 065–060 ...... PANMYCIN AQUADROPS (tetracycline hydrochloride) Liquid. 065–061 ...... TETRACHEL–VET (tetracycline hydrochloride) Drops and Syrup. 065–066 ...... TETRACHEL–VET (tetracycline hydrochloride) Tablets 100. 065–069 ...... TETRACHEL–VET (tetracycline hydrochloride) Capsules 500. 065–090 ...... DELTA ALBAPLEX (tetracycline hydrochloride, novobiocin sodium, prednisolone) Tablets. 065–099 ...... ALBAPLEX (tetracycline hydrochloride and novobiocin sodium) Capsules. 065–107 ...... ENTROMYCIN (bacitracin methylene disalicylate and streptomycin sulfate) Soluble Powder. 065–121 ...... Tetracycline-Vet (tetracycline hydrochloride) Capsules 250. 065–123 ...... Tetracycline Soluble Powder. 065–140 ...... TET–SOL 324 (tetracycline hydrochloride) Soluble Powder. 065–241 ...... MYCHEL–VET (chloramphenicol) Capsules (50 mg). 065–270 ...... POLYOTIC (tetracycline hydrochloride) Oblets. 065–280 ...... FORTRACIN (bacitracin methylene disalicyclate) Soluble. 065–313 ...... BACIFERM 50 (bacitracin zinc) Soluble Powder. 065–409 ...... PANMYCIN (tetracycline hydrochloride) Capsules. 065–410 ...... TETRA–SAL (tetracycline hydrochloride). 065–441 ...... POLYOTIC (tetracycline hydrochloride) Soluble Powder. 065–470 ...... BMD (bacitracin methylene disalicyclate) 50% Soluble Powder. 065–489 ...... MYCHEL–VET (chloramphenicol) Tablets. 091–065 ...... ROBIZONE–V (phenylbutazone) Tablets 100 mg. 091–327 ...... GASTROGRAFIN (diatrizoate meglumine and diatrizoate sodium) Oral Solution. 091–739 ...... STRONGID T (pyrantel pamoate) Oral Suspension. 092–237 ...... RIPERCOL L-Piperazine (levamisole hydrochloride and piperazine dihydrochloride) Oral Solution. 093–105 ...... ROBIZONE–V (phenylbutazone) Tablets 1 g. 093–107 ...... ALBON S.R. (sulfadimethoxine) Boluses. 093–512 ...... DIROCIDE (diethylcarbamazine citrate) Tablets. 093–688 ...... RIPERCOL L-Piperazine (levamisole hydrochloride and piperazine dihydrochloride) Soluble Powder. 093–903 ...... RUMATEL (morantel tartrate) Cattle Wormer Bolus. 095–333 ...... DIFOLIN (dichlorophene and toluene) Capsules. 095–641 ...... ARQUEL (meclofenamic acid) Granules. 096–509 ...... NBC Kaps Wormer (n-butyl chloride) Capsules. 096–674 ...... EQUIPROXEN (naproxen) Granules. 100–094 ...... Poultry Sulfa (sulfamerazine, sulfamethazine, sulfaquinoxaline) Soluble Powder. 100–237 ...... NEMEX (pyrantel pamoate) Oral Suspension.

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TABLE 1—NADAS AND ANADAS BEING TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC.—Continued

File No. Product name

100–929 ...... PRIMOR (sulfadimethoxine and ormetoprim) Tablets. 102–709 ...... CHEQUE (mibolerone) Drops. 103–390 ...... TORBUTROL (butorphanol tartrate) Tablets. 104–493 ...... FILARIBITS (diethylcarbamazine) Chewable Tablets. 107–085 ...... TRAMISOL (levamisole hydrochloride) Tablets. 108–687 ...... PET DERM III (dexamethasone) Tablets. 109–722 ...... ANTHELCIDE EQ (oxibendazole) Suspension. 110–048 ...... VALBAZEN (albendazole) Oral Suspension. 110–201 ...... ARQUEL (meclofenamic acid) Tablets. 110–776 ...... BENZELMIN (oxfendazole) Powder For Suspension. 110–777 ...... BENZELMIN (oxfendazole) Top Dress Pellets. 111–636 ...... LINCOMIX (lincomycin hydrochloride) Soluble Powder 115–578 ...... DI–TRIM (trimethoprim and sulfadiazine) Tablets. 120–161 ...... ANTIROBE (clindamycin hydrochloride) Capsules. 121–042 ...... ANTHELCIDE EQ (oxibendazole) Paste. 125–961 ...... RE–SORB Powder for Oral Solution. 126–232 ...... CALFSPAN (sulfamethazine) Tablets. 126–237 ...... TRAMISOL (levamisole hydrochloride) Gel. 128–070 ...... VALBAZEN (albendazole) Oral Paste. 128–517 ...... PET–DEC (diethylcarbamazine citrate) Tablets. 129–831 ...... BANMINTH–P/STRONGID (pyrantel pamoate) Paste. 130–435 ...... OXY–TET (oxytetracycline hydrochloride) Soluble Powder. 131–808 ...... DIROCIDE (diethylcarbamazine citrate) Syrup. 132–105 ...... BENZELMIN (oxfendazole) Equine Anthelmintic Paste. 133–841 ...... BENZELMIN (oxfendazole) Equine Anthelmintic Suspension. 134–779 ...... PARATECT FLEX (morantel Tartrate) Bolus. 135–544 ...... WINSTROL–V (stanozolol) Chewable Tablets. 135–940 ...... ANTIROBE AQUADROPS (clindamycin hydrochloride) Liquid. 136–342 ...... DI–TRIM 400 (trimethoprim and sulfadiazine) Paste. 136–483 ...... FILARIBITS PLUS (diethylcarbamazine citrate and oxibendazole) Chewable Tablets. 136–740 ...... BENZELMIN PLUS (oxfendazole and trichlorfon) Paste. 140–578 ...... SOLU–TET 324 (tetracycline hydrochloride) Soluble Powder. 140–819 ...... STRONGID C and C 2X (pyrantel tartrate) Equine Anthelminthic. 140–892 ...... SYNANTHIC (oxfendazole) Bovine Dewormer Paste 18.5%. 140–893 ...... CESTEX (epsiprantel) Tablets. 140–909 ...... SULKA–S (sulfamethazine) Bolus. 140–934 ...... VALBAZEN (albendazole) Oral Suspension. 141–004 ...... ROBAMOX–V (amoxicillin trihydrate) for Oral Suspension. 141–005 ...... ROBAMOX–V (amoxicillin trihydrate) Tablets. 141–051 ...... PROHEART (moxidectin) Tablets. 141–053 ...... RIMADYL (carprofen) Caplets for Dogs. 141–060 ...... DECCOX–M (decoquinate) Medicated Powder for Whole Milk. 141–080 ...... ANIPRYL (selegiline hydrochloride) Tablets. 141–087 ...... QUEST 2% (moxidectin) Equine Oral Gel. 141–111 ...... RIMADYL (carprofen) Chewable Tablets. 141–151 ...... ZENIQUIN (marbofloxacin) Tablets. 141–216 ...... QUEST PLUS (moxidectin and praziquantel) Gel. 141–232 ...... SIMPLICEF (cefpodoxime) Tablets. 141–260 ...... SLENTROL (dirlotapide) Oral Solution. 141–262 ...... CERENIA (maropitant) Tablets. 141–295 ...... PALLADIA (toceranib phosphate) Tablets. 200–046 ...... Neomycin Sulfate Soluble Powder. 200–106 ...... R–PEN (penicillin G potassium) Soluble Powder. 200–113 ...... BIOSOL (neomycin sulfate) Oral Liquid. 200–122 ...... SOLU–PEN (penicillin G potassium) Soluble Powder. 200–130 ...... NEO–SOL 50 (neomycin sulfate) Oral Solution. 200–189 ...... Lincomycin Soluble. 200–233 ...... LINCO Soluble. 200–244 ...... TUCOPRIM (trimethoprim and sulfadiazine) Powder. 200–441 ...... AUREOMYCYN (chlortetracycline) Soluble Powder.

Accordingly, the Agency is amending Following this change of sponsorship, In addition, FDA has noticed that the regulations in 21 CFR part 520 to Pfizer, Inc., and its wholly owned certain sections of part 520 contain reflect these transfers of ownership. subsidiaries are no longer sponsors of an entries describing conditions of use for Also, the regulations are being amended approved NADA. Accordingly, the new animal drug products for which no to make minor corrections and to reflect Agency is amending the regulations in NADA is approved. These errors were a current format. This is being done to 21 CFR 510.600(c) to reflect this change introduced by the Agency during the increase the accuracy and readability of of sponsorship. 1992 recodification of the regulations the regulations. for certifiable antibiotics (57 FR 37318,

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August 18, 1992). That rule did not (c) Conditions of use in dogs—(1) (2) Indications for use. For reducing identify whether particular regulations Amount. Administer orally at a dosage excessive smooth muscle contractions, were the subject of an approved NADA of 5 to 15 milligrams per pound of body such as occur in urethral spasms and consequently resulted in weight daily. associated with urolithiasis. codification of certain conditions of use (2) Indications for use. As an aid in (3) Limitations. Federal law restricts for which there is no approved NADA. the treatment of mild congestive heart this drug to use by or on the order of At this time, the Agency is amending failure and for rapid reduction of a licensed veterinarian. the regulations to remove these entries. intraocular pressure. ■ 10. Revise § 520.82b to read as This action is being taken to improve (3) Limitations. Federal law restricts follows: the accuracy of the regulations. this drug to use by or on the order of This rule does not meet the definition a licensed veterinarian. § 520.82b Aminopropazine and neomycin. of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because § 520.38a [Amended] (a) Specifications. Each tablet it is a rule of ‘‘particular applicability.’’ contains aminopropazine fumarate ■ Therefore, it is not subject to the 5. In paragraph (b) of § 520.38a, equivalent to 25 percent congressional review requirements in 5 remove ‘‘000069’’ and in its place add aminopropazine base and neomycin U.S.C. 801–808. ‘‘054771’’. sulfate equivalent to 50 milligrams (mg) List of Subjects § 520.38b [Amended] of neomycin base. (b) Sponsor. See No. 000061 in 21 CFR Part 510 ■ 6. In paragraph (b) of § 520.38b, § 510.600(c) of this chapter. remove ‘‘000069’’ and in its place add Administrative practice and (c) Conditions of use in dogs—(1) ‘‘054771’’. Amount. Administer orally at a dosage procedure, Animal drugs, Labeling, ■ Reporting and recordkeeping 7. Revise § 520.62 to read as follows: of 1 to 2 mg per pound of body weight, requirements. repeated every 12 hours as indicated. § 520.62 Aminopentamide. (2) Indications for use. For control of 21 CFR Part 520 (a) Specifications. Each tablet bacterial diarrhea caused by organisms contains 0.2 milligram (mg) Animal drugs. susceptible to neomycin and to reduce aminopentamide hydrogen sulphate. smooth muscle contractions. Therefore, under the Federal Food, (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts Drug, and Cosmetic Act and under § 510.600(c) of this chapter. this drug to use by or on the order of authority delegated to the Commissioner (c) Conditions of use in dogs and a licensed veterinarian. of Food and Drugs and redelegated to cats—(1) Amount. Administer orally the Center for Veterinary Medicine, 21 every 8 to 12 hours as follows: For ■ 11. In § 520.88a, revise paragraphs (a), CFR parts 510 and 520 are amended as animals weighing up to 10 pounds (lbs): (b), (c)(1)(i) and (iii), and (c)(2)(i) and follows: 0.1 mg; for animals weighing 11 to 20 (iii) to read as follows: lbs: 0.2 mg; for animals weighing 21 to PART 510—NEW ANIMAL DRUGS § 520.88a Amoxicillin trihydrate film- 50 lbs: 0.3 mg; for animals weighing 51 coated tablets. to 100 lbs: 0.4 mg; for animal weighing ■ 1. The authority citation for 21 CFR (a) Specifications. Each tablet over 100 lbs: 0.5 mg. Dosage may be part 510 continues to read as follows: contains amoxicillin trihydrate gradually increased up to a maximum of equivalent to 50, 100, 150, 200, or 400 Authority: 21 U.S.C. 321, 331, 351, 352, five times the suggested dosage. Oral 353, 360b, 371, 379e. milligrams (mg) amoxicillin. administration of tablets may be (b) Sponsor. See No. 054771 in § 510.600 [Amended] preceded by subcutaneous or § 510.600(c) of this chapter. intramuscular use of the injectable form ■ 2. In § 510.600, in the table in (c) * * * of the drug. paragraph (c)(1), remove the entries for (1) * * * (2) Indications for use. For the (i) Amount. Administer orally 5 mg ‘‘Alpharma, LLC’’; ‘‘Fort Dodge Animal treatment of vomiting and/or diarrhea, Health, Division of Wyeth’’; ‘‘Fort Dodge per pound (/lb) of body weight, twice a nausea, acute abdominal visceral spasm, day for 5 to 7 days. Animal Health, Division of Wyeth pylorospasm, or hypertrophic gastritis. Holdings Corp.’’; ‘‘Pfizer, Inc.’’; and (3) Limitations. Federal law restricts * * * * * (iii) Limitations. Federal law restricts ‘‘Pharmacia & Upjohn Co.’’; and in the this drug to use by or on the order of this drug to use by or on the order of table in paragraph (c)(2), remove the a licensed veterinarian. a licensed veterinarian. entries for ‘‘000009’’, ‘‘000069’’, ■ ‘‘000856’’, ‘‘046573’’, and ‘‘053501’’. 8. Revise § 520.82 to read as follows: (2) * * * § 520.82 Aminopropazine oral dosage (i) Amount. Administer orally 5 to 10 PART 520—ORAL DOSAGE FORM forms. mg/lb of body weight, once daily for 5 NEW ANIMAL DRUGS to 7 days. ■ 9. Revise § 520.82a to read as follows: * * * * * ■ 3. The authority citation for 21 CFR § 520.82a Aminopropazine. (iii) Limitations. Federal law restricts part 520 continues to read as follows: (a) Specifications. Each tablet this drug to use by or on the order of Authority: 21 U.S.C. 360b. contains aminopropazine fumarate a licensed veterinarian. ■ 4. Revise § 520.28 to read as follows: equivalent to 25 percent ■ 12. In § 520.88b, revise paragraphs (a), aminopropazine base. § 520.28 Acetazolamide. (b), (b)(1)(i)(A) and (C), (b)(1)(ii)(A) and (b) Sponsor. See No. 000061 in (C), and (c)(1)(i) and (iii) to read as (a) Specifications. A powder § 510.600(c) of this chapter. follows: containing acetazolamide sodium, USP (c) Conditions of use in dogs and equivalent to 25 percent acetazolamide cats—(1) Amount. Administer orally at § 520.88b Amoxicillin trihydrate for oral activity. a dosage of 1 to 2 milligrams per pound suspension. (b) Sponsor. See No. 054771 in of body weight, repeated every 12 hours (a) Specifications. When § 510.600(c) of this chapter. as indicated. reconstituted, each milliliter contains

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amoxicillin trihydrate equivalent to 50 (d) Conditions of use in preruminating § 520.88g Amoxicillin trihydrate and milligrams (mg) amoxicillin. calves including veal calves—(1) clavulanate potassium film-coated tablets. (b) Sponsor. See No. 054771 in Amount. Administer 400 mg per 100 * * * * * § 510.600(c) of this chapter. pounds of body weight twice daily by (b) Sponsor. See No. 054771 in (1) * * * drench or in milk. Treatment should be § 510.600(c) of this chapter. (i) * * * continued for 48 hours after all (c) * * * (A) Amount. Administer orally 5 mg symptoms have subsided but not to (1) * * * per pound (/lb) of body weight, twice a exceed 5 days. (i) Amount. 6.25 milligrams day for 5 to 7 days. * * * * * (equivalent to 5 milligrams amoxicillin * * * * * (3) Limitations. Do not slaughter and 1.25 milligrams clavulanic acid) per (C) Limitations. Federal law restricts animals during treatment or for 20 days pound of body weight twice daily for 5 this drug to use by or on the order of after the latest treatment. Federal law to 7 days or for 48 hours after all signs a licensed veterinarian. have subsided. Deep pyoderma may (ii) * * * restricts this drug to use by or on the order of a licensed veterinarian. require treatment for 21 days; do not (A) Amount. Administer orally 5 to 10 treat for more than 30 days. mg/lb of body weight, once daily for 5 ■ 15. In § 520.88e, revise paragraphs (a), * * * * * to 7 days. (b), (d) heading, (d)(1), and(3) to read as (iii) Limitations. Federal law restricts * * * * * follows: this drug to use by or on the order of (C) Limitations. Federal law restricts § 520.88e Amoxicillin trihydrate boluses. a licensed veterinarian. this drug to use by or on the order of (2) * * * a licensed veterinarian. (a) Specifications. Each bolus contains (i) Amount. 62.5 milligrams (1 * * * * * amoxicillin trihydrate equivalent to 400 milliliter) (50 milligrams amoxicillin (c) * * * milligrams (mg) amoxicillin. and 12.5 milligrams clavulanic acid) (1) Conditions of use in dogs—(i) (b) Sponsor. See No. 054771 in twice daily for 5 to 7 days or for 48 Amount. Administer orally 5 mg/lb of § 510.600(c) of this chapter. hours after all signs have subsided. body weight, twice a day for 5 to 7 days. * * * * * Urinary tract infections may require * * * * * (d) Conditions of use in cattle—(1) treatment for 10 to 14 days or longer. (iii) Limitations. Federal law restricts Amount. Administer 400 mg per 100 The maximum duration of treatment this drug to use by or on the order of pounds of body weight twice daily. should not exceed 30 days. a licensed veterinarian. Treatment should be continued for 48 * * * * * * * * * * hours after all symptoms have subsided (iii) Limitations. Federal law restricts but not to exceed 5 days. ■ 13. In § 520.88c, revise paragraphs (a), this drug to use by or on the order of (b), (d) heading, (d)(1), and (d)(3) to read * * * * * a licensed veterinarian. as follows: (3) Limitations. Do not slaughter ■ 18. In § 520.88h, revise paragraphs (b), animals during treatment or for 20 days (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to § 520.88c Amoxicillin trihydrate oral after the latest treatment. Federal law read as follows: suspension. restricts this drug to use by or on the (a) Specifications. Each 0.8-milliliter order of a licensed veterinarian. § 520.88h Amoxicillin trihydrate and dose contains amoxicillin trihydrate clavulanate potassium for oral suspension. equivalent to 40 milligrams (mg) ■ 16. Revise § 520.88f to read as follows: * * * * * amoxicillin. § 520.88f Amoxicillin trihydrate tablets. (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. (a) Specifications. Each tablet (c) * * * contains amoxicillin trihydrate * * * * * (1) * * * (d) Conditions of use in swine—(1) equivalent to 50, 100, 200, or 400 (i) Amount. 6.25 milligrams Amount. Administer 40 mg orally twice milligrams (mg) amoxicillin. (equivalent to 5 milligrams amoxicillin a day using a dosing pump. Treat (b) Sponsors. See Nos. 051311 and and 1.25 milligrams clavulanic acid) per animals for 48 hours after all symptoms 054771 in § 510.600(c) of this chapter. pound of body weight twice daily for 5 have subsided but not beyond 5 days. (c) Conditions of use in dogs—(1) to 7 days or for 48 hours after all signs Amount. Administer 5 mg per pound of * * * * * have subsided. Deep pyoderma may (3) Limitations. Do not slaughter body weight twice daily for 5 to 7 days require treatment for 21 days; do not during treatment or for 15 days after or 48 hours after all symptoms have treat for more than 30 days. subsided. latest treatment. Federal law restricts * * * * * (2) Indications for use. For treatment this drug to use by or on the order of (iii) Limitations. Federal law restricts of bacterial dermatitis due to a licensed veterinarian. this drug to use by or on the order of Staphylococcus aureus, Streptococcus a licensed veterinarian. ■ 14. In § 520.88d, revise paragraphs (a), spp., Staphylococcus spp., and (2) * * * (b), (d) heading, (d)(1), and (d)(3) to read Escherichia coli; and soft tissue (i) Amount. 62.5 milligrams (1 as follows: infections (abscesses, wounds, milliliter) (50 milligrams amoxicillin lacerations) due to S. aureus, § 520.88d Amoxicillin trihydrate soluble and 12.5 milligrams clavulanic acid) powder. Streptococcus spp., E. coli, Proteus twice daily. Administer 48 hours after mirabilis, and Staphylococcus spp. (a) Specifications. Each gram of all signs have subsided. Maximum (3) Limitations. Federal law restricts powder contains amoxicillin trihydrate duration of treatment should not exceed this drug to use by or on the order of equivalent to 115.4 milligrams (mg) 30 days. a licensed veterinarian. amoxicillin. * * * * * (b) Sponsor. See No. 054771 in ■ 17. In § 520.88g, revise paragraphs (b), (iii) Limitations. Federal law restricts § 510.600(c) of this chapter. (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to this drug to use by or on the order of * * * * * read as follows: a licensed veterinarian.

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§ 520.90a [Reserved] ■ 23. In § 520.90e, revise the section to 1, 5, or 10 milligrams (mg) ■ 19. Remove and reserve § 520.90a. heading and paragraph (d)(3) to read as butorphanol base. ■ 20. In § 520.90b, revise the section follows: (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. heading, paragraph (b), paragraph (c) § 520.90e Ampicillin for soluble powder. heading, and paragraph (c)(3) to read as (c) Conditions of use in dogs—(1) follows: * * * * * Amount. Administer 0.25 mg (d) * * * butorphanol base per pound of body § 520.90b Ampicillin tablets. (3) Limitations. Treated swine must weight. Repeat at intervals of 6 to 12 * * * * * not be slaughtered for food during hours as required. Treatment should not (b) Sponsor. See No. 054771 in treatment and for 24 hours following the normally be required for longer than 7 § 510.600(c) of this chapter. last treatment. Federal law restricts this days. (c) Conditions of use in dogs— drug to use by or on the order of a (2) Indications for use. For the relief * * * * * licensed veterinarian. of chronic nonproductive cough (3) Limitations. Federal law restricts ■ 24. In § 520.90f, revise the section associated with tracheobronchitis, this drug to use by or on the order of heading and revise paragraph (b) and in tracheitis, tonsillitis, laryngitis, and a licensed veterinarian. paragraphs (d)(1)(ii) and (d)(2)(ii), pharyngitis associated with ■ 21. In § 520.90c, revise the section remove the second sentence.. inflammatory conditions of the upper heading, paragraphs (b), (c)(1)(iii), and The revisions read as follows: respiratory tract. (c)(2)(iii) to read as follows: (3) Limitations. Federal law restricts § 520.90f Ampicillin boluses. this drug to use by or on the order of § 520.90c Ampicillin capsules. * * * * * a licensed veterinarian. * * * * * (b) Sponsors. See sponsor numbers in § 520.260 [Amended] (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter as follows: § 510.600(c) of this chapter. (1) No. 055529 for use as in paragraph ■ 30. In § 520.260, remove footnote 1 (c) * * * (d)(1) of this section; wherever it occurs; and in paragraph (1) * * * (2) No. 054771 for use as in paragraph (b)(2), remove ‘‘000069’’ and in its place (iii) Limitations. Federal law restricts (d)(2) of this section. add ‘‘054771’’. this drug to use by or on the order of * * * * * ■ 31. In § 520.300a, revise paragraph (c) a licensed veterinarian. ■ 25. In § 520.110, revise paragraph (d) to read as follows: (2) * * * to read as follows: (iii) Limitations. Federal law restricts § 520.300a Cambendazole suspension. this drug to use by or on the order of § 520.110 Apramycin sulfate soluble * * * * * a licensed veterinarian. powder. (c) Conditions of use in horses—(1) ■ 22. In § 520.90d, revise the section * * * * * Amount. Administer by stomach tube or heading, paragraphs (c)(1)(i) and (iii), (d) Conditions of use in swine—(1) as a drench at a dose of 0.9 gram of and (c)(2)(i) and (iii) to read as follows: Amount. Administer in drinking water cambendazole per 100 pounds of body at the rate of 12.5 milligrams of weight (20 milligrams per kilogram). § 520.90d Ampicillin for oral suspension. apramycin per kilogram (5.7 milligrams (2) Indications for use. For the control * * * * * per pound) of body weight per day for of large strongyles (Strongylus vulgaris, (c) * * * 7 days. S. edentatus, S. equinus); small (1) * * * (2) Indications for use. For the control strongyles (Trichonema, (i) Amount. Administer to 10 of porcine colibacillosis (weanling pig Poteriostomum, Cylicobrachytus, milligrams per pound of body weight scours) caused by strains of Escherichia Craterostomum, Oesophagodontus); orally, 2 or 3 times daily, 1 to 2 hours coli sensitive to apramycin. roundworms (Parascaris); pinworms prior to feeding. In severe or acute (3) Limitations. Prepare fresh (Oxyuris); and threadworms conditions, 10 milligrams per pound of medicated water daily. Do not slaughter (Strongyloides). body weight 3 times daily. Duration of treated swine for 28 days following (3) Limitations. Do not use in horses treatment is usually 3 to 5 days. treatment. intended for human consumption. Continue treatment 48 hours after the Federal law restricts this drug to use by animal’s temperature has returned to § 520.154a [Amended] or on the order of a licensed normal and all other signs of infection ■ 26. In paragraph (b) of § 520.154a, veterinarian. have subsided. remove ‘‘046573’’ and in its place add ■ 32. In § 520.300b, revise paragraph (c) * * * * * ‘‘054771’’. to read as follows: (iii) Limitations. Federal law restricts this drug to use by or on the order of § 520.154b [Amended] § 520.300b Cambendazole pellets. a licensed veterinarian. ■ 27. In paragraph (b) of § 520.154b, * * * * * (2) * * * remove ‘‘046573’’ and in its place add (c) Conditions of use in horses—(1) (i) Amount. Administer 10 to 30 ‘‘054771’’. Amount. Administer 20 milligrams milligrams per pound of body weight cambendazole per kilogram body weight orally, 2 or 3 times daily, 1 to 2 hours § 520.154c [Amended] (6 ounces per 1,000 pounds) by mixing prior to feeding. Duration of treatment is ■ 28. In paragraph (b) of § 520.154c, with normal grain ration given at one usually 3 to 5 days. Continue treatment remove ‘‘053501’’ and in its place add feeding. Doses for individual horses 48 hours after the animal’s temperature ‘‘054771’’. should be mixed and fed separately to has returned to normal and all other ■ 29. Revise § 520.246 to read as assure that each horse will consume the signs of infection have subsided. follows: correct amount. For animals maintained * * * * * on premises where reinfection is likely (iii) Limitations. Federal law restricts § 520.246 Butorphanol tablets. to occur, re-treatments may be this drug to use by or on the order of (a) Specifications. Each tablet necessary. For most effective results, re- a licensed veterinarian. contains butorphanol tartrate equivalent treat in 6 to 8 weeks.

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(2) Indications for use. For the control place add ‘‘054771’’; and remove ■ 47. In § 520.534, revise paragraph (a), of large strongyles (Strongylus vulgaris, paragraph (b)(1)(iii). and in paragraph (b), remove ‘‘046573’’ S. edentatus, S. equinus); small and in its place add ‘‘054771’’. strongyles (Trichonema, § 520.390b [Amended] The revision reads as follows: Poteriostomum, Cylicobrachytus, ■ 38. In § 520.390b, in paragraph (b), § 520.534 Decoquinate. Craterostomum, Oesophagodontus); remove ‘‘000069 and 050057’’ and in its roundworms (Parascaris); pinworms place add ‘‘050057 and 054771’’. (a) Specifications. Each gram of (Oxyuris); and threadworms powder contains 8 milligrams (0.8 (Strongyloides). § 520.390c [Amended] percent) decoquinate. (3) Limitations. Do not administer to ■ 39. In § 520.390c, in paragraph (b), * * * * * pregnant mares during first 3 months of remove ‘‘000856’’ and in its place add ■ 48. Revise § 520.540a to read as pregnancy. Do not use in horses ‘‘054771’’. follows: intended for human consumption. Consult your veterinarian for assistance § 520.420 [Amended] § 520.540a Dexamethasone powder. in the diagnosis, treatment, and control ■ 40. In § 520.420, remove footnote 1 (a) Specifications. Each packet of parasitism. wherever it occurs. contains 10 milligrams (mg) of dexamethasone. ■ 33. In § 520.300c, revise paragraph (c) § 520.434 [Amended] (b) Sponsor. See No. 000061 in to read as follows: ■ 41. In § 520.434, in paragraph (b), § 510.600(c) of this chapter. § 520.300c Cambendazole paste. remove ‘‘000009’’ and in its place add (c) Conditions of use in cattle and * * * * * ‘‘054771’’; and in paragraph (c)(3), horses—(1) Amount. Administer 5 to 10 (c) Conditions of use in horses—(1) remove the first four sentences. mg per animal the first day then 5 mg Amount. Administer 20 milligrams per day as required by drench or by § 520.441 [Amended] cambendazole per kilogram body weight sprinkling on a small amount of feed. (5 grams per 550 pounds (250 ■ 42. In § 520.441, in paragraph (b)(2), (2) Indications for use. As supportive kilograms)) by depositing the paste on remove ‘‘046573 and 000010’’ and in its therapy following parenteral steroid the back of the tongue using a dosing place add ‘‘000010 and 054771’’. administration for management or gun. For animals maintained on inflammatory conditions such as acute premises where reinfection is likely to § 520.446 [Amended] arthritic lameness, and for various stress occur, re-treatments may be necessary. ■ 43. In § 520.446, in paragraph (b)(1), conditions where corticosteroids are For most effective results, re-treat in 6 remove ‘‘000009 and 000859’’ and in its required while the animal is being to 8 weeks. place add ‘‘000859 and 054771’’. treated for a specific condition. (3) Limitations. Federal law restricts (2) Indications for use. For the control § 520.447 [Amended] this drug to use by or on the order of of large strongyles (Strongylus vulgaris, a licensed veterinarian. A withdrawal S. edentatus, S. equinus); small ■ 44. In § 520.447, in paragraph (b), period has not been established for this strongyles (Trichonema, remove ‘‘000009, 000859, 051311’’ and product in preruminating calves. Do not Poteriostomum, Cylicobrachytus, in its place add ‘‘000859, 051311, use in calves to be processed for veal. Craterostomum, Oesophagodontus); 054771’’. Do not use in horses intended for roundworms (Parascaris); pinworms human consumption. (Oxyuris); and threadworms § 520.530 [Amended] ■ (Strongyloides). ■ 45. In § 520.530, in paragraph (b), 49. In § 520.540b, remove footnote 1 (3) Limitations. Do not administer to remove ‘‘053501’’ and in its place add wherever it occurs; and revise pregnant mares during first 3 months of ’’ 054771’’; and in paragraph (d)(3), paragraphs (a)(3) and (b)(3) to read as pregnancy. Do not use in horses remove the first two sentences. follows: intended for human consumption. ■ 46. Amend § 520.531 as follows: § 520.540b Dexamethasone tablets and Consult your veterinarian for assistance ■ a. Add paragraph (a); boluses. in the diagnosis, treatment, and control ■ b. Remove paragraph (c); (a) * * * of parasitism. ■ c. Redesignate paragraph (d) as (3) Conditions of use in cattle and § 520.309 [Amended] paragraph (c); and horses—(i) Amount. Administer orally 5 ■ d. Revise paragraph (b) and newly to 10 milligrams on the first day, then ■ 34. In § 520.309, in paragraph (b)(1), redesignated paragraph (c)(3). 5 milligrams per day as required. remove ‘‘000069’’ and in its place add The addition and revision read as (ii) Indications for use. As supportive ‘‘054771’’. follows: therapy following parenteral steroid § 520.310 [Amended] administration for management or § 520.531 Cythioate tablets. inflammatory conditions such as acute ■ 35. In § 520.310, in paragraph (b), (a) Specifications. Each tablet arthritic lameness, and for various stress remove ‘‘000856’’ and in its place add contains 30 or 90 milligrams (mg) conditions where corticosteroids are ‘‘054771’’; and remove footnote 1 cythioate. required while the animal is being wherever it occurs. (b) Sponsors. See sponsor numbers in treated for a specific condition. § 510.600(c) of this chapter as follows: (iii) Limitations. Federal law restricts § 520.370 [Amended] (1) No. 000859 for use of 30- and 90- this drug to use by or on the order of ■ 36. In § 520.370, in paragraph (b), mg tablets; a licensed veterinarian. A withdrawal remove ‘‘000009 and 026637’’ and in its (2) No. 054771 for use of the 30-mg period has not been established for this place add ‘‘026637 and 054771’’. tablet. product in preruminating calves. Do not (c) * * * use in calves to be processed for veal. § 520.390a [Amended] (3) Limitations. Federal law restricts Do not use in horses intended for ■ 37. In § 520.390a, in paragraph this drug to use by or on the order of human consumption. (b)(1)(ii), remove ‘‘000856’’ and in its a licensed veterinarian. (b) * * *

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(3) Conditions of use in dogs and § 520.608 Dicloxacillin. pound (/lb) of body weight for 3 to 5 cats—(i) Amount. Dogs: Administer * * * * * days; orally 0.25 to 1.25 milligrams per day (b) Sponsor. See No. 054771 in (ii) For hookworms (Ancylostoma for up to 7 days. Cats: Administer orally § 510.600 (c) of this chapter. caninum, Uncinaria stenocephala) and 0.125 to 0.5 milligrams per day for up (c) Conditions of use in dogs—(1) whipworms (Trichuris vulpis): 10 mg/lb to 7 days. Amount. Administer orally 5 to 10 of body weight for 7 days; (ii) Indications for use. As an anti- milligrams per pound of body weight, (iii) For Strongyloides (Strongyloides inflammatory agent. three times daily. In severe cases, up to canis, Strongyloides stercoralis): 10 mg/ (iii) Limitations. Federal law restricts 25 milligrams per pound of body weight lb of body weight for 10 to 12 days; this drug to use by or on the order of three times daily. (iv) For heartworm microfilariae a licensed veterinarian. (2) Indications for use. For the (Dirofilaria immitus): 3 to 5 mg/lb of ■ 50. Amend § 520.540c as follows: treatment of pyoderma (pyogenic body weight for 7 to 10 days. Treatment ■ a. Remove footnote 1 wherever it dermatitis) due to penicillinase- for heartworm microfilariae should producing staphylococci sensitive to occurs; follow 6 weeks after therapy for adult ■ b. In paragraph (b), remove ‘‘000069’’ dicloxacillin. worms. and in its place add ‘‘054771’’; and (3) Limitations. Federal law restricts ■ c. Revise paragraph (c). this drug to use by or on the order of (2) Limitations. Federal law restricts The revision reads as follows: a licensed veterinarian. this drug to use by or on the order of a licensed veterinarian. § 520.540c Dexamethasone chewable § 520.622a [Amended] ■ tablets. 62. Revise § 520.763b to read as ■ 55. In § 520.622a, in paragraph (a)(2), follows: * * * * * remove ‘‘053501’’ and in its place add (c) Conditions of use in dogs—(1) ‘‘054771’’. § 520.763b Dithiazanine powder. Amount. Administer by free-choice (a) Specifications. Each tablespoon of feeding or crumbled over food 0.25 to § 520.622b [Amended] powder contains 200 milligrams (mg) 1.25 milligrams daily in single or two ■ 56. In § 520.622b, in paragraph (a)(2), dithiazanine iodide. divided doses until response is noted or remove ‘‘053501’’ and in its place add (b) Sponsor. See No. 000010 in 7 days have elapsed. When response is ‘‘054771’’. § 510.600(c) of this chapter. attained, dosage should be gradually (c) Conditions of use in dogs—(1) reduced by 0.125 milligram per day § 520.622c [Amended] Indications for use and amount. until maintenance level is achieved. ■ 57. In § 520.622c, in paragraph (b)(2), Administer orally by mixing in food as (2) Indications for use. As supportive remove ‘‘000069’’ and in its place add therapy in nonspecific dermatosis and follows: ‘‘054771’’. (i) For large roundworms (Toxocara inflammatory conditions. ■ (3) Limitations. Federal law restricts 58. In § 520.623, revise the section canis, Toxascaris leonina): 10 mg per this drug to use by or on the order of heading and paragraphs (b) and (c)(3) to pound (/lb) of body weight for 3 to 5 a licensed veterinarian. read as follows: days; § 520.623 Diethylcarbamazine and (ii) For hookworms (Ancylostoma § 520.550 [Removed] oxibendazole chewable tablets. caninum, Uncinaria stenocephala) and ■ 51. Remove § 520.550. * * * * * whipworms (Trichuris vulpis): 10 mg/lb ■ 52. In § 520.563, revise the section (b) Sponsor. See No. 054771 in of body weight for 7 days; heading, remove ‘‘053501’’ in paragraph § 510.600(c) of this chapter. (iii) For Strongyloides (Strongyloides (b) and in its place add ‘‘054771’’, and (c) * * * canis, Strongyloides stercoralis): 10 mg/ revise paragraph (c). (3) Limitations. Federal law restricts lb of body weight for 10 to 12 days; The revisions read as follows: this drug to use by or on the order of (iv) For heartworm microfilariae a licensed veterinarian. (Dirofilaria immitus): 3 to 5 mg/lb of § 520.563 Dexamethasone chewable tablets. body weight for 7 to 10 days. Treatment § 520.666 [Amended] for heartworm microfilariae should * * * * * ■ 59. In § 520.666, in paragraph (b), follow 6 weeks after therapy for adult (c) Conditions of use in dogs and remove ‘‘000069’’ and in its place add worms. cats—(1) Amount. Administer orally 0.5 ‘‘054771’’. (2) Limitations. Federal law restricts to 1.0 milliliter per pound of body ■ 60. Revise § 520.763 to read as this drug to use by or on the order of weight by gavage or stomach tube. follows: a licensed veterinarian. Administered rectally 0.5 to 1.0 ■ milliliter per pound of body weight § 520.763 Dithiazanine oral dosage forms. 63. In § 520.763c, redesignate paragraph (d) as paragraph (c); and diluted with 1 part of the drug to 5 parts ■ 61. Revise § 520.763a to read as revise paragraphs (a), (b), and the of water. follows: (2) Indications for use. For redesignated paragraph (c) heading to radiography of the gastrointestinal tract. § 520.763a Dithiazanine tablets. read as follows: (3) Limitations. Federal law restricts (a) Specifications. Each tablet § 520.763c Dithiazanine and piperazine this drug to use by or on the order of contains 10, 50, 100, or 200 milligrams suspension. a licensed veterinarian. (mg) dithiazanine iodide. (a) Specifications. Each milliliter of (b) Sponsor. See No. 054628 in § 520.580 [Amended] suspension contains 69 milligrams (mg) § 510.600(c) of this chapter. ■ 53. In § 520.580, in paragraph (b)(2), (c) Conditions of use in dogs—(1) dithiazanine iodide and 83 mg remove ‘‘054628’’ and in its place add Indications for use and amount. piperazine base (as piperazine citrate). ‘‘054771’’. Administer orally immediately after (b) Sponsor. See No. 054628 in ■ 54. In § 520.608, revise the section feeding as follows: § 510.600(c) of this chapter. heading and paragraphs (b) and (c) to (i) For large roundworms (Toxocara (c) Conditions of use in horses— read as follows: canis, Toxascaris leonina): 10 mg per * * * * *

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■ 64. Amend § 520.784 by revising the ■ c. Revise paragraph (c). (b) Sponsor. See No. 000859 in section heading and paragraph (c) to The revisions read as follows: § 510.600(c) of this chapter. read as follows: (c) Conditions of use in horses—(1) § 520.863 Ethylisobutrazine. Amount. 3 milliliters per 100 pounds § 520.784 Doxylamine. * * * * * body weight or 1 fluid ounce per 1000 * * * * * (c) Conditions of use in dogs—(1) pounds (6 milligrams per kilogram body (c) Conditions of use—(1) Amount. Amount. Administer orally 2 to 5 weight). Administer by stomach tube or Horses: Administer orally 1 to 2 milligrams per pound of body weight drench, or by mixing well into a portion milligrams (mg) per pound (/lb) of body once daily. of the normal grain ration. For animals weight per day divided into 3 or 4 equal (2) Indications for use. As a maintained on premises where doses. Dogs and cats: Administer orally tranquilizer. reinfection is likely to occur, 2 to 3 mg/lb of body weight per day (3) Limitations. Federal law restricts retreatment may be necessary. For most divided into 3 or 4 equal doses. this drug to use by or on the order of effective results, retreat in 6 to 8 weeks. (2) Indications for use. For use when a licensed veterinarian. (2) Indications for use. For removal of antihistaminic therapy may be expected ■ 69. In § 520.870, add paragraph (c) ascarids (Parascaris equorum—adult to alleviate some signs of disease in and remove paragraph (d). and sexually immature), pinworms horses, dogs, and cats. The addition reads as follows: (Oxyuris equi—adult and 4th stage (3) Limitations. Do not use in horses larvae), large strongyles (Strongylus § 520.870 Etodolac. intended for human consumption. vulgaris, S. edentatus, S. equinus), and Federal law restricts this drug to use by * * * * * various small strongyles in horses, or on the order of a licensed (c) Conditions of use in dogs—(1) breeding stallions and mares, pregnant veterinarian. Amount. Administer 10 to 15 mg per mares, foals, and ponies. kilogram (4.5 to 6.8 mg per pound) of ■ 65. Revise § 520.804 to read as (3) Limitations. Do not use in horses body weight per day orally. follows: intended for human consumption. (2) Indications for use. For the Federal law restricts this drug to use by § 520.804 Enalapril. management of pain and inflammation or on the order of a licensed (a) Specifications. Each tablet associated with osteoarthritis. veterinarian. (3) Limitations. Federal law restricts contains 1.0, 2.5, 5.0, 10, or 20 * * * * * milligrams (mg) of enalapril maleate. this drug to use by or on the order of a licensed veterinarian. ■ 72. In § 520.903d, revise the section (b) Sponsor. See No. 050604 in heading and paragraph (c)(3) and ■ 70. Revise § 520.903a to read as § 510.600(c) of this chapter. remove paragraph (c)(4). follows: (c) Conditions of use in dogs—(i) The revisions read as follows: Amount. Administer orally 0.5 to 1.0 mg § 520.903a Febantel paste. of enalapril maleate per kilogram of § 520.903d Febantel and praziquantel body weight per day. (a) Specifications. Each gram of paste paste. (ii) Indications for use. For the contains 455 milligrams (45.5 percent) * * * * * treatment of mild, moderate, and severe febantel. (c) * * * (modified New York Heart Association (b) Sponsor. See No. 000859 in (3) Limitations. Federal law restricts Class II, III, IV) heart failure in dogs. § 510.600(c) of this chapter. this drug to use by or on the order of (c) Conditions of use in horses—(1) (iii) Limitations. Federal law restricts a licensed veterinarian. Amount. Administer paste orally at 6 this drug to use by or on the order of ■ 73. In § 520.903e, revise paragraphs milligrams per kilogram (2.73 a licensed veterinarian. (b) and (c)(3) to read as follows: milligrams per pound) of body weight ■ 66. In § 520.816, revise the section on the base of the tongue or well mixed § 520.903e Febantel tablets. heading and paragraphs (b) and (c)(3) to into a portion of the normal grain ration. read as follows: * * * * * For animals maintained on premises (b) Sponsor. See No. 000859 in § 520.816 Epsiprantel. where reinfection is likely to occur, § 510.600(c) of this chapter. retreatment may be necessary. For most * * * * * (c) * * * effective results, retreat in 6 to 8 weeks. (b) Sponsor. See No. 050604 in (3) Limitations. Federal law restricts (2) Indications for use. For removal of § 510.600(c) of this chapter. this drug to use by or on the order of large strongyles (Strongylus vulgaris, S. (c) * * * a licensed veterinarian. edentatus, S. equinus); ascarids (3) Limitations. Federal law restricts ■ 74. In § 520.960, revise the section (Parascaris equorum—sexually mature this drug to use by or on the order of heading and paragraphs (b) and (c)(3) to and immature); pinworms (Oxyuris a licensed veterinarian. read as follows: equi—adult and 4th stage larva); and ■ 67. In § 520.823, revise the section various small strongyles in horses, foals, § 520.960 Flumethasone. heading and paragraph (a) to read as and ponies. * * * * * follows: (3) Limitations. Do not use in horses (b) Sponsor. See No. 054771 in § 520.823 Erythromycin. intended for human consumption. § 510.600(c) of this chapter. Consult your veterinarian for assistance (a) Specifications. Each gram of (c) * * * in the diagnosis, treatment, and control (3) Limitations. Federal law restricts powder contains erythromycin of parasitism. this drug to use by or on the order of phosphate equivalent to 0.89 gram of ■ a licensed veterinarian. erythromycin master standard. 71. In § 520.903b, revise paragraphs (a), (b), and (c) to read as follows: ■ 75. Add § 520.1060 to read as follows: * * * * * ■ 68. Amend § 520.863 as follows: § 520.903b Febantel suspension. § 520.1060 Glucose and glycine. ■ a. Revise the section heading; (a) Specifications. Each ounce of (a) Specifications. Each packet of ■ b. Remove footnote 1 wherever it suspension contains 2.75 grams (9.3 powder contains 8.82 grams sodium occurs; and percent ounce) febantel. chloride, 4.20 grams potassium

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phosphate, 0.5 gram citric acid ■ b. Redesignate paragraphs (b) through ■ 80. In § 520.1158, revise the section anhydrous, 0.12 gram potassium citrate, (f) as paragraphs (a) through (e), heading and paragraphs (b) and (c)(3) to 6.36 grams aminoacetic acid (glycine), respectively; and read as follows: and 44.0 grams glucose. ■ c. Revise newly redesignated § 520.1158 Iodochlorhydroxyquin. (b) Sponsor. See No. 054771 in paragraphs (a) and (e). § 510.600(c) of this chapter. The revisions read as follows: * * * * * (b) Sponsor. See No. 054771 in (c) Conditions of use in calves—(1) § 520.1120a Haloxon drench. Amount. Dissolve each packet in 2 § 510.600 (c) of this chapter. * * * * * quarts of warm water and administer to (c) * * * (a) Specifications. Each packet (3) Limitations. Do not use in horses each calf as follows: contains 141.5 grams haloxon. (i) Scouring and/or dehydrated calves. intended for human consumption. * * * * * Feed 2 quarts of solution, twice daily for Federal law restricts this drug to use by (e) Conditions of use in cattle—(1) or on the order of a licensed 2 days (four feedings). No milk or milk Amount. Dissolve each packet in 32 replacer should be fed during this veterinarian. fluid ounces of water and administer as ■ 81. In § 520.1196, revise the section period. For the next four feedings (days follows: For animals weighing up to 100 heading and paragraphs (c)(1)(i) and (iii) 3 and 4), use 1 quart of solution together pounds: 1/2 fluid ounce; for animals to read as follows: with 1 quart of milk replacer. weighing 100 to 150 pounds: 3/4 fluid Thereafter, feed as normal. ounce; for animals weighing 150 to 200 § 520.1196 Ivermectin and pyrantel tablets. (ii) Newly purchased calves. Feed 2 pounds: 1 fluid ounce; for animals * * * * * quarts of solution instead of milk as the weighing 200 to 300 pounds: 1 1/2 fluid first feed upon arrival. For the next (c) * * * ounces; for animals weighing 300 to 450 (1) * * * scheduled feeding, use 1 quart of pounds: 2 fluid ounces; for animals solution mixed together with 1 quart of (i) Amount. Administer a minimum of weighing 450 to 700 pounds: 3 fluid m milk or milk replacer. Thereafter, feed 6 g of ivermectin and 5 mg of pyrantel ounces; for animals weighing 700 to m as normal. per kilogram (2.72 g and 2.27 mg per 1,000 pounds: 4 fluid ounces; for pound) of body weight monthly. (2) Indications for use. For control of animals weighing 1,000 to 1,200 dehydration associated with diarrhea pounds: 5 fluid ounces; for animals * * * * * (scours); and as an early treatment at the weighing over 1,200 pounds: 6 fluid (iii) Limitations. Federal law restricts first signs of scouring. It may also be ounces. Retreat in 3 to 4 weeks. this drug to use by or on the order of used as followup treatment following (2) Indications for use. For control of a licensed veterinarian. intravenous fluid therapy. gastrointestinal roundworms of the * * * * * genera Haemonchus, Ostertagia, (3) Limitations. The product should § 520.1199 [Amended] not be used in animals with severe Trichostrongylus, and Cooperia. dehydration (down, comatose, or in a (3) Limitations. Do not treat dairy ■ 82. In § 520.1199, in paragraph (b), state of shock). Such animals need animals of breeding age. Do not treat remove ‘‘Sponsors’’ and in its place add intravenous therapy. A veterinarian within 1 week of slaughter. ‘‘Sponsor’’. ■ 78. Amend § 520.1120b as follows: should be consulted in severely § 520.1204 [Amended] scouring calves. The product is not ■ a. Remove paragraph (a); nutritionally complete if administered ■ b. Redesignate paragraphs (b) through ■ 83. In § 520.1204, in paragraph (b), by itself for long periods of time. It (e) as paragraphs (a) through (d), remove ‘‘000856’’ and in its place add should not be administered beyond the respectively; and ‘‘054771’’. ■ c. Revise newly redesignated recommended treatment period without § 520.1242a [Amended] the addition of milk or milk replacer. paragraph (d). The revisions read as follows: ■ ■ 76. In § 520.1100, revise paragraphs 84. In § 520.1242a, in paragraph (b)(2), (d)(1)(ii) and (d)(2)(i)(A) to read as § 520.1120b Haloxon boluses. remove ‘‘053501’’ and in its place add ‘‘054771’’. follows: * * * * * (d) Conditions of use in cattle—(1) ■ 85. Revise § 520.1242b to read as § 520.1100 Griseofulvin. Amount. Administered one bolus per follows: * * * * * 500 pounds body weight (35 to 50 § 520.1242b Levamisol boluses or oblets. (d) * * * milligrams per kilogram of body (1) * * * weight). Retreat in 3 to 4 weeks. (a) Specifications. Each bolus contains (ii) Limitations. Do not use in horses (2) Indications for use. For control of 2.19 grams levamisol hydrochloride. intended for human consumption. gastrointestinal roundworms of the Each oblet contains 0.184 grams (2) * * * genera Haemonchus, Ostertagia, levamisol hydrochloride. (b) Sponsors. See Nos. 000061 and (i) * * * Trichostrongylus, and Cooperia. 054771 in § 510.600(c) of this chapter. (A) Daily (single or divided) dose as (3) Limitations. Do not treat dairy (c) Required labeling. Consult your follows: For animals weighing up to 6 animals of breeding age or older. Do not veterinarian for assistance in the pounds: 62.5 milligrams; for animals treat within 1 week of slaughter. diagnosis, treatment, and control of weighing 6 to 18 pounds: 125 ■ 79. In § 520.1157, revise the section parasitism. milligrams; for animals weighing 18 to heading and paragraph (c)(3) to read as (d) Related tolerances. See § 556.350 36 pounds: 250 milligrams; for animals follows: of this chapter. weighing 36 to 48 pounds: 375 § 520.1157 Iodinated casein. (e) Conditions of use—(1) Cattle—(i) milligrams; for animal weighing 48 to 75 Amount. Administer orally 2.19-gram pounds: 500 milligrams. * * * * * (c) * * * boluses as a single dose as follows: 250 * * * * * (3) Limitations. Federal law restricts to 450 pounds, 1⁄2 bolus; 450 to 750 ■ 77. Amend § 520.1120a as follows: this drug to use by or on the order of pounds, 1 bolus; and 750 to 1,050 ■ a. Remove paragraph (a); a licensed veterinarian. pounds, 11⁄2 boluses.

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(ii) Indications for use. Anthelmintic spp.), ascarids (Parascaris equorum), remove ‘‘046573’’ and in its place add effective against the following nematode and pinworms (Oxyuris equi). ‘‘054771’’. infections: Stomach worms (3) Limitations. Do not use in horses (Haemonchus, Trichostrongylus, intended for human consumption. § 520.1265 [Amended] Ostertagia), intestinal worms Federal law restricts this drug to use by ■ 92. In § 520.1265, in paragraph (b)(1) (Trichostrongylus, Cooperia, or on the order of a licensed remove ‘‘000009’’ and in its place add Nematodirus, Bunostomum, veterinarian. ‘‘054771’’. Oesophagostomum), and lungworms ■ § 520.1242e [Amended] 93. Revise § 520.1284 to read as (Dictyocaulus). follows: (iii) Limitations. Conditions of ■ 87. In paragraph (b) of § 520.1242e, constant helminth exposure may require remove ‘‘053501’’ and in its place add § 520.1284 Liothyronine. re-treatment within 2 to 4 weeks after ‘‘054771’’. (a) Specifications. Each tablet the first treatment. Do not slaughter for ■ 88. In § 520.1242f, revise the section contains 60 or 120 micrograms (mg) food within 48 hours of treatment. Not heading and paragraphs (a) and (b) to liothyronine as the sodium salt. for use in dairy animals of breeding age. read as follows: (b) Sponsor. See No. 054771 in Consult veterinarian before using in § 510.600(c) of this chapter. severely debilitated animals. § 520.1242f Levamisol gel. (c) Conditions of use in dogs—(1) (2) Sheep—(i) Amount. Administer (a) Specifications. Each gram of gel Amount. Administer orally to dogs at orally one 0.184-gram oblet for each 50 contains 115 milligrams (11.5 percent) levels up to 12.8 mg per kilogram (/kg) pounds of body weight. levamisol hydrochloride. of body weight per day. Dosage should (ii) Indications for use. Anthelmintic (b) Sponsor. See No. 054771 in be adjusted according to the severity of effective against the following nematode § 510.600(c) of this chapter. the condition and the response of the infections: Stomach worms * * * * * patient. Dosage at the total replacement (Haemonchus, Trichostrongylus, m ■ 89. Amend § 520.1242g as follows: level (12.8 g/kg of body weight) should Ostertagia), intestinal worms ■ be considered for initiating therapy and (Trichostrongylus, Cooperia, a. Remove paragraph (a); ■ b. Redesignate paragraphs (b) through then titrated downward for optimum Nematodirus, Bunostomum, maintenance effect. Twice daily Oesophagostomum, Chabertia), and (f) as paragraphs (a) through (e); and ■ c. Revise newly redesignated administration is recommended. lungworms (Dictyocaulus). (2) Indications for use. For treatment (iii) Limitations. Conditions of paragraph (d). The revision reads as follows: of hypothyroidism in dogs. constant helminth exposure may require (3) Limitations. Federal law restricts re-treatment within 2 to 4 weeks after § 520.1242g Levamisole resinate and this drug to use by or on the order of the first treatment. Do not slaughter for famphur paste. a licensed veterinarian. food within 72 hours of treatment. * * * * * ■ 94. In § 520.1310, in paragraph (b), Consult a veterinarian before using in (d) Related tolerances. See §§ 556.273 remove ‘‘000069’’ and in its place add severely debilitated animals. and 556.350 of this chapter. ‘‘054771’’; and revise the section ■ 86. Revise § 520.1242c to read as * * * * * heading to read as follows: follows: ■ 90. Revise § 520.1263a to read as § 520.1310 Marbofloxacin. § 520.1242c Levamisol and piperazine. follows: * * * * * (a) Specifications. (1) Each ounce of § 520.1263a Lincomycin tablets and syrup. solution contains 0.36 gram of § 520.1315 [Amended] (a) Specifications. (1) Each ounce of levamisole hydrochloride and ■ 95. In paragraph (b) of § 520.1315, piperazine dihydrochloride equivalent syrup contains lincomycin hydrochloride equivalent to either 25 or remove ‘‘000069’’ and in its place add to 3.98 grams of piperazine base. ‘‘054771’’. (2) A soluble powder which when 50 milligrams (mg) lincomycin. constituted with water contains in each (2) Each tablet contains lincomycin ■ 96. Revise § 520.1320 to read as fluid ounce 0.45 gram of levamisole hydrochloride equivalent to either 25 or follows: hydrochloride and piperazine 50 mg lincomycin. dihydrochloride equivalent to 5.0 grams (b) Sponsor. See No. 054771 in § 520.1320 Mebendazole. of piperazine base. § 510.600(c) of this chapter. (a) Specifications. (1) Each gram of (b) Sponsor. See No. 054771 in (c) Conditions of use in dogs and powder contains either 40 or 166.7 § 510.600(c) of this chapter. cats—(1) Amount. Administer orally 10 milligrams of mebendazole. (c) Conditions of use in horses—(1) mg per pound of body weight every 12 (2) Each gram of paste contains 200 Amount. Aqueous solution: administer hours, or 7 mg per pound of body milligrams of mebendazole. by stomach tube or drench 1 fluid ounce weight every 8 hours, for up to 12 days. (3) Each milliliter of suspension per 100 pounds of body weight. (2) Indications for use. For infections contains 33.3 milligrams of Reconstituted soluble powder: caused by gram-positive organisms mebendazole. administer by stomach tube 1 fluid which are sensitive to its action, (b) Sponsor. See No. 000061 in ounce per 125 pounds of body weight. particularly streptococci and § 510.600(c) of this chapter. If reinfection occurs, re-treat animals at staphylococci. (c) Conditions of use—(1) Horses—(i) 6- to 8-week intervals. (3) Limitations. Federal law restricts Amount. 1 gram of mebendazole per 250 (2) Indications for use. An this drug to use by or on the order of pounds of body weight per dose, as an anthelmintic effective against infections a licensed veterinarian. oral powder, paste or suspension. of large strongyles (Strongylus vulgaris, (ii) Indications for use. For treatment S. edentatus), small strongyles § 520.1263c [Amended] of infections caused by large (Cylicocercus spp., Cylicocyclus spp., ■ 91. In § 520.1263c, in paragraph (b)(1) roundworms (Parascaris equorum); Cylicodontophorus spp., remove ‘‘000009’’ and in its place add large strongyles (Strongylus edentatus, Cylicostephanus spp., Cylicotetrapedon ‘‘054771’’; and in paragraph (b)(2) S. equinus, S. vulgaris); small

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strongyles; and mature and immature Federal law restricts this drug to use by ■ 103. Revise § 520.1408 to read as (4th larval stage) pinworms (Oxyuris or on the order of a licensed follows: equi). veterinarian. § 520.1408 Methylprednisolone. (iii) Limitations. The drug is ■ compatible with carbon disulfide. Do 100. In § 520.1331 revise paragraphs (a) Specifications. Each tablet not use in horses intended for human (b) and (c)(3) to read as follows: contains 1, 2, or 4 milligrams (mg) of methylprednisolone. consumption. Federal law restricts this § 520.1331 Meclofenamic acid tablets. (b) Sponsors. See sponsors in drug to use by or on the order of a * * * * * licensed veterinarian. § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (1) No. 054628 for use of 1- and 2-mg (2) Dogs—(i) Amount. Administer 100 § 510.600(c) of this chapter. tablets. milligrams of mebendazole per 10 (c) * * * (2) No. 054771 for use of 1- and 4-mg pounds of body weight, once daily for (3) Limitations. Federal law restricts tablets. 3 days, as an oral powder by mixing this drug to use by or on the order of (c) Conditions of use in dogs and with a small quantity of food, preferably a licensed veterinarian. cats—(1) Amount. 5 to 15 pounds (lbs): before the regular meal. ■ 101. In § 520.1341, revise the section 2 mg; 15 to 40 lbs: 2 to 4 mg; 40 to 80 (ii) Indications for use. The drug is lbs: 4 to 8 mg. Administer total daily used for treatment of infections of heading and paragraphs (b) and (c) to read as follows: dose orally in equally divided doses 6 roundworms (Toxocara canis), to 10 hours apart until response is noted hookworms (Ancylostoma caninum, § 520.1341 Megestrol. or 7 days have elapsed. Uncinaria stenocephala), whipworms (2) Indications for use. As an anti- (Trichuris vulpis), and tapeworms * * * * * (b) Sponsor. See No. 000061 in inflammatory agent. (Taenia pisiformis). § 510.600(c) of this chapter. (3) Limitations. Federal law restricts (iii) Limitations. Federal law restricts (c) Conditions of use in dogs—(1) this drug to use by or on the order of this drug to use by or on the order of Amount. Administer orally, intact, or a licensed veterinarian. a licensed veterinarian. crushed and mixed with food as ■ 104. Amend § 520.1409 as follows: ■ 97. In § 520.1326a revise the follows: ■ a. Revise the section heading and paragraph (c) heading and paragraph (i) For the postponement of estrus by paragraph (b); (c)(3) to read as follows: proestrus treatment: 1 milligram per ■ b. Remove paragraphs (c) and (d); pound of body weight per day for 8 ■ c. Redesignate paragraph (e) as § 520.1326a Mebendazole and trichlorfon days. paragraph (c); and powder. (ii) For the postponement of estrus by ■ d. Revise newly redesignated * * * * * anestrus treatment: 0.25 milligram per paragraph (c). (c) Conditions of use in horses— pound of body weight per day for 32 The revisions read as follows: * * * * * days. (iii) For alleviation of false pregnancy: § 520.1409 Methylprednisolone and (3) Limitations. Do not use in horses aspirin. intended for human consumption. 1 milligram per pound of body weight per day for 8 days. * * * * * Federal law restricts this drug to use by (b) Sponsor. See No. 054771 in or on the order of a licensed (2) Indications for use. For the postponement of estrus and the § 510.600(c) of this chapter. veterinarian. (c) Conditions of use in dogs—(1) alleviation of false pregnancy in female 1 ■ 98. In § 520.1326b revise the dogs. Amount. Under 15 pounds, ⁄4 to 1 paragraph (c) heading to read as follows: (3) Limitations. Federal law restricts tablet daily; 15 to 60 pounds, 1 to 2 this drug to use by or on the order of tablets daily; 60 pounds and over, 2 § 520.1326b Mebendazole and trichlorfon a licensed veterinarian. tablets daily. Administer total daily paste. dose in divided doses 6 to 10 hours * * * * * ■ 102. Revise § 520.1380 to read as apart, with a light feeding. When (c) Conditions of use in horses— follows: response is attained, dosage should be gradually reduced until maintenance * * * * * § 520.1380 Methocarbamol. level is achieved. ■ 99. Revise § 520.1330 to read as (a) Specifications. Each tablet (2) Indications for use. As an anti- follows: contains 500 milligrams (mg) of inflammatory and analgesic agent. methocarbamol. (3) Limitations. Federal law restricts § 520.1330 Meclofenamic acid granules. (b) Sponsor. See No. 054771 in this drug to use by or on the order of (a) Specifications. Each gram of § 510.600(c) of this chapter. a licensed veterinarian. granules contains 5 milligrams (5 (c) Conditions of use in dogs and percent) meclofenamic acid. cats—(1) Amount. Administer 60 mg § 520.1422 [Amended] (b) Sponsor. See No. 054771 in per pound of body weight in two or ■ 105. In § 520.1422, in paragraph (b), § 510.600(c) of this chapter. three equally divided doses, followed remove ‘‘053501’’ and in its place add (c) Conditions of use in horses—(1) each following day by 30 to 60 mg per ‘‘054771’’. Amount. Administer 1 milligram per pound of body weight, usually not to ■ 106. In § 520.1430 revise the section pound of body weight (1 gram per 1000 exceed 14 to 21 days. heading and paragraphs (b) and (c) to pounds) once daily for 5 to 7 days by (2) Indications for use. As an adjunct read as follows: addition to the daily grain ration. to therapy for acute inflammatory and (2) Indications for use. For the traumatic conditions of the skeletal § 520.1430 Megestrol acetate tablets. treatment of acute or chronic muscles in order to reduce muscular * * * * * inflammatory diseases involving the spasms. (b) Sponsor. See No. 054771 in musculoskeletal system. (3) Limitations. Federal law restricts § 510.600(c) of this chapter. (3) Limitations. Do not use in horses this drug to use by or on the order of (c) Conditions of use in dogs—(1) intended for human consumption. a licensed veterinarian. Amount. 30 micrograms for animals

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weighing 1 to 25 pounds; 60 micrograms § 520.1468 Naproxen. labeled: ‘‘Federal law restricts this drug for animals weighing 26 to 50 pounds; (a) Specifications. Each gram of to use by or on the order of a licensed 120 micrograms for animals weighing 51 granules contains 500 milligrams (mg) veterinarian.’’ to 100 pounds; 180 micrograms for (50 percent) naproxen. (d) Conditions of use in horses—(1) animals weighing over 100 pounds, (b) Sponsor. See No. 054771 in Amount. For uses other than for German Shepherds, or German § 510.600(c) of this chapter. threadworms (Strongyloides westeri), 10 Shepherd mix. Administer daily, orally (c) Conditions of use in horses—(1) mg oxibendazole per kilogram (/kg) or in a small amount of food, at least 30 Amount. 10 mg per kilogram of body body weight; for threadworms days before expected initiation of heat, weight twice daily top dressed on feed (Strongyloides westeri), 15 mg/kg. and continue daily as long as desired, for up to 14 consecutive days. Horses maintained on premises where but not for more than 24 months. (2) Indications for use. For the relief reinfection is likely to occur should be (2) Indications for use. For the of inflammation and associated pain re-treated in 6 to 8 weeks. Administer prevention of estrus (heat) in adult and lameness exhibited with arthritis, as suspension product by stomach tube in female dogs not intended primarily for well as myositis and other soft tissue 3 to 4 pints of warm water, or by top breeding purposes. diseases of the musculoskeletal system. dressing or mixing into a portion of the normal grain ration. (3) Limitations. Federal law restricts (3) Limitations. Do not use in horses intended for human consumption. (2) Indications for use. For removal this drug to use by or on the order of and control of large strongyles a licensed veterinarian. Federal law restricts this drug to use by or on the order of a licensed (Strongylus edentatus, S. equinus, S. § 520.1450a [Amended] veterinarian. vulgaris); small strongyles (genera Cylicostephanus, Cylicocyclus, ■ 107. In § 520.1450a, in paragraph (b), § 520.1484 [Amended] Cyathostomum, Triodontophorus, remove ‘‘000069’’ and in its place add ■ 114. In § 520.1484, in paragraph (b)(1) Cylicodontophorus, and ‘‘054771’’. remove ‘‘000069’’ and in its place add Gyalocephalus); large roundworms (Parascaris equorum); pinworms § 520.1450b [Amended] ‘‘054771’’; in paragraph (b)(2) remove ‘‘000009, 046573,’’ and in its place add (Oxyuris equi) including various larval ■ 108. In § 520.1450b, in paragraph (b), ‘‘054771,’’; and in paragraph (b)(3) stages; and threadworms (Strongyloides remove ‘‘000069’’ and in its place add remove ‘‘000009, 000859,’’ and in its westeri). ‘‘054771’’. place add ‘‘000859, 054771,’’. (3) Limitations. Do not use in horses intended for human consumption. § 520.1450c [Amended] § 520.1628 [Amended] § 520.1640 [Removed] ■ 109. In § 520.1450c, in paragraph (b), ■ 115. In paragraph (b) of § 520.1628, ■ 120. Remove § 520.1640. remove ‘‘000069’’ and in its place add remove ‘‘000856’’ and in its place add ‘‘054771’’. ‘‘054771’’. § 520.1660a [Amended] § 520.1451 [Amended] § 520.1629 [Amended] ■ 121. In paragraph (b) of § 520.1660a, remove ‘‘000069’’ and in its place add ■ 116. In § 520.1629, in paragraphs ■ 110. In § 520.1451, in paragraph (b), ‘‘054771’’. remove ‘‘000856’’ and in its place add (a)(2) and (b)(2), remove ‘‘000856’’ and ‘‘054771’’; remove paragraph (c); in its place add ‘‘054771’’. § 520.1660b [Amended] redesignate paragraph (d) as paragraph ■ 117. Revise paragraph (b) of ■ 122. In § 520.1660b, in paragraph (b), (c); and in newly redesignated § 520.1630 to read as follows: remove ‘‘000069’’ and in its place add paragraph (c)(3), remove the first § 520.1630 Oxfendazole suspension. ‘‘054771’’; and in paragraph (c), sentence. wherever it occurs, remove footnote 1. * * * * * ■ 111. In § 520.1452, in paragraph (b), (b) Sponsor. See Nos. 000010 and § 520.1660c [Amended] remove ‘‘000856’’ and in its place add 054771 in § 510.600(c) of this chapter. ■ 123. In § 520.1660c, in paragraphs (b) ‘‘054771’’; and revise paragraph (d)(3) to * * * * * and (d)(3), remove ‘‘000069’’ and in its read as follows: § 520.1631 [Amended] place add ‘‘No. 054771’’. § 520.1452 Moxidectin gel. ■ 118. In § 520.1631, in paragraph (b), § 520.1660d [Amended] * * * * * remove ‘‘000856’’ and in its place add ■ 124. In § 520.1660d, in paragraphs (d) * * * ‘‘054771’’. (b)(1), (d)(1)(ii)(A)(3), (d)(1)(ii)(B)(3), (3) Limitations. Do not use in horses ■ 119. Revise § 520.1638 to read as (d)(1)(ii)(C)(3), and (d)(1)(iii)(C), remove intended for human consumption. follows: ‘‘000069’’ and in its place add ■ ‘‘054771’’; in paragraph (b)(2), remove 112. In § 520.1453, in paragraph (b), § 520.1638 Oxibendazole. remove ‘‘000856’’ and in its place add ‘‘046573’’ and in its place add ‘‘054771’’; and revise paragraph (d)(3) to (a) Specifications—(1) Each gram of ‘‘054771’’; in paragraphs (d)(1)(ii)(A)(3), read as follows: paste contains 227 milligrams (mg) (22.7 (d)(1)(ii)(B)(3), (d)(1)(ii)(C)(3), and percent) oxibendazole. (d)(1)(iii)(C), remove ‘‘046573, 053389’’ § 520.1453 Moxidectin and praziquantel (2) Each milliliter of suspension and in its place add ‘‘048164, 054771’’; gel. contains 100 mg (10 percent) and in paragraph (d)(1)(ii)(C)(3), in the * * * * * oxibendazole. seventh sentence, remove ‘‘salughter’’ (d) * * * (b) Sponsor. See No. 054771 in and in its place add ‘‘slaughter’’. § 510.600(c) of this chapter. (3) Limitations. Do not use in horses (c) Special considerations—(1) See § 520.1696b [Amended] intended for human consumption. § 500.25 of this chapter. ■ 125. In § 520.1696b, in paragraph (b), ■ 113. Revise § 520.1468 to read as (2) Suspension product described in remove ‘‘046573, 053501’’ and in its follows: paragraph (a)(2) of this section shall be place add ‘‘054771’’.

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■ 126. Amend § 520.1696c as follows: § 520.1720c Phenylbutazone paste. ‘‘No. 054771’’; and revise the paragraph ■ a. Remove paragraph (c); * * * * * (c) heading and paragraphs (c)(1) and (3) ■ b. Redesignate paragraph (d) as (c) * * * to read as follows: paragraph (c); and (3) Limitations. Do not use in horses ■ c. Revise newly redesignated intended for human consumption. § 520.1802c Piperazine-carbon disulfide complex with phenothiazine suspension. paragraph (c) heading and (c)(3). Federal law prohibits the use of this The revisions read as follows: drug in female dairy cattle 20 months of * * * * * § 520.1696c Penicillin V powder. age or older. Federal law restricts this (c) Conditions of use in horses and drug to use by or on the order of a ponies—(1) Amount. Administer 1 fluid * * * * * (c) Conditions of use in dogs and licensed veterinarian. ounce per 100 pounds of body weight cats— ■ 131. Amend § 520.1720d as follows: by stomach tube or dose syringe after ■ a. Remove paragraph (c); withholding feed overnight or for 8 to * * * * * ■ b. Redesignate paragraph (d) as 10 hours. (3) Limitations. Federal law restricts paragraph (c); and * * * * * this drug to use by or on the order of ■ c. Revise newly redesignated (3) Limitations. Do not use in horses a licensed veterinarian. paragraph (c)(3). ■ 127. Amend § 520.1696d as follows: The revisions read as follows: intended for human consumption. ■ a. Revise paragraph (b); Federal law restricts this drug to use by ■ b. Remove paragraph (c); § 520.1720d Phenylbutazone gel. or on the order of a licensed ■ c. Redesignate paragraph (d) as * * * * * veterinarian. paragraph (c); (c) * * * ■ ■ d. Revise newly redesignated 135. In § 520.1803, revise paragraphs (3) Limitations. Do not use in horses (a) and (c) to read as follows: paragraph (c) heading and (c)(3). intended for human consumption. The revisions read as follows: Federal law prohibits the use of this § 520.1803 Piperazine citrate capsules. drug in female dairy cattle 20 months of § 520.1696d Penicillin V tablets. (a) Specifications. Each capsule age or older. Federal law restricts this * * * * * contains piperazine citrate equivalent to drug to use by or on the order of a (b) Sponsors. See Nos. 050604 and 140 milligrams of piperazine base. licensed veterinarian. 054771 in § 510.600(c) of this chapter. * * * * * (c) Conditions of use in dogs and ■ 132. Amend § 520.1802a as follows: cats— ■ a. In paragraph (b), remove ‘‘000009’’ (c) Conditions of use in dogs and and in its place add ‘‘No. 054771’’; cats—(1) Amount. The contents of 1 * * * * * ■ (3) Limitations. Federal law restricts b. Remove footnote 1 wherever it capsule should be mixed with the food this drug to use by or on the order of appears in paragraph (c); and of the animal for each 5 pounds, or ■ c. Revise the paragraph (c) heading a licensed veterinarian. fraction thereof of body weight, except and paragraphs (c)(1) and (3) dogs weighing over 25 pounds should § 520.1720a [Amended] The revisions read as follows: be given the contents of 6 capsules. The drug should be mixed in 1/2 of the ■ 128. In § 520.1720a, in paragraph § 520.1802a Piperazine-carbon disulfide (b)(3), remove ‘‘000856’’ and in its place complex suspension. regular feeding and when the animal add ‘‘054771’’. has finished eating the dosed food, the * * * * * remainder of the food may be given. ■ 129. Revise § 520.1720b to read as (c) Conditions of use in horses and Dogs and cats may be wormed at 6 to follows: ponies—(1) Amount. Administer 1 fluid 8 weeks of age. The first treatment ounce per 100 pounds of body weight § 520.1720b Phenylbutazone granules. should be repeated 10 days later. by stomach tube or dose syringe after (a) Specifications. Each package of Reinfection may occur. Repeat treatment withholding feed overnight or for 8 to granules contains 1 or 8 grams of if indicated. 10 hours. phenylbutazone. (2) Indications for use. For the (b) Sponsors. See sponsors in * * * * * (3) Limitations. Do not use in horses removal of large roundworms (Toxocara § 510.600(c) of this chapter. canis and Toxascaris leonina). (1) No. 000061 for 8-gram package. intended for human consumption. (2) No. 059320 for 1-gram package. Federal law restricts this drug to use by (3) Limitations. Severely debilitated (c) Conditions of use in horses—(1) or on the order of a licensed animals should not be treated except on Amount. Administer 1 to 2 grams per veterinarian. the advice of a veterinarian. 500 pounds of body weight, not to ■ 133. Amend § 520.1802b as follows: § 520.1804 [Amended] exceed 4 grams, daily as required. by ■ a. In paragraph (b), remove ‘‘000009’’ adding to a portion of the usual grain and in its place add ‘‘No. 054771’’; ■ 136. In § 520.1804, in paragraph (b), ration. ■ b. Revise the paragraph (c) heading; remove ‘‘051311’’ and in its place add (2) Indications for use. For the and ‘‘054771’’; and in paragraph (c) remove treatment of inflammatory conditions ■ c. Remove footnote 1 wherever it footnote 1 wherever it appears. associated with the musculoskeletal appears in paragraph (c). system. The revision reads as follows: ■ 137. In § 520.1805, revise paragraph (3) Limitations. Do not use in horses (c)(3) to read as follows: intended for human consumption. § 520.1802b Piperazine-carbon disulfide complex boluses. § 520.1805 Piperazine phosphate and Federal law prohibits the use of this thenium closylate tablets. drug in female dairy cattle 20 months of * * * * * * * * * * age or older. Federal law restricts this (c) Conditions of use in horses and drug to use by or on the order of a ponies— (c) * * * licensed veterinarian. * * * * * (3) Limitations. Federal law restricts ■ 130. In § 520.1720c, revise paragraph ■ 134. In § 520.1802c, in paragraph (b), this drug to use by or on the order of (c)(3) to read as follows: remove ‘‘000009’’ and in its place add a licensed veterinarian.

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§ 520.1807 [Amended] (1) No. 054628 for use of 250 § 520.1962 Promazine. ■ 138. In § 520.1807, in paragraph (b), milligram tablets. (a) Specifications. Conforms to N.F. remove ‘‘015565’’ and in its place add (2) No. 054771 for use of 50 and 250 XII for promazine hydrochloride. ‘‘No. 015565’’. milligram tablets. (b) Sponsor. See No. 054771 in (c) * * * § 510.600(c) of this chapter. § 520.1840 [Amended] (3) Limitations. Federal law restricts (c) Conditions of use in horses—(1) ■ 139. In § 520.1840, in paragraph (b)(1), this drug to use by or on the order of Amount. Administer 0.45 to 0.9 remove ‘‘000069’’ and in its place add a licensed veterinarian. milligrams per pound of body weight mixed with an amount of feed that will ‘‘054771’’. ■ 144. Revise § 520.1920 to read as follows: be readily consumed. ■ 140. In § 520.1855, revise paragraph (2) Indications for use. For quieting (c)(3) to read as follows: § 520.1920 Prochlorperazine and excitable, unruly, or intractable horses. § 520.1855 Ponazuril. isopropamide. (3) Limitations. Do not use in horses (a) Specifications. Each capsules intended for human consumption. * * * * * Federal law restricts this drug to use by (c) * * * contains either: (1) 3.33 milligrams of or on the order of a licensed (3) Limitations. Do not use in horses veterinarian. intended for human consumption. prochlorperazine (as the dimaleate) and ■ 147. Revise § 520.2002 to read as Federal law restricts this drug to use by 1.67 milligrams of isopropamide (as the follows: or on the order of a licensed iodide); or veterinarian. (2) 10 milligrams of prochlorperazine § 520.2002 Propiopromazine. (as the dimaleate) and 5 milligrams of ■ 141. Amend § 520.1860 as follows: (a) Specifications. Each chewable isopropamide (as the iodide). ■ a. Remove paragraph (c); tablet contains 10 or 20 milligrams of (b) Sponsor. See No. 054771 in ■ b. Redesignate paragraph (d) as propiopromazine hydrochloride. paragraph (c); and § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in ■ c. Add paragraph (c)(3). (c) Conditions of use in dogs—(1) § 510.600(c) of this chapter. The addition reads as follows: Amount. (i) Capsules described in (c) Conditions of use in dogs—(1) paragraph (a)(1) of this section are Amount. Administer 0.5 to 2.0 § 520.1860 Pradofloxacin. administered orally to dogs weighing milligrams per pound of body weight * * * * * from 4 to 15 pounds at the rate of 1 once or twice daily, depending upon the (c) * * * capsule twice daily. These capsules are degree of tranquilization desired. (3) Limitations. Federal law prohibits administered orally to dogs weighing (2) Indications for use. For oral the extralabel use of this drug in food- from 16 to 30 pounds at the rate of 1 or administration as a tranquilizer. As an producing animals. Federal law restricts 2 capsules twice daily. For dogs aid in handling difficult, excited, and this drug to use by or on the order of weighing less than 4 pounds, administer unruly dogs, and in controlling a licensed veterinarian. orally an appropriate fraction of the excessive kennel barking, car sickness, ■ 142. Amend § 520.1880 as follows: contents of one of these capsules. and severe dermatitis. It is also ■ a. Revise the section heading; (ii) Capsules described in paragraph indicated for use in minor surgery and ■ b. Remove paragraph (c); (a)(2) of this section are given to dogs prior to routine examinations, ■ c Redesignate paragraph (d) as weighing 30 pounds and over at the rate laboratory procedures, and diagnostic paragraph (c); and of 1 capsule twice daily. procedures. ■ d. Revise the newly redesignated (2) Indications for use. For the (3) Limitations. Federal law restricts paragraph (c) heading and paragraphs treatment of gastrointestinal this drug to use by or on the order of (c)(1) and (2). disturbances associated with emotional a licensed veterinarian. The revisions read as follows: stress. (3) Limitations. Federal law restricts § 520.2043 [Amended] § 520.1880 Prednisolone. this drug to use by or on the order of ■ 148. In § 520.2043, in paragraph (b)(1), * * * * * a licensed veterinarian. remove ‘‘000069, 000859’’ and in its (c) Conditions of use in dogs—(1) ■ 145. In § 520.1921, revise the section place add ‘‘000859, 054771’’; and in Amount. Administer 2.5 milligrams per heading, paragraph (b), the paragraph (c) paragraph (b)(2), remove ‘‘000069’’ and 4.5 kilograms (10 pounds) body weight heading, and paragraphs (c)(2) and (3) to in its place add ‘‘054771’’. per day. Administer total daily dose read as follows: orally in equally divided doses 6 to 10 § 520.2044 [Amended] hours apart until response is noted or 7 § 520.1921 Prochlorperazine, ■ 149. In § 520.2044, in paragraph isopropamide, and neomycin. days have elapsed. When response is (b)(1),remove ‘‘000069’’ and in its place attained, dosage should be gradually * * * * * add ‘‘054771’’. (b) Sponsor. See No. 054771 in reduced until maintenance level is ■ achieved. § 510.600(c) of this chapter. 150. Revise § 520.2045 to read as (2) Indications for use. For use as an (c) Conditions of use in dogs— follows: anti-inflammatory agent. * * * * * § 520.2045 Pyrantel tartrate powder. * * * * * (2) Indications for use. For the (a) Specifications. Each gram of ■ 143. In § 520.1900, revise the section treatment infectious bacterial powder contains 106 milligrams (10.6 heading and paragraphs (b) and (c)(3) to gastroenteritis associated with percent) or 113 milligrams (11.3 read as follows: emotional stress. percent) pyrantel tartrate. (3) Limitations. Federal law restricts (b) Sponsor. See No. 054771 in § 520.1900 Primidone. this drug to use by or on the order of § 510.600(c) of this chapter for use of * * * * * a licensed veterinarian. 11.3 percent powder as in paragraph (b) Sponsors. See sponsor numbers in ■ 146. Revise § 520.1962 to read as (d)(1) and 10.6 percent powder as in § 510.600(c) of this chapter. follows: paragraph (d)(2) and of this section.

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(c) Related tolerances. See § 556.560 not use in horses intended for human ■ 154. In § 520.2123a, revise paragraphs of this chapter. consumption. (a) and (b) to read as follows: (d) Conditions of use—(1) Horses—(i) ■ Amount. Administer as a single dose at 152. Revise § 520.2098 to read as § 520.2123a Spectinomycin tablets. 0.57 gram of pyrantel tartrate per 100 follows: (a) Specifications. Each tablet pounds of body weight mixed with the § 520.2098 Selegiline. contains spectinomycin dihydrochloride equivalent to 100 usual grain ration. Do not administer by (a) Specifications. Each tablet stomach tube or dose syringe. contains 2, 5, 10, 15, or 30 milligrams milligrams (mg) spectinomycin. (b) Sponsors. See Nos. 054771 and (ii) Indications for use. For the (mg) selegiline hydrochloride. removal and control of infections from (b) Sponsor. See No. 054771 in 061623 in § 510.600(c) of this chapter. the following mature parasites: Large § 510.600(c) of this chapter. * * * * * strongyles (Strongylus vulgaris, S. (c) Conditions of use in dogs—(1) edentatus, S. equinus), small strongyles Amounts and indications for use. (i) § 520.2123c [Amended] (Trichonema spp., Triodontophorus), Administer 1 mg per kilogram (0.45 mg ■ 155. In § 520.2123c, in paragraph (b), pinworms (Oxyuris), and large per pound) of body weight once daily remove ‘‘0000856, 000859, and 061623’’ roundworms (Parascaris). for control of clinical signs associated and in its place add ‘‘000859, 054771, (iii) Limitations. Do not treat severely with uncomplicated pituitary- and 061623’’. debilitated animals with this drug. Do dependent hyperadrenocorticism in not use in horses intended for human dogs. ■ 156. Revise § 520.2150 to read as consumption. (ii) Administer 0.5 to 1.0 mg per follows: (2) Swine—(i) Amount. Add to feed at kilogram of body weight once daily for 0.4 gram pyrantel tartrate per pound of the control of clinical signs associated § 520.2150 Stanozolol. non-pelleted ration. The ration is with canine cognitive dysfunction (a) Specifications. Each tablet or administered as a single treatment as the syndrome. chewable tablet contains 2 milligrams sole ration at the rate of 1 pound per 40 (2) Limitations. Federal law restricts stanozolol. pounds of animal weight for animals up this drug to use by or on the order of (b) Sponsor. No. 054771 in to 200 pounds. Animals 200 pounds and a licensed veterinarian. § 510.600(c) of this chapter. (c) Conditions of use in dogs and over are administered 5 pounds of ■ ration per animal. 153. Revise § 520.2100 to read as cats—(1) Amount—(i) Dogs: follows: 1 (ii) Indications for use. For the Administered orally to small breeds, ⁄2 removal and control of large § 520.2100 Selenium and vitamin E. to 1 tablet twice daily for several weeks; roundworms (Ascaris suum) and (a) Specifications. Each capsule to large breeds, 1 to 2 tablets twice daily nodular worm (Oesophagostomum) contains: for several weeks. The tablets may be infections. (1) 2.19 milligrams (mg) sodium crushed and administered in feed. 1 (iii) Limitations. Consult veterinarian selenite (equivalent to 1 mg selenium) (ii) Cats: Administered orally ⁄2 to 1 before using in severely debilitated and 56.2 mg (68 I.U.) vitamin E as d- tablet twice daily for several weeks. animals. Do not treat within 24 hours of alpha tocopheryl acid succinate; or (2) Indications for use. As an anabolic slaughter. (2) 0.548 mg sodium selenite steroid treatment. (3) Limitations. Federal law restricts ■ (equivalent to 0.25 mg selenium) and 14 151. Add § 520.2046 to read as this drug to use by or on the order of follows: mg (17 I.U.) vitamin E as d-alpha tocopheryl acid succinate. a licensed veterinarian. § 520.2046 Pyrantel tartrate pellets. (b) Sponsor. See No. 000061 in (a) Specifications. (1) Each gram of § 510.600(c) of this chapter. § 520.2150a [Removed] pellets contains 12.5 milligrams (mg) (c) Conditions of use in dogs—(1) ■ 157. Remove § 520.2150a. (1.25 percent) pyrantel tartrate; or Amount. (i) Dogs over 20 pounds: (2) Each gram of pellets contains 21.1 Administer 1 capsule described in § 520.2150b [Removed] mg (2.11 percent) pyrantel tartrate. paragraph (a)(1) per 20 pounds of body ■ 158. Remove § 520.2150b. (b) Sponsors. See sponsor numbers in weight to a maximum of 5 capsules. § 510.600(c) of this chapter: Repeat at 3 day intervals until a § 520.2158 [Removed] (1) No. 054771 for use of products satisfactory therapeutic response is ■ 159. Remove § 520.2158. described in paragraph (a) as in observed. Maintenance dosage is 1 paragraph (c) of this section. capsule per 40 pounds of body weight § 520.2158a as [Redesignated (2) No. 061623 for use of product every 3 to 7 days, or longer, as required. as§ 520.2158] described in paragraph (a)(1) as in (ii) Dogs under 20 pounds: ■ 160–161. Redesignate § 520.2158a as paragraph (c) of this section. Administer 1 capsule described in § 520.2158 and revise the section (c) Conditions of use in horses—(1) paragraph (a)(2) per 5 pounds of body heading and paragraph (a) to read as Amount. Administer as a single dose at weight with a minimum of 1 capsule. follows: 12.5 mg per 2.2 pounds of body weight Repeat at 3-day intervals until a mixed with the usual grain ration. satisfactory response is observed. § 520.2158 Streptomycin. (2) Indications for use. For the Maintenance dosage is 1 capsule per 10 (a) Specifications. Each milliliter of removal and control of infections from pounds of body weight every 3 to 7 solution contains 250 milligrams (25 the following mature parasites: Large days, or longer, as required. percent) streptomycin sulfate. strongyles (Strongylus vulgaris, S. (2) Indications for use. As an aid in * * * * * edentatus, S. equinus), small strongyles alleviating and controlling (Trichonema spp., Triodontophorus), inflammation, pain, and lameness § 520.2158b [Removed] pinworms (Oxyuris), and large associated with certain arthropathies. ■ 162. Remove § 520.2158b. roundworms (Parascaris). (3) Limitations. Federal law restricts (3) Limitations. Do not treat severely this drug to use by or on the order of § 520.2158c [Removed] debilitated animals with this drug. Do a licensed veterinarian. ■ 163. Remove § 520.2158c.

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§ 520.2160 [Removed] § 520.2220a Sulfadimethoxine solution and has not been established for this product ■ 164. Remove § 520.2160. soluble powder. in preruminating calves. Do not use in ■ 165. Amend § 520.2170 as follows: (a) Specifications. (1) Each ounce of calves to be processed for veal. Federal ■ a. Revise the section heading; solution contains 3.75 grams (12.5 law prohibits the extralabel use of this ■ b. Remove paragraph (d); percent) sulfadimethoxine. product in lactating dairy cattle. ■ c. Redesignate paragraphs (b), (c), and (2) Each 107 grams of powder ■ 170. Revise § 520.2220b to read as (e) as paragraphs (c), (b), and (d), contains the equivalent of 94.6 grams follows: respectively; and sulfadimethoxine as sulfadimethoxine ■ d. Revise newly redesignated sodium. § 520.2220b Sulfadimethoxine suspension. paragraph (d) heading and paragraphs (b) Sponsors. See sponsor numbers in (a) Specifications. Each milliliter of (d)(1) and (3). § 510.600(c) of this chapter: suspension contains 50 milligrams (mg) The revisions read as follows: (1) Nos. 000859, 054628, 054771, sulfadimethoxine. 054925, and 057561 for use of the (b) Sponsors. See Nos. 000061 and § 520.2170 Sulfabromomethazine. product described in paragraph (a)(1) of 054771 in § 510.600(c) of this chapter. * * * * * this section. (c) Conditions of use in dogs and (d) Conditions of use in cattle—(1) (2) Nos. 054771, 054925, 057561, cats—(1) Amount. Administer orally 25 Amount. Administer 90 milligrams per 058829, 061623, and 066104 for use of mg per pound of body weight, followed pound body weight orally. Repeat in 48 the product described in paragraph by 12.5 mg per pound of body weight hours if necessary (a)(2) of this section. daily. * * * * * (c) Related tolerances. See § 556.640 (2) Indications for use. For the (3) Limitations. Milk taken from of this chapter. treatment of sulfonamide susceptible animals within 96 hours (8 milkings) of (d) Conditions of use—(1) Broiler and bacterial infections in dogs and cats and latest treatment must not be used for replacement chickens—(i) Amount. enteritis associated with coccidiosis in food. Do not administer within 18 days Administer 1.875 grams per gallon (0.05 dogs. of slaughter. percent) of drinking water for 6 (3) Limitations. Federal law restricts ■ 166. Revise § 520.2184 to read as consecutive days. this drug to use by or on the order of (ii) Indications for use. For treatment follows: a licensed veterinarian. of outbreaks of coccidiosis, fowl ■ 171. Revise § 520.2220c to read as § 520.2184 Sulfachloropyrazine. cholera, and infectious coryza. follows: (a) Specifications. Each gram of (iii) Limitations. Do not administer to powder contains 476 milligrams of chickens over 16 weeks of age. As sole § 520.2220c Sulfadimethoxine tablet. sodium sulfachloropyrazine source of drinking water and (a) Specifications. Each tablet monohydrate. sulfonamide medication. Withdraw 5 contains 125, 250, or 500 milligrams (b) Sponsor. See No. 054771 in days before slaughter. (mg) sulfadimethoxine. § 510.600(c) of this chapter. (2) Turkeys—(i) Amount. Administer (b) Sponsors. See Nos. 000061 and (c) Related tolerance. See § 556.625 of 0.938 grams per gallon (0.025 percent) 054771 in § 510.600(c) of this chapter. this chapter. of drinking water for 6 consecutive (c) [Reserved] (d) Conditions of use in chickens. It is days. (d) Conditions of use in dogs and used in the drinking water of broilers, (ii) Indications for use. Growing cats—(1) Amount. Administer 25 breeder flocks, and replacement turkeys: For treatment of disease milligrams (mg) per pound of body chickens as follows: outbreaks of coccidiosis and fowl weight on the first day followed by 12.5 (1) Amount. Administer in drinking cholera. milligrams (mg) per pound of body water as 0.03 percent solution for 3 (iii) Limitations. Do not administer to weight per day until the animal is free days. turkeys over 24 weeks of age. Use as the of symptoms for 48 hours. (2) Indications for use. For the sole source of drinking water and (2) Indications for use. Treatment of treatment of coccidiosis. sulfonamide medication. Withdraw 5 sulfadimethoxine-susceptible bacterial (3) Limitations. Administer as sole days before slaughter. infections. source of drinking water and of (3) Cattle—(i) Amount. 1.18 to 2.36 (3) Limitations. Federal law restricts sulfonamide medication. Withdraw 4 grams per gallon (0.031 to 0.062 this drug to use by or on the order of days prior to slaughter. Do not use in percent) of drinking water. As a drench, a licensed veterinarian. chickens producing eggs for human administer 2.5 grams per 100 pounds of ■ 172. Revise § 520.2220d to read as consumption. body weight for first day, then 1.25 follows: ■ 167. In § 520.2200, revise paragraph grams per 100 pounds of body weight (d)(3)(iii) to read as follows: per day for the next 4 consecutive days. § 520.2220d Sulfadimethoxine bolus. If no improvement within 2 to 3 days, (a) Specifications. Each bolus contains § 520.2200 Sulfachlorpyridazine. reevaluate diagnosis. Do not treat 2.5, 5, or 15 grams sulfadimethoxine. * * * * * beyond 5 days. (b) Sponsor. See No. 054771 in (d) * * * (ii) Indications for use. Dairy calves, § 510.600(c) of this chapter. (3) * * * dairy heifers, and beef cattle: For the (c) Related tolerances. See § 556.640 (iii) Limitations. Federal law restricts treatment of shipping fever complex and of this chapter. this drug to use by or on the order of bacterial pneumonia associated with (d) Conditions of use in cattle—(1) a licensed veterinarian. Pasteurella spp. sensitive to Amount. Administer 2.5 grams per 100 sulfadimethoxine; and calf diphtheria pounds body weight for 1 day followed § 520.2218 [Amended] and foot rot associated with by 1.25 grams per 100 pounds body ■ 168. In § 520.2218, in paragraph (b), Fusobacterium necrophorum weight per day; treat for 4 to 5 days. remove ‘‘046573’’ and in its place add (Sphaerophorus necrophorus) sensitive (2) Indications for use. For the ‘‘054771’’. to sulfadimethoxine. treatment of shipping fever complex and ■ 169. Revise § 520.2220a to read as (iii) Limitations. Withdraw 7 days bacterial pneumonia associated with follows: before slaughter. A withdrawal period Pasteurella spp. sensitive to

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sulfadimethoxine; and calf diphtheria weight. Do not exceed a total of 21 (c) Related tolerances. See § 556.650 and foot rot associated with consecutive days. of this chapter. Fusobacterium necrophorum sensitive (2) Indications of use. Treatment of (d) Conditions of use in cattle—(1) to sulfadimethoxine. skin and soft tissue infections (wounds 2.5- or 15-gram tablets—(i) Amount. (3) Limitations. Do not administer and abscesses) in dogs caused by strains Administer 25 milligrams per pound of within 7 days of slaughter; milk that has of Staphylococcus aureus and body weight per day for 4 days. Use as been taken from animals during Escherichia coli and urinary tract the sole source of sulfonamide. treatment and 60 hours (5 milkings) infections caused by E. coli, (ii) Indications for use. For treatment after the latest treatment must not be Staphylococcus spp., and Proteus of respiratory infections (pneumonia, used for food. A withdrawal period has mirabilus susceptible to ormetoprim- shipping fever), foot rot, calf scours; as not been established for this product in potentiated sulfadimethoxine. adjunctive therapy in septicemia preruminating calves. Do not use in (3) Limitations. Federal law restricts accompanying mastitis and metritis. calves to be processed for veal. this drug to use by or on the order of (iii) Limitations. Do not treat within ■ 173. Add § 520.2220e to read as a licensed veterinarian. 16 days of slaughter. Milk that has been follows: ■ 175. Revise § 520.2240a to read as taken from animals during treatment follows: and for 72 hours (6 milkings) after latest § 520.2220e Sulfadimethoxine extended- treatment must not be used for food. release bolus. § 520.2240a Sulfaethoxypyridazine Federal law restricts this drug to use by (a) Specifications. Each extended- solution. or on the order of a licensed release bolus contains 12.5 grams (a) Specifications. Each milliliter of veterinarian. sulfadimethoxine. solution contains 62.5 milligrams (mg) (2) 15-gram extended-release tablets— (b) Sponsor. See No. 054771 in sodium sulfaethoxypyridazine. (i) Amount. Administer 100 milligrams § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 per pound of body weight. Use as the (c) Related tolerances. See § 556.640 § 510.600(c) of this chapter. sole source of sulfonamide. of this chapter. (c) Related tolerances. See § 556.650 (ii) Indications for use. For treatment (d) Conditions of use in beef cattle of this chapter. of foot rot and respiratory infections and non-lactating dairy cattle—(1) (d) Conditions of use—(1) Swine—(i) (shipping fever and pneumonia) caused Amount. Administer one 12.5-gram- Amount. Administer 3.8 grams per by sulfonamide-susceptible pathogens sustained-release bolus for the nearest gallon for first day followed by 1.9 (E. coli, Streptococci, Staphylococci, 200 pounds of body weight, i.e., 62.5 grams per gallon for not less than 3 days Sphaerophorus necrophorus and Gram- milligrams per pound of body weight. nor more than 9 days. Use as the sole negative rods including Pasteurella); Do not repeat treatment for 7 days. source of sulfonamide. and for use prophylactically during (2) Indications for use. For the (ii) Indications for use. For treatment periods of stress for reducing losses due treatment of shipping fever complex and of bacterial scours pneumonia enteritis, to sulfonamide sensitive disease bacterial pneumonia associated with bronchitis, septicemia accompanying conditions. Pasteurella spp. sensitive to Salmonella choleraesuis infection. (iii) Limitations. Do not treat within sulfadimethoxine; and calf diphtheria (iii) Limitations. Do not treat within 16 days of slaughter. Not for use in and foot rot associated with 10 days of slaughter. Federal law lactating dairy cows. Federal law Fusobacterium necrophorum sensitive restricts this drug to use by or on the restricts this drug to use by or on the to sulfadimethoxine. order of a licensed veterinarian. order of a licensed veterinarian. (3) Limitations. Do not use in female (2) Cattle—(i) Amount. For use at 2.5 dairy cattle 20 months of age or older. grams per gallon. Administer at the rate § 520.2260a [Amended] Do not administer within 12 days of of 1 gallon per 100 pounds of body ■ 177. In § 520.2260a, in paragraph slaughter. Federal law restricts this drug weight per day for 4 days. Use as the (b)(1), remove ‘‘053501’’ and in its place to use by or on the order of a licensed sole source of sulfonamide. add ‘‘054771’’. veterinarian. (ii) Indications for use. For treatment ■ 178. Amend § 520.2260b as follows: ■ 174. Add § 520.2220f to read as of respiratory infections (pneumonia, ■ a. In paragraph (b)(1), remove follows: shipping fever), foot rot, calf scours; and ‘‘053501’’ and in its place add as adjunctive therapy in septicemia ‘‘054771’’; § 520.2220f Sulfadimethoxine and accompanying mastitis and metritis. ■ b. In paragraph (c)(2), remove footnote ormetoprim tablet. (iii) Limitations. Do not treat within 1 wherever it occurs; and (a) Specifications. Each tablet 16 days of slaughter. Milk that has been ■ c. In paragraph (c)(2)(iii), remove the contains 120 milligrams (mg) (100 mg taken from animals during treatment eighth sentence and in its place add two sulfadimethoxine and 20 mg and for 72 hours (6 milkings) after latest sentences. ormetoprim), 240 mg (200 mg treatment must not be used for food. The additions read as follows: sulfadimethoxine and 40 mg Federal law restricts this drug to use by ormetoprim), 600 mg (500 mg or on the order of a licensed § 520.2260b Sulfamethazine extended- release boluses. sulfadimethoxine and 100 mg veterinarian. ormetoprim), or 1200 mg (1000 mg ■ 176. Revise § 520.2240b to read as * * * * * (c) * * * sulfadimethoxine and 200 mg follows: ormetoprim). (2) * * * (b) Sponsor. See No. 054771 in § 520.2240b Sulfaethoxypyridazine tablets. (iii) * * * Do not use in female dairy § 510.600(c) of this chapter. (a) Specifications—(1) Each tablet cattle 20 months of age or older. Use of (c) Conditions of use in dogs—(1) contains 2.5 or 15 grams sulfamethazine in this class of cattle Amount. On the first day of treatment, sulfaethoxypyridazine. may cause milk residues. * * * administer 25 mg per pound (55 mg per (2) Each extended-release tablet * * * * * kilogram) of body weight. Then follow contains 5 grams sulfaethoxypyridazine. ■ 179. Amend § 520.2260c as follows: with a daily dosage of 12.5 mg per (b) Sponsor. See No. 054771 ■ a. Redesignate paragraphs (a) and (b) pound (27.5 mg per kilogram) of body § 510.600(c) of this chapter. as paragraphs (b) and (d), respectively;

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■ b. Add new paragraphs (a) and (c); ■ 182. In § 520.2280, revise the section (b) Sponsor. See No. 054771 in and heading and paragraphs (b) and (c) to § 510.600(c) of this chapter. ■ c. Revise newly redesignated read as follows: * * * * * paragraphs (b) and (d)(3). ■ 187. In § 520.2345b, revise paragraph The additions and revisions read as § 520.2280 Sulfamethizole and methenamine. (b) to read as follows: follows: * * * * * § 520.2345b Tetracycline tablets. § 520.2260c Sulfamethazine extended- (b) Sponsor. See No. 054771 in release tablets. * * * * * § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in (c) Conditions of use in dogs and (a) Specifications. Each extended- § 510.600(c) of this chapter. release tablet contains 8 grams cats—(1) Amount. Administer orally 1 sulfamethazine. tablet per 20 pounds of body weight 3 * * * * * (b) Sponsor. See No. 054771 in times per day until clinical signs are ■ 188. In § 520.2345c, revise paragraph § 510.600(c) of this chapter. alleviated. To reduce the possibility of (b) to read as follows: (c) Related tolerances. See § 556.670 relapse, continue therapy for a week to § 520.2345c Tetracycline boluses. of this chapter. 10 days. (d) * * * (2) Indications for use. For treatment * * * * * (b) Sponsor. See No. 054771 in (3) Limitations. Treated animals must of urinary tract infections such as § 510.600(c) of this chapter. not be slaughtered for food within 18 cystitis, nephritis, prostatitis, urethritis, days after the latest treatment. Federal and pyelonephritis. As an aid in the * * * * * law restricts this drug to use by or on management of complications resulting ■ 189. Amend § 520.2345d as follows; the order of a licensed veterinarian. from surgical manipulations of the ■ a. In paragraph (b)(1), remove ■ 180. Amend § 520.2261a as follows: urinary tract such as removal of calculi ‘‘000069’’ and in its place add ■ from the bladder, in ureterostomies, and ‘‘054771’’; a. Remove paragraph (d); ■ ■ b. Redesignate paragraphs (a), (b), and in instrumentation of the urethra and b. In paragraphs (b)(3), (d)(1)(iii), and (c) as paragraphs (b), (c), and (d), bladder. (d)(2)(iii), remove ‘‘046573’’ and in its (3) Limitations. Federal law restricts place add ‘‘054771’’; and respectively; ■ ■ c. Add new paragraph (a); this drug to use by or on the order of c. Add paragraph (b)(5). The addition reads as follows: ■ d. Revise newly redesignated a licensed veterinarian. paragraphs (b) and (c); and ■ 183. In § 520.2325a, revise the section § 520.2345d Tetracycline powder. ■ e. In newly redesignated paragraph heading and in paragraph (a)(3), remove * * * * * (d)(2)(iii), remove ‘‘Salmonella ‘‘046573’’ and in its place add (b) * * * pullorum’’ and in its place add ‘‘054771’’. (5) No. 000010: 25 grams per pound ‘‘Salmonella Pullorum’’. The revision reads as follows: as in paragraphs (d)(1) and (d)(2) of this The addition and revisions read as § 520.2325a Sulfaquinoxaline powder and section. follows: solution. * * * * * § 520.2261a Sulfamethazine solution. * * * * * ■ 190. In § 520.2345e, revise the section (a) Specifications. Each milliliter of ■ 184. Revise § 520.2325b to read as heading and paragraph (b) and remove solution contains 125 milligrams (12.5 follows: paragraph (c)(1)(iv). percent) sulfamethazine sodium. The revisions read as follows: § 520.2325b Sulfaquinoxaline drench. (b) Sponsors. See Nos. 000010 and § 520.2345e Tetracycline solution. 061623 in § 510.600(c) of this chapter. (a) Specifications. A soluble powder containing 25 percent sulfaquinoxaline. * * * * * (c) Related tolerances. See § 556.670 (b) Sponsor. See No. 054771 in of this chapter. (b) Sponsor. See No. 050749 in § 510.600(c) of this chapter. § 510.600(c) of this chapter. * * * * * (c) Conditions of use in cattle—(1) * * * * * ■ 181. In § 520.2261b, revise paragraph Amount. Administer 1 teaspoon of 25 ■ 191. In § 520.2345f, in paragraph (b), (d)(1)(ii) and add four sentences to percent sulfaquinoxaline soluble remove ‘‘No. 000009’’ and in its place paragraph (d)(4)(iii) to read as follows: powder for each 125 pounds of body add ‘‘See No. 054771’’; and revise the § 520.2261b Sulfamethazine powder. weight for 3 to 5 days as a drench. paragraph (c) heading and paragraph (2) Indications for use. For the control (c)(3) to read as follows: * * * * * and treatment of outbreaks of (d) * * * coccidiosis in cattle and calves caused § 520.2345f Tetracycline phosphate (1) * * * by Eimeria bovis or E. zuernii. complex and sodium novobiocin capsules. (ii) Indications for use. For control of (3) Limitations. Do not give to cattle * * * * * infectious coryza (Avibacterium within 10 days of slaughter for food. Not (c) Conditions of use in dogs— paragallinarum), coccidiosis (Eimeria for use in lactating dairy cattle. * * * * * tenella, E. necatrix), acute fowl cholera (3) Limitations. Federal law restricts (Pasteurella multocida), and pullorum § 520.2330 [Amended] this drug to use by or on the order of disease (Salmonella Pullorum). ■ 185. In paragraph (b) of § 520.2330, a licensed veterinarian. * * * * * remove ‘‘000856’’ and in its place add ■ 192. In § 520.2345g, in paragraph (b), (4) * * * ‘‘054771’’; and in paragraph (c), remove remove ‘‘No. 000009’’ and in its place (iii) * * * Do not use in female dairy footnote 1 wherever it occurs. add ‘‘See No. 054771’’; and revise the cattle 20 months of age or older. Use of ■ 186. In § 520.2345a, revise the section paragraph (c) heading and paragraph sulfamethazine in this class of cattle heading and paragraph (b) to read as (c)(3) to read as follows: may cause milk residues. A withdrawal follows: period has not been established in § 520.2345g Tetracycline hydrochloride preruminating calves. Do not use in § 520.2345a Tetracycline capsules. and sodium novobiocin tablets. calves to be processed for veal. * * * * * * * * * *

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(c) Conditions of use in dogs— (2) No. 050604 for use as in paragraph (Gasterophilus spp.), large strongyles * * * * * (d)(1)(ii) of this section. (Strongylus spp.), small strongyles (3) Limitations. Federal law restricts (3) No. 012286 for use as in paragraph (genera Cyathostomum, this drug to use by or on the order of (d)(2) of this section. Cylicobrachytus, Craterostomum, a licensed veterinarian. * * * * * Oesophagodontus, Poteriostomum), ■ 193. In § 520.2345h, in paragraph (b), ■ 196. Amend § 520.2380b as follows: pinworms (Oxyuris spp., Strongyloides remove ‘‘000009’’ and in its place add ■ a. Revise the section heading; spp.), and ascarids (Parascaris spp.). ‘‘054771’’; and revise the paragraph (c) ■ b. Remove paragraph (a); (3) Limitations. Do not use in horses heading and paragraph (c)(3) to read as ■ c. Redesignate paragraphs (b) through intended for human consumption. follows: (e) as paragraphs (a) through (d), Federal law restricts this drug to use by respectively; and or on the order of a licensed § 520.2345h Tetracycline hydrochloride, ■ d. Revise newly redesignated veterinarian. sodium novobiocin, and prednisolone paragraph (b). ■ 200. In § 520.2380f, revise the section tablets. The revisions read as follows: heading, the paragraph (c) heading, and * * * * * paragraphs (c)(1) and (3) to read as (c) Conditions of use in dogs— § 520.2380b Thiabendazole drench or paste. follows: * * * * * * * * * * (3) Limitations. Federal law restricts § 520.2380f Thiabendazole and piperazine (b) Sponsor. See No. 050604 in phosphate. this drug to use by or on the order of § 510.600(c) of this chapter. a licensed veterinarian. * * * * * * * * * * ■ 194. Amend § 520.2362 as follows: (c) Conditions of use in horses—(1) ■ a. Revise the section heading; § 520.2380c [Amended] Amount. 2 grams of thiabendazole and ■ b. Remove paragraph (a); ■ 197. In § 520.2380c, remove paragraph 2.5 grams of piperazine (0.3 ounce of ■ c. Redesignate paragraphs (b), (c), and (a); and redesignate paragraphs (b) powder) per 100 pounds of body weight. (d) as paragraphs (a), (b), and (c), through (e) as paragraphs (a) through Use a single oral dose. Administer as a respectively; and (d), respectively. drench or by stomach tube suspended in ■ d. Revise newly redesignated 1 pint of warm water; by dose syringe ■ 198. In § 520.2380d, revise the section paragraphs (a) and (c). suspended in 1⁄2 ounce of water for each The revisions read as follows: heading and paragraph (c) to read as 100 pounds of body weight; or sprinkled follows: over a small amount of daily feed. § 520.2362 Thenium closylate. § 520.2380d Thiabendazole and piperazine * * * * * (a) Specifications. Each tablet citrate. (3) Limitations. Do not use in horses contains thenium closylate equivalent to * * * * * intended for human consumption. If the 500 milligrams thenium base. (c) Conditions of use in horses—(1) label bears directions for administration * * * * * Amount. Administer 1 ounce of by stomach tube or drench, it shall also (c) Conditions of use in dogs—(1) suspension per 100 pounds of body bear the statement ‘‘Caution: Federal Amount. Dogs weighing over 10 weight by stomach tube or as a drench. law restricts this drug to use by or on pounds: Administer 1 tablet as a single (2) Indications for use. For the control the order of a licensed veterinarian.’’; if dose. Dogs weighing 5 to 10 pounds: of large strongyles, small strongyles, not labeled for use by stomach tube or Administered one-half tablet twice pinworms, Strongyloides and ascarids drench, the label shall bear the during a single day. Repeat treatment (including members of the genera statement, ‘‘Consult your veterinarian after 2 or 3 weeks. Strongylus spp., Cyathostomum spp., for assistance in the diagnosis, (2) Indications for use. For treatment Cylicobrachytus spp. and related genera treatment, and control of parasitism.’’ of canine ancylostomiasis by the Craterostomum spp., Oesophagodontus removal from the intestines of the adult spp., Poteriostomum spp., Oxyuris spp., § 520.2475 [Amended] forms of the species Ancylostoma Strongyloides spp., and Parascaris spp.). ■ 201. In § 520.2475, in paragraph (b), caninum and Uncinaria stenocephala (3) Limitations. Do not use in horses remove ‘‘000009’’ and in its place add (hookworms). intended for human consumption. ‘‘054771’’. (3) Limitations. Federal law restricts Federal law restricts this drug to use by this drug to use by or on the order of or on the order of a licensed § 520.2520b [Redesignated as § 520.2520a] a licensed veterinarian. veterinarian. ■ 202. Redesignate § 520.2520b as ■ ■ 195. Amend § 520.2380a as follows: 199. In § 520.2380e, revise the section § 520.2520a; and revise it to read as ■ a. Remove paragraph (a); heading and paragraph (c) to read as follows: ■ b. Redesignate paragraphs (b) through follows: (e) as paragraphs (a) through (d), § 520.2520a Trichlorfon and atropine. § 520.2380e Thiabendazole and triclorfon. respectively; and (a) Specifications. (1) For trichlorfon: ■ c. Revise newly redesignated * * * * * (c) Conditions of use in horses—(1) O,O-Dimethyl 2,2,2-trichloro-1- paragraph (b). hydroxyethyl phosphonate. The revision reads as follows: Amount. Administer 2 grams of thiabendazole with 1.8 grams of (2) For atropine: Atropine N.F. § 520.2380a Thiabendazole top dressing trichlorfon per 100 pounds of body (b) Sponsor. See No. 054771 in and mineral protein block. weight sprinkled on the animals’ usual § 510.600(c) of this chapter. * * * * * daily ration of feed, or may be mixed in (c) Conditions of use in mice—(1) (b) Sponsors. See sponsors in 5 to 10 fluid ounces of water and Amount. Administer 1.67 grams of § 510.600(c) of this chapter for use as in administered by stomach tube or trichlorfon and 7.7 milligrams of paragraph (d) of this section. drench. atropine per liter continuously for 7 to (1) No. 051311 for use as in paragraph (2) Indications for use. For the 14 days as the sole source of drinking (d)(1)(i) of this section. treatment and control of bots water.

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(2) Indications for use. For the ■ d. Revise the newly redesignated parasitic, pustular and nonspecific. As treatment of Syphacia obvelata paragraph (c) heading and paragraph adjunctive therapy in various cough (pinworm) in laboratory mice. (c)(3). conditions including treatment of (3) Limitations. Federal law restricts The revisions read as follows: ‘‘kennel cough’’ or tracheobronchitis, this drug to use by or on the order of bronchitis including allergic bronchitis, a licensed veterinarian. § 520.2520d Trichlorfon, phenothiazine, in tonsillitis, acute upper respiratory and piperazine. infections and coughs of nonspecific § 520.2520e [Redesignated as § 520.2520b] * * * * * origin. ■ 203a. Redesignate § 520.2520e as (b) Sponsor. See No. 054771 in (3) Limitations. Federal law restricts § 520.2520b. § 510.600(c) of this chapter. this drug to use by or on the order of ■ 203b. Amend newly redesignated (c) Conditions of use in horses— a licensed veterinarian. § 520.2520b as follows: * * * * * ■ 208. Revise § 520.2605 to read as ■ a. Revise paragraph (b); (3) Limitations. Do not use in horses follows: ■ b. Remove paragraphs (c) and (d); intended for human consumption. ■ c. Redesignate paragraph (e) as Federal law restricts this drug to use by § 520.2605 Trimeprazine and prednisolone paragraph (c); and or on the order of a licensed capsules. ■ d. Revise the newly redesignated veterinarian. (a) Specifications. Each capsule paragraph (c) heading and paragraph ■ 206. Revise § 520.2582 to read as contains: (c)(3). follows: (1) 3.75 milligrams (mg) trimeprazine The revisions read as follows: in sustained released form (as § 520.2582 Triflupromazine. trimeprazine tartrate) and 1 mg § 520.2520b Trichlorfon boluses. (a) Specifications. Each tablet prednisolone (Capsule No. 1); or * * * * * contains 10 or 25 milligrams (mg) (2) 7.5 mg trimeprazine in sustained (b) Sponsor. See No. 054771 in triflupromazine hydrochloride. release form (as trimeprazine tartrate) § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in and 2 mg prednisolone (Capsule No. 2). (c) Conditions of use in horses— § 510.600(c) of this chapter. (b) Sponsor. See No. 054771 in * * * * * (c) Conditions of use in dogs and § 510.600(c) of this chapter. (3) Limitations. Do not use in horses cats—(1) Amount. Administer orally 1 (c) Conditions of use in dogs—(1) intended for human consumption. to 2 mg per pound of body weight daily, Amount. Administer orally once daily Federal law restricts this drug to use by followed by 1 mg daily. an initial dosage: or on the order of a licensed (2) Indications for use. For relief of (i) For dogs weighing up to 10 veterinarian. anxiety, to help control psychomotor pounds: one Capsule No. 1; over-activity, and to increase the (ii) For dogs weighing 11 to 20 § 520.2520f [Redesignated as § 520.2520c] tolerance of animals to pain and pounds, one Capsule No. 2 or two ■ 204a. Redesignate § 520.2520f as pruritus. For use in various clinical Capsule No. 1; § 520.2520c. procedures which require the aid of a (iii) For dogs weighing 21 to 40 tranquilizer, antiemetic, or pounds, two Capsule No. 2 or four ■ 204b. Amend newly redesignated preanesthetic. Capsule No. 1; and § 520.2520c as follows: (iv) For dogs weighing over 40 ■ (3) Limitations. Federal law restricts a. Revise paragraph (b); pounds, three Capsule No. 2 or six ■ this drug to use by or on the order of b. Remove paragraphs (c) and (d); a licensed veterinarian. Capsule No. 1. ■ c. Redesignate paragraph (e) as ■ After 4 days, the dosage is reduced to paragraph (c); and 207. Revise § 520.2604 to read as approximately 1⁄2 the initial dosage or to ■ follows: d. Revise the newly redesignated an amount just sufficient to maintain paragraph (c) heading and paragraph § 520.2604 Trimeprazine and prednisolone remission of symptoms. (c)(3). tablets. (2) Indications for use. For the relief The revisions read as follows: (a) Specifications. Each tablet of itching regardless of cause; and for § 520.2520c Trichlorfon granules. contains 5 milligrams (mg) trimeprazine reduction of inflammation commonly tartrate and 2 mg prednisolone. * * * * * associated with most skin disorders of (b) Sponsor. See No. 054771 in (b) Sponsor. See No. 054771 in dogs such as eczema, caused by internal § 510.600(c) of this chapter. disorders, otitis, and dermatitis, allergic, § 510.600(c) of this chapter. (c) Conditions of use in dogs—(1) (c) Conditions of use in horses— parasitic, pustular and nonspecific. As Amount. Administer orally an initial adjunctive therapy in various cough * * * * * dosage: for dogs weighing up to 10 conditions including treatment of (3) Limitations. Do not use in horses pounds, 1⁄2 tablet twice daily; for dogs ‘‘kennel cough’’ or tracheobronchitis, intended for human consumption. weighing 11 to 20 pounds, 1 tablet twice bronchitis including allergic bronchitis, Federal law restricts this drug to use by daily; for dogs weighing 21 to 40 in tonsillitis, acute upper respiratory or on the order of a licensed pounds, 2 tablets twice daily; and for infections and coughs of nonspecific veterinarian. dogs weighing over 40 pounds, 3 tablets origin. § 520.2520g [Redesignated as § 520.2520d] twice daily. After 4 days, reduce dosage (3) Limitations. Federal law restricts to one-half the initial dose or to an this drug to use by or on the order of ■ 205a. Redesignate § 520.2520g as amount sufficient to maintain remission a licensed veterinarian. § 520.2520d. of symptoms. ■ 209. Revise § 520.2610 to read as ■ 205b. Amend newly redesignated (2) Indications for use. For the relief follows: § 520.2520d as follows: of itching regardless of cause; and for ■ a. Revise paragraph (b); reduction of inflammation commonly § 520.2610 Trimethoprim and sulfadiazine ■ b. Remove paragraphs (c) and (d); associated with most skin disorders of tablets. ■ c. Redesignate paragraph (e) as dogs such as eczema, caused by internal (a) Specifications. Each tablet paragraph (c); and disorders, otitis, and dermatitis, allergic, contains 30 milligrams (mg) (5 mg

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trimethoprim and 25 mg sulfadiazine), and paragraphs (c)(1) and (3) to read as ACTION: Notice of enforcement of 120 mg (20 mg trimethoprim and 100 follows: regulations. mg sulfadiazine), 480 mg (80 mg § 520.2613 Trimeprazine and sulfadiazine trimethoprim and 400 mg sulfadiazine) powder. SUMMARY: The Coast Guard will enforce or 960 mg (160 mg trimethoprim and the events taking place throughout the 800 mg sulfadiazine). (a) Specifications. Each gram of powder contains 67 milligrams (mg) Sector Northern New England Captain (b) Sponsors. See Nos. 000061 and trimethoprim and 333 mg sulfadiazine. of the Port (COTP) Zone. This action is 054771 in § 510.600(c) of this chapter. (b) Sponsors. See Nos. 054771 and necessary to protect marine traffic and (c) Conditions of use in dogs—(1) 058711 in § 510.600(c) of this chapter. spectators from the hazards associated Amount. Administer orally at 30 mg per (c) Conditions of use in horses—(1) with powerboat races, regattas, boat kilogram of body weight (14 milligrams Amount. Administer orally 3.75 grams parades, rowing and paddling boat per pound) once daily. Alternatively, of powder per 110 pounds (50 races, swim events, and fireworks especially in severe infections, the kilograms) of body weight in a small displays. During the enforcement initial dose may be followed by one-half amount of feed, as a single daily dose, period, no person or vessel may enter the recommended daily dose every 12 for 5 to 7 days. the Special Local Regulation area or hours. Administer for 2 to 3 days after * * * * * symptoms have subsided. Do not treat Safety Zone without permission of the (3) Limitations. Do not use in horses COTP. for more than 14 consecutive days. intended for human consumption. (2) Indications for use. The drug is Federal law restricts this drug to use by DATES: The marine events listed in 33 used in dogs where systemic or on the order of a licensed CFR 100.120 and 33 CFR 165.171 will antibacterial action against sensitive veterinarian. take place from June 14, 2014 through organisms is required, either alone or as Dated: April 29, 2014. July 28, 2014, during the times and an adjunct to surgery or debridement dates specified in Tables 1 and 2 below. with associated infection. The drug is Steven D. Vaughn, indicated where control of bacterial Director, Office of New Animal Drug FOR FURTHER INFORMATION CONTACT: If infection is required during the Evaluation, Center for Veterinary Medicine. you have questions on this notice, call treatment of acute urinary tract [FR Doc. 2014–10415 Filed 5–19–14; 8:45 am] or email Lieutenant Junior Grade infections, acute bacterial complications BILLING CODE 4160–01–P Elizabeth Gunn, U.S. Coast Guard, of distemper, acute respiratory tract Sector Northern New England, infections, acute alimentary tract Waterways Management Division, via infections, wound infections, and DEPARTMENT OF HOMELAND telephone at 207–767–0398 or email at abscesses. SECURITY [email protected]. (3) Limitations. Federal law restricts Coast Guard SUPPLEMENTARY INFORMATION: The Coast this drug to use by or on the order of Guard will enforce the Special Local a licensed veterinarian. 33 CFR Parts 100 and 165 Regulations and Safety Zones listed in § 520.2611 [Amended] [Docket No. USCG–2013–0904] 33 CFR 100.120 and 33 CFR 165.171. ■ 210. In § 520.2611, in paragraph (b)(1), These regulations will be enforced for remove ‘‘000856’’ and in its place add Special Local Regulations and Safety the duration of each event, on or about ‘‘054771’’. Zones; Recurring Events in Northern the dates indicated in TABLES 1 and 2. New England ■ 211. In § 520.2613, revise paragraphs (a) and (b), the paragraph (c) heading, AGENCY: Coast Guard, DHS.

TABLE 1 [33 CFR 100.120]

JUNE

Charlie Begin Memorial Lobster Boat Races ...... • Event Type: Power Boat Race. • Sponsor: Boothbay Harbor Lobster Boat Race Committee. • Date: June 14, 2014. • Time: 10:00 a.m. to 2:00 p.m. • Location: The regulated area includes all waters of Boothbay Harbor, Maine in the vicinity of John’s Island within the following points (NAD 83): 43°50′04″ N, 069°38′37″ W. 43°50′54″ N, 069°38′06″ W. 43°50′49″ N, 069°37′50″ W. 43°50′00″ N, 069°38′20″ W.

Rockland Harbor Lobster Boat Races ...... • Event Type: Power Boat Race. • Sponsor: Rockland Harbor Lobster Boat Race Committee. • Date: June 15, 2014. • Time: 10:00 a.m. to 3:00 p.m. • Location: The regulated area includes all waters of Rockland Harbor, Maine in the vicinity of the Rockland Breakwater Light within the fol- lowing points (NAD 83): 44°05′59″ N, 069°04′53″ W. 44°06′43″ N, 069°05′25″ W. 44°06′50″ N, 069°05′05″ W.

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