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

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1 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520 [Docket No. FDA 2014 N 0002] Oral Dosage Form New Animal Drugs; Change of Sponsor AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; technical amendments. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 172 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) for oral dosage form new animal drug products from Pfizer, Inc., including its several subsidiaries and divisions, to Zoetis, Inc. FDA is also amending the animal drug regulations to remove entries describing conditions of use for new animal drug products for which no NADA is approved, to make minor corrections, and to reflect a current format. This is being done to increase the accuracy and readability of the regulations. DATES: This rule is effective May 20, FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for Veterinary Medicine (HFV 100), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, , steven.vaughn@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 E. 42d St., New York, NY 10017, and its wholly owned subsidiaries Alpharma, LLC; Fort Dodge Animal Health, Division of Wyeth; Fort Dodge Animal Health, Division of Wyeth Holdings Corp.; and its division, Pharmacia & Upjohn Co., have informed FDA that they have transferred ownership of, and all rights and interest in, the 172 approved NADAs and 14 approved ANADAs in table 1 to Zoetis, Inc., 333 Portage St., Kalamazoo, MI as TABLE 1 NADAS AND ANADAS BEING TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC. File No. Product name SULQUIN (sulfaquinoxaline) 6 50 Soluble Powder SUL Q NO X (sulfaquinoxaline) Liquid 34% TERRAMYCIN VET (oxytetracycline hydrochloride) Capsules SOXISOL (sulfisoxazole) Tablets TERRAMYCIN (oxytetracycline hydrochloride) Soluble Powder CARAFEN (ammonium chloride and caramiphen edisylate) Cough Syrup Primidone Tablets MYLEPSIN (primidone) Tablets TERRAMYCIN (oxytetracycline hydrochloride) Scour Tablets PARVEX (piperazine and carbon disulfide) Suspension NEOMIX 325 (neomycin sulfate) Soluble Powder MEDROL (methylprednisolone) Tablets VETAME (triflupromazine hydrochloride) Tablets VETAMOX (acetazolamide sodium) Soluble Powder PARVEX (piperazine and carbon disulfide) Bolus CORTABA (methylprednisolone and acetylsalicylic acid) Tablets TEMARIL P (trimeprazine tartrate and prednisolone) Tablets Promazine Granules DYREX (trichlorfon) Bolus, Capsules, Granules, Tablets DARBAZINE SPANSULE (prochlorperazine and isopropamide) Capsules Freed No. 10 or 25 (trichlorfon and atropine) S.E.Z. (sulfaethoxypyridazine) for Drinking Water 6.25% CYTOBIN (liothyronine sodium) Tablets ALBON (sulfadimethoxine) Tablets Spectinomycin Tablet and Injection DYREX T.F. (trichlorfon, phenothiazine, and piperazine dihydrochloride) Powder Sodium Sulfachloropyrazine Solution WINSTROL V (stanozolol) Tablets MYLEPSIN (primidone) Tablets FLUCORT (flumethasone) Tablets MESULFIN (sulfamethizole and methenamine mandelate) Tablets AGRIBON (sulfadimethoxine) 12.5% Drinking Water Solution RHEAFORM (iodochlorhydroxyquin) Bolus ESB 3 (sodium sulfachloropyrazine monohydrate) Solution and Soluble Powder ALBON (sulfadimethoxine) Boluses NEO DARBAZINE SPANSULE (prochlorperazine, isopropamide, and neomycin sulfate) Capsule PACITRAN (metoserpate hydrochloride) MAGNA TERRAMYCIN (oxytetracycline hydrochloride and carbomycin) Soluble Powder PARVEX PLUS (piperazine, carbon disulfide, phenothiazine) Suspension PROBAN (cythioate) Tablets 30 mg PROBAN (cythioate) Oral Liquid S.E.Z. (sulfaethoxypyridazine) Drinking Water Solution S.E.Z. (sulfaethoxypyridazine) Oblets 15 G BLOAT GUARD (poloxalene) Drench Concentrate LINCOCIN (lincomycin hydrochloride) Tablets TEMARIL P SPANSULE (trimeprazine tartrate and prednisolone) Capsules DYREX (trichlorfon and atropine) Powder MAOLATE (chlorphenesin carbamate) Tablets TRAMISOL (levamisole hydrochloride) Cattle Wormer Bolus. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1

2 28814 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations TABLE 1 NADAS AND ANADAS BEING TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC. Continued File No. Product name RIPERCOL L (levamisole hydrochloride) Soluble Drench Powder THERABLOAT (poloxalene) Oral Liquid LINCOCIN (lincomycin hydrochloride) Aquadrops Spectinomycin Oral Liquid TRANVET (propiopromazine hydrochloride) Chewable Tablets AMFOROL (kanamycin sulfate, attapulgite, bismuth subcarbonate) Suspension TRAMISOL (levamisole hydrochloride) Soluble Drench Powder for Sheep TRAMISOL (levamisole hydrochloride) Sheep Wormer Oblets AMFOROL (kanamycin sulfate, attapulgite, bismuth subcarbonate) Oral Tablets BANMINTH/STRONGID (pyrantel tartrate) Pellets CENTRINE (aminopentamide hydrogen sulfate) Oral Tablets ALBON (sulfadimethoxine) Oral Suspension 5% RIPERCOL L (levamisole hydrochloride) Soluble Powder EQUIBUTE (phenylbutazone) Tablets 100 mg ROBAXIN V (methocarbamol) Tablets L S 50 (lincomycin hydrochloride and spectinomycin sulfate) Water Soluble Powder AGRIBON (sulfadimethoxine) Soluble Powder S.E.Z. (sulfaethoxypyridazine) C R Oblets 15 Gm SPANBOLET II (sulfamethazine) OMNIPEN (ampicillin anhydrous) Capsules 250 mg AUREOMYCIN (chlortetracycline bisulfate) Soluble Powder DICLOXIN (dicloxacillin sodium monohydrate) Capsules AMPI TAB (ampicillin trihydrate) Tablets CHLOROMYCETIN (chloramphenicol palmitate) Oral Suspension CHLOROMYCETIN (chloramphenicol) Tablets Penicillin G Potassium, USP PANMYCIN (tetracycline hydrochloride) Tablets AMPI BOL (ampicillin trihydrate) Boluses ALBAPLEX (tetracycline hydrochloride novobiocin sodium) Tablets AMOXI TABS (amoxicillin trihydrate) Tablets AMOXI DOSER (amoxicillin trihydrate) Oral Suspension AMOXI TABS (amoxicillin trihydrate) Tablets AMOXI DROP (amoxicillin trihydrate) Oral Suspension AMOXI BOL (amoxicillin trihydrate) Boluses AMOXI SOL (amoxicillin trihydrate) Soluble Powder CLAVAMOX (amoxicillin trihydrate and clavulanate potassium) Tablets CLAVAMOX (amoxicillin trihydrate and clavulanate potassium) Drops PANMYCIN 500 (tetracycline hydrochloride) Bolus PANMYCIN AQUADROPS (tetracycline hydrochloride) Liquid TETRACHEL VET (tetracycline hydrochloride) Drops and Syrup TETRACHEL VET (tetracycline hydrochloride) Tablets TETRACHEL VET (tetracycline hydrochloride) Capsules DELTA ALBAPLEX (tetracycline hydrochloride, novobiocin sodium, prednisolone) Tablets ALBAPLEX (tetracycline hydrochloride and novobiocin sodium) Capsules ENTROMYCIN (bacitracin methylene disalicylate and streptomycin sulfate) Soluble Powder Tetracycline-Vet (tetracycline hydrochloride) Capsules Tetracycline Soluble Powder TET SOL 324 (tetracycline hydrochloride) Soluble Powder MYCHEL VET (chloramphenicol) Capsules (50 mg) POLYOTIC (tetracycline hydrochloride) Oblets FORTRACIN (bacitracin methylene disalicyclate) Soluble BACIFERM 50 (bacitracin zinc) Soluble Powder PANMYCIN (tetracycline hydrochloride) Capsules TETRA SAL (tetracycline hydrochloride) POLYOTIC (tetracycline hydrochloride) Soluble Powder BMD (bacitracin methylene disalicyclate) 50% Soluble Powder MYCHEL VET (chloramphenicol) Tablets ROBIZONE V (phenylbutazone) Tablets 100 mg GASTROGRAFIN (diatrizoate meglumine and diatrizoate sodium) Oral Solution STRONGID T (pyrantel pamoate) Oral Suspension RIPERCOL L-Piperazine (levamisole hydrochloride and piperazine dihydrochloride) Oral Solution ROBIZONE V (phenylbutazone) Tablets 1 g ALBON S.R. (sulfadimethoxine) Boluses DIROCIDE (diethylcarbamazine citrate) Tablets RIPERCOL L-Piperazine (levamisole hydrochloride and piperazine dihydrochloride) Soluble Powder RUMATEL (morantel tartrate) Cattle Wormer Bolus DIFOLIN (dichlorophene and toluene) Capsules ARQUEL (meclofenamic acid) Granules NBC Kaps Wormer (n-butyl chloride) Capsules EQUIPROXEN (naproxen) Granules Poultry Sulfa (sulfamerazine, sulfamethazine, sulfaquinoxaline) Soluble Powder NEMEX (pyrantel pamoate) Oral Suspension. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1

3 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations TABLE 1 NADAS AND ANADAS BEING TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC. Continued File No. Product name PRIMOR (sulfadimethoxine and ormetoprim) Tablets CHEQUE (mibolerone) Drops TORBUTROL (butorphanol tartrate) Tablets FILARIBITS (diethylcarbamazine) Chewable Tablets TRAMISOL (levamisole hydrochloride) Tablets PET DERM III (dexamethasone) Tablets ANTHELCIDE EQ (oxibendazole) Suspension VALBAZEN (albendazole) Oral Suspension ARQUEL (meclofenamic acid) Tablets BENZELMIN (oxfendazole) Powder For Suspension BENZELMIN (oxfendazole) Top Dress Pellets LINCOMIX (lincomycin hydrochloride) Soluble Powder DI TRIM (trimethoprim and sulfadiazine) Tablets ANTIROBE (clindamycin hydrochloride) Capsules ANTHELCIDE EQ (oxibendazole) Paste RE SORB Powder for Oral Solution CALFSPAN (sulfamethazine) Tablets TRAMISOL (levamisole hydrochloride) Gel VALBAZEN (albendazole) Oral Paste PET DEC (diethylcarbamazine citrate) Tablets BANMINTH P/STRONGID (pyrantel pamoate) Paste OXY TET (oxytetracycline hydrochloride) Soluble Powder DIROCIDE (diethylcarbamazine citrate) Syrup BENZELMIN (oxfendazole) Equine Anthelmintic Paste BENZELMIN (oxfendazole) Equine Anthelmintic Suspension PARATECT FLEX (morantel Tartrate) Bolus WINSTROL V (stanozolol) Chewable Tablets ANTIROBE AQUADROPS (clindamycin hydrochloride) Liquid DI TRIM 400 (trimethoprim and sulfadiazine) Paste FILARIBITS PLUS (diethylcarbamazine citrate and oxibendazole) Chewable Tablets BENZELMIN PLUS (oxfendazole and trichlorfon) Paste SOLU TET 324 (tetracycline hydrochloride) Soluble Powder STRONGID C and C 2X (pyrantel tartrate) Equine Anthelminthic SYNANTHIC (oxfendazole) Bovine Dewormer Paste 18.5% CESTEX (epsiprantel) Tablets SULKA S (sulfamethazine) Bolus VALBAZEN (albendazole) Oral Suspension ROBAMOX V (amoxicillin trihydrate) for Oral Suspension ROBAMOX V (amoxicillin trihydrate) Tablets PROHEART (moxidectin) Tablets RIMADYL (carprofen) Caplets for Dogs DECCOX M (decoquinate) Medicated Powder for Whole Milk ANIPRYL (selegiline hydrochloride) Tablets QUEST 2% (moxidectin) Equine Oral Gel RIMADYL (carprofen) Chewable Tablets ZENIQUIN (marbofloxacin) Tablets QUEST PLUS (moxidectin and praziquantel) Gel SIMPLICEF (cefpodoxime) Tablets SLENTROL (dirlotapide) Oral Solution CERENIA (maropitant) Tablets PALLADIA (toceranib phosphate) Tablets Neomycin Sulfate Soluble Powder R PEN (penicillin G potassium) Soluble Powder BIOSOL (neomycin sulfate) Oral Liquid SOLU PEN (penicillin G potassium) Soluble Powder NEO SOL 50 (neomycin sulfate) Oral Solution Lincomycin Soluble LINCO Soluble TUCOPRIM (trimethoprim and sulfadiazine) Powder AUREOMYCYN (chlortetracycline) Soluble Powder. Accordingly, the Agency is amending the regulations in 21 CFR part 520 to reflect these transfers of ownership. Also, the regulations are being amended to make minor corrections and to reflect a current format. This is being done to increase the accuracy and readability of the regulations. Following this change of sponsorship, Pfizer, Inc., and its wholly owned subsidiaries are no longer sponsors of an approved NADA. Accordingly, the Agency is amending the regulations in 21 CFR (c) to reflect this change of sponsorship. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1 In addition, FDA has noticed that certain sections of part 520 contain entries describing conditions of use for new animal drug products for which no NADA is approved. These errors were introduced by the Agency during the 1992 recodification of the regulations for certifiable antibiotics (57 FR 37318,

4 28816 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations August 18, 1992). That rule did not identify whether particular regulations were the subject of an approved NADA and consequently resulted in codification of certain conditions of use for which there is no approved NADA. At this time, the Agency is amending the regulations to remove these entries. This action is being taken to improve the accuracy of the regulations. This rule does not meet the definition of rule in 5 U.S.C. 804(3)(A) because it is a rule of particular applicability. Therefore, it is not subject to the congressional review requirements in 5 U.S.C List of Subjects 21 CFR Part 510 Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements. 21 CFR Part 520 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 510 and 520 are amended as PART 510 NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 510 continues to read as Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e [Amended] 2. In , in the table in paragraph (c)(1), remove the entries for Alpharma, LLC ; Fort Dodge Animal Health, Division of Wyeth ; Fort Dodge Animal Health, Division of Wyeth Holdings Corp. ; Pfizer, Inc. ; and Pharmacia & Upjohn Co. ; and in the table in paragraph (c)(2), remove the entries for , , , , and PART 520 ORAL DOSAGE FORM NEW ANIMAL DRUGS 3. The authority citation for 21 CFR part 520 continues to read as Authority: 21 U.S.C. 360b. 4. Revise to read as Acetazolamide. (a) Specifications. A powder containing acetazolamide sodium, USP equivalent to 25 percent acetazolamide activity. Amount. Administer orally at a dosage of 5 to 15 milligrams per pound of body weight daily. (2) Indications for use. As an aid in the treatment of mild congestive heart failure and for rapid reduction of intraocular pressure a [Amended] 5. In paragraph (b) of a, b [Amended] 6. In paragraph (b) of b, 7. Revise to read as Aminopentamide. contains 0.2 milligram (mg) aminopentamide hydrogen sulphate. cats (1) Amount. Administer orally every 8 to 12 hours as For animals weighing up to 10 pounds (lbs): 0.1 mg; for animals weighing 11 to 20 lbs: 0.2 mg; for animals weighing 21 to 50 lbs: 0.3 mg; for animals weighing 51 to 100 lbs: 0.4 mg; for animal weighing over 100 lbs: 0.5 mg. Dosage may be gradually increased up to a maximum of five times the suggested dosage. Oral administration of tablets may be preceded by subcutaneous or intramuscular use of the injectable form of the drug. treatment of vomiting and/or diarrhea, nausea, acute abdominal visceral spasm, pylorospasm, or hypertrophic gastritis. 8. Revise to read as Aminopropazine oral dosage forms. 9. Revise a to read as a Aminopropazine. contains aminopropazine fumarate equivalent to 25 percent aminopropazine base. (b) Sponsor. See No in cats (1) Amount. Administer orally at a dosage of 1 to 2 milligrams per pound of body weight, repeated every 12 hours as indicated. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1 (2) Indications for use. For reducing excessive smooth muscle contractions, such as occur in urethral spasms associated with urolithiasis. 10. Revise b to read as b Aminopropazine and neomycin. contains aminopropazine fumarate equivalent to 25 percent aminopropazine base and neomycin sulfate equivalent to 50 milligrams (mg) of neomycin base. (b) Sponsor. See No in Amount. Administer orally at a dosage of 1 to 2 mg per pound of body weight, repeated every 12 hours as indicated. (2) Indications for use. For control of bacterial diarrhea caused by organisms susceptible to neomycin and to reduce smooth muscle contractions. 11. In a, revise paragraphs (a), (b), (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to read as a Amoxicillin trihydrate filmcoated tablets. contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams (mg) amoxicillin. (1) * * * (i) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days. (2) * * * (i) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days. 12. In b, revise paragraphs (a), (b), (b)(1)(i)(a) and (C), (b)(1)(ii)(a) and (C), and (c)(1)(i) and (iii) to read as b Amoxicillin trihydrate for oral suspension. (a) Specifications. When reconstituted, each milliliter contains

5 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin. (1) * * * (i) * * * (A) Amount. Administer orally 5 mg per pound (/lb) of body weight, twice a day for 5 to 7 days. (C) Limitations. Federal law restricts (ii) * * * (A) Amount. Administer orally 5 to 10 mg/lb of body weight, once daily for 5 to 7 days. (C) Limitations. Federal law restricts (1) Conditions of use in dogs (i) Amount. Administer orally 5 mg/lb of body weight, twice a day for 5 to 7 days. 13. In c, revise paragraphs (a), (b), (d) heading, (d)(1), and (d)(3) to read as c Amoxicillin trihydrate oral suspension. (a) Specifications. Each 0.8-milliliter dose contains amoxicillin trihydrate equivalent to 40 milligrams (mg) amoxicillin. (d) Conditions of use in swine (1) Amount. Administer 40 mg orally twice a day using a dosing pump. Treat animals for 48 hours after all symptoms have subsided but not beyond 5 days. (3) Limitations. Do not slaughter during treatment or for 15 days after latest treatment. Federal law restricts 14. In d, revise paragraphs (a), (b), (d) heading, (d)(1), and (d)(3) to read as d Amoxicillin trihydrate soluble powder. (a) Specifications. Each gram of powder contains amoxicillin trihydrate equivalent to milligrams (mg) amoxicillin. (d) Conditions of use in preruminating calves including veal calves (1) Amount. Administer 400 mg per 100 pounds of body weight twice daily by drench or in milk. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. (3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of 15. In e, revise paragraphs (a), (b), (d) heading, (d)(1), and(3) to read as e Amoxicillin trihydrate boluses. (a) Specifications. Each bolus contains amoxicillin trihydrate equivalent to 400 milligrams (mg) amoxicillin. (d) Conditions of use in cattle (1) Amount. Administer 400 mg per 100 pounds of body weight twice daily. Treatment should be continued for 48 hours after all symptoms have subsided but not to exceed 5 days. (3) Limitations. Do not slaughter animals during treatment or for 20 days after the latest treatment. Federal law restricts this drug to use by or on the order of 16. Revise f to read as f Amoxicillin trihydrate tablets. contains amoxicillin trihydrate equivalent to 50, 100, 200, or 400 milligrams (mg) amoxicillin. (b) Sponsors. See Nos and in Amount. Administer 5 mg per pound of body weight twice daily for 5 to 7 days or 48 hours after all symptoms have subsided. (2) Indications for use. For treatment of bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and Escherichia coli; and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, Proteus mirabilis, and Staphylococcus spp. 17. In g, revise paragraphs (b), (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to read as VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR g Amoxicillin trihydrate and clavulanate potassium film-coated tablets. (1) * * * (i) Amount milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days. (2) * * * (i) Amount milligrams (1 milliliter) (50 milligrams amoxicillin and 12.5 milligrams clavulanic acid) twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days. 18. In h, revise paragraphs (b), (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to read as h Amoxicillin trihydrate and clavulanate potassium for oral suspension. (1) * * * (i) Amount milligrams (equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic acid) per pound of body weight twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days. (2) * * * (i) Amount milligrams (1 milliliter) (50 milligrams amoxicillin and 12.5 milligrams clavulanic acid) twice daily. Administer 48 hours after all signs have subsided. Maximum duration of treatment should not exceed 30 days.

6 28818 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations a [Reserved] 19. Remove and reserve a. 20. In b, revise the section heading, paragraph (b), paragraph (c) heading, and paragraph (c)(3) to read as b Ampicillin tablets. (c) Conditions of use in dogs 21. In c, revise the section heading, paragraphs (b), (c)(1)(iii), and (c)(2)(iii) to read as c Ampicillin capsules. (1) * * * (2) * * * 22. In d, revise the section heading, paragraphs (c)(1)(i) and (iii), and (c)(2)(i) and (iii) to read as d Ampicillin for oral suspension. (1) * * * (i) Amount. Administer to 10 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. In severe or acute conditions, 10 milligrams per pound of body weight 3 times daily. Duration of treatment is usually 3 to 5 days. Continue treatment 48 hours after the animal s temperature has returned to normal and all other signs of infection have subsided. (2) * * * (i) Amount. Administer 10 to 30 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. Duration of treatment is usually 3 to 5 days. Continue treatment 48 hours after the animal s temperature has returned to normal and all other signs of infection have subsided. 23. In e, revise the section heading and paragraph (d)(3) to read as e Ampicillin for soluble powder. (d) * * * (3) Limitations. Treated swine must not be slaughtered for food during treatment and for 24 hours following the last treatment. Federal law restricts this drug to use by or on the order of a licensed 24. In f, revise the section heading and revise paragraph (b) and in paragraphs (d)(1)(ii) and (d)(2)(ii), remove the second sentence.. The revisions read as f Ampicillin boluses. (b) Sponsors. See sponsor numbers in (c) of this chapter as (1) No for use as in paragraph (d)(1) of this section; (2) No for use as in paragraph (d)(2) of this section. 25. In , revise paragraph (d) to read as Apramycin sulfate soluble powder. (d) Conditions of use in swine (1) Amount. Administer in drinking water at the rate of 12.5 milligrams of apramycin per kilogram (5.7 milligrams per pound) of body weight per day for 7 days. control of porcine colibacillosis (weanling pig scours) caused by strains of Escherichia coli sensitive to apramycin. (3) Limitations. Prepare fresh medicated water daily. Do not slaughter treated swine for 28 days following treatment a [Amended] 26. In paragraph (b) of a, remove and in its place add b [Amended] 27. In paragraph (b) of b, remove and in its place add c [Amended] 28. In paragraph (b) of c, remove and in its place add 29. Revise to read as Butorphanol tablets. contains butorphanol tartrate equivalent VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1 to 1, 5, or 10 milligrams (mg) butorphanol base. Amount. Administer 0.25 mg butorphanol base per pound of body weight. Repeat at intervals of 6 to 12 hours as required. Treatment should not normally be required for longer than 7 days. relief of chronic nonproductive cough associated with tracheobronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract [Amended] 30. In , remove footnote 1 wherever it occurs; and in paragraph (b)(2), remove and in its place add 31. In a, revise paragraph (c) to read as a Cambendazole suspension. Amount. Administer by stomach tube or as a drench at a dose of 0.9 gram of cambendazole per 100 pounds of body weight (20 milligrams per kilogram). control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides). 32. In b, revise paragraph (c) to read as b Cambendazole pellets. Amount. Administer 20 milligrams cambendazole per kilogram body weight (6 ounces per 1,000 pounds) by mixing with normal grain ration given at one feeding. Doses for individual horses should be mixed and fed separately to assure that each horse will consume the correct amount. For animals maintained on premises where reinfection is likely to occur, re-treatments may be necessary. For most effective results, retreat in 6 to 8 weeks.

7 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides). (3) Limitations. Do not administer to pregnant mares during first 3 months of pregnancy. Do not use in horses Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. 33. In c, revise paragraph (c) to read as c Cambendazole paste. Amount. Administer 20 milligrams cambendazole per kilogram body weight (5 grams per 550 pounds (250 kilograms)) by depositing the paste on the back of the tongue using a dosing gun. For animals maintained on premises where reinfection is likely to occur, re-treatments may be necessary. For most effective results, re-treat in 6 to 8 weeks. control of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles (Trichonema, Poteriostomum, Cylicobrachytus, Craterostomum, Oesophagodontus); roundworms (Parascaris); pinworms (Oxyuris); and threadworms (Strongyloides). (3) Limitations. Do not administer to pregnant mares during first 3 months of pregnancy. Do not use in horses Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism [Amended] 34. In , in paragraph (b)(1), [Amended] 35. In , in paragraph (b), remove and in its place add ; and remove footnote 1 wherever it occurs [Amended] 36. In , in paragraph (b), remove and and in its place add and a [Amended] 37. In a, in paragraph (b)(1)(ii), remove and in its place add ; and remove paragraph (b)(1)(iii) b [Amended] 38. In b, in paragraph (b), remove and and in its place add and c [Amended] 39. In c, in paragraph (b), remove and in its place add [Amended] 40. In , remove footnote 1 wherever it occurs [Amended] 41. In , in paragraph (b), remove and in its place add ; and in paragraph (c)(3), remove the first four sentences [Amended] 42. In , in paragraph (b)(2), remove and and in its place add and [Amended] 43. In , in paragraph (b)(1), remove and and in its place add and [Amended] 44. In , in paragraph (b), remove , , and in its place add , , [Amended] 45. In , in paragraph (b), remove and in its place add ; and in paragraph (d)(3), remove the first two sentences. 46. Amend as a. Add paragraph (a); b. Remove paragraph (c); c. Redesignate paragraph (d) as paragraph (c); and d. Revise paragraph (b) and newly redesignated paragraph (c)(3). The addition and revision read as Cythioate tablets. contains 30 or 90 milligrams (mg) cythioate. (b) Sponsors. See sponsor numbers in (c) of this chapter as (1) No for use of 30- and 90- mg tablets; (2) No for use of the 30-mg tablet. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1 47. In , revise paragraph (a), and in paragraph (b), remove and in its place add The revision reads as Decoquinate. (a) Specifications. Each gram of powder contains 8 milligrams (0.8 percent) decoquinate. 48. Revise a to read as a Dexamethasone powder. (a) Specifications. Each packet contains 10 milligrams (mg) of dexamethasone. (b) Sponsor. See No in (c) Conditions of use in cattle and horses (1) Amount. Administer 5 to 10 mg per animal the first day then 5 mg per day as required by drench or by sprinkling on a small amount of feed. (2) Indications for use. As supportive therapy following parenteral steroid administration for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption. 49. In b, remove footnote 1 wherever it occurs; and revise paragraphs (a)(3) and (b)(3) to read as b Dexamethasone tablets and boluses. (a) * * * (3) Conditions of use in cattle and horses (i) Amount. Administer orally 5 to 10 milligrams on the first day, then 5 milligrams per day as required. (ii) Indications for use. As supportive therapy following parenteral steroid administration for management or inflammatory conditions such as acute arthritic lameness, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not use in horses intended for human consumption. (b) * * *

8 28820 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations (3) Conditions of use in dogs and cats (i) Amount. Dogs: Administer orally 0.25 to 1.25 milligrams per day for up to 7 days. Cats: Administer orally to 0.5 milligrams per day for up to 7 days. (ii) Indications for use. As an antiinflammatory agent. 50. Amend c as a. Remove footnote 1 wherever it occurs; b. In paragraph (b), remove and in its place add ; and c. Revise paragraph (c). The revision reads as c Dexamethasone chewable tablets. Amount. Administer by free-choice feeding or crumbled over food 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by milligram per day until maintenance level is achieved. (2) Indications for use. As supportive therapy in nonspecific dermatosis and inflammatory conditions [Removed] 51. Remove In , revise the section heading, remove in paragraph (b) and in its place add , and revise paragraph (c). The revisions read as Dexamethasone chewable tablets. cats (1) Amount. Administer orally 0.5 to 1.0 milliliter per pound of body weight by gavage or stomach tube. Administered rectally 0.5 to 1.0 milliliter per pound of body weight diluted with 1 part of the drug to 5 parts of water. (2) Indications for use. For radiography of the gastrointestinal tract [Amended] 53. In , in paragraph (b)(2), remove and in its place add 54. In , revise the section heading and paragraphs (b) and (c) to read as Dicloxacillin (c) of this chapter. Amount. Administer orally 5 to 10 milligrams per pound of body weight, three times daily. In severe cases, up to 25 milligrams per pound of body weight three times daily. treatment of pyoderma (pyogenic dermatitis) due to penicillinaseproducing staphylococci sensitive to dicloxacillin a [Amended] 55. In a, in paragraph (a)(2), remove and in its place add b [Amended] 56. In b, in paragraph (a)(2), remove and in its place add c [Amended] 57. In c, in paragraph (b)(2), 58. In , revise the section heading and paragraphs (b) and (c)(3) to read as Diethylcarbamazine and oxibendazole chewable tablets [Amended] 59. In , in paragraph (b), 60. Revise to read as Dithiazanine oral dosage forms. 61. Revise a to read as a Dithiazanine tablets. contains 10, 50, 100, or 200 milligrams (mg) dithiazanine iodide. (b) Sponsor. See No in Indications for use and amount. Administer orally immediately after feeding as (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 mg per VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1 pound (/lb) of body weight for 3 to 5 days; (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) and whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days; (iii) For Strongyloides (Strongyloides canis, Strongyloides stercoralis): 10 mg/ lb of body weight for 10 to 12 days; (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should follow 6 weeks after therapy for adult worms. (2) Limitations. Federal law restricts 62. Revise b to read as b Dithiazanine powder. (a) Specifications. Each tablespoon of powder contains 200 milligrams (mg) dithiazanine iodide. (b) Sponsor. See No in Indications for use and amount. Administer orally by mixing in food as (i) For large roundworms (Toxocara canis, Toxascaris leonina): 10 mg per pound (/lb) of body weight for 3 to 5 days; (ii) For hookworms (Ancylostoma caninum, Uncinaria stenocephala) and whipworms (Trichuris vulpis): 10 mg/lb of body weight for 7 days; (iii) For Strongyloides (Strongyloides canis, Strongyloides stercoralis): 10 mg/ lb of body weight for 10 to 12 days; (iv) For heartworm microfilariae (Dirofilaria immitus): 3 to 5 mg/lb of body weight for 7 to 10 days. Treatment for heartworm microfilariae should follow 6 weeks after therapy for adult worms. (2) Limitations. Federal law restricts 63. In c, redesignate paragraph (d) as paragraph (c); and revise paragraphs (a), (b), and the redesignated paragraph (c) heading to read as c Dithiazanine and piperazine suspension. (a) Specifications. Each milliliter of suspension contains 69 milligrams (mg) dithiazanine iodide and 83 mg piperazine base (as piperazine citrate). (b) Sponsor. See No in (c) Conditions of use in horses

9 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations Amend by revising the section heading and paragraph (c) to read as Doxylamine. (c) Conditions of use (1) Amount. Horses: Administer orally 1 to 2 milligrams (mg) per pound (/lb) of body weight per day divided into 3 or 4 equal doses. Dogs and cats: Administer orally 2 to 3 mg/lb of body weight per day divided into 3 or 4 equal doses. (2) Indications for use. For use when antihistaminic therapy may be expected to alleviate some signs of disease in horses, dogs, and cats. 65. Revise to read as Enalapril. contains 1.0, 2.5, 5.0, 10, or 20 milligrams (mg) of enalapril maleate. (b) Sponsor. See No in (c) Conditions of use in dogs (i) Amount. Administer orally 0.5 to 1.0 mg of enalapril maleate per kilogram of body weight per day. (ii) Indications for use. For the treatment of mild, moderate, and severe (modified New York Heart Association Class II, III, IV) heart failure in dogs. 66. In , revise the section heading and paragraphs (b) and (c)(3) to read as Epsiprantel. (b) Sponsor. See No in 67. In , revise the section heading and paragraph (a) to read as Erythromycin. (a) Specifications. Each gram of powder contains erythromycin phosphate equivalent to 0.89 gram of erythromycin master standard. 68. Amend as a. Revise the section heading; b. Remove footnote 1 wherever it occurs; and c. Revise paragraph (c). The revisions read as Ethylisobutrazine. Amount. Administer orally 2 to 5 milligrams per pound of body weight once daily. (2) Indications for use. As a tranquilizer. 69. In , add paragraph (c) and remove paragraph (d). The addition reads as Etodolac. Amount. Administer 10 to 15 mg per kilogram (4.5 to 6.8 mg per pound) of body weight per day orally. management of pain and inflammation associated with osteoarthritis. 70. Revise a to read as a Febantel paste. (a) Specifications. Each gram of paste contains 455 milligrams (45.5 percent) febantel. (b) Sponsor. See No in Amount. Administer paste orally at 6 milligrams per kilogram (2.73 milligrams per pound) of body weight on the base of the tongue or well mixed into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks. (2) Indications for use. For removal of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); ascarids (Parascaris equorum sexually mature and immature); pinworms (Oxyuris equi adult and 4th stage larva); and various small strongyles in horses, foals, and ponies. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. 71. In b, revise paragraphs (a), (b), and (c) to read as b Febantel suspension. (a) Specifications. Each ounce of suspension contains 2.75 grams (9.3 percent ounce) febantel. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1 (b) Sponsor. See No in Amount. 3 milliliters per 100 pounds body weight or 1 fluid ounce per 1000 pounds (6 milligrams per kilogram body weight). Administer by stomach tube or drench, or by mixing well into a portion of the normal grain ration. For animals maintained on premises where reinfection is likely to occur, retreatment may be necessary. For most effective results, retreat in 6 to 8 weeks. (2) Indications for use. For removal of ascarids (Parascaris equorum adult and sexually immature), pinworms (Oxyuris equi adult and 4th stage larvae), large strongyles (Strongylus vulgaris, S. edentatus, S. equinus), and various small strongyles in horses, breeding stallions and mares, pregnant mares, foals, and ponies. 72. In d, revise the section heading and paragraph (c)(3) and remove paragraph (c)(4). The revisions read as d Febantel and praziquantel paste. 73. In e, revise paragraphs (b) and (c)(3) to read as e Febantel tablets. (b) Sponsor. See No in 74. In , revise the section heading and paragraphs (b) and (c)(3) to read as Flumethasone. 75. Add to read as Glucose and glycine. (a) Specifications. Each packet of powder contains 8.82 grams sodium chloride, 4.20 grams potassium

10 28822 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations phosphate, 0.5 gram citric acid anhydrous, 0.12 gram potassium citrate, 6.36 grams aminoacetic acid (glycine), and 44.0 grams glucose. (c) Conditions of use in calves (1) Amount. Dissolve each packet in 2 quarts of warm water and administer to each calf as (i) Scouring and/or dehydrated calves. Feed 2 quarts of solution, twice daily for 2 days (four feedings). No milk or milk replacer should be fed during this period. For the next four feedings (days 3 and 4), use 1 quart of solution together with 1 quart of milk replacer. Thereafter, feed as normal. (ii) Newly purchased calves. Feed 2 quarts of solution instead of milk as the first feed upon arrival. For the next scheduled feeding, use 1 quart of solution mixed together with 1 quart of milk or milk replacer. Thereafter, feed as normal. (2) Indications for use. For control of dehydration associated with diarrhea (scours); and as an early treatment at the first signs of scouring. It may also be used as followup treatment following intravenous fluid therapy. (3) Limitations. The product should not be used in animals with severe dehydration (down, comatose, or in a state of shock). Such animals need intravenous therapy. A veterinarian should be consulted in severely scouring calves. The product is not nutritionally complete if administered by itself for long periods of time. It should not be administered beyond the recommended treatment period without the addition of milk or milk replacer. 76. In , revise paragraphs (d)(1)(ii) and (d)(2)(i)(a) to read as Griseofulvin. (d) * * * (1) * * * (ii) Limitations. Do not use in horses (2) * * * (i) * * * (A) Daily (single or divided) dose as For animals weighing up to 6 pounds: 62.5 milligrams; for animals weighing 6 to 18 pounds: 125 milligrams; for animals weighing 18 to 36 pounds: 250 milligrams; for animals weighing 36 to 48 pounds: 375 milligrams; for animal weighing 48 to 75 pounds: 500 milligrams. 77. Amend a as a. Remove paragraph (a); b. Redesignate paragraphs (b) through (f) as paragraphs (a) through (e), respectively; and c. Revise newly redesignated paragraphs (a) and (e). The revisions read as a Haloxon drench. (a) Specifications. Each packet contains grams haloxon. (e) Conditions of use in cattle (1) Amount. Dissolve each packet in 32 fluid ounces of water and administer as For animals weighing up to 100 pounds: 1/2 fluid ounce; for animals weighing 100 to 150 pounds: 3/4 fluid ounce; for animals weighing 150 to 200 pounds: 1 fluid ounce; for animals weighing 200 to 300 pounds: 1 1/2 fluid ounces; for animals weighing 300 to 450 pounds: 2 fluid ounces; for animals weighing 450 to 700 pounds: 3 fluid ounces; for animals weighing 700 to 1,000 pounds: 4 fluid ounces; for animals weighing 1,000 to 1,200 pounds: 5 fluid ounces; for animals weighing over 1,200 pounds: 6 fluid ounces. Retreat in 3 to 4 weeks. (2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia. (3) Limitations. Do not treat dairy animals of breeding age. Do not treat within 1 week of slaughter. 78. Amend b as a. Remove paragraph (a); b. Redesignate paragraphs (b) through (e) as paragraphs (a) through (d), respectively; and c. Revise newly redesignated paragraph (d). The revisions read as b Haloxon boluses. (d) Conditions of use in cattle (1) Amount. Administered one bolus per 500 pounds body weight (35 to 50 milligrams per kilogram of body weight). Retreat in 3 to 4 weeks. (2) Indications for use. For control of gastrointestinal roundworms of the genera Haemonchus, Ostertagia, Trichostrongylus, and Cooperia. (3) Limitations. Do not treat dairy animals of breeding age or older. Do not treat within 1 week of slaughter. 79. In , revise the section heading and paragraph (c)(3) to read as Iodinated casein. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR1 80. In , revise the section heading and paragraphs (b) and (c)(3) to read as Iodochlorhydroxyquin (c) of this chapter. 81. In , revise the section heading and paragraphs (c)(1)(i) and (iii) to read as Ivermectin and pyrantel tablets. (1) * * * (i) Amount. Administer a minimum of 6 mg of ivermectin and 5 mg of pyrantel per kilogram (2.72 mg and 2.27 mg per pound) of body weight monthly [Amended] 82. In , in paragraph (b), remove Sponsors and in its place add Sponsor [Amended] 83. In , in paragraph (b), remove and in its place add a [Amended] 84. In a, in paragraph (b)(2), remove and in its place add 85. Revise b to read as b Levamisol boluses or oblets. (a) Specifications. Each bolus contains 2.19 grams levamisol hydrochloride. Each oblet contains grams levamisol hydrochloride. (b) Sponsors. See Nos and in (c) Required labeling. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (d) Related tolerances. See of this chapter. (e) Conditions of use (1) Cattle (i) Amount. Administer orally 2.19-gram boluses as a single dose as 250 to 450 pounds, 1 2 bolus; 450 to 750 pounds, 1 bolus; and 750 to 1,050 pounds, boluses.

11 Federal Register / Vol. 79, No. 97 / Tuesday, May 20, 2014 / Rules and Regulations (ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum), and lungworms (Dictyocaulus). (iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 48 hours of treatment. Not for use in dairy animals of breeding age. Consult veterinarian before using in severely debilitated animals. (2) Sheep (i) Amount. Administer orally one gram oblet for each 50 pounds of body weight. (ii) Indications for use. Anthelmintic effective against the following nematode infections: Stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and lungworms (Dictyocaulus). (iii) Limitations. Conditions of constant helminth exposure may require re-treatment within 2 to 4 weeks after the first treatment. Do not slaughter for food within 72 hours of treatment. Consult a veterinarian before using in severely debilitated animals. 86. Revise c to read as c Levamisol and piperazine. (a) Specifications. (1) Each ounce of solution contains 0.36 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 3.98 grams of piperazine base. (2) A soluble powder which when constituted with water contains in each fluid ounce 0.45 gram of levamisole hydrochloride and piperazine dihydrochloride equivalent to 5.0 grams of piperazine base. Amount. Aqueous solution: administer by stomach tube or drench 1 fluid ounce per 100 pounds of body weight. Reconstituted soluble powder: administer by stomach tube 1 fluid ounce per 125 pounds of body weight. If reinfection occurs, re-treat animals at 6- to 8-week intervals. (2) Indications for use. An anthelmintic effective against infections of large strongyles (Strongylus vulgaris, S. edentatus), small strongyles (Cylicocercus spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Cylicotetrapedon spp.), ascarids (Parascaris equorum), and pinworms (Oxyuris equi) e [Amended] 87. In paragraph (b) of e, remove and in its place add 88. In f, revise the section heading and paragraphs (a) and (b) to read as f Levamisol gel. (a) Specifications. Each gram of gel contains 115 milligrams (11.5 percent) levamisol hydrochloride. 89. Amend g as a. Remove paragraph (a); b. Redesignate paragraphs (b) through (f) as paragraphs (a) through (e); and c. Revise newly redesignated paragraph (d). The revision reads as g Levamisole resinate and famphur paste. (d) Related tolerances. See and of this chapter. 90. Revise a to read as a Lincomycin tablets and syrup. (a) Specifications. (1) Each ounce of syrup contains lincomycin hydrochloride equivalent to either 25 or 50 milligrams (mg) lincomycin. (2) Each tablet contains lincomycin hydrochloride equivalent to either 25 or 50 mg lincomycin. cats (1) Amount. Administer orally 10 mg per pound of body weight every 12 hours, or 7 mg per pound of body weight every 8 hours, for up to 12 days. (2) Indications for use. For infections caused by gram-positive organisms which are sensitive to its action, particularly streptococci and staphylococci c [Amended] 91. In c, in paragraph (b)(1) remove and in its place add ; and in paragraph (b)(2) remove and in its place add [Amended] 92. In , in paragraph (b)(1) remove and in its place add 93. Revise to read as Liothyronine. contains 60 or 120 micrograms (mg) liothyronine as the sodium salt. Amount. Administer orally to dogs at levels up to 12.8 mg per kilogram (/kg) of body weight per day. Dosage should be adjusted according to the severity of the condition and the response of the patient. Dosage at the total replacement level (12.8 mg/kg of body weight) should be considered for initiating therapy and then titrated downward for optimum maintenance effect. Twice daily administration is recommended. (2) Indications for use. For treatment of hypothyroidism in dogs. 94. In , in paragraph (b), ; and revise the section heading to read as Marbofloxacin. VerDate Mar<15> :05 May 19, 2014 Jkt PO Frm Fmt 4700 Sfmt 4700 E:\FR\FM\20MYR1.SGM 20MYR [Amended] 95. In paragraph (b) of , 96. Revise to read as Mebendazole. (a) Specifications. (1) Each gram of powder contains either 40 or milligrams of mebendazole. (2) Each gram of paste contains 200 milligrams of mebendazole. (3) Each milliliter of suspension contains 33.3 milligrams of mebendazole. (b) Sponsor. See No in (c) Conditions of use (1) Horses (i) Amount. 1 gram of mebendazole per 250 pounds of body weight per dose, as an oral powder, paste or suspension. (ii) Indications for use. For treatment of infections caused by large roundworms (Parascaris equorum); large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small