(c) * * *

(1) * * *

(2) * * *

(a) Specifications. Each chewable tablet contains:

(1) 56.25 milligrams (mg) lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt);

(2) 112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt);

(3) 225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt);

(4) 450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or

(5) 900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt).

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of use —

(1) Amount. Administer orally at the minimum dosage of 9 mg/pound (mg/lb) (20 mg/kilogram (mg/kg)) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt).

(2) Indications for use. For the treatment of infestations caused by New World screwworm ( Cochliomyia hominivorax) larvae (myiasis) in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

(b) * * *

(1) Nos. 061133 and 066104 for use as in paragraph (d) of this section.

(d) * * *

(1) Swine —

(i) Amount. Administer at a dose rate of 250 milligrams (mg) of lincomycin per gallon of drinking water. In clinical studies, this dose rate provided an average of 3.8 mg of lincomycin per pound of body weight per day. The drug should be administered for a minimum of 5 consecutive days beyond the disappearance of symptoms (bloody stools) up to a maximum of 10 consecutive days. If water treatment is discontinued prior to this time, a lincomycin treatment program may be continued with lincomycin Type A medicated article at 100 grams lincomycin per ton of complete feed as the sole ration according to label directions. A dose of 3.8 mg lincomycin per pound of body weight may be maintained by medicating the drinking water at a concentration of 250 mg per gallon of drinking water when pigs are consuming 1.5 gallons per 100 lb of body weight per day. Under these circumstances the concentration of lincomycin required in medicated water may be adjusted to compensate for variations in age and weight of animals, the nature and severity of disease symptoms, environmental temperature and humidity, each of which affects water consumption. For use in automatic water proportioner to deliver 1 ounce of stock solution per gallon of drinking water. NOTE: After a treatment program is discontinued, a control program for swine dysentery may be followed by feeding lincomycin Type A ( printed page 20341) medicated article at 40 grams lincomycin per ton of complete feed as the sole ration.

(ii) Indications for use. For the treatment of swine dysentery (bloody scours) in swine. Not for use in pregnant swine or swine intended for breeding.

(iii) Limitations. Discard medicated drinking water if not used within 2 days. Fresh stock should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. If clinical signs of bloody scours (watery, mucoid, or bloody stools) have not improved during the first 6 days of medication, discontinue treatment and redetermine the diagnosis. On rare occasions, some pigs may show reddening of the skin, swelling of the anus, and irritable behavior. These conditions have been self-correcting within five to seven days without discontinuing the lincomycin treatment. The safety of lincomycin has not been demonstrated for pregnant swine or swine intended for breeding. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Broiler Chickens —

(i) Amount. Administer at a dose rate of 64 mg of lincomycin per gallon of drinking water. Start medication as soon as the diagnosis of necrotic enteritis is determined. The drug should be administered for 7 consecutive days. NOTE: After water medication is discontinued, a control program for necrotic enteritis may be followed by feeding lincomycin Type A medicated article at 2 grams lincomycin per ton of complete feed.

(ii) * * *

(iii) Limitations. Not for use in laying hens or breeder chickens. Discard medicated drinking water if not used within 2 days. Fresh stock should be prepared daily. Do not use the water treatment and the feed treatment simultaneously. Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Honey bees —

(i) Amount. Administer 100 mg lincomycin per hive once weekly for 3 weeks. Mix 250 mg LINCOMIX Soluble Powder (100 mg lincomycin) with 20 g confectioners'/powder sugar and dust over the top bars of the brood chamber.

(ii) Indications for use. For the control of American foulbrood ( Paenibacillus larvae) in honey bees.

(c) * * *

(1) * * *

(i) * * *

(ii) Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations ( Ctenocephalides felis), and the treatment and control of tick infestations ( Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)) for one month in dogs and puppies 8 weeks of age and older, and weighing 4.4 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

(c) * * *

(1) * * *

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara cani s and adult Toxascaris leonina), hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala), and tapeworm ( Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations ( Ctenocephalides felis) and the treatment and control of tick infestations ( Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)) for one month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

(d) * * *

(1) * * *

(ii) Turkeys —

(A) * * *

( 3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 016592. Zero-day withdrawal for those products sponsored by Nos. 016592 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) * * *

( 3) Do not use in birds producing eggs for human consumption. Withdraw 5 days prior to slaughter those products sponsored by Nos. 054771 and 061133 in § 510.600(c) of this chapter. Withdraw 4 days prior to slaughter those products sponsored by No. 016592. Zero-day withdrawal for those products sponsored by Nos. 016592 and 069254. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(c) * * *

(2) Indications for use. For the delay of onset of congestive heart failure in dogs with Stage B2 preclinical myxomatous mitral valve disease. Stage B2 preclinical myxomatous mitral valve disease (MMVD) refers to dogs with asymptomatic MMVD that have a moderate or loud mitral murmur due to mitral regurgitation and cardiomegaly. For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical MMVD or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure ( e.g., ( printed page 20342) furosemide, etc.,) as appropriate on a case-by-case basis.

(a) Specifications.

(1) Each tablet contains 34 milligrams (mg) praziquantel.

(2) Each tablet contains 11.5 or 23 mg praziquantel.

(3) Each chewable tablet contains 23 mg praziquantel.

(b) * * *

(3) No. 086101 for use of product as described in paragraph (a)(3) of this section as in paragraph (c)(2) of this section.

(a) Specifications. Each tablet contains:

(1) 10, 20, or 40 milligrams (mg) robenacoxib for use in dogs; or

(2) 6 mg robenacoxib for use in cats.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) No. 058198 for use of product described in paragraph (a)(1) and (a)(2) of this section as in paragraph (c)(1) and (c)(2) of this section.

(2) No. 086117 for use of product described in paragraph (a)(2) of this section as in paragraph (c)(2) of this section.

(a) Specifications. Each tablet contains 2.5, 10, 22.5, or 50 milligrams (mg) verdinexor.

(b) Sponsor. See No. 086121 in § 510.600(c) of this chapter.

(c) Conditions of use —

(1) Amount. Administer verdinexor tablets orally at an initial dose of 1.25 mg per kilogram (mg/kg) of body weight twice per week with at least 72 hours between doses. If tolerated after 2 weeks, increase the dose to 1.5 mg/kg twice per week with at least 72 hours between doses.

(2) Indications for use. For the treatment of lymphoma in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

(a) Sponsor. See No. 043264 in § 510.600(c) of this chapter.

(b) Specifications. Each milliliter (mL) contains 0.25 milligrams (mg) cosyntropin, 1 mg glacial acetic acid, 0.82 mg sodium acetate trihydrate, 8.1 mg sodium chloride, and water for injection (to 100%).

(c) Conditions of use —

(1) Amount. Administer 0.25 mg (1 mL) per dog weighing 10-110 pounds (4.5-50 kilograms) by intravenous or intramuscular injection.

(2) Indications for use. For the evaluation of adrenal function in dogs.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. It is a violation of Federal law to use this product other than as directed in the labeling.

(c) * * *

(3) * * *

(i) Dosage. Calves: 2.5 to 3.75 milliliters per 100 pounds of body weight. Lambs 2 weeks of age and older: 1 milliliter per 40 pounds of body weight, minimum 1 milliliter. Ewes: 2.5 milliliters per 100 pounds of body weight. Sows: 1 milliliter per 40 pounds of body weight. Weanling pigs: 1 milliliter per 40 pounds of body weight, minimum 1 milliliter.

(c) * * *

(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5 gram (g), 15 g, or 30 g bottles (2 drops from the 215 g bottle) once daily into the ear canal. For dogs weighing 30 lb or more, instill 8 drops from the 7.5 g, 15 g, or 30 g bottles (4 drops from the 215 g bottle) once daily into the ear canal. Therapy should continue for 7 consecutive days.

(d) * * *

(1) * * *

(e) * * *

(1) Chickens —

(2) Cattle—

(d) * * *

(1) Laidlomycin propionate potassium Type B liquid medicated feeds may be manufactured from dry laidlomycin propionate potassium Type A medicated articles. The Type B liquid medicated feeds must have a pH of 6.0 to 8.0, dry matter of 62 to 75 percent, and bear appropriate mixing directions as follows:

(2) The expiration date of the Type B liquid medicated feed is 21 days after date of manufacture. The expiration date for the dry Type C medicated feed made from the Type B liquid medicated feed is 7 days after date of manufacture.

(3) Labeling for all Type B medicated feeds (liquid and dry) and Type C medicated feeds containing laidlomycin propionate potassium shall bear the following statements:

(e) Conditions of use. It is used in growing beef steers and heifers fed in confinement for slaughter as follows: ( printed page 20344)

(f) Laidlomycin propionate potassium may also be used in combination with chlortetracycline as in § 558.128.

(a) Specifications. Type A medicated articles containing 20 or 50 grams of lincomycin (as lincomycin hydrochloride agricultural grade) per pound.

(b) Sponsor. See No. 066104 in § 510.600(c) of this chapter.

(d) * * *

(3) * * *

(i) “Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.”

(4) * * *

(i) “Occasionally, swine fed lincomycin may within the first 2 days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within 5 to 8 days without discontinuing the lincomycin treatment.”

(ii) “The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.”

(e) * * *

(1) Chickens —

(2) Swine —

(e) * * *

(1) Chickens — ( printed page 20346)

(b) * * *

(1) * * *

(2) Nos. 051311 and 066104: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride.

(d) Special considerations.

(1) Labeling of Type A medicated articles and Type B and Type C feeds shall bear the following: “Not for use in animals intended for breeding.”

(2) Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for swine shall bear the following:

(i) “No increased benefit has been shown when ractopamine hydrochloride concentrations in the diet are greater than 4.5 g/ton (5 ppm).”

(ii) “Ractopamine hydrochloride use may increase the number of injured, lame, and/or fatigued pigs during marketing. Behavioral signs such as hyperactivity, anxiety, and aggression have been reported in pigs fed ractopamine hydrochloride.”

(iii) “Additional Recommendations: To help mitigate the signs identified in the Animal Safety Warnings section, see the Pork Quality Assurance (PQA Plus) and Transport Quality Assurance (TQA) recommendations for best practices in swine care during handling, transport, and marketing.”

(6) Labeling of Type A medicated articles and Type B and Type C medicated feeds intended for cattle feeds shall bear the following:

(i) “Behavioral signs such as agitation and decreased feed consumption have been reported in cattle fed ractopamine hydrochloride.”

(ii) “Additional Recommendations: See the Beef Quality Assurance (BQA) recommendations for best practices in cattle care and handling during ractopamine hydrochloride feeding, transport, and marketing to help mitigate the behavioral signs stated in the Animal Safety Warnings section above.”

(e) * * *

(1) Swine —

(2) Cattle —

(3) Turkeys —

(e) * * *

(2) Cattle —