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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been established for this product in preruminating calves.
3 Beef cattlei Amount.
Administer orally 4.6 mg/lb of body weight 10 mg/kg.
ii Indications for use. For the treatment and control of stomach worms fourth-stage inhibited larvae/type II
ostertagiasis, Ostertagia ostertagi, and tapeworms, Moniezia benedeni.
iii Limitations. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been established for this product in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
4 Goatsi Amount. Administer orally 2.3 mg/lb of body weight 5 mg/
kg.
ii Indications for use. For the treatment and control of stomach worms adults Haemonchus contortus and Teladorsagia circumcincta.
iii Limitations. Goats must not be slaughtered for human consumption within 6 days following last treatment with this drug product. Because a milk discard time has not been established, do not use in lactating goats.

520.905e
Removed
8. Remove 520.905e.
9. In 520.1286, revise paragraph c2ii to read as follows:

520.1286

Lotilaner.

lotter on DSK11XQN23PROD with RULES1

c
2
ii Indications for use. Kills adult fleas, and for the treatment and prevention of flea infestations Ctenocephalides felis for 1 month in cats and kittens 8 weeks of age and older, and weighing 2.0 pounds or greater; and for the treatment and control of Ixodes scapularis blacklegged tick for 1 month in cats and kittens 6 months of age and older, and weighing 2.0 pounds or greater.

10. In 520.2086, in paragraph c2, add a sentence at the end of the paragraph to read as follows:

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16:24 Nov 05, 2021

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520.2086

Sarolaner.

c
2 For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.

PART 522IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
11. The authority citation for part 522
continues to read as follows:

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

12. In 522.812, revise paragraphs b1 and e1i to read as follows:

522.812

Enrofloxacin.

b
1 Nos. 016729, 017033, 055529, and 058198 for use of product described in paragraph a1 of this section as in paragraph e1 of this section; and

e
1
i Amount. 2.5 mg per kilogram /kg of body weight 1.13 mg per pound as a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days.

13. Revise 522.1225 to read as follows:
522.1225

Ketoprofen.

a Specifications. Each milliliter of solution contains 100 milligrams mg ketoprofen.
b Sponsors. See sponsors in 510.600c of this chapter.
1 No. 054771 for use as in paragraphs d1 and d2 of this section.
2 No. 061133 for use as in paragraph d1 of this section.
c Related tolerances. See 556.345
of this chapter.
d Conditions of use1 Horsesi Amount. Administer by intravenous injection 1.0 mg per pound /lb of body weight once daily for up to 5 days.
ii Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders in horses.
iii Limitations. Do not use in horses intended for human consumption.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
2 Cattlei Amount. Administer by subcutaneous injection 3 mg per kilogram 1.36 mg/lb of body weight once daily for up to 3 days.

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ii Indications for use. For the control of pyrexia associated with bovine respiratory disease BRD in beef heifers, beef steers, beef calves 2 months of age and older, beef bulls, replacement dairy heifers, and dairy bulls.
iii Limitations. Not for use in reproducing animals over 1 year of age.
Cattle must not be slaughtered for human consumption within 48 hours following last treatment with this drug product. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been established for this product in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
522.1697, 522.1698, and 522.1704
Redesignated
14. Redesignate 522.1697, 522.1698, and 522.1704 as 522.1700, 522.1702, and 522.1703.
15. Add 522.2632 to read as follows:

522.2632

Tulathromycin and ketoprofen.

a Specifications. Each milliliter of solution contains 100 milligrams mg tulathromycin and 120 milligrams mg ketoprofen.
b Sponsor. See No. 054771 in 510.600c of this chapter.
c Related tolerances. See 556.345
and 556.745 of this chapter.
d Conditions of use1 Cattlei Amount. Administer as a single subcutaneous injection 2.5 mg tulathromycin and 3 mg ketoprofen per kilogram 1.1 mL/100 lb of body weight.
ii Indications for use. For the treatment of bovine respiratory disease BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers.
iii Limitations. Not for use in reproducing animals over 1 year of age.
Cattle must not be slaughtered for human consumption within 18 days following last treatment with this drug product. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A
withdrawal period has not been
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