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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
established for this product in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
2 Reserved
PART 556TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD

c Related conditions of use. See 522.2630 and 522.2632 of this chapter.

18. The authority citation for part 556
continues to read as follows:

PART 558NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS

Authority: 21 U.S.C. 342, 360b, 371.

PART 524OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS

19. In 556.275, revise paragraph c to read as follows:

16. The authority citation for part 524
continues to read as follows:

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

17. In 524.1146, revise paragraphs b1 and 2 to read as follows:

556.275

Imidacloprid and moxidectin.

b
1 Nos. 017030, 058198, and 061651
for use of product described in paragraph a1 of this section as in paragraph d1 of this section.
2 Nos. 017030, 058198, and 061651
for use of product described in paragraph a2 of this section as in paragraph d2 of this section.

c Related conditions of use. See 520.905a, 520.905b, 520.905c, 520.905d, and 558.258 of this chapter.
20. Add 556.345 to read as follows:

Ketoprofen.

Tulathromycin.

23. In 558.128, revise paragraph e4 introductory text to read as follows:

558.128

Chlortetracycline.

a Acceptable daily intake ADI. The ADI for total residue of ketoprofen is 5
mg/kg of body weight per day.
b Tolerances. The tolerances for ketoprofen marker residue are:
1 Cattle. i Kidney target tissue:
0.36 ppm.
ii Reserved c Related conditions of use. See 522.1225 and 522.2632 of this chapter.
21. In 556.745, revise paragraph c to read as follows:
556.745

e
4 Cattle. It is used as follows:

24. In 558.258, revise paragraph e3iii to read as follows:
558.258

Fenbendazole.

e
3
iii Free-choice medicated feedsA
Proprietary formulas 510.455e2 of this chapter. The following feeds can be manufactured only per an approved proprietary formula and specifications:

Amount fenbendazole
Indications for use
Limitations
1 750 mg/lb of protein block to provide 5 mg/kg body weight 2.27 mg/lb.

Beef cattle: For the treatment and control of: Lungworms:
adult Dictyocaulus viviparus; Stomach worms: Adult brown stomach worms Ostertagia ostertagi, adult and fourth-stage larvae barberpole worms Haemonchus contortus, fourth-stage larvae barberpole worms H.
placei, and adult and fourth-stage larvae small stomach worms Trichostrongylus axei; Intestinal worms adult and fourth-stage larvae: Hookworms Bunostomum phlebotomum, thread-necked intestinal worms Nematodirus helvetianus, small intestinal worms Cooperia punctata and C. oncophora, bankrupt worms Trichostrongylus colubriformis, and nodular worms Oesophagostomum radiatum.
Beef cattle: For the treatment and control of: Lungworms:
adult Dictyocaulus viviparus; Stomach worms: Adult brown stomach worms Ostertagia ostertagi, adult and fourth-stage larvae barberpole worms Haemonchus contortus, fourth-stage larvae barberpole worms H.
placei, and adult and fourth-stage larvae small stomach worms Trichostrongylus axei; Intestinal worms adult and fourth-stage larvae: Hookworms Bunostomum phlebotomum, thread-necked intestinal worms Nematodirus helvetianus, small intestinal worms Cooperia punctata and C. oncophora, bankrupt worms Trichostrongylus colubriformis, and nodular worms Oesophagostomum radiatum.

Feed free choice at a rate of 0.1 pound of block per 100
pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consumption within 16 days following last treatment with this drug product. Not for use in female dairy cattle 20
months 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 pre-ruminating calves.

000061

Feed free choice at a rate of 0.1 pound of block per 100
pounds of body weight per day for 3 days to deliver a total of 2.27 mg fenbendazole per pound of body weight. Cattle must not be slaughtered for human consumption within 11 days following last treatment with this drug product. Not for use in female dairy cattle 20
months 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 pre-ruminating calves.

000061

2 750 mg/lb of molasses block to provide 5 mg/kg body weight 2.27 mg/lb.

lotter on DSK11XQN23PROD with RULES1

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc1, 371.

Fenbendazole.

556.345
524.1146

22. The authority citation for part 558
continues to read as follows:

B Published formulas 510.455e1 of this chapter. The following feeds can be manufactured
only per one of the formulas and specifications published below:

1 Amount. 5 mg/kg body weight 2.27 mg/lb, including the following formulations:

Ingredient 1

Percent
i Free-choice, dry Type C feed:

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