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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations 520.2138

18. In 520.1720a, add paragraph b5 to read as follows:

520.1720a boluses.

Phenylbutazone tablets and

b
5 No. 058198 for use of 1-g tablets in horses.

19. In 520.1860, revise paragraph b to read as follows:
520.1860

Pradofloxacin.

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

20. In 520.1870, revise paragraph b to read as follows:
520.1870

Praziquantel tablets.

b Sponsors. See sponsors in 510.600c of this chapter.
1 No. 058198 for use of product described in paragraph a1 of this section as in paragraph c1 of this section and for use of product described in paragraph a2 of this section as in paragraph c2 of this section.
2 No. 069043 for use of product described in paragraph a1 of this section as in paragraphs c1 of this section.

21. In 520.1871, revise paragraph b1 to read as follows:
520.1871

Praziquantel and pyrantel.

b
1 See No. 058198 for use of tablets described in paragraph a1 of this section for use as in paragraph d1 of this section.

22. In 520.1872, revise paragraph b to read as follows:
520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.

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

23. In 520.2043, revise paragraph b2 to read as follows:
520.2043

jbell on DSKJLSW7X2PROD with RULES

b
2 Nos. 054771, 058198, and 058829
for use of the products described in paragraph a2 of this section as in paragraph d2 of this section.

24. Add 520.2138 to read as follows:

VerDate Sep<11>2014

16:22 Mar 18, 2021

Jkt 253001

520.2260b Sulfamethazine sustainedrelease boluses.

522.812

b 22.5-gram bolus1 Sponsor. See No. 058198 in 510.600c of this chapter for use of a 22.5-gram sulfamethazine prolonged-release bolus.

e 22.5-gram bolus1 Sponsor. See No. 058198 in 510.600c of this chapter for use of a 22.5-gram sulfamethazine sustained release bolus.

26. In 520.2455, revise paragraphs b1 and 2 to read as follows:
520.2455

b
1 No. 058198 for products described in paragraphs a1 and 3 of this section.
2 No. 066104 for the product described in paragraph a1 of this section.

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

PO 00000

Frm 00013

Fmt 4700

28. In 522.23, revise paragraph b to read as follows:

522.23

Acepromazine.

b Sponsors. See Nos. 000010 and 058198 in 510.600c of this chapter.

29. In 522.234, revise paragraph b to read as follows:
522.234

Butamisole.

b Sponsors. See Nos. 054771 and 058198 in 510.600c of this chapter.

30. In 522.246, revise paragraphs b2 and 3 to read as follows:
522.246

Butorphanol.

b
2 No. 058198 for use of the product described in paragraph a2 of this section as in paragraph d2 of this section.
3 Nos. 000061, 058198, and 059399
for use of the product described in paragraph a3 of this section as in paragraph d3 of this section.

31. In 522.812, revise paragraphs b1 and 2 to read as follows:
Enrofloxacin.

b
1 Nos. 017033, 055529, and 058198
for use of product described in paragraph a1 of this section as in paragraph e1 of this section; and 2 Nos. 055529, 058198, and 061133
for use of product described in paragraph a2 of this section as in paragraphs e2 and 3 of this section.

32. In 522.955, revise paragraph b2 to read as follows:
522.955

Florfenicol.

Tiamulin.

Pyrantel pamoate suspension.

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

Spironolactone and benazepril.

a Specifications. Each chewable tablet contains 20 milligrams mg spironolactone and 2.5 mg benazepril hydrochloride, 40 mg spironolactone and 5 mg benazepril hydrochloride, or 80 mg spironolactone and 10 mg benazepril hydrochloride.
b Sponsor. See No. 013744 in 510.600c of this chapter.
c Conditions of use in dogs1
Amount. Administer orally once daily, with food, at a dose of 0.9 mg per pound lb 2 mg per kilogram kg spironolactone and 0.11 mg/lb 0.25 mg/
kg benazepril hydrochloride, according to dog body weight using a suitable combination of whole and/or half tablets.
2 Indications for use. With concurrent therapy e.g., furosemide, etc. for the management of clinical signs of mild, moderate, or severe congestive heart failure in dogs due to atrioventricular valvular insufficiency AVVI.
3 Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
25. In 520.2260b, add a heading for paragraph b, revise paragraph b1, add a heading for paragraph e, and revise paragraph e1 to read as follows:

14819

Sfmt 4700

b
2 Nos. 000061 and 058198 for use of product described in paragraph a2 of this section as in paragraph d1ii of this section.

33. In 522.970, revise paragraph b1 to read as follows:
522.970

Flunixin.

b
1 See Nos. 000061, 016592, 055529, 058198, and 061133 for use as in paragraph e of this section.

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