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13184

Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
Drug labeler code
Firm name and address

069254

Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.

086101

Felix Pharmaceuticals Pvt. Ltd., 2528 North Wall Quay, Dublin 1, Ireland.

PART 516NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES
3. The authority citation for part 516
continues to read as follows:

Authority: 21 U.S.C. 360ccc1, 360ccc2, 371.

4. Add 516.812 to subpart E to read as follows:

516.812

Enrofloxacin.

jbell on DSKJLSW7X2PROD with RULES

5. The authority citation for part 520
continues to read as follows:

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

VerDate Sep<11>2014

16:10 Mar 05, 2021

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6. In 520.100, remove paragraph a3, revise paragraph b2, add paragraph b3, and revise paragraph d2 introductory text.
The revisions and addition read as follows:

520.100

Amprolium.

a Specifications. Each milliliter mL
of solution contains 100 milligrams mg enrofloxacin.
b Sponsor. See No. 000859 in 510.600c of this chapter.
c Conditions of use in cattle1
Amount. Administer, by subcutaneous injection, a single dose of 12.5 mg/
kilogram of body weight 5.7 mL/100
pounds of body weight. Administered dose volume should not exceed 20 mL
per injection site.
2 Indications for use. For the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20
months of age and all classes of beef cattle except beef calves less than 2
months of age and beef bulls intended for breeding any age. Not for use in any other class of dairy cattle or in veal calves.
3 Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals. Cattle intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
PART 520ORAL DOSAGE FORM
NEW ANIMAL DRUGS

b
2 No. 066104 for use of product described in paragraph a1 of this section as in paragraph d of this section.
3 No. 051072 for use of product described in paragraph a1 of this section as in paragraph d1 of this section.

d
2 Calves. Administer concentrate solution or soluble powder as a drench or in drinking water as follows:

7. In 520.304, revise paragraph b, remove reserved paragraph c, and redesignate paragraph d as paragraph c.
The revision reads as follows:
520.304

Carprofen.

b Sponsors. See sponsors in 510.600c of this chapter for use as in paragraph c of this section.
1 Nos. 017033, 054771, 055529, and 062250 for use of products described in paragraph a as in paragraph c of this section.
2 No. 000859 for use of product described in paragraph a2 as in paragraph c of this section.

8. In 520.812, revise paragraphs a and b to read as follows:

b Sponsors. See sponsor numbers in 510.600c of this chapter for use as in paragraph c of this section.
1 No. 000859 for use of products described in paragraphs a1i, a2, and a3 of this section.
2 No. 017033 for use of product described in paragraph a1i of this section.
3 No. 058198 for use of product described in paragraph a1ii of this section.
4 No. 086101 for use of product described in paragraph a2 of this section.

520.1443

Amended
9. In 520.1443, in paragraph b, remove 051311 and in its place add 000061.

520.1447

Amended
10. In 520.1447, in paragraph b, remove 051311 and in its place add 000061.

520.1510

Amended
11. In 520.1510, in paragraph b2, remove 051311 and in its place add 000061.

520.2455

Amended
12. In 520.2455, in paragraph b4, remove No. 061133 and in its place add Nos. 016592 and 061133.

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

Authority: 21 U.S.C. 360b.
522.536

Amended
14. In 522.536, in paragraph b, remove No. 052483 and in its place add Nos. 015914 and 052483.
15. In 522.1077:
a. Revise paragraphs a3, b, d, and e1i;
b. Remove paragraph e1ii;
c. Redesignate paragraphs e1iii through e1vii as paragraphs e1ii through e1vi;
d. Revise newly redesignated paragraphs e1ii and iii; and

520.812

Enrofloxacin.

a Specifications1 Each tablet contains:
i 22.7, 68.0, or 136.0 milligrams mg enrofloxacin; or ii 22.7, 68.0, 136.0, or 272 mg enrofloxacin.
2 Each chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.
3 Each soft chewable tablet contains 22.7, 68.0, or 136.0 mg enrofloxacin.

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