Quiero saber acerca de...

Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations e. Remove and reserve paragraph e2.
The revisions read as follows:

jbell on DSKJLSW7X2PROD with RULES

522.1077

Gonadorelin.

a
3 50 mg of gonadorelin as gonadorelin diacetate tetrahydrate equivalent to 43 mg gonadorelin; or

b Sponsors. See sponsor numbers in 510.600c of this chapter.
1 No. 000061 for use of the 43-mg/
mL product described in paragraph a1 as in paragraphs e1i and iii of this section.
2 No. 068504 for use of the 100-mg/
mL product described in paragraph a2 as in paragraph e1iv of this section.
3 No. 061133 for use of the 50-mg/
mL product described in paragraph a3 as in paragraphs e1i of this section.
4 No. 000010 for use of the 43-mg/
mL product described in paragraph a3 as in paragraphs e1i and v of this section.
5 No. 054771 for use of the 50-mg/
mL product described in paragraph a4 as in paragraphs e1ii and vi of this section.

d Special considerations1
Concurrent luteolytic drug use is approved as follows:
i Cloprostenol injection for use as in paragraph e1iii of this section as provided by No. 000061 in 510.600c of this chapter.
ii Cloprostenol injection for use as in paragraph e1iv of this section as provided by No. 068504 in 510.600c of this chapter.
iii Cloprostenol injection for use as in paragraph e1v of this section as provided by Nos. 000010 in 510.600c of this chapter.
iv Dinoprost injection for use as in paragraphs e1vi of this section as provided by No. 054771 in 510.600c of this chapter.
2 Federal law restricts this drug to use by or on the order of a licensed veterinarian.
e
1 Indications for use and amounts i For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 mg gonadorelin No. 000061 or 100 mg gonadorelin diacetate tetrahydrate Nos.
000010 and 061133 by intramuscular or intravenous injection.
ii For the treatment of ovarian follicular cysts in cattle: Administer 100
mg gonadorelin hydrochloride by intramuscular injection.
iii For use with cloprostenol sodium to synchronize estrous cycles to allow
VerDate Sep<11>2014

16:10 Mar 05, 2021

Jkt 253001

for fixed-time artificial insemination FTAI in beef cows and lactating dairy cows: Administer to each cow 86 mg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 mg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 mg gonadorelin by intramuscular injection.

PART 524OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
16. The authority citation for part 524
continues to read as follows:

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

17. In 524.1146, revise paragraph b2 and add paragraph b3 to read as follows:

524.1146

Imidacloprid and moxidectin.

b
2 Nos. 000859 and 017030 for use of product described in paragraph a2 of this section as in paragraph d2 of this section.
3 No. 000859 for use of product described in paragraph a2 of this section as in paragraph d3 of this section.

524.1193

Amended
18. In 524.1193, in paragraph b2, remove 016592, 054925, and 058005
and in its place add 016592 and 054925.
19. Add 524.2080 to read as follows:

524.2080

Ropinirole.

a Specifications. Each milliliter of solution contains 30 milligrams mg ropinirole equivalent to 34.2 mg ropinirole hydrochloride.
b Sponsor. See No. 052483 in 510.600c of this chapter.
c Conditions of use1 Amount.
Using the table provided in labeling, administer the number of eye drops topically, corresponding to body weight, that results in a target dose of 3.75 mg per square meter mg/m2 dose band 2.7
to 5.4 mg/m2. If the dog does not vomit within 20 minutes of the first dose, then a second dose may be administered.
2 Indications for use. For the induction of vomiting in dogs.
3 Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
524.2098

Amended
20. In 524.2098, in paragraph b, remove Nos. 054771, 055529, and 061651 and in its place add Nos.
051072, 054771, 055529, and 061651.

PO 00000

Frm 00037

Fmt 4700

Sfmt 4700

13185

PART 526INTRAMAMMARY DOSAGE
FORM NEW ANIMAL DRUGS
21. The authority citation for part 526
continues to read as follows:

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

22. In 526.88, revise the section heading, paragraph a, the paragraph d subject heading, and paragraphs d1 and 3 to read as follows:

526.88

Amoxicillin.

a Specifications. Each single-dose, 10-milliliter syringe contains amoxicillin trihydrate equivalent to 62.5
milligrams mg amoxicillin.

d Conditions of use in lactating cows1 Amount. Infuse the contents of one syringe equivalent to 62.5 mg amoxicillin into each infected quarter every 12 hours for a maximum of 3
doses.

3 Limitations. Milk taken from animals during treatment and for 60
hours 5 milkings after the last treatment must not be used for food.
Treated animals must not be slaughtered for food purposes within 12 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
23. In 526.313, revise paragraphs a and d and add paragraph e to read as follows:
526. 313

Ceftiofur.

a Specifications. Each single-dose, 10-milliliter syringe contains:
1 125 milligrams mg ceftiofur equivalents as the hydrochloride salt; or 2 500 mg ceftiofur equivalents as the hydrochloride salt.

d Conditions of use for syringe described in paragraph a1 of this section in lactating cows1 Amount.
Infuse the contents of one syringe 125
mg ceftiofur equivalents into each affected quarter. Repeat treatment in 24
hours. Once daily treatment may be repeated for up to 8 consecutive days.
2 Indications for use. For the treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli; and the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and S. dysgalactiae.
3 Limitations. Milk taken from cows during treatment a maximum of 8 daily infusions and for 72 hours after the last treatment must not be used for human consumption. Following label use for up to 8 consecutive days, a 2-day preslaughter withdrawal period is
E:FRFM08MRR1.SGM

08MRR1