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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
jbell on DSKJLSW7X2PROD with RULES

526.1698 Penicillin G procaine and novobiocin.

526.1810

a Specifications. Each single-use, 10milliliter syringe contains a suspension of:
1 Penicillin G procaine equivalent to 100,000 units penicillin G and 150
milligrams mg novobiocin as novobiocin sodium; or 2 Penicillin G procaine equivalent to 200,000 units penicillin G and 400 mg novobiocin as novobiocin sodium.

d Conditions of use for syringe described in paragraph a1 of this section in lactating cows1 Amount.
Infuse the contents of one syringe equivalent to 100,000 units penicillin G
and 150 mg novobiocin into each infected quarter after milking. Repeat once after 24 hours.
2 Indications for use. For the treatment of mastitis caused by susceptible strains of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis in lactating cows.
3 Limitations. For udder instillation in lactating cows only. Do not milk for at least 6 hours after treatment;
thereafter, milk at regular intervals. Milk taken from treated animals within 72
hours 6 milkings after the latest treatment must not be used for food.
Treated animals must not be slaughtered for food for 15 days following the latest treatment. If redness, swelling, or abnormal milk persists, discontinue use and consult a veterinarian.
e Conditions of use for syringe described in paragraph a2 of this section in lactating cows1 Amount.
Infuse the contents of one syringe equivalent to 200,000 units penicillin G
and 400 mg novobiocin into each quarter at dry off.
2 Indications for use. For the treatment of subclinical mastitis caused by susceptible strains of Staphylococcus aureus and Streptococcus agalactiae in dry cows.
3 Limitations. For udder instillation in dry cows only. Do not use less than 30 days prior to calving. Milk from treated cows must not be used for food during the first 72 hours after calving.
Treated animals must not be slaughtered for food for 30 days following udder infusion.
37. In 526.1810, revise paragraph a, the paragraph d subject heading, and the first sentence of paragraph d1 to read as follows:

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16:10 Mar 05, 2021

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Pirlimycin.

a Specifications. Each single-dose, 10-milliliter syringe contains 50
milligrams mg of pirlimycin as pirlimycin hydrochloride.

d Conditions of use in lactating cows1 Amount. Infuse the contents of one syringe 50 mg pirlimycin into each infected quarter.

PART 529CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
38. The authority citation for part 529
continues to read as follows:

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

39. Add 529.443 to read as follows:

529.443

556.170

Amended
44. In 556.170, in paragraph c, remove 520.543 and in its place add 520.534.

556.180

Amended
45. In 556.180, in paragraph c, remove 558.205 and in its place add 558.198.

556.185

Amended
46. In 556.185, in paragraph c, remove 558.198 and in its place add 558.205.

556.226

Amended
47. In 556.226, in paragraph c, remove 522.812 and in its place add 516.812 and 522.812.

Ciclesonide.

a Specifications. A non-pressurized metered dose inhaler and drug cartridge combination containing a solution of 30
milligrams/milliliter of the prodrug ciclesonide. Each actuation releases 343
micrograms mcg of ciclesonide.
b Sponsor. See No. 000010 in 510.600c of this chapter.
c Conditions of use1 Amount.
Administer an initial dose of 8
actuations 2,744 mcg ciclesonide twice daily for 5 days, followed by 12
actuations 4,116 mcg ciclesonide once daily for 5 days.
2 Indications for use. For the management of clinical signs associated with severe equine asthma.
3 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.
529.2150

in its place add 526.464 and 526.465.

Redesignated as 529.2110

556.300

Amended
48. In 556.300, in paragraph c, remove 522.1044a, 520.1044b, 520.1044c, and 524.1044e and in its place add 520.1044a, 520.1044b, 520.1044c, 522.1044, 524.1044e, and 529.1044b.

556.360

Amended
49. In 556.360, in paragraph c, add 520.1265, after 520.1260,.

556.510

Amended
50. In 556.510, in paragraph c, remove 526.1696a, 526.1696b, 526.1696c, and 526.1696d and in its place add 526.1696, 526.1697, and 526.1698.

556.670

Amended

40. Redesignate 529.2150 as 529.2110.

51. In 556.670, in paragraph c, remove 520.2218 and add 520.445, 520.2218 in its place.

PART 556TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD

PART 558NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS

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

Authority: 21 U.S.C. 342, 360b, 371.
556.38

Amended
43. In 556.165, in paragraph c, remove 526.464a and 526.464b and
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Fmt 4700

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

53. In 558.68, revise paragraphs e1ii, iii, and v to read as follows:

558.68

Amended

PO 00000

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

42. In 556.38, in paragraph c, add 520.88e, after 520.88d,.

556.165

Sfmt 4700

Avilamycin.

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