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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.
List of Subjects 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 556
Animal drugs, Food.
21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 510, 520, 522, 524, 556, and 558 are amended as follows:
PART 510NEW ANIMAL DRUGS

510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

1. The authority citation for part 510
continues to read as follows:

21 CFR Parts 520, 522, and 524

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Animal drugs.

2. In 510.600:
a. In the table in paragraph c1, revise the entries for Alexion Pharmaceuticals, Inc. and Purina Animal Nutrition LLC; and b. In the table in paragraph c2, revise the entries for 017800 and 069334.
The revisions read as follows:

c
1

Drug labeler code
Firm name and address

Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210

Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 551262910

069334
017800

2
Drug labeler code
Firm name and address

017800

Purina Animal Nutrition LLC, 4001 Lexington Ave., North Arden Hills, MN 551262910.

069334

Alexion Pharmaceuticals, Inc., 121 Seaport Blvd., Boston, MA 02210.

2 Nos. 058198 and 086101 for use of product described in paragraph a2 as in paragraph c of this section.

PART 520ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:

6. In 520.538, remove paragraph c and redesignate paragraph d as new paragraph c; and revise paragraph b to read as follows:

520.88g Amoxicillin trihydrate and clavulanate potassium tablets.

520.538

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

4. In 520.88g, revise paragraph b2
to read as follows:

lotter on DSK11XQN23PROD with RULES1

b
2 Nos. 026637 and 069043 for use of tablets as in paragraph c of this section.

5. In 520.304, revise paragraph b2
to read as follows:
520.304

b

VerDate Sep<11>2014

b Sponsors. See Nos. 013744, 058198, and 086101 in 510.600c of this chapter.

7. In 520.905a, revise paragraphs e2, 3, and 4 to read as follows:

520.905a
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2 Beef and dairy cattlei Amount.
Administer orally 2.3 mg/lb of body weight 5 mg/kg.
ii Indications for use. 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 and H. placei;
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.
iii Limitations. Milk taken from cows during treatment and for 48 hours
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