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

Butorphanol Tartrate Injection.
TIAGARD tiamulin Liquid Concentrate.
Butorphanol Tartrate Injection.
QUELLIN carprofen Tablets.
LONCOR 300 florfenicol Injectable Solution.
BAYTRIL enrofloxacin Soft Chewable Tablets.

Following these changes of sponsorship, neither Bayer HealthCare LLC nor Pharmasone LLC are the sponsor of an approved application.
Accordingly, they will be removed from the list of sponsors of approved applications in 21 CFR 510.600c. As provided in the regulatory text, the animal drug regulations are amended to reflect these changes of sponsorship.

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III. Technical Amendments FDA is making the following amendments to improve the accuracy, consistency, and readability of the animal drug regulations:
21 CFR 520.905a is amended to reflect the approved conditions of use for fenbendazole suspension in laying hens.
21 CFR 522.1182 is amended to reflect the 2016 change of sponsorship of an injectable ferric hydroxide product in young piglets.
21 CFR 522.1193 is amended to reflect the approved withdrawal period for a clorsulon injectable solution product.
21 CFR 522.1696a is amended to reflect an associated limitation for a penicillin G benzathine and penicillin G
procaine injectable suspension product.
21 CFR 522.1890 is amended to reflect the current format for titling regulations for injectable dosage form new animal drugs.
Entries in parts 556 and 558 21
CFR parts 556 and 558 for a coumaphos Type A medicated article are being added. These sections were withdrawn in error 85 FR 18114, April 1, 2020.
Part 558 is amended to reflect current naming and organization for specifications and application sponsors.
21 CFR 558.261 is amended to reflect an approved incorporation level of florfenicol in medicated feed for fish.
21 CFR 558.311 for lasalocid in medicated feed is amended to reflect a current tabular organization by species.
21 CFR 558.355 is amended to provide accurate cross references for approved uses to special considerations and label statements for monensin medicated feeds.
21 CFR 558.450 is amended to add two indications for use of oxytetracycline in medicated feed for fish that were removed during the
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recent codification of a supplemental approval 84 FR 12491 at 12502, April 2, 2019.
Part 558 is amended by removing 21 CFR 558.465, which is redundant with 21 CFR 558.464. The cross reference for poloxalene in part 556 is amended to reflect this action.
Part 558 is amended by adding 21
CFR 558.470 to reflect the approved conditions of use of a polyoxyethylene medicated feed block, which previously had been removed from 21 CFR part 520
without being added to part 558.
Typographical errors are being corrected wherever they have been found.
IV. Legal Authority This rule sets forth technical amendments to the regulations to codify recent actions on approved new animal drug applications and corrections to improve the accuracy of the regulations, and as such does not impose any burden on regulated entities. This rule is issued under section 512i of the Federal Food, Drug, and Cosmetic Act FD&C
Act 21 U.S.C. 360bi, which requires Federal Register publication of the conditions of use of an approved or conditionally approved new animal drug and the name and address of the drugs sponsor in a notice, which upon publication shall be effective as a regulation. A notice published pursuant to section 512i is not subject to the notice-and-comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 551 et seq. See section 512i of the FD&C Act; 21 CFR
10.40e3; S. Rep. 901308, at 5 1968.
This document does not meet the definition of rule in 5 U.S.C.
8043A because it is a rule of particular applicability. Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801808.
Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as an agency statement of general applicability and 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.

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List of Subjects 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, and 529
Animal drugs.
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, 529, 556, and 558 are amended as follows:
PART 510NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
510.600

Amended
2. In 510.600, in the table in paragraph c1, remove the entry for Bayer HealthCare LLC and in the table in paragraph c2, remove the entry for 000859.

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

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

4. In 520.304, add paragraph a3, revise paragraphs b1 and 2, and add paragraph b3 to read as follows:

520.304

Carprofen.

a
3 Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.
b
1 Nos. 017033, 054771, 055529, and 062250 for use of product described in paragraphs a1 and 2 of this section as in paragraph c of this section.
2 No. 058198 for use of product described in paragraph a1 of this section as in paragraph c of this section.

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