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Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations 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
U.S.C. 360bi; 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.
List of Subjects
516, 520, 522, 524, 526, 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.

2. In 510.600
a. In the table in paragraph c1:
i. Revise the entries for Cronus Pharma Specialities India Private Ltd.
and Dechra Veterinary Products LLC;
ii. Add an entry in alphabetical order for Felix Pharmaceuticals Pvt. Ltd.;
and iii. Revise the entry for Pharmgate, Inc.; and b. In the table in paragraph c2:
i. Add an entry in numerical order for 017033;
ii. Remove the entry for 026637;
iii. Revise the entries for 069043
and 069254; and iv. Add an entry in numerical order for 086101.
The additions and revisions read as follows:

21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 516
Administrative practice and procedure, Animal drugs, Confidential business information, Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, 524, 526, 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,
510.600 Names, addresses, and drug labeler codes of sponsors of approved applications.

c
1

Drug labeler code
Firm name and address

Cronus Pharma Specialities India Private Ltd., Sy No-99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad Telangana 501218, India

Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211

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

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

069043
017033
086101
069254

2

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Drug labeler code
Firm name and address

017033

Dechra Veterinary Products LLC, 7015 College Blvd., Suite 525, Overland Park, KS 66211.

069043

Cronus Pharma Specialities India Private Ltd., Sy No-99/1, GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad Telangana 501218, India.

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