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57995

Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations
21 CFR
section
File No.

Product name
Transferring sponsor
New sponsor
200237

Isoflurane, U.S.P

Piramal Enterprises Ltd., Ananta, Agastya Corporate Park, Opp Fire Brigade, Kamani Junction, LBS Mag Kurla West, Mumbai, 400070, India.

Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India.

Following these changes of sponsorship, G. C. Hanford Manufacturing Co. and Piramal Enterprises Ltd. are no longer the sponsor of an approved application.
Accordingly, the regulations in 21 CFR
510.600c are being amended to reflect these changes.
III. Technical Amendments FDA is making the following amendments to improve the accuracy, consistency, and readability of the animal drug regulations:
21 CFR 510.600 is amended by revising the entries for Cronus Pharma Specialities India Private Ltd. to reflect the correct address for the firm.
21 CFR 520.2090 is amended to reflect the current approved indications for use for sarolaner, moxidectin, and pyrantel tablets.
21 CFR 522.970 is amended to reflect the approved species for a flunixin injectable solution.
21 CFR 558.76 for use of bacitracin methylenedisalicylate in medicated feed is amended to reflect a current tabular format organized by species.
21 CFR 558.128 is amended to reflect sponsors of combination medicated feeds containing chlortetracycline for which there is no preslaughter withdrawal period.
21 CFR 558.355 for use of monensin in medicated feeds is amended to reflect the sponsor of an approved generic product and to remove a redundant condition of use.
IV. Legal Authority This final 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 notices . . .
effective as a regulation, of the conditions of use of approved new animal drugs. 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.
Although denominated a rule pursuant to the FD&C Act, 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 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, and 526
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, 21 CFR parts 510, 516, 520, 522, 526, 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. Add in alphabetical order an entry for Anivive Lifesciences, Inc.;
ii. Revise the entry for Cronus Pharma Specialities India Private Ltd.;
iii. Remove the entries for G. C.
Hanford Manufacturing Co. and Piramal Enterprises Ltd.; and iv. Add in alphabetical order an entry for Piramal Pharma Ltd.; and b. In the table in paragraph c2:
i. Remove the entry for 010515;
ii. Revise the entries for 065085 and 069043; and iii. Add in numerical order an entry for 086121.
The revisions and additions read as follows:

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

c
1

Drug labeler code
Firm name and address
lotter on DSK11XQN23PROD with RULES1

N/A.

Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA 90807

Cronus Pharma Specialities India Private Ltd., Sy No99/1, M/s GMR Hyderabad Aviation SEZ Ltd., Mamidipalli Village, Shamshabad Mandal, Ranga Reddy, Hyderabad, Telangana, 501218, India

Piramal Pharma Ltd., Ground Floor, Piramal Ananta, Agastya Corporate Park, Mumbai, Maharashtra, 400070, India
.

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086121

069043

065085