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Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations
for a significant regulatory action as specified in Executive Order 12866.
Paperwork Reduction Act There is no new collection of information required in this document;
therefore, the provisions of the Paperwork Reduction Act of 1995 44
U.S.C. 3507 are inapplicable.

Dated: October 15, 2021.
Robert F. Altneu, Director, Regulations & Disclosure Law Division, Regulations & Rulings, Office of Trade, U.S. Customs and Border Protection.
BILLING CODE 911114P

I. Approvals
Signing Authority This document is limited to a technical correction of CBP regulations.
Accordingly, it is being signed under the authority of 19 CFR 0.1b. Acting Commissioner Troy A. Miller, having reviewed and approved this document, is delegating the authority to electronically sign this document to Robert F. Altneu, who is the Director of the Regulations and Disclosure Law Division for CBP, for purposes of publication in the Federal Register.
List of Subjects in 19 CFR Part 122
Air carriers, Aircraft, Airports, Customs duties and inspection, Freight.

HHS.

PART 122AIR COMMERCE
REGULATIONS
1. The general authority citation for part 122 continues to read as follows:

Authority: 5 U.S.C. 301; 19 U.S.C. 58b, 66, 1415, 1431, 1433, 1436, 1448, 1459, 1590, 1594, 1623, 1624, 1644, 1644a, 2071 note.

122.15

Amended
2. In 122.15, amend the table in paragraph b by removing the entry for Monroe, North Carolina.

George K. Haibel, Center for Veterinary Medicine HFV6, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 2404025689, george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

FR Doc. 202122880 Filed 101921; 8:45 am
DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Amendments to Regulations Part 122, of title 19 of the Code of Federal Regulations 19 CFR part 122 is amended as set forth below:

FOR FURTHER INFORMATION CONTACT:

Food and Drug Administration 21 CFR Parts 510, 516, 520, 522, 526, 556 and 558
Docket No. FDA2021N0002

New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship AGENCY:

Food and Drug Administration,
Final rule; technical amendments.

ACTION:

The Food and Drug Administration FDA or we is amending the animal drug regulations to reflect application-related actions for new animal drug applications NADAs, abbreviated new animal drug applications ANADAs, and conditional new animal drug applications cNADAs during January, February, and March 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
DATES: This rule is effective October 20, 2021.
SUMMARY:

FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and conditional approval actions for cNADAs during January, February, and March 2021, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act NEPA and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval FOI
Summaries under the Freedom of Information Act FOIA. These public documents may be seen in the office of the Dockets Management Staff HFA
305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday, 2404027500.
Persons with access to the internet may obtain these documents at the CVM
FOIA Electronic Reading Room: https
www.fda.gov/about-fda/centerveterinary-medicine/cvm-foiaelectronic-reading-room. Marketing exclusivity and patent information may be accessed in FDAs publication, Approved Animal Drug Products Online Green Book at: https www.fda.gov/
animal-veterinary/products/approvedanimal-drug-products-green-book.
FDA has verified the website addresses as of the date this document publishes in the Federal Register, but websites are subject to change over time.

TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2021

lotter on DSK11XQN23PROD with RULES1

Approval date
File No.

Sponsor
Product name
Species
Effect of the action
Public documents
Supplemental approval for the addition of Mycoplasma hyopneumoniae to the list of pathogens for the control of swine respiratory disease indication.
Conditional approval for the treatment of lymphoma in dogs.

FOI Summary.

January 8, 2021

141336

ECO LLC, 344 Nassau St., Princeton, NJ
08540.

AIVLOSIN 62.5% w/w tylvalosin as tylvalosin tartrate Water Soluble Granules.

Swine

January 11, 2021

141526

LAVERDIACA1
verdinexor tablets.

Dogs

January 12, 2021

200675

Original approval as a generic copy of NADA 141225.

FOI Summary.

200676

Ractopamine hydrochloride and monensin Type B and Type C
medicated feeds.
Ractopamine hydrochloride, monensin, and tylosin phosphate Type B and Type C
medicated feeds.

Cattle

January 12, 2021

Anivive Lifesciences, Inc., 3250 Airflite Way, Suite 400, Long Beach, CA
90807.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113
Sofia, Bulgaria.
Do

Cattle

Original approval as a generic copy of NADA 141224.

FOI Summary.

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FOI Summary.