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Federal Register / Vol. 86, No. 213 / Monday, November 8, 2021 / Rules and Regulations
principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph k1 of this AD. Information may be emailed to: 9ANM-Seattle-ACO-AMOC-Requests@faa.gov.
2 Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
3 An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization ODA that has been authorized by the Manager, Seattle ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
4 AMOCs approved for AD 20050518
are approved as AMOCs for the corresponding provisions of Boeing Alert Service Bulletin 73753A1251, Revision 2, dated January 20, 2021, that are required by paragraph g of this AD.
5 Except as specified by paragraph h of this AD: For service information that contains steps that are labeled as Required for Compliance RC, the provisions of paragraphs j5i and ii of this AD apply.
i The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled RC Exempt, then the RC
requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
ii Steps not labeled as RC may be deviated from using accepted methods in accordance with the operators maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

IBR of the service information listed in this paragraph under 5 U.S.C. 552a and 1 CFR
part 51.
2 You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
i Boeing Alert Service Bulletin 737
53A1251, Revision 2, dated January 20, 2021.
ii Reserved 3 For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services C&DS, 2600 Westminster Blvd., MC 110SK57, Seal Beach, CA 907405600;
telephone 5627971717; internet https
www.myboeingfleet.com.
4 You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 2062313195.
5 You may view this service information that is incorporated by reference at the National Archives and Records Administration NARA. For information on the availability of this material at NARA, email fr.inspection@nara.gov, or go to:
https www.archives.gov/federal-register/cfr/
ibr-locations.html.

k Related Information 1 For more information about this AD, contact Wayne Lockett, Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA
98198; phone and fax: 2062313524; email:
wayne.lockett@faa.gov.
2 Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs l3 and 4 of this AD.

New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address
l Material Incorporated by Reference 1 The Director of the Federal Register approved the incorporation by reference
Issued on October 8, 2021.
Gaetano A. Sciortino, Deputy Director for Strategic Initiatives, Compliance & Airworthiness Division, Aircraft Certification Service.
FR Doc. 202124225 Filed 11521; 8:45 am BILLING CODE 491013P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Parts 510, 520, 522, 524, 556, and 558
Docket No. FDA2021N0002

Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
AGENCY:

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
SUMMARY:

and abbreviated new animal drug applications ANADAs during April, May, and June 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.
This rule is effective November 8, 2021.

DATES:

FOR FURTHER INFORMATION CONTACT:

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:

I. Approvals FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during April, May, and June 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 HFA305, 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/approved-animal-drugproducts-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.

lotter on DSK11XQN23PROD with RULES1

TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2021
Approval date
File No.

April 5, 2021

200697

I
VerDate Sep<11>2014

Sponsor
I

Accord Healthcare, Inc., 1009 Slater Rd., Suite 210B, Durham, NC
27703.

16:24 Nov 05, 2021

Jkt 256001

PO 00000

Product name Enrofloxacin Injectable Solution 2.27%.

Frm 00018

Fmt 4700

Species Dogs

Effect of the action Original approval as a generic copy of NADA 140913.

I

I

Sfmt 4700

E:FRFM08NOR1.SGM

08NOR1

Public documents FOI Summary.