Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations 84695 

aircraft in air commerce by prescribing 

regulations for practices, methods, and 

procedures the Administrator finds 

necessary for safety in air commerce. 

This regulation is within the scope of 

that authority. 

Regulatory Findings 

The FAA determined that this AD 

will not have federalism implications 

under Executive Order 13132. This AD 

will not have a substantial direct effect 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government. 

For the reasons discussed above, I 

certify that this AD: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Will not affect intrastate aviation 

in Alaska, and 

(3) Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by: 

■ a. Removing Airworthiness Directive 

(AD) 2010–26–05, Amendment 39– 

16544 (75 FR 79952, December 21, 

2010), and 

■ b. Adding the following new AD: 

2010–26–05R1 Dassault Aviation: 

Amendment 39–22621; Docket No. 

FAA–2023–1719; Project Identifier AD– 

2008–NM–202–AD. 

(a) Effective Date 

This AD is effective December 6, 2023. 

(b) Affected AD 

This AD replaces AD 2010–26–05, 

Amendment 39–16544 (75 FR 79952, 

December 21, 2010) (AD 2010–26–05). 

(c) Applicability 

This action applies to the airplanes 

identified in paragraphs (c)(1) and (2) of this 

AD, certificated in any category. 

(1) Dassault Aviation Model Falcon 10 

airplanes; Model FAN JET FALCON, FAN 

JET FALCON SERIES C, D, E, F, and G 

airplanes; and Model MYSTERE–FALCON 

20–C5, 20–D5, 20–E5, and 20–F5 airplanes; 

all serial numbers, equipped with Liebherr or 

ABG-Semca pressurization outflow valves. 

(2) Dassault Aviation Model MYSTERE– 

FALCON 200 airplanes, Model MYSTERE– 

FALCON 50 and MYSTERE–FALCON 900 

airplanes, and FALCON 900EX airplanes; 

and Model FALCON 2000 and FALCON 

2000EX airplanes; all serial numbers. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 21, Air conditioning. 

(e) Terminating Action 

This AD terminates all requirements of AD 

2010–26–05. 

(f) Related Information 

For more information about this AD, 

contact Tom Rodriguez, Aviation Safety 

Engineer, FAA, 1600 Stewart Avenue, Suite 

410, Westbury, NY 11590; telephone: 206– 

231–3226; email: tom.rodriguez@faa.gov. 

(g) Material Incorporated by Reference 

None. 

Issued on November 29, 2023. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2023–26662 Filed 12–5–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 73 

[Docket No. FAA–2023–2220; Airspace 

Docket No. 23–AWP–59] 

RIN 2120–AA66 

Amendment of Restricted Area R–2512 

Holtville, CA 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule; correction. 

SUMMARY: This action corrects a final 

rule published by the FAA in the 

Federal Register on November 16, 2023, 

that amends restricted area R–2512 in 

the vicinity of Holtville, CA. 

DATES: Effective date 0901 UTC, January 

25, 2024. The Director of the Federal 

Register approves this incorporation by 

reference action under 1 CFR part 51, 

subject to the annual revision of FAA 

Order 7400.10 and publication of 

conforming amendments. 

ADDRESSES: A copy of the Notice of 

Proposed Rulemaking (NPRM), all 

comments received, the final rule, this 

final rule correction, and all background 

material may be viewed online at 

www.regulations.gov using the FAA 

Docket number. Electronic retrieval help 

and guidelines are available on the 

website. It is available 24 hours each 

day, 365 days each year. 

FAA Order JO 7400.11H, Airspace 

Designations and Reporting Points, and 

subsequent amendments can be viewed 

online at www.faa.gov/air_traffic/ 

publications/. You may also contact the 

Rules and Regulations Group, Office of 

Policy, Federal Aviation 

Administration, 800 Independence 

Avenue SW, Washington, DC 20591; 

telephone: (202) 267–8783. 

FOR FURTHER INFORMATION CONTACT: 

Steven Roff, Rules and Regulations 

Group, Office of Policy, Federal 

Aviation Administration, 800 

Independence Avenue SW, Washington, 

DC 20591; telephone: (202) 267–8783. 

SUPPLEMENTARY INFORMATION: 

History 

The FAA published a final rule in the 

Federal Register for Docket No. FAA– 

2023–2220 (88 FR 78636; November 16, 

2023), that amended restricted area R– 

2512 in the vicinity of Holtville, CA. 

The section of 14 CFR part 73 to be 

amended by the final rule was 

incorrectly stated as 73.22. The correct 

section of 14 CFR part 73 to be amended 

is 73.25. This rule corrects this 

typographical error. 

Correction to Final Rule 

Accordingly, pursuant to the 

authority delegated to me, the airspace 

amendment reflected in Docket No. 

FAA–2023–2220, as published in the 

Federal Register of November 16, 2023 

(88 FR 78636), FR Doc. 2023–25347, is 

corrected as follows: 

§ 73.25 [Amended] 

■ 2. Section 73.25 is amended as 

follows: 

* * * * * 

R–2512 Holtville, CA [Amended] 

Boundaries. Beginning at lat. 

33°05′00′′ N, long. 115°17′33′′ W; to lat. 

33°00′00′′ N, long. 115°13′33′′ W; to lat. 

32°51′00′′ N, long. 115°05′33′′ W; to lat. 

32°51′00′′ N, long. 115°17′03′′ W; to lat. 

32°58′00′′ N, long. 115°17′33′′ W; to lat. 

33°05′00′′ N, long. 115°20′03′′ W; to the 

point of beginning. 

Designated altitudes. Surface to 

23,000 feet MSL. 

Time of designation. 0600–2300 local 

time daily; other times by NOTAM 24 

hours in advance. 

Controlling agency. FAA, Los Angeles 

ARTCC. 


lotter on DSK11XQN23PROD with RULES1
84696 Federal Register / Vol. 88, No. 233 / Wednesday, December 6, 2023 / Rules and Regulations 

Using Agency. U.S. Marine Corps, 

Commanding Officer, Marine Corps Air 

Station Yuma, Yuma, AZ. 

* * * * * 

Issued in Washington, DC, on November 

30, 2023. 

Karen Chiodini, 

Acting Manager, Rules and Regulations 

Group. 

[FR Doc. 2023–26706 Filed 12–5–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510, 516, 520, 522, 524, 

and 558 

[Docket No. FDA–2023–N–0002] 

New Animal Drugs; Approval of New 

Animal Drug Applications; Withdrawal 

of Approval of New Animal Drug 

Applications; Change of Sponsor; 

Change of Sponsor Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendments. 

SUMMARY: 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 

conditionally approved new animal 

drug applications (CNADAs) during 

July, August, and September 2023. The 

animal drug regulations are also being 

amended to improve their accuracy and 

readability. 

DATES: This rule is effective December 6, 

2023. 

FOR FURTHER INFORMATION CONTACT: 

George K. Haibel, Center for Veterinary 

Medicine (HFV–6), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–5689, 

George.Haibel@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Approvals 

FDA is amending the animal drug 

regulations to reflect approval actions 

for NADAs, ANADAs, and CNADAs 

during July, August, and September 

2023, 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 (FOIA Summaries) 

under the Freedom of Information Act 

(FOIA). These documents, along with 

marketing exclusivity and patent 

information, may be obtained at 

AnimalDrugs@FDA: https://

animaldrugsatfda.fda.gov/adafda/ 

views/#/search. 

TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS, ANADAS, AND CNADAS APPROVED DURING JULY, AUGUST, AND

SEPTEMBER 2023 REQUIRING EVIDENCE OF SAFETY AND/OR EFFECTIVENESS

Approval date File No. Sponsor Product name Effect of the action 21 CFR 

section 

July 6, 2023 ................ 200–752 Cronus Pharma Specialties India Private 

Ltd., Sy No-99/1, M/ 

s GMR Hyderabad 

Aviation SEZ Ltd., 

Mamidipalli Village, 

Shamshabad 

Mandal, Ranga 

Reddy, Hyderabad, 

Telangana, 501218, 

India.

DEXMEDVET 

(dexmedetomidine 

hydrochloride) 

Injectable Solution.

Original approval as a sedative, 

analgesic, and preanesthetic in 

dogs and cats as a generic 

copy of NADA 141–267.

522.558 

July 11, 2023 .............. 200–753 Do ............................... CROPAMEZOLE 

(atipamezole hydrochloride) Injectable 

Solution.

Original approval for reversal of 

sedation and analgesia in dogs 

as a generic copy of NADA 

141–033.

522.147 

July 19, 2023 .............. 141–554 Boehringer Ingelheim 

Animal Health USA, 

Inc., 3239 Satellite 

Blvd., Duluth, 

GA30096.

NEXGARD PLUS 

(afoxolaner, 

moxidectin, and 

pyrantel chewable 

tablets).

Original approval for the prevention, treatment, and control of 

internal and external parasites 

in dogs.

520.35 

August 3, 2023 ........... 200–755 Felix Pharmaceuticals 

Pvt. Ltd., 25–28 

North Wall Quay, 

Dublin 1, Ireland.

Firocoxib Chewable 

Tablets.

Original approval for the control of 

pain and inflammation associated with osteoarthritis and for 

the control of postoperative 

pain and inflammation associated with soft-tissue and orthopedic surgery as a generic copy 

of NADA 141–230.

520.928 


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