68004 Federal Register / Vol. 88, No. 190 / Tuesday, October 3, 2023 / Proposed Rules 

Subtitle VII, Part A, Subpart III, Section 

44701: General requirements. Under 

that section, Congress charges the FAA 

with promoting safe flight of civil 

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 because it addresses an 

unsafe condition that is likely to exist or 

develop on products identified in this 

rulemaking action. 

Regulatory Findings 

The FAA determined that this 

proposed AD would not have federalism 

implications under Executive Order 

13132. This proposed AD would 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 this proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Would not affect intrastate 

aviation in Alaska, and 

(3) Would 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 Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 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 adding 

the following new airworthiness 

directive: 

Centerpointe Aerospace Inc.: Docket No. 

FAA–2023–1891; Project Identifier AD– 

2023–00612–R. 

(a) Comments Due Date 

The FAA must receive comments on this 

airworthiness directive (AD) by November 

17, 2023. 

(b) Affected ADs 

None. 

(c) Applicability 

This AD applies to Centerpointe Aerospace 

Inc, Model S–58BT, S–58DT, S–58ET, S– 

58FT, S–58HT, and S–58JT helicopters, 

certificated in any category. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 6300, Main Rotor Drive System. 

(e) Unsafe Condition 

This AD was prompted by the discovery of 

a fatigue crack on the angle gearbox mount 

(AGBM). The FAA is issuing this AD to 

detect fatigue cracking of the AGBM. The 

unsafe condition, if not addressed, could lead 

to loss of the angle gearbox, resulting in loss 

of main rotor drive and subsequent loss of 

control of the helicopter. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

(1) Within 250 hours time-in-service (TIS) 

after the effective date of this AD, and 

thereafter at intervals not to exceed 250 hours 

TIS, perform a fluorescent penetrant 

inspection (FPI) to inspect for any crack on 

the AGBM in the eight areas depicted in the 

Accomplishment Instructions, Figures 1A 

and 1B, of Centerpointe Aerospace Service 

Bulletin No. 58B75, dated April 26, 2023. 

This FPI must be accomplished by a Level II 

or Level III inspector certified in the FAAacceptable standards for nondestructive 

inspection personnel. 

(2) If there is any crack, before further 

flight, remove the AGBM from service. 

(h) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Central Certification 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. In 

accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District 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 (i) of this AD. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(i) Additional Information 

Jacob Fitch, Aviation Safety Engineer, 

FAA, 10101 Hillwood Pkwy., Fort Worth, TX 

76177; phone: (817) 222–4130; email: 

jacob.fitch@faa.gov. 

(j) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) 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) Centerpointe Aerospace Service Bulletin 

No. 58B75, dated April 26, 2023. 

(ii) [Reserved] 

(3) For Centerpointe service information 

identified in this NPRM, contact 

Centerpointe Aerospace Inc. at 279 Blackland 

Road, Fate, TX 75189; (972) 636–9601; email 

Operations@avnresources.com; https://

www.californiahelicopter.com. 

(4) You may view this service information 

at the FAA, Office of the Regional Counsel, 

Southwest Region, 10101 Hillwood Pkwy., 

Room 6N–321, Fort Worth, TX 76177. For 

information on the availability of this 

material at the FAA, call (817) 222–5110. 

(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: 

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued on September 22, 2023. 

Victor Wicklund, 

Deputy Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2023–21684 Filed 10–2–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2023–1957; Airspace 

Docket No. 23–AAL–28RIN 2120–AA66] 

Amendment of Jet Route J–133 and 

Establishment of Area Navigation 

Route Q–801 in the Vicinity of 

Anchorage, AK 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: This action proposes to 

amend Jet Route J–133 by revoking a 

portion of the airway and establishing 

Canadian Area Navigation Route 

(RNAV) Q–801 in the vicinity of 

Anchorage, AK. The proposed 

amendment of J–133 is due to the 

pending decommissioning of several 

Navigational Aids (NAVAID) that 

provide course guidance along the 

airway. The proposed establishment of 

RNAV route Q–801 serves as a 

mitigation to J–133 and provides 

additional routing to the southeast for 

aircraft traveling to Canada or to the 

Pacific Northwest United States. 

DATES: Comments must be received on 

or before November 17, 2023. 

ADDRESSES: Send comments identified 

by FAA Docket No. FAA–2023–1957 

and Airspace Docket No. 23–AAL–28 

using any of the following methods: 


ddrumheller on DSK120RN23PROD with PROPOSALS1
Federal Register / Vol. 88, No. 190 / Tuesday, October 3, 2023 / Proposed Rules 68005 

* Federal eRulemaking Portal: Go to 

www.regulations.gov and follow the 

online instructions for sending your 

comments electronically. 

* Mail: Send comments to Docket 

Operations, M–30; U.S. Department of 

Transportation, 1200 New Jersey 

Avenue SE, Room W12–140, West 

Building Ground Floor, Washington, DC 

20590–0001. 

* Hand Delivery or Courier: Take 

comments to Docket Operations in 

Room W12–140 of the West Building 

Ground Floor at 1200 New Jersey 

Avenue SE, Washington, DC, between 9 

a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. 

* Fax: Fax comments to Docket 

Operations at (202) 493–2251. 

Docket: Background documents or 

comments received may be read at 

www.regulations.gov at any time. 

Follow the online instructions for 

accessing the docket or go to the Docket 

Operations in Room W12–140 of the 

West Building Ground Floor at 1200 

New Jersey Avenue SE, Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

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: 

Authority for This Rulemaking 

The FAA’s authority to issue rules 

regarding aviation safety is found in 

Title 49 of the United States Code. 

Subtitle I, Section 106 describes the 

authority of the FAA Administrator. 

Subtitle VII, Aviation Programs, 

describes in more detail the scope of the 

agency’s authority. This rulemaking is 

promulgated under the authority 

described in Subtitle VII, Part A, 

Subpart I, Section 40103. Under that 

section, the FAA is charged with 

prescribing regulations to assign the use 

of the airspace necessary to ensure the 

safety of aircraft and the efficient use of 

airspace. This regulation is within the 

scope of that authority as it would 

modify the airway structure as 

necessary to preserve the safe and 

efficient flow of air traffic within the 

National Airspace System. 

Comments Invited 

The FAA invites interested persons to 

participate in this rulemaking by 

submitting written comments, data, or 

views. Comments are specifically 

invited on the overall regulatory, 

aeronautical, economic, environmental, 

and energy-related aspects of the 

proposal. The most helpful comments 

reference a specific portion of the 

proposal, explain the reason for any 

recommended change, and include 

supporting data. To ensure the docket 

does not contain duplicate comments, 

commenters should submit only one 

time if comments are filed 

electronically, or commenters should 

send only one copy of written 

comments if comments are filed in 

writing. 

The FAA will file in the docket all 

comments it receives, as well as a report 

summarizing each substantive public 

contact with FAA personnel concerning 

this proposed rulemaking. Before acting 

on this proposal, the FAA will consider 

all comments it receives on or before the 

closing date for comments. The FAA 

will consider comments filed after the 

comment period has closed if it is 

possible to do so without incurring 

expense or delay. The FAA may change 

this proposal in light of the comments 

it receives. 

Privacy: In accordance with 5 U.S.C. 

553(c), DOT solicits comments from the 

public to better inform its rulemaking 

process. DOT posts these comments, 

without edit, including any personal 

information the commenter provides, to 

www.regulations.gov, as described in 

the system of records notice (DOT/ALL– 

14 FDMS), which can be reviewed at 

www.dot.gov/privacy. 

Availability of Rulemaking Documents 

An electronic copy of this document 

may be downloaded through the 

internet at www.regulations.gov. 

Recently published rulemaking 

documents can also be accessed through 

the FAA’s web page at www.faa.gov/air_

traffic/publications/airspace_

amendments/. 

You may review the public docket 

containing the proposal, any comments 

received and any final disposition in 

person in the Dockets Operations office 

(see ADDRESSES section for address, 

phone number, and hours of 

operations). An informal docket may 

also be examined during normal 

business hours at the office of the 

Western Service Center, Federal 

Aviation Administration, 2200 South 

216th St., Des Moines, WA 98198. 

Incorporation by Reference 

Jet Routes are published in paragraph 

2004 of FAA Order JO 7400.11, Airspace 

Designations and Reporting Points, 

which is incorporated by reference in 14 

CFR 71.1 on an annual basis. Canadian 

Area Navigation Routes are published in 

paragraph 2007 of FAA Order JO 

7400.11, Airspace Designations and 

Reporting Points, which is incorporated 

by reference in 14 CFR 71.1 on an 

annual basis. This document proposes 

to amend the current version of that 

order, FAA Order JO 7400.11H, dated 

August 11, 2023, and effective 

September 15, 2023. These updates 

would be published in the next update 

to FAA Order JO 7400.11. That order is 

publicly available as listed in the 

ADDRESSES section of this document. 

FAA Order JO 7400.11H lists Class A, 

B, C, D, and E airspace areas, air traffic 

service routes, and reporting points. 

Background 

In 2003, Congress enacted the Vision 

100-Century of Aviation 

Reauthorization Act (Pub. L. 108–176), 

which established a joint planning and 

development office in the FAA to 

manage the work related to the Next 

Generation Air Transportation System 

(NextGen). Today, NextGen is an 

ongoing FAA-led modernization of the 

nation’s air transportation system to 

make flying safer, more efficient, and 

more predictable. 

In support of NextGen, this proposal 

is part of an ongoing, large, and 

comprehensive airway modernization 

project in the state of Alaska. Part of this 

project is to transition the Alaskan en 

route navigation structure away from 

dependency on Nondirectional Radio 

Beacons (NDB) and move to develop 

and improve the RNAV route structure. 

The FAA is planning to decommission 

the Orca Bay, Yakataga, and Sitka NDBs 

in the state of Alaska. As a result, 

portions of Jet Route J–133 will become 

unusable. 

The FAA proposes to amend Jet Route 

J–133 by revoking the portion between 

the Anchorage, AK, Very High 

Frequency Omnidirectional Range/ 

Distance Measuring Equipment (VOR/ 

DME) and the Sitka, AK, NDB. This 

portion of J–133 would be replaced by 

the proposed RNAV route Q–801. Q– 

801 would extend between Anchorage, 

AK, VOR/DME and HARPR, OR, 

waypoint (WP). 

The Proposal 

The FAA is proposing an amendment 

to 14 CFR part 71 to amend Jet Route J– 

133 and to establish Canadian RNAV 

route Q–801 in United States airspace. 


ddrumheller on DSK120RN23PROD with PROPOSALS1
68006 Federal Register / Vol. 88, No. 190 / Tuesday, October 3, 2023 / Proposed Rules 

NAV CANADA is amending RNAV 

route Q–801 in their airspace to ensure 

continuity and cross-border 

connectivity with the new RNAV route 

Q–801 proposed in this NPRM. The 

proposed Air Traffic Service (ATS) 

route actions are described below. 

J–133: Jet route J–133 currently 

extends between Galena, AK, VOR/DME 

and Sitka, AK, NDB. The FAA proposes 

to revoke the portion between the 

Anchorage, AK, VOR/DME and the 

Sitka, AK, NDB. As amended, Jet route 

J–133 would extend between Galena, 

AK, VOR/DME and Anchorage, AK, 

VOR/DME. 

Q–801: Q–801 would extend between 

the Anchorage, AK, VOR/DME and the 

HARPR, OR, WP. The new route would 

remain within United States airspace 

between the Anchorage VOR/DME and 

the EEVER, AK, Fix and between the 

CYVIC, WA, WP and the HARPR WP. 

The new EEVER route point is being 

established on the Alaska/Canada 

border north of the MOCHA, AK, Fix. 

The new CYVIC route point is being 

established on the United States/Canada 

border in Washington state replacing, 

the CFPXC computer navigation fix 

(CNF) currently charted. This action is 

part of an ongoing FAA initiative to 

replace CNF and unpronounceable 

border fix/waypoint names with 

standard, pronounceable, five-letter 

names. This proposed action would 

establish RNAV route Q–801 within the 

United States and exclude the airspace 

in Canada. 

Regulatory Notices and Analyses 

The FAA has determined that this 

proposed regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore: (1) is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under DOT Regulatory Policies 

and Procedures (44 FR 11034; February 

26, 1979); and (3) does not warrant 

preparation of a regulatory evaluation as 

the anticipated impact is so minimal. 

Since this is a routine matter that will 

only affect air traffic procedures and air 

navigation, it is certified that this 

proposed rule, when promulgated, will 

not have a significant economic impact 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Environmental Review 

This proposal will be subject to an 

environmental analysis in accordance 

with FAA Order 1050.1F, 

‘‘Environmental Impacts: Policies and 

Procedures’’ prior to any FAA final 

regulatory action. 

List of Subjects in 14 CFR Part 71 

Airspace, Incorporation by reference, 

Navigation (air). 

The Proposed Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

proposes to amend 14 CFR part 71 as 

follows: 

PART 71—DESIGNATION OF CLASS A, 

B, C, D, AND E AIRSPACE AREAS; AIR 

TRAFFIC SERVICE ROUTES; AND 

REPORTING POINTS 

■ 1. The authority citation for 14 CFR 

part 71 continues to read as follows: 

Authority: 49 U.S.C. 106(f), 106(g); 40103, 

40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 

1959–1963 Comp., p. 389. 

§ 71.1 [Amended] 

■ 2. The incorporation by reference in 

14 CFR 71.1 of FAA Order JO 7400.11H, 

Airspace Designations and Reporting 

Points, dated August 11, 2023, and 

effective September 15, 2023, is 

amended as follows: 

Paragraph 2004 Jet Routes 

* * * * * 

J–133 [Amended] 

From Galena, AK to Anchorage, AK. 

* * * * * 

Paragraph 2007 Canadian Area Navigation 

Routes. 

Q–801 HARPR, OR to Anchorage, AK (TED) [NEW] 

HARPR, OR WP (Lat. 42°28′50.00′′ N, long. 122°53′01.54′′ W) 

FELIX, OR WP (Lat. 43°19′13.98′′ N, long. 123°05′39.51′′ W) 

ECTOF, OR WP (Lat. 44°10′49.55′′ N, long. 123°18′57.87′′ W) 

WAPTO, WA FIX (Lat. 47°28′19.54′′ N, long. 124°13′50.38′′ W) 

Tatoosh, WA (TOU) VORTAC (Lat. 48°17′59.64′′ N, long. 124°37′37.36′′ W) 

CYVIC, WA WP (Lat. 48°29′59.97′′ N, long. 124°54′39.80′′ W) 

GOVAD, Canada FIX (Lat. 49°02′48.65′′ N, long. 125°42′15.09′′ W) 

FINGS, Canada FIX (Lat. 50°15′00.00′′ N, long. 127°34′00.00′′ W) 

SIMSU, Canada FIX (Lat. 50°46′56.00′′ N, long. 128°25′37.00′′ W) 

CAFTA, Canada FIX (Lat. 51°17′43.00′′ N, long. 129°05′19.00′′ W) 

EEVER, AK FIX (Lat. 54°35′01.79′′ N, long. 133°05′54.23′′ W) 

MACIE, AK WP (Lat. 57°43′38.87′′ N, long. 137°50′47.74′′ W) 

LAIRE, AK FIX (Lat. 58°48′14.67′′ N, long. 140°31′43.36′′ W) 

FROZN, AK WP (Lat. 59°40′34.90′′ N, long. 143°29′31.48′′ W) 

Johnstone Point, AK (JOH) VOR/DME (Lat. 60°28′51.43′′ N, long. 146°35′57.61′′ W) 

Anchorage, AK (TED) VOR/DME (Lat. 61°10′04.32′′ N, long. 149°57′36.52′′ W) 

* * * * * 

Issued in Washington, DC, on September 

28, 2023. 

Karen L. Chiodini, 

Acting Manager, Rules and Regulations 

Group. 

[FR Doc. 2023–21811 Filed 10–2–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 809 

[Docket No. FDA–2023–N–2177] 

RIN 0910–AI85 

Medical Devices; Laboratory 

Developed Tests 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to amend its 

regulations to make explicit that in vitro 

diagnostic products (IVDs) are devices 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) including 

when the manufacturer of the IVD is a 

laboratory. In conjunction with this 

amendment, FDA is proposing a policy 

under which FDA intends to phase out 

its general enforcement discretion 

approach for laboratory developed tests 


ddrumheller on DSK120RN23PROD with PROPOSALS1