11290 Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Rules and Regulations 

300–103–0, 335–300–105–0, 335–300–106–0, 

335–300–107–0, 335–300–108–0, 335–300– 

109–0, or 335–300–110–0, installed. 

(2) For CFM56–7B20, CFM56–7B20/2, 

CFM56–7B20/3, CFM56–7B22, CFM56– 

7B22/2, CFM56–7B22/3, CFM56–7B22/3B1, 

CFM56–7B22/B1, CFM56–7B24, CFM56– 

7B24/2, CFM56–7B24/3, CFM56–7B24/3B1, 

CFM56–7B24/B1, CFM56–7B26, CFM56– 

7B26/2, CFM56–7B26/3, CFM56–7B26/3B1, 

CFM56–7B26/3B2, CFM56–7B26/3B2F, 

CFM56–7B26/3F, CFM56–7B26/B1, CFM56– 

7B26/B2, CFM56–7B27, CFM56–7B27/2, 

CFM56–7B27/3, CFM56–7B27/3B1, CFM56– 

7B27/3B1F, CFM56–7B27/3B3, CFM56– 

7B27/3F, CFM56–7B27/B1, and CFM56– 

7B27/B3 model turbofan engines, AGB P/N: 

340–046–503–0, 340–046–504–0, or 340– 

046–505–0, installed. 

(3) For CFM56–7B27A, CFM56–7B27A/3, 

or CFM56–7B27AE model turbofan engines, 

AGB P/N: 340–188–601–0, 340–188–603–0, 

or 340–188–605–0, installed. 

(d) Subject 

Joint Aircraft System Component (JASC) 

Code 7260, Turbine Engine Accessory Drive. 

(e) Unsafe Condition 

This AD was prompted by a dual engine 

loss of oil event and 42 prior events of total 

loss of engine oil during flight. The FAA is 

issuing this AD to prevent loss of engine oil 

while in flight. The unsafe condition, if not 

addressed, could result in engine failure, loss 

of thrust control, reduced control of the 

aircraft, and damage to the airplane. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Required Actions 

(1) After the effective date of this AD, after 

any maintenance that involves removal and 

re-installation of the AGB handcranking pad 

cover, perform an independent inspection to 

verify re-installation of the AGB 

handcranking pad cover; or 

(2) Prior to the next removal of the AGB 

handcranking pad cover from the engine, 

insert the independent inspection required 

by paragraph (g)(1) of this AD as a required 

inspection item in the existing approved 

continuous airworthiness maintenance 

program for the aircraft. 

(h) Mandatory Terminating Action 

As a mandatory terminating action to the 

requirements of paragraph (g) of this AD: 

(1) For affected CFM56–3, CFM56–3B, and 

CFM56–3C model turbofan engines, at the 

next engine shop visit, or before December 

31, 2026, whichever occurs first after the 

effective date of this AD, replace the affected 

AGB with a part eligible for installation. 

(2) For affected CFM56–7B model turbofan 

engines, except for CFM56–7B27A, CFM56– 

7B27A/3, and CFM56–7B27AE model 

turbofan engines, at the next engine shop 

visit, or before December 31, 2024, whichever 

occurs first after the effective date of this AD, 

replace the affected AGB with a part eligible 

for installation. 

(i) Definition 

(1) For the purpose of this AD, an ‘‘engine 

shop visit’’ is the induction of an engine into 

the shop for maintenance involving the 

separation of pairs of major mating engine 

case flanges, except for the following 

situations, which do not constitute an engine 

shop visit: 

(i) Separation of engine flanges solely for 

the purposes of transportation of the engine 

without subsequent maintenance; or 

(ii) Separation of engine flanges solely for 

the purpose of replacing the fan or propulsor 

without subsequent maintenance. 

(2) For the purpose of this AD, for affected 

CFM56–3, CFM56–3B, and CFM56–3C model 

turbofan engines, a part eligible for 

installation is: 

(i) An AGB with a P/N other than 335– 

300–103–0, 335–300–105–0, 335–300–106–0, 

335–300–107–0, 335–300–108–0, 335–300– 

109–0, 335–300–110–0; or 

(ii) An AGB that, using an FAA-approved 

procedure, has been re-worked with a 

dynamic oil seal in the handcranking pad 

cover assembly and re-identified with a new 

P/N not listed in paragraph (i)(2)(i) of this 

AD. 

Note 1 to paragraph (i)(2)(ii): Procedures to 

install a dynamic oil seal in the 

handcranking pad cover assembly can be 

found in CFM International SB CFM56–3 

S/B 72–1129, Revision 7, dated May 6, 2020. 

(3) For the purpose of this AD, for affected 

CFM56–7B model turbofan engines, except 

for CFM56–7B27A, CFM56–7B27A/3, and 

CFM56–7B27AE model turbofan engines, a 

part eligible for installation is: 

(i) An AGB with a P/N other than 340– 

046–503–0, 340–046–504–0, or 340–046– 

505–0; or 

(ii) An affected AGB that, using an FAAapproved procedure, has been re-worked 

with a dynamic oil seal in the handcranking 

pad cover assembly and re-identified with a 

new P/N not listed in paragraph (i)(3)(i) of 

this AD. 

Note 2 to paragraph (i)(3)(ii): Procedures to 

install a dynamic oil seal in the 

handcranking pad cover assembly can be 

found in CFM International SB CFM56–7B 

S/B 72–0879, Revision 7, dated February 10, 

2021, CFM56–7B S/B 72–0564, Revision 9, 

dated December 3, 2021, or CFM56–7B S/B 

72–1071, initial issue, dated December 3, 

2021. 

(j) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, ECO 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 (k) of this AD. You 

may email your request to: ANE-AD-AMOC@

faa.gov. 

(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. 

(k) Related Information 

For more information about this AD, 

contact Kevin Clark, Aviation Safety 

Engineer, ECO Branch, FAA, 1200 District 

Avenue, Burlington, MA 01803; phone: (781) 

238–7088; fax: (781) 238–7199; email: 

kevin.m.clark@faa.gov. 

(l) Material Incorporated by Reference 

None. 

Issued on February 23, 2022. 

Derek Morgan, 

Acting Director, Compliance & Airworthiness 

Division, Aircraft Certification Service. 

[FR Doc. 2022–04149 Filed 2–28–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 95 

[Docket No. 31417; Amdt. No. 564] 

IFR Altitudes; Miscellaneous 

Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This document adopts 

miscellaneous amendments to the 

required IFR (instrument flight rules) 

altitudes and changeover points for 

certain Federal airways, jet routes, or 

direct routes for which a minimum or 

maximum en route authorized IFR 

altitude is prescribed. This regulatory 

action is needed because of changes 

occurring in the National Airspace 

System. These changes are designed to 

provide for the safe and efficient use of 

the navigable airspace under instrument 

conditions in the affected areas. 

DATES: 0901 UTC, effective March 24, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Thomas J. Nichols, Flight Procedures 

and Airspace Group, Flight 

Technologies and Procedures Division, 

Flight Standards Service, Federal 

Aviation Administration. Mailing 

Address: FAA Mike Monroney 

Aeronautical Center, Flight Procedures 

and Airspace Group, 6500 South 

MacArthur Blvd., Registry Bldg. 29 

Room 104, Oklahoma City, OK 73125. 

Telephone: (405) 954–4164. 

SUPPLEMENTARY INFORMATION: This 

amendment to part 95 of the Federal 

Aviation Regulations (14 CFR part 95) 

amends, suspends, or revokes IFR 

altitudes governing the operation of all 

aircraft in flight over a specified route 

or any portion of that route, as well as 

the changeover points (COPs) for 


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Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Rules and Regulations 11291 

Federal airways, jet routes, or direct 

routes as prescribed in part 95. 

The Rule 

The specified IFR altitudes, when 

used in conjunction with the prescribed 

changeover points for those routes, 

ensure navigation aid coverage that is 

adequate for safe flight operations and 

free of frequency interference. The 

reasons and circumstances that create 

the need for this amendment involve 

matters of flight safety and operational 

efficiency in the National Airspace 

System, are related to published 

aeronautical charts that are essential to 

the user, and provide for the safe and 

efficient use of the navigable airspace. 

In addition, those various reasons or 

circumstances require making this 

amendment effective before the next 

scheduled charting and publication date 

of the flight information to assure its 

timely availability to the user. The 

effective date of this amendment reflects 

those considerations. In view of the 

close and immediate relationship 

between these regulatory changes and 

safety in air commerce, I find that notice 

and public procedure before adopting 

this amendment are impracticable and 

contrary to the public interest and that 

good cause exists for making the 

amendment effective in less than 30 

days. 

Conclusion 

The FAA has determined that this 

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. For the same 

reason, the FAA certifies that this 

amendment will not have a significant 

economic impact on a substantial 

number of small entities under the 

criteria of the Regulatory Flexibility Act. 

List of Subjects in 14 CFR Part 95 

Airspace, Navigation (air). 

Issued in Washington, DC, on February 18, 

2022. 

Thomas J. Nichols, 

Aviation Safety, Flight Standards Service, 

Manager, Standards Section, Flight 

Procedures & Airspace Group, Flight 

Technologies and Procedures Division. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me by the 

Administrator, part 95 of the Federal 

Aviation Regulations (14 CFR part 95) is 

amended as follows effective at 0901 

UTC, March 24, 2022. 

PART 95—IFR ALTITUDES 

■ 1. The authority citation for part 95 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40103, 40113, 

and 14 CFR 11.49(b)(2). 

■ 2. Part 95 is amended to read as 

follows: 

REVISIONS TO IFR ALTITUDES & CHANGEOVER POINT

[Amendment 564 Effective Date, March 24, 2022] 

From To MEA MAA 

§ 95.3000 Low Altitude RNAV Routes 

§ 95.3302 RNAV Route T302 

Is Amended by Adding 

LLUKY, NE WP ................................................................. ROKKK, IA WP ................................................................ 4400 17500 

ROKKK, IA WP ................................................................. WATERLOO, IA VOR/DME ............................................. 3000 17500 

WATERLOO, IA VOR/DME .............................................. DUBUQUE, IA VORTAC .................................................. 2900 17500 

DUBUQUE, IA VORTAC .................................................. JOOLZ, IL WP .................................................................. * 2900 17500 

* 2500–MOCA 

JOOLZ, IL WP .................................................................. GRIFT, IL WP .................................................................. 3000 17500 

§ 95.3411 RNAV Route T411 

Is Added to Read 

RAZORBACK, AR VORTAC ............................................ DROOP, MO WP ............................................................. 3200 17500 

DROOP, MO WP .............................................................. BUTLER, MO VORTAC ................................................... 2800 17500 

BUTLER, MO VORTAC .................................................... TOPEKA, KS VORTAC .................................................... 3100 17500 

TOPEKA, KS VORTAC .................................................... LINCOLN, NE VORTAC .................................................. 3200 17500 

§ 95.3413 RNAV Route T413 

Is Added to Read 

RAZORBACK, AR VORTAC ............................................ DROOP, MO WP ............................................................. 3200 17500 

DROOP, MO WP .............................................................. EMPORIA, KS VORTAC .................................................. 3100 17500 

EMPORIA, KS VORTAC .................................................. SALINA, KS VORTAC ..................................................... 3300 17500 

SALINA, KS VORTAC ...................................................... GRAND ISLAND, NE VOR/DME ..................................... 3900 17500 

GRAND ISLAND, NE VOR/DME ...................................... ISTIQ, NE WP .................................................................. 3800 17500 

ISTIQ, NE WP ................................................................... LLUKY, NE WP ................................................................ 4000 17500 

LLUKY, NE WP ................................................................. MMINI, NE WP ................................................................. 4000 17500 

MMINI, NE WP ................................................................. JMBAG, SD WP ............................................................... 4300 17500 

JMBAG, SD WP ................................................................ PIERRE, SD VORTAC ..................................................... 4200 17500 

From To MEA 

§ 95.6001 Victor Routes-U.S. 

§ 95.6013 VOR Federal Airway V13 Is Amended To Delete 

RAZORBACK, AR VORTAC ......................................................... * PINNE, MO WP ......................................................................... 3000 


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From To MEA 

* 4500–MRA 

PINNE, MO WP ............................................................................ NEOSHO, MO VOR/DME ........................................................... 3000 

NEOSHO, MO VOR/DME ............................................................. NASHE, MO FIX .......................................................................... 2900 

NASHE, MO FIX ........................................................................... DIZZI, MO WP ............................................................................. 2700 

DIZZI, MO WP .............................................................................. BUTLER, MO VORTAC ............................................................... * 2600 

* 2000–MOCA 

§ 95.6014 VOR Federal Airway V14 Is Amended To Delete 

TULSA, OK VORTAC ................................................................... ADAIR, OK FIX ............................................................................ 2500 

ADAIR, OK FIX ............................................................................. NEOSHO, MO VOR/DME ........................................................... 3000 

NEOSHO, MO VOR/DME ............................................................. SPRINGFIELD, MO VORTAC ..................................................... 3000 

§ 95.6015 VOR Federal Airway V15 Is Amended To Delete 

OKMULGEE, OK VOR/DME ......................................................... MALTS, OK FIX ........................................................................... 3500 

MALTS, OK FIX ............................................................................ * PRYOR, OK FIX ........................................................................ ** 2900 

* 2900–MRA 

** 2200–MOCA 

PRYOR, OK FIX ........................................................................... NEOSHO, MO VOR/DME ........................................................... 3000 

§ 95.6027 VOR Federal Airway V27 Is Amended To Read in Part 

GAVIOTA, CA VORTAC ............................................................... * ORCUT, CA FIX ........................................................................ 6000 

* 6000–MCA ORCUT, CA FIX, SE BND.

§ 95.6037 VOR Federal Airway V37 Is Amended To Delete 

ELLWOOD CITY, PA VOR/DME .................................................. ERIE, PA TACAN ........................................................................ 3000 

§ 95.6043 VOR Federal Airway V43 Is Amended To Delete 

YOUNGSTOWN, OH VORTAC .................................................... ERIE, PA TACAN ........................................................................ * 5000 

* 3000–GNSS MEA 

§ 95.6270 VOR Federal Airway V270 Is Amended To Delete 

ERIE, PA VORTAC ....................................................................... JAMESTOWN, NY VOR/DME ..................................................... 4000 

§ 95.6307 VOR Federal Airway V307 Is Amended To Delete 

HARRISON, AR VOR/DME .......................................................... NEOSHO, MO VOR/DME ........................................................... * 3400 

* 2800–MOCA 

NEOSHO, MO VOR/DME ............................................................. OSWEGO, KS VOR/DME ........................................................... 3000 

§ 95.6506 VOR Federal Airway V506 Is Amended To Delete 

TULSA, OK VORTAC ................................................................... VINTA, OK FIX ............................................................................ 2700 

VINTA, OK FIX .............................................................................. NEOSHO, MO VOR/DME ........................................................... 3000 

NEOSHO, MO VOR/DME ............................................................. BILIE, MO FIX ............................................................................. 3000 

BILIE, MO FIX ............................................................................... SPRINGFIELD, MO VORTAC ..................................................... 3000 

From To MEA MAA 

§ 95.7001 Jet Routes 

§ 95.7181 Jet Route J181 

Is Amended To Delete 

OKMULGEE, OK VOR/DME ............................................ NEOSHO, MO VOR/DME ................................................ 18000 45000 

NEOSHO, MO VOR/DME ................................................. HALLSVILLE, MO VORTAC ............................................ 18000 45000 

Airway Segment Changeover Points 

From To Distance From 

§ 95.8005 Jet Route Changeover Points 

J181 Is Amended To Delete Changeover Point 

OKMULGEE, OK VOR/DME ............................... NEOSHO, MO VOR/DME .................................. 58 OKMULGEE. 

NEOSHO, MO VOR/DME .................................... HALLSVILLE, MO VORTAC .............................. 130 NEOSHO. 


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Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Rules and Regulations 11293 

1FDA notes that the ‘‘ACTION’’ caption for this 

final order is styled as ‘‘Final amendment; final 

order,’’ rather than ‘‘Final order.’’ Beginning in 

December 2019, this editorial change was made to 

indicate that the document ‘‘amends’’ the Code of 

Federal Regulations. The change was made in 

accordance with the Office of Federal Register’s 

(OFR) interpretations of the Federal Register Act (44 

U.S.C. chapter 15), its implementing regulations (1 

CFR 5.9 and parts 21 and 22), and the Document 

Drafting Handbook. 

[FR Doc. 2022–04022 Filed 2–28–22; 8:45 a.m.] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 888 

[Docket No. FDA–2022–N–0114] 

Medical Devices; Orthopedic Devices; 

Classification of the Screw Sleeve 

Bone Fixation Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the screw sleeve bone 

fixation device into class II (special 

controls). The special controls that 

apply to the device type are identified 

in this order and will be part of the 

codified language for the screw sleeve 

bone fixation device’s classification. We 

are taking this action because we have 

determined that classifying the device 

into class II (special controls) will 

provide a reasonable assurance of safety 

and effectiveness of the device. We 

believe this action will also enhance 

patients’ access to beneficial innovative 

devices. 

DATES:

This order is effective March 1, 2022. 

The classification was applicable on 

May 1, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Jesse Muir, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4508, Silver Spring, 

MD 20993–0002, 240–402–6679, 

Jesse.Muir@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

screw sleeve bone fixation device as 

class II (special controls), which we 

have determined will provide a 

reasonable assurance of safety and 

effectiveness. In addition, we believe 

this action will enhance patients’ access 

to beneficial innovation, by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act (21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

We determine whether a new device is 

substantially equivalent to a predicate 

device by means of the procedures for 

premarket notification under section 

510(k) of the FD&C Act (21 U.S.C. 

360(k)) and part 807 (21 CFR part 807). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115) established 

the first procedure for De Novo 

classification. Section 607 of the Food 

and Drug Administration Safety and 

Innovation Act (Pub. L. 112–144) 

modified the De Novo application 

process by adding a second procedure. 

A device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA is required to 

classify the device by written order 

within 120 days. The classification will 

be according to the criteria under 

section 513(a)(1) of the FD&C Act. 

Although the device was automatically 

placed within class III, the De Novo 

classification is considered to be the 

initial classification of the device. 

When FDA classifies a device into 

class I or II via the De Novo process, the 

device can serve as a predicate for 

future devices of that type, including for 

510(k)s (see section 513(f)(2)(B)(i) of the 

FD&C Act). As a result, other device 

sponsors do not have to submit a De 

Novo request or premarket approval 

application to market a substantially 

equivalent device (see section 513(i) of 

the FD&C Act, defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less-burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On December 13, 2018, FDA received 

Woven Orthopedic Technologies, LLC’s 

request for De Novo classification of the 

OGmend® Implant System. FDA 

reviewed the request in order to classify 

the device under the criteria for 

classification set forth in section 

513(a)(1) of the FD&C Act. 

We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to the general 

controls, will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

Therefore, on May 1, 2020, FDA 

issued an order to the requester 

classifying the device into class II. In 

this final order, FDA is codifying the 

classification of the device by adding 21 

CFR 888.3043.1 We have named the 

generic type of device ‘‘screw sleeve 

bone fixation device,’’ and it is intended 

to be implanted in conjunction with a 

non-resorbable, metallic bone screw 

where the screw has lost purchase due 

to loosening, backout, or breakage. The 

device fits between the screw threads 

and surrounding bone and provides 

increased surface area to create an 


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