77196 Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 

contrary to the public interest and, 

where applicable, under 5 U.S.C. 553(d), 

good cause exists for making some 

SIAPs effective in less than 30 days. 

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. 

Lists of Subjects in 14 CFR Part 97 

Air Traffic Control, Airports, 

Incorporation by reference, Navigation 

(Air). 

Issued in Washington, DC, on October 27, 

2023. 

Thomas J. Nichols, 

Manager, Aviation Safety, Flight Standards 

Service, Standards Section, Flight Procedures 

& Airspace Group, Flight Technologies & 

Procedures Division. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, 14 CFR part 

97 is amended by establishing, 

amending, suspending, or removing 

Standard Instrument Approach 

Procedures and/or Takeoff Minimums 

and Obstacle Departure Procedures 

effective at 0901 UTC on the dates 

specified, as follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

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

40106, 40113, 40114, 40120, 44502, 44514, 

44701, 44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

Effective 30 November 2023 

Noatak, AK, WTK/PAWN, RNAV (GPS) RWY 

1, Orig–B 

Noatak, AK, WTK/PAWN, RNAV (GPS) RWY 

19, Orig–B 

Lake Wales, FL, X07, RNAV (GPS) RWY 6, 

Amdt 2 

Lake Wales, FL, X07, RNAV (GPS) RWY 24, 

Amdt 2 

Sterling/Rockfalls, IL, KSQI, RNAV (GPS) 

RWY 7, Amdt 1A 

Sterling/Rockfalls, IL, KSQI, RNAV (GPS) 

RWY 25, Amdt 1A 

Calvert City, KY, M34, RNAV (GPS) RWY 28, 

Orig 

Calvert City, KY, M34, Takeoff Minimums 

and Obstacle DP, Orig 

Marion, KY, KGDA, RNAV (GPS) RWY 7, 

Amdt 4 

Marion, KY, KGDA, RNAV (GPS) RWY 25, 

Amdt 3A 

Prestonsburg, KY, SJS, RNAV (GPS) RWY 3, 

Amdt 2 

Prestonsburg, KY, KSJS, RNAV (GPS) RWY 

21, Amdt 3 

Prestonsburg, KY, KSJS, Takeoff Minimums 

and Obstacle DP, Amdt 3 

Boston, MA, KBOS, RNAV (GPS) X RWY 

22L, Amdt 1E 

Boston, MA, KBOS, RNAV (GPS) Y RWY 

22L, Orig 

Ocean City, MD, KOXB, LOC RWY 32, Orig 

Ocean City, MD, KOXB, LOC RWY 32, Orig, 

CANCELED 

Ocean City, MD, KOXB, RNAV (GPS) RWY 

14, Orig 

Ocean City, MD, KOXB, RNAV (GPS) RWY 

14, Orig–H, CANCELED 

Ocean City, MD, KOXB, RNAV (GPS) RWY 

32, Orig 

Ocean City, MD, KOXB, RNAV (GPS) RWY 

32, Orig–D, CANCELED 

Ocean City, MD, KOXB, Takeoff Minimums 

and Obstacle DP, Amdt 4 

Greenville, ME, 3B1, RNAV (GPS) RWY 32, 

Orig 

Lincoln, ME, KLRG, RNAV (GPS) RWY 16, 

Amdt 1 

Lincoln, ME, LRG, RNAV (GPS) RWY 34, 

Amdt 2 

Lincoln, ME, KLRG, Takeoff Minimums and 

Obstacle DP, Amdt 4 

Hancock, MI, CMX, ILS OR LOC RWY 32, 

Amdt 15C 

Hancock, MI, CMX, LOC BC RWY 14, Amdt 

12C 

Hancock, MI, KCMX, RNAV (GPS) RWY 14, 

Amdt 1B 

Hancock, MI, KCMX, RNAV (GPS) RWY 32, 

Orig–C 

Hancock, MI, KCMX, Takeoff Minimums and 

Obstacle DP, Amdt 3B 

Hancock, MI, KCMX, VOR RWY 25, Amdt 

17E 

Traverse City, MI, KTVC, ILS OR LOC RWY 

10, Orig 

Mankato, MN, MKT, COPTER ILS Z OR LOC 

Z RWY 33, Amdt 1 

Mankato, MN, MKT, ILS Y OR LOC Y RWY 

33, Amdt 2 

Mankato, MN, MKT, RNAV (GPS) RWY 4, 

Amdt 1 

Mankato, MN, MKT, RNAV (GPS) RWY 15, 

Amdt 1 

Mankato, MN, MKT, RNAV (GPS) RWY 22, 

Amdt 1 

Mankato, MN, MKT, RNAV (GPS) RWY 33, 

Amdt 1 

Mankato, MN, MKT, VOR RWY 15, Amdt 7B, 

CANCELED 

Owatonna, MN, KOWA, ILS OR LOC RWY 

30, Amdt 4 

Owatonna, MN, KOWA, RNAV (GPS) RWY 

12, Amdt 2 

Waseca, MN, ACQ, RNAV (GPS) RWY 15, 

Amdt 2 

Statesville, NC, KSVH, RNAV (GPS) RWY 10, 

Amdt 2 

Statesville, NC, KSVH, Takeoff Minimums 

and Obstacle DP, Amdt 1 

Readington, NJ, N51, RNAV (GPS) RWY 4, 

Amdt 1 

Readington, NJ, N51, Takeoff Minimums and 

Obstacle DP, Amdt 2 

Readington, NJ, N51, VOR RWY 4, Amdt 2 

Hamilton, OH, HAO, RNAV (GPS) RWY 11, 

Amdt 1C 

Hamilton, OH, HAO, RNAV (GPS) RWY 29, 

Amdt 2A 

Johnstown, PA, KJST, ILS OR LOC RWY 33, 

Amdt 7C 

Johnstown, PA, KJST, VOR Z RWY 15, Amdt 

7B 

Shamokin, PA, N79, RNAV (GPS) RWY 8, 

Amdt 1 

Shamokin, PA, N79, RNAV (GPS) RWY 26, 

Amdt 1 

Shamokin, PA, N79, VOR RWY 8, Amdt 4 

[FR Doc. 2023–24659 Filed 11–8–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 31515; Amdt. No. 4086] 

Standard Instrument Approach 

Procedures, and Takeoff Minimums 

and Obstacle Departure Procedures; 

Miscellaneous Amendments 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule. 

SUMMARY: This rule amends, suspends, 

or removes Standard Instrument 

Approach Procedures (SIAPs) and 

associated Takeoff Minimums and 

Obstacle Departure Procedures for 

operations at certain airports. These 

regulatory actions are needed because of 

the adoption of new or revised criteria, 

or because of changes occurring in the 

National Airspace System, such as the 

commissioning of new navigational 

facilities, adding new obstacles, or 

changing air traffic requirements. These 

changes are designed to provide for the 

safe and efficient use of the navigable 

airspace and to promote safe flight 

operations under instrument flight rules 

at the affected airports. 

DATES: This rule is effective November 

9, 2023. The compliance date for each 

SIAP, associated Takeoff Minimums, 

and ODP is specified in the amendatory 

provisions. 

The incorporation by reference of 

certain publications listed in the 

regulations is approved by the Director 

of the Federal Register as of November 

9, 2023. 

ADDRESSES: Availability of matter 

incorporated by reference in the 

amendment is as follows: 


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Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 77197 

For Examination 

1. U.S. Department of Transportation, 

Docket Ops-M30, 1200 New Jersey 

Avenue SE, West Bldg., Ground Floor, 

Washington, DC 20590–0001; 

2. The FAA Air Traffic Organization 

Service Area in which the affected 

airport is located; 

3. The office of Aeronautical 

Information Services, 6500 South 

MacArthur Blvd., Oklahoma City, OK 

73169 or, 

4. 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. 

Availability 

All SIAPs and Takeoff Minimums and 

ODPs are available online free of charge. 

Visit the National Flight Data Center 

online at nfdc.faa.gov to register. 

Additionally, individual SIAP and 

Takeoff Minimums and ODP copies may 

be obtained from the FAA Air Traffic 

Organization Service Area in which the 

affected airport is located. 

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., STB Annex, Bldg. 26, 

Room 217, Oklahoma City, OK 73099. 

Telephone: (405) 954–1139. 

SUPPLEMENTARY INFORMATION: This rule 

amends 14 CFR part 97 by amending the 

referenced SIAPs. The complete 

regulatory description of each SIAP is 

listed on the appropriate FAA Form 

8260, as modified by the National Flight 

Data Center (NFDC)/Permanent Notice 

to Airmen (P–NOTAM), and is 

incorporated by reference under 5 

U.S.C. 552(a), 1 CFR part 51, and 14 

CFR 97.20. The large number of SIAPs, 

their complex nature, and the need for 

a special format make their verbatim 

publication in the Federal Register 

expensive and impractical. Further, 

airmen do not use the regulatory text of 

the SIAPs, but refer to their graphic 

depiction on charts printed by 

publishers of aeronautical materials. 

Thus, the advantages of incorporation 

by reference are realized and 

publication of the complete description 

of each SIAP contained on FAA form 

documents is unnecessary. This 

amendment provides the affected CFR 

sections, and specifies the SIAPs and 

Takeoff Minimums and ODPs with their 

applicable effective dates. This 

amendment also identifies the airport 

and its location, the procedure and the 

amendment number. 

Availability and Summary of Material 

Incorporated by Reference 

The material incorporated by 

reference is publicly available as listed 

in the ADDRESSES section. 

The material incorporated by 

reference describes SIAPs, Takeoff 

Minimums and ODPs as identified in 

the amendatory language for part 97 of 

this final rule. 

The Rule 

This amendment to 14 CFR part 97 is 

effective upon publication of each 

separate SIAP and Takeoff Minimums 

and ODP as amended in the transmittal. 

For safety and timeliness of change 

considerations, this amendment 

incorporates only specific changes 

contained for each SIAP and Takeoff 

Minimums and ODP as modified by 

FDC permanent NOTAMs. 

The SIAPs and Takeoff Minimums 

and ODPs, as modified by FDC 

permanent NOTAM, and contained in 

this amendment are based on criteria 

contained in the U.S. Standard for 

Terminal Instrument Procedures 

(TERPS). In developing these changes to 

SIAPs and Takeoff Minimums and 

ODPs, the TERPS criteria were applied 

only to specific conditions existing at 

the affected airports. All SIAP 

amendments in this rule have been 

previously issued by the FAA in a FDC 

NOTAM as an emergency action of 

immediate flight safety relating directly 

to published aeronautical charts. 

The circumstances that created the 

need for these SIAP and Takeoff 

Minimums and ODP amendments 

require making them effective in less 

than 30 days. 

Because of the close and immediate 

relationship between these SIAPs, 

Takeoff Minimums and ODPs, and 

safety in air commerce, I find that notice 

and public procedure under 5 U.S.C. 

553(b) are impracticable and contrary to 

the public interest and, where 

applicable, under 5 U.S.C. 553(d), good 

cause exists for making these SIAPs 

effective in less than 30 days. 

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 97 

Air Traffic Control, Airports, 

Incorporation by reference, Navigation 

(Air). 

Issued in Washington, DC, on October 27, 

2023. 

Thomas J. Nichols, 

Aviation Safety, Flight Standards Service, 

Manager, Standards Section, Flight 

Procedures & Airspace Group, Flight 

Technologies & Procedures Division. 

Adoption of the Amendment 

Accordingly, pursuant to the 

authority delegated to me, 14 CFR part 

97 is amended by amending Standard 

Instrument Approach Procedures and 

Takeoff Minimums and ODPs, effective 

at 0901 UTC on the dates specified, as 

follows: 

PART 97—STANDARD INSTRUMENT 

APPROACH PROCEDURES 

■ 1. The authority citation for part 97 

continues to read as follows: 

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

40106, 40113, 40114, 40120, 44502, 44514, 

44701, 44719, 44721–44722. 

■ 2. Part 97 is amended to read as 

follows: 

By amending: § 97.23 VOR, VOR/ 

DME, VOR or TACAN, and VOR/DME 

or TACAN; § 97.25 LOC, LOC/DME, 

LDA, LDA/DME, SDF, SDF/DME; 

§ 97.27 NDB, NDB/DME; § 97.29 ILS, 

ILS/DME, MLS, MLS/DME, MLS/RNAV; 

§ 97.31 RADAR SIAPs; § 97.33 RNAV 

SIAPs; and § 97.35 COPTER SIAPs, 

Identified as follows: 

* * * Effective Upon Publication 

AIRAC date State City Airport name FDC No. FDC date Procedure name 

30–Nov–23 ..... TX Jasper ............ Jasper County/Bell Fld ..... 3/0837 10/2/23 RNAV (GPS) RWY 18, Orig–A. 

30–Nov–23 ..... TX Jasper ............ Jasper County/Bell Fld ..... 3/0838 10/2/23 RNAV (GPS) RWY 36, Orig–C. 


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77198 Federal Register / Vol. 88, No. 216 / Thursday, November 9, 2023 / Rules and Regulations 

AIRAC date State City Airport name FDC No. FDC date Procedure name 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3119 10/11/23 ILS OR LOC RWY 6, Amdt 10B. 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3122 10/11/23 RNAV (GPS) RWY 29, Amdt 2B. 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3123 10/11/23 RNAV (GPS) RWY 24, Amdt 1B. 

30–Nov–23 ..... CT Bridgeport ...... Bridgeport/Sikorsky .......... 3/3125 10/11/23 RNAV (GPS) RWY 6, Amdt 1B. 

30–Nov–23 ..... MI Hancock ......... Houghton County Meml ... 3/6218 10/16/23 RNAV (GPS) RWY 25, Amdt 1B. 

30–Nov–23 ..... KS Manhattan ...... Manhattan Rgnl ................ 3/6770 10/19/23 ILS OR LOC RWY 3, Amdt 8. 

30–Nov–23 ..... MA Plymouth ........ Plymouth Muni ................. 3/8906 10/20/23 RNAV (GPS) RWY 33, Amdt 1. 

30–Nov–23 ..... MA Plymouth ........ Plymouth Muni ................. 3/8908 10/20/23 RNAV (GPS) RWY 15, Orig–A. 

[FR Doc. 2023–24660 Filed 11–8–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 864 

[Docket No. FDA–2023–N–4487] 

Medical Devices; Hematology and 

Pathology Devices; Classification of 

the Container System for the 

Processing and Storage of Red Blood 

Cell Components Under Reduced 

Oxygen Conditions 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

classifying the container system for the 

processing and storage of Red Blood 

Cell components under reduced oxygen 

conditions 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 classification 

of the container system for the 

processing and storage of Red Blood 

Cell components under reduced oxygen 

conditions. 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 November 

9, 2023. The classification was 

applicable on September 15, 2023. 

FOR FURTHER INFORMATION CONTACT: 

Karen Fikes, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

container system for the processing and 

storage of Red Blood Cell components 

under reduced oxygen conditions as 

class II (special controls), which we 

have determined will provide a 

reasonable assurance of safety and 

effectiveness. 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 (see 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; (see also 21 CFR part 860, 

subpart D). 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 510(k) process, when necessary, to 

market their device. 

II. De Novo Classification 

On January 5, 2022, FDA received 

Hemanext, Inc.’s request for De Novo 

classification of the Hemanext One. 

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, 


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