58496 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations 

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 August 18, 

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 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 5 October 2023 

Fairbanks, AK, PAFA, ILS OR LOC RWY 2L, 

ILS RWY 2L (SA CAT I), ILS RWY 2L (CAT 

II), ILS RWY 2L (CAT III), Amdt 11 

Fairbanks, AK, PAFA, RNAV (RNP) Z RWY 

2L, Amdt 2 

Fairbanks, AK, PAFA, RNAV (RNP) Z RWY 

20R, Amdt 2 

Shishmaref, AK, PASH, NDB RWY 5, Amdt 

1A, CANCELED 

Shishmaref, AK, PASH, RNAV (GPS) RWY 5, 

Amdt 1 

Shishmaref, AK, PASH, RNAV (GPS) RWY 

23, Amdt 1 

Shishmaref, AK, PASH, Takeoff Minimums 

and Obstacle DP, Amdt 1 

Manila, AR, KMXA, RNAV (GPS) RWY 36, 

Amdt 1 

Lancaster, CA, KWJF, PALMDALE ONE, 

Graphic DP 

Lancaster, CA, KWJF, RNAV (GPS) RWY 24, 

Orig-B 

Lancaster, CA, KWJF, Takeoff Minimums and 

Obstacle DP, Amdt 1 

Colorado Springs, CO, KFLY, FALCON ONE, 

Graphic DP 

Colorado Springs, CO, KFLY, RNAV (GPS) 

RWY 15, Orig 

Colorado Springs, CO, KFLY, RNAV (GPS) 

RWY 33, Orig 

Colorado Springs, CO, KFLY, Takeoff 

Minimums and Obstacle DP, Orig 

Arcadia, FL, X06, RNAV (GPS)–A, Amdt 1 

Arcadia, FL, X06, RNAV (GPS)–B, Amdt 1 

Elberton, GA, KEBA, RNAV (GPS) RWY 11, 

Amdt 2 

Elberton, GA, KEBA, RNAV (GPS) RWY 29, 

Amdt 1B 

Elberton, GA, KEBA, VOR RWY 11, Amdt 5 

Nahunta, GA, 4J1, RNAV (GPS) RWY 1, 

Amdt 1 

Nahunta, GA, 4J1, RNAV (GPS) RWY 19, 

Amdt 1 

Nahunta, GA, 4J1, RNAV (GPS) Y RWY 1, 

Orig-B, CANCELED 

Nahunta, GA, 4J1, RNAV (GPS) Z RWY 19, 

Orig-B, CANCELED 

Kahului, HI, PHOG, ILS Y OR LOC Y RWY 

2, Orig-A 

Kahului, HI, PHOG, ILS Z OR LOC Z RWY 

2, Amdt 26A 

Kahului, HI, PHOG, NDB RWY 2, Orig-B, 

CANCELED 

Kahului, HI, PHOG, VOR Y RWY 20, Amdt 

1, CANCELED 

South Bend, IN, KSBN, RNAV (GPS) RWY 

9R, Amdt 1C 

South Bend, IN, KSBN, RNAV (GPS) RWY 

36, Amdt 1C 

Vidalia, LA, 0R4, RNAV (GPS) RWY 14, 

Amdt 1 

Sandusky, MI, Y83, RNAV (GPS) RWY 10, 

Orig 

Sandusky, MI, Y83, RNAV (GPS) RWY 28, 

Orig 

Sandusky, MI, Y83, Takeoff Minimums and 

Obstacle DP, Orig 

Natchez, MS, KHEZ, ILS OR LOC RWY 14, 

Amdt 3 

Natchez, MS, KHEZ, VOR RWY 18, Amdt 

11A, CANCELED 

Oxford, MS, KUOX, RNAV (GPS) RWY 9, 

Amdt 2 

Oxford, MS, KUOX, RNAV (GPS) RWY 27, 

Amdt 2 

Oxford, MS, KUOX, VOR–A, Amdt 5B 

Winnemucca, NV, KWMC, FESKO ONE, 

Graphic DP 

Winnemucca, NV, KWMC, Takeoff 

Minimums and Obstacle DP, Amdt 3 

Winnemucca, NV, KWMC, WINNEMUCCA 

ONE, Graphic DP, CANCELED 

Miller, SD, KMKA, RNAV (GPS) RWY 33, 

Amdt 1C 

Alice, TX, KALI, LOC/DME RWY 31, Orig-F 

Alice, TX, KALI, RNAV (GPS) RWY 31, Amdt 

1G 

Alice, TX, KALI, VOR RWY 31, Amdt 13G 

Milwaukee, WI, KMKE, Takeoff Minimums 

and Obstacle DP, Amdt 9 

Buckhannon, WV, W22, RNAV (GPS) RWY 

11, Amdt 2E 

[FR Doc. 2023–18462 Filed 8–25–23; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 31504; Amdt. No. 4076] 

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 August 28, 

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 August 28, 

2023. 

ADDRESSES: Availability of matter 

incorporated by reference in the 

amendment is as follows: 

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 


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Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations 58497 

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 August 18, 

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 

5-Oct-23 ....... WV Charleston .............. West Virginia Intl Yeager ........ 3/0120 8/11/23 ILS OR LOC RWY 5, Orig-A. 

5-Oct-23 ....... PA Reading .................. Reading Rgnl/Carl A Spaatz 

Fld.

3/2093 8/10/23 RNAV (GPS) RWY 31, Orig. 

5-Oct-23 ....... OH Washington Court 

House.

Fayette County ........................ 3/2336 8/11/23 RNAV (GPS) RWY 23, Amdt 1A. 

5-Oct-23 ....... OH Coshocton ............... Richard Downing ..................... 3/2817 8/11/23 RNAV (GPS) RWY 4, Orig. 

5-Oct-23 ....... WI Mosinee .................. Central Wisconsin ................... 3/3041 7/27/23 RNAV (GPS) RWY 17, Amdt 1C. 

5-Oct-23 ....... GA Americus ................. Jimmy Carter Rgnl .................. 3/3101 6/21/23 RNAV (GPS) RWY 23, Amdt 1C. 

5-Oct-23 ....... AR Fayetteville .............. Drake Fld ................................. 3/7177 8/9/23 RNAV (GPS) RWY 16, Amdt 1B.


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58498 Federal Register / Vol. 88, No. 165 / Monday, August 28, 2023 / Rules and Regulations 

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

5-Oct-23 ....... AR Fayetteville .............. Drake Fld ................................. 3/7180 8/9/23 LOC RWY 16, Orig. 

5-Oct-23 ....... AR Fayetteville .............. Drake Fld ................................. 3/7182 8/9/23 RNAV (GPS) RWY 34, Amdt 1C.

[FR Doc. 2023–18463 Filed 8–25–23; 8:45 a.m.] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Chapter I 

[Docket No. FDA–2023–D–1909] 

Enhanced Drug Distribution Security 

Requirements Under Section 582(g)(1) 

of the Federal Food, Drug, and 

Cosmetic Act—Compliance Policies; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing the availability of a final 

guidance for industry entitled 

‘‘Enhanced Drug Distribution Security 

Requirements Under Section 582(g)(1) 

of the Federal Food, Drug, and Cosmetic 

Act—Compliance Policies.’’ This 

guidance describes FDA’s compliance 

policies regarding enforcement of 

requirements for the interoperable, 

electronic, package level product tracing 

(referred to as enhanced drug 

distribution security requirements) 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) that will go 

into effect on November 27, 2023. FDA 

believes the compliance policies 

outlined in this guidance will help 

supply chain stakeholders, particularly 

trading partners, by accommodating the 

additional time that may be needed to 

continue to develop and refine 

appropriate systems and processes to 

conduct interoperable, electronic tracing 

at the package level, to achieve robust 

supply chain security under the Drug 

Supply Chain Security Act (DSCSA) 

while helping ensure continued patient 

access to prescription drugs. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 28, 2023. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–D–1909 for ‘‘Enhanced Drug 

Distribution Security Requirements 

Under Section 582(g)(1) of the Federal 

Food, Drug, and Cosmetic Act— 

Compliance Policies.’’ Received 

comments will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002 or to the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 


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