Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Rules and Regulations 29659 

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

27L, Orig-C 

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

27R, Amdt 1A 

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

36, Amdt 1B 

South Bend, IN, South Bend Intl, Takeoff 

Minimums and Obstacle DP, Amdt 9A 

Dodge City, KS, KDDC, VOR RWY 32, Amdt 

5C 

Hugoton, KS, KHQG, RNAV (GPS) RWY 2, 

Orig-B 

Hugoton, KS, KHQG, RNAV (GPS) RWY 20, 

Orig-B 

Hugoton, KS, KHQG, Takeoff Minimums and 

Obstacle DP, Amdt 2 

Pittsburg, KS, KPTS, RNAV (GPS) RWY 4, 

Amdt 2 

Pittsburg, KS, KPTS, VOR RWY 4, Amdt 3G, 

CANCELLED 

Jackson, KY, KJKL, RNAV (GPS) RWY 1, 

Amdt 1 

Lewisport, KY, KY8, RNAV (GPS) RWY 23, 

Amdt 2 

Lewisport, KY, KY8, Takeoff Minimums and 

Obstacle DP, Amdt 1 

Mayfield, KY, M25, RNAV (GPS) RWY 19, 

Amdt 2 

New Orleans, LA, KMSY, ILS OR LOC RWY 

2, Amdt 20A 

New Orleans, LA, KMSY, RNAV (RNP) Z 

RWY 11, Amdt 1B 

Frederick, MD, KFDK, RNAV (GPS) RWY 5, 

Amdt 1 

Carrabassett, ME, B21, RNAV (GPS)–A, Amdt 

1B 

Majuro Atoll, MH, PKMJ, RNAV (GPS) RWY 

7, Orig-F 

Majuro Atoll, MH, PKMJ, RNAV (GPS) RWY 

25, Orig-F 

Detroit, MI, KYIP, ILS OR LOC RWY 5, Orig 

Detroit, MI, KYIP, ILS OR LOC RWY 5R, 

Amdt 16, CANCELLED 

Detroit, MI, KYIP, ILS OR LOC RWY 23, Orig 

Detroit, MI, KYIP, ILS OR LOC RWY 23L, 

Amdt 8, CANCELLED 

Detroit, MI, KYIP, RNAV (GPS) RWY 5, Orig 

Detroit, MI, KYIP, RNAV (GPS) RWY 5R, 

Amdt 2, CANCELLED 

Detroit, MI, KYIP, RNAV (GPS) RWY 23, Orig 

Detroit, MI, KYIP, RNAV (GPS) RWY 23L, 

Amdt 2, CANCELLED 

Detroit, MI, Willow Run, Takeoff Minimums 

and Obstacle DP, Amdt 11 

Escanaba, MI, KESC, ILS OR LOC RWY 9, 

Amdt 3A 

Iron Mountain Kingsford, MI, KIMT, RNAV 

(GPS) RWY 1, Orig-C 

Iron Mountain Kingsford, MI, KIMT, RNAV 

(GPS) RWY 19, Orig-C 

Iron Mountain Kingsford, MI, KIMT, VOR 

RWY 31. Amdt 16C 

Menominee, MI, KMNM, ILS OR LOC RWY 

3, Amdt 3A 

Menominee, MI, KMNM, VOR–A, Amdt 3C, 

CANCELLED 

Troy, MI, KVLL, RNAV (GPS) RWY 10, Amdt 

3A 

Troy, MI, KVLL, Takeoff Minimums and 

Obstacle DP, Amdt 4B 

Detroit Lakes, MN, KDTL, VOR RWY 14, 

Amdt 2, CANCELLED 

Cleveland, OH, KBKL, ILS OR LOC RWY 

24R, Amdt 2 

Columbus, OH, KOSU, Takeoff Minimums 

and Obstacle DP, Orig-A 

Miami, OK, KMIO, VOR/DME–A, Amdt 2C, 

CANCELLED 

La Grande, OR, KLGD, NDB–B, Amdt 2A 

Sunriver, OR, S21, RNAV (GPS) RWY 18, 

Amdt 1 

Erie, PA, KERI, RNAV (GPS) RWY 24, Amdt 

2A 

Conway, SC, KHYW, NDB RWY 4, Orig-C, 

CANCELLED 

Conway, SC, KHYW, NDB RWY 22, Amdt 

1A, CANCELLED 

Canadian, TX, KHHF, RNAV (GPS) RWY 4, 

Amdt 2A 

Dumas, TX, KDUX, RNAV (GPS) RWY 1, 

Amdt 1 

Dumas, TX, KDUX, RNAV (GPS) RWY 19, 

Amdt 1 

Gruver, TX, E19, RNAV (GPS) RWY 2, OrigB 

Gruver, TX, E19, RNAV (GPS) RWY 20, OrigC 

Pampa, TX, KPPA, RNAV (GPS) RWY 17, 

Orig-C 

Pampa, TX, KPPA, VOR/DME–A, Amdt 3A, 

CANCELLED 

Panhandle, TX, T45, RNAV (GPS) RWY 17, 

Orig-C 

Perryton, TX, KPYX, RNAV (GPS) RWY 17, 

Orig-D 

Spearman, TX, E42, VOR/DME RWY 2, Amdt 

1, CANCELLED 

Pasco, WA, KPSC, ILS OR LOC RWY 21R, 

Amdt 13C 

Pasco, WA, KPSC, VOR RWY 30, Amdt 5C 

Richland, WA, KRLD, LOC RWY 19, Amdt 

9A 

Sturgeon Bay, WI, KSUE, RNAV (GPS) RWY 

20, Amdt 2 

Sturgeon Bay, WI, KSUE, RNAV (GPS) RWY 

28, Amdt 1 

[FR Doc. 2022–10444 Filed 5–13–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 97 

[Docket No. 31428; Amdt. No. 4008] 

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 May 16, 

2022. 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 May 16, 

2022. 

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 

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., Registry Bldg. 29, 

Room 104, Oklahoma City, OK 73169. 

Telephone: (405) 954–4164. 

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 


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29660 Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Rules and Regulations 

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 April 29, 

2022. 

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, Title 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 FDC No. FDC date Subject 

16–Jun–22 ..... UT Provo .................. Provo Muni ........................................... 2/0598 4/25/22 VOR/DME RWY 13, Amdt 2. 

16–Jun–22 ..... NE Cozad ................. Cozad Muni .......................................... 2/0746 4/25/22 VOR RWY 13, Amdt 2B. 

16–Jun–22 ..... KS Atwood ............... Atwood-Rawlins County City-County ... 2/0749 4/25/22 Takeoff Minimums and Obstacle DP, Orig-A. 

16–Jun–22 ..... WI Wautoma ............ Wautoma Muni ..................................... 2/0751 4/21/22 Takeoff Minimums and Obstacle DP, Orig. 

16–Jun–22 ..... TX Beaumont ........... Beaumont Muni .................................... 2/2086 4/18/22 VOR/DME RWY 13, Amdt 3D. 

16–Jun–22 ..... TX Beaumont ........... Beaumont Muni .................................... 2/2087 4/18/22 VOR/DME RWY 31, Amdt 4D. 

16–Jun–22 ..... WI Superior ............. Richard I Bong ..................................... 2/3062 4/19/22 RNAV (GPS) RWY 4, Orig-C. 

16–Jun–22 ..... WI Superior ............. Richard I Bong ..................................... 2/3073 4/19/22 RNAV (GPS) RWY 14, Orig-C. 

16–Jun–22 ..... WI Superior ............. Richard I Bong ..................................... 2/3074 4/19/22 RNAV (GPS) RWY 22, Orig-B. 

16–Jun–22 ..... WI Superior ............. Richard I Bong ..................................... 2/3079 4/19/22 RNAV (GPS) RWY 32, Orig-C. 

16–Jun–22 ..... OR Corvallis ............. Corvallis Muni ....................................... 2/3151 4/7/22 VOR–A, Amdt 11. 

16–Jun–22 ..... IL Decatur .............. Decatur ................................................. 2/3252 4/13/22 RNAV (GPS) RWY 18, Amdt 1A. 

16–Jun–22 ..... NM Grants ................ Grants-Milan Muni ................................ 2/4257 4/15/22 RNAV (GPS) RWY 31, Orig-B. 

16–Jun–22 ..... NM Grants ................ Grants-Milan Muni ................................ 2/4258 4/15/22 RNAV (GPS) RWY 13, Orig-B. 

16–Jun–22 ..... GA Atlanta ................ Hartsfield-Jackson Atlanta Intl ............. 2/4353 4/14/22 ILS OR LOC RWY 10, ILS RWY 10 (SA CAT I), ILS 

RWY 10 (CAT II), ILS RWY 10 (CAT III), Amdt 5A. 

16–Jun–22 ..... CA Visalia ................ Visalia Muni .......................................... 2/4501 4/13/22 ILS OR LOC RWY 30, Amdt 9. 

16–Jun–22 ..... IA Carroll ................ Arthur N Neu ........................................ 2/7399 4/15/22 RNAV (GPS) RWY 13, Amdt 1B. 

16–Jun–22 ..... IA Carroll ................ Arthur N Neu ........................................ 2/7400 4/15/22 RNAV (GPS) RWY 31, Amdt 1B. 

16–Jun–22 ..... IA Oelwein .............. Oelwein Muni ....................................... 2/7413 4/15/22 RNAV (GPS) RWY 13, Orig-A. 

16–Jun–22 ..... PA Johnstown .......... John Murtha Johnstown/Cambria 

County.

2/8118 4/21/22 RNAV (GPS) RWY 15, Amdt 1A. 

16–Jun–22 ..... MO Lebanon ............. Floyd W Jones Lebanon ...................... 2/8522 4/19/22 RNAV (GPS) RWY 18, Orig-B. 

16–Jun–22 ..... MO Lebanon ............. Floyd W Jones Lebanon ...................... 2/8523 4/19/22 RNAV (GPS) RWY 36, Orig-B. 


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Federal Register / Vol. 87, No. 94 / Monday, May 16, 2022 / Rules and Regulations 29661 

AIRAC date State City Airport FDC No. FDC date Subject 

16–Jun–22 ..... OR Redmond ........... Roberts Fld ........................................... 2/8524 4/25/22 ILS OR LOC RWY 23, Amdt 5. 

16–Jun–22 ..... OR Redmond ........... Roberts Fld ........................................... 2/8525 4/25/22 RNAV (GPS) Z RWY 29, Amdt 1A. 

16–Jun–22 ..... TX Austin ................. Austin Exec .......................................... 2/8614 4/15/22 RNAV (GPS) RWY 13, Orig-A. 

16–Jun–22 ..... ID Grangeville ......... Idaho County ........................................ 2/8625 4/25/22 RNAV (GPS) RWY 26, Orig. 

16–Jun–22 ..... TX Beaumont ........... Beaumont Muni .................................... 2/8948 4/18/22 RNAV (GPS) RWY 13, Amdt 1. 

16–Jun–22 ..... TX Beaumont ........... Beaumont Muni .................................... 2/8953 4/18/22 RNAV (GPS) RWY 31, Amdt 1. 

16–Jun–22 ..... TX Ennis .................. Ennis Muni ........................................... 2/9668 4/21/22 VOR/DME–A, Amdt 1A.

16–Jun–22 ..... PA Butler .................. Pittsburgh/Butler Rgnl .......................... 2/9976 3/29/22 RNAV (GPS) RWY 26, Amdt 2. 

[FR Doc. 2022–10443 Filed 5–13–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2019–N–5192] 

Microbiology Devices; Reclassification 

of Human Immunodeficiency Virus 

Serological Diagnostic and 

Supplemental Tests and Human 

Immunodeficiency Virus Nucleic Acid 

Diagnostic and Supplemental Tests 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final amendment; final order. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) is issuing a final order to 

reclassify certain human 

immunodeficiency virus (HIV) 

serological diagnostic and supplemental 

tests and HIV nucleic acid (NAT) 

diagnostic and supplemental tests, 

postamendments class III devices with 

the product code MZF, into class II 

(special controls), subject to premarket 

notification. Through this final order, 

FDA is also adding two new device 

classification regulations and 

identifying special controls that the 

Agency believes are necessary to 

provide a reasonable assurance of safety 

and effectiveness for these device types. 

This final order will reduce the 

regulatory burdens associated with 

these device types, as manufacturers 

will no longer be required to submit a 

premarket approval application (PMA) 

but can instead submit a premarket 

notification (510(k)) and receive 

clearance before marketing their device. 

DATES: This order is effective June 15, 

2022. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Segal, Center for Biologics 

Evaluation and Review, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), as amended, establishes 

a comprehensive system for the 

regulation of medical devices intended 

for human use. Section 513 of the FD&C 

Act (21 U.S.C. 360c) established three 

categories (classes) of devices, reflecting 

the regulatory controls needed to 

provide reasonable assurance of their 

safety and effectiveness. The three 

categories of devices are class I (general 

controls), class II (general controls and 

special controls), and class III (general 

controls and premarket approval). 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices), are 

automatically classified by section 

513(f)(1) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval, unless and 

until, (1) FDA reclassifies the device 

into class I or class II, or (2) FDA issues 

an order finding the device to be 

substantially equivalent, in accordance 

with section 513(i) of the FD&C Act, to 

a predicate device that does not require 

premarket approval. FDA determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act and part 807 (21 CFR part 

807), subpart E, of the regulations. 

A postamendments device that has 

been initially classified in class III 

under section 513(f)(1) of the FD&C Act 

may be reclassified into class I or II 

under section 513(f)(3) of the FD&C Act. 

Section 513(f)(3) of the FD&C Act 

provides that FDA, acting by 

administrative order, can reclassify the 

device into class I or class II on its own 

initiative, or in response to a petition 

from the manufacturer or importer of 

the device. To change the classification 

of the device, the proposed new class 

must have sufficient regulatory controls 

to provide a reasonable assurance of the 

safety and effectiveness of the device for 

its intended use. 

On February 21, 2020, FDA published 

in the Federal Register a proposed order 

(85 FR 10110) to reclassify certain HIV 

serological diagnostic and supplemental 

tests and HIV NAT diagnostic and 

supplemental tests from class III to class 

II (special controls), subject to 

premarket notification. The comment 

period on the proposed order closed on 

April 21, 2020. 

II. Comments on the Proposed Order 

In response to the February 21, 2020, 

proposed order, FDA received several 

comments from public health 

organizations, device manufacturers, 

and individuals by the close of the 

comment period, each containing one or 

more comments on one or more issues. 

We describe and respond to the 

comments in this section of the 

document. The order of response to the 

comments is purely for organizational 

purposes and does not signify the 

comment’s value or importance nor the 

order in which the comments were 

received. 

(Comment 1) Nearly all comments 

expressed general support for the 

proposed reclassification along with 

appropriate controls to assure safety and 

efficacy. The comments noted that 

reclassification could improve access to 

HIV testing, support earlier diagnosis 

and facilitate prevention of HIV, 

enhance laboratory efficiency and 

patient management, and strengthen 

public health surveillance. 

(Response 1) We acknowledge and 

appreciate the supportive comments. 

We are reclassifying these devices and 

establishing the special controls 

published in the proposed order with 

some clarifications and modifications, 

as summarized in section III. 

(Comment 2) Several comments 

recommended the reclassification of 

HIV viral load monitoring tests, which 

were not included within the scope of 

the proposed order. The comments 

expressed differing opinions regarding 

whether HIV viral load reclassification 

should be included in this final order. 

One comment also noted that, at the 

119th meeting of the Blood Products 

Advisory Committee (BPAC) held on 

July 19, 2018 (the Panel), there was clear 

support from the committee for 

reclassification of HIV viral load 

monitoring tests. 

(Response 2) We appreciate the 

comments and note that FDA published 


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