Excel Tables for Proposed Rule- 10 CFR Parts 30, Part 35 and NRC Form 313- Medical Use of Byproduct Material

Copy of Part 35 proposed rule FINAL in ROCIS.xlsx

NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation

Excel Tables for Proposed Rule- 10 CFR Parts 30, Part 35 and NRC Form 313- Medical Use of Byproduct Material

OMB: 3150-0120

Document [xlsx]
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Overview

Prg Codes
TBL 1, 2 & 3 NRC Reporting
TBL 4, 5 & 6 AS Reporting
TBL 7,8 NRC RecordKeeping
TBL 9,10 AS RecordKeeping
TBL 11,12 3rd Party
TBL 13,14 One time Reporting
TBL 15,16 One Time Rdkeeping
TOTAL BURDEN
Total R&R


Sheet 1: Prg Codes

License Title Program codes NRC MML Total NRC Licensees Agreement States Total Licensees

Medical Institution-Broad 2110 23 44 67 395 462

Medical Institution-Written Directive Required 2120 257 81 338 1994 2332

Medical Institution-Written Directive Not Required 2121 145 13 158 932 1090

Medical Private Practice-Written Directive Required 2200 58 0 58 342 400

Medical Private Practice-Written Directive Not Required 2201 286 0 286 1687 1973

Eye Applicators Strontium-90 2210 14 0 14 83 97

Mobile Medicine Service – Written Directive Not Required 2220 41 0 41 242 283

High Dose-Rate Remote Afterloader 2230 85 0 85 502 587

Mobile Medical Service – Written Directive Required 2231 2 0 2 12 14

Medical Therapy – Other Emerging Technology 2240 26 0 26 153 179

Teletherapy 2300 2 0 2 12 0

Gamma Stereotactic Radiosurgery 2310 8 0 8 47 55

Sub Totals
947 138 1085 6401

TOTAL


7468



















1 NRC Material License Program Codes, November 2012.







2 Data from NRC License Tracking System (LTS), November 2012.






7827
3 Estimated, based on 1 to 5.9 ratio of NRC licensees to Agreement States licensees.

























Radiopharmacies (Part 30) 2500 52 0 52 307 359


Sheet 2: TBL 1, 2 & 3 NRC Reporting

Ed: Table 1 – Reporting Burden for NRC Licensees (3150-0010)
Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.14(b)(1) All 37 1 37 0.25 9.25 $2,535
35.14(b)(6) 2120, 2200, 2230, 2240 507 2 1,014 0.25 253.50 $69,459
35.204(e) 2110, 2120, 2121,2200, 2201,2220, 2231 Burden covered in 35.3204(a) & (b)



$0
35.3045(a)(2)
Burden covered in 35.3045(c), (d) & (e)



$0
35.3045(c) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 1 1 1 -0.50 -0.50 -$137
35.3045(d) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 1 1 1 -8.00 -8.00 -$2,192
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 3 1 3 -2.00 -6.00 -$1,644
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220 1 1 1 0.25 0.25 $69
35.3204(b) 2110, 2120, 2121, 2200, 2201, 2220 1 1 1 2.00 2.00 $548
Total
551
1,058
250.50 $68,637
















Table 2 – Reporting Burden for NRC Licensees (3150-0017)
Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
30.34(g) 2511 1 1 1 0.50 0.50 $137
Total
1
1
0.50 $137
















Table 3 – Reporting Burden for NRC Licensees (3150-0120)
Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.12(b) All (ARSO) 33 1 33 0.25 8.25 $2,261
35.12(b) All (copy) 33 1 33 -0.25 -8.25 -$2,261
35.12(c)(1) All (Renewals) 108 1 108 -0.25 -27.00 -$7,398
35.12(c)(1) All (Amendments) 1085 1 1,085 -0.25 -271.25 -$74,323
35.13(d) All (Turnover) 33 1 33 0.50 16.50 $4,521
35.13(d) All (Amendments) 108 1 108 0.50 54.00 $14,796
35.13(i) 2120, 2200, 2230, 2240 507 2 1,014 -0.50 -507.00 -$138,918
35.50(a) All (Turnover) 10 1 10 -0.50 -5.00 -$1,370
35.50(c)(1) Subset of 35.50(a)




$0
35.50(c)(3) 2201 1 1 1 -0.50 -0.50 -$137
35.51(a) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 (Turnover) 5 1 5 -0.50 -2.50 -$685
35.55(a) 2110, 2120 (Turnover) 1 1 1 -0.50 -0.50 -$137
35.57(a)(1) 21210, 2120, 2200, 2210, 2230, 2231, 2240, 2310 6 1 6 -0.50 -3.00 -$822
35.57(a)(2) All 11 1 11 -0.50 -5.50 -$1,507
35.57(a)(3) 2210, 2120, 2200, 2210, 2230, 2231, 2240, 2310 6 1 6 -0.50 -3.00 -$822
35.57(b)(1) All 325 1 325 -0.50 -162.50 -$44,525
35.57(b)(2) All 27 1 27 -0.50 -13.50 -$3,699
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2200, 2231 2 1 2 0.50 1.00 $274
35.190(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 8 1 8 -0.50 -4.00 -$1,096
35.290(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 8 1 8 -0.50 -4.00 -$1,096
35.390(a) 2110, 2120, 2200, 2231 (Turnover) 4 1 4 -0.50 -2.00 -$548
35.392(a) 2110, 2120, 2200, 2231 (Turnover) 4 1 4 -0.50 -2.00 -$548
35.394(a) 2110, 2120, 2200, 2231 (Turnover) 4 1 4 -0.50 -2.00 -$548
35.433 No Additional Burden




$0
35.490(a) 2110, 2120, 2200, 2210, 2240 (Turnover) 5 1 5 -0.50 -2.50 -$685
35.690(a) 2110, 2230, 2300, 2310 (Turnover) 2 1 2 -0.50 -1.00 -$274
Total
2336
176
-947.25 -$259,547








NOTE: Grayed numbers indicate new responses to complete NRC Form 313. Other responses are a reduction in the time associatied with completing the form for existing respondents.







Sheet 3: TBL 4, 5 & 6 AS Reporting

Table 4 – Reporting Burden for Agreement States Licensees (3150-0010)

Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.14(b)(1) All 225 1 225 0.25 56.25 $15,413
35.14(b)(6) 2120, 2200, 2230, 2240 2991 2 5,982 0.25 1,495.50 $409,767
35.204(e) 2110, 2120, 2121,2200, 2201,2220, 2231 Burden covered in 35.3204(a) & (b)



$0
35.3045(a)(2)
Burden covered in 35.3045(c), (d) & (e)



$0
35.3045(c) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 6 1 6 -0.50 -3.00 -$822
35.3045(d) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 6 1 6 -8.00 -48.00 -$13,152
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 5 3 15 -2.00 -30.00 -$8,220
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220 6 1 6 0.25 1.50 $411
35.3204(b) 2110, 2120, 2121, 2200, 2201, 2220 6 1 6 2.00 12.00 $3,288
Total
3245
6,246
1,484.25 $406,685
















Table 5 – Reporting Burden for Agreement States Licensees (3150-0017)

Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
30.34(g) 2511 1 6 6 0.50 3.00 $822
Total
1
6
3.00 $822
















Table 6 – Reporting Burden for Agreement States Licensees (3150-0120)

Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.12(b) All (ARSO) 192 1 192 0.25 48.00 $13,152
35.12(b) All (copy) 192 1 192 -0.25 -48.00 -$13,152
35.12(c)(1) All (Renewals) 369 1 369 -0.25 -92.25 -$25,277
35.12(c)(1) All (Amendments) 6401 1 6,401 -0.25 -1,600.25 -$438,469
35.13(d) All (Turnover) 192 1 192 0.50 96.00 $26,304
35.13(d) All (Amendments) 639 1 639 0.50 319.50 $87,543
35.13(i) 2120, 2200, 2230, 2240 2991 2 5,982 -0.50 -2,991.00 -$819,534
35.50(a) All (Turnover) 57 1 57 -0.50 -28.50 -$7,809
35.50(c)(1) Subset of 35.50(a)




$0
35.50(c)(3) 2201 2 1 2 -0.50 -1.00 -$274
35.51(a) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 (Turnover) 32 1 32 -0.50 -16.00 -$4,384
35.55(a) 2110, 2120 (Turnover) 6 1 6 -0.50 -3.00 -$822
35.57(a)(1) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 35 1 35 -0.50 -17.50 -$4,795
35.57(a)(2) All 64 1 64 -0.50 -32.00 -$8,768
35.57(a)(3) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 35 1 35 -0.50 -17.50 -$4,795
35.57(b)(1) All 1917 1 1,917 -0.50 -958.50 -$262,629
35.57(b)(2) All 160 1 160 -0.50 -80.00 -$21,920
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2200, 2231 9 1 9 0.50 4.50 $1,233
35.190(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 50 1 50 -0.50 -25.00 -$6,850
35.290(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 50 1 50 -0.50 -25.00 -$6,850
35.390(a) 2110, 2120, 2200, 2231 (Turnover) 25 1 25 -0.50 -12.50 -$3,425
35.392(a) 2110, 2120, 2200, 2231 (Turnover) 25 1 25 -0.50 -12.50 -$3,425
35.394(a) 2110, 2120, 2200, 2231 (Turnover) 25 1 25 -0.50 -12.50 -$3,425
35.433 No Additional Burden




$0
35.490(a) 2110, 2120, 2200, 2210, 2240 (Turnover) 27 1 27 -0.50 -13.50 -$3,699
35.690(a) 2110, 2230, 2300, 2310 (Turnover) 8 1 8 -0.50 -4.00 -$1,096
Total
13503
1,032
-5,522.50 -$1,513,165








NOTE: Grayed numbers indicate new responses to complete NRC Form 313. Other responses are a reduction in the time associatied with completing the form for existing respondents.







Sheet 4: TBL 7,8 NRC RecordKeeping

Table 7 – Recordkeeping Burden for NRC Licensees for Part 35 (3150-0010)
Section Program Codes No. of NRC Number of Records per Licensee Total Number of Records Burden Hours Total Annual Cost @ $274/Hour Record Retention
Recordkeepers
per Record Burden Hours Period





35.24(b) All Burden covered in 35.2024(c)





35.41(a) 35.41(b)(5) & 35.41(b)(6) Burden covered in 35.2041





35.41(b)(5) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 Covered in 35.41(a) (18)





35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (15)





35.65(b((2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 2 1 2 2.50 5.00 $1,370 Inventory and leak testing 3 years
35.204(b) 2110, 2120 Covered under 35.2204 (61)





35.610(d) 2110, 2120, 2230, 2300, 2310 Covered in 35.2310





35.2024(c) From 35.24(b) (Turnover) 33 1 33 1.00 33.00 $9,042 5 years after ARSO is removed from license
35.2041 From 35.41(a) (Turnover) 33 1 33 9.00 297.00 $81,378 Duration of the license
35.2204 From 35.204(b) 48 1 48 13.00 624.00 $170,976 3 years
35.2310 From 35.610(d) 25 1 25 1.00 25.00 $6,850 3 years
Total
141
141
984.00 $269,616










Table 8 – Recordkeeping Burden for NRC Licensees for Part 30 (3150-0010)


Section No. of NRC Number of Records per Licensee Total Number of Records Burden Hours per Record Total Annual Cost @ $274/Hour Record Retention

Recordkeepers Burden Hours Period

30.34(g) 52 52 13 676 $185,224 3 years 

Total 52 52
676 $185,224

Sheet 5: TBL 9,10 AS RecordKeeping

Table 9 – Recordkeeping Burden for Agreement State Licensees for Part 35 (3150-0010)
Section Program Codes No. of Agreement State Number of Records per Licensee
Burden Hours Total Annual Cost @ $274/Hour Record Retention
Recordkeepers Total Number of Records per Record Burden Hours Period





35.24(b) All Burden covered in 35.2024(c)





35.41(a) 35.41(b)(5) & 35.41(b)(6) Burden covered in 35.2041





35.41(b)(5) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 Covered in 35.41(a) (106)





35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (88)





35.65(b((2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 8 1 8 2.50 20.00 $5,480 Inventory and leak testing 3 years
35.204(b) 2110, 2120, 2121, 2200, 2201, 2220 Covered under 35.2204 (2390)





35.610(d) 2110, 2120, 2230, 2300, 2310 Covered in 35.2310





35.2024(c) From 35.24(b) (Turnover) 192 1 192 1.00 192.00 $52,608 5 years after ARSO is removed from license
35.2041 From 35.41(a) (Turnover) 194 1 194 9.00 1,746.00 $478,404 Duration of the license
35.2204 From 35.204(b) 283 1 283 13.00 3,679.00 $1,008,046 3 years
35.2310 From 35.610(d) 147 1 147 1.00 147.00 $40,278 3 years
Total
824
824
5,784.00 $1,584,816










Table 10 – Recordkeeping Burden for Agreement State Licensees for Part 30 (3150-0017)


Section No. of Agreement State Number of Records per Licensee Total Number of Records Burden Hours per Record Total Annual Cost @ $274/Hour Record Retention

Recordkeepers Burden Hours Period

30.34(g) 307 1 307 13 3991 $1,093,534 3 years

Total 307
307
3991 $1,093,534

Sheet 6: TBL 11,12 3rd Party

Table 11 - Third-party Disclosure Burden for NRC Licensees (3150-0010)
Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 1 3 3 -2.00 -6.00 -$1,644
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220, 2500 2 1 2 0.25 0.50 $137
Total
3 4 5
-5.50 -$1,507
















Table 12 - Third-party Disclosure Burden for Agreement State Licensees (3150-0010)
Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 5 3 15 -2.00 -30.00 -$8,220
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220, 2500 12 1 12 0.25 3.00 $822
Total
17 4 27
-27.00 -$7,398
































Sheet 7: TBL 13,14 One time Reporting

Table 13 - One-Time Implementation Reporting Burden for NRC Licensees for Form 313 (3150-0120)
Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.13(d) All 1085 1 1,085 0.50 542.50 $148,645
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 10 1 10 0.50 5.00 $1,370
Total
2095
1095
547.50 $150,015
Annualized Total


365.00
182.50 $50,005








Table 14 - One-Time Implementation Reporting Burden for Agreement State Licensees for Form 313 (3150-0120)
Section Program Codes Number of Respondents Responses Per Respondent Total Number of Responses Burden per Response (Hours) Total Annual Burden (Hours) Cost @ $274/Hr
35.13(d) All 6401 1 6,401 0.50 3200.50 $876,937
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 55 1 55 2.00 110.00 $30,140
Total
6456
6456
3310.50 $907,077
Annualized Total


2152.00
1103.50 $302,359

Sheet 8: TBL 15,16 One Time Rdkeeping

Table 15 - One Time Implementation Recordkeeping Burden for Agreement State Licensees for Part 35 (3150-0010)
Section Program Codes No. of NRC Number of Records per Licensee Total Number of Records Burden Hours Total Annual Cost @ $274/HR Record Retention
Recordkeepers
per Record Burden Hours Period





35.24(b) All Burden covered in 35.2024(c)





35.41(a) 35.41(b)(5) & 35.41(b)(6) Burden covered in 35.2041





35.41(b)(5) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 Covered in 35.41(a) (3540)




35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (2885)





35.41(c)
Covered in 35.2041





35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 56 1 56 2.00 112.00 $30,688 Inventory and leak testing 3 years
35.2024(c) From 35.24(b) 6401 1 6,401 1.00 6,401.00 $1,753,874 5 years after ARSO is removed from license
35.2041 From 35.41(a) 6425 1 6,425 9.00 57,825.00 $15,844,050 Duration of the license
Total


12,882.00
64,338.00 $17,628,612
Annualized Total




21446.00 $5,876,204


















Table 16 - One-Time Implementation Recordkeeping Burden for NRC Licensees for Part 35 (3150-0010)
Section Program Codes No. of NRC Number of Records per Licensee Total Number of Records Burden Hours Total Annual Cost @ $274/HR Record Retention
Recordkeepers
per Record Burden Hours Period





35.24(b) All Burden covered in 35.2024(c)





35.41(a) 35.41(b)(5) & 35.41(b)(6) Burden covered in 35.2041





35.41(b)(5) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 Covered in 35.41(a) (600)





35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (489)





35.41(c)
Covered in 35.2041





35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 10 1 10 2.00 20.00 $5,480 Inventory and leak testing 3 years
35.2024(c) From 35.24(b) 1085 1 1,085 1.00 1,085.00 $297,290 5 years after ARSO is removed from license
35.2041 From 35.41(a) 1089 1 1,089 9.00 9,801.00 $2,685,474 Duration of the license
Total


2,184.00
10,906.00 $2,988,244
Annualized Total




3635.33 $996,081

Sheet 9: TOTAL BURDEN

Table 17 – Total Recurring Annual Burden in Hours for NRC Licensees

Table 23:TOTAL BURDEN FOR PROPOSED RULE

Reporting Burden Recordkeeping Burden 3rd Party Disclosure Burden Total


Reporting Burden Recordkeeping Burden 3rd Party Disclosure Burden Total Cost at $274/hr
10 CFR Part 30 0.50 676.00 0.00 676.50

10 CFR Part 30 3.50 4,667.00 0.00 4,670.50 $1,279,717
10 CFR Part 35 250.50 984.00 -5.50 1,229.00

10 CFR Part 35 1,734.75 31,849.33 -32.50 33,551.58 $9,193,134
Form 313 -947.25 0.00 0.00 -947.25

Form 313 -5,183.75 0.00 0.00 -5,183.75 -$1,420,348
Total: -696.25 1,660.00 -5.50 958.25

Total: -3,445.50 36,516.33 -32.50 33,038.33 $9,052,503













Table 18 – Total Recurring Annual Burden in Hours for Agreement State Licensees








Reporting Burden Recordkeeping Burden 3rd Party Disclosure Burden Total







10 CFR Part 30 3.00 3,991.00 0.00 3,994.00







10 CFR Part 35 1,484.25 5,784.00 -27.00 7,241.25







Form 313 -5,522.50 0.00 0.00 -5,522.50







Total: -4,035.25 9,775.00 -27.00 5,712.75




















Table 19 – Total Recurring Annual Burden in Hours for All Licensees








Reporting Burden Recordkeeping Burden 3rd Party Disclosure Burden Total







10 CFR Part 30 3.50 4,667.00 0.00 4,670.50







10 CFR Part 35 1,734.75 6,768.00 -32.50 8,470.25







Form 313 -6,469.75 0.00 0.00 -6,469.75







Total: -4,731.50 11,435.00 -32.50 6,671.00




















Table 20 – Total One-Time Burden in Hours for NRC Licensees (Annualized)









Reporting Burden Recordkeeping Burden Total








10 CFR Part 30 0.00 0.00 0.00








10 CFR Part 35 0.00 3,635.33 3,635.33








Form 313 182.50 0.00 182.50








Total: 182.50 3,635.33 3,817.83





















Table 21 – Total One-Time Burden in Hours for Agreement State Licensees (Annualized)









Reporting Burden Recordkeeping Burden Total








10 CFR Part 30 0.00 0.00 0.00








10 CFR Part 35 0.00 21,446.00 21,446.00








Form 313 1,103.50 0.00 1,103.50








Total: 1,103.50 21,446.00 22,549.50





















Table 22 – Total One-Time Burden in Hours for All Licensees (Annualized)









Reporting Burden Recordkeeping Burden Total








10 CFR Part 30 0.00 0.00 0.00








10 CFR Part 35 0.00 25,081.33 25,081.33








Form 313 1,286.00 0.00 1,286.00








Total: 1,286.00 25,081.33 26,367.33









Sheet 10: Total R&R


Table 24 – Total Annual Responses for All Licensees

NRC Licensees Agreement State Licensees TOTAL

Responses Recordkeepers Total Responses Recordkeepers Total
10 CFR Part 30 (OMB 3150-0017) 1 52 53 6 307 313 366
10 CFR Part 35 (OMB 3150-0010) 1,063 141 1,204 6,273 824 7097 8,301
Form 313 (OMB 3150-0120) 541 0 541 3,184 0 3184 3,725
Total:

1,798

10,594 12,392
















Table 25 – Total Respondents




Number of Respondents NRC Number of Respondents Agreement States Total











10 CFR Part 30 (OMB 3150-0017) 52 307 359



10 CFR Part 35 (OMB 3150-0010) 1,085 6,401 7,486



Form 313 (OMB 3150-0120) 1,085 6,401 7,486



Unduplicated total:

7,845



The respondents for Part 35 and Form 313 are the same licensees.






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