Excel Burden Tables- Final Rule Supporting Statement,10 CFR Part 30, 32, and 35 - Medical Use of Byproduct Material

OMB Tables for Part 35 final rule (2017).xlsx

10 CFR 30, Rules of General Applicability to Domestic Licensing of Byproduct Material

Excel Burden Tables- Final Rule Supporting Statement,10 CFR Part 30, 32, and 35 - Medical Use of Byproduct Material

OMB: 3150-0017

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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 21 44 65 384 449

Medical Institution-Written Directive Required 2120 230 81 311 1835 2146

Medical Institution-Written Directive Not Required 2121 148 13 161 950 1111

Medical Private Practice-Written Directive Required 2200 43 0 43 254 297

Medical Private Practice-Written Directive Not Required 2201 232 0 232 1369 1601

Eye Applicators Strontium-90 2210 11 0 11 65 76

Mobile Medicine Service – Written Directive Not Required 2220 33 0 33 195 228

High Dose-Rate Remote Afterloader 2230 90 4 94 555 649

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

Medical Therapy – Other Emerging Technology 2240 35 0 35 207 242

Teletherapy 2300 1 0 1 6 7

Gamma Stereotactic Radiosurgery 2310 8 0 8 47 55

Nuclear Pharmacy (part 30) 2500 33 0 33 195 228

Sub Totals
887 142 1029 6074

TOTAL


7103



















1 NRC Material License Program Codes, July 2015.






0
2 Data from NRC License Tracking System (LTS), July 2015.







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







4 Master Material Licenses (MMLs, such as Army, Navy, VA).








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 @ $268/Hr
35.14(b)(1) All 36 1 36 0.25 9.00 $2,412
35.14(b)(6) 2120, 2200, 2230, 2240 483 2 966 0.25 241.50 $64,722
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 -$134
35.3045(d) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 1 1 1 -8.00 -8.00 -$2,144
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 3 1 3 -2.00 -6.00 -$1,608
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220 1 1 1 0.25 0.25 $67
35.3204(b) 2110, 2120, 2121, 2200, 2201, 2220 1 1 1 2.00 2.00 $536
Total
551
1,009
238.25 $63,851
















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 @ $268/Hr
30.34(g) 2500 1 1 1 0.50 0.50 $134
Total
1
1
0.50 $134
















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 @ $268/Hr
35.12(b) All (ARSO) 31 1 31 0.25 7.75 $2,077
35.12(b) All (copy) 31 1 31 -0.25 -7.75 -$2,077
35.12(c)(1) All (Renewals) 103 1 103 -0.25 -25.75 -$6,901
35.12(c)(1) All (Amendments) 1029 1 1,029 -0.25 -257.25 -$68,943
35.13(d) All (Turnover) 31 1 31 0.50 15.50 $4,154
35.13(d) All (Amendments) 103 1 103 0.50 51.50 $13,802
35.13(i) 2120, 2200, 2230, 2240 483 2 966 -0.50 -483.00 -$129,444
35.50(a) All (Turnover) 10 1 10 -0.50 -5.00 -$1,340
35.50(c)(1) Subset of 35.50(a)




$0
35.50(c)(3) 2201 1 1 1 -0.50 -0.50 -$134
35.51(a) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 (Turnover) 6 1 6 -0.50 -3.00 -$804
35.55(a) 2110, 2120 (Turnover) 1 1 1 -0.50 -0.50 -$134
35.57(a)(1) 21210, 2120, 2200, 2210, 2230, 2231, 2240, 2310 6 1 6 -0.50 -3.00 -$804
35.57(a)(2) All 10 1 10 -0.50 -5.00 -$1,340
35.57(a)(3) 2210, 2120, 2200, 2210, 2230, 2231, 2240, 2310 6 1 6 -0.50 -3.00 -$804
35.57(b)(1) All 309 1 309 -0.50 -154.50 -$41,406
35.57(b)(2) All 26 1 26 -0.50 -13.00 -$3,484
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2200, 2231 2 1 2 0.50 1.00 $268
35.190(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 8 1 8 -0.50 -4.00 -$1,072
35.290(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 8 1 8 -0.50 -4.00 -$1,072
35.390(a) 2110, 2120, 2200, 2231 (Turnover) 4 1 4 -0.50 -2.00 -$536
35.392(a) 2110, 2120, 2200, 2231 (Turnover) 4 1 4 -0.50 -2.00 -$536
35.394(a) 2110, 2120, 2200, 2231 (Turnover) 4 1 4 -0.50 -2.00 -$536
35.433 No Additional Burden




$0
35.490(a) 2110, 2120, 2200, 2210, 2240 (Turnover) 4 1 4 -0.50 -2.00 -$536
35.690(a) 2110, 2230, 2300, 2310 (Turnover) 2 1 2 -0.50 -1.00 -$268
Total
2222
167
-902.50 -$241,870








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 @ $268/Hr
35.14(b)(1) All 213 1 213 0.25 53.25 $14,271
35.14(b)(6) 2120, 2200, 2230, 2240 2850 2 5,700 0.25 1,425.00 $381,900
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 -$804
35.3045(d) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 6 1 6 -8.00 -48.00 -$12,864
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 5 3 15 -2.00 -30.00 -$8,040
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220 6 1 6 0.25 1.50 $402
35.3204(b) 2110, 2120, 2121, 2200, 2201, 2220 6 1 6 2.00 12.00 $3,216
Total
3092
5,952
1,410.75 $378,081
















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 @ $268/Hr
30.34(g) 2500 1 6 6 0.50 3.00 $804
Total
1
6
3.00 $804
















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 @ $268/Hr
35.12(b) All (ARSO) 182 1 182 0.25 45.50 $12,194
35.12(b) All (copy) 182 1 182 -0.25 -45.50 -$12,194
35.12(c)(1) All (Renewals) 607 1 607 -0.25 -151.75 -$40,669
35.12(c)(1) All (Amendments) 6074 1 6,074 -0.25 -1,518.50 -$406,958
35.13(d) All (Turnover) 182 1 182 0.50 91.00 $24,388
35.13(d) All (Amendments) 607 1 607 0.50 303.50 $81,338
35.13(i) 2120, 2200, 2230, 2240 2850 2 5,700 -0.50 -2,850.00 -$763,800
35.50(a) All (Turnover) 55 1 55 -0.50 -27.50 -$7,370
35.50(c)(1) Subset of 35.50(a)




$0
35.50(c)(3) 2201 6 1 6 -0.50 -3.00 -$804
35.51(a) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 (Turnover) 35 1 35 -0.50 -17.50 -$4,690
35.55(a) 2110, 2120 (Turnover) 6 1 6 -0.50 -3.00 -$804
35.57(a)(1) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 34 1 34 -0.50 -17.00 -$4,556
35.57(a)(2) All 61 1 61 -0.50 -30.50 -$8,174
35.57(a)(3) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2310 34 1 34 -0.50 -17.00 -$4,556
35.57(b)(1) All 1822 1 1,822 -0.50 -911.00 -$244,148
35.57(b)(2) All 152 1 152 -0.50 -76.00 -$20,368
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2200, 2231 9 1 9 0.50 4.50 $1,206
35.190(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 45 1 45 -0.50 -22.50 -$6,030
35.290(a) 2110, 2120, 2121, 2200, 2201, 2220 (Turnover) 45 1 45 -0.50 -22.50 -$6,030
35.390(a) 2110, 2120, 2200, 2231 (Turnover) 22 1 22 -0.50 -11.00 -$2,948
35.392(a) 2110, 2120, 2200, 2231 (Turnover) 22 1 22 -0.50 -11.00 -$2,948
35.394(a) 2110, 2120, 2200, 2231 (Turnover) 22 1 22 -0.50 -11.00 -$2,948
35.433 No Additional Burden




$0
35.490(a) 2110, 2120, 2200, 2210, 2240 (Turnover) 25 1 25 -0.50 -12.50 -$3,350
35.690(a) 2110, 2230, 2300, 2310 (Turnover) 9 1 9 -0.50 -4.50 -$1,206
Total
13088
980
-5,318.75 -$1,425,425








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 @ $268/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) (17)





35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (14)





35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 2 1 2 2.50 5.00 $1,340 Inventory and leak testing 3 years
35.204(b) 2110, 2120 Covered under 35.2204 (847)





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





35.2024(c) From 35.24(b) (Turnover) 31 1 31 1.00 31.00 $8,308 5 years after ARSO is removed from license
35.2041 From 35.41(a) (Turnover) 31 1 31 9.00 279.00 $74,772 Duration of the license
35.2204 From 35.204(b) 42 1 42 13.00 546.00 $146,328 3 years
35.2310 From 35.610(d) 24 1 24 1.00 24.00 $6,432 3 years
Total
130
130
885.00 $237,180










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 @ $268/Hour Record Retention

Recordkeepers Burden Hours Period

30.34(g) 33 33 13 429 $114,972 3 years 

Total 33 33
429 $114,972

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 @ $268/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) (100)





35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (83)





35.65(b((2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 9 1 9 2.50 22.50 $6,030 Inventory and leak testing 3 years
35.204(b) 2110, 2120, 2121, 2200, 2201, 2220 Covered under 35.2204 (4997)





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





35.2024(c) From 35.24(b) (Turnover) 183 1 183 1.00 183.00 $49,044 5 years after ARSO is removed from license
35.2041 From 35.41(a) (Turnover) 183 1 183 9.00 1,647.00 $441,396 Duration of the license
35.2204 From 35.204(b) 250 1 250 13.00 3,250.00 $871,000 3 years
35.2310 From 35.610(d) 142 1 142 1.00 142.00 $38,056 3 years
Total
767
767
5,244.50 $1,405,526










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 @ $268/Hour Record Retention

Recordkeepers Burden Hours Period

30.34(g) 195 1 195 13 2,535.00 $679,380 3 years

Total 195
195
2,535.00 $679,380

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 @ $268/Hr
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 1 3 3 -2.00 -6.00 -$1,608
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220, 2500 2 1 2 0.25 0.50 $134
Total
3 4 5
-5.50 -$1,474
















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 @ $268/Hr
35.3045(e) 2110, 2120, 2200, 2210, 2230, 2231, 2240, 2300, 2310 5 3 15 -2.00 -30.00 -$8,040
35.3204(a) 2110, 2120, 2121, 2200, 2201, 2220, 2500 12 1 12 0.25 3.00 $804
Total
17 4 27
-27.00 -$7,236
































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 @ $268/Hr
35.13(d) All 1029 1 1,029 0.50 514.50 $137,886
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 8 1 8 0.50 4.00 $1,072
Total
1037
1037
518.50 $138,958
Annualized Total


345.67
172.83 $46,319








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 @ $268/Hr
35.13(d) All 6074 1 6,074 0.50 3,037.00 $813,916
35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 47 1 47 2.00 94.00 $25,192
Total
6121
6121
3,131.00 $839,108
Annualized Total


2040.33
1,043.67 $279,703

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 @ $268/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) (3365)




35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (2680)





35.41(c)
Covered in 35.2041





35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 50 1 50 2.00 100.00 $26,800 Inventory and leak testing 3 years
35.2024(c) From 35.24(b) 6074 1 6,074 1.00 6,074.00 $1,627,832 5 years after ARSO is removed from license
35.2041 From 35.41(a) 6045 1 6,045 9.00 54,405.00 $14,580,540 Duration of the license
Total


12,169.00
60,579.00 $16,235,172
Annualized Total




20,193.00 $5,411,724


















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 @ $268/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) (570)





35.41(b)(6) 2110, 2120, 2200, 2240 Covered in 35.41(a) (454)





35.41(c)
Covered in 35.2041





35.65(b)(2) 2110, 2120, 2121, 2200, 2201, 2220, 2231 8 1 8 2.00 16.00 $4,288 Inventory and leak testing 3 years
35.2024(c) From 35.24(b) 1029 1 1,029 1.00 1,029.00 $275,772 5 years after ARSO is removed from license
35.2041 From 35.41(a) 1024 1 1,024 9.00 9,216.00 $2,469,888 Duration of the license
Total


2,061.00
10,261.00 $2,749,948
Annualized Total




3,420.33 $916,649

Sheet 9: TOTAL BURDEN

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

Table 23:TOTAL BURDEN FOR FINAL RULE

Reporting Burden Recordkeeping Burden 3rd Party Disclosure Burden Total


Reporting Burden Recordkeeping Burden 3rd Party Disclosure Burden Total Cost at $268/hr
10 CFR Part 30 0.50 429.00 0.00 429.50

10 CFR Part 30 3.50 2,964.00 0.00 2,967.50 $795,290
10 CFR Part 35 238.25 885.00 -5.50 1,117.75

10 CFR Part 35 1,649.00 29,742.83 -32.50 31,359.33 $8,404,301
Form 313 -902.50 0.00 0.00 -902.50

Form 313 -5,004.75 0.00 0.00 -5,004.75 -$1,341,273
Total: -663.75 1,314.00 -5.50 644.75

Total: -3,352.25 32,706.83 -32.50 29,322.08 $7,858,318













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 2,535.00 0.00 2,538.00







10 CFR Part 35 1,410.75 5,244.50 -27.00 6,628.25







Form 313 -5,318.75 0.00 0.00 -5,318.75







Total: -3,905.00 7,779.50 -27.00 3,847.50




















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 2,964.00 0.00 2,967.50







10 CFR Part 35 1,649.00 6,129.50 -32.50 7,746.00







Form 313 -6,221.25 0.00 0.00 -6,221.25







Total: -4,568.75 9,093.50 -32.50 4,492.25




















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 3,420.33 3,420.33








Form 313 172.83 0.00 172.83








Total: 172.83 3,420.33 3,593.17





















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 20,193.00 20,193.00








Form 313 1,043.67 0.00 1,043.67








Total: 1,043.67 20,193.00 21,236.67





















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 23,613.33 23,613.33








Form 313 1,216.50 0.00 1,216.50








Total: 1,216.50 23,613.33 24,829.83









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 33 34 6 195 201 235
10 CFR Part 35 (OMB 3150-0010) 1,014 130 1,144 5,979 767 6,746 7,890
Form 313 (OMB 3150-0120) 513 0 513 3,020 0 3,020 3,533
Total:

1,691

9,967 11,658
















Table 25 – Total Respondents




Number of Respondents NRC Number of Respondents Agreement States Total











10 CFR Part 30 (OMB 3150-0017) 33 195 228



10 CFR Part 35 (OMB 3150-0010) 1,029 6,074 7,103



Form 313 (OMB 3150-0120) 1,029 6,074 7,103



Unduplicated total:

7,331



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






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