ML17236A380
| ML17236A380 | |
| Person / Time | |
|---|---|
| Issue date: | 08/24/2017 |
| From: | Office of Nuclear Security and Incident Response, NRC/OCIO |
| To: | |
| Shared Package | |
| ML17236A377 | List: |
| References | |
| Download: ML17236A380 (24) | |
Text
FINAL Supporting Statement, 10 CFR Part 26 Description of Data Element Value Unit FFD Drug & Alcohol (D&A) Testing Programs 28 FFD program D&A testing programs 26 FFD program Reactor Construction Site D&A testing programs 2
FFD program Number of Sites covered by an FFD D&A Testing Program 69 site Operating Reactors 59 site Reactors under Construction 2
site V.C. Summer (Units 2&3); Vogtle (Units 3&4)
Corporate Offices 5
site Duke, Exelon, Southern, TVA, and Xcel Fuel Cycle Facilities 2
site B&W, NFS Contractor/Vendor (C/V) 1 site INPO Drug Testing Laboratories Licensee Testing Facilities (LTFs) 6 LTF HHS-certified laboratories (HHS labs) 9 HHS lab Laboratory Testing 67 Number of sites using an LTF 6
LTF Number of sites only using an HHS-lab 61 HHS lab D&A Testing Program Data D&A Pgrm Construction Total Total Tests (all Reasons For Testing) 146,831 12,674 159,505 Pre-access 81,219 6,898 88,117 Random 57,476 4,653 62,128 For Cause 405 243 648 Post Event 480 375 855 Followup 7,250 505 7,756 Total Individuals with D&A testing violations (all Test Types) 826 253 1,079 Pre-access 568 147 715 Random 144 61 205 For Cause 56 32 88 Post Event 4
7 12 Followup 54 6
60 Total Testing violations (by results)
D&A Pgrm Construction Total Number of drug & alcohol positive, adulterated, substituted, and refusal to test results 826 253 1,079 Number of drug only positive, adulterated, substituted, and refusal to test results 621 217 838 D&A Pgrm Construction 103,933 7,634 Number of Reportable Events per Year (average 2013-2015) 2013 2014 2015 24-hour reports under 26.719(b) 37 report 26.719(b) hour event reports 40 38 33 30-day reports under 26.719(c) 8 report 26.719(c) day event reports 16 5
3 10 CFR 170.20 Average Cost per Professional Hour (2017)
$265 hourly rate Previous clearance = $272/hour Fatigue management programs 21 program FFD program performance data (2015)
Individuals subject to a random D&A testing program FFD program performance data (2013-2015)
Data Source FFD program performance data (2015) 2015 FFD program performance data Excludes DECON sites (Crystal River, Fort Calhoun, Kewaunee, San Onofre, Vermont Yankee)
FFD program performance data (2015)
FFD program performance data (2015)
FFD program performance data (average of 2013-2015)
FFD program performance data (average of 2013-2015)
FFD program performance data (average of 2013-2015)
Page 1 of 24
FINAL Supporting Statement, 10 CFR Part 26 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total +
All Sites 90,049 728 64,374 212 658 90 877 12 7,936 61 163,895 1,102 247 Construction sites 6,898 147 4,653 61 243 32 375 7
505 6
12,674 253 37 217 DECON sites 1,932 13 2,246 7
10 2
22 0
181 1
4,390 23 6
Sites w/o Construction & DECON 81,219 568 57,476 144 405 56 480 4
7,250 54 146,831 826 205 621 Results by Year Summary Results 2015 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total +
All Sites 88,593 790 64,755 225 654 106 1,016 17 8,380 60 163,398 1,198 248 Construction sites 6,395 130 6,179 86 276 49 535 13 703 9
14,088 287 35 DECON sites 2,014 16 1,556 5
4 1
18 0
108 1
3,700 23 4
Sites w/o Construction & DECON 80,184 644 57,020 134 374 56 463 4
7,569 50 145,610 888 209 679 Summary Results 2014 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total +
All Sites 92,368 762 64,689 221 694 83 897 13 7,942 54 166,590 1,133 255 Construction sites 8,414 191 4,957 63 266 33 392 7
510 1
14,539 295 46 DECON sites 1,243 4
1,994 11 10 4
16 0
154 0
3,417 19 8
Sites w/o Construction & DECON 82,711 567 57,738 147 418 46 489 6
7,278 53 148,634 819 201 618 Summary Results 2013 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total +
All Sites 89,187 631 63,678 190 627 80 718 5
7,487 69 161,697 975 238 Construction sites 5,886 120 2,822 34 186 15 197 2
303 7
9,394 178 29 DECON sites 2,538 19 3,187 6
17 0
32 0
280 2
6,054 27 5
Sites w/o Construction & DECON 80,763 492 57,669 150 424 65 489 3
6,904 60 146,249 770 204 566 Summary Results 2012 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total +
All Sites 101,438 765 67,943 205 724 86 883 7
8,147 50 179,135 1,113 255 Construction sites 4,675 102 2,819 31 237 14 157 2
276 4
8,164 153 25 DECON sites 2,873 12 3,402 8
30 3
24 0
372 2
6,701 25 7
Sites w/o Construction & DECON 93,890 651 61,722 166 457 69 702 5
7,499 44 164,270 935 223 712 Random For Cause Post-Event Followup Pre-Access Random For Cause Post-Event Followup Pre-Access Random For Cause Post-Event Followup Total Results without Alcohol Total Results without Alcohol Alcohol Totals Alcohol Totals Alcohol Totals Alcohol Totals Alcohol Totals Average Results (2013-2015)
FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Total Results without Alcohol Total Results without Alcohol Total Results without Alcohol Pre-Access Random For Cause Post-Event Followup Pre-Access Random For Cause Post-Event Followup Pre-Access Page 2 of 24
FINAL Supporting Statement, 10 CFR Part 26 FFD program performance data (2012-2015) - 2012 data used in previous clearance; 2013-2015 used in current clearance Average Population Subject to Random Testing 2012 2013 2014 2015 Average 2013-2015 All Sites 123,278 115,532 115,709 115,254 115,498 All sites (w/o Construction & DECON) 112,732 104,728 104,037 103,033 103,933 CONSTRUCTION V.C. Summer Units 2 and 3 1,642 1,950 3,064 3,802 Vogtle Units 3 and 4 2,736 3,099 5,037 5,950 4,378 5,049 8,101 9,752 7,634 DECOMMISSIONING Crystal River 1,544 922 592 392 Fort Calhoun 1,441 1,204 1,184 Kewaunee 829 495 295 205 San Onofre 2,934 1,899 723 688 Vermont Yankee 861 998 757 0
<< Is not reporting data since ceasing operations at the end of 2014 Total 6,168 5,755 3,571 2,469 3,932 Alcohol Positive Results 2012 2013 2014 2015 Total All Sites 255 238 255 248 Total All Sites w/o Construction & DECON 223 204 201 209 CONSTRUCTION V.C. Summer Units 2 and 3 10 18 21 18 Vogtle Units 3 and 4 15 11 25 17 Total 25 29 46 35 DECOMMISSIONING Crystal River 0
0 3
0 Fort Calhoun 0
3 1
4 Kewaunee 2
0 2
0 San Onofre 1
0 0
0 Vermont Yankee 4
2 2
0 Total 7
5 8
4 HHS-Certified Labs Performing Testing for Part 26 Licensees & Other Entities 2014 OMB Clearance (used 2012 FFD program performance data) 2017 OMB Clearance (used 2015 FFD program performance data) 1 Alere Toxicology 1 Alere Toxicology (Gretna, LA) 2 Clinical Reference Lab (Lenexa, KS) 2 Clinical Reference Lab (Lenexa, KS) 3 Drug Scan (Horsham, PA) 3 Drug Scan (Horsham, PA) 4 Laboratory Corporation of America (RTP, NC) 4 Laboratory Corporation of America (RTP, NC) 5 Laboratory Corporation of America 5 MedTox Laboratories (St. Paul, MN) 6 MedTox Laboratories (St. Paul, MN) 6 Quest Diagnostics (Lenexa, KS) 7 Quest Diagnostics (Lenexa, KS) 7 Quest Diagnostics (Norristown, PA) 8 Quest Diagnostics (Norristown, PA) 8 Quest Diagnostics (Atlanta, GA) 9 Quest Diagnostics (Tucker, GA) 9 Southwest Laboratories (Phoenix, AZ) 10 Quest Diagnostics (Atlanta, GA) 11 Southwest Laboratories (Phoenix, AZ) 12 not specified in hardcopy report Page 3 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Updated
- Duplicative
- Moved
- New
- Removed Section Number of Record-keepers Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized)
Number of Record-keepers Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized)
Updated 26.27(a): Develop FFD policy statement 0 107.0 0 112.0 Updated 26.27(a): Develop FFD procedures 0 213.0 0 212.0 Updated 26.29(a) and (b): Develop FFD training course and exam 0 96.3 0 100.0 Moved (to Table 4) 26.29(b): All current staff take FFD exam and FFD exam graded 0 400.4 Moved to Table 4 (Third-Party Disclosure Burden)
Moved (to Table 4) 26.29(c)(2): FFD training for current staff 0 4,710.7 Moved to Table 4 (Third-Party Disclosure Burden)
Updated 26.31(b)(1)(v): Develop behavioral observation program (BOP) procedures Burden accounted for under 26.27 (0 programs)
Burden accounted for under 26.27(a)
NEW 26.31(d)(1)(i)(C): Develop rigorous testing procedures to ensure that the MRO can evaluate the use of substances not included in the NRC-required testing panel (if additional substance testing is performed)
Not included in previous clearance Burden accounted for under 26.27(a)
Moved (from Table 2) 26.31(d)(1)(i)(D) and (d)(1)(ii): Documentation of forensic toxicologist review and certification of additional drug(s) to be included in the licensee or other entity's drug testing panel Previously accounted for in Table 2 as Annualized Burden 3.0 5.3 16.0 16.0 Duplicative Burden 26.31(d)(1)(iii): Document additional drugs in testing panel 0 0.3 Burden accounted for in section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C)
Moved (from Table 2) 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C): Documentation of forensic toxicologist review and certification of lower drug testing cutoff levels than specified by Part 26, and inclusion of cutoff levels in the FFD policy and procedures Previously accounted for in Table 2 as Annualized Burden 3.0 5.3 16.0 16.0 Updated 26.37(a): Develop a system of files and procedures to protect personal information collected under Part 26 0 2.7 0 24.0 REMOVED 26.37(b): Obtain signed consent for release of information 0 98.1 REMOVED
[covered by Table 2 - 26.37(b)]
Updated 26.39(a) and (b): Develop procedures for the review of a determination that an individual has violated the FFD policy 0 13.3 0 120.0 Updated 26.85(a): Develop urine collector qualification training 0 5.3 0 13.3 Updated 26.85(b): Develop alcohol collector qualification training 0 5.3 0 5.3 Updated 26.127(a) - (e): Develop LTF procedures for specimen handling and chain-of-custody, assays performed, instrument and test setup, and remedial actions for systems and testing devices 0 80.0 0 80.0 Updated 26.137(a): Develop LTF procedures for quality assurance/
quality control (QA/QC) program 0 13.3 0 13.3 Moved (from Table 2) 26.153(e): Record of pre-award inspection of new HHS lab (completed prior to awarding contract for testing services)
Previously accounted for in Table 2 as Annualized Burden 3.0 13.3 40.0 40.0 Moved (from Table 2) 26.153(f): Record that Part 26 specified requirements included in a licensee's or other entity's contract with a new HHS lab Previously accounted for in Table 2 as Annualized Burden 3.0 13.3 40.0 40.0 Updated 26.155(a)(1), (a)(3) - (a)(5); (b),(c), (e), and (f):
Confirm HHS lab personnel qualifications and procedures place pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 0 2.7 Burden accounted for under 26.153(e)
Updated 26.157(a) - (e): Confirm HHS lab procedures in place for accession, receipt, shipment, and testing of specimens pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 0 2.7 Burden accounted for under 26.153(e)
Updated 26.159(a), (c), (e), (f): Confirm HHS lab procedures for specimen security, chain of custody, and preservation in place pursuant to HHS laboratory certification requirements also meet Part 26 requirements (new HHS lab) 0 2.7 Burden accounted for under 26.153(e) 26.203(a): Prepare fatigue management policy (In addition to 26.27 burden) 2.0 7.3 14.6 0 7.3 (14.6) 26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden) 2.0 1.7 3.4 0 1.7 (3.4) 26.203(c): Prepare training on fatigue management.
2.0 2.0 4.0 0 2.0 (4.0) 26.205(b): Develop work hour tracking system 2.0 7.7 15.4 0
7.7 (15.4) 26.205(c): Develop individual work scheduling system 2.0 2.0 4.0 0 2.0 (4.0)
Updated 26.401(b): Prepare a reactor construction site D&A testing program plan 0 60.0 Burden accounted for under section 26.403(a) and (b)
Updated 26.403(a): Develop FFD policy statement (reactor construction site D&A testing program) 0 107.0 0 112.0 Moved (to Table 2) 26.403(a): Distribute FFD policy statement to subject individuals (reactor construction site D&A testing program) 0 5.0 Moved to Table 2 Updated 26.403(b): Develop written FFD procedures (reactor construction site D&A testing program) 0 213.0 0 216.0 Moved (from Table 2) 26.405(d): Record of testing for specified drugs, adulterants, and alcohol, at Part 26 specified cutoff levels Previously accounted for in Table 2 as Annualized Burden Burden accounted for under section 26.403(a)
NEW 26.405(e): Develop specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the specimen, and stringent quality controls to ensure accurate test results Previously accounted for in Table 2 as Annualized Burden Burden accounted for under section 26.403(b)
Extension (2017-2020)
Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Table 1: One Time Recordkeeping Burden Estimate Change Page 4 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Updated
- Duplicative
- Moved
- New
- Removed Section Number of Record-keepers Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized)
Number of Record-keepers Burden Hrs per Recordkeeper (Annualized)
Total Burden Hrs (Annualized)
Extension (2017-2020)
Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Table 1: One Time Recordkeeping Burden Estimate Change Updated 26.406(a), (b), and (d): Develop a fitness monitoring program (applies if reactor construction site D&A testing program does not conduct random testing) 0 26.7 0 40.0 Updated 26.406(c): Develop procedures for fitness monitors (applies if reactor construction site D&A testing program does not conduct random testing) 0 40.0 0 40.0 Updated 26.407: Develop procedures for behavioral observation (reactor construction site D&A testing program) 0 40.0 0 40.0 NEW 26.411(a): Develop procedures for maintaining a system of files to protect personal information collected under Subpart K of Part 26 Not included in previous clearance 0 40.0 Updated 26.413: Develop procedures for the review of a determination that an individual violated the FFD policy (reactor construction site D&A testing program) 0 120.0 0 120.0 Moved (from Table 2) 26.713(g): Documentation on testing for additional drugs as permitted under section 26.31(d)(1), use of more stringent testing cutoff levels as permitted under section 26.31(d)(3), or both.
Previously accounted for in Table 2 as Annualized Burden Burden accounted for under section 26.31(d)(1)(i)(D) and (d)(1)(ii), and section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c)
Table 1: Total 41.4 112.0 70.6 Page 5 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Updated 26.4(j):For personnel granted authorization by a licensee, who are covered by the D&A testing program regulated by a State or Federal agency - (1) record of training that demonstrates section 26.29(a) training requirements met (if not already covered by the program); (2) record of notice of any FFD policy violation 30.5 2.0 61.0 33.5 2.0 67.0 6.0 Updated 26.27(b): Make FFD policy statement readily available to subject personnel 28.0 4.0 112.0 26.0 16.0 416.0 304.0 Updated 26.27(c): Updates to FFD policy and procedures 28.0 8.0 224.0 26.0 80.0 2,080.0 1,856.0 Updated 26.27(d): Provide FFD policy and procedures to NRC for review (performed during periodic inspections) 28.0 4.0 112.0 26.0 4.0 104.0 (8.0)
Updated 26.29(b): Record of training completion (initial training on FFD policy) and results of comprehensive examination 28.0 2.0 56.0 26.0 104.1 2,707.3 2,651.3 Updated 26.29(c)(2): Record of training completion (annual refresher training on FFD policy) 28.0 2.0 56.0 26.0 133.2 3,464.4 3,408.4 26.29(d): Record acceptance of FFD training from other licensees' programs 28.0 4.0 112.0 26.0 4.0 104.0 (8.0)
Updated 26.31(b)(1)(i): Records of background investigations, credit and criminal history checks, and psychological assessments of checks for performed on individuals designated as FFD personnel 28.0 17.5 490.0 26.0 16.0 416.0 (74.0)
Duplicative Burden 26.31(b)(1)(v): Record results of behavioral observation for FFD program personnel 28.0 80.0 2,240.0 Burden accounted for under section 26.189(c)
(2,240.0)
Moved (to Table 1) 26.31(d)(1)(i)(D): Document analysis and certification for testing of drugs not included in the NRC minimum testing panel 2.3 4.0 9.2 Moved to Table 1 (9.2)
Moved (to Table 1) 26.31(d)(2)(ii): Document licensee additions to tested drugs 2.3 8.0 18.4 Moved to Table 1 (18.4)
NEW 26.31(d)(3)(ii): Document LTF technician qualifications to perform validity and drug tests.
Not included in clearance Burden accounted for under section 26.125(b) and (c)
Moved (to Table 1) 26.31(d)(3)(iii)(A): Document more stringent cutoff levels 2.0 8.0 16.0 Moved to Table 1 (16.0)
Moved (to Table 1) 26.31(d)(3)(iii)(C): Document evaluation and certification of more stringent cutoff levels 2.0 8.0 16.0 Moved to Table 1 (16.0)
REMOVED 26.31(d)(6): Donor provides written permission to conduct another analysis or test on a specimen
- 1.0 -
Removed.
This is a testing limitation provision and does not have a corresponding recordkeeping or reporting burden.
Duplicative Burden 26.33: Behavioral observation records 28.0 400.0 11,200.0 Burden accounted for under section 26.189(c)
(11,200.0)
Moved (to Table 4) 26.35(a): Employee assistance program (EAP) records 28.0 16.0 448.0 Moved to Table 4 (448.0)
Updated 26.35(c): Record of written waiver of right to privacy from individuals given to the Employee Assistance Program (EAP) 28.0 2.0 56.0 13.0 2.0 26.0 (30.0)
Updated 26.35(c): Record of EAP disclosure to a licensee or other entity that an individual poses an immediate hazard, or who has waived in writing the right to privacy 14.0 1.0 14.0 13.0 1.0 13.0 (1.0)
Updated 26.37(b)(1): Record of signed consent from individual to disclose information collected under Part 26 to the individuals representative on an FFD matter 28.0 40.0 1,120.0 26.0 2.5 64.5 (1,055.5)
Updated 26.37(c): Record of signed release from subject individual to disclose personal information collected under Part 26 to other licensees or other entities 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0)
Updated 26.37(d): FFD management provides records to individual on an FFD violation 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0)
Duplicative Burden 26.39(a): Maintain procedures for the review of FFD violation determinations 28.0 40.0 1,120.0 Burden accounted for under section 26.27(c)
(1,120.0)
NEW 26.39(b): D&A testing program provides notice to an individual of the grounds of an FFD policy violation determination and review procedures Not included in clearance 26.0 87.3 2,270.6 2,270.6 Updated 26.39(d): If a review of an FFD violation finds in favor of the individual, the licensee or other entity updates records (delete or correct information found to be inaccurate) 28.0 40.0 1,120.0 6.0 16.0 96.0 (1,024.0)
Updated 26.39(e): C/V with a D&A testing program provides review procedures to each individual that has violated the FFD policy - 0.5 - 1.0 0.5 0.5 0.5 26.41(a), (b), and (c): Record of audits Burden accounted for under section 26.41(f)
Burden accounted for under section 26.41(f) and (g) 26.41(d): Record of review of C/V audit results 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) 26.41(f): Document and report audit results 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0)
Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Page 6 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.41(g): Sharing of audit reports - D&A testing programs may jointly conduct audits or accept audits of C/Vs and HHS labs conducted by other D&A testing programs (if the audit addresses the same services utilized by each program) 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0)
Updated 26.53(e)(2): Record that C/Vs informed licensee of the denial or termination of an individual's authorization 1.0 120.0 120.0 1.0 13.0 13.0 (107.0) 26.53(g): Record that CVs and other licensees informed of Part 26 violations 7.0 8.0 56.0 0 8.0 (56.0)
Updated 26.53(h): Obtain and retain written consent from each individual before initiating any actions under Subpart C of Part 26 28.0 1,677.0 46,956.0 26.0 156.2 4,061.0 (42,895.0)
Updated 26.53(i): Individual applying for authorization is informed in writing of the reason(s) for denial or termination of authorization 28.0 23.3 652.4 26.0 21.8 567.7 (84.7)
Updated 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update 26.59(a)(1) - (a)(2): Authorization reinstatement For each individual applying for authorization, a record of a completed self-disclosure, employment history, and suitable inquiry is maintained Burden accounted for under sections 26.61 and 26.63 Burden accounted for under sections 26.61(a), (a)(1), and (a)(2),
and 26.63 (a), (c), and (e)
Updated 26.59(c)(1): Obtain, review, and retain an applicants self-disclosure Burden accounted for under section 26.61 Burden accounted for under section 26.61(a), (a)(1) and (a)(2)
Updated 26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an applicants written self-disclosure and employment history 28.0 1,197.0 33,516.0 26.0 1,561.9 40,609.7 7,093.7 NEW 26.61(b) and (c): Specify the information to be collected in the self-disclosure and employment history Not included in clearance Burden accounted for under section 26.61(a), (a)(1) and (a)(2)
Updated 26.63(a), (c), and (e): Obtain, review, and retain an applicants suitable inquiry 28.0 1,197.0 33,516.0 26.0 1,561.9 40,609.7 7,093.7 Updated 26.63(c)(2): Obtain, review, and retain information on an applicants U.S. military service (i.e., form DD 214) 28.0 4.0 112.0 26.0 4.0 104.0 (8.0)
Updated 26.63(c)(3): Document inability to obtain information from an applicants past employer(s) 28.0 2.7 75.6 26.0 3.0 78.0 2.4 26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD programs 28.0 1.0 28.0 26.0 1.0 26.0 (2.0)
NEW 26.63(f): Specifies the time periods that a suitable inquiry must cover (for initial authorization, authorization update, and authorization reinstatement)
Not included in clearance Burden accounted for under section 26.63(a), (c) and (e) 26.65(d) and (e): Record of reinstatement or administrative withdrawal of authorization 28.0 4.0 112.0 26.0 4.0 104.0 (8.0)
Updated 26.65(f): Authorization reinstatement after an interruption --
record of administrative withdrawal of authorization under section 26.65(d)(1)(ii) or (e)(2)(iii)(B) 28.0 1.0 28.0 26.0 1.0 26.0 (2.0)
Duplicative Burden 26.67 Record of random D&A testing of persons who have applied for authorization and who have received a pre-access test, but who have yet to be granted authorization 28.0 5.5 154.0 Burden accounted for under section 26.183(d)(2)(i)
(154.0)
Updated 26.69(b) and (c)(1): Authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified
-- obtain, review, and retain an applicants self-disclosure and employment history Burden accounted for under section 26.713(a)(1)
Burden accounted for under section 26.61(a)
Updated 26.69(c)(2): Record that the licensee or other entity identified and resolved PDI (not reviewed and favorably resolved by a previous licensee or other entity) 28.0 40.0 1,120.0 26.0 62.5 1,624.4 504.4 Updated 26.69(c)(3): Record that the licensee or other entity verified that an applicant with a prior FFD testing violation (i.e., a 5-year denial for a 2nd positive result) has abstained from substance abuse for at least 5 years 28.0 40.0 1,120.0 Burden accounted for under section 26.69(c)(4)
(1,120.0)
Updated 26.69(c)(4): Record that an SAE conducted a determination of fitness and concluded that an applicant with PDI is fit to safely and competently perform duties (i.e., evaluated clinically appropriate treatment and followup testing plans were developed by an SAE -- for an applicant with a prior 1st positive result; ensured treatment recommendations and followup testing from an SAEs determination of fitness are initiated -- for an applicant with a prior 2nd positive result; or verified the applicant is in compliance with and successfully completed any followup testing and treatment plans) 28.0 3.0 84.0 26.0 40.0 1,040.0 956.0 Updated 26.69(c)(5): Record of negative results for pre-access D&A testing (needed prior to granting authorization) 28.0 1.0 28.0 26.0 52.1 1,353.7 1,325.7 Updated 26.69(d): Record of reviewing officials determination on an applicants request for access authorization 28.0 24.0 672.0 26.0 24.0 624.0 (48.0)
Page 7 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.69(e): Record that follow-up testing and treatment plan for an applicant from the D&A testing program of another licensee or other entity has been verified (that is treatment and follow-up testing successfully completed) 28.0 8.0 224.0 26.0 8.0 208.0 (16.0)
Updated 26.69(e)(1): Record that information transmitted on testing and treatment plans to other FFD programs (at donor request) 28.0 8.0 224.0 26.0 8.0 208.0 (16.0)
Consolidated 26.75(a) - (e), and (g): Records of sanctions for FFD violations 28.0 12.0 336.0 Burden accounted for under section 26.39(b)
(336.0)
Updated 26.75(h): Record that an individuals authorization was administratively withdrawn due to impairment confirmed under section 26.189, or because the individual posed a safety hazard 28.0 18.0 504.0 26.0 15.6 405.3 (98.7)
Updated 26.75(i): Record of temporary administrative withdrawal of an individual's authorization due to an initial positive test result for marijuana and/or cocaine at an LTF 28.0 80.0 2,240.0 0
80.0 (2,240.0)
Updated 26.75(i)(3): Eliminate from an individuals record any references to a temporary administrative withdrawal of authorization due to an initial positive marijuana and/or cocaine test result at an LTF that did not confirm positive after testing at an HHS lab 28.0 1.0 28.0 0
1.0 (28.0)
Updated 26.85(a) and (b): Training of urine and alcohol collectors and maintain training records in personnel files 28.0 8.0 224.0 26.0 8.0 208.0 (16.0)
Updated 26.87(d)(3): If a collection site cannot be dedicated solely to collecting specimens, secure the portion of the facility when a specimen collection is in process and post a sign indicating access permitted only to authorized personnel 28.0 1.0 28.0 26.0 1.0 26.0 (2.0)
Updated 26.87(f)(1) and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom used) and document on the custody-and-control form (CCF) the name of a same gender observer (in the exceptional event that a designated collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 28.0 2.0 56.0 2.0 0.5 1.0 (55.0)
Updated 26.89(a): Collector notifies FFD management that a donor failed to report to the collection site 28.0 1.0 28.0 4.0 0.25 1.0 (27.0) 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-testing form obtained 28.0 1.5 42.0 26.0 1.5 39.0 (3.0)
Updated 26.89(b)(3): Record that FFD management informed that an individual did not present identification (pre-access testing) 28.0 1.0 28.0 26.0 1.0 26.0 (2.0)
Consolidated 26.89(c): Collector documents on CCF a donor's refusal to cooperate with the collection process 28.0 1.0 28.0 Burden accounted for under section 26.107(b)
(28.0)
Updated 26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT) device test results Burden accounted for under section 26.715(b)(2)
Burden accounted for under section 26.715(b)(2) 26.91(e)(4): Record that results cancelled after EBT calibration check failure
- 6.0 -
0 6.0 Updated 26.91(e)(5): EBT maintenance records 28.0 6.0 168.0 26.0 6.0 156.0 (12.0)
Updated 26.93(a)(6): Document that alcohol pre-test questions communicated to the donor 28.0 80.0 2,240.0 26.0 47.1 1,223.6 (1,016.4) 26.95(b)(5): Record donor identity for initial alcohol breath test 28.0 80.0 2,240.0 26.0 47.1 1,223.6 (1,016.4)
Updated 26.97(b)(2): Record reason for new oral fluid alcohol test
- 5.0 -
0 0.25 Updated 26.97(c)(1): Document reason for failure of 2nd collection attempt
- 2.5 -
0 0.25 26.97(d): Record results and alcohol screening device used
- 0.25 -
0 0.25 Updated 26.99(b): Record time of initial alcohol test of 0.02 percent or higher blood alcohol concentration (BAC)
Burden accounted for under section 26.715(b)(2)
Burden accounted for under section 26.715(b)(2)
Duplicative Burden 26.101(b)(7): Record time and BAC result of confirmatory alcohol test Burden accounted for under section 26.715(b)(2)
Updated 26.103(b): Record that FFD management notified of a confirmatory alcohol test result of 0.01 to 0.02 percent BAC 8.0 0.25 2.0 8.0 0.25 2.0 Updated 26.107(b): Collector documents on CCF any donor conduct during collection process indicating an attempt to tamper with a specimen, and notifies FFD management 28.0 0.1 2.8 26.0 0.25 6.5 3.7 Updated 26.109(b)(3): Collector documents on CCF that the donor was unable to provide a specimen in the 3-hour time allotted (i.e., a shy bladder), and notifies FFD management 28.0 0.5 14.0 26.0 0.25 6.5 (7.5)
Page 8 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Consolidated 26.109(b)(4): Collector documents on CCF if a specimen (less than 30 mL) appears to be tampered with and/or donor behavior during collection indicated a possible subversion attempt, and notifies FFD management 28.0 0.3 8.4 Burden accounted for under section 26.107(b)
(8.4)
Consolidated 26.111(b): Collector documents on CCF if specimen characteristics (color, clarity) indicate possible tampering by the donor 4.0 0.3 1.0 Burden accounted for under section 26.107(b)
(1.0)
Consolidated 26.111(c): Collector documents on CCF unusual specimen temperature and/or observations during the collection indicating possible tampering, and notifies FFD management.
28.0 0.3 8.4 Burden accounted for under section 26.107(b)
(8.4)
Updated 26.113(b)(3): Collector completes CCF for split-specimen collection 28.0 0.3 8.4 Burden accounted for under section 26.117(c) - (e)
(8.4)
Updated 26.115(b): Collector documents on CCF approval from FFD manager or MRO to collect a specimen under direct observation 28.0 0.5 14.0 26.0 0.5 13.0 (1.0)
Duplicative Burden 26.115(d): Collector documents on CCF that observed collection performed and reason for the observed collection 28.0 0.3 8.4 Burden accounted for under section 26.115(b)
(8.4)
Duplicative Burden 26.115(f)(3): Collector documents on CCF the name of observer of directly observed collection 28.0 0.3 8.4 Burden accounted for under section 26.115(b)
(8.4)
Updated 26.117(c) - (e): Collector prepares ID labels and CCF forms for specimen shipment 28.0 60.0 1,680.0 26.0 188.2 4,894.4 3,214.4 Updated 26.119(a), (e), and (f): Written evaluation from the physician who performed a medical evaluation of a donor with a shy bladder (i.e., unable to provide a specimen of adequate volume in the allotted 3-hours) 28.0 6.0 168.0 13.0 2.0 26.0 (142.0)
Updated 26.119(b): Record that MRO provided information and instructions to the physician who is to perform the examination of a donor with a shy bladder 28.0 2.0 56.0 13.0 1.0 13.0 (43.0)
Updated 26.125(b) and (c): Records on the proficiency and qualifications of LTF personnel 7.0 16.0 112.0 6.0 16.0 96.0 (16.0)
Updated 26.127 (a) - (e): Maintain LTF written procedures on the handling of specimens, chain-of-custody procedures, testing assays, instrument and device setup, and remedial actions for systems and testing devices.
7.0 200.0 1,400.0 6.0 40.0 240.0 (1,160.0)
Updated 26.129(a): Maintain documentation of access to secure areas of an LTF by all authorized individuals (i.e., an access log) 7.0 2.5 17.5 6.0 4.0 24.0 6.5 Updated 26.129(b): LTF inspects specimen packages, CCFs, and obtains memorandum from specimen collectors to correct identified discrepancies 7.0 0.5 3.5 6.0 0.5 3.0 (0.5)
Updated 26.129(b)(1): LTF record of report to senior licensee or other entity management of attempts to tamper with specimens in transit 7.0 1.0 7.0 0 1.0 (7.0) 26.129(d): LTF procedures for tracking CCF of specimens 7.0 80.0 560.0 6.0 80.0 480.0 (80.0)
Updated 26.135(b): LTF record of direction from MRO to send Bottle B of a split specimen to a second HHS lab for testing 7.0 2.2 15.4 6.0 0.5 3.0 (12.4) 26.137(a): Record of a QA/QC program and procedures for LTF 7.0 4.0 28.0 6.0 4.0 24.0 (4.0)
Updated 26.137(b)(1)(ii): LTF documentation of performance testing of a device not approved by SAMHSA for point-of-collection testing 2.0 40.0 80.0 0 40.0 (80.0)
Updated 26.137(b)(1)(iii): LTF documentation of annual test results for a device not approved by SAMHSA for point-of-collection testing 2.0 20.0 40.0 0 20.0 (40.0)
Updated 26.137(b)(3): LTF records submitting 1 in 10 specimens that test negative on validity screening testing are sent to an HHS lab as part of the LTF's QA program 7.0 40.0 280.0 0 40.0 (280.0)
NEW 26.137(d)(6): LTF records that 1 in 10 specimens that test negative on initial validity testing are sent to an HHS lab for testing as part of the LTFs QA program Not included in clearance 6.0 40.0 240.0 240.0 Duplicative Burden 26.137(e)(7): LTF documented procedures to protect against carryover material 7.0 2.0 14.0 Burden accounted for under section 26.127 (a) - (e)
(14.0)
Updated 26.137(f)(5): LTF records on testing errors 7.0 24.0 168.0 6.0 8.0 48.0 (120.0)
Updated 26.137(h): LTF labeling of standards and controls 7.0 65.0 455.0 6.0 40.0 240.0 (215.0)
Updated 26.139(d): Record that the LTF prepared a summary of test results for inclusion in the FFD annual program performance report submitted under section 26.717 7.0 40.0 280.0 6.0 40.0 240.0 (40.0)
Moved (to Table 1) 26.153(e): Record of pre-award inspection of new HHS lab (completed prior to awarding contract for testing services) 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)
Moved (to Table 1) 26.153(f): Records that Part 26 specified requirements included in contract with HHS lab 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)
Page 9 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.153(g): Record of memorandum sent to the HHS lab explaining use of non-federal CCF form 28.0 0.5 14.0 26.0 0.5 13.0 (1.0)
Updated 26.159(b)(1): Record that the licensee or other entity received noticed from an HHS lab within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the lab identifying evidence of tampering with specimen.
28.0 1.0 28.0 0
1.0 (28.0) 26.159(i): Record of written authorization to store specimens other than 1 year 28.0 0.5 14.0 26.0 0.5 13.0 (1.0)
Duplicative Burden 26.163(a)(2): Record that special analyses testing conducted on a dilute specimen and report of the test results 28.0 1.0 28.0 Burden accounted for under section 26.169(c)(1)
(28.0)
Duplicative Burden 26.165(b)(1): Record of a donor request for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab 28.0 1.0 28.0 Burden accounted for under section 26.165(b)(6)
(28.0)
Duplicative Burden 26.165(b)(2): Record that MRO informed the donor of the opportunity to request the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab 28.0 0.5 14.0 Burden accounted for under section 26.185(c)
(14.0)
Updated 26.165(b)(3): Donor's written permission provided to the MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab Burden accounted for under section 26.165(b)(1)
Burden accounted for under section 26.165(b)(6)
Duplicative Burden 26.165(b)(4): Record that the donor presented documentation to the MRO on the inability to submit a timely request to initiate specimen retesting at a second HHS lab 6.0 0.2 1.2 Burden accounted for under section 26.185(c)
(1.2)
Updated 26.165(b)(6): MRO reviews HHS lab results on the retesting of an aliquot of a single specimen or testing of the Bottle B split specimen, informs the donor of the results, and notified FFD management 28.0 3.0 84.0 26.0 1.2 31.1 (53.0)
Updated 26.165(c)(4): Results report received from the second HHS lab that performed retesting an aliquot of a single specimen or the testing of the Bottle B split specimen 12.0 2.5 30.0 Burden accounted for under section 26.165(b)(6)
(30.0)
Updated 26.165(f)(1): Adjustments to personnel files and written notifications regarding the results of retesting an aliquot of a single specimen or testing of the Bottle B split specimen, including temporary administrative action 28.0 6.0 168.0 0
6.0 (168.0)
Updated 26.165(f)(1)(iv) and (f)(2): Written record and notice that records purged of references to temporary administrative action 28.0 8.0 224.0 0
8.0 (224.0)
Updated 26.167(f)(3): Record received from the Responsible Person of an HHS lab on a false positive BPTS testing error (determined to be technical or methodological),
demonstrating that retesting of all positive, adulterated, substituted, and invalid specimens from the time of final resolution of the error back to the time of the last satisfactory performance test cycle has been completed 12.0 1.0 12.0 0
1.0 (12.0)
NEW 26.168(a) Maintain documentation of HHS lab certification of BPTS formulation Not included in clearance 26.0 2.6 67.0 67.0 Moved (from Table 4) 26.168(i)(2): Licensee or other entity completes CCF for a BPTS, places fictional initials on specimen labels, and indicates on the MRO copy of the CCF that the specimen is a BPTS Moved from Table 4 26.0 34.4 893.3 893.3 Updated 26.169(a): Records of reports of test results from the HHS lab Burden covered under section 26.169(c)(1) through (c)(5)
Burden accounted for under section 26.183(c)(1)
Duplicative Burden 26.169(c)(1): Records of HHS lab reports of positive, adulterated, substituted, dilute, and invalid test results received by the MRO 12.0 80.0 960.0 Burden accounted for under section 26.183(c)(1)
(960.0)
Duplicative Burden 26.169(c)(2): Records of HHS lab reports of the numerical values of all positive drug test results (i.e., quantitative test results requested by MRO) 12.0 1.0 12.0 Burden accounted for under section 26.183(c)(1)
(12.0)
Duplicative Burden 26.169(c)(2): Records of HHS lab reports of quantitative test results for opiates 12.0 0.5 6.0 Burden accounted for under section 26.183(c)(1)
(6.0)
Duplicative Burden 26.169(c)(3): Records of HHS lab reports of quantitative test results for adulterated or substituted test results 12.0 2.5 30.0 Burden accounted for under section 26.183(c)(1)
(30.0)
Duplicative Burden 26.169(c)(4): Record of MRO contact with HHS lab to discuss whether testing by another HHS lab should be conducted on a specimen with an invalid result 12.0 2.0 24.0 Burden accounted for under section 26.185(f)(1)
(24.0)
Duplicative Burden 2.0 1.0 2.0 Burden accounted for under section 26.183(c)(1)
(2.0)
Updated 26.169(f): Records of HHS lab transmittals of CCF copies for negative results to the MRO 12.0 109.5 1,314.0 26.0 47.1 1,223.6 (90.4)
Page 10 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Duplicative Burden 26.169(g): HHS lab copy of the original CCF for each positive, adulterated, substituted, dilute, and invalid test results to the MRO 12.0 44.7 536.4 Burden accounted for under section 26.169(c)(1)
(536.4)
Updated 26.169(h): Record of HHS lab statistical summary report of urinalysis testing results (for the calendar year) 12.0 40.0 480.0 26.0 2.0 52.0 (428.0)
Updated 26.183(a): Documentation of MRO qualifications 28.0 3.5 98.0 26.0 4.0 104.0 6.0 Updated 26.183(c)(1): MRO review of HHS lab test result record for positive, adulterated, substituted, invalid, or at the licensee's or other entity's discretion, dilute specimen 28.0 19.1 534.8 26.0 2.0 51.8 (483.1)
Updated 26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug positive, adulterated, substituted, or refusal to test result to the licensees designated reviewing official 28.0 19.1 534.8 26.0 2.0 51.8 (483.1)
Updated 26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results to FFD management 28.0 292.2 8,181.6 26.0 282.4 7,341.5 (840.1)
Updated 26.183(d)(2)(ii): Record of MRO staff review of CCFs for positive, adulterated, substituted and invalid results and forwards changes to MRO for review 28.0 1.9 53.2 26.0 2.4 62.1 8.9 Updated 26.185(a) Record of MRO review of a drug positive, adulterated, substituted, dilute, or invalid HHS lab test result 28.0 26.0 728.0 Burden accounted for under section 26.183(c)(1)
(728.0)
Updated 26.185(c): Record of MRO discussion of positive, adulterated, substituted, dilute, or invalid test result with donor 28.0 26.0 728.0 26.0 11.9 310.5 (417.5)
Duplicative Burden 26.185(d)(1): Documentation that donor declined to discuss test results with MRO 28.0 2.0 56.0 Burden accounted for under section 26.185(c)
(56.0)
Updated 26.185(e): Documentation reviewed by the MRO on a donors inability to discuss test results and a request to reopen proceeding 28.0 0.3 8.4 26.0 0.5 13.0 4.6 Updated 26.185(f)(1): Record of MRO consultation with HHS lab to determine whether additional testing needed for an invalid specimen 28.0 0.5 14.0 26.0 0.5 13.0 (1.0)
Duplicative Burden 26.185(f)(2): Record of MRO contact with donor about an invalid test result, and medical information received 28.0 0.5 14.0 Burden accounted for under section 26.185(c)
(14.0)
Duplicative Burden 26.185(h)(1): Record of MRO contact with donor about a substituted test result, and medical information received 28.0 2.0 56.0 Burden accounted for under section 26.185(c)
(56.0)
Duplicative Burden 26.185(h)(2): Record of MRO confirmation of a substituted test result (no legitimate medical explanation) 28.0 2.0 56.0 Burden accounted for under section 26.183(d)(1)(ii)(D)
(56.0)
Duplicative Burden 26.185(h)(3): MRO record of determination of a legitimate medical explanation for a substituted test result 28.0 1.0 28.0 Burden accounted for under section 26.183(d)(2)(i)
(28.0)
Duplicative Burden 26.185(i)(1): Record of MRO contact with donor about an adulterated test result, and medical information received 28.0 2.0 56.0 Burden accounted for under section 26.185(c)
(56.0)
Duplicative Burden 26.185(i)(2): Record of MRO confirmation of an adulterated test result (no legitimate medical explanation) 28.0 2.0 56.0 Burden accounted for under section 26.183(d)(1)(ii)(D)
(56.0)
Duplicative Burden 26.185(i)(3): MRO record of determination of a legitimate medical explanation for an adulterated test result 28.0 1.0 28.0 Burden accounted for under section 26.183(d)(2)(i)
(28.0)
Updated 26.185(j): Prescription medication drug positives (applies to amphetamine, morphine, and codeine results) - records of MRO review of HHS lab result, discussion of positive result with donor, and review medication information from the donor 28.0 1.5 42.0 26.0 2.3 60.0 18.0 Duplicative Burden 26.185(k): Record of MRO report to licensee that no FFD policy violation has occurred (i.e., legitimate prescription medication used in a manner and at the dosage prescribed).
If the individual poses a potential risk to public health and safety because of impairment while on duty - the MRO will ensure that a determination of fitness is performed) 28.0 1.0 28.0 Burden accounted for under sections 26.183(d)(2)(i) and 26.185(c)
(28.0) 26.185(m): Record of MRO review of inspection and audit reports, QC data, multiple specimens, and other data to determine if positive, adulterated, substituted, or invalid result is scientifically insufficient for determination of FFD policy violation 28.0 1.0 28.0 26.0 1.0 26.0 (2.0)
Updated 26.185(n): Record of MRO review of a positive, adulterated or substituted test result from a second HHS lab (results of retesting a single specimen or testing of a Bottle B split specimen), and MRO communication of the test result to the donor, and report results to FFD management 28.0 2.0 56.0 26.0 0.60 15.5 (40.5)
Updated 26.185(o): Record of MRO request and HHS lab report of quantitation test results for testing performed on a specimen from a donor applying for reauthorization following a 1st positive drug test result 28.0 1.5 42.0 26.0 0.50 13.0 (29.0)
Duplicative Burden 26.185(p): MRO written notice to licensee or other entity of a positive, adulterated, substituted, or invalid test result 28.0 8.0 224.0 Burden accounted for under section 26.185(c)
(224.0)
Page 11 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Consolidated 26.713(a)(2): Records pertaining to the determination of a violation of FFD policy and related management actions 28.0 80.0 2,240.0 Burden accounted for under section 26.39(b)
(2,240.0)
Updated 26.713(a)(3): Documentation of the granting and termination of authorization 28.0 80.0 2,240.0 26.0 80.0 2,080.0 (160.0)
Updated 26.713(a)(4): Records of determinations of fitness performed under section 26.189 (including recommendations for treatment and followup testing plans) 28.0 80.0 2,240.0 26.0 80.0 2,080.0 (160.0)
Duplicative Burden 26.713(b)(1): Records of FFD training and examinations conducted under section 26.29 28.0 160.0 4,480.0 Burden accounted for under sections 26.29(a) and (b)
(4,480.0)
Duplicative Burden 26.713(b)(2): Records of audits, audit findings, and corrective actions taken under section 26.41 28.0 80.0 2,240.0 Burden accounted for under sections 26.41(a)-(d), (f) and (g)
(2,240.0)
Consolidated 26.713(c): Records on 5-year and permanent denials of authorization 28.0 40.0 1,120.0 Burden accounted for under section 26.39(b)
(1,120.0)
Updated 26.713(d): Records of superseded versions of FFD policies and procedures 28.0 80.0 2,240.0 26.0 8.0 208.0 (2,032.0)
Updated 26.713(e): Records of written agreements for services under Part 26 28.0 16.0 448.0 26.0 16.0 416.0 (32.0)
Duplicative Burden 26.713(f): Records of background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel conducted under section 26.31(b)(1)(i) 28.0 80.0 2,240.0 Burden accounted for under section 26.31(b)(1)(i)
(2,240.0)
Moved (to Table 1) 26.713(g): Documentation on testing for additional drugs as permitted under section 26.31(d)(1), use of more stringent testing cutoff levels as permitted under section 26.31(d)(3),
or both 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)
Updated 26.715(a): Documentation of all aspect of testing process at collection sites and LTFs (not otherwise specified in section 26.715(b))
28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0)
Updated 26.715(b)(1): Retain personnel files on staff at collection sites and LTFs 28.0 20.0 560.0 26.0 20.0 520.0 (40.0)
Updated 26.715(b)(2): Retain collection site and LTF chain-of-custody documents 28.0 240.0 6,720.0 26.0 240.0 6,240.0 (480.0)
Updated 26.715(b)(3): Retain LTF QA/QA records 28.0 120.0 3,360.0 6.0 120.0 720.0 (2,640.0)
Updated 26.715(b)(4): Retain superseded procedures (LTFs and collection sites) 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0)
Updated 26.715(b)(5): Retain all test data from LTF (including calibration curves and any calculations used in determining test results 28.0 240.0 6,720.0 6.0 240.0 1,440.0 (5,280.0)
Updated 26.715(b)(6): LTF test reports 28.0 240.0 6,720.0 6.0 240.0 1,440.0 (5,280.0)
Updated 26.715(b)(7): LTF performance testing records 28.0 80.0 2,240.0 6.0 80.0 480.0 (1,760.0)
Updated 26.715(b)(8): Records from LTF and HHS lab on the investigation of testing errors or unsatisfactory performance, and any corrective actions taken 28.0 40.0 1,120.0 8.0 40.0 320.0 (800.0)
Moved (to Table 4) 26.715(b)(9): Performance records on HHS lab certification inspections 28.0 40.0 1,120.0 Moved to Table 4 (1,120.0)
Updated 26.715(b)(10): Records of preventative maintenance on LTF instruments 28.0 40.0 1,120.0 6.0 40.0 240.0 (880.0)
Updated 26.715(b)(11): Retain records that summarize any test results the MRO determined to be scientifically insufficient for further action 28.0 20.0 560.0 1.0 3.0 3.0 (557.0)
Updated 26.715(b)(12): LTF retains computer-generated data 28.0 120.0 3,360.0 6.0 120.0 720.0 (2,640.0)
Duplicative Burden 26.715(b)(13): Retain records (e.g., an access log) of authorized visitors, maintenance personnel and service personnel who accessed LTF secure areas 28.0 20.0 560.0 Burden accounted for under section 26.129(a)
(560.0)
Updated 26.715(b)(14): Retain records of the inspection, maintenance and calibration of EBTs (collection sites) 28.0 20.0 560.0 26.0 20.0 520.0 (40.0) 26.717(a) and (b): Collect FFD performance data for D&A testing programs 28.0 100.0 2,800.0 26.0 100.0 2,600.0 (200.0) 26.717(a) and (b): Collect FFD performance data for fatigue management program 23.0 100.0 2,300.0 21.0 100.0 2,100.0 (200.0) 26.717(c): Analyze D&A testing program FFD data annually 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) 26.717(c): Analyze fatigue management program data annually 23.0 40.0 920.0 21.0 40.0 840.0 (80.0) 26.717(d): D&A test results leading to termination 1.0 1.0 1.0 1.0 1.0 1.0 Duplicative Burden 26.717(g): Collect and report D&A testing program data to the NRC (for C/V with a testing program) 1.0 120.0 120.0 Burden accounted for under section 26.717(a) and (b)
(120.0)
Updated 26.719(b): Prepare information to make a 24-hour event report to the NRC 1.2 1.0 1.2 37.0 1.0 37.0 35.8 Updated 26.719 (c): Prepare 30-day event report documentation.
0.2 40.0 8.0 8.0 40.0 320.0 312.0 26.719(d): Document non-reportable indicators of FFD program weaknesses 30.0 20.0 600.0 28.0 20.0 560.0 (40.0)
Page 13 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change 26.187(d): SAE training requirements 28.0 20.0 560.0 26.0 20.0 520.0 (40.0) 26.187(f): Documentation of SAE credentials and training 28.0 1.0 28.0 26.0 1.0 26.0 (2.0)
Updated 26.189(b): Determination of fitness record 28.0 80.2 2,245.6 26.0 80.0 2,080.0 (165.6)
Updated 26.189(c): Record of for cause determination of fitness 28.0 16.3 456.4 26.0 15.6 405.3 (51.1)
Updated 26.189(d): Record of modification of an initial determination of fitness 28.0 1.0 28.0 1.0 1.0 1.0 (27.0) 26.203(a): Prepare fatigue management policy (In addition to 26.27 burden) 2.0 7.3 14.6 0 7.3 (14.6) 26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden) 2.0 1.7 3.4 0 1.7 (3.4) 26.203(c): Prepare training on fatigue management.
2.0 2.0 4.0 0 2.0 (4.0)
Updated 26.203(d)(1) and (d)(2): Records of work hours, shift schedules, and shift cycles Burden accounted for under 26.205(c), (d)(1), and (e)(4)
Burden accounted for under 26.205(c), (d)(1), and (e)(4) 26.203(d)(3): Documentation of waivers Burden accounted for under section 26.207(a)(4)
Burden accounted for under section 26.207(a)(4) 26.203(d)(4): Documentation of work hour reviews Burden accounted for under 26.205(d)(2), (e)(3) and (e)(4)
Burden accounted for under 26.205(d)(2), (e)(3) and (e)(4) 26.203(d)(5): Documentation of fatigue assessment Burden accounted for under section 26.211(f)
Burden accounted for under section 26.211(f) 26.205(b): Record of calculation of work hours 23.0 160.0 3,680.0 21.0 160.0 3,360.0 (320.0) 26.205(c): Schedule work hours 23.0 2,080.0 47,840.0 21.0 2,080.0 43,680.0 (4,160.0) 26.205(d)(1): Record of implementation of work hour controls 23.0 50.0 1,150.0 21.0 50.0 1,050.0 (100.0) 26.205(d)(2): Record of adequate rest breaks 23.0 50.0 1,150.0 21.0 50.0 1,050.0 (100.0) 26.205(e)(1) and (2): Record of review of control of work hours twice per calendar year 23.0 40.0 920.0 21.0 40.0 840.0 (80.0) 26.205(e)(3): Document methods for reviews 23.0 20.0 460.0 21.0 20.0 420.0 (40.0) 26.205(e)(4): Record and trend problems in regarding work hours 23.0 20.0 460.0 21.0 20.0 420.0 (40.0)
Updated 26.207(a)(4): Document basis for waiver 3.0 6.0 18.0 21.0 6.0 126.0 108.0 26.211(f): Document results of fatigue assessments 23.0 50.0 1,150.0 21.0 50.0 1,050.0 (100.0)
NEW 26.403(a): Updates to FFD policy and procedures (reactor construction site D&A testing program)
Not included in clearance 2.0 16.0 32.0 32.0 Moved (from Table 1) 26.403(a): Provide FFD policy to individuals subject to a reactor construction site D&A testing program Moved from Table 1 2.0 8.0 16.0 16.0 Updated 26.405(b): Records of random D&A tests 2.0 705.0 1,410.0 2.0 193.9 387.7 (1,022.3)
Updated 26.405(c)(1): Records of pre-assignment D&A test 2.0 2,338.0 4,676.0 2.0 287.4 574.8 (4,101.2)
Updated 26.405(c)(2) and (c)(3): Records of for-cause and post accident D&A tests 2.0 197.0 394.0 2.0 308.8 617.7 223.7 Updated 26.405(c)(4): Records of follow-up D&A tests 2.0 34.5 69.0 2.0 21.1 42.1 (26.9)
Moved (to Table 1) 26.405(d): Record of testing for specified drugs, adulterants, and alcohol, at Part 26 specified cutoff levels Burden accounted for under section 26.405(a) - (c)(4)
Moved to Table 1 Updated 26.405(e): Updates to specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the specimen, and stringent quality controls to ensure accurate test results 2.0 40.0 80.0 2.0 40.0 80.0 26.405(f): Record that testing conducted at an HHS lab 2.0 40.0 80.0 2.0 40.0 80.0 Updated 26.405(g): Record of MRO review of positive, adulterated, substituted, and invalid drug and validity test results (reactor construction site D&A testing program) 2.0 50.0 100.0 2.0 81.3 162.5 62.5 Updated 26.406(c): Updates to fitness monitoring procedures (programs that do not adopt random testing and behavioral observation)
- 80.0 0 80.0 Updated 26.411(a): Updates to procedures for maintaining a system of files to protect personal information collected under Subpart K of Part 26 2.0 4.0 8.0 2.0 40.0 80.0 72.0 Updated 26.411(a) and (b): Collection of personal information under Subpart K of Part 26 2.0 2,190.5 4,381.0 2.0 3,817.0 7,634.0 3,253.0 26.413: Document results of review process 2.0 80.0 160.0 2.0 80.0 160.0 26.415: Document and report audit results 2.0 40.0 80.0 2.0 40.0 80.0 Updated 26.417(a): Records pertaining to the administration of a reactor construction site D&A testing program 2.0 20.0 40.0 2.0 20.0 40.0 NEW 26.417(b)(1): Report to NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> programmatic failures in a reactor construction site D&A testing program Not included in clearance Burden accounted for under section 26.719(b)
Updated 26.417(b)(2) Collect FFD program performance data for reactor construction site D&A testing program 2.0 100.0 200.0 2.0 100.0 200.0 Duplicative Burden 26.713(a)(1): Records of self-disclosures, employment histories, and suitable inquiries (under sections 26.55, 26.57, 26.59, and 26.69) that result in the granting of authorization 28.0 80.0 2,240.0 Burden accounted for under section 26.61(a), and 26.63(a), (c), and (e)
(2,240.0)
Page 12 of 24
Final Supporting Statement, 10 CFR Part 26 Index Key:
- New
- Updated
- Moved
- Duplicative
- Removed Section Number of Record-keepers Burden Hours per Recordkeeper Total Annual Burden Hours Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Table 2: Annual Recordkeeping Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-Extension (2017-2020)
Burden Estimate Change Updated 26.821(a): Provide NRC with access to records (to inspect, copy, or take away copies of records) 30.0 4.0 120.0 28.0 4.0 112.0 (8.0)
Updated 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/Vs documents, records, and reports 1.0 4.0 4.0 1.0 4.0 4.0 Table 2 Total 314,177.4 220,886.5 (93,290.9)
-29.7%
Page 14 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Updated
- Removed Section Number of Respondents Responses per Respondent Total Responses Burden per
Response
(hours)
Total Burden Hours Number of Respondents Responses per Respondent Total Responses Burden per
Response
(hours)
Total Burden Hours 26.9: Application to NRC for exemption 0 1.0 - - -
0 1.0 - - - -
Updated 26.77(c) Report impaired NRC employee 30.0 - - 1.0 -
0 - - 1.0 - -
Updated 26.137(b)(3): Report false negative LTF validity screening result Burden accounted for under section 26.719(c)(3)
No LTF conducts validity screening testing (if any did, burden would be accounted for under section 26.719(c)(3)
Removed 26.139(d): Prepare information from LTF for annual FFD program performance report Burden accounted for under section 26.717(e) and (f)
REMOVED (Activity covered in Table 2)
Removed 26.187(f): Provide SAE qualifications documentation to NRC upon request 1.0 1.0 1.0 1.0 1.0 REMOVED (Activity covered in Table 2)
(1.0)
Updated 26.203(e)(1): Prepare information on waivers of work hour controls for inclusion in FFD program performance report to NRC required by 26.717 23.0 1.0 23.0 50.0 1,150.0 21.0 1.0 21.0 50.0 1,050.0 (100.0)
Updated 26.203(e)(2): Prepare summary of fatigue corrective actions for inclusion in FFD program performance report to NRC required by 26.717 23.0 1.0 23.0 6.0 138.0 21.0 1.0 21.0 6.0 126.0 (12.0)
Updated 26.417(b)(1): Report to NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a programmatic failure in a reactor construction site D&A testing program 2.0 1.0 2.0 4.0 8.0 Burden accounted for under section 26.719(b)
(8.0)
Updated 26.417(b)(2): Prepare annual FFD program performance report for reactor construction site D&A testing program 2.0 1.0 2.0 80.0 160.0 2.0 1.0 2.0 80.0 160.0 Removed 26.717(d): Report termination drug and alcohol test results in annual program performance summary by processing stage Burden accounted for under section 26.717(e) and (f). NRC's 2012 FFD program performance indicate 1,089 positive, adulterated, substituted, and refusal to test results.
Removed (All burden is captured under a single 26.717 line items for D&A results)
Updated 26.717: Annual FFD program performance report for fatigue management programs 62.0 1.0 62.0 8.0 496.0 59.0 1.0 59.0 8.0 472.0 (24.0)
Updated 26.717: Annual FFD program performance for D&A testing programs 65.0 1.0 65.0 60.0 3,900.0 67.0 1.0 67.0 60.0 4,020.0 120.0 Updated 26.719(a): Report a significant FFD program violation, programmatic failure, or D&A testing error Burden accounted for under section 26.719(b) and (c)
Burden reported under sections 26.719(b), and (c)(1) - (c)(3)
Updated 26.719(b): Report to the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a significant D&A testing violation 15.0 2.5 37.1 4.0 148.2 37.0 1.0 37.0 4.0 148.0 (0.2)
Updated 26.719(c)(1): Submit a report to the NRC within 30 days of completing an investigation into an LTF or HHS lab testing error 6.0 1.0 6.0 24.0 144.0 8.0 1.0 8.0 24.0 192.0 48.0 Updated 26.719(c)(2): Notify the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receiving notice of a false positive on a BPTS test result 1.0 1.0 1.0 4.0 4.0 0 1.0 - 4.0 - (4.0)
Updated 26.719(c)(3): Notify the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receiving a false negative test result on a QA check of a validity screening test from an LTF 4.0 1.0 4.0 4.0 16.0 0 1.0 - 4.0 - (16.0)
Table 3 Total 226.1 6,165.2 215.0 6,168.0 2.8 Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 3: Annual Reporting Burden Estimate Change Page 15 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Consolidated
- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Number of Responses Burden Hours per
Response
Total Annual Burden Hours Updated 26.4(j): For personnel granted authorization by a licensee, who are covered by a D&A testing program regulated by a State or Federal agency - (1) provision of training record to the licensee to demonstrate section 26.29(a) training requirements met (if not already covered in the existing program); (2) notification of any FFD policy violations by those granted authorization by the licensee or other entity 14.0 2.0 28.0 33.5 2.0 67.0 39.0 Moved (from Table 1) 26.29(b): Complete initial training on FFD policy and take comprehensive examination Not included in clearance (was in Table 1 but zero programs) 81,219.3 2.0 162,438.6 162,438.6 Moved (from Table 1) 26.29(c)(2): Complete annual refresher training on FFD policy Not included in clearance (was in Table 1 but zero programs) 103,932.7 1.5 155,899.0 155,899.0 Updated 26.31(b)(1)(i): Individual applying for access to serve as FFD program personnel provides background check information for the background investigation, credit and criminal history checks, and psychological assessment 93,890.0 1.0 93,890.0 335.0 1.0 335.0 (93,555.0)
Removed 26.31(d)(6): Donor provides written permission to conduct another analysis or test with specimen 8.0 1.0 8.0 Removed (not an information collection)
(8.0)
Updated 26.35(a): Employee assistance program (EAP) records 14.0 32.0 448.0 26.0 32.0 832.0 384.0 Updated 26.35(c): Individual completes and provides the EAP with a written waiver of right to privacy to share information with FFD management 5,636.0 0.3 1,690.8 1,039.3 0.25 259.8 (1,431.0)
Updated 26.35(c): Record of EAP disclosure to FFD management about an individual that poses an immediate hazard 15.0 1.0 15.0 13.0 1.0 13.0 (2.0)
Updated 26.37(b): Individuals provide signed consent for release of information 1,127.0 0.3 338.1 258.0 0.25 64.5 (273.6)
Updated 26.37(b)(1): Individual provides signed designation of personal representative for an FFD matter 961.0 1.0 961.0 258.0 0.25 64.5 (896.5)
Updated 26.37(d): Request by donor or donors presentative to the licensee or other entity to provide personal records collected under Part 26 961.0 1.0 961.0 26.0 0.25 6.5 (954.5)
Updated 26.53(h): Applicant provides written consent before any actions are initiated under Subpart C of Part 26 93,890.0 0.3 28,167.0 81,219.3 0.25 20,304.8 (7,862.2)
Updated 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update 26.59(a)(1) - (a)(2): Authorization reinstatement Each individual applying for authorization must complete a self-disclosure, employment history, and suitable inquiry Burden accounted for under sections 26.61 and 26.63 Burden accounted for under sections 26.61(a) and 26.63(a),(c) and (e)
Updated 26.59(c)(1): Applicant prepares self-disclosure (for authorization reinstatement period of interruption of no more than 30 days)
Burden accounted for under section 26.61 Burden accounted for under sections 26.61(a)
Updated 26.61(a): Applicant prepares self-disclosure and employment history 93,890.0 1.0 93,890.0 81,219.3 1.0 81,219.3 (12,670.7)
Updated 26.63(a), (c), and (e): Former employer(s) provide information to the licensee or other entity to verify an applicants suitable inquiry information on previous authorization(s) 93,890.0 0.80 75,112.0 81,219.3 0.75 60,914.5 (14,197.5)
Updated 26.63(c)(2): U.S. Department of Defense (DOD) provides licensee or other entity with form DD 214 which details an applicants military service record Burden of supplying DD 214 affects DOD Burden of supplying DD 214 affects DOD, or is accounted for under section 26.61(a) (if supplied by the applicant)
Updated 26.63(c)(3): Former employer refuses to provide information to the licensee or other entity about an applicants prior employment history 180.0 0.5 90.0 180.0 0.1 15.0 (75.0)
Updated 26.67: Records of random D&A testing of persons who have applied for authorization, but who have not been granted unescorted access authorization 335.0 0.5 167.5 406.1 0.5 203.0 35.55 Updated 26.69(b) and (c)(1): Applicant provides written self-disclosure and employment history to the licensee or other entity (for authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified)
Burden accounted for under section 26.63 Burden accounted for under section 26.61(a)
Updated 26.69(c)(2): Former employer(s) of an applicant provide response to licensee or other entity request to confirm suitable inquiry information for an applicant with PDI 939.0 2.0 1,878.0 812.2 2.0 1,624.4 (253.6)
Updated 26.85(c): Alternative collectors not employed by licensee provide proof of qualification 22.0 1.0 22.0 26.0 1.0 26.0 4.0 Updated 26.85(e): Maintain personnel files for alternative collectors 22.0 4.0 88.0 26.0 4.0 104.0 16.0 Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Page 16 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Consolidated
- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Number of Responses Burden Hours per
Response
Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Consolidated (in Table 2) 26.87(f)(1), and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom) and document on the custody-and-control form (CCF) the name of a same gender observer (in the exceptional event that a designated collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 2.0 1.0 2.0 Consolidated in Table 2 (2.0)
Updated 26.89(a): Record that a donor did not appear for testing (non licensee collection site) 2.0 1.0 2.0 2.0 1.0 2.0 Updated 26.89(b)(3): Record FFD management informed that an individual did not present identification (non-licensee collection site) 2.0 1.0 2.0 2.0 1.0 2.0 Updated 26.89(c): Record that FFD management informed that a donor refused to cooperate with the collection procedures (non-licensee collection site) 2.0 1.0 2.0
- 0.25 -
(2.0)
Updated 26.91(e)(4): Record that results cancelled after EBT calibration check failure (non-licensee collection site) 1.0 1.0 1.0
- 1.0 -
(1.0)
Updated 26.91(e)(5): Prepare record of EBT maintenance (non-licensee collection site) 22.0 4.0 88.0 26.0 4.0 104.0 16.0 Updated 26.93(a)(6): Document alcohol pre-test questions asked and answered (non-licensee collection site) 280.0 0.3 84.0 260.0 0.25 65.0 (19.0)
Updated 26.95(b)(5): Record donor identity for initial alcohol breath test (non-licensee collection site) 280.0 0.3 84.0 260.0 0.25 65.0 (19.0)
Updated 26.97(b)(2): Record reason for new oral fluid alcohol test (non-licensee collection site) 8.0 0.5 4.0
- 0.5 -
(4.0)
Updated 26.97(c)(1): Document reason for failure of second collection attempt (non-licensee collection site) 1.0 1.0 1.0
- 1.0 -
(1.0)
Updated 26.97(d): Record results and alcohol screening device used (non-licensee collection site) 8.0 0.3 2.4
- 0.25 -
(2.40)
Duplicative Burden 26.99(b): Record test time of initial test with 0.02 percent BAC or higher (non-licensee collection site) 1.0 0.3 0.3 Burden accounted for under section 26.715(b)(2)
(0.30)
Duplicative Burden 26.101(b)(7): EBT printout of confirmatory alcohol test result includes time of test (non-licensee collection site) 1.0 0.3 0.3 Burden accounted for under section 26.715(b)(2)
(0.30)
Updated 26.103(b): Collector informs FFD management of result between 0.01 and 0.02 percent BAC when donor in work status 3 or more hours (non-licensee collection site)
- 0.5 - - 0.25 -
Duplicative Burden 26.107(b): Collector documents tampering attempt on CCF form (non-licensee collection site)
- 1.0 -
Burden accounted for under section 26.111(b)
Updated 26.109(b)(3): Collector documents on CCF sh-bladder situation and notifies FFD management (non-licensee collection site)
- 0.5 - - 0.25 -
Updated 26.109(b)(4): Collector documents on CCF confirmation from FFD management to conduct a an observed collection (non-licensee collection site)
- 0.3 - - 0.25 -
Updated 26.111(b): Collector documents on CCF if specimen characteristics (color, clarity) indicate possible tampering by the donor (non-licensee collection site) 2.0 0.5 1.0
- 0.25 -
(1.0)
Updated 26.111(c): Collector documents on CCF unusual specimen temperature and/or other observations made during the collection of possible tampering attempt and notifies FFD management (non-licensee collection site)
- 0.4 -
0.25 -
Duplicative Burden 26.113(b)(3): Collector completes CCF for split-specimen collection (non-licensee collection site)
- 0.3 -
Burden accounted for under section 26.117(c) - (e)
Updated 26.115(b): Collector documents on CCF approval from FFD manager or MRO to collect a specimen under direct observation (non-licensee collection site)
- 0.3 - - 0.25 -
Updated 26.115(d): Collector documents on CCF directly observed collection performed and the reason for the observed collection (non-licensee collection site)
- 0.3 -
Burden accounted for under section 26.115(b) 26.115(f)(3): Record of name of observer (non-licensee collection site)
- 0.3 - - 0.25 -
Updated 26.117(c) - (e): Collector prepares ID labels and CCF forms for specimen shipment (non-licensee collection site) 280.0 0.3 84.0 260.0 0.25 65.0 (19.0)
Updated 26.119(a), (e), and (f): Physician evaluating shy-bladder claim prepares report of medical examination of donor and provides this information to the MRO
- 6.0 - 13.0 2.0 26.0 26.0 Consolidated (in Table 2) 26.119(b): MRO provides information to physician as background for evaluation of a shy bladder claim
- 2.0 -
Consolidated in Table 2 Updated 26.129(b): Collector prepares memorandum to and sends to LTF documenting investigation of discrepancies between bottles and CCF (non-licensee collection site)
- 1.0 -
1.0 -
Page 17 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Consolidated
- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Number of Responses Burden Hours per
Response
Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Updated 26.135(b): Donor request to MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab (initial specimen testing performed at an LTF) 1.0 0.5 0.5 Burden accounted for under section 26.165(b)(1)
(0.50)
Removed 26.137(b)(3): LTF records submitting 1 in 10 negative specimens for validity screening to HHS lab
- 40.0 -
Not Third Party Burden (accounted for in Table 2)
Updated 26.153(g): Supply memorandum to HHS lab explaining use of non-federal CCF form (non-licensee collection site) 2.0 0.5 1.0 2.0 0.5 1.0 Updated 26.155(a)(1): Document of HHS lab manager qualifications Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.155(a)(3): HHS lab personnel training documentation Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.155(a)(4): HHS lab manager reviews and approved lab procedures Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.155(a)(5): HHS lab manager maintains QA program Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.155(b): Certifying scientist at HHS lab certifies test results Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(c): Supervise technical analysts at HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.155(e): Continuing education of HHS lab staff Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.155(f): HHS lab personnel records Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.157(a): Written HHS lab procedures for accession, receipt, shipment, and testing of urine specimens Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.157(b): Written HHS lab chain-of-custody procedures for HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.157(c): Written HHS lab procedures for each testing assay performed Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.157(d): Written HHS lab procedures for device set-up and operation Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.157(e): Written HHS lab procedures for remedial actions to address system and instrument errors Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.159(a): Retain records (e.g., an access log) of authorized visitors, maintenance personnel, and service personnel who accessed secure areas of HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 NEW 26.159(b)(1): Record that the HHS lab notified the licensee or other entity within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying evidence of specimen tampering Not included in previous clearance 0 1.0 -
Updated 26.159(c) - (e): Use and storage of CCF forms at HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden accounted for under section 26.715(b)(2)
Updated 26.159(f): Use of CCF by HHS lab when shipping a specimen to another HHS lab Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden accounted for under section 26.165(b)(1)
Updated 26.165(b)(1): At the direction of the MRO, the initial HHS lab that conducted testing send a donors specimen (i.e., an aliquot of a single specimen or Bottle B of the split specimen) to a second HHS lab for further testing 1.0 1.0 1.0 31.1 1.0 31.1 30.1 Consolidated (in Table 2) 26.165(b)(2): Record that MRO informed the donor of the opportunity to request the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab 1.0 0.3 0.3 Consolidated in Table 2 (0.30)
Updated 26.165(b)(3): Donor provides written request to the MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen 1.0 1.0 1.0 31.1 1.0 31.1 30.1 Duplicative Burden 26.165(b)(4): Donor presents documentation to the MRO on the reason for not being able to make a timely retest request - 1.0 -
Burden accounted for under section 26.185(e)
Page 18 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Consolidated
- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Number of Responses Burden Hours per
Response
Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Duplicative Burden 26.165(b)(6) HHS lab provides report to the MRO of the quantitative test results of the retesting of aliquot of a single specimen or the testing of the Bottle B split specimen 1.0 0.5 0.5 Burden accounted for under section 26.185(n)
(0.50)
Updated 26.167(a): HHS lab documents QA program (encompasses all aspects of the testing process)
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.167(c)(2)(i): Refractometer at the HHS lab must display specific gravity to 4 decimals and be interfaced with laboratory information management system or computer and/or document result by hard copy or electronic display Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.167(f)(3): False positive error on BPTS test and the error is technical or methodological, the HHS lab Responsible Person must document that retesting of all positive, adulterated, substituted, and invalid specimens from the time of final resolution of the error back to the time of the last satisfactory performance test cycle has been completed, as requested by the licensee or other entity Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158
- 8.0 -
Updated 26.167(h): HHS lab labels standards and controls Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.168(a): Blind performance test sample (BPTS) supplier provides HHS lab certification letter of BPTS formulation to licensee or other entity Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 2.0 8.0 16.0 16.0 Updated 26.168(h)(2): BPTS sample supplier provides expiration date on each BPTS Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 2.0 8.0 16.0 16.0 Moved (to Table 2) 26.168(i)(2): Licensee or other entity completes CCF for a BPTS, places fictional initials on specimen labels, and indicates on the MRO copy of the CCF that the specimen is a BPTS Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Moved to Table 2 Updated 26.169(a): HHS lab reports test results to the MRO of the licensee or other entity Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 Burden accounted for under section 26.169(c)(1)
Updated 26.169(c)(1): HHS lab provides record to the MRO for each positive, adulterated, substituted, dilute, and invalid test result 686.0 0.25 171.5 621.0 0.25 155.3 (16.3)
Duplicative Burden 26.169(c)(2): HHS lab provides quantitative test result record for positive drug test (at the request of the MRO) 5.0 1.0 5.0 Burden accounted for under section 26.169(c)(1)
(5.0)
Duplicative Burden 26.169(c)(2): HHS lab record of quantitative test results for opiates to the MRO (at the request of the MRO) 16.0 1.0 16.0 Burden accounted for under section 26.169(c)(1)
(16.0)
Duplicative Burden 26.169(c)(3): HHS lab provides quantitative test result record for adulterated or substituted test results (at the request of the MRO) 5.0 1.0 5.0 Burden accounted for under section 26.169(c)(1)
(5.0)
Updated 26.169(c)(4): HHS lab record of contact with MRO to discuss if additional testing by another HHS lab should be conducted on a specimen with an invalid test result 10.0 0.5 5.0 10.0 0.5 5.0 Updated 26.169(f): HHS lab transmits to the MRO a copy of CCF for specimens with negative test results Electronic transmission Burden accounted for under section 26.715(b)(2)
Duplicative Burden 26.169(g): HHS lab transmits to the MRO a copy of the original CCF signed by the certifying scientist (for positive, adulterated, substituted, dilute and invalid test result) 686.0 0.5 343.0 Burden accounted for under section 26.169(c)(1)
(343.0)
Updated 26.169(h): HHS lab prepares and submits annual statistical summary report of urinalysis testing results 10.0 40.0 400.0 67.0 2.0 134.0 (266.0)
Consolidated (in Table 2) 26.183(a): Documentation of MRO qualifications 28.0 1.0 28.0 Consolidated in Table 2 (28.0)
Consolidated (in Table 2) 26.183(c)(1): MRO review of records for positive, adulterated, substituted, invalid, or, at the licensees or other entity's discretion, dilute test results that confirm as an FFD violation Burden accounted for under section 26.185(a)
Consolidated in Table 2 Consolidated (in Table 2) 26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results 16,383.0 0.1 819.2 Consolidated in Table 2 (819.15)
Consolidated (in Table 2) 26.183(d)(2)(ii): Record of MRO staff review of CCF forms and forward changes to MRO 54.0 0.1 5.4 Consolidated in Table 2 (5.40)
Consolidated (in Table 2) 26.185(a) Record of MRO review of all positive, adulterated, substituted, or invalid test results and report to licensee or other entity 635.0 1.0 635.0 Consolidated in Table 2 (635.0)
Updated 26.185(c): Donor discussion with MRO of positive, adulterated, substituted, dilute, or invalid test result 635.0 1.0 635.0 621.0 0.5 310.5 (324.5)
Page 19 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Consolidated
- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Number of Responses Burden Hours per
Response
Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change Consolidated (in Table 2) 26.185(d)(1): Documentation that donor declined to discuss test results 81.0 1.0 81.0 Consolidated in Table 2 (81.0)
Updated 26.185(e): Donor provides documentation to the MRO demonstrating an inability to discuss test results and requesting the test result determination be reopened 8.0 1.0 8.0 8.0 1.0 8.0 Updated 26.185(f)(1): HHS lab consultation with MRO on whether additional testing of a specimen with an invalid test result should be performed at a second HHS lab Burden accounted for under section 26.185(c) 26.0 0.50 13.0 13.0 Updated 26.185(f)(2): Donor discussion with MRO regarding an invalid test result Burden accounted for under section 26.185(c)
Burden accounted for under section 26.185(c)
Updated 26.185(h)(1): Donor discussion with MRO regarding a substituted test result Burden accounted for under section 26.185(c)
Burden accounted for under section 26.185(c)
Consolidated (in Table 2) 26.185(h)(2): MRO notification to licensee that no valid medical explanation presented Burden accounted for under section 26.185(c)
Consolidated in Table 2 Consolidated (in Table 2) 26.185(h)(3): MRO notification to licensee that valid medical explanation presented Burden accounted for under section 26.185(c)
Consolidated in Table 2 Updated 26.185(i)(1): Donor discussion with MRO regarding an adulterated test result Burden accounted for under section 26.185(c)
Burden accounted for under section 26.185(c)
Consolidated (in Table 2) 26.185(i)(2): MRO notification to licensee that no valid medical explanation presented Burden accounted for under section 26.185(c)
Consolidated in Table 2 Consolidated (in Table 2) 26.185(i)(3): MRO notification to licensee that valid medical explanation presented for an adulterated test result Burden accounted for under section 26.185(c)
Consolidated in Table 2 Updated 26.185(j) Donor discussion with MRO regarding a positive test result from use of a prescription medication (amphetamine, morphine, codeine), and donor provides documentation on medication use to the MRO (e.g.,
prescription information and pharmacy, prescribing physician information)
Burden accounted for under section 26.185(c) 60.0 1.0 60.0 60.0 Consolidated (in Table 2) 26.185(k): MRO report to licensee that no FFD policy violation has occurred 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
Consolidated (in Table 2) 26.185(m): MRO review of inspection and audit reports, quality control data, multiple specimens, and other data to determine if positive, adulterated, substituted, or invalid result is scientifically insufficient for determination of FFD policy violation 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
Updated 26.185(n): Second HHS lab provides the MRO with test result report (for retesting of an aliquot of a single specimen or the testing of a Bottle B split specimen) 54.0 1.0 54.0 31.1 0.25 7.8 (46.2)
Duplicative Burden 26.185(o): HHS lab provides report with quantitative test results for a specimen from a donor applying for reauthorization following a 1st positive drug test result (at MRO request) 8.0 0.5 4.0 Duplicate with row below (4.0)
Duplicative Burden 26.185(o): HHS lab provides quantitation of test results for testing performed on a specimen from a donor applying for reauthorization following a 1st positive drug test result (at MRO request) 8.0 1.0 8.0 Burden accounted for under sections 26.169(c)(1)
(8.0)
Consolidated (in Table 2) 26.185(p): MRO notice to licensee of determination of FFD policy violation Burden accounted for under section 26.185(c)
Consolidated in Table 2 Consolidated (in Table 2) 26.187(d): SAE training requirements 24.0 20.0 480.0 Consolidated in Table 2 (480.0)
Consolidated (in Table 2) 26.187(f): Documentation of SAE credentials and training 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
Updated 26.189(b): If a qualified treatment professional other than the MRO or SAE performs a determination of fitness on an individual, that treatment professional completes and provides a written determination to the MRO 69.0 1.0 69.0 26.0 1.0 26.0 (43.0)
Consolidated (in Table 2) 26.189(c): Written record of a For-cause determination of fitness 6.9 1.0 6.9 Consolidated in Table 2 (6.90)
Consolidated (in Table 2) 26.189(d): Modification of an initial determination of fitness based on information from other sources 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
Updated 26.209(a): Individual declares that due to fatigue, he or she is unable to safety and competently perform his or her duties 23.0 0.3 6.9 21.0 0.3 6.3 (0.60)
Removed 26.405(g): For a reactor construction site FFD program, MRO reports of positive, adulterated, substituted, or invalid drug test results (for a reactor construction site FFD D&A testing program) 90.0 1.0 90.0 Removed (This is not third-party burden)
(90.0)
Updated 26.411(b): Applicant provides written consent to the reactor construction site D&A testing program 4,675.0 0.3 1,402.5 6,898.0 0.25 1,724.5 322.00 NEW 26.715(a): Documentation of all aspects of HHS lab testing process, not specified elsewhere in section 26.715(b)
Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Page 20 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Consolidated
- Duplicative
- Moved
- New
- Removed
- Updated Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Number of Responses Burden Hours per
Response
Total Annual Burden Hours Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Table 4: Annual Third-Party Disclosure Burden Estimate Change NEW 26.715(b)(1): Retain personnel files on HHS lab staff Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 NEW 26.715(b)(2): Retain HHS lab chain-of-custody documents Previously accounted for in Table 2 as Annualized Burden 9.0 240.0 2,160.0 2,160.00 NEW 26.715(b)(3): Retain HHS lab QA/QC records Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 NEW 26.715(b)(4): Retain HHS lab superseded procedures Previously accounted for in Table 2 as Annualized Burden 9.0 40.0 360.0 360.00 NEW 26.715(b)(5) Retain all test data from HHS lab (including calibration curves and any calculations used in determining test results)
Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 NEW 26.715(b)(6): HHS lab test reports Previously accounted for in Table 2 as Annualized Burden 9.0 240.00 2,160.0 2,160.00 NEW 26.715(b)(7): HHS lab performance testing records Previously accounted for in Table 2 as Annualized Burden Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Updated 26.719(c): HHS lab provides information to the licensee or other entity on investigation completed on a testing error (information for 30-day event report to NRC) 6.0 8.0 48.0 8.0 8.0 64.0 16.00 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/Vs documents, records, and reports 5.0 4.0 20.0 5.0 4.0 20.0 Table 4 Total 410,999.9 303,559.1 441,569.1 492,029.4 188,470.3 62.1%
Page 21 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Updated
- Consolidated
- Removed NRC ACTION No. Actions/
Year Burden Hours /
Action Total Hours No. Actions/
Year Burden Hours /
Action Total Hours Updated Review exemption request under section 26.9 2.0 16.0 32.0 - 16.0 -
(32.0)
Updated Review FFD policies and procedures under section 26.27(d)
(performed during periodic inspections) 12.0 8.0 96.0 12.0 8.0 96.0 Updated Review records under section 26.75(h) to ensure only appropriate records maintained for a licensee or other entity who administratively withdraws access for initial positive drug tests for marijuana or cocaine at an LTF (performed during periodic inspections) 12.0 4.0 48.0 - 4.0 -
(48.0)
Updated Review and evaluate report made under section 26.77(c) regarding an NRC employee or contractor being unfit for duty
- No reports anticipated
- - 4.0 -
Updated Review documentation provided by SAE upon request by NRC under section 26.187(f) 1.0 4.0 4.0 1.0 4.0 4.0 Consolidated Review and evaluate a 24-hour report made under section 26.417(b)(1) to the NRC Operations Center regarding a significant FFD program failure 1.0 16.0 16.0 Burden accounted for under section 26.719(b)
(16.0)
Updated Annual FFD program performance report -
Review, analyze, and summarize information received under 26.417(b)(2) from a reactor construction site D&A testing program.
2.0 25.0 50.0 2.0 25.0 50.0 Updated Annual fatigue management performance report --
Review, analyze, and summarize fatigue management data specified in section 26.201(e) that is submitted under section 26.717 62.0 10.0 620.0 59.0 10.0 590.0 (30.0)
Updated Annual FFD program performance report -
Review, analyze, and summarize information received under 26.717 from a D&A testing program 65.0 25.0 1,625.0 67.0 12.0 804.0 (821.0)
Removed Review reports under section 26.719(a) of significant violations of FFD policy, D&A testing program failures, and errors in laboratory testing Burden reported under section 26.719 (b) and (c)
REMOVED Table 5: Annualized NRC Burden Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Burden Estimate Change Page 22 of 24
FINAL Supporting Statement, 10 CFR Part 26 Index Key:
- Updated
- Consolidated
- Removed NRC ACTION No. Actions/
Year Burden Hours /
Action Total Hours No. Actions/
Year Burden Hours /
Action Total Hours Table 5: Annualized NRC Burden Approved Clearance Values (approved 11/30/14 - ICR 201407-3150-007)
Extension (2017-2020)
Burden Estimate Change Updated 24-hour report -- Review, evaluate, and respond to a report made under section 26.719(b) to the NRC Operations Center regarding a significant FFD policy violation or programmatic failure 37.0 16.0 592.0 37.0 8.0 296.0 (296.0)
Updated 30-day report -- Review, evaluate, and respond to a report made under section 26.719(c) to the NRC detailing the investigation of any testing errors or unsatisfactory performance discovered at an LTF or HHS lab.
6.0 4.0 24.0 8.0 4.0 32.0 8.0 Table 5 Total 200.0 3,107.0 186.0 1,872.0 (1,235.0)
-39.7%
Page 23 of 24
FINAL Supporting Statement, 10 CFR Part 26 Summary of Estimated Burden Hours and Costs (2017-2020) 2014-2017 2017-2020 1
Recordkeeping (One-Time) 112.0
$ 29,680 41.4 112.0 70.6 170.5%
2 Recordkeeping (Annual) 49.0 220,886.5
$ 58,534,918 314,177.4 220,886.5 (93,290.9)
-29.7%
3 Annual Reporting 215.0 6,168.0
$ 1,634,520 6,165.2 6,168.0 2.8 0.0%
4 Third Party Disclosure (Annual) 441,569.1 492,029.4
$ 130,387,785 303,559.1 492,029.4 188,470.3 62.1%
441,833.1 719,195.9
$ 190,586,904 623,943.1 719,195.9 95,252.8 15.3%
Tables 1 + 2 + 4 Burden >>>
713,027.9 Records storage costs >>>
75,580.95 5
NRC Action 186.0 1,872.0
$ 496,080 Change Annualized Burden Annualized Burden Change Hours Table Description Annualized Burden Hours Cost at
$265/hour Annualized Burden Hours Cost at
$265/hour TOTAL Responses Table Description Actions Page 24 of 24