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 Data Source FFD Drug & Alcohol (D&A) Testing Programs 28 FFD program D&A testing programs 26 FFD program FFD program performance data (2015)
Reactor Construction Site D&A testing programs 2 FFD program Number of Sites covered by an FFD D&A Testing Program 69 site 2015 FFD program performance data Excludes DECON sites (Crystal River, Fort Calhoun, Kewaunee, San Operating Reactors 59 site Onofre, Vermont Yankee)
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 FFD program performance data (2015)
HHS-certified laboratories (HHS labs) 9 HHS lab Laboratory Testing 67 Number of sites using an LTF 6 LTF FFD program performance data (2015)
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 FFD program performance data (average of 2013-2015)
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 FFD program performance data (average of 2013-2015)
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, 826 253 1,079 substituted, and refusal to test results FFD program performance data (average of 2013-2015)
Number of drug only positive, adulterated, 621 217 838 substituted, and refusal to test results D&A Pgrm Construction Individuals subject to a random D&A testing program FFD program performance data (2013-2015) 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)
Page 1 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 Pre-Access Random For Cause Post-Event Followup Alcohol Total Results Average Results (2013-2015)
Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol 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 Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2015 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol 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 Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2014 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol 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 Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2013 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol 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 Pre-Access Random For Cause Post-Event Followup Alcohol Total Results 2012 Tested Positive Tested Positive Tested Positive Tested Positive Tested Positive Total Tests Total + Totals without Alcohol 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 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 Average Population Subject to Random Testing 2012 2013 2014 2015 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 Approved Clearance Values Extension Table 1: One Time Recordkeeping (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key: Burden
- Updated Estimate Number of Burden Hrs Total Number of Burden Hrs Total
- Duplicative Section Record- per Recordkeeper Burden Hrs Record- per Recordkeeper Burden Hrs Change
- Moved
- New keepers (Annualized) (Annualized) keepers (Annualized) (Annualized)
- Removed 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 26.29(b): All current staff take FFD exam and FFD exam Moved to Table 4 0 400.4 - -
(to Table 4) graded (Third-Party Disclosure Burden)
Moved Moved to Table 4 26.29(c)(2): FFD training for current staff 0 4,710.7 - -
(to Table 4) (Third-Party Disclosure Burden) 26.31(b)(1)(v): Develop behavioral observation program Updated Burden accounted for under 26.27 (0 programs) Burden accounted for under 26.27(a) -
(BOP) procedures 26.31(d)(1)(i)(C): Develop rigorous testing procedures to ensure that the MRO can evaluate the use of substances NEW Not included in previous clearance Burden accounted for under 26.27(a) not included in the NRC-required testing panel (if additional substance testing is performed) 26.31(d)(1)(i)(D) and (d)(1)(ii): Documentation of forensic Moved toxicologist review and certification of additional drug(s) to Previously accounted for in Table 2 3.0 5.3 16.0 16.0 (from Table 2) be included in the licensee or other entity's drug testing as Annualized Burden panel Duplicative Burden accounted for in section 26.31(d)(1)(iii): Document additional drugs in testing panel 0 0.3 - -
Burden 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C) 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C): Documentation of Moved forensic toxicologist review and certification of lower drug Previously accounted for in Table 2 3.0 5.3 16.0 16.0 (from Table 2) testing cutoff levels than specified by Part 26, and as Annualized Burden inclusion of cutoff levels in the FFD policy and procedures 26.37(a): Develop a system of files and procedures to Updated 0 2.7 - 0 24.0 - -
protect personal information collected under Part 26 REMOVED REMOVED 26.37(b): Obtain signed consent for release of information 0 98.1 - -
[covered by Table 2 - 26.37(b)]
26.39(a) and (b): Develop procedures for the review of a Updated 0 13.3 - 0 120.0 - -
determination that an individual has violated the FFD policy 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 - -
26.127(a) - (e): Develop LTF procedures for specimen handling and chain-of-custody, assays performed, Updated 0 80.0 - 0 80.0 - -
instrument and test setup, and remedial actions for systems and testing devices 26.137(a): Develop LTF procedures for quality assurance/
Updated 0 13.3 - 0 13.3 - -
quality control (QA/QC) program Moved 26.153(e): Record of pre-award inspection of new HHS lab Previously accounted for in Table 2 3.0 13.3 40.0 40.0 (from Table 2) (completed prior to awarding contract for testing services) as Annualized Burden 26.153(f): Record that Part 26 specified requirements Moved Previously accounted for in Table 2 included in a licensee's or other entity's contract with a new 3.0 13.3 40.0 40.0 (from Table 2) as Annualized Burden HHS lab 26.155(a)(1), (a)(3) - (a)(5); (b),(c), (e), and (f):
Confirm HHS lab personnel qualifications and procedures Updated 0 2.7 - Burden accounted for under 26.153(e) -
place pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 26.157(a) - (e): Confirm HHS lab procedures in place for accession, receipt, shipment, and testing of specimens Updated 0 2.7 - Burden accounted for under 26.153(e) -
pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab) 26.159(a), (c), (e), (f): Confirm HHS lab procedures for specimen security, chain of custody, and preservation in Updated place pursuant to HHS laboratory certification 0 2.7 - Burden accounted for under 26.153(e) -
requirements also meet Part 26 requirements (new HHS lab) 26.203(a): Prepare fatigue management policy (In addition 2.0 7.3 14.6 0 7.3 - (14.6) to 26.27 burden) 26.203(b): Prepare fatigue management procedures (in 2.0 1.7 3.4 0 1.7 - (3.4) addition to 26.27 burden) 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) 26.401(b): Prepare a reactor construction site D&A testing Burden accounted for under Updated 0 60.0 - -
program plan section 26.403(a) and (b) 26.403(a): Develop FFD policy statement Updated 0 107.0 - 0 112.0 - -
(reactor construction site D&A testing program)
Moved 26.403(a): Distribute FFD policy statement to subject 0 5.0 - Moved to Table 2 -
(to Table 2) individuals (reactor construction site D&A testing program) 26.403(b): Develop written FFD procedures Updated 0 213.0 - 0 216.0 - -
(reactor construction site D&A testing program)
Moved 26.405(d): Record of testing for specified drugs, Previously accounted for in Table 2 Burden accounted for under section 26.403(a) -
(from Table 2) adulterants, and alcohol, at Part 26 specified cutoff levels as Annualized Burden 26.405(e): Develop specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the Previously accounted for in Table 2 NEW Burden accounted for under section 26.403(b) specimen, and stringent quality controls to ensure accurate as Annualized Burden test results Page 4 of 24
FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 1: One Time Recordkeeping (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key: Burden
- Updated Estimate Number of Burden Hrs Total Number of Burden Hrs Total
- Duplicative Section Record- per Recordkeeper Burden Hrs Record- per Recordkeeper Burden Hrs Change
- Moved
- New keepers (Annualized) (Annualized) keepers (Annualized) (Annualized)
- Removed 26.406(a), (b), and (d): Develop a fitness monitoring Updated program (applies if reactor construction site D&A testing 0 26.7 - 0 40.0 - -
program does not conduct random testing) 26.406(c): Develop procedures for fitness monitors Updated (applies if reactor construction site D&A testing program 0 40.0 - 0 40.0 - -
does not conduct random testing) 26.407: Develop procedures for behavioral observation Updated 0 40.0 - 0 40.0 - -
(reactor construction site D&A testing program) 26.411(a): Develop procedures for maintaining a system of NEW files to protect personal information collected under Not included in previous clearance 0 40.0 -
Subpart K of Part 26 26.413: Develop procedures for the review of a Updated determination that an individual violated the FFD policy 0 120.0 - 0 120.0 - -
(reactor construction site D&A testing program) 26.713(g): Documentation on testing for additional drugs Burden accounted for under Moved as permitted under section 26.31(d)(1), use of more Previously accounted for in Table 2 section 26.31(d)(1)(i)(D) and (d)(1)(ii), and (from Table 2) stringent testing cutoff levels as permitted under section as Annualized Burden section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c) 26.31(d)(3), or both.
Table 1: Total 41.4 112.0 70.6 Page 5 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 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 Updated 30.5 2.0 61.0 33.5 2.0 67.0 6.0 demonstrates section 26.29(a) training requirements met (if not already covered by the program); (2) record of notice of any FFD policy violation 26.27(b): Make FFD policy statement readily available to Updated 28.0 4.0 112.0 26.0 16.0 416.0 304.0 subject personnel 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 26.27(d): Provide FFD policy and procedures to NRC for Updated 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) review (performed during periodic inspections) 26.29(b): Record of training completion (initial training on Updated 28.0 2.0 56.0 26.0 104.1 2,707.3 2,651.3 FFD policy) and results of comprehensive examination 26.29(c)(2): Record of training completion (annual refresher Updated 28.0 2.0 56.0 26.0 133.2 3,464.4 3,408.4 training on FFD policy) 26.29(d): Record acceptance of FFD training from other 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) licensees' programs 26.31(b)(1)(i): Records of background investigations, credit and criminal history checks, and psychological assessments Updated 28.0 17.5 490.0 26.0 16.0 416.0 (74.0) of checks for performed on individuals designated as FFD personnel Duplicative 26.31(b)(1)(v): Record results of behavioral observation for Burden accounted for under 28.0 80.0 2,240.0 (2,240.0)
Burden FFD program personnel section 26.189(c) 26.31(d)(1)(i)(D): Document analysis and certification for Moved testing of drugs not included in the NRC minimum testing 2.3 4.0 9.2 Moved to Table 1 (9.2)
(to Table 1) panel Moved 26.31(d)(2)(ii): Document licensee additions to tested drugs 2.3 8.0 18.4 Moved to Table 1 (18.4)
(to Table 1) 26.31(d)(3)(ii): Document LTF technician qualifications to Burden accounted for under NEW Not included in clearance perform validity and drug tests. section 26.125(b) and (c)
Moved 26.31(d)(3)(iii)(A): Document more stringent cutoff levels 2.0 8.0 16.0 Moved to Table 1 (16.0)
(to Table 1)
Moved 26.31(d)(3)(iii)(C): Document evaluation and certification of 2.0 8.0 16.0 Moved to Table 1 (16.0)
(to Table 1) more stringent cutoff levels Removed.
26.31(d)(6): Donor provides written permission to conduct This is a testing limitation provision and REMOVED - 1.0 - -
another analysis or test on a specimen does not have a corresponding recordkeeping or reporting burden.
Duplicative Burden accounted for under 26.33: Behavioral observation records 28.0 400.0 11,200.0 (11,200.0)
Burden section 26.189(c)
Moved 26.35(a): Employee assistance program (EAP) records 28.0 16.0 448.0 Moved to Table 4 (448.0)
(to Table 4) 26.35(c): Record of written waiver of right to privacy from Updated 28.0 2.0 56.0 13.0 2.0 26.0 (30.0) individuals given to the Employee Assistance Program (EAP) 26.35(c): Record of EAP disclosure to a licensee or other Updated entity that an individual poses an immediate hazard, or who 14.0 1.0 14.0 13.0 1.0 13.0 (1.0) has waived in writing the right to privacy 26.37(b)(1): Record of signed consent from individual to Updated disclose information collected under Part 26 to the 28.0 40.0 1,120.0 26.0 2.5 64.5 (1,055.5) individuals representative on an FFD matter 26.37(c): Record of signed release from subject individual to Updated disclose personal information collected under Part 26 to other 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) licensees or other entities 26.37(d): FFD management provides records to individual on Updated 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) an FFD violation Duplicative 26.39(a): Maintain procedures for the review of FFD violation Burden accounted for under 28.0 40.0 1,120.0 (1,120.0)
Burden determinations section 26.27(c) 26.39(b): D&A testing program provides notice to an NEW individual of the grounds of an FFD policy violation Not included in clearance 26.0 87.3 2,270.6 2,270.6 determination and review procedures 26.39(d): If a review of an FFD violation finds in favor of the Updated individual, the licensee or other entity updates records (delete 28.0 40.0 1,120.0 6.0 16.0 96.0 (1,024.0) or correct information found to be inaccurate) 26.39(e): C/V with a D&A testing program provides review Updated - 0.5 - 1.0 0.5 0.5 0.5 procedures to each individual that has violated the FFD policy Burden accounted for under Burden accounted for under 26.41(a), (b), and (c): Record of audits -
section 26.41(f) 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)
Page 6 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 26.41(g): Sharing of audit reports - D&A testing programs may jointly conduct audits or accept audits of C/Vs and HHS Updated 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) labs conducted by other D&A testing programs (if the audit addresses the same services utilized by each program) 26.53(e)(2): Record that C/Vs informed licensee of the denial Updated 1.0 120.0 120.0 1.0 13.0 13.0 (107.0) or termination of an individual's authorization 26.53(g): Record that CVs and other licensees informed of 7.0 8.0 56.0 0 8.0 - (56.0)
Part 26 violations 26.53(h): Obtain and retain written consent from each Updated individual before initiating any actions under Subpart C of 28.0 1,677.0 46,956.0 26.0 156.2 4,061.0 (42,895.0)
Part 26 26.53(i): Individual applying for authorization is informed in Updated writing of the reason(s) for denial or termination of 28.0 23.3 652.4 26.0 21.8 567.7 (84.7) authorization 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update Burden accounted for under sections 26.59(a)(1) - (a)(2): Authorization reinstatement Burden accounted for under Updated 26.61(a), (a)(1), and (a)(2), -
For each individual applying for authorization, a record of a sections 26.61 and 26.63 and 26.63 (a), (c), and (e) completed self-disclosure, employment history, and suitable inquiry is maintained 26.59(c)(1): Obtain, review, and retain an applicants self- Burden accounted for under Burden accounted for under Updated -
disclosure section 26.61 section 26.61(a), (a)(1) and (a)(2) 26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an Updated 28.0 1,197.0 33,516.0 26.0 1,561.9 40,609.7 7,093.7 applicants written self-disclosure and employment history 26.61(b) and (c): Specify the information to be collected in Burden accounted for under NEW Not included in clearance the self-disclosure and employment history section 26.61(a), (a)(1) and (a)(2) 26.63(a), (c), and (e): Obtain, review, and retain an Updated 28.0 1,197.0 33,516.0 26.0 1,561.9 40,609.7 7,093.7 applicants suitable inquiry 26.63(c)(2): Obtain, review, and retain information on an Updated 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) applicants U.S. military service (i.e., form DD 214) 26.63(c)(3): Document inability to obtain information from an Updated 28.0 2.7 75.6 26.0 3.0 78.0 2.4 applicants past employer(s) 26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) programs 26.63(f): Specifies the time periods that a suitable inquiry Burden accounted for under NEW must cover (for initial authorization, authorization update, and Not included in clearance section 26.63(a), (c) and (e) authorization reinstatement) 26.65(d) and (e): Record of reinstatement or administrative 28.0 4.0 112.0 26.0 4.0 104.0 (8.0) withdrawal of authorization 26.65(f): Authorization reinstatement after an interruption --
Updated record of administrative withdrawal of authorization under 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) section 26.65(d)(1)(ii) or (e)(2)(iii)(B) 26.67 Record of random D&A testing of persons who have Duplicative Burden accounted for under section applied for authorization and who have received a pre-access 28.0 5.5 154.0 (154.0)
Burden 26.183(d)(2)(i) test, but who have yet to be granted authorization 26.69(b) and (c)(1): Authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified Burden accounted for under Burden accounted for under Updated -
-- obtain, review, and retain an applicants self-disclosure and section 26.713(a)(1) section 26.61(a) employment history 26.69(c)(2): Record that the licensee or other entity identified Updated and resolved PDI (not reviewed and favorably resolved by a 28.0 40.0 1,120.0 26.0 62.5 1,624.4 504.4 previous licensee or other entity) 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- Burden accounted for under Updated 28.0 40.0 1,120.0 (1,120.0) year denial for a 2nd positive result) has abstained from section 26.69(c)(4) substance abuse for at least 5 years 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 Updated 28.0 3.0 84.0 26.0 40.0 1,040.0 956.0 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) 26.69(c)(5): Record of negative results for pre-access D&A Updated 28.0 1.0 28.0 26.0 52.1 1,353.7 1,325.7 testing (needed prior to granting authorization) 26.69(d): Record of reviewing officials determination on an Updated 28.0 24.0 672.0 26.0 24.0 624.0 (48.0) applicants request for access authorization Page 7 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 26.69(e): Record that follow-up testing and treatment plan for an applicant from the D&A testing program of another Updated 28.0 8.0 224.0 26.0 8.0 208.0 (16.0) licensee or other entity has been verified (that is treatment and follow-up testing successfully completed) 26.69(e)(1): Record that information transmitted on testing Updated and treatment plans to other FFD programs (at donor 28.0 8.0 224.0 26.0 8.0 208.0 (16.0) request) 26.75(a) - (e), and (g): Records of sanctions for FFD Burden accounted for under Consolidated 28.0 12.0 336.0 (336.0) violations section 26.39(b) 26.75(h): Record that an individuals authorization was administratively withdrawn due to impairment confirmed Updated 28.0 18.0 504.0 26.0 15.6 405.3 (98.7) under section 26.189, or because the individual posed a safety hazard 26.75(i): Record of temporary administrative withdrawal of an Updated individual's authorization due to an initial positive test result 28.0 80.0 2,240.0 0 80.0 - (2,240.0) for marijuana and/or cocaine at an LTF 26.75(i)(3): Eliminate from an individuals record any references to a temporary administrative withdrawal of Updated authorization due to an initial positive marijuana and/or 28.0 1.0 28.0 0 1.0 - (28.0) cocaine test result at an LTF that did not confirm positive after testing at an HHS lab 26.85(a) and (b): Training of urine and alcohol collectors and Updated 28.0 8.0 224.0 26.0 8.0 208.0 (16.0) maintain training records in personnel files 26.87(d)(3): If a collection site cannot be dedicated solely to collecting specimens, secure the portion of the facility when a Updated 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) specimen collection is in process and post a sign indicating access permitted only to authorized personnel 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 Updated gender observer (in the exceptional event that a designated 28.0 2.0 56.0 2.0 0.5 1.0 (55.0) collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 26.89(a): Collector notifies FFD management that a donor Updated 28.0 1.0 28.0 4.0 0.25 1.0 (27.0) failed to report to the collection site 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-28.0 1.5 42.0 26.0 1.5 39.0 (3.0) testing form obtained 26.89(b)(3): Record that FFD management informed that an Updated 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) individual did not present identification (pre-access testing) 26.89(c): Collector documents on CCF a donor's refusal to Burden accounted for under section Consolidated 28.0 1.0 28.0 (28.0) cooperate with the collection process 26.107(b) 26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT) Burden accounted for under section Burden accounted for under section Updated -
device test results 26.715(b)(2) 26.715(b)(2) 26.91(e)(4): Record that results cancelled after EBT
- 6.0 - 0 6.0 - -
calibration check failure Updated 26.91(e)(5): EBT maintenance records 28.0 6.0 168.0 26.0 6.0 156.0 (12.0) 26.93(a)(6): Document that alcohol pre-test questions Updated 28.0 80.0 2,240.0 26.0 47.1 1,223.6 (1,016.4) communicated to the donor 26.95(b)(5): Record donor identity for initial alcohol breath 28.0 80.0 2,240.0 26.0 47.1 1,223.6 (1,016.4) test Updated 26.97(b)(2): Record reason for new oral fluid alcohol test - 5.0 - 0 0.25 - -
26.97(c)(1): Document reason for failure of 2nd collection Updated - 2.5 - 0 0.25 - -
attempt 26.97(d): Record results and alcohol screening device used - 0.25 - 0 0.25 - -
26.99(b): Record time of initial alcohol test of 0.02 percent or Burden accounted for under section Burden accounted for under section Updated -
higher blood alcohol concentration (BAC) 26.715(b)(2) 26.715(b)(2)
Duplicative 26.101(b)(7): Record time and BAC result of confirmatory Burden accounted for under section Burden alcohol test 26.715(b)(2) 26.103(b): Record that FFD management notified of a Updated 8.0 0.25 2.0 8.0 0.25 2.0 -
confirmatory alcohol test result of 0.01 to 0.02 percent BAC 26.107(b): Collector documents on CCF any donor conduct Updated during collection process indicating an attempt to tamper with 28.0 0.1 2.8 26.0 0.25 6.5 3.7 a specimen, and notifies FFD management 26.109(b)(3): Collector documents on CCF that the donor Updated was unable to provide a specimen in the 3-hour time allotted 28.0 0.5 14.0 26.0 0.25 6.5 (7.5)
(i.e., a shy bladder), and notifies FFD management Page 8 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 26.109(b)(4): Collector documents on CCF if a specimen (less than 30 mL) appears to be tampered with and/or donor Burden accounted for under section Consolidated 28.0 0.3 8.4 (8.4) behavior during collection indicated a possible subversion 26.107(b) attempt, and notifies FFD management 26.111(b): Collector documents on CCF if specimen Burden accounted for under section Consolidated characteristics (color, clarity) indicate possible tampering by 4.0 0.3 1.0 (1.0) 26.107(b) the donor 26.111(c): Collector documents on CCF unusual specimen Burden accounted for under section Consolidated temperature and/or observations during the collection 28.0 0.3 8.4 (8.4) 26.107(b) indicating possible tampering, and notifies FFD management.
26.113(b)(3): Collector completes CCF for split-specimen Burden accounted for under Updated 28.0 0.3 8.4 (8.4) collection section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD Updated manager or MRO to collect a specimen under direct 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) observation Duplicative 26.115(d): Collector documents on CCF that observed Burden accounted for under 28.0 0.3 8.4 (8.4)
Burden collection performed and reason for the observed collection section 26.115(b)
Duplicative 26.115(f)(3): Collector documents on CCF the name of Burden accounted for under 28.0 0.3 8.4 (8.4)
Burden observer of directly observed collection section 26.115(b) 26.117(c) - (e): Collector prepares ID labels and CCF forms Updated 28.0 60.0 1,680.0 26.0 188.2 4,894.4 3,214.4 for specimen shipment 26.119(a), (e), and (f): Written evaluation from the physician who performed a medical evaluation of a donor with a shy Updated 28.0 6.0 168.0 13.0 2.0 26.0 (142.0) bladder (i.e., unable to provide a specimen of adequate volume in the allotted 3-hours) 26.119(b): Record that MRO provided information and Updated instructions to the physician who is to perform the 28.0 2.0 56.0 13.0 1.0 13.0 (43.0) examination of a donor with a shy bladder 26.125(b) and (c): Records on the proficiency and Updated 7.0 16.0 112.0 6.0 16.0 96.0 (16.0) qualifications of LTF personnel 26.127 (a) - (e): Maintain LTF written procedures on the handling of specimens, chain-of-custody procedures, testing Updated 7.0 200.0 1,400.0 6.0 40.0 240.0 (1,160.0) assays, instrument and device setup, and remedial actions for systems and testing devices.
26.129(a): Maintain documentation of access to secure areas Updated 7.0 2.5 17.5 6.0 4.0 24.0 6.5 of an LTF by all authorized individuals (i.e., an access log) 26.129(b): LTF inspects specimen packages, CCFs, and Updated obtains memorandum from specimen collectors to correct 7.0 0.5 3.5 6.0 0.5 3.0 (0.5) identified discrepancies 26.129(b)(1): LTF record of report to senior licensee or other Updated entity management of attempts to tamper with specimens in 7.0 1.0 7.0 0 1.0 - (7.0) transit 26.129(d): LTF procedures for tracking CCF of specimens 7.0 80.0 560.0 6.0 80.0 480.0 (80.0) 26.135(b): LTF record of direction from MRO to send Bottle Updated 7.0 2.2 15.4 6.0 0.5 3.0 (12.4)
B of a split specimen to a second HHS lab for testing 26.137(a): Record of a QA/QC program and procedures for 7.0 4.0 28.0 6.0 4.0 24.0 (4.0)
LTF 26.137(b)(1)(ii): LTF documentation of performance testing Updated of a device not approved by SAMHSA for point-of-collection 2.0 40.0 80.0 0 40.0 - (80.0) testing 26.137(b)(1)(iii): LTF documentation of annual test results for Updated a device not approved by SAMHSA for point-of-collection 2.0 20.0 40.0 0 20.0 - (40.0) testing 26.137(b)(3): LTF records submitting 1 in 10 specimens that Updated test negative on validity screening testing are sent to an HHS 7.0 40.0 280.0 0 40.0 - (280.0) lab as part of the LTF's QA program 26.137(d)(6): LTF records that 1 in 10 specimens that test NEW negative on initial validity testing are sent to an HHS lab for Not included in clearance 6.0 40.0 240.0 240.0 testing as part of the LTFs QA program Duplicative 26.137(e)(7): LTF documented procedures to protect against Burden accounted for under 7.0 2.0 14.0 (14.0)
Burden carryover material section 26.127 (a) - (e)
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) 26.139(d): Record that the LTF prepared a summary of test Updated results for inclusion in the FFD annual program performance 7.0 40.0 280.0 6.0 40.0 240.0 (40.0) report submitted under section 26.717 Moved 26.153(e): Record of pre-award inspection of new HHS lab 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)
(to Table 1) (completed prior to awarding contract for testing services)
Moved 26.153(f): Records that Part 26 specified requirements 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)
(to Table 1) included in contract with HHS lab Page 9 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 26.153(g): Record of memorandum sent to the HHS lab Updated 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) explaining use of non-federal CCF form 26.159(b)(1): Record that the licensee or other entity Updated 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 28.0 1.0 28.0 0 1.0 - (28.0) identifying evidence of tampering with specimen.
26.159(i): Record of written authorization to store specimens 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) other than 1 year Duplicative 26.163(a)(2): Record that special analyses testing conducted Burden accounted for under section 28.0 1.0 28.0 (28.0)
Burden on a dilute specimen and report of the test results 26.169(c)(1) 26.165(b)(1): Record of a donor request for the retesting of Duplicative Burden accounted for under section an aliquot of a single specimen or the testing of the Bottle B 28.0 1.0 28.0 (28.0)
Burden 26.165(b)(6) split specimen at a second HHS lab 26.165(b)(2): Record that MRO informed the donor of the Duplicative opportunity to request the retesting of an aliquot of a single Burden accounted for under section 28.0 0.5 14.0 (14.0)
Burden specimen or the testing of the Bottle B split specimen at a 26.185(c) second HHS lab 26.165(b)(3): Donor's written permission provided to the MRO for the retesting of an aliquot of a single specimen or Burden accounted for under section Burden accounted for under section Updated -
the testing of the Bottle B split specimen at a second HHS 26.165(b)(1) 26.165(b)(6) lab 26.165(b)(4): Record that the donor presented Duplicative Burden accounted for under section documentation to the MRO on the inability to submit a timely 6.0 0.2 1.2 (1.2)
Burden 26.185(c) request to initiate specimen retesting at a second HHS lab 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 Updated 28.0 3.0 84.0 26.0 1.2 31.1 (53.0) split specimen, informs the donor of the results, and notified FFD management 26.165(c)(4): Results report received from the second HHS Burden accounted for under Updated lab that performed retesting an aliquot of a single specimen 12.0 2.5 30.0 (30.0) section 26.165(b)(6) or the testing of the Bottle B split specimen 26.165(f)(1): Adjustments to personnel files and written notifications regarding the results of retesting an aliquot of a Updated 28.0 6.0 168.0 0 6.0 - (168.0) single specimen or testing of the Bottle B split specimen, including temporary administrative action 26.165(f)(1)(iv) and (f)(2): Written record and notice that Updated records purged of references to temporary administrative 28.0 8.0 224.0 0 8.0 - (224.0) action 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),
Updated demonstrating that retesting of all positive, adulterated, 12.0 1.0 12.0 0 1.0 - (12.0) 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 26.168(a) Maintain documentation of HHS lab certification of NEW Not included in clearance 26.0 2.6 67.0 67.0 BPTS formulation 26.168(i)(2): Licensee or other entity completes CCF for a Moved BPTS, places fictional initials on specimen labels, and Moved from Table 4 26.0 34.4 893.3 893.3 (from Table 4) indicates on the MRO copy of the CCF that the specimen is a BPTS 26.169(a): Records of reports of test results from the HHS Burden covered under Burden accounted for under Updated -
lab section 26.169(c)(1) through (c)(5) section 26.183(c)(1) 26.169(c)(1): Records of HHS lab reports of positive, Duplicative Burden accounted for under adulterated, substituted, dilute, and invalid test results 12.0 80.0 960.0 (960.0)
Burden section 26.183(c)(1) received by the MRO 26.169(c)(2): Records of HHS lab reports of the numerical Duplicative Burden accounted for under values of all positive drug test results (i.e., quantitative test 12.0 1.0 12.0 (12.0)
Burden section 26.183(c)(1) results requested by MRO)
Duplicative 26.169(c)(2): Records of HHS lab reports of quantitative test Burden accounted for under 12.0 0.5 6.0 (6.0)
Burden results for opiates section 26.183(c)(1)
Duplicative 26.169(c)(3): Records of HHS lab reports of quantitative test Burden accounted for under 12.0 2.5 30.0 (30.0)
Burden results for adulterated or substituted test results section 26.183(c)(1) 26.169(c)(4): Record of MRO contact with HHS lab to Duplicative Burden accounted for under discuss whether testing by another HHS lab should be 12.0 2.0 24.0 (24.0)
Burden section 26.185(f)(1) conducted on a specimen with an invalid result Duplicative Burden accounted for under 2.0 1.0 2.0 (2.0)
Burden section 26.183(c)(1) 26.169(f): Records of HHS lab transmittals of CCF copies for Updated 12.0 109.5 1,314.0 26.0 47.1 1,223.6 (90.4) negative results to the MRO Page 10 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 26.169(g): HHS lab copy of the original CCF for each Duplicative Burden accounted for under positive, adulterated, substituted, dilute, and invalid test 12.0 44.7 536.4 (536.4)
Burden section 26.169(c)(1) results to the MRO 26.169(h): Record of HHS lab statistical summary report of Updated 12.0 40.0 480.0 26.0 2.0 52.0 (428.0) urinalysis testing results (for the calendar year)
Updated 26.183(a): Documentation of MRO qualifications 28.0 3.5 98.0 26.0 4.0 104.0 6.0 26.183(c)(1): MRO review of HHS lab test result record for Updated positive, adulterated, substituted, invalid, or at the licensee's 28.0 19.1 534.8 26.0 2.0 51.8 (483.1) or other entity's discretion, dilute specimen 26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug Updated positive, adulterated, substituted, or refusal to test result to 28.0 19.1 534.8 26.0 2.0 51.8 (483.1) the licensees designated reviewing official 26.183(d)(2)(i): Record of MRO staff review and reporting of Updated 28.0 292.2 8,181.6 26.0 282.4 7,341.5 (840.1) negative test results to FFD management 26.183(d)(2)(ii): Record of MRO staff review of CCFs for Updated positive, adulterated, substituted and invalid results and 28.0 1.9 53.2 26.0 2.4 62.1 8.9 forwards changes to MRO for review 26.185(a) Record of MRO review of a drug positive, Burden accounted for under Updated 28.0 26.0 728.0 (728.0) adulterated, substituted, dilute, or invalid HHS lab test result section 26.183(c)(1) 26.185(c): Record of MRO discussion of positive, Updated adulterated, substituted, dilute, or invalid test result with 28.0 26.0 728.0 26.0 11.9 310.5 (417.5) donor Duplicative 26.185(d)(1): Documentation that donor declined to discuss Burden accounted for under section 28.0 2.0 56.0 (56.0)
Burden test results with MRO 26.185(c) 26.185(e): Documentation reviewed by the MRO on a donors Updated inability to discuss test results and a request to reopen 28.0 0.3 8.4 26.0 0.5 13.0 4.6 proceeding 26.185(f)(1): Record of MRO consultation with HHS lab to Updated determine whether additional testing needed for an invalid 28.0 0.5 14.0 26.0 0.5 13.0 (1.0) specimen Duplicative 26.185(f)(2): Record of MRO contact with donor about an Burden accounted for under 28.0 0.5 14.0 (14.0)
Burden invalid test result, and medical information received section 26.185(c)
Duplicative 26.185(h)(1): Record of MRO contact with donor about a Burden accounted for under 28.0 2.0 56.0 (56.0)
Burden substituted test result, and medical information received section 26.185(c)
Duplicative 26.185(h)(2): Record of MRO confirmation of a substituted Burden accounted for under 28.0 2.0 56.0 (56.0)
Burden test result (no legitimate medical explanation) section 26.183(d)(1)(ii)(D)
Duplicative 26.185(h)(3): MRO record of determination of a legitimate Burden accounted for under 28.0 1.0 28.0 (28.0)
Burden medical explanation for a substituted test result section 26.183(d)(2)(i)
Duplicative 26.185(i)(1): Record of MRO contact with donor about an Burden accounted for under 28.0 2.0 56.0 (56.0)
Burden adulterated test result, and medical information received section 26.185(c)
Duplicative 26.185(i)(2): Record of MRO confirmation of an adulterated Burden accounted for under 28.0 2.0 56.0 (56.0)
Burden test result (no legitimate medical explanation) section 26.183(d)(1)(ii)(D)
Duplicative 26.185(i)(3): MRO record of determination of a legitimate Burden accounted for under 28.0 1.0 28.0 (28.0)
Burden medical explanation for an adulterated test result section 26.183(d)(2)(i) 26.185(j): Prescription medication drug positives (applies to amphetamine, morphine, and codeine results) - records of Updated 28.0 1.5 42.0 26.0 2.3 60.0 18.0 MRO review of HHS lab result, discussion of positive result with donor, and review medication information from the donor 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). Burden accounted for under Duplicative If the individual poses a potential risk to public health and 28.0 1.0 28.0 sections 26.183(d)(2)(i) and 26.185(c) (28.0)
Burden safety because of impairment while on duty - the MRO will ensure that a determination of fitness is performed) 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 28.0 1.0 28.0 26.0 1.0 26.0 (2.0) is scientifically insufficient for determination of FFD policy violation 26.185(n): Record of MRO review of a positive, adulterated or substituted test result from a second HHS lab (results of Updated retesting a single specimen or testing of a Bottle B split 28.0 2.0 56.0 26.0 0.60 15.5 (40.5) specimen), and MRO communication of the test result to the donor, and report results to FFD management 26.185(o): Record of MRO request and HHS lab report of quantitation test results for testing performed on a specimen Updated 28.0 1.5 42.0 26.0 0.50 13.0 (29.0) from a donor applying for reauthorization following a 1st positive drug test result Duplicative 26.185(p): MRO written notice to licensee or other entity of a Burden accounted for under 28.0 8.0 224.0 (224.0)
Burden positive, adulterated, substituted, or invalid test result section 26.185(c)
Page 11 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 26.713(a)(2): Records pertaining to the determination of a Burden accounted for under Consolidated 28.0 80.0 2,240.0 (2,240.0) violation of FFD policy and related management actions section 26.39(b) 26.713(a)(3): Documentation of the granting and termination Updated 28.0 80.0 2,240.0 26.0 80.0 2,080.0 (160.0) of authorization 26.713(a)(4): Records of determinations of fitness Updated performed under section 26.189 (including recommendations 28.0 80.0 2,240.0 26.0 80.0 2,080.0 (160.0) for treatment and followup testing plans)
Duplicative 26.713(b)(1): Records of FFD training and examinations Burden accounted for under 28.0 160.0 4,480.0 (4,480.0)
Burden conducted under section 26.29 sections 26.29(a) and (b)
Duplicative 26.713(b)(2): Records of audits, audit findings, and corrective Burden accounted for under 28.0 80.0 2,240.0 (2,240.0)
Burden actions taken under section 26.41 sections 26.41(a)-(d), (f) and (g) 26.713(c): Records on 5-year and permanent denials of Burden accounted for under Consolidated 28.0 40.0 1,120.0 (1,120.0) authorization section 26.39(b) 26.713(d): Records of superseded versions of FFD policies Updated 28.0 80.0 2,240.0 26.0 8.0 208.0 (2,032.0) and procedures 26.713(e): Records of written agreements for services under Updated 28.0 16.0 448.0 26.0 16.0 416.0 (32.0)
Part 26 26.713(f): Records of background investigations, credit and Duplicative criminal history checks, and psychological assessments of Burden accounted for under 28.0 80.0 2,240.0 (2,240.0)
Burden FFD program personnel conducted under section section 26.31(b)(1)(i) 26.31(b)(1)(i) 26.713(g): Documentation on testing for additional drugs as Moved permitted under section 26.31(d)(1), use of more stringent 28.0 40.0 1,120.0 Moved to Table 1 (1,120.0)
(to Table 1) testing cutoff levels as permitted under section 26.31(d)(3),
or both 26.715(a): Documentation of all aspect of testing process at Updated collection sites and LTFs (not otherwise specified in section 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) 26.715(b))
26.715(b)(1): Retain personnel files on staff at collection sites Updated 28.0 20.0 560.0 26.0 20.0 520.0 (40.0) and LTFs 26.715(b)(2): Retain collection site and LTF chain-of-custody Updated 28.0 240.0 6,720.0 26.0 240.0 6,240.0 (480.0) documents 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) 26.715(b)(4): Retain superseded procedures (LTFs and Updated 28.0 40.0 1,120.0 26.0 40.0 1,040.0 (80.0) collection sites) 26.715(b)(5): Retain all test data from LTF (including Updated calibration curves and any calculations used in determining 28.0 240.0 6,720.0 6.0 240.0 1,440.0 (5,280.0) test results 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) 26.715(b)(8): Records from LTF and HHS lab on the Updated investigation of testing errors or unsatisfactory performance, 28.0 40.0 1,120.0 8.0 40.0 320.0 (800.0) and any corrective actions taken Moved 26.715(b)(9): Performance records on HHS lab certification 28.0 40.0 1,120.0 Moved to Table 4 (1,120.0)
(to Table 4) inspections 26.715(b)(10): Records of preventative maintenance on LTF Updated 28.0 40.0 1,120.0 6.0 40.0 240.0 (880.0) instruments 26.715(b)(11): Retain records that summarize any test Updated results the MRO determined to be scientifically insufficient for 28.0 20.0 560.0 1.0 3.0 3.0 (557.0) further action 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) 26.715(b)(13): Retain records (e.g., an access log) of Duplicative Burden accounted for under section authorized visitors, maintenance personnel and service 28.0 20.0 560.0 (560.0)
Burden 26.129(a) personnel who accessed LTF secure areas 26.715(b)(14): Retain records of the inspection, maintenance Updated 28.0 20.0 560.0 26.0 20.0 520.0 (40.0) and calibration of EBTs (collection sites) 26.717(a) and (b): Collect FFD performance data for D&A 28.0 100.0 2,800.0 26.0 100.0 2,600.0 (200.0) testing programs 26.717(a) and (b): Collect FFD performance data for fatigue 23.0 100.0 2,300.0 21.0 100.0 2,100.0 (200.0) management program 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 23.0 40.0 920.0 21.0 40.0 840.0 (80.0) annually 26.717(d): D&A test results leading to termination 1.0 1.0 1.0 1.0 1.0 1.0 -
Duplicative 26.717(g): Collect and report D&A testing program data to Burden accounted for under 1.0 120.0 120.0 (120.0)
Burden the NRC (for C/V with a testing program) section 26.717(a) and (b) 26.719(b): Prepare information to make a 24-hour event Updated 1.2 1.0 1.2 37.0 1.0 37.0 35.8 report to the NRC 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 30.0 20.0 600.0 28.0 20.0 560.0 (40.0) program weaknesses Page 13 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 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) 26.189(d): Record of modification of an initial determination Updated 28.0 1.0 28.0 1.0 1.0 1.0 (27.0) of fitness 26.203(a): Prepare fatigue management policy (In addition to 2.0 7.3 14.6 0 7.3 - (14.6) 26.27 burden) 26.203(b): Prepare fatigue management procedures (in 2.0 1.7 3.4 0 1.7 - (3.4) addition to 26.27 burden) 26.203(c): Prepare training on fatigue management. 2.0 2.0 4.0 0 2.0 - (4.0) 26.203(d)(1) and (d)(2): Records of work hours, shift Burden accounted for under Burden accounted for under Updated -
schedules, and shift cycles 26.205(c), (d)(1), and (e)(4) 26.205(c), (d)(1), and (e)(4)
Burden accounted for under Burden accounted for under 26.203(d)(3): Documentation of waivers -
section 26.207(a)(4) section 26.207(a)(4)
Burden accounted for under Burden accounted for under 26.203(d)(4): Documentation of work hour reviews -
26.205(d)(2), (e)(3) and (e)(4) 26.205(d)(2), (e)(3) and (e)(4)
Burden accounted for under Burden accounted for under 26.203(d)(5): Documentation of fatigue assessment -
section 26.211(f) 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 23.0 50.0 1,150.0 21.0 50.0 1,050.0 (100.0) controls 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 23.0 40.0 920.0 21.0 40.0 840.0 (80.0) hours twice per calendar year 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 23.0 20.0 460.0 21.0 20.0 420.0 (40.0) hours 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) 26.403(a): Updates to FFD policy and procedures NEW Not included in clearance 2.0 16.0 32.0 32.0 (reactor construction site D&A testing program)
Moved 26.403(a): Provide FFD policy to individuals subject to a Moved from Table 1 2.0 8.0 16.0 16.0 (from Table 1) reactor construction site D&A testing program 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) 26.405(c)(2) and (c)(3): Records of for-cause and post Updated 2.0 197.0 394.0 2.0 308.8 617.7 223.7 accident D&A tests 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 26.405(d): Record of testing for specified drugs, adulterants, Burden accounted for under Moved to Table 1 -
(to Table 1) and alcohol, at Part 26 specified cutoff levels section 26.405(a) - (c)(4) 26.405(e): Updates to specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the Updated 2.0 40.0 80.0 2.0 40.0 80.0 -
specimen, and stringent quality controls to ensure accurate test results 26.405(f): Record that testing conducted at an HHS lab 2.0 40.0 80.0 2.0 40.0 80.0 -
26.405(g): Record of MRO review of positive, adulterated, Updated substituted, and invalid drug and validity test results (reactor 2.0 50.0 100.0 2.0 81.3 162.5 62.5 construction site D&A testing program) 26.406(c): Updates to fitness monitoring procedures Updated (programs that do not adopt random testing and behavioral - 80.0 - 0 80.0 - -
observation) 26.411(a): Updates to procedures for maintaining a system Updated of files to protect personal information collected under 2.0 4.0 8.0 2.0 40.0 80.0 72.0 Subpart K of Part 26 26.411(a) and (b): Collection of personal information under Updated 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 -
26.417(a): Records pertaining to the administration of a Updated 2.0 20.0 40.0 2.0 20.0 40.0 -
reactor construction site D&A testing program 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 /> Burden accounted for under NEW programmatic failures in a reactor construction site D&A Not included in clearance section 26.719(b) testing program 26.417(b)(2) Collect FFD program performance data for Updated 2.0 100.0 200.0 2.0 100.0 200.0 -
reactor construction site D&A testing program 26.713(a)(1): Records of self-disclosures, employment Duplicative Burden accounted for under section histories, and suitable inquiries (under sections 26.55, 26.57, 28.0 80.0 2,240.0 (2,240.0)
Burden 26.61(a), and 26.63(a), (c), and (e) 26.59, and 26.69) that result in the granting of authorization Page 12 of 24
Final Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 2: Annual Recordkeeping (approved 11/30/14 - ICR 201407-3150- (2017-2020)
Index Key:
Burden
- New Total Burden Total Number of Burden Number of Estimate
- Updated Annual Hours per Annual Section Record- Hours per Record- Change
- Moved Burden Record- Burden keepers Recordkeeper keepers
- Duplicative Hours keeper Hours
- Removed 26.821(a): Provide NRC with access to records (to inspect, Updated 30.0 4.0 120.0 28.0 4.0 112.0 (8.0) copy, or take away copies of records) 26.821(b): Written agreement between C/Vs and licensees to Updated permit authorized NRC representatives to inspect, copy, or 1.0 4.0 4.0 1.0 4.0 4.0 -
take away copies of C/Vs documents, records, and reports 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 Approved Clearance Values Extension Table 3: Annual Reporting (approved 11/30/14 - ICR 201407-3150-007) (2017-2020) Burden Index Key: Responses Burden per Total Responses Burden per Total Estimate Number Total Number Total
- Updated Section per Response Burden per Response Burden Change of Respondents Responses of Respondents Responses
- Removed Respondent (hours) Hours Respondent (hours) 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 - -
26.137(b)(3): Report false negative LTF No LTF conducts validity screening testing Updated Burden accounted for under section 26.719(c)(3) -
validity screening result (if any did, burden would be accounted for under section 26.719(c)(3) 26.139(d): Prepare information from LTF for REMOVED Removed Burden accounted for under section 26.717(e) and (f) -
annual FFD program performance report (Activity covered in Table 2) 26.187(f): Provide SAE qualifications REMOVED Removed 1.0 1.0 1.0 1.0 1.0 (1.0) documentation to NRC upon request (Activity covered in Table 2) 26.203(e)(1): Prepare information on waivers of work hour controls for inclusion Updated 23.0 1.0 23.0 50.0 1,150.0 21.0 1.0 21.0 50.0 1,050.0 (100.0) in FFD program performance report to NRC required by 26.717 26.203(e)(2): Prepare summary of fatigue 6.0 corrective actions for inclusion in FFD Updated 23.0 1.0 23.0 138.0 21.0 1.0 21.0 6.0 126.0 (12.0) program performance report to NRC required by 26.717 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 Updated 2.0 1.0 2.0 4.0 8.0 Burden accounted for under section 26.719(b) (8.0) programmatic failure in a reactor construction site D&A testing program 26.417(b)(2): Prepare annual FFD program Updated performance report for reactor construction 2.0 1.0 2.0 80.0 160.0 2.0 1.0 2.0 80.0 160.0 -
site D&A testing program Burden accounted for under section 26.717(e) and (f). NRC's 2012 FFD program 26.717(d): Report termination drug and Removed Removed alcohol test results in annual program performance indicate 1,089 positive, adulterated, substituted, and refusal to test -
(All burden is captured under a single 26.717 line items for D&A results) performance summary by processing stage results.
26.717: Annual FFD program performance Updated 62.0 1.0 62.0 8.0 496.0 59.0 1.0 59.0 8.0 472.0 (24.0) report for fatigue management programs 26.717: Annual FFD program performance Updated 65.0 1.0 65.0 60.0 3,900.0 67.0 1.0 67.0 60.0 4,020.0 120.0 for D&A testing programs 26.719(a): Report a significant FFD Updated program violation, programmatic failure, or Burden accounted for under section 26.719(b) and (c) Burden reported under sections 26.719(b), and (c)(1) - (c)(3) -
D&A testing error 26.719(b): Report to the NRC by telephone Updated 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 15.0 2.5 37.1 4.0 148.2 37.0 1.0 37.0 4.0 148.0 (0.2)
D&A testing violation 26.719(c)(1): Submit a report to the NRC within 30 days of completing an Updated 6.0 1.0 6.0 24.0 144.0 8.0 1.0 8.0 24.0 192.0 48.0 investigation into an LTF or HHS lab testing error 26.719(c)(2): Notify the NRC by telephone Updated 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 1.0 1.0 1.0 4.0 4.0 0 1.0 - 4.0 - (4.0) positive on a BPTS test result 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 Updated 4.0 1.0 4.0 4.0 16.0 0 1.0 - 4.0 - (16.0) test result on a QA check of a validity screening test from an LTF Table 3 Total 226.1 6,165.2 215.0 6,168.0 2.8 Page 15 of 24
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key:
- Consolidated Burden
- Duplicative Total Total Estimate Number Burden Burden
- Moved Section Annual Number Annual Change of Hours per Hours per
- New Burden of Responses Burden Responses Response Response
- Removed Hours 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 Updated requirements met (if not already covered in the existing 14.0 2.0 28.0 33.5 2.0 67.0 39.0 program); (2) notification of any FFD policy violations by those granted authorization by the licensee or other entity Moved 26.29(b): Complete initial training on FFD policy and take Not included in clearance 81,219.3 2.0 162,438.6 162,438.6 (from Table 1) comprehensive examination (was in Table 1 but zero programs)
Moved 26.29(c)(2): Complete annual refresher training on FFD Not included in clearance 103,932.7 1.5 155,899.0 155,899.0 (from Table 1) policy (was in Table 1 but zero programs) 26.31(b)(1)(i): Individual applying for access to serve as FFD program personnel provides background check Updated information for the background investigation, credit and 93,890.0 1.0 93,890.0 335.0 1.0 335.0 (93,555.0) criminal history checks, and psychological assessment 26.31(d)(6): Donor provides written permission to conduct Removed Removed 8.0 1.0 8.0 (8.0) another analysis or test with specimen (not an information collection)
Updated 26.35(a): Employee assistance program (EAP) records 14.0 32.0 448.0 26.0 32.0 832.0 384.0 26.35(c): Individual completes and provides the EAP with a Updated written waiver of right to privacy to share information with 5,636.0 0.3 1,690.8 1,039.3 0.25 259.8 (1,431.0)
FFD management 26.35(c): Record of EAP disclosure to FFD management Updated 15.0 1.0 15.0 13.0 1.0 13.0 (2.0) about an individual that poses an immediate hazard 26.37(b): Individuals provide signed consent for release of Updated 1,127.0 0.3 338.1 258.0 0.25 64.5 (273.6) information 26.37(b)(1): Individual provides signed designation of Updated 961.0 1.0 961.0 258.0 0.25 64.5 (896.5) personal representative for an FFD matter 26.37(d): Request by donor or donors presentative to the Updated licensee or other entity to provide personal records collected 961.0 1.0 961.0 26.0 0.25 6.5 (954.5) under Part 26 26.53(h): Applicant provides written consent before any Updated 93,890.0 0.3 28,167.0 81,219.3 0.25 20,304.8 (7,862.2) actions are initiated under Subpart C of Part 26 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update 26.59(a)(1) - (a)(2): Authorization reinstatement Burden accounted for under Burden accounted for under Updated Each individual applying for authorization must complete a -
sections 26.61 and 26.63 sections 26.61(a) and 26.63(a),(c) and (e) self-disclosure, employment history, and suitable inquiry 26.59(c)(1): Applicant prepares self-disclosure (for Burden accounted for under Burden accounted for under Updated authorization reinstatement period of interruption of no more -
section 26.61 sections 26.61(a) than 30 days) 26.61(a): Applicant prepares self-disclosure and Updated 93,890.0 1.0 93,890.0 81,219.3 1.0 81,219.3 (12,670.7) employment history 26.63(a), (c), and (e): Former employer(s) provide information to the licensee or other entity to verify an Updated applicants suitable inquiry information on previous 93,890.0 0.80 75,112.0 81,219.3 0.75 60,914.5 (14,197.5) authorization(s) 26.63(c)(2): U.S. Department of Defense (DOD) provides Burden of supplying DD 214 affects DOD, or Updated licensee or other entity with form DD 214 which details an Burden of supplying DD 214 affects DOD is accounted for under section 26.61(a) (if -
applicants military service record supplied by the applicant) 26.63(c)(3): Former employer refuses to provide information Updated to the licensee or other entity about an applicants prior 180.0 0.5 90.0 180.0 0.1 15.0 (75.0) employment history 26.67: Records of random D&A testing of persons who have Updated applied for authorization, but who have not been granted 335.0 0.5 167.5 406.1 0.5 203.0 35.55 unescorted access authorization 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 Burden accounted for under Burden accounted for under Updated -
or alcohol test result, or if other PDI is identified) section 26.63 section 26.61(a) 26.69(c)(2): Former employer(s) of an applicant provide Updated response to licensee or other entity request to confirm 939.0 2.0 1,878.0 812.2 2.0 1,624.4 (253.6) suitable inquiry information for an applicant with PDI 26.85(c): Alternative collectors not employed by licensee Updated 22.0 1.0 22.0 26.0 1.0 26.0 4.0 provide proof of qualification 26.85(e): Maintain personnel files for alternative collectors Updated 22.0 4.0 88.0 26.0 4.0 104.0 16.0 Page 16 of 24
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key:
- Consolidated Burden
- Duplicative Total Total Estimate Number Burden Burden
- Moved Section Annual Number Annual Change of Hours per Hours per
- New Burden of Responses Burden Responses Response Response
- Removed Hours Hours
- Updated 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 Consolidated observer (in the exceptional event that a designated 2.0 1.0 2.0 Consolidated in Table 2 (2.0)
(in Table 2) collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 26.89(a): Record that a donor did not appear for testing (non Updated 2.0 1.0 2.0 2.0 1.0 2.0 -
licensee collection site) 26.89(b)(3): Record FFD management informed that an Updated individual did not present identification (non-licensee 2.0 1.0 2.0 2.0 1.0 2.0 -
collection site) 26.89(c): Record that FFD management informed that a Updated donor refused to cooperate with the collection procedures 2.0 1.0 2.0 - 0.25 - (2.0)
(non-licensee collection site) 26.91(e)(4): Record that results cancelled after EBT Updated 1.0 1.0 1.0 - 1.0 - (1.0) calibration check failure (non-licensee collection site) 26.91(e)(5): Prepare record of EBT maintenance (non-Updated 22.0 4.0 88.0 26.0 4.0 104.0 16.0 licensee collection site) 26.93(a)(6): Document alcohol pre-test questions asked and Updated 280.0 0.3 84.0 260.0 0.25 65.0 (19.0) answered (non-licensee collection site) 26.95(b)(5): Record donor identity for initial alcohol breath Updated 280.0 0.3 84.0 260.0 0.25 65.0 (19.0) test (non-licensee collection site) 26.97(b)(2): Record reason for new oral fluid alcohol test Updated 8.0 0.5 4.0 - 0.5 - (4.0)
(non-licensee collection site) 26.97(c)(1): Document reason for failure of second Updated 1.0 1.0 1.0 - 1.0 - (1.0) collection attempt (non-licensee collection site) 26.97(d): Record results and alcohol screening device used Updated 8.0 0.3 2.4 - 0.25 - (2.40)
(non-licensee collection site)
Duplicative 26.99(b): Record test time of initial test with 0.02 percent Burden accounted for under 1.0 0.3 0.3 (0.30)
Burden BAC or higher (non-licensee collection site) section 26.715(b)(2)
Duplicative 26.101(b)(7): EBT printout of confirmatory alcohol test result Burden accounted for under 1.0 0.3 0.3 (0.30)
Burden includes time of test (non-licensee collection site) section 26.715(b)(2) 26.103(b): Collector informs FFD management of result Updated between 0.01 and 0.02 percent BAC when donor in work - 0.5 - - 0.25 - -
status 3 or more hours (non-licensee collection site)
Duplicative 26.107(b): Collector documents tampering attempt on CCF Burden accounted for under
- 1.0 - -
Burden form (non-licensee collection site) section 26.111(b) 26.109(b)(3): Collector documents on CCF sh- bladder Updated situation and notifies FFD management (non-licensee - 0.5 - - 0.25 - -
collection site) 26.109(b)(4): Collector documents on CCF confirmation Updated from FFD management to conduct a an observed collection - 0.3 - - 0.25 - -
(non-licensee collection site) 26.111(b): Collector documents on CCF if specimen Updated characteristics (color, clarity) indicate possible tampering by 2.0 0.5 1.0 - 0.25 - (1.0) the donor (non-licensee collection site) 26.111(c): Collector documents on CCF unusual specimen temperature and/or other observations made during the Updated collection of possible tampering attempt and notifies FFD - 0.4 - 0.25 - -
management (non-licensee collection site)
Duplicative 26.113(b)(3): Collector completes CCF for split-specimen Burden accounted for under
- 0.3 - -
Burden collection (non-licensee collection site) section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD Updated manager or MRO to collect a specimen under direct - 0.3 - - 0.25 - -
observation (non-licensee collection site) 26.115(d): Collector documents on CCF directly observed Burden accounted for under Updated collection performed and the reason for the observed - 0.3 - -
section 26.115(b) collection (non-licensee collection site) 26.115(f)(3): Record of name of observer (non-licensee
- 0.3 - - 0.25 - -
collection site) 26.117(c) - (e): Collector prepares ID labels and CCF forms Updated for specimen shipment (non-licensee collection site) 280.0 0.3 84.0 260.0 0.25 65.0 (19.0) 26.119(a), (e), and (f): Physician evaluating shy-bladder Updated claim prepares report of medical examination of donor and - 6.0 - 13.0 2.0 26.0 26.0 provides this information to the MRO Consolidated 26.119(b): MRO provides information to physician as
- 2.0 - Consolidated in Table 2 -
(in Table 2) background for evaluation of a shy bladder claim 26.129(b): Collector prepares memorandum to and sends to Updated LTF documenting investigation of discrepancies between - 1.0 - 1.0 - -
bottles and CCF (non-licensee collection site)
Page 17 of 24
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key:
- Consolidated Burden
- Duplicative Total Total Estimate Number Burden Burden
- Moved Section Annual Number Annual Change of Hours per Hours per
- New Burden of Responses Burden Responses Response Response
- Removed Hours Hours
- 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 Burden accounted for under Updated split specimen at a second HHS lab (initial specimen testing 1.0 0.5 0.5 (0.50) section 26.165(b)(1) performed at an LTF) 26.137(b)(3): LTF records submitting 1 in 10 negative Not Third Party Burden Removed specimens for validity screening to HHS lab - 40.0 - -
(accounted for in Table 2) 26.153(g): Supply memorandum to HHS lab explaining use Updated of non-federal CCF form (non-licensee collection site) 2.0 0.5 1.0 2.0 0.5 1.0 -
26.155(a)(1): Document of HHS lab manager qualifications Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(a)(3): HHS lab personnel training documentation Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(a)(4): HHS lab manager reviews and approved lab Burden covered by HHS lab certification Burden covered by HHS lab certification Updated procedures -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(a)(5): HHS lab manager maintains QA program Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(b): Certifying scientist at HHS lab certifies test Burden covered by HHS lab certification Burden covered by HHS lab certification Updated results -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(c): Supervise technical analysts at HHS lab Burden covered by HHS lab certification Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(e): Continuing education of HHS lab staff Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.155(f): HHS lab personnel records Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(a): Written HHS lab procedures for accession, Burden covered by HHS lab certification Burden covered by HHS lab certification Updated receipt, shipment, and testing of urine specimens -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(b): Written HHS lab chain-of-custody procedures for Burden covered by HHS lab certification Burden covered by HHS lab certification HHS lab -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(c): Written HHS lab procedures for each testing Burden covered by HHS lab certification Burden covered by HHS lab certification Updated assay performed -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(d): Written HHS lab procedures for device set-up Burden covered by HHS lab certification Burden covered by HHS lab certification Updated and operation -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.157(e): Written HHS lab procedures for remedial actions Burden covered by HHS lab certification Burden covered by HHS lab certification Updated to address system and instrument errors -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.159(a): Retain records (e.g., an access log) of authorized Burden covered by HHS lab certification Burden covered by HHS lab certification Updated visitors, maintenance personnel, and service personnel who -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 accessed secure areas of HHS lab 26.159(b)(1): Record that the HHS lab notified the licensee NEW 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 Not included in previous clearance 0 1.0 -
specimen tampering 26.159(c) - (e): Use and storage of CCF forms at HHS lab Burden covered by HHS lab certification Burden accounted for under Updated -
requirements OMB Clearance # 0930-0158 section 26.715(b)(2) 26.159(f): Use of CCF by HHS lab when shipping a Burden covered by HHS lab certification Burden accounted for under Updated -
specimen to another HHS lab requirements OMB Clearance # 0930-0158 section 26.165(b)(1) 26.165(b)(1): At the direction of the MRO, the initial HHS lab that conducted testing send a donors specimen (i.e., an Updated aliquot of a single specimen or Bottle B of the split 1.0 1.0 1.0 31.1 1.0 31.1 30.1 specimen) to a second HHS lab for further testing 26.165(b)(2): Record that MRO informed the donor of the Consolidated opportunity to request the retesting of an aliquot of a single 1.0 0.3 0.3 Consolidated in Table 2 (0.30)
(in Table 2) specimen or the testing of the Bottle B split specimen at a second HHS lab 26.165(b)(3): Donor provides written request to the MRO for Updated the retesting of an aliquot of a single specimen or the testing 1.0 1.0 1.0 31.1 1.0 31.1 30.1 of the Bottle B split specimen 26.165(b)(4): Donor presents documentation to the MRO on Duplicative Burden accounted for under the reason for not being able to make a timely retest request - 1.0 - -
Burden section 26.185(e)
Page 18 of 24
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key:
- Consolidated Burden
- Duplicative Total Total Estimate Number Burden Burden
- Moved Section Annual Number Annual Change of Hours per Hours per
- New Burden of Responses Burden Responses Response Response
- Removed Hours Hours
- Updated 26.165(b)(6) HHS lab provides report to the MRO of the Duplicative quantitative test results of the retesting of aliquot of a single Burden accounted for under specimen or the testing of the Bottle B split specimen 1.0 0.5 0.5 (0.50)
Burden section 26.185(n) 26.167(a): HHS lab documents QA program (encompasses Burden covered by HHS lab certification Burden covered by HHS lab certification Updated all aspects of the testing process) -
requirements OMB Clearance # 0930-0158 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 Burden covered by HHS lab certification Burden covered by HHS lab certification and/or document result by hard copy or electronic display requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 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 Burden covered by HHS lab certification Updated time of final resolution of the error back to the time of the - 8.0 - -
requirements OMB Clearance # 0930-0158 last satisfactory performance test cycle has been completed, as requested by the licensee or other entity 26.167(h): HHS lab labels standards and controls Burden covered by HHS lab certification Burden covered by HHS lab certification Updated -
requirements OMB Clearance # 0930-0158 requirements OMB Clearance No. 0930-0158 26.168(a): Blind performance test sample (BPTS) supplier provides HHS lab certification letter of BPTS formulation to Burden covered by HHS lab certification Updated 2.0 8.0 16.0 16.0 licensee or other entity requirements OMB Clearance # 0930-0158 26.168(h)(2): BPTS sample supplier provides expiration Burden covered by HHS lab certification Updated date on each BPTS 2.0 8.0 16.0 16.0 requirements OMB Clearance # 0930-0158 26.168(i)(2): Licensee or other entity completes CCF for a Moved BPTS, places fictional initials on specimen labels, and Burden covered by HHS lab certification indicates on the MRO copy of the CCF that the specimen is Moved to Table 2 -
(to Table 2) requirements OMB Clearance # 0930-0158 a BPTS 26.169(a): HHS lab reports test results to the MRO of the Burden covered by HHS lab certification Burden accounted for under Updated licensee or other entity -
requirements OMB Clearance # 0930-0158 section 26.169(c)(1) 26.169(c)(1): HHS lab provides record to the MRO for each Updated positive, adulterated, substituted, dilute, and invalid test 686.0 0.25 171.5 621.0 0.25 155.3 (16.3) result Duplicative 26.169(c)(2): HHS lab provides quantitative test result Burden accounted for under 5.0 1.0 5.0 (5.0)
Burden record for positive drug test (at the request of the MRO) section 26.169(c)(1)
Duplicative 26.169(c)(2): HHS lab record of quantitative test results for Burden accounted for under 16.0 1.0 16.0 (16.0)
Burden opiates to the MRO (at the request of the MRO) section 26.169(c)(1) 26.169(c)(3): HHS lab provides quantitative test result Duplicative Burden accounted for under record for adulterated or substituted test results (at the 5.0 1.0 5.0 (5.0)
Burden section 26.169(c)(1) request of the MRO) 26.169(c)(4): HHS lab record of contact with MRO to Updated discuss if additional testing by another HHS lab should be 10.0 0.5 5.0 10.0 0.5 5.0 -
conducted on a specimen with an invalid test result 26.169(f): HHS lab transmits to the MRO a copy of CCF for Burden accounted for under Updated Electronic transmission -
specimens with negative test results section 26.715(b)(2) 26.169(g): HHS lab transmits to the MRO a copy of the Duplicative original CCF signed by the certifying scientist (for positive, Burden accounted for under adulterated, substituted, dilute and invalid test result) 686.0 0.5 343.0 (343.0)
Burden section 26.169(c)(1) 26.169(h): HHS lab prepares and submits annual statistical Updated summary report of urinalysis testing results 10.0 40.0 400.0 67.0 2.0 134.0 (266.0)
Consolidated 26.183(a): Documentation of MRO qualifications 28.0 1.0 28.0 Consolidated in Table 2 (28.0)
(in Table 2) 26.183(c)(1): MRO review of records for positive, Consolidated adulterated, substituted, invalid, or, at the licensees or other Burden accounted for under section 26.185(a) Consolidated in Table 2 -
(in Table 2) entity's discretion, dilute test results that confirm as an FFD violation Consolidated 26.183(d)(2)(i): Record of MRO staff review and reporting of 16,383.0 0.1 819.2 Consolidated in Table 2 (819.15)
(in Table 2) negative test results Consolidated 26.183(d)(2)(ii): Record of MRO staff review of CCF forms 54.0 0.1 5.4 Consolidated in Table 2 (5.40)
(in Table 2) and forward changes to MRO 26.185(a) Record of MRO review of all positive, adulterated, Consolidated substituted, or invalid test results and report to licensee or 635.0 1.0 635.0 Consolidated in Table 2 (635.0)
(in Table 2) other entity 26.185(c): Donor discussion with MRO of positive, Updated 635.0 1.0 635.0 621.0 0.5 310.5 (324.5) adulterated, substituted, dilute, or invalid test result Page 19 of 24
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key:
- Consolidated Burden
- Duplicative Total Total Estimate Number Burden Burden
- Moved Section Annual Number Annual Change of Hours per Hours per
- New Burden of Responses Burden Responses Response Response
- Removed Hours Hours
- Updated Consolidated 26.185(d)(1): Documentation that donor declined to discuss 81.0 1.0 81.0 Consolidated in Table 2 (81.0)
(in Table 2) test results 26.185(e): Donor provides documentation to the MRO Updated demonstrating an inability to discuss test results and 8.0 1.0 8.0 8.0 1.0 8.0 -
requesting the test result determination be reopened 26.185(f)(1): HHS lab consultation with MRO on whether Burden accounted for under Updated additional testing of a specimen with an invalid test result 26.0 0.50 13.0 13.0 section 26.185(c) should be performed at a second HHS lab 26.185(f)(2): Donor discussion with MRO regarding an Burden accounted for under Burden accounted for under Updated -
invalid test result section 26.185(c) section 26.185(c) 26.185(h)(1): Donor discussion with MRO regarding a Burden accounted for under Burden accounted for under Updated -
substituted test result section 26.185(c) section 26.185(c)
Consolidated 26.185(h)(2): MRO notification to licensee that no valid Burden accounted for under section 26.185(c) Consolidated in Table 2 -
(in Table 2) medical explanation presented Consolidated 26.185(h)(3): MRO notification to licensee that valid medical Burden accounted for under section 26.185(c) Consolidated in Table 2 -
(in Table 2) explanation presented 26.185(i)(1): Donor discussion with MRO regarding an Burden accounted for under Burden accounted for under Updated -
adulterated test result section 26.185(c) section 26.185(c)
Consolidated 26.185(i)(2): MRO notification to licensee that no valid Burden accounted for under section 26.185(c) Consolidated in Table 2 -
(in Table 2) medical explanation presented 26.185(i)(3): MRO notification to licensee that valid medical Consolidated explanation presented for an adulterated test result Burden accounted for under section 26.185(c) Consolidated in Table 2 -
(in Table 2) 26.185(j) Donor discussion with MRO regarding a positive test result from use of a prescription medication (amphetamine, morphine, codeine), and donor provides Burden accounted for under Updated documentation on medication use to the MRO (e.g., 60.0 1.0 60.0 60.0 section 26.185(c) prescription information and pharmacy, prescribing physician information)
Consolidated 26.185(k): MRO report to licensee that no FFD policy 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
(in Table 2) violation has occurred 26.185(m): MRO review of inspection and audit reports, quality control data, multiple specimens, and other data to Consolidated determine if positive, adulterated, substituted, or invalid 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
(in Table 2) result is scientifically insufficient for determination of FFD policy violation 26.185(n): Second HHS lab provides the MRO with test Updated result report (for retesting of an aliquot of a single specimen 54.0 1.0 54.0 31.1 0.25 7.8 (46.2) or the testing of a Bottle B split specimen) 26.185(o): HHS lab provides report with quantitative test Duplicative results for a specimen from a donor applying for reauthorization following a 1st positive drug test result (at 8.0 0.5 4.0 Duplicate with row below (4.0)
Burden MRO request) 26.185(o): HHS lab provides quantitation of test results for Duplicative testing performed on a specimen from a donor applying for Burden accounted for under reauthorization following a 1st positive drug test result (at 8.0 1.0 8.0 (8.0)
Burden sections 26.169(c)(1)
MRO request)
Consolidated 26.185(p): MRO notice to licensee of determination of FFD Burden accounted for under section 26.185(c) Consolidated in Table 2 -
(in Table 2) policy violation Consolidated 26.187(d): SAE training requirements 24.0 20.0 480.0 Consolidated in Table 2 (480.0)
(in Table 2)
Consolidated 26.187(f): Documentation of SAE credentials and training 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
(in Table 2) 26.189(b): If a qualified treatment professional other than the MRO or SAE performs a determination of fitness on an Updated individual, that treatment professional completes and 69.0 1.0 69.0 26.0 1.0 26.0 (43.0) provides a written determination to the MRO Consolidated 26.189(c): Written record of a For-cause determination of 6.9 1.0 6.9 Consolidated in Table 2 (6.90)
(in Table 2) fitness Consolidated 26.189(d): Modification of an initial determination of fitness 24.0 1.0 24.0 Consolidated in Table 2 (24.0)
(in Table 2) based on information from other sources 26.209(a): Individual declares that due to fatigue, he or she Updated is unable to safety and competently perform his or her 23.0 0.3 6.9 21.0 0.3 6.3 (0.60) duties 26.405(g): For a reactor construction site FFD program, MRO reports of positive, adulterated, substituted, or invalid Removed Removed drug test results (for a reactor construction site FFD D&A 90.0 1.0 90.0 (90.0)
(This is not third-party burden) testing program) 26.411(b): Applicant provides written consent to the reactor Updated construction site D&A testing program 4,675.0 0.3 1,402.5 6,898.0 0.25 1,724.5 322.00 26.715(a): Documentation of all aspects of HHS lab testing Previously accounted for in Table 2 Burden covered by HHS lab certification NEW process, not specified elsewhere in section 26.715(b) -
as Annualized Burden requirements OMB Clearance No. 0930-0158 Page 20 of 24
FINAL Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Approved Clearance Values Extension (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Index Key:
- Consolidated Burden
- Duplicative Total Total Estimate Number Burden Burden
- Moved Section Annual Number Annual Change of Hours per Hours per
- New Burden of Responses Burden Responses Response Response
- Removed Hours Hours
- Updated 26.715(b)(1): Retain personnel files on HHS lab staff Previously accounted for in Table 2 Burden covered by HHS lab certification NEW -
as Annualized Burden requirements OMB Clearance No. 0930-0158 26.715(b)(2): Retain HHS lab chain-of-custody documents Previously accounted for in Table 2 NEW 9.0 240.0 2,160.0 2,160.00 as Annualized Burden 26.715(b)(3): Retain HHS lab QA/QC records Previously accounted for in Table 2 Burden covered by HHS lab certification NEW -
as Annualized Burden requirements OMB Clearance No. 0930-0158 26.715(b)(4): Retain HHS lab superseded procedures Previously accounted for in Table 2 NEW 9.0 40.0 360.0 360.00 as Annualized Burden 26.715(b)(5) Retain all test data from HHS lab (including Previously accounted for in Table 2 Burden covered by HHS lab certification NEW calibration curves and any calculations used in determining -
as Annualized Burden requirements OMB Clearance No. 0930-0158 test results) 26.715(b)(6): HHS lab test reports Previously accounted for in Table 2 NEW 9.0 240.00 2,160.0 2,160.00 as Annualized Burden 26.715(b)(7): HHS lab performance testing records Previously accounted for in Table 2 Burden covered by HHS lab certification NEW -
as Annualized Burden requirements OMB Clearance No. 0930-0158 26.719(c): HHS lab provides information to the licensee or Updated other entity on investigation completed on a testing error 6.0 8.0 48.0 8.0 8.0 64.0 16.00 (information for 30-day event report to NRC) 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 5.0 4.0 20.0 5.0 4.0 20.0 -
reports 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 Approved Clearance Values Extension Table 5: Annualized NRC Burden (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Burden Index Key: Estimate Burden Burden
- Updated No. Actions/ Total No. Actions/ Total Change NRC ACTION Hours / Hours /
- Consolidated Year Hours Year Hours
- Removed Action Action Updated Review exemption request under section 26.9 2.0 16.0 32.0 - 16.0 - (32.0)
Review FFD policies and procedures under section 26.27(d)
Updated 12.0 8.0 96.0 12.0 8.0 96.0 -
(performed during periodic inspections)
Review records under section 26.75(h) to ensure only appropriate records maintained for a licensee or other entity Updated who administratively withdraws access for initial positive drug 12.0 4.0 48.0 - 4.0 - (48.0) tests for marijuana or cocaine at an LTF (performed during periodic inspections)
Review and evaluate report made under section 26.77(c)
No reports Updated regarding an NRC employee or contractor being unfit for duty - - - 4.0 - -
anticipated Review documentation provided by SAE upon request by Updated 1.0 4.0 4.0 1.0 4.0 4.0 -
NRC under section 26.187(f)
Review and evaluate a 24-hour report made under section Burden accounted for under Consolidated 26.417(b)(1) to the NRC Operations Center regarding a 1.0 16.0 16.0 (16.0) section 26.719(b) significant FFD program failure Annual FFD program performance report -
Review, analyze, and summarize information received under Updated 2.0 25.0 50.0 2.0 25.0 50.0 -
26.417(b)(2) from a reactor construction site D&A testing program.
Annual fatigue management performance report --
Review, analyze, and summarize fatigue management data Updated specified in section 26.201(e) that is submitted under section 62.0 10.0 620.0 59.0 10.0 590.0 (30.0) 26.717 Annual FFD program performance report -
Updated Review, analyze, and summarize information received under 65.0 25.0 1,625.0 67.0 12.0 804.0 (821.0) 26.717 from a D&A testing program Review reports under section 26.719(a) of significant Burden reported under Removed violations of FFD policy, D&A testing program failures, and REMOVED -
section 26.719 (b) and (c) errors in laboratory testing Page 22 of 24
FINAL Supporting Statement, 10 CFR Part 26 Approved Clearance Values Extension Table 5: Annualized NRC Burden (approved 11/30/14 - ICR 201407-3150-007) (2017-2020)
Burden Index Key: Estimate Burden Burden
- Updated No. Actions/ Total No. Actions/ Total Change NRC ACTION Hours / Hours /
- Consolidated Year Hours Year Hours
- Removed Action Action 24-hour report -- Review, evaluate, and respond to a report made under section 26.719(b) to the NRC Operations Center Updated 37.0 16.0 592.0 37.0 8.0 296.0 (296.0) regarding a significant FFD policy violation or programmatic failure 30-day report -- Review, evaluate, and respond to a report made under section 26.719(c) to the NRC detailing the Updated investigation of any testing errors or unsatisfactory 6.0 4.0 24.0 8.0 4.0 32.0 8.0 performance discovered at an LTF or HHS lab.
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 Annualized Cost at Annualized Annualized Change Change Table Description Responses Burden Hours $265/hour Burden Burden Hours %
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%
TOTAL 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 Annualized Cost at Table Description Actions Burden Hours $265/hour 5 NRC Action 186.0 1,872.0 $ 496,080 Page 24 of 24