ML20213C285

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Part 26 Supporting Statement - Spreadsheet - 2021-2024 - 2020-08-06
ML20213C285
Person / Time
Issue date: 10/29/2020
From: Brian Zaleski
NRC/NSIR/DPCP/RSB
To:
Brian Zaleski, 301-287-0638
Shared Package
ML20213C130 List:
References
Download: ML20213C285 (24)
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Text

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 1: One Time Recordkeeping (May 2021 - April 2024)

Number of Burden Hours Total Section Record- per Recordkeeper Burden Hours keepers (Annualized) (Annualized) 26.27(a): Develop FFD policy statement 0 112.0 0 26.27(a): Develop FFD procedures 0 212.0 0 26.29(a) and (b): Develop FFD training course and exam 0 100.0 0 26.31(b)(1)(v): Develop behavioral observation program 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 not Burden accounted for under 26.27(a) 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 toxicologist review and certification of additional drug(s) to be 1.0 5.3 5.3 included in the licensee or other entity's drug testing panel Burden accounted for in section 26.31(d)(1)(iii): Document additional drugs in testing panel 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C) 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C): Documentation of forensic toxicologist review and certification of lower drug 1.0 5.3 5.3 testing cutoff levels than specified by Part 26, and inclusion of cutoff levels in the FFD policy and procedures 26.37(a): Develop a system of files and procedures to protect 0 24.0 0 personal information collected under Part 26 26.39(a) and (b): Develop procedures for the review of a 0 120.0 0 determination that an individual has violated the FFD policy 26.85(a): Develop urine collector qualification training 0 13.3 0 26.85(b): Develop alcohol collector qualification training 0 5.3 0 26.127(a) - (e): Develop LTF procedures for specimen handling and chain-of-custody, assays performed, instrument 0 80.0 0 and test setup, and remedial actions for systems and testing devices 26.137(a): Develop LTF procedures for quality assurance/

0 13.3 0 quality control (QA/QC) program 26.153(e): Record of pre-award inspection of new HHS lab 3.0 13.3 40.0 (completed prior to awarding contract for testing services) 26.153(f): Record that Part 26 specified requirements included in a licensee's or other entity's contract with a new 3.0 13.3 40.0 HHS lab 26.155(a)(1), (a)(3) - (a)(5); (b),(c), (e), and (f):

Confirm HHS lab personnel qualifications and procedures Burden accounted for under 26.153(e) place pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab)

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DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 1: One Time Recordkeeping (May 2021 - April 2024)

Number of Burden Hours Total Section Record- per Recordkeeper Burden Hours keepers (Annualized) (Annualized) 26.157(a) - (e): Confirm HHS lab procedures in place for accession, receipt, shipment, and testing of specimens 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 Burden accounted for under 26.153(e) place pursuant to HHS laboratory certification requirements also meet Part 26 requirements (new HHS lab) 26.203(a): Prepare fatigue management policy 0 7.3 0 (in addition to 26.27 burden) 26.203(b): Prepare fatigue management procedures 0 1.7 0 (in addition to 26.27 burden) 26.203(c): Prepare training on fatigue management. 0 2.0 0 26.205(b): Develop work hour tracking system 0 7.7 0 26.205(c): Develop individual work scheduling system 0 2.0 0 26.401(b): Prepare a reactor construction site D&A testing Burden accounted for under program plan section 26.403(a) and (b) 26.403(a): Develop FFD policy statement 0 112.0 0 (reactor construction site D&A testing program) 26.403(b): Develop written FFD procedures 0 216.0 0 (reactor construction site D&A testing program) 26.405(d): Record of testing for specified drugs, adulterants, Burden accounted for under and alcohol, at Part 26 specified cutoff levels section 26.403(a) 26.405(e): Develop specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the Burden accounted for under specimen, and stringent quality controls to ensure accurate section 26.403(b) test results 26.406(a), (b), and (d): Develop a fitness monitoring program (applies if reactor construction site D&A testing program 0 40.0 0 does not conduct random testing) 26.406(c): Develop procedures for fitness monitors (applies if reactor construction site D&A testing program 0 40.0 0 does not conduct random testing) 26.407: Develop procedures for behavioral observation 0 40.0 0 (reactor construction site D&A testing program) 26.411(a): Develop procedures for maintaining a system of files to protect personal information collected under Subpart 0 40.0 0 K of Part 26 26.413: Develop procedures for the review of a determination that an individual violated the FFD policy (reactor 0 120.0 0 construction site D&A testing program)

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DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 1: One Time Recordkeeping (May 2021 - April 2024)

Number of Burden Hours Total Section Record- per Recordkeeper Burden Hours keepers (Annualized) (Annualized) 26.713(g): Documentation on testing for additional drugs as Burden accounted for under permitted under section 26.31(d)(1), use of more stringent section 26.31(d)(1)(i)(D) and (d)(1)(ii), and testing cutoff levels as permitted under section 26.31(d)(3),

section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c) or both.

Total 90.7 Page 3 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.4(j):For personnel granted authorization by a licensee, who are covered by the D&A testing program regulated by a State or Federal agency - (1) record of training that demonstrates 31.0 2.0 62.0 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 24.0 16.0 384.0 subject personnel 26.27(c): Updates to FFD policy and procedures 24.0 80.0 1,920.0 26.27(d): Provide FFD policy and procedures to NRC for 19.0 2.0 38.0 review (performed during periodic inspections) 26.29(b): Record of training completion (initial training on FFD 24.0 97.9 2,349.8 policy) and results of comprehensive examination 26.29(c)(2): Record of training completion 24.0 123.0 2,952.9 (annual refresher training on FFD policy) 26.29(d): Record acceptance of FFD training from other 24.0 4.0 96.0 licensees' programs 26.31(b)(1)(i): Records of background investigations, credit and criminal history checks, and psychological assessments 24.0 16.0 384.0 of checks for performed on individuals designated as FFD personnel 26.31(b)(1)(v): Record results of behavioral observation for Burden accounted for under FFD program personnel section 26.189(c) 26.31(d)(3)(ii): Document LTF technician qualifications to Burden accounted for under perform validity and drug tests. section 26.125(b) and (c)

Burden accounted for under 26.33: Behavioral observation records section 26.189(c) 26.35(c): Record of written waiver of right to privacy from 12.0 2.0 24.0 individuals given to the Employee Assistance Program (EAP) 26.35(c): Record of EAP disclosure to a licensee or other entity that an individual poses an immediate hazard, or who 12.0 1.0 12.0 has waived in writing the right to privacy 26.37(b)(1): Record of signed consent from individual to disclose information collected under Part 26 to the individuals 24.0 2.3 54.1 representative on an FFD matter 26.37(c): Record of signed release from subject individual to disclose personal information collected under Part 26 to other 24.0 40.0 960.0 licensees or other entities 26.37(d): FFD management provides records to individual on 24.0 40.0 960.0 an FFD violation 26.39(a): Maintain procedures for the review of FFD violation Burden accounted for under determinations section 26.27(c)

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DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.39(b): D&A testing program provides notice to an individual of the grounds of an FFD policy violation 24.0 85.0 2,040.5 determination and review procedures 26.39(d): If a review of an FFD violation finds in favor of the individual, the licensee or other entity updates records (delete 6.0 16.0 96.0 or correct information found to be inaccurate) 26.39(e): C/V with a D&A testing program provides review 0 0.5 0 procedures to each individual that has violated the FFD policy Burden accounted for under 26.41(a), (b), and (c): Record of audits section 26.41(f) and (g) 26.41(d): Record of review of C/V audit results 24.0 40.0 960.0 26.41(f): Document and report audit results 24.0 40.0 960.0 26.41(g): Sharing of audit reports - D&A testing programs may jointly conduct audits or accept audits of C/Vs and HHS 24.0 40.0 960.0 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 0 12.0 0 or termination of an individual's authorization 26.53(g): Record that CVs and other licensees informed of 0 8.0 0 Part 26 violations 26.53(h): Obtain and retain written consent from each individual before initiating any actions under Subpart C of Part 24.0 146.9 3,524.7 26 26.53(i): Individual applying for authorization is informed in writing of the reason(s) for denial or termination of 24.0 21.9 525.5 authorization 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update Burden accounted for under 26.59(a)(1) - (a)(2): Authorization reinstatement sections 26.61(a), (a)(1), and (a)(2),

For each individual applying for authorization, a record of a 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 disclosure section 26.61(a), (a)(1) and (a)(2) 26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an 24.0 1,468.6 35,246.6 applicants written self-disclosure and employment history 26.61(b) and (c): Specify the information to be collected in the Burden accounted for under 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 24.0 1,468.6 35,246.6 applicants suitable inquiry 26.63(c)(2): Obtain, review, and retain information on an 24.0 4.0 96.0 applicants U.S. military service (i.e., form DD 214)

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DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.63(c)(3): Document inability to obtain information from an 24.0 3.0 72.0 applicants past employer(s) 26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD 24.0 1.0 24.0 programs 26.63(f): Specifies the time periods that a suitable inquiry Burden accounted for under must cover (for initial authorization, authorization update, and section 26.63(a), (c) and (e) authorization reinstatement) 26.65(d) and (e): Record of reinstatement or administrative 24.0 4.0 96.0 withdrawal of authorization 26.65(f): Authorization reinstatement after an interruption --

record of administrative withdrawal of authorization under 24.0 1.0 24.0 section 26.65(d)(1)(ii) or (e)(2)(iii)(B) 26.67 Record of random D&A testing of persons who have Burden accounted for under applied for authorization and who have received a pre-access section 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

- obtain, review, and retain an applicants self-disclosure and section 26.61(a) employment history 26.69(c)(2): Record that the licensee or other entity identified and resolved PDI (not reviewed and favorably resolved by a 24.0 58.7 1,409.9 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 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 24.0 40.0 960.0 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 24.0 49.0 1,174.9 testing (needed prior to granting authorization) 26.69(d): Record of reviewing officials determination on an 24.0 24.0 576.0 applicants request for access authorization Page 6 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.69(e): Record that follow-up testing and treatment plan for an applicant from the D&A testing program of another 24.0 8.0 192.0 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 and treatment plans to other FFD programs (at donor 24.0 8.0 192.0 request) 26.75(a) - (e), and (g): Records of sanctions for FFD Burden accounted for under violations section 26.39(b) 26.75(h): Record that an individuals authorization was administratively withdrawn due to impairment confirmed 24.0 11.0 264.3 under section 26.189, or because the individual posed a safety hazard 26.75(i): Record of temporary administrative withdrawal of an individual's authorization due to an initial positive test result 0 80.0 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 authorization due to an initial positive marijuana and/or 0 1.0 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 24.0 8.0 192.0 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 24.0 1.0 24.0 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 gender observer (in the exceptional event that a designated 2.0 0.5 1.0 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 5.0 0.25 1.3 failed to report to the collection site 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-24.0 1.5 36.0 testing form obtained 26.89(b)(3): Record that FFD management informed that an 24.0 1.0 24.0 individual did not present identification (pre-access testing) 26.89(c): Collector documents on CCF a donor's refusal to Burden accounted for under cooperate with the collection process section 26.107(b) 26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT) Burden accounted for under device test results section 26.715(b)(2)

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DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.91(e)(4): Record that results cancelled after EBT 0 6.0 0 calibration check failure Burden accounted for under 26.91(e)(5): EBT maintenance records section 26.715(b)(14) 26.93(a)(6): Document that alcohol pre-test questions 24.0 43.7 1,049.5 communicated to the donor 26.95(b)(5): Record donor identity for initial alcohol breath test 24.0 43.7 1,049.5 26.97(b)(2): Record reason for new oral fluid alcohol test 0 0.25 0 nd 26.97(c)(1): Document reason for failure of 2 collection 0 0.25 0 attempt 26.97(d): Record results and alcohol screening device used 0 0.25 0 26.99(b): Record time of initial alcohol test of 0.02 percent or Burden accounted for under higher blood alcohol concentration (BAC) section 26.715(b)(2) 26.101(b)(7): Record time and BAC result of confirmatory Burden accounted for under alcohol test section 26.715(b)(2) 26.103(b): Record that FFD management notified of a 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 during collection process indicating an attempt to tamper with 24.0 1.33 31.9 a specimen, and notifies FFD management 26.109(b)(3): Collector documents on CCF that the donor was Burden accounted for under unable to provide a specimen in the 3-hour time allotted (i.e.,

section 26.107(b) a shy bladder), and notifies FFD management 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 behavior during collection indicated a possible subversion section 26.107(b) attempt, and notifies FFD management 26.111(b): Collector documents on CCF if specimen Burden accounted for under characteristics (color, clarity) indicate possible tampering by section 26.107(b) the donor 26.111(c): Collector documents on CCF unusual specimen Burden accounted for under temperature and/or observations during the collection section 26.107(b) indicating possible tampering, and notifies FFD management 26.113(b)(3): Collector completes CCF for split-specimen Burden accounted for under collection section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD Burden accounted for under manager or MRO to collect a specimen under direct section 26.107(b) observation 26.115(d): Collector documents on CCF that observed Burden accounted for under collection performed and reason for the observed collection section 26.107(b) 26.115(f)(3): Collector documents on CCF the name of Burden accounted for under observer of directly observed collection section 26.107(b)

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DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.117(c) - (e): Collector prepares ID labels and CCF forms 24.0 174.9 4,198.0 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 12.0 2.0 24.0 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 instructions to the physician who is to perform the 12.0 1.0 12.0 examination of a donor with a shy bladder 26.125(b) and (c): Records on the proficiency and 3.0 16.0 48.0 qualifications of LTF personnel 26.127 (a) - (e): Maintain LTF written procedures on the handling of specimens, chain-of-custody procedures, testing 3.0 40.0 120.0 assays, instrument and device setup, and remedial actions for systems and testing devices.

26.129(a): Maintain documentation of access to secure areas 3.0 4.0 12.0 of an LTF by all authorized individuals (i.e., an access log) 26.129(b): LTF inspects specimen packages, CCFs, and obtains memorandum from specimen collectors to correct 3.0 0.5 1.5 identified discrepancies 26.129(b)(1): LTF record of report to senior licensee or other entity management of attempts to tamper with specimens in 0 1.0 0 transit 26.129(d): LTF personnel documenting the testing process 3.0 80.0 240.0 and transfers of custody of each specimen and aliquots 26.135(b): LTF record of direction from MRO to send Bottle B 3.0 0.5 1.5 of a split specimen to a second HHS lab for testing 26.137(a): Record of a QA/QC program and procedures for 3.0 4.0 12.0 LTF 26.137(b)(1)(ii): LTF documentation of performance testing of a device not approved by SAMHSA for point-of-collection 0 40.0 0 testing 26.137(b)(1)(iii): LTF documentation of annual test results for a device not approved by SAMHSA for point-of-collection 0 20.0 0 testing 26.137(b)(3): LTF records submitting 1 in 10 specimens that test negative on validity screening testing are sent to an HHS 0 40.0 0 lab as part of the LTF's QA program 26.137(d)(6): LTF records that 1 in 10 specimens that test negative on initial validity testing are sent to an HHS lab for 3.0 40.0 120.0 testing as part of the LTFs QA program 26.137(e)(7): LTF documented procedures to protect against Burden accounted for under carryover material section 26.127 (a) - (e) 26.137(f)(5): LTF records on testing errors 3.0 8.0 24.0 Page 9 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.137(h): LTF labeling of standards and controls 3.0 40.0 120.0 26.139(d): Record that the LTF prepared a summary of test results for inclusion in the FFD annual program performance 3.0 40.0 120.0 report submitted under section 26.717 26.153(g): Record of memorandum sent to the HHS lab 24.0 0.5 12.0 explaining use of non-federal CCF form 26.159(b)(1): Record that the licensee or other entity received noticed from an HHS lab within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the lab identifying 0 1.0 0 evidence of tampering with specimen.

26.159(i): Record of written authorization to store specimens 24.0 0.5 12.0 other than 1 year 26.163(a)(2): Record that special analyses testing conducted Burden accounted for under on a dilute specimen and report of the test results section 26.169(c)(1) 26.165(b)(1): Record of a donor request for the retesting of an Burden accounted for under aliquot of a single specimen or the testing of the Bottle B split section 26.165(b)(6) specimen at a second HHS lab 26.165(b)(2): Record that MRO informed the donor of the opportunity to request the retesting of an aliquot of a single Burden accounted for under specimen or the testing of the Bottle B split specimen at a section 26.185(c) second HHS lab 26.165(b)(3): Donor's written permission provided to the MRO Burden accounted for under for the retesting of an aliquot of a single specimen or the section 26.165(b)(6) testing of the Bottle B split specimen at a second HHS lab 26.165(b)(4): Record that the donor presented documentation Burden accounted for under to the MRO on the inability to submit a timely request to section 26.185(c) 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 24.0 1.2 29.0 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 lab that performed retesting an aliquot of a single specimen or section 26.165(b)(6) 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 0 6.0 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 records purged of references to temporary administrative 0 8.0 0 action Page 10 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.167(f)(3): Record received from the Responsible Person of an HHS lab on a false positive BPTS testing error (determined to be technical or methodological),

demonstrating that retesting of all positive, adulterated, 0 1.0 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 24.0 2.6 62.0 BPTS formulation 26.168(i)(2): Licensee or other entity completes CCF for a BPTS, places fictional initials on specimen labels, and 24.0 34.4 826.7 indicates on the MRO copy of the CCF that the specimen is a BPTS Burden accounted for under 26.169(a): Records of reports of test results from the HHS lab section 26.183(c)(1) 26.169(c)(1): Records of HHS lab reports of positive, Burden accounted for under adulterated, substituted, dilute, and invalid test results section 26.183(c)(1) received by the MRO 26.169(c)(2): Records of HHS lab reports of the numerical Burden accounted for under values of all positive drug test results (i.e., quantitative test section 26.183(c)(1) results requested by MRO) 26.169(c)(2): Records of HHS lab reports of quantitative test Burden accounted for under results for opiates section 26.183(c)(1) 26.169(c)(3): Records of HHS lab reports of quantitative test Burden accounted for under results for adulterated or substituted test results section 26.183(c)(1) 26.169(c)(4): Record of MRO contact with HHS lab to discuss Burden accounted for under whether testing by another HHS lab should be conducted on a section 26.185(f)(1) specimen with an invalid result 26.169(c)(5): Records of HHS lab reports of concentrations Burden accounted for under exceeding linear range section 26.183(c)(1) 26.169(f): Records of HHS lab transmittals of CCF copies for 24.0 43.7 1,049.5 negative results to the MRO 26.169(g): HHS lab copy of the original CCF for each positive, Burden accounted for under adulterated, substituted, dilute, and invalid test results to the section 26.169(c)(1)

MRO 26.169(h): Record of HHS lab statistical summary report of 24.0 2.0 48.0 urinalysis testing results (for the calendar year) 26.183(a): Documentation of MRO qualifications 24.0 4.0 96.0 26.183(c)(1): MRO review of HHS lab test result record for positive, adulterated, substituted, invalid, or at the licensee's 24.0 2.0 48.1 or other entity's discretion, dilute specimen 26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug positive, adulterated, substituted, or refusal to test result to 24.0 2.0 48.1 the licensees designated reviewing official Page 11 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.183(d)(2)(i): Record of MRO staff review and reporting of 24.0 262.4 6,297.0 negative test results to FFD management 26.183(d)(2)(ii): Record of MRO staff review of CCFs for positive, adulterated, substituted and invalid results and 24.0 2.4 57.7 forwards changes to MRO for review 26.185(a) Record of MRO review of a drug positive, Burden accounted for under adulterated, substituted, dilute, or invalid HHS lab test result section 26.183(c)(1) 26.185(c): Record of MRO discussion of positive, adulterated, substituted, dilute, or invalid test result with donor 24.0 12.0 288.3 26.185(d)(1): Documentation that donor declined to discuss Burden accounted for under test results with MRO section 26.185(c) 26.185(e): Documentation reviewed by the MRO on a donors inability to discuss test results and a request to reopen 24.0 0.5 12.0 proceeding 26.185(f)(1): Record of MRO consultation with HHS lab to determine whether additional testing needed for an invalid 24.0 0.5 12.0 specimen 26.185(f)(2): Record of MRO contact with donor about an Burden accounted for under invalid test result, and medical information received section 26.185(c) 26.185(h)(1): Record of MRO contact with donor about a Burden accounted for under substituted test result, and medical information received section 26.185(c) 26.185(h)(2): Record of MRO confirmation of a substituted Burden accounted for under test result (no legitimate medical explanation) section 26.183(d)(1)(ii)(D) 26.185(h)(3): MRO record of determination of a legitimate Burden accounted for under medical explanation for a substituted test result section 26.183(d)(2)(i) 26.185(i)(1): Record of MRO contact with donor about an Burden accounted for under adulterated test result, and medical information received section 26.185(c) 26.185(i)(2): Record of MRO confirmation of an adulterated Burden accounted for under test result (no legitimate medical explanation) section 26.183(d)(1)(ii)(D) 26.185(i)(3): MRO record of determination of a legitimate Burden accounted for under 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 24.0 2.5 60.0 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 Burden accounted for under medication used in a manner and at the dosage prescribed).

sections 26.183(d)(2)(i) and 26.185(c)

If the individual poses a potential risk to public health and safety because of impairment while on duty - the MRO will ensure that a determination of fitness is performed)

Page 12 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 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 0 1.0 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 Burden accounted for under retesting a single specimen or testing of a Bottle B split section 26.165(b)(6) 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 24.0 0.5 12.0 from a donor applying for reauthorization following a 1st positive drug test result 26.185(p): MRO written notice to licensee or other entity of a Burden accounted for under positive, adulterated, substituted, or invalid test result section 26.185(c) 26.187(d): SAE training requirements 24.0 20.0 480.0 26.187(f): Documentation of SAE credentials and training 24.0 1.0 24.0 26.189(b): Determination of fitness record 24.0 80.0 1,920.0 26.189(c): Record of for cause determination of fitness 24.0 11.0 264.3 26.189(d): Record of modification of an initial determination of 1.0 1.0 1.0 fitness 26.203(a): Updates to fatigue management policy 0 7.3 0 (in addition to 26.27 burden) 26.203(b): Updates to fatigue management procedures 0 1.7 0 (in addition to 26.27 burden) 26.203(c): Updates to training on fatigue management. 0 2.0 0 26.203(d)(1) and (d)(2): Records of work hours, shift Burden accounted for under schedules, and shift cycles 26.205(c), (d)(1), and (e)(4)

Burden accounted for under 26.203(d)(3): Documentation of waivers section 26.207(a)(4)

Burden accounted for under 26.203(d)(4): Documentation of work hour reviews 26.205(d)(2), (e)(3) and (e)(4)

Burden accounted for under 26.203(d)(5): Documentation of fatigue assessment section 26.211(f) 26.205(b): Record of calculation of work hours 54.0 50.0 2,700.0 26.205(c): Schedule work hours 54.0 720.0 38,880.0 26.205(d)(1): Record of implementation of work hour controls 54.0 16.0 864.0 26.205(d)(2): Record of adequate rest breaks 54.0 16.0 864.0 26.205(e)(1) and (2): Record of review of control of work 54.0 12.0 648.0 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> twice per calendar year 26.205(e)(3): Document methods for reviews 54.0 6.0 324.0 26.205(e)(4): Record and trend problems in regarding work 54.0 6.0 324.0 hours0 days <br />0 hours <br />0 weeks <br />0 months <br /> Page 13 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.207(a)(4): Document basis for waiver 54.0 2.0 108.0 26.211(f): Document results of fatigue assessments 54.0 16.0 864.0 26.403(a): Updates to FFD policy and procedures 0.3 16.0 5.3 (reactor construction site D&A testing program) 26.403(a): Provide FFD policy to individuals subject to a 0.3 8.0 2.7 reactor construction site D&A testing program 26.405(b): Records of random D&A tests 0.3 488.4 162.8 26.405(c)(1): Records of pre-assignment D&A test 0.3 542.8 180.9 26.405(c)(2) and (c)(3): Records of for-cause and post 0.3 531.3 177.1 accident D&A tests 26.405(c)(4): Records of follow-up D&A tests 0.3 40.2 13.4 26.405(e): Updates to specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the 0 40.0 0 specimen, and stringent quality controls to ensure accurate test results 26.405(f): Record that testing conducted at an HHS lab 0.3 40.0 13.3 26.405(g): Record of MRO review of positive, adulterated, substituted, and invalid drug and validity test results (reactor 0.3 179.3 59.8 construction site D&A testing program) 26.406(c): Updates to fitness monitoring procedures (programs that do not adopt random testing and behavioral 0 80.0 0 observation) 26.411(a): Updates to procedures for maintaining a system of files to protect personal information collected under Subpart K 0.3 40.0 13.3 of Part 26 26.411(a) and (b): Collection of personal information under Subpart K of Part 26 0.3 8,043.3 2,681.1 26.413: Document results of review process 0.3 80.0 26.7 26.415: Document and report audit results 0.3 40.0 13.3 26.417(a): Records pertaining to the administration of a 0.3 20.0 6.7 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 programmatic failures in a reactor construction site D&A section 26.719(b) testing program 26.417(b)(2) Collect FFD program performance data for 0.3 100.0 33.3 reactor construction site D&A testing program 26.713(a)(1): Records of self-disclosures, employment Burden accounted for under histories, and suitable inquiries (under sections 26.55, 26.57, section 26.61(a), and 26.63(a), (c), and (e) 26.59, and 26.69) that result in the granting of authorization 26.713(a)(2): Records pertaining to the determination of a Burden accounted for under violation of FFD policy and related management actions section 26.39(b) 26.713(a)(3): Documentation of the granting and termination 24.0 80.0 1,920.0 of authorization Page 14 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.713(a)(4): Records of determinations of fitness performed under section 26.189 (including recommendations for 24.0 80.0 1,920.0 treatment and followup testing plans) 26.713(b)(1): Records of FFD training and examinations Burden accounted for under conducted under section 26.29 sections 26.29(a) and (b) 26.713(b)(2): Records of audits, audit findings, and corrective Burden accounted for under 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 authorization section 26.39(b) 26.713(d): Records of superseded versions of FFD policies 24.0 8.0 192.0 and procedures 26.713(e): Records of written agreements for services under 24.0 16.0 384.0 Part 26 26.713(f): Records of background investigations, credit and criminal history checks, and psychological assessments of Burden accounted for under FFD program personnel conducted under section section 26.31(b)(1)(i) 26.31(b)(1)(i) 26.715(a): Documentation of all aspect of testing process at collection sites and LTFs (not otherwise specified in section 24.0 40.0 960.0 26.715(b))

26.715(b)(1): Retain personnel files on staff at collection sites 24.0 20.0 480.0 and LTFs 26.715(b)(2): Retain collection site and LTF chain-of-custody 24.0 240.0 5,760.0 documents 26.715(b)(3): Retain LTF QA/QA records 3.0 120.0 360.0 26.715(b)(4): Retain superseded procedures (LTFs and 24.0 40.0 960.0 collection sites) 26.715(b)(5): Retain all test data from LTF (including calibration curves and any calculations used in determining 3.0 240.0 720.0 test results 26.715(b)(6): LTF test reports 3.0 240.0 720.0 26.715(b)(7): LTF performance testing records 3.0 80.0 240.0 26.715(b)(8): Records from LTF and HHS lab on the investigation of testing errors or unsatisfactory performance, 6.0 40.0 240.0 and any corrective actions taken 26.715(b)(10): Records of preventative maintenance on LTF 3.0 40.0 120.0 instruments 26.715(b)(11): Retain records that summarize any test results the MRO determined to be scientifically insufficient for further 0 3.0 0 action 26.715(b)(12): LTF retains computer-generated data 3.0 120.0 360.0 26.715(b)(13): Retain records (e.g., an access log) of Burden accounted for under authorized visitors, maintenance personnel and service section 26.129(a) personnel who accessed LTF secure areas Page 15 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 2: Annual Recordkeeping (May 2021 - April 2024)

Burden Number of Total Annual Hours per Section Record- Burden Record-keepers Hours keeper 26.715(b)(14): Retain records of the inspection, maintenance 62.0 8.0 496.0 and calibration of EBTs (collection sites) 26.717(a) and (b): Collect FFD performance data for D&A 62.0 40.0 2,480.0 testing programs 26.717(a) and (b): Collect FFD performance data for fatigue 54.0 40.0 2,160.0 management program 26.717(c): Analyze D&A testing program FFD data annually 62.0 16.0 992.0 26.717(c): Analyze fatigue management program data 54.0 16.0 864.0 annually 26.717(d): D&A test results leading to termination 1.0 1.0 1.0 26.717(g): Collect and report D&A testing program data to the Burden accounted for under 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 36.0 1.0 36.0 report to the NRC 26.719(c): Prepare 30-day event report documentation. 6.0 40.0 240.0 26.719(d): Document non-reportable indicators of FFD 24.0 20.0 480.0 program weaknesses 26.821(a): Provide NRC with access to records (to inspect, 25.0 4.0 100.0 copy, or take away copies of records) 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or 1.0 4.0 4.0 take away copies of C/Vs documents, records, and reports Total 186,116.3 Page 16 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 3: Annual Reporting (May 2021- April 2024)

Number Responses Burden per Total Total Section of per Response Burden Responses Respondents Respondent (hours) Hours 26.9: Application to NRC for exemption (D&A

- 1.0 0 40.0 -

testing program) 26.9: Application to NRC for exemption (fatigue 40.0 1.0 40.0 2.0 80.0 management program) - COVID-19 26.77(c) Report impaired NRC employee 0 0 0 1.0 -

26.137(b)(3): Report false negative LTF validity No LTF conducts validity screening testing screening result (if any did, burden would be accounted for under section 26.719(c)(3) 26.203(e)(1): Prepare information on waivers of work hour controls for inclusion in the annual 54.0 1.0 54.0 16.0 864.0 FFD program performance report for fatigue management programs 26.203(e)(2): Prepare summary of fatigue corrective actions for inclusion in the annual 54.0 1.0 54.0 2.0 108.0 FFD program performance report for fatigue management programs 26.417(b)(1): Report to NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a programmatic Burden accounted for under section 26.719(b) failure in a reactor construction site D&A testing program 26.417(b)(2): Prepare annual FFD program performance report for reactor construction site 0.3 1.0 0.3 80.0 26.7 D&A testing program 26.717: Annual FFD program performance 54.0 1.0 54.0 8.0 432.0 report for fatigue management programs 26.717: Annual FFD program performance for 62.0 1.0 62.0 60.0 3,720.0 D&A testing programs 26.719(a): Report a significant FFD program violation, programmatic failure, or D&A testing Burden reported under sections 26.719(b), and (c)(1) - (c)(3) error 26.719(b): Report to the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a significant D&A 36.0 1.0 36.0 4.0 144.0 testing violation 26.719(c)(1): Submit a report to the NRC within 30 days of completing an investigation into an 6.0 1.0 6.0 24.0 144.0 LTF or HHS lab testing error 26.719(c)(2): Notify the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receiving notice of a false 0 1.0 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 test 0 1.0 0 4.0 -

result on a QA check of a validity screening test from an LTF Total 306.3 5,518.7 Page 17 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Extension (May 2021- April 2024)

Total Number Burden Section Annual of Hours per Burden Responses Response Hours 26.4(j): For personnel granted authorization by a licensee, who are covered by a D&A testing program regulated by a State or Federal agency - (1) provision of training record to the licensee to demonstrate section 26.29(a) training requirements met (if not already covered in the 31.0 2.0 62.0 existing program); (2) notification of any FFD policy violations by those granted authorization by the licensee or other entity 26.29(b): Complete initial training on FFD policy and take 70,493.2 2.0 140,986.3 comprehensive examination 26.29(c)(2): Complete annual refresher training on FFD policy 88,587.0 1.5 132,880.5 26.31(b)(1)(i): Individual applying for access to serve as FFD program personnel provides background check information for the background 310.0 1.0 310.0 investigation, credit and criminal history checks, and psychological assessment 26.35(a): Employee assistance program (EAP) records 24.0 32.0 768.0 26.35(c): Individual completes and provides the EAP with a written 886.0 0.25 221.5 waiver of right to privacy to share information with FFD management 26.35(c): Record of EAP disclosure to FFD management about an 12.0 1.0 12.0 individual that poses an immediate hazard 26.37(b): Individuals provide signed consent for release of information 216.5 0.25 54.1 26.37(b)(1): Individual provides signed designation of personal 216.5 0.25 54.1 representative for an FFD matter 26.37(d): Request by donor or donors representative to the licensee or 22.0 0.25 5.5 other entity to provide personal records collected under Part 26 26.53(h): Applicant provides written consent before any actions are 70,493.2 0.25 17,623.3 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 Each individual applying for authorization must complete a self- sections 26.61(a) and 26.63(a),(c) and (e) disclosure, employment history, and suitable inquiry 26.59(c)(1): Applicant prepares self-disclosure (for authorization Burden accounted for under reinstatement period of interruption of no more than 30 days) sections 26.61(a) 26.61(a): Applicant prepares self-disclosure and employment history 70,493.2 1.0 70,493.2 26.63(a), (c), and (e): Former employer(s) provide information to the licensee or other entity to verify an applicants suitable inquiry 70,493.2 0.75 52,869.9 information on previous authorization(s) 26.63(c)(2): U.S. Department of Defense (DOD) provides licensee or Burden of supplying DD 214 affects DOD, or is other entity with form DD 214 which details an applicants military accounted for under section 26.61(a) (if service record supplied by the applicant) 26.63(c)(3): Former employer refuses to provide information to the 140.0 0.1 11.7 licensee or other entity about an applicants prior employment history 26.67: Records of random D&A testing of persons who have applied for authorization, but who have not been granted unescorted access 352.5 0.5 176.2 authorization 26.69(b) and (c)(1): Applicant provides written self-disclosure and employment history to the licensee or other entity (for authorization Burden accounted for under following a 1st or 2nd positive drug or alcohol test result, or if other PDI section 26.61(a) is identified)

Page 18 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Extension (May 2021- April 2024)

Total Number Burden Section Annual of Hours per Burden Responses Response Hours 26.69(c)(2): Former employer(s) of an applicant provide response to licensee or other entity request to confirm suitable inquiry information for 704.9 2.0 1,409.9 an applicant with PDI 26.85(c): Alternative collectors not employed by licensee provide proof 24.0 1.0 24.0 of qualification 26.85(e): Maintain personnel files for alternative collectors 24.0 4.0 96.0 26.89(a): Record that a donor did not appear for testing (non-licensee 2.0 1.0 2.0 collection site) 26.89(b)(3): Record FFD management informed that an individual did 2.0 1.0 2.0 not present identification (non-licensee collection site) 26.89(c): Record that FFD management informed that a donor refused to cooperate with the collection procedures (non-licensee collection site) 0 0.25 0 26.91(e)(4): Record that results cancelled after EBT calibration check 0 1.0 0 failure (non-licensee collection site) 26.91(e)(5): Prepare record of EBT maintenance (non-licensee 24.0 4.0 96.0 collection site) 26.93(a)(6): Document alcohol pre-test questions asked and answered 240.0 0.25 60.0 (non-licensee collection site) 26.95(b)(5): Record donor identity for initial alcohol breath test (non-240.0 0.25 60.0 licensee collection site) 26.97(b)(2): Record reason for new oral fluid alcohol test (non-licensee 0 0.5 0 collection site) 26.97(c)(1): Document reason for failure of second collection attempt 0 1.0 0 (non-licensee collection site) 26.97(d): Record results and alcohol screening device used (non-0 0.25 0 licensee collection site) 26.99(b): Record test time of initial test with 0.02 percent BAC or higher Burden accounted for under (non-licensee collection site) section 26.715(b)(2) 26.101(b)(7): EBT printout of confirmatory alcohol test result includes Burden accounted for under time of test (non-licensee collection site) section 26.715(b)(2) 26.103(b): Collector informs FFD management of result between 0.01 and 0.02 percent BAC when donor in work status 3 or more hours (non- 0 0.25 0 licensee collection site) 26.107(b): Collector documents tampering attempt on CCF form (non- Burden accounted for under licensee collection site) section 26.111(b) 26.109(b)(3): Collector documents on CCF shy-bladder situation and 0 0.25 0 notifies FFD management (non-licensee collection site) 26.109(b)(4): Collector documents on CCF confirmation from FFD management to conduct an observed collection (non-licensee collection 0 0.25 0 site) 26.111(b): Collector documents on CCF if specimen characteristics (color, clarity) indicate possible tampering by the donor (non-licensee 0 0.25 0 collection site) 26.111(c): Collector documents on CCF unusual specimen temperature and/or other observations made during the collection of possible tampering attempt and notifies FFD management (non-licensee 0 0.25 0 collection site)

Page 19 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Extension (May 2021- April 2024)

Total Number Burden Section Annual of Hours per Burden Responses Response Hours 26.113(b)(3): Collector completes CCF for split-specimen collection (non- Burden accounted for under licensee collection site) section 26.117(c) - (e) 26.115(b): Collector documents on CCF approval from FFD manager or MRO to collect a specimen under direct observation (non-licensee 0 0.25 0 collection site) 26.115(d): Collector documents on CCF directly observed collection Burden accounted for under performed and the reason for the observed collection (non-licensee section 26.115(b) collection site) 26.115(f)(3): Record of name of observer (non-licensee collection site) 0 0.25 0 26.117(c) - (e): Collector prepares ID labels and CCF forms for 240.0 0.25 60.0 specimen shipment (non-licensee collection site) 26.119(a), (e), and (f): Physician evaluating shy-bladder claim prepares report of medical examination of donor and provides this information to 12.0 2.0 24.0 the MRO 26.129(b): Collector prepares memorandum to and sends to LTF documenting investigation of discrepancies between bottles and CCF 0 1.0 0 (non-licensee collection site) 26.135(b): Donor request to MRO for the retesting of an aliquot of a Burden accounted for under single specimen or the testing of the Bottle B split specimen at a second section 26.165(b)(1)

HHS lab (initial specimen testing performed at an LTF) 26.153(g): Supply memorandum to HHS lab explaining use of non-2.0 0.5 1.0 federal CCF form (non-licensee collection site) 26.155(a)(1): Document of HHS lab manager qualifications Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(a)(3): HHS lab personnel training documentation Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(a)(4): HHS lab manager reviews and approved lab procedures Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(a)(5): HHS lab manager maintains QA program Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(b): Certifying scientist at HHS lab certifies test results Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(c): Supervise technical analysts at HHS lab Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(e): Continuing education of HHS lab staff Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.155(f): HHS lab personnel records Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.157(a): Written HHS lab procedures for accession, receipt, shipment, Burden covered by HHS lab certification and testing of urine specimens requirements OMB Clearance No. 0930-0158 26.157(b): Written HHS lab chain-of-custody procedures for HHS lab Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.157(c): Written HHS lab procedures for each testing assay Burden covered by HHS lab certification performed requirements OMB Clearance No. 0930-0158 26.157(d): Written HHS lab procedures for device set-up and operation Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.157(e): Written HHS lab procedures for remedial actions to address Burden covered by HHS lab certification system and instrument errors requirements OMB Clearance No. 0930-0158 Page 20 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Extension (May 2021- April 2024)

Total Number Burden Section Annual of Hours per Burden Responses Response Hours 26.159(a): Retain records (e.g., an access log) of authorized visitors, Burden covered by HHS lab certification maintenance personnel, and service personnel who accessed secure requirements OMB Clearance No. 0930-0158 areas of HHS lab 26.159(b)(1): Record that the HHS lab notified the licensee or other 0 1.0 0 entity within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying evidence of specimen tampering 26.159(c) - (e): Use and storage of CCF forms at HHS lab Burden accounted for under section 26.715(b)(2) 26.159(f): Use of CCF by HHS lab when shipping a specimen to another Burden accounted for under HHS lab 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 aliquot of a single 29.0 1.0 29.0 specimen or Bottle B of the split specimen) to a second HHS lab for further testing 26.165(b)(3): Donor provides written request to the MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B 29.0 1.0 29.0 split specimen 26.165(b)(4): Donor presents documentation to the MRO on the reason Burden accounted for under for not being able to make a timely retest request section 26.185(e) 26.165(b)(6) HHS lab provides report to the MRO of the quantitative test Burden accounted for under results of the retesting of aliquot of a single specimen or the testing of section 26.185(n) the Bottle B split specimen 26.167(a): HHS lab documents QA program (encompasses all aspects Burden covered by HHS lab certification of the testing process) 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 Burden covered by HHS lab certification management system or computer and/or document result by hard copy requirements OMB Clearance No. 0930-0158 or electronic display 26.167(f)(3): False positive error on BPTS test and the error is technical or methodological, the HHS lab Responsible Person must document that retesting of all positive, adulterated, substituted, and invalid specimens from the time of final resolution of the error back to the time 0 8.0 0 of the 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 requirements OMB Clearance No. 0930-0158 26.168(a): Blind performance test sample (BPTS) supplier provides HHS lab certification letter of BPTS formulation to licensee or other 1.0 8.0 8.0 entity 26.168(h)(2): BPTS sample supplier provides expiration date on each 1.0 8.0 8.0 BPTS 26.169(a): HHS lab reports test results to the MRO of the licensee or Burden accounted for under other entity section 26.169(c)(1) 26.169(c)(1): HHS lab provides record to the MRO for each positive, 577.0 0.25 144.3 adulterated, substituted, dilute, and invalid test result 26.169(c)(2): HHS lab provides quantitative test result record for positive Burden accounted for under drug test (at the request of the MRO) section 26.169(c)(1) 26.169(c)(3): HHS lab provides quantitative test result record for Burden accounted for under adulterated or substituted test results (at the request of the MRO) section 26.169(c)(1)

Page 21 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Extension (May 2021- April 2024)

Total Number Burden Section Annual of Hours per Burden Responses Response Hours 26.169(c)(4): HHS lab record of contact with MRO to discuss if additional testing by another HHS lab should be conducted on a 10.0 0.5 5.0 specimen with an invalid test result 26.169(f): HHS lab transmits to the MRO a copy of CCF for specimens Burden accounted for under with negative test results section 26.715(b)(2) 26.169(g): HHS lab transmits to the MRO a copy of the original CCF Burden accounted for under signed by the certifying scientist (for positive, adulterated, substituted, section 26.169(c)(1) dilute and invalid test result) 26.169(h): HHS lab prepares and submits annual statistical summary 62.0 2.0 124.0 report of urinalysis testing results 26.185(c): Donor discussion with MRO of positive, adulterated, 577.0 0.5 288.5 substituted, dilute, or invalid test result 26.185(e): Donor provides documentation to the MRO demonstrating an inability to discuss test results and requesting the test result 8.0 1.0 8.0 determination be reopened 26.185(f)(1): HHS lab consultation with MRO on whether additional testing of a specimen with an invalid test result should be performed at a 24.0 0.50 12.0 second HHS lab 26.185(f)(2): Donor discussion with MRO regarding an invalid test result Burden accounted for under section 26.185(c) 26.185(h)(1): Donor discussion with MRO regarding a substituted test Burden accounted for under result section 26.185(c) 26.185(i)(1): Donor discussion with MRO regarding an adulterated test Burden accounted for under result section 26.185(c) 26.185(j) Donor discussion with MRO regarding a positive test result from use of a prescription medication (amphetamine, morphine, codeine), and donor provides documentation on medication use to the 60.0 1.0 60.0 MRO (e.g., prescription information and pharmacy, prescribing physician information) 26.185(n): Second HHS lab provides the MRO with test result report (for retesting of an aliquot of a single specimen or the testing of a Bottle B 29.0 0.25 7.3 split specimen) 26.185(o): HHS lab provides quantitation of test results for testing Burden accounted for under performed on a specimen from a donor applying for reauthorization section 26.169(c)(1) following a 1st positive drug test result (at MRO request) 26.189(b): If a qualified treatment professional other than the MRO or SAE performs a determination of fitness on an individual, that treatment 24.0 1.0 24.0 professional completes and provides a written determination to the MRO 26.209(a): Individual declares that due to fatigue, he or she is unable to safety and competently perform his or her duties 10.0 0.50 5.0 26.411(b): Applicant provides written consent to the reactor construction 2,171.0 0.25 542.8 site D&A testing program 26.715(a): Documentation of all aspects of HHS lab testing process, not Burden covered by HHS lab certification specified elsewhere in section 26.715(b) requirements OMB Clearance No. 0930-0158 26.715(b)(1): Retain personnel files on HHS lab staff Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.715(b)(2): Retain HHS lab chain-of-custody documents 10.0 240.0 2,400.0 Page 22 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Extension (May 2021- April 2024)

Total Number Burden Section Annual of Hours per Burden Responses Response Hours 26.715(b)(3): Retain HHS lab QA/QC records Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.715(b)(4): Retain HHS lab superseded procedures 10.0 40.0 400.0 26.715(b)(5) Retain all test data from HHS lab (including calibration Burden covered by HHS lab certification curves and any calculations used in determining test results) requirements OMB Clearance No. 0930-0158 26.715(b)(6): HHS lab test reports 10.0 240.00 2,400.0 26.715(b)(7): HHS lab performance testing records Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.719(c): HHS lab provides information to the licensee or other entity on investigation completed on a testing error (information for 30-day 6.0 8.0 48.0 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 1.0 4.0 4.0 C/Vs documents, records, and reports Total 377,934.1 424,909.9 Page 23 of 24

DRAFT Supporting Statement, 10 CFR Part 26 Extension Table 5: Annualized NRC Burden (May 2021 - April 2024)

Burden No. Actions/ Total NRC ACTION Hours /

Year Hours Action Review exemption request under section 26.9 0 40.0 0 (D&A testing program)

Review exemption request under section 26.9 40 12.0 480 (Fatigue management program) - COVID-19 Review FFD policies and procedures under section 26.27(d) 19.0 8.0 152.0 (performed during periodic inspections)

Review records under section 26.75(h) to ensure only appropriate records maintained for a licensee or other entity who administratively withdraws access for initial positive drug tests for marijuana or cocaine 0 4.0 0 at an LTF (performed during periodic inspections)

Review and evaluate report made under section 26.77(c) regarding an 0 4.0 0 NRC employee or contractor being unfit for duty Review documentation provided by SAE upon request by NRC under 1.0 4.0 4.0 section 26.187(f)

Review and evaluate a 24-hour report made under section 26.417(b)(1)

Burden accounted for under to the NRC Operations Center regarding a significant FFD program section 26.719(b) failure Annual FFD program performance report -

Review, analyze, and summarize information received under 0.3 25.0 8.3 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 specified in 54.0 0.75 40.5 section 26.203(e) that is submitted under section 26.717 Annual FFD program performance report -

Review, analyze, and summarize information received under 26.717 62.0 12.0 744.0 from a D&A testing program 24-hour report -- Review, evaluate, and respond to a report made under section 26.719(b) to the NRC Operations Center regarding a significant 36.0 8.0 288.0 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 investigation of any testing errors or unsatisfactory performance discovered at an LTF or HHS lab. 6.0 4.0 24.0 Total 218.3 1,740.8 Page 24 of 24

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