ML20213C285
| 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) | |
Text
DRAFT Supporting Statement, 10 CFR Part 26 Table 1: One Time Recordkeeping Section Number of Record-keepers Burden Hours per Recordkeeper (Annualized)
Total Burden Hours (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 (BOP) procedures Burden accounted for under 26.27(a) 26.31(d)(1)(i)(C): Develop rigorous testing procedures to ensure that the MRO can evaluate the use of substances not included in the NRC-required testing panel (if additional substance testing is performed)
Burden accounted for under 26.27(a) 26.31(d)(1)(i)(D) and (d)(1)(ii): Documentation of forensic toxicologist review and certification of additional drug(s) to be included in the licensee or other entity's drug testing panel 1.0 5.3 5.3 26.31(d)(1)(iii): Document additional drugs in testing panel Burden accounted for in section 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 testing cutoff levels than specified by Part 26, and inclusion of cutoff levels in the FFD policy and procedures 1.0 5.3 5.3 26.37(a): Develop a system of files and procedures to protect personal information collected under Part 26 0 24.0 0
26.39(a) and (b): Develop procedures for the review of a determination that an individual has violated the FFD policy 0 120.0 0
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 and test setup, and remedial actions for systems and testing devices 0 80.0 0
26.137(a): Develop LTF procedures for quality assurance/
quality control (QA/QC) program 0 13.3 0
26.153(e): Record of pre-award inspection of new HHS lab (completed prior to awarding contract for testing services) 3.0 13.3 40.0 26.153(f): Record that Part 26 specified requirements included in a licensee's or other entity's contract with a new HHS lab 3.0 13.3 40.0 26.155(a)(1), (a)(3) - (a)(5); (b),(c), (e), and (f):
Confirm HHS lab personnel qualifications and procedures place pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab)
Burden accounted for under 26.153(e)
Extension (May 2021 - April 2024)
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DRAFT Supporting Statement, 10 CFR Part 26 Table 1: One Time Recordkeeping Section Number of Record-keepers Burden Hours per Recordkeeper (Annualized)
Total Burden Hours (Annualized)
Extension (May 2021 - April 2024) 26.157(a) - (e): Confirm HHS lab procedures in place for accession, receipt, shipment, and testing of specimens pursuant to HHS laboratory certification also meet Part 26 requirements (new HHS lab)
Burden accounted for under 26.153(e) 26.159(a), (c), (e), (f): Confirm HHS lab procedures for specimen security, chain of custody, and preservation in place pursuant to HHS laboratory certification requirements also meet Part 26 requirements (new HHS lab)
Burden accounted for under 26.153(e) 26.203(a): Prepare fatigue management policy (in addition to 26.27 burden) 0 7.3 0
26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden) 0 1.7 0
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 program plan Burden accounted for under section 26.403(a) and (b) 26.403(a): Develop FFD policy statement (reactor construction site D&A testing program) 0 112.0 0
26.403(b): Develop written FFD procedures (reactor construction site D&A testing program) 0 216.0 0
26.405(d): Record of testing for specified drugs, adulterants, and alcohol, at Part 26 specified cutoff levels Burden accounted for under section 26.403(a) 26.405(e): Develop specimen collection and D&A testing procedures to protect the donor's privacy, integrity of the specimen, and stringent quality controls to ensure accurate test results Burden accounted for under section 26.403(b) 26.406(a), (b), and (d): Develop a fitness monitoring program (applies if reactor construction site D&A testing program does not conduct random testing) 0 40.0 0
26.406(c): Develop procedures for fitness monitors (applies if reactor construction site D&A testing program does not conduct random testing) 0 40.0 0
26.407: Develop procedures for behavioral observation (reactor construction site D&A testing program) 0 40.0 0
26.411(a): Develop procedures for maintaining a system of files to protect personal information collected under Subpart K of Part 26 0 40.0 0
26.413: Develop procedures for the review of a determination that an individual violated the FFD policy (reactor construction site D&A testing program) 0 120.0 0
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DRAFT Supporting Statement, 10 CFR Part 26 Table 1: One Time Recordkeeping Section Number of Record-keepers Burden Hours per Recordkeeper (Annualized)
Total Burden Hours (Annualized)
Extension (May 2021 - April 2024) 26.713(g): Documentation on testing for additional drugs as permitted under section 26.31(d)(1), use of more stringent testing cutoff levels as permitted under section 26.31(d)(3),
or both.
Burden accounted for under section 26.31(d)(1)(i)(D) and (d)(1)(ii), and section 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c)
Total 90.7 Page 3 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours 26.4(j):For personnel granted authorization by a licensee, who are covered by the D&A testing program regulated by a State or Federal agency - (1) record of training that demonstrates section 26.29(a) training requirements met (if not already covered by the program); (2) record of notice of any FFD policy violation 31.0 2.0 62.0 26.27(b): Make FFD policy statement readily available to subject personnel 24.0 16.0 384.0 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 review (performed during periodic inspections) 19.0 2.0 38.0 26.29(b): Record of training completion (initial training on FFD policy) and results of comprehensive examination 24.0 97.9 2,349.8 26.29(c)(2): Record of training completion (annual refresher training on FFD policy) 24.0 123.0 2,952.9 26.29(d): Record acceptance of FFD training from other licensees' programs 24.0 4.0 96.0 26.31(b)(1)(i): Records of background investigations, credit and criminal history checks, and psychological assessments of checks for performed on individuals designated as FFD personnel 24.0 16.0 384.0 26.31(b)(1)(v): Record results of behavioral observation for FFD program personnel Burden accounted for under section 26.189(c) 26.31(d)(3)(ii): Document LTF technician qualifications to perform validity and drug tests.
Burden accounted for under section 26.125(b) and (c) 26.33: Behavioral observation records Burden accounted for under section 26.189(c) 26.35(c): Record of written waiver of right to privacy from individuals given to the Employee Assistance Program (EAP) 12.0 2.0 24.0 26.35(c): Record of EAP disclosure to a licensee or other entity that an individual poses an immediate hazard, or who has waived in writing the right to privacy 12.0 1.0 12.0 26.37(b)(1): Record of signed consent from individual to disclose information collected under Part 26 to the individuals representative on an FFD matter 24.0 2.3 54.1 26.37(c): Record of signed release from subject individual to disclose personal information collected under Part 26 to other licensees or other entities 24.0 40.0 960.0 26.37(d): FFD management provides records to individual on an FFD violation 24.0 40.0 960.0 26.39(a): Maintain procedures for the review of FFD violation determinations Burden accounted for under section 26.27(c)
Extension (May 2021 - April 2024)
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DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.39(b): D&A testing program provides notice to an individual of the grounds of an FFD policy violation determination and review procedures 24.0 85.0 2,040.5 26.39(d): If a review of an FFD violation finds in favor of the individual, the licensee or other entity updates records (delete or correct information found to be inaccurate) 6.0 16.0 96.0 26.39(e): C/V with a D&A testing program provides review procedures to each individual that has violated the FFD policy 0 0.5 0
26.41(a), (b), and (c): Record of audits Burden accounted for under 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 labs conducted by other D&A testing programs (if the audit addresses the same services utilized by each program) 24.0 40.0 960.0 26.53(e)(2): Record that C/Vs informed licensee of the denial or termination of an individual's authorization 0 12.0 0
26.53(g): Record that CVs and other licensees informed of Part 26 violations 0 8.0 0
26.53(h): Obtain and retain written consent from each individual before initiating any actions under Subpart C of Part 26 24.0 146.9 3,524.7 26.53(i): Individual applying for authorization is informed in writing of the reason(s) for denial or termination of authorization 24.0 21.9 525.5 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update 26.59(a)(1) - (a)(2): Authorization reinstatement For each individual applying for authorization, a record of a completed self-disclosure, employment history, and suitable inquiry is maintained Burden accounted for under sections 26.61(a), (a)(1), and (a)(2),
and 26.63 (a), (c), and (e) 26.59(c)(1): Obtain, review, and retain an applicants self-disclosure Burden accounted for under section 26.61(a), (a)(1) and (a)(2) 26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an applicants written self-disclosure and employment history 24.0 1,468.6 35,246.6 26.61(b) and (c): Specify the information to be collected in the self-disclosure and employment history Burden accounted for under section 26.61(a), (a)(1) and (a)(2) 26.63(a), (c), and (e): Obtain, review, and retain an applicants suitable inquiry 24.0 1,468.6 35,246.6 26.63(c)(2): Obtain, review, and retain information on an applicants U.S. military service (i.e., form DD 214) 24.0 4.0 96.0 Page 5 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.63(c)(3): Document inability to obtain information from an applicants past employer(s) 24.0 3.0 72.0 26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD programs 24.0 1.0 24.0 26.63(f): Specifies the time periods that a suitable inquiry must cover (for initial authorization, authorization update, and authorization reinstatement)
Burden accounted for under section 26.63(a), (c) and (e) 26.65(d) and (e): Record of reinstatement or administrative withdrawal of authorization 24.0 4.0 96.0 26.65(f): Authorization reinstatement after an interruption --
record of administrative withdrawal of authorization under section 26.65(d)(1)(ii) or (e)(2)(iii)(B) 24.0 1.0 24.0 26.67 Record of random D&A testing of persons who have applied for authorization and who have received a pre-access test, but who have yet to be granted authorization Burden accounted for under section 26.183(d)(2)(i) 26.69(b) and (c)(1): Authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified -
- obtain, review, and retain an applicants self-disclosure and employment history Burden accounted for under section 26.61(a) 26.69(c)(2): Record that the licensee or other entity identified and resolved PDI (not reviewed and favorably resolved by a previous licensee or other entity) 24.0 58.7 1,409.9 26.69(c)(3): Record that the licensee or other entity verified that an applicant with a prior FFD testing violation (i.e., a 5-year denial for a 2nd positive result) has abstained from substance abuse for at least 5 years Burden accounted for under section 26.69(c)(4) 26.69(c)(4): Record that an SAE conducted a determination of fitness and concluded that an applicant with PDI is fit to safely and competently perform duties (i.e., evaluated clinically appropriate treatment and followup testing plans were developed by an SAE -- for an applicant with a prior 1st positive result; ensured treatment recommendations and followup testing from an SAEs determination of fitness are initiated -- for an applicant with a prior 2nd positive result; or verified the applicant is in compliance with and successfully completed any followup testing and treatment plans) 24.0 40.0 960.0 26.69(c)(5): Record of negative results for pre-access D&A testing (needed prior to granting authorization) 24.0 49.0 1,174.9 26.69(d): Record of reviewing officials determination on an applicants request for access authorization 24.0 24.0 576.0 Page 6 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.69(e): Record that follow-up testing and treatment plan for an applicant from the D&A testing program of another licensee or other entity has been verified (that is treatment and follow-up testing successfully completed) 24.0 8.0 192.0 26.69(e)(1): Record that information transmitted on testing and treatment plans to other FFD programs (at donor request) 24.0 8.0 192.0 26.75(a) - (e), and (g): Records of sanctions for FFD violations Burden accounted for under section 26.39(b) 26.75(h): Record that an individuals authorization was administratively withdrawn due to impairment confirmed under section 26.189, or because the individual posed a safety hazard 24.0 11.0 264.3 26.75(i): Record of temporary administrative withdrawal of an individual's authorization due to an initial positive test result for marijuana and/or cocaine at an LTF 0 80.0 0
26.75(i)(3): Eliminate from an individuals record any references to a temporary administrative withdrawal of authorization due to an initial positive marijuana and/or cocaine test result at an LTF that did not confirm positive after testing at an HHS lab 0 1.0 0
26.85(a) and (b): Training of urine and alcohol collectors and maintain training records in personnel files 24.0 8.0 192.0 26.87(d)(3): If a collection site cannot be dedicated solely to collecting specimens, secure the portion of the facility when a specimen collection is in process and post a sign indicating access permitted only to authorized personnel 24.0 1.0 24.0 26.87(f)(1) and (f)(3) - (f)(5): Post a sign outside the collection area (if a public restroom used) and document on the custody-and-control form (CCF) the name of a same gender observer (in the exceptional event that a designated collection site is inaccessible, the collector is not the same gender as the donor and a urine specimen must be immediately collected) 2.0 0.5 1.0 26.89(a): Collector notifies FFD management that a donor failed to report to the collection site 5.0 0.25 1.3 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-testing form obtained 24.0 1.5 36.0 26.89(b)(3): Record that FFD management informed that an individual did not present identification (pre-access testing) 24.0 1.0 24.0 26.89(c): Collector documents on CCF a donor's refusal to cooperate with the collection process Burden accounted for under section 26.107(b) 26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT) device test results Burden accounted for under section 26.715(b)(2)
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DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.91(e)(4): Record that results cancelled after EBT calibration check failure 0 6.0 0
26.91(e)(5): EBT maintenance records Burden accounted for under section 26.715(b)(14) 26.93(a)(6): Document that alcohol pre-test questions communicated to the donor 24.0 43.7 1,049.5 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
26.97(c)(1): Document reason for failure of 2nd collection attempt 0 0.25 0
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 higher blood alcohol concentration (BAC)
Burden accounted for under section 26.715(b)(2) 26.101(b)(7): Record time and BAC result of confirmatory alcohol test Burden accounted for under section 26.715(b)(2) 26.103(b): Record that FFD management notified of a confirmatory alcohol test result of 0.01 to 0.02 percent BAC 8.0 0.25 2.0 26.107(b): Collector documents on CCF any donor conduct during collection process indicating an attempt to tamper with a specimen, and notifies FFD management 24.0 1.33 31.9 26.109(b)(3): Collector documents on CCF that the donor was unable to provide a specimen in the 3-hour time allotted (i.e.,
a shy bladder), and notifies FFD management Burden accounted for under section 26.107(b) 26.109(b)(4): Collector documents on CCF if a specimen (less than 30 mL) appears to be tampered with and/or donor behavior during collection indicated a possible subversion attempt, and notifies FFD management Burden accounted for under section 26.107(b) 26.111(b): Collector documents on CCF if specimen characteristics (color, clarity) indicate possible tampering by the donor Burden accounted for under section 26.107(b) 26.111(c): Collector documents on CCF unusual specimen temperature and/or observations during the collection indicating possible tampering, and notifies FFD management Burden accounted for under section 26.107(b) 26.113(b)(3): Collector completes CCF for split-specimen collection Burden accounted for under 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 Burden accounted for under section 26.107(b) 26.115(d): Collector documents on CCF that observed collection performed and reason for the observed collection Burden accounted for under section 26.107(b) 26.115(f)(3): Collector documents on CCF the name of observer of directly observed collection Burden accounted for under section 26.107(b)
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DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.117(c) - (e): Collector prepares ID labels and CCF forms for specimen shipment 24.0 174.9 4,198.0 26.119(a), (e), and (f): Written evaluation from the physician who performed a medical evaluation of a donor with a shy bladder (i.e., unable to provide a specimen of adequate volume in the allotted 3-hours) 12.0 2.0 24.0 26.119(b): Record that MRO provided information and instructions to the physician who is to perform the examination of a donor with a shy bladder 12.0 1.0 12.0 26.125(b) and (c): Records on the proficiency and qualifications of LTF personnel 3.0 16.0 48.0 26.127 (a) - (e): Maintain LTF written procedures on the handling of specimens, chain-of-custody procedures, testing assays, instrument and device setup, and remedial actions for systems and testing devices.
3.0 40.0 120.0 26.129(a): Maintain documentation of access to secure areas of an LTF by all authorized individuals (i.e., an access log) 3.0 4.0 12.0 26.129(b): LTF inspects specimen packages, CCFs, and obtains memorandum from specimen collectors to correct identified discrepancies 3.0 0.5 1.5 26.129(b)(1): LTF record of report to senior licensee or other entity management of attempts to tamper with specimens in transit 0 1.0 0
26.129(d): LTF personnel documenting the testing process and transfers of custody of each specimen and aliquots 3.0 80.0 240.0 26.135(b): LTF record of direction from MRO to send Bottle B of a split specimen to a second HHS lab for testing 3.0 0.5 1.5 26.137(a): Record of a QA/QC program and procedures for LTF 3.0 4.0 12.0 26.137(b)(1)(ii): LTF documentation of performance testing of a device not approved by SAMHSA for point-of-collection testing 0 40.0 0
26.137(b)(1)(iii): LTF documentation of annual test results for a device not approved by SAMHSA for point-of-collection testing 0 20.0 0
26.137(b)(3): LTF records submitting 1 in 10 specimens that test negative on validity screening testing are sent to an HHS lab as part of the LTF's QA program 0 40.0 0
26.137(d)(6): LTF records that 1 in 10 specimens that test negative on initial validity testing are sent to an HHS lab for testing as part of the LTFs QA program 3.0 40.0 120.0 26.137(e)(7): LTF documented procedures to protect against carryover material Burden accounted for under 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 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 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 report submitted under section 26.717 3.0 40.0 120.0 26.153(g): Record of memorandum sent to the HHS lab explaining use of non-federal CCF form 24.0 0.5 12.0 26.159(b)(1): Record that the licensee or other entity received noticed from an HHS lab within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the lab identifying evidence of tampering with specimen.
0 1.0 0
26.159(i): Record of written authorization to store specimens other than 1 year 24.0 0.5 12.0 26.163(a)(2): Record that special analyses testing conducted on a dilute specimen and report of the test results Burden accounted for under section 26.169(c)(1) 26.165(b)(1): Record of a donor request for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab Burden accounted for under section 26.165(b)(6) 26.165(b)(2): Record that MRO informed the donor of the opportunity to request the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab Burden accounted for under section 26.185(c) 26.165(b)(3): Donor's written permission provided to the MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab Burden accounted for under section 26.165(b)(6) 26.165(b)(4): Record that the donor presented documentation to the MRO on the inability to submit a timely request to initiate specimen retesting at a second HHS lab Burden accounted for under section 26.185(c) 26.165(b)(6): MRO reviews HHS lab results on the retesting of an aliquot of a single specimen or testing of the Bottle B split specimen, informs the donor of the results, and notified FFD management 24.0 1.2 29.0 26.165(c)(4): Results report received from the second HHS lab that performed retesting an aliquot of a single specimen or the testing of the Bottle B split specimen Burden accounted for under section 26.165(b)(6) 26.165(f)(1): Adjustments to personnel files and written notifications regarding the results of retesting an aliquot of a single specimen or testing of the Bottle B split specimen, including temporary administrative action 0 6.0 0
26.165(f)(1)(iv) and (f)(2): Written record and notice that records purged of references to temporary administrative action 0 8.0 0
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DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.167(f)(3): Record received from the Responsible Person of an HHS lab on a false positive BPTS testing error (determined to be technical or methodological),
demonstrating that retesting of all positive, adulterated, substituted, and invalid specimens from the time of final resolution of the error back to the time of the last satisfactory performance test cycle has been completed 0 1.0 0
26.168(a) Maintain documentation of HHS lab certification of BPTS formulation 24.0 2.6 62.0 26.168(i)(2): Licensee or other entity completes CCF for a BPTS, places fictional initials on specimen labels, and indicates on the MRO copy of the CCF that the specimen is a BPTS 24.0 34.4 826.7 26.169(a): Records of reports of test results from the HHS lab Burden accounted for under section 26.183(c)(1) 26.169(c)(1): Records of HHS lab reports of positive, adulterated, substituted, dilute, and invalid test results received by the MRO Burden accounted for under section 26.183(c)(1) 26.169(c)(2): Records of HHS lab reports of the numerical values of all positive drug test results (i.e., quantitative test results requested by MRO)
Burden accounted for under section 26.183(c)(1) 26.169(c)(2): Records of HHS lab reports of quantitative test results for opiates Burden accounted for under section 26.183(c)(1) 26.169(c)(3): Records of HHS lab reports of quantitative test results for adulterated or substituted test results Burden accounted for under section 26.183(c)(1) 26.169(c)(4): Record of MRO contact with HHS lab to discuss whether testing by another HHS lab should be conducted on a specimen with an invalid result Burden accounted for under section 26.185(f)(1) 26.169(c)(5): Records of HHS lab reports of concentrations exceeding linear range Burden accounted for under section 26.183(c)(1) 26.169(f): Records of HHS lab transmittals of CCF copies for negative results to the MRO 24.0 43.7 1,049.5 26.169(g): HHS lab copy of the original CCF for each positive, adulterated, substituted, dilute, and invalid test results to the MRO Burden accounted for under section 26.169(c)(1) 26.169(h): Record of HHS lab statistical summary report of urinalysis testing results (for the calendar year) 24.0 2.0 48.0 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 or other entity's discretion, dilute specimen 24.0 2.0 48.1 26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug positive, adulterated, substituted, or refusal to test result to the licensees designated reviewing official 24.0 2.0 48.1 Page 11 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results to FFD management 24.0 262.4 6,297.0 26.183(d)(2)(ii): Record of MRO staff review of CCFs for positive, adulterated, substituted and invalid results and forwards changes to MRO for review 24.0 2.4 57.7 26.185(a) Record of MRO review of a drug positive, adulterated, substituted, dilute, or invalid HHS lab test result Burden accounted for under 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 test results with MRO Burden accounted for under 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 proceeding 24.0 0.5 12.0 26.185(f)(1): Record of MRO consultation with HHS lab to determine whether additional testing needed for an invalid specimen 24.0 0.5 12.0 26.185(f)(2): Record of MRO contact with donor about an invalid test result, and medical information received Burden accounted for under section 26.185(c) 26.185(h)(1): Record of MRO contact with donor about a substituted test result, and medical information received Burden accounted for under section 26.185(c) 26.185(h)(2): Record of MRO confirmation of a substituted test result (no legitimate medical explanation)
Burden accounted for under section 26.183(d)(1)(ii)(D) 26.185(h)(3): MRO record of determination of a legitimate medical explanation for a substituted test result Burden accounted for under section 26.183(d)(2)(i) 26.185(i)(1): Record of MRO contact with donor about an adulterated test result, and medical information received Burden accounted for under section 26.185(c) 26.185(i)(2): Record of MRO confirmation of an adulterated test result (no legitimate medical explanation)
Burden accounted for under section 26.183(d)(1)(ii)(D) 26.185(i)(3): MRO record of determination of a legitimate medical explanation for an adulterated test result Burden accounted for under section 26.183(d)(2)(i) 26.185(j): Prescription medication drug positives (applies to amphetamine, morphine, and codeine results) - records of MRO review of HHS lab result, discussion of positive result with donor, and review medication information from the donor 24.0 2.5 60.0 26.185(k): Record of MRO report to licensee that no FFD policy violation has occurred (i.e., legitimate prescription medication used in a manner and at the dosage prescribed).
If the individual poses a potential risk to public health and safety because of impairment while on duty - the MRO will ensure that a determination of fitness is performed)
Burden accounted for under sections 26.183(d)(2)(i) and 26.185(c)
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DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.185(m): Record of MRO review of inspection and audit reports, QC data, multiple specimens, and other data to determine if positive, adulterated, substituted, or invalid result is scientifically insufficient for determination of FFD policy violation 0 1.0 0
26.185(n): Record of MRO review of a positive, adulterated or substituted test result from a second HHS lab (results of retesting a single specimen or testing of a Bottle B split specimen), and MRO communication of the test result to the donor, and report results to FFD management Burden accounted for under section 26.165(b)(6) 26.185(o): Record of MRO request and HHS lab report of quantitation test results for testing performed on a specimen from a donor applying for reauthorization following a 1st positive drug test result 24.0 0.5 12.0 26.185(p): MRO written notice to licensee or other entity of a positive, adulterated, substituted, or invalid test result Burden accounted for under 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 fitness 1.0 1.0 1.0 26.203(a): Updates to fatigue management policy (in addition to 26.27 burden) 0 7.3 0
26.203(b): Updates to fatigue management procedures (in addition to 26.27 burden) 0 1.7 0
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 schedules, and shift cycles Burden accounted for under 26.205(c), (d)(1), and (e)(4) 26.203(d)(3): Documentation of waivers Burden accounted for under section 26.207(a)(4) 26.203(d)(4): Documentation of work hour reviews Burden accounted for under 26.205(d)(2), (e)(3) and (e)(4) 26.203(d)(5): Documentation of fatigue assessment Burden accounted for under section 26.211(f) 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 hours twice per calendar year 54.0 12.0 648.0 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 hours 54.0 6.0 324.0 Page 13 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 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 (reactor construction site D&A testing program) 0.3 16.0 5.3 26.403(a): Provide FFD policy to individuals subject to a reactor construction site D&A testing program 0.3 8.0 2.7 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 accident D&A tests 0.3 531.3 177.1 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 specimen, and stringent quality controls to ensure accurate test results 0 40.0 0
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 construction site D&A testing program) 0.3 179.3 59.8 26.406(c): Updates to fitness monitoring procedures (programs that do not adopt random testing and behavioral observation) 0 80.0 0
26.411(a): Updates to procedures for maintaining a system of files to protect personal information collected under Subpart K of Part 26 0.3 40.0 13.3 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 reactor construction site D&A testing program 0.3 20.0 6.7 26.417(b)(1): Report to NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> programmatic failures in a reactor construction site D&A testing program Burden accounted for under section 26.719(b) 26.417(b)(2) Collect FFD program performance data for reactor construction site D&A testing program 0.3 100.0 33.3 26.713(a)(1): Records of self-disclosures, employment histories, and suitable inquiries (under sections 26.55, 26.57, 26.59, and 26.69) that result in the granting of authorization Burden accounted for under section 26.61(a), and 26.63(a), (c), and (e) 26.713(a)(2): Records pertaining to the determination of a violation of FFD policy and related management actions Burden accounted for under section 26.39(b) 26.713(a)(3): Documentation of the granting and termination of authorization 24.0 80.0 1,920.0 Page 14 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.713(a)(4): Records of determinations of fitness performed under section 26.189 (including recommendations for treatment and followup testing plans) 24.0 80.0 1,920.0 26.713(b)(1): Records of FFD training and examinations conducted under section 26.29 Burden accounted for under sections 26.29(a) and (b) 26.713(b)(2): Records of audits, audit findings, and corrective actions taken under section 26.41 Burden accounted for under sections 26.41(a) - (d), (f) and (g) 26.713(c): Records on 5-year and permanent denials of authorization Burden accounted for under section 26.39(b) 26.713(d): Records of superseded versions of FFD policies and procedures 24.0 8.0 192.0 26.713(e): Records of written agreements for services under Part 26 24.0 16.0 384.0 26.713(f): Records of background investigations, credit and criminal history checks, and psychological assessments of FFD program personnel conducted under section 26.31(b)(1)(i)
Burden accounted for under section 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 26.715(b))
24.0 40.0 960.0 26.715(b)(1): Retain personnel files on staff at collection sites and LTFs 24.0 20.0 480.0 26.715(b)(2): Retain collection site and LTF chain-of-custody documents 24.0 240.0 5,760.0 26.715(b)(3): Retain LTF QA/QA records 3.0 120.0 360.0 26.715(b)(4): Retain superseded procedures (LTFs and collection sites) 24.0 40.0 960.0 26.715(b)(5): Retain all test data from LTF (including calibration curves and any calculations used in determining test results 3.0 240.0 720.0 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, and any corrective actions taken 6.0 40.0 240.0 26.715(b)(10): Records of preventative maintenance on LTF instruments 3.0 40.0 120.0 26.715(b)(11): Retain records that summarize any test results the MRO determined to be scientifically insufficient for further action 0 3.0 0
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 authorized visitors, maintenance personnel and service personnel who accessed LTF secure areas Burden accounted for under section 26.129(a)
Page 15 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 2: Annual Recordkeeping Section Number of Record-keepers Burden Hours per Record-keeper Total Annual Burden Hours Extension (May 2021 - April 2024) 26.715(b)(14): Retain records of the inspection, maintenance and calibration of EBTs (collection sites) 62.0 8.0 496.0 26.717(a) and (b): Collect FFD performance data for D&A testing programs 62.0 40.0 2,480.0 26.717(a) and (b): Collect FFD performance data for fatigue management program 54.0 40.0 2,160.0 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 annually 54.0 16.0 864.0 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 NRC (for C/V with a testing program)
Burden accounted for under section 26.717(a) and (b) 26.719(b): Prepare information to make a 24-hour event report to the NRC 36.0 1.0 36.0 26.719(c): Prepare 30-day event report documentation.
6.0 40.0 240.0 26.719(d): Document non-reportable indicators of FFD program weaknesses 24.0 20.0 480.0 26.821(a): Provide NRC with access to records (to inspect, copy, or take away copies of records) 25.0 4.0 100.0 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/Vs documents, records, and reports 1.0 4.0 4.0 Total 186,116.3 Page 16 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 3: Annual Reporting Section Number of Respondents Responses per Respondent Total Responses Burden per
Response
(hours)
Total Burden Hours 26.9: Application to NRC for exemption (D&A testing program) 1.0 0 40.0 -
26.9: Application to NRC for exemption (fatigue management program) - COVID-19 40.0 1.0 40.0 2.0 80.0 26.77(c) Report impaired NRC employee 0
0 0 1.0 -
26.137(b)(3): Report false negative LTF validity screening result No LTF conducts validity screening testing (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 FFD program performance report for fatigue management programs 54.0 1.0 54.0 16.0 864.0 26.203(e)(2): Prepare summary of fatigue corrective actions for inclusion in the annual FFD program performance report for fatigue management programs 54.0 1.0 54.0 2.0 108.0 26.417(b)(1): Report to NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a programmatic failure in a reactor construction site D&A testing program Burden accounted for under section 26.719(b) 26.417(b)(2): Prepare annual FFD program performance report for reactor construction site D&A testing program 0.3 1.0 0.3 80.0 26.7 26.717: Annual FFD program performance report for fatigue management programs 54.0 1.0 54.0 8.0 432.0 26.717: Annual FFD program performance for D&A testing programs 62.0 1.0 62.0 60.0 3,720.0 26.719(a): Report a significant FFD program violation, programmatic failure, or D&A testing error Burden reported under sections 26.719(b), and (c)(1) - (c)(3) 26.719(b): Report to the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying a significant D&A testing violation 36.0 1.0 36.0 4.0 144.0 26.719(c)(1): Submit a report to the NRC within 30 days of completing an investigation into an LTF or HHS lab testing error 6.0 1.0 6.0 24.0 144.0 26.719(c)(2): Notify the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receiving notice of a false positive on a BPTS test result 0 1.0 0 4.0 -
26.719(c)(3): Notify the NRC by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of receiving a false negative test result on a QA check of a validity screening test from an LTF 0 1.0 0 4.0 -
Total 306.3 5,518.7 Extension (May 2021-April 2024)
Page 17 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Section Number of Responses Burden Hours per
Response
Total Annual Burden 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 existing program); (2) notification of any FFD policy violations by those granted authorization by the licensee or other entity 31.0 2.0 62.0 26.29(b): Complete initial training on FFD policy and take comprehensive examination 70,493.2 2.0 140,986.3 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 investigation, credit and criminal history checks, and psychological assessment 310.0 1.0 310.0 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 waiver of right to privacy to share information with FFD management 886.0 0.25 221.5 26.35(c): Record of EAP disclosure to FFD management about an individual that poses an immediate hazard 12.0 1.0 12.0 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 representative for an FFD matter 216.5 0.25 54.1 26.37(d): Request by donor or donors representative to the licensee or other entity to provide personal records collected under Part 26 22.0 0.25 5.5 26.53(h): Applicant provides written consent before any actions are initiated under Subpart C of Part 26 70,493.2 0.25 17,623.3 26.55(a)(1) - (a)(2): Initial authorization 26.57(a)(1) - (a)(2): Authorization update 26.59(a)(1) - (a)(2): Authorization reinstatement Each individual applying for authorization must complete a self-disclosure, employment history, and suitable inquiry Burden accounted for under sections 26.61(a) and 26.63(a),(c) and (e) 26.59(c)(1): Applicant prepares self-disclosure (for authorization reinstatement period of interruption of no more than 30 days)
Burden accounted for under 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 information on previous authorization(s) 70,493.2 0.75 52,869.9 26.63(c)(2): U.S. Department of Defense (DOD) provides licensee or other entity with form DD 214 which details an applicants military service record Burden of supplying DD 214 affects DOD, or is accounted for under section 26.61(a) (if supplied by the applicant) 26.63(c)(3): Former employer refuses to provide information to the licensee or other entity about an applicants prior employment history 140.0 0.1 11.7 26.67: Records of random D&A testing of persons who have applied for authorization, but who have not been granted unescorted access authorization 352.5 0.5 176.2 26.69(b) and (c)(1): Applicant provides written self-disclosure and employment history to the licensee or other entity (for authorization following a 1st or 2nd positive drug or alcohol test result, or if other PDI is identified)
Burden accounted for under section 26.61(a)
Extension (May 2021-April 2024)
Page 18 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Extension (May 2021-April 2024) 26.69(c)(2): Former employer(s) of an applicant provide response to licensee or other entity request to confirm suitable inquiry information for an applicant with PDI 704.9 2.0 1,409.9 26.85(c): Alternative collectors not employed by licensee provide proof of qualification 24.0 1.0 24.0 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 collection site) 2.0 1.0 2.0 26.89(b)(3): Record FFD management informed that an individual did not present identification (non-licensee collection site) 2.0 1.0 2.0 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 failure (non-licensee collection site) 0 1.0 0
26.91(e)(5): Prepare record of EBT maintenance (non-licensee collection site) 24.0 4.0 96.0 26.93(a)(6): Document alcohol pre-test questions asked and answered (non-licensee collection site) 240.0 0.25 60.0 26.95(b)(5): Record donor identity for initial alcohol breath test (non-licensee collection site) 240.0 0.25 60.0 26.97(b)(2): Record reason for new oral fluid alcohol test (non-licensee collection site) 0 0.5 0
26.97(c)(1): Document reason for failure of second collection attempt (non-licensee collection site) 0 1.0 0
26.97(d): Record results and alcohol screening device used (non-licensee collection site) 0 0.25 0
26.99(b): Record test time of initial test with 0.02 percent BAC or higher (non-licensee collection site)
Burden accounted for under section 26.715(b)(2) 26.101(b)(7): EBT printout of confirmatory alcohol test result includes time of test (non-licensee collection site)
Burden accounted for under 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-licensee collection site) 0 0.25 0
26.107(b): Collector documents tampering attempt on CCF form (non-licensee collection site)
Burden accounted for under section 26.111(b) 26.109(b)(3): Collector documents on CCF shy-bladder situation and notifies FFD management (non-licensee collection site) 0 0.25 0
26.109(b)(4): Collector documents on CCF confirmation from FFD management to conduct an observed collection (non-licensee collection site) 0 0.25 0
26.111(b): Collector documents on CCF if specimen characteristics (color, clarity) indicate possible tampering by the donor (non-licensee collection site) 0 0.25 0
26.111(c): Collector documents on CCF unusual specimen temperature and/or other observations made during the collection of possible tampering attempt and notifies FFD management (non-licensee collection site) 0 0.25 0
Page 19 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Extension (May 2021-April 2024) 26.113(b)(3): Collector completes CCF for split-specimen collection (non-licensee collection site)
Burden accounted for under 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 collection site) 0 0.25 0
26.115(d): Collector documents on CCF directly observed collection performed and the reason for the observed collection (non-licensee collection site)
Burden accounted for under section 26.115(b) 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 specimen shipment (non-licensee collection site) 240.0 0.25 60.0 26.119(a), (e), and (f): Physician evaluating shy-bladder claim prepares report of medical examination of donor and provides this information to the MRO 12.0 2.0 24.0 26.129(b): Collector prepares memorandum to and sends to LTF documenting investigation of discrepancies between bottles and CCF (non-licensee collection site) 0 1.0 0
26.135(b): Donor request to MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen at a second HHS lab (initial specimen testing performed at an LTF)
Burden accounted for under section 26.165(b)(1) 26.153(g): Supply memorandum to HHS lab explaining use of non-federal CCF form (non-licensee collection site) 2.0 0.5 1.0 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, and testing of urine specimens Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.157(b): Written HHS lab chain-of-custody procedures for HHS lab Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.157(c): Written HHS lab procedures for each testing assay performed Burden covered by HHS lab certification 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 system and instrument errors Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 Page 20 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Extension (May 2021-April 2024) 26.159(a): Retain records (e.g., an access log) of authorized visitors, maintenance personnel, and service personnel who accessed secure areas of HHS lab Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.159(b)(1): Record that the HHS lab notified the licensee or other entity within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of identifying evidence of specimen tampering 0 1.0 0
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 HHS lab Burden accounted for under 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 specimen or Bottle B of the split specimen) to a second HHS lab for further testing 29.0 1.0 29.0 26.165(b)(3): Donor provides written request to the MRO for the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen 29.0 1.0 29.0 26.165(b)(4): Donor presents documentation to the MRO on the reason for not being able to make a timely retest request Burden accounted for under section 26.185(e) 26.165(b)(6) HHS lab provides report to the MRO of the quantitative test results of the retesting of aliquot of a single specimen or the testing of the Bottle B split specimen Burden accounted for under section 26.185(n) 26.167(a): HHS lab documents QA program (encompasses all aspects of the testing process)
Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158 26.167(c)(2)(i): Refractometer at the HHS lab must display specific gravity to 4 decimals and be interfaced with laboratory information management system or computer and/or document result by hard copy or electronic display Burden covered by HHS lab certification requirements OMB Clearance 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 time of final resolution of the error back to the time of the last satisfactory performance test cycle has been completed, as requested by the licensee or other entity 0 8.0 0
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 entity 1.0 8.0 8.0 26.168(h)(2): BPTS sample supplier provides expiration date on each BPTS 1.0 8.0 8.0 26.169(a): HHS lab reports test results to the MRO of the licensee or other entity Burden accounted for under section 26.169(c)(1) 26.169(c)(1): HHS lab provides record to the MRO for each positive, adulterated, substituted, dilute, and invalid test result 577.0 0.25 144.3 26.169(c)(2): HHS lab provides quantitative test result record for positive drug test (at the request of the MRO)
Burden accounted for under section 26.169(c)(1) 26.169(c)(3): HHS lab provides quantitative test result record for adulterated or substituted test results (at the request of the MRO)
Burden accounted for under section 26.169(c)(1)
Page 21 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 4: Annual Third-Party Disclosure Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Extension (May 2021-April 2024) 26.169(c)(4): HHS lab record of contact with MRO to discuss if additional testing by another HHS lab should be conducted on a specimen with an invalid test result 10.0 0.5 5.0 26.169(f): HHS lab transmits to the MRO a copy of CCF for specimens with negative test results Burden accounted for under section 26.715(b)(2) 26.169(g): HHS lab transmits to the MRO a copy of the original CCF signed by the certifying scientist (for positive, adulterated, substituted, dilute and invalid test result)
Burden accounted for under section 26.169(c)(1) 26.169(h): HHS lab prepares and submits annual statistical summary report of urinalysis testing results 62.0 2.0 124.0 26.185(c): Donor discussion with MRO of positive, adulterated, substituted, dilute, or invalid test result 577.0 0.5 288.5 26.185(e): Donor provides documentation to the MRO demonstrating an inability to discuss test results and requesting the test result determination be reopened 8.0 1.0 8.0 26.185(f)(1): HHS lab consultation with MRO on whether additional testing of a specimen with an invalid test result should be performed at a second HHS lab 24.0 0.50 12.0 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 result Burden accounted for under section 26.185(c) 26.185(i)(1): Donor discussion with MRO regarding an adulterated test result Burden accounted for under 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 MRO (e.g., prescription information and pharmacy, prescribing physician information) 60.0 1.0 60.0 26.185(n): Second HHS lab provides the MRO with test result report (for retesting of an aliquot of a single specimen or the testing of a Bottle B split specimen) 29.0 0.25 7.3 26.185(o): HHS lab provides quantitation of test results for testing performed on a specimen from a donor applying for reauthorization following a 1st positive drug test result (at MRO request)
Burden accounted for under section 26.169(c)(1) 26.189(b): If a qualified treatment professional other than the MRO or SAE performs a determination of fitness on an individual, that treatment professional completes and provides a written determination to the MRO 24.0 1.0 24.0 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 site D&A testing program 2,171.0 0.25 542.8 26.715(a): Documentation of all aspects of HHS lab testing process, not specified elsewhere in section 26.715(b)
Burden covered by HHS lab certification 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 Section Number of Responses Burden Hours per
Response
Total Annual Burden Hours Extension (May 2021-April 2024) 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 curves and any calculations used in determining test results)
Burden covered by HHS lab certification 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 event report to NRC) 6.0 8.0 48.0 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/Vs documents, records, and reports 1.0 4.0 4.0 Total 377,934.1 424,909.9 Page 23 of 24
DRAFT Supporting Statement, 10 CFR Part 26 Table 5: Annualized NRC Burden NRC ACTION No. Actions/
Year Burden Hours /
Action Total Hours Review exemption request under section 26.9 (D&A testing program) 0 40.0 0
Review exemption request under section 26.9 (Fatigue management program) - COVID-19 40 12.0 480 Review FFD policies and procedures under section 26.27(d)
(performed during periodic inspections) 19.0 8.0 152.0 Review records under section 26.75(h) to ensure only appropriate records maintained for a licensee or other entity who administratively withdraws access for initial positive drug tests for marijuana or cocaine at an LTF (performed during periodic inspections) 0 4.0 0
Review and evaluate report made under section 26.77(c) regarding an NRC employee or contractor being unfit for duty 0 4.0 0
Review documentation provided by SAE upon request by NRC under section 26.187(f) 1.0 4.0 4.0 Review and evaluate a 24-hour report made under section 26.417(b)(1) to the NRC Operations Center regarding a significant FFD program failure Burden accounted for under section 26.719(b)
Annual FFD program performance report -
Review, analyze, and summarize information received under 26.417(b)(2) from a reactor construction site D&A testing program.
0.3 25.0 8.3 Annual fatigue management performance report --
Review, analyze, and summarize fatigue management data specified in section 26.203(e) that is submitted under section 26.717 54.0 0.75 40.5 Annual FFD program performance report -
Review, analyze, and summarize information received under 26.717 from a D&A testing program 62.0 12.0 744.0 24-hour report -- Review, evaluate, and respond to a report made under section 26.719(b) to the NRC Operations Center regarding a significant FFD policy violation or programmatic failure 36.0 8.0 288.0 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 Extension (May 2021 - April 2024)
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