Supplementary Burden Spreadsheet for 10 CFR Part 26 information collection renewal

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Overview

T1_1X_Rcdkping
T2_Ann_Rcdkping
T3_AnnRpting
T4_Ann_3rdParty
T5_Ann_NRC
TOTALS

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Sheet 1: T1_1X_Rcdkping

	Table 1: One Time Recordkeeping	Extension (October 2024 - September 2027)
	Section	Number of Recordkeepers	Burden Hours per Recordkeeper (Annualized)*	Total Burden Hours (Annualized)	Notes
	26.27(a): Develop FFD policy statement	0 programs	112.0	0
	26.27(a): Develop FFD procedures	0 programs	212.0	0
	26.29(a) and (b): Develop FFD training course and exam	0 programs	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	0 programs	5.3	0	Number of Recordkeepers - 26.31(d)(1)(i)(D) and (d)(1)(ii). Based on the drug testing panel changes in the 2022 Part 26 final rule, the NRC staff does not anticipate that any D&A testing program will test for additional substances beyond the minimum drug testing panel required by Part 26 for the current clearance period. The prior clearance estimated 1 D&A testing program would test for additional substances.
	26.31(d)(1)(iii): Document additional drugs in testing panel	Burden accounted for under 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	0 programs	5.3	0	Number of Recordkeepers - 26.31(d)(3)(iii)(A) and (d)(3)(iii)(C). Based on the drug testing cutoff level changes in the 2022 Part 26 final rule, the NRC staff does not anticipate that any D&A testing program will use more stringent drug testing cutoff level(s) than required by Part 26 for the current clearance period. The prior clearance estimated 1 D&A testing program would use more stringent drug testing cutoff level(s).
	26.37(a): Develop a system of files and procedures to protect personal information collected under Part 26	0 programs	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 programs	120.0	0
	26.85(a): Develop specimen collector qualification training	0 programs	18.7	0	The 2022 Part 26 final rule consolidated collector training requirements into 26.85(a). Prior to the final rule, the collector requirements appeared under 26.85(a) for urine collectors and 26.85(b) for alcohol collectors. This change did not affect the estimated burden for training (i.e., the burden is now collectively reflected under 26.85(a)).
	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 programs	80.0	0
	26.137(a): Develop LTF procedures for quality assurance/ quality control (QA/QC) program	0 programs	13.3	0
	26.153(e): Record of pre-award inspection of new HHS lab (completed prior to awarding contract for testing services)	3 programs	13.3	40.0	Number of Recordkeepers - 26.153(e). It is estimated that 1 D&A testing program per year will change one of its two existing HHS labs. This assumption also applies to 26.153(f) in Table 1.
	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 programs	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 lab certification also meet Part 26 requirements (new HHS lab)	Deleted in 2022 Part 26 Final Rule
	26.157(a): Confirm HHS lab procedures specific to Part 26 in place that document the accession, receipt, shipment, and testing of specimens (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 lab 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 programs	7.3	0
	26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden)	0 programs	1.7	0
	26.203(c): Prepare training on fatigue management.	0 programs	2.0	0
	26.205(b): Develop work hour tracking system	0 programs	7.7	0
	26.205(c): Develop individual work scheduling system	0 programs	2.0	0
	26.401(b): Prepare a reactor construction site D&A testing program plan	Burden accounted for under 26.403(a) and (b)
	26.403(a): Develop FFD policy statement (new reactor construction site D&A testing program)	4 sites	112.0	448.0	Number of Recordkeepers - 26.403(a). The NRC staff estimates that construction activities will begin at 4 small modular reactor (SMR) construction sites in the third year of this clearance period. This assumption also applies to 26.403(b), 26.407, 26.411(a), and 26.413 in Table 1.
	26.403(b): Develop written FFD procedures (new reactor construction site D&A testing program)	4 sites	216.0	864.0
	26.405(d): Record of testing for specified drugs, adulterants, and alcohol, at Part 26 specified cutoff levels	Burden accounted for under 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 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 (new reactor construction site D&A testing program)	4 sites	40.0	160.0
	26.411(a): Develop procedures for maintaining a system of files to protect personal information collected under Subpart K of Part 26 (new reactor construction site D&A testing program)	4 sites	40.0	160.0
	26.413: Develop procedures for the review of a determination that an individual violated the FFD policy (new reactor construction site D&A testing program)	4 sites	120.0	480.0
	26.713(g): Documentation on testing for additional drugs as permitted under 26.31(d)(1), use of more stringent testing cutoff levels as permitted under 26.31(d)(3), or both	Burden accounted for under 26.31(d)(1)(i)(D) and (d)(1)(ii), and 26.31(d)(3)(iii)(A) and (d)(3)(iii)(c)
	Total			2,192.0
	* An annualized one-time burden is calculated by dividing each burden hour estimate by the 3 years covered by this clearance. While the recordkeeping burdens in Table 1 are not applicable to most D&A testing programs or any fatigue management program during this clearance period, the “Burden Hours per Program (Annualized)” information is retained for future reference.

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Sheet 2: T2_Ann_Rcdkping

	Table 2: Annual Recordkeeping	Extension (October 2024 - September 2027)
	Section	Number of Record- keepers	Burden Hours per Record- keeper	Total Annual Burden Hours	Notes
	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 26.29(a) training requirements met (if not already covered by the program); (2) record of notice of any FFD policy violation	30 sites	2.0	60.0	Number of Recordkeepers - 26.4(j). It is estimated that 50 percent of the 60 sites implementing a D&A testing program grant authorization to offsite response personnel subject to a State or Federal agency D&A testing program (e.g., emergency fire and medical response personnel, strategic special nuclear material (SSNM) transporters).
	26.27(b): Make FFD policy statement readily available to subject personnel	24 programs	16.0	384.0	Number of Recordkeepers - 26.27(b). The NRC staff estimates 24 D&A testing programs for this clearance period, which is the same as in the previous clearance.
	26.27(c): Updates to FFD policy and procedures	24 programs	80.0	1,920.0
	26.27(d): Provide FFD policy and procedures to NRC for review (performed during periodic inspections)	18 sites	2.0	36.0	Number of Recordkeepers - 26.27(d). The NRC inspects the FFD program at each operating reactor site and each Category I special nuclear material (SNM) site every 3 years. (53 reactor sites + 2 Category I SNM sites = 55 sites / 3 years = 18 sites per year)
	26.29(b): Record of training completion (initial training on FFD policy) and results of comprehensive examination	24 programs	83.7	2,008.6	Burden Hours per Recordkeeper 26.29(b). A D&A testing program is estimated to spend 2 minutes (0.033 hour) per individual to print and retain a record detailing training completion and examination results. It is estimated that 60,257 individuals will complete training each year. The 60,257 value is the average number of individuals pre-access tested from CY 2019 through CY 2021. (0.033 hour per individual X 60,257 individuals per year = 2,008.6 hours per year / 24 D&A testing programs = 83.7 hours per D&A testing program per year) The previous clearance estimated that 68,285 individuals would be pre-access tested each year.
	26.29(c)(2): Record of training completion (annual refresher training on FFD policy)	24 programs	106.3	2,550.9	Burden Hours per Recordkeeper - 26.29(c)(2). A D&A testing program is estimated to spend 2 minutes (0.033 hour) per individual to print and retain a record on training completion. It is estimated that 76,527 individuals will complete annual FFD refresher training each year, which is the average number of individuals subject to a random testing program from CY 2019 through CY 2021. The previous clearance estimated that 85,916 individuals would be subject to annual refresher training.
	26.29(d): Record acceptance of FFD training from other licensees' programs	24 programs	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 programs	16.0	384.0	Burden Hours per Recordkeeper - 26.31(b)(1)(i). It is estimated that each D&A testing program spends 16 hours per year to evaluate records provided by individuals seeking to be or serving as FFD program personnel.
	26.31(b)(1)(v): Record results of behavioral observation for FFD program personnel	Burden accounted for under 26.189(c)
	26.31(d)(3)(ii): Document LTF technician qualifications to perform validity and drug tests.	Burden accounted for under 26.125(b) and (c)
	26.33: Behavioral observation records	Burden accounted for under 26.189(c)
	26.35(c): Record of written waiver of right to privacy from individuals given to the Employee Assistance Program (EAP)	12 programs	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 programs	1.0	12.0
	26.37(b)(1): Record of signed consent from an individual to disclose information on an FFD matter that was collected under Part 26 to the individual’s representative	24 programs	2.9	70.5	Burden Hours per Recordkeeper - 26.37(b)(1). It is estimated that an individual spends 15 minutes (0.25 hour) to read and sign a consent form to provide access to a representative to assist with an FFD violation. It is estimated that the 281 individuals that annually test positive on random, for-cause, post-event, and follow-up tests would request assistance from a representative. The 281 value is the average number of testing violations from CY 2019 through CY 2021, adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule. The previous clearance estimated 209 individuals would request assistance each year.
	26.37(c): Record of signed release from an individual to disclose personal information collected under Part 26 to other licensees or other entities	24 programs	40.0	960.0
	26.37(d): FFD management provides records to individual on an FFD violation	24 programs	40.0	960.0
	26.39(a): Maintain procedures for the review of FFD violation determinations	Burden accounted for under 26.27(c)
	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 programs	93.0	2,230.8	Total Annual Burden Hours - 26.39(b). A D&A testing program is estimated to spend 2.75 hours per individual with an FFD policy violation to develop a written notification on the FFD policy violation and review procedures. D&A testing programs typically use a standard notification letter and include specific information about the FFD policy violation, denial period, and method to appeal the decision. It is estimated that 892 individuals per year will have an FFD policy violation. The 892 value is the average number of drug and alcohol testing violations from CY 2019 through CY 2021, adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule. The previous clearance estimated that 721 individuals would have an FFD policy violation each year.
	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)	0.3 programs	16.0	5.3	Number of Recordkeepers - 26.39(d). It is estimated that one FFD violation will be overturned on appeal during the 3-year period of this clearance. The previous clearance estimated 6 FFD violations per year would be overturned on appeal. The number of instances in which an FFD violation is over turned on appeal is rare.
	26.39(e): C/V with a D&A testing program provides review procedures to each individual that has violated the FFD policy	0.3 programs	0.5	0.2	Number of Recordkeepers - 26.39(e). Only one C/V, the Institute of Nuclear Power Operations (INPO), maintains an independent D&A testing program under Part 26. All other C/Vs fall under licensee D&A testing programs and would not be subject to this recordkeeping requirement. INPO reported 1 positive test result from CY 2019 through CY 2021. The annual estimated recordkeeper is reported as 0.3 programs to reflect 1 positive result / 3 years for the INPO D&A testing program.
	26.41(a), (b), and (c)(1): Record of audits	Burden accounted for under 26.41(f) and (g)
	26.41(d): Record of review of C/V audit results	24 programs	40.0	960.0
	26.41(f): Document and report audit results	24 programs	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 programs	40.0	960.0
	26.53(e)(2): Record that C/Vs informed licensee of the denial or termination of an individual's authorization	8 programs	0.5	4.0	Burden Hours per Recordkeeper - 26.53(e)(2). The estimated burden for a C/V to notify a D&A testing program of the termination of an individual’s authorization is 30 minutes (0.5 hour) per program (i.e., 24 D&A testing programs would be notified of each event). For the current clearance period, the NRC estimated under 26.39(e) that the 1 C/V with a D&A testing program would have 1 positive test result over the 3 year clearance period. [(1 positive result x 24 D&A testing programs) / 3 years = 8 programs notified per year]
	26.53(g): Record that CVs and other licensees informed of Part 26 violations	0 programs	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 programs	125.5	3,012.9	Total Annual Burden Hours - 26.53(h). A D&A testing program is estimated to spend 3 minutes (0.05 hour) to file a signed consent form received from an individual before initiating a pre-access test. Most of the burden for reading and signing the consent form is accounted for as third-party burden in Table 4 D&A testing programs are estimated to obtain written consent from 60,257 individuals per year, which is the average number of individuals with pre-access tests from CY 2019 through CY 2021. The previous clearance estimated 68,285 individuals per year would complete this activity.
	26.53(i): Individual applying for authorization is informed in writing of the reason(s) for denial or termination of authorization	24 programs	26.1	627.0	Total Annual Burden Hours - 26.53(i). A D&A testing program is estimated to spend 1 hour per pre-access D&A testing violation. It is estimated that 627 individuals per year applying for authorization at a D&A testing program will have a pre-access testing violation (i.e., a positive test result for drug(s) and/or alcohol, an adulterated or substituted validity test result, or a refusal to test). The 627 value is the average number of pre-access testing violations reported in CY 2019 through CY 2021, adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule. The previous clearance estimated that 506 individuals would have a pre-access testing violation each year.
	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 26.61(a), (a)(1), and (a)(2), and 26.63 (a), (c), and (e)
	26.59(c)(1): Obtain, review, and retain an applicant’s self-disclosure	Burden accounted for under 26.61(a), (a)(1) and (a)(2)
	26.61(a), (a)(1), and (a)(2): Obtain, review, and retain an applicant’s written self-disclosure and employment history	24 programs	1,255.4	30,128.5	Total Annual Burden Hours - 26.61(a), (a)(1) and (a)(2). A D&A testing program is estimated to spend an average of 30 minutes (0.5 hour) to review, verify, and file information provided in an applicant’s self-disclosure and employment history. This activity is completed for each of the 60,257 individuals per year that apply for authorization at D&A testing programs (i.e., the average number of pre-access tests performed from CY 2019 through CY 2021). The previous clearance estimated that 68,285 individuals applied for authorization each year.
	26.61(b) and (c): Specify the information to be collected in the self-disclosure and employment history	Burden accounted for under 26.61(a), (a)(1) and (a)(2)
	26.63(a), (c), and (e): Obtain, review, and retain an applicant’s suitable inquiry	24 programs	1,255.4	30,128.5	Total Annual Burden Hours - 26.63(a), (c), and (e). A D&A testing program is estimated to spend an average of 30 minutes (0.5 hour) to review, verify, and retain information provided in an applicant’s suitable inquiry. This activity is completed for each of the 60,257 individuals estimated to apply for authorization at D&A testing programs per year (i.e., individuals pre-access tested). The previous clearance estimated that 68,285 individuals applied for authorization each year.
	26.63(c)(2): Obtain, review, and retain information on an applicant’s U.S. military service (i.e., form DD 214)	24 programs	4.0	96.0
	26.63(c)(3): Document inability to obtain information from an applicant’s past employer(s)	24 programs	3.0	72.0
	26.63(d) and (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD programs	24 programs	1.0	24.0
	26.65(d) and (e): Record of reinstatement or administrative withdrawal of authorization	24 programs	4.0	96.0
	26.65(f): Authorization reinstatement after an interruption – record of administrative withdrawal of authorization under 26.65(d)(1)(ii) or 26.65(e)(2)(iii)(B)	24 programs	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 26.183(d)(1)(ii)(D) and 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 potentially disqualifying information (PDI) is identified – obtain, review, and retain an applicant’s self-disclosure and employment history	Burden accounted for under 26.61(a), (a)(1) and (a)(2)
	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 programs	50.2	1,205.1	Total Annual Burden Hours - 26.69(c)(2). A D&A testing program is estimated to spend 2.0 hours per application to resolve identified FFD PDI. It is estimated that FFD PDI is identified in the applications of 603 individuals each year (i.e., 1 percent of the 60,257 individuals pre-access tested each year). The previous clearance estimated FFD PDI would be identified in the applications of 683 individuals per year.
	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 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 SAE’s 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 programs	40.0	960.0
	26.69(c)(5): Record of negative results for pre-access D&A testing (needed prior to granting authorization)	24 programs	41.8	1,004.3	Total Annual Burden Hours - 26.69(c)(5). It is estimated that a licensee’s reviewing official will spend 1 minute (0.017 hour) per person to confirm the receipt of negative pre-access testing results. It is estimated that an average of 60,257 individuals will be pre-access tested each year (i.e., the average number of pre-access tests peformed from CY 2019 through CY 2021). The previous clearance estimated that 68,285 individuals would be pre-access tested per year.
	26.69(d): Record of reviewing official’s determination on an applicant’s request for access authorization	24 programs	24.0	576.0
	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 programs	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 programs	8.0	192.0
	26.75(a) – (e), and (g): Records of sanctions for FFD violations	Burden accounted for under 26.39(b)
	26.75(h): Record that an individual’s authorization was administratively withdrawn due to impairment confirmed under 26.189, or because the individual posed a safety hazard	24 programs	7.1	171.3	Total Annual Burden Hours - 26.75(h). It is estimated that a D&A testing program will spend 1 hour per for-cause testing instance. It is estimated that an average of 171 for-cause tests will be performed by D&A testing programs each year (i.e., the average number of for-cause tests performed from CY 2019 through CY 2021). The previous clearance estimated 260 for-cause tests per year.
	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 (only applies to D&A testing programs using LTFs)	0 LTFs	80.0	0
	26.75(i)(3): Eliminate from an individual’s 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 LTFs	1.0	0
	26.85(a): Training of specimen collectors and maintain training records in personnel files	24 programs	8.0	192.0	The 2022 Part 26 final rule consolidated collector training requirements into 26.85(a). Prior to the final rule, the collector requirements appeared under 26.85(a) for urine collectors and 26.85(b) for alcohol collectors. This change did not affect the estimated burden for training.
	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 programs	1.0	24.0
	26.87(f)(1) and (f)(3) – (f)(5): Post a sign outside the collection area (if a public restroom is used) and document on the Federal 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 programs	0.5	1.0
	26.89(a): Collector notifies FFD management that a donor failed to report to the collection site	5 programs	0.25	1.25
	26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-testing form obtained	24 programs	1.5	36.0
	26.89(b)(3): Record that FFD management informed that an individual did not present identification (pre-access testing)	24 programs	1.0	24.0
	26.89(c): Collector documents on the Federal CCF a donor's refusal to cooperate with the collection process	Burden accounted for under 26.107(b)
	26.91(c)(1) - (c)(3): Record of evidential breath testing (EBT) device test results	Burden accounted for under 26.715(b)(2)
	26.91(e)(4): Record that results cancelled after EBT calibration check failure	0 programs	6.0	0
	26.91(e)(5): EBT maintenance records	Burden accounted for under 26.715(b)(14)
	26.93(a)(6): Document that alcohol pre-test questions communicated to the donor	24 programs	37.3	894.4	Total Annual Burden Hours - 26.93(a)(6). Prior to initiating an alcohol test, a collector is estimated to take 30 seconds (0.008 hour) to ask and document the communication of the pre-test questions. It is estimated that 107,331 individuals will be alcohol tested each year by D&A testing programs. This value is the average number of tests conducted from CY 2019 through CY 2021. The previous clearance estimated that 122,016 individuals per year would be alcohol tested.
	26.95(b)(5): Record donor identity for initial alcohol breath test	24 programs	37.3	894.4	Total Annual Burden Hours - 26.95(b)(5). It is estimated that recording a donor's identity prior to conducting an alcohol test will take the collector 30 seconds (0.008 hour). It is estimated that 107,331 individuals will be alcohol tested each year by D&A testing programs. The previous clearance estimated that 122,016 individuals would be alcohol tested each year.
	26.97(b)(2): Record reason for new oral fluid alcohol test	0 programs	0.25	0
	26.97(c)(1): Document reason for failure of 2nd collection attempt	0 programs	0.25	0
	26.97(d): Record results and alcohol screening device used	0 programs	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 26.715(b)(2)
	26.101(b)(7): Record time and BAC result of confirmatory alcohol test	Burden accounted for under 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 the Federal CCF (or through another documentation method consistent with collection procedures) a description of any donor conduct during collection process that indicates an attempt to tamper with a specimen, and notifies FFD management	24 programs	1.61	38.8	Burden Hours per Recordkeeper - 26.107(b). It is estimated that a collector will spend an average of 15 minutes (0.25 hours) per subversion attempt to document observations and complete required notification activities. It is estimated that 155 subversion attempts will occur each year, which is the average number of subversions attempts from CY 2019 through CY 2021 (i.e., 132 in CY 2019, 151 in CY 2020, and 182 in CY 2018). The previous clearance estimated 128 subversion attempts per year (i.e., 98 in CY 2016, 133 in CY 2017, and 152 in CY 2018).
	26.107(d): Collector documents a description of the refusal to test on the Federal CCF (or through another documentation method consistent with collection procedures)	Burden accounted for under 26.107(b)			The 2022 Part 26 final rule included this new requirement on required collector actions in instances when a refusal to test is determined during the collection process.
	26.109(b)(3): Collector documents on the Federal 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 26.107(b)
	26.109(b)(4): Collector documents on the Federal 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 26.107(b)
	26.111(b): Collector documents on the Federal CCF (or through another documentation method consistent with collection procedures) if specimen characteristics (color, clarity) indicate possible tampering by the donor	Burden accounted for under 26.107(b)
	26.111(c): Collector documents on the Federal CCF unusual specimen temperature and/or observations during the collection indicating possible tampering, and notifies FFD management	Burden accounted for under 26.107(b)
	26.113(b)(3): Collector completes the Federal CCF for split-specimen collection	Burden accounted for under 26.117(c) - (e)
	26.115(b): Collector documents on the Federal CCF approval from the FFD manager or MRO to collect a specimen under direct observation	Burden accounted for under 26.107(b)
	26.115(d): Collector documents on the Federal CCF that an observed collection was performed and the reason for the observed collection	Burden accounted for under 26.107(b)
	26.115(f)(3): Collector documents on the Federal CCF the name of the observer of the directly observed collection	Burden accounted for under 26.107(b)
	26.117(c) - (e): Collector prepares ID labels and Federal CCF forms for specimen shipment	24 programs	149.1	3,577.7	Burden Hours per Recordkeeper - 26.117(c) - (e). It is estimated that a collector spends 2 minutes (0.033 hour) per specimen collection to prepare the specimen ID labels, Federal CCF, and specimen packaging for shipment. The average number of specimen collections estimated to be completed in a year is 107,331. This estimate is the average number of tests performed from CY 2019 through CY 2021. The previous clearance estimated 122,016 collections per year.
	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 programs	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 programs	1.0	12.0
	26.125(b) and (c): Records on the proficiency and qualifications of LTF personnel	0 LTFs	16.0	0	Number of Recordkeepers - 26.125(b) and (c). Since the last clearance, the remaining 3 LTFs have ceased operations and all D&A testing programs now only use HHS labs for testing. The NRC staff estimates no D&A testing programs will utilize an LTF for this clearance period. This assumption change will impact all requirements in Table 2 applicable to LTFs.
	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	0 LTFs	40.0	0
	26.129(a): Maintain documentation of access to secure areas of an LTF by all authorized individuals (i.e., an access log)	0 LTFs	4.0	0
	26.129(b): LTF inspects specimen packages, Federal CCFs, and obtains memorandum from specimen collectors to correct identified discrepancies	0 LTFs	0.5	0
	26.129(b)(1): LTF record of report to senior licensee or other entity management of attempts to tamper with specimens in transit	0 LTFs	1.0	0
	26.129(d): LTF personnel documenting the testing process and transfers of custody of each specimen and aliquots	0 LTFs	80.0	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	Burden accounted for under 26.165(b)(6)
	26.137(a): Record of a QA/QC program and procedures for LTF	0 LTFs	4.0	0
	26.137(b)(1)(ii): LTF documentation of performance testing of a device not approved by SAMHSA for point-of-collection testing	0 LTFs	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 LTFs	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 LTFs	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 LTF’s QA program	0 LTFs	40.0	0
	26.137(e)(7): LTF documented procedures to protect against carryover material	Burden accounted for under 26.127 (a) - (e)
	26.137(f)(5): LTF records on testing errors	0 LTFs	8.0	0
	26.137(h): LTF labeling of standards and controls	0 LTFs	40.0	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 26.717	0 LTFs	40.0	0
	26.153(g): Record of memorandum sent to the HHS lab explaining use of non-Federal CCF	24 programs	0.5	12.0
	26.159(b)(1): Record that the licensee or other entity received notice from an HHS lab within 24 hours of the lab identifying evidence of tampering with specimen.	0 programs	1.0	0
	26.159(i): Record of written authorization to store specimens other than 1 year	24 programs	0.5	12.0
	26.163(a)(2): Record that special analyses testing conducted on dilute specimens and specimens collected under the direct observation conditions in 26.115(a)(1) through (3) and (a)(5) and report of the test results	Burden accounted for under 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 26.165(b)(6)
	26.165(b)(2): Record that the 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 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 26.165(b)(6)
	26.165(b)(4): Record that a 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 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 notifies FFD management	24 programs	1.5	37.0	Burden Hours per Recordkeeper - 26.165(b)(6). An MRO is estimated to spend 1 hour to: contact the initial HHS lab that performed testing and request that a donor’s specimen be sent to a second HHS lab; review the test results received from the second HHS lab; communicate the test result to the donor; and notify FFD management. It is estimated that 37 individuals each year will request the retesting of a specimen that is drug positive, adulterated, or substituted. The 37 value is 5 percent of the 738 test results that meet this category from CY 2019 through CY 2021, adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule. The previous clearance estimated 28 retest requests per year.
	26.165(c)(4): Results report received from the second HHS lab that performed retesting on an aliquot of a single specimen or the testing of the Bottle B split specimen	Burden accounted for under 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 programs	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 programs	8.0	0
	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 programs	1.0	0
	26.168(g) Maintain documentation of HHS lab certification of BPTS formulation	60 sites	1.0	60.0	Total Annual Burden Hours - 26.168(g). It is estimated that each site with a D&A testing program will spend 1 hour per year to maintain documentation on HHS lab certification of BPTS formulation. (60 sites x 1.0 hour per site = 60 hours) The previous collection accounted for the same total burden, but presented it by D&A testing program instead of by site with a D&A testing program. Presenting burden by site is more consistent with the implementation of 26.168. Also note that the previous clearance referenced 26.168(a), which was incorrect, this clearance now references 26.168(g).
	26.168(i)(2): D&A testing program completes Federal CCF for a BPTS, places fictional initials on specimen labels, and indicates on the MRO copy of the Federal CCF that the specimen is a BPTS	60 sites	4.7	280.0	Total Annual Burden Hours - 26.168(i)(2). It is estimated that preparing one BPTS takes 5 minutes (0.083 hour), with 56 BPTS prepared per year for each site with a D&A testing program (i.e., 14 BPTSs per calendar quarter per site). [0.083 hour per BPTS x 56 BPTSs per site x 60 sites per year = 280 hours per year] The previous clearance (2021-2024) estimated that 40 BPTSs would be prepared per year per site with a D&A testing program. The 2022 Part 26 final rule expanded the drug testing panel -- these changes resulted in an additional 3 BPTSs submitted per quarter per site per year. The 2022 final rule clearance accounted for the 3 additional BPTSs per quarter per site and also updated the time to prepare a BPTS (changed from 20 minutes to 5 minutes based on industry practice). This clearance includes these 2022 final rule changes. Finally, an assessment of industry practice and the formulation of BPTSs by the supplier used by industry has resulted in the total BPTSs submitted per quarter per site with a D&A testing program to be updated to 14 BPTSs (i.e., 56 BPTSs per year).
	26.169(a): Records of HHS lab test result reports	Burden accounted for under 26.183(c)(1)
	26.169(c)(1): Records of HHS lab reports for positive, adulterated, substituted, dilute, and invalid test results received by the MRO	Burden accounted for under 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; HHS lab must provide quantitative results for morphine and codeine)	Burden accounted for under 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 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 26.185(f)(1)
	26.169(c)(5): Records of HHS lab reports of concentrations exceeding linear range	Burden accounted for under 26.183(c)(1)
	26.169(f): Records of HHS lab transmittals of Federal CCF copies to the MRO (negative results)	24 programs	37.3	894.4	Burden Hours per Recordkeeper - 26.169(f). All HHS labs electronically report drug and validity test results to the MRO. A burden of 30 seconds (0.0083 hour) is estimated per record. It is estimated that an average of 107,331 specimens per year will be tested at HHS labs (i.e., the average number of drug tests completed from CY 2019 through CY 2021). The previous clearance estimated that 122,016 specimens would be tested each year by HHS labs.
	26.169(g): HHS lab copy of the original Federal CCF for each drug positive, dilute and drug positive, adulterated, substituted, and invalid test result provided to the MRO	Burden accounted for under 26.169(c)(1)
	26.169(h): Record of HHS lab statistical summary report of urinalysis testing results (for the calendar year)	24 programs	2.0	48.0
	26.183(a): Documentation of MRO qualifications	24 programs	4.0	96.0
	26.183(c)(1): MRO review of HHS lab test result report for drug positive, dilute and drug positive, adulterated, substituted, and invalid specimens	24 programs	2.6	61.5	Burden Hours per Recordkeeper - 26.183(c)(1). It is estimated that the MRO will spend 5 minutes (0.083 hour) reviewing an individual’s specimen test results. The NRC staff estimates 738 drug positive (including dilute positives), adulterated, substituted, and refusal to test results each year, which is the average number of these test results reported by D&A testing programs from CY 2019 through CY 2021, adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule. The previous clearance estimated 559 drug positive, adulterated, substituted, and refusal to test results each year.
	26.183(d)(1)(ii)(D): Record of MRO report of confirmed drug positive, adulterated, substituted, or refusal to test result to the licensee’s designated reviewing official	24 programs	2.6	61.5	Burden Hours per Recordkeeper - 26.183(d)(1)(ii)(D). It is estimated that the MRO or MRO staff spend 5 minutes (0.083 hour) per drug positive, adulterated, substituted and refusal to test result to communicate the determination to D&A testing program's designated reviewing official. The number of records reviewed (738 tests per year) is discussed under 26.183(c)(1).
	26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results to FFD management	24 programs	223.6	5,366.6	Burden Hours per Recordkeeper - 26.183(d)(2)(i). It is estimated that MRO staff spend 3 minutes (0.05 hour) to review each HHS lab result (an average of 107,331 tests were performed from CY 2019 through CY 2021 by D&A testing programs). The previous clearance estimated reviewing an average of 122,016 test results per year.
	26.183(d)(2)(ii): Record of MRO staff review of Federal CCFs and forward changes to the MRO for review (for drug positive, adulterated, substituted and invalid test results)	24 programs	3.1	73.8	Burden Hours per Recordkeeper - 26.183(d)(2)(ii). It is estimated that MRO staff spend 6 minutes (0.10 hour) to review each positive, adulterated, substituted, and invalid test result record. The number of records reviewed (738) per year is discussed under 26.183(c)(1).
	26.185(a) Record of MRO review of a drug positive, dilute and drug positive, adulterated, substituted, or invalid HHS lab test result	Burden accounted for under 26.183(c)(1)
	26.185(c): Record of MRO discussion with the donor about an HHS lab test result (i.e., drug positive, dilute and drug positive, adulterated, substituted, and invalid)	24 programs	15.4	369.0	Burden Hours per Recordkeeper - 26.185(c). It is estimated that an MRO spends an average of 30 minutes (0.5 hour) to contact the donor, discuss the HHS lab test results, document the discussion, and report the FFD policy violation to the D&A testing program. The number of individuals contacted (738) per year is discussed under 26.183(c)(1).
	26.185(d)(1): Documentation that donor declined to discuss test results with MRO	Burden accounted for under 26.185(c)
	26.185(e): Documentation reviewed by the MRO on a donor’s inability to discuss test results and a request to reopen proceeding	24 programs	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 programs	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 26.185(c)
	26.185(f)(3): Record of information obtained from the MRO contact with the D&A testing program, collection site, and/or LTF or HHS lab regarding specimen handling conditions (invalid results pH of 9.0 to 9.5)	1 program	1.0	1.0	The 2022 Part 26 final rule included this new requirement for an MRO review of invalid specimens with a pH of 9.0 to 9.5.
	26.185(h)(1): Record of MRO contact with donor about a substituted test result, and medical information received	Burden accounted for under 26.185(c)
	26.185(h)(2): Record of MRO confirmation of a substituted test result (no legitimate medical explanation)	Burden accounted for under 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 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 26.185(c)
	26.185(i)(2): Record of MRO confirmation of an adulterated test result (no legitimate medical explanation)	Burden accounted for under 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 26.183(d)(2)(i)
	26.185(j): Prescription medication drug positives – records of MRO review of HHS lab result, discussion of positive result with donor, and review medication information from the donor (e.g., prescription bottle information, dispensing pharmacy, prescribing physician)	24 programs	3.8	92.0	Burden Hours per Recordkeeper - 26.185(j). It is estimated that an MRO spends an average of 1 hour to review a positive test result associated with the use of a prescription medication. This activity consists of obtaining information from the donor and confirming the information with a prescribing physician or pharmacy. The NRC staff estimates 92 positive results each year associated with legitimate medical use, which is adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule changes. The previous clearance estimated 60 positive results per year.
	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 26.183(d)(2)(i) and 26.185(c)
	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 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 programs	0.5	12.0
	26.185(p): Record of MRO written notice to the D&A testing program of a positive, adulterated, substituted, or invalid test result	Burden accounted for under 26.185(c)
	26.187(d): SAE training requirements	24 programs	20.0	480.0
	26.187(f): Documentation of SAE credentials and training	24 programs	1.0	24.0
	26.189(b): Determination of fitness record	24 programs	80.0	1,920.0
	26.189(c): Record of for cause determination of fitness	24 programs	7.1	171.0	Total Annual Burden Hours - 26.189(c). It is estimated that 171 for-cause tests will be performed by D&A testing programs each year (i.e., the average number of for-cause tests performed from CY 2019 through CY 2021). It is estimated that a D&A testing program will spend 1 hour to evaluate an individual and document the criteria met to conduct for-cause testing. The previous clearance estimated 260 for-cause tests performed each year.
	26.189(d): Record of modification of an initial determination of fitness	1 programs	1.0	1.0
	26.203(a): Updates to fatigue management policy (in addition to 26.27 burden)	0 programs	7.3	0
	26.203(b): Updates to fatigue management procedures (in addition to 26.27 burden)	0 programs	1.7	0
	26.203(c): Updates to training on fatigue management.	0 programs	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 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 26.211(f)
	26.205(b): Record of calculation of work hours	53 sites	50.0	2,650.0
	26.205(c): Schedule work hours	53 sites	720.0	38,160.0
	26.205(d)(1): Record of implementation of work hour controls	53 sites	16.0	848.0
	26.205(d)(2): Record of adequate rest breaks	53 sites	16.0	848.0
	26.205(e)(1) and (2): Record of review of control of work hours twice per calendar year	53 sites	12.0	636.0
	26.205(e)(3): Document methods for reviews	53 sites	6.0	318.0
	26.205(e)(4): Record and trend problems in regarding work hours	53 sites	6.0	318.0
	26.207(a)(4): Document basis for waiver	53 sites	2.0	106.0
	26.211(f): Document results of fatigue assessments	53 sites	16.0	848.0
	26.403(a): Updates to FFD policy and procedures (reactor construction site D&A testing program)	0 sites	16.0	0	Number of Recordkeepers - 26.403(a). For this clearance, no annual burden is estimated for updates to the FFD policy and procedures. The reason is that the NRC staff is anticipating that construction activity at the four SMR reactor construction sites will not begin until the third year of the clearance. As such, the burden to initially develop an FFD policy and procedures is accounted for in Table 1 for 26.403(a). The previous clearance (2021-2024) accounted for construction activity at the Vogtle Unit 4 site (which was estimated to complete covered activities under Subpart K of Part 26 in the first year of that clearance).
	26.403(a): Provide FFD policy to individuals subject to a reactor construction site D&A testing program	1.3 sites	8.0	10.7	Number of Recordkeepers - 26.403(a). The only reactor construction activity estimated to occur during this clearance period is construction starting at four SMR reactor construction sites in the third year of the clearance period. As such, the number of recordkeepers is reported at 1.3 sites because the burden in this table is annualized. (4 reactor construction sites / 3 years = 1.3 sites per year)
	26.405(b): Records of random D&A tests	1.3 sites	139.0	185.3	Burden Hours per Recordkeeper - 26.405(b). It is estimated that a reactor construction D&A testing program will spend 5 minutes (0.083 hour) to document a random test result. The NRC estimates that in the third year of this clearance, 1,668 random tests will be performed by the new SMR reactor construction site D&A testing programs. (0.083 hour x 1,668 tests = 139 hours) The previous clearance (2021-2024) accounted for construction activity at the Vogtle Unit 4 site (which was estimated to complete covered activities under Subpart K of Part 26 in the first year of that clearance).
	26.405(c)(1): Records of pre-assignment D&A test	1.3 sites	335.7	447.6	Total Annual Burden Hours - 26.405(c)(1). It is estimated that a reactor construction D&A testing program will spend 5 minutes (0.083 hour) to document a pre-assignment test result. The NRC estimates that 4,028 pre-assignment tests will be performed in the third year of this clearance by the new SMR reactor construction site D&A testing programs. (0.083 hour x 4,028 = 336 hours) The previous clearance (2021-2024) accounted for construction activity at the Vogtle Unit 4 site (which was estimated to complete covered activities under Subpart K of Part 26 in the first year of that clearance).
	26.405(c)(2) and (c)(3): Records of for-cause and post accident D&A tests	1.3 sites	180.0	240.0	Total Annual Burden Hours - 26.405(c)(2) and (c)(3). It is estimated that a reactor construction D&A testing program will spend 1 hour per person to document a for-cause or post-event testing event (determination for testing and test result). The NRC estimates that an average of 180 for-cause and post-event tests will be performed in the third year of this clearance by the new SMR reactor construction site D&A testing programs. The previous clearance (2021-2024) accounted for construction activity at the Vogtle Unit 4 site (which was estimated to complete covered activities under Subpart K of Part 26 in the first year of that clearance).
	26.405(c)(4): Records of followup D&A tests	1.3 sites	11.0	14.7	Total Annual Burden Hours - 26.405(c)(4). It is estimated that a reactor construction D&A testing program will spend 5 minutes (0.083 hour) to document a followup test result. The NRC estimates that an average of 132 followup tests will be performed in the third year of this clearance. (0.083 hour x 132 followup tests = 11 hours) The previous clearance (2021-2024) accounted for construction activity at the Vogtle Unit 4 site (which was estimated to complete covered activities under Subpart K of Part 26 in the first year of that clearance).
	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 sites	40.0	0
	26.405(f): Record that testing conducted at an HHS lab	1.3 sites	40.0	53.3
	26.405(g): Record of MRO review of drug positive, adulterated, substituted, and invalid test results (reactor construction site D&A testing program)	1.3 sites	69.0	92.0	Total Annual Burden Hours - 26.405(g). It is estimated that the MRO of a reactor construction D&A testing program will spend 45 minutes (0.75 hour) per test to review the HHS lab result, discuss the result with the donor, and communicate with FFD management about the confirmed result. The NRC estimates that an average of 92 drug positive, adulterated, substituted and refusal to test results per year. The previous clearance (2021-2024) accounted for construction activity at the Vogtle Unit 4 site (which was estimated to complete covered activities under Subpart K of Part 26 in the first year of that clearance).
	26.406(c): Updates to fitness monitoring procedures (programs that do not adopt random testing and behavioral observation)	0 sites	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 sites	40.0	0	Number of Recordkeepers - 26.411(a). For this clearance, no annual burden is estimated for maintaining a system of files to protect information. The reason is that the NRC staff is anticipating that construction activity at the four SMR reactor construction sites will not begin until the third year of this clearance. As such, the burden to initially develop procedures to maintain a system of files is accounted for in Table 1 under 26.411(a).
	26.411(a) and (b): Collection of personal information under Subpart K of Part 26	1.3 sites	3,100.0	4,133.3	Total Annual Burden Hours - 26.411(a) and (b). It is estimated that construction site D&A testing programs will spend 1.0 hour per person to collect personal information. The NRC estimates that 3,100 individuals will be subject to testing in the third year of this clearance period, when construction is estimated to commence at 4 SMR reactor construction sites. The previous clearance (2021-2024) accounted for construction activity at the Vogtle Unit 4 site (which was estimated to complete covered activities under Subpart K of Part 26 in the first year of that clearance).
	26.413: Document results of review process	1.3 sites	80.0	106.7
	26.415: Document and report audit results	1.3 sites	40.0	53.3
	26.417(a): Records pertaining to the administration of a reactor construction site D&A testing program	1.3 sites	20.0	26.7
	26.417(b)(1): Report to NRC by telephone within 24 hours programmatic failures in a reactor construction site D&A testing program	Burden accounted for under 26.719(b)
	26.417(b)(2) Collect FFD program performance data for reactor construction site D&A testing programs	1.3 sites	100.0	133.3
	26.713(a)(1): Records of self-disclosures, employment histories, and suitable inquiries (under 26.55, 26.57, 26.59, and 26.69) that result in the granting of authorization	Burden accounted for under 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 26.39(b)
	26.713(a)(3): Documentation of the granting and termination of authorization	24 programs	80.0	1,920.0
	26.713(a)(4): Records of determinations of fitness performed under 26.189 (including recommendations for treatment and followup testing plans)	Burden accounted for under 26.189			Duplicative burden removed - 26.713(a)(4). The previous clearance estimated 80 hours of burden per D&A testing program. The burden for developing and maintaining determination of fitness records is already accounted for under 26.189. This assumption over-estimated annual burden by 1,920 hours (i.e., 80 hours x 24 programs).
	26.713(b)(1): Records of FFD training and examinations conducted under 26.29	Burden accounted for under 26.29(a) and (b)
	26.713(b)(2): Records of audits, audit findings, and corrective actions taken under 26.41	Burden accounted for under 26.41(a) - (d), (f) and (g)
	26.713(c): Records on 5-year and permanent denials of authorization	Burden accounted for under 26.39(b)
	26.713(d): Records of superseded versions of FFD policies and procedures	24 programs	8.0	192.0
	26.713(e): Records of written agreements for services under Part 26	24 programs	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 26.31(b)(1)(i)	Burden accounted for under 26.31(b)(1)(i)
	26.715(a): Documentation of all aspect of testing process at collection sites and LTFs (not otherwise specified in 26.715(b))	24 programs	40.0	960.0
	26.715(b)(1): Retain personnel files on staff at collection sites and LTFs	24 programs	20.0	480.0
	26.715(b)(2): Retain collection site and LTF chain-of-custody documents	24 programs	240.0	5,760.0
	26.715(b)(3): Retain LTF QA/QA records	0 LTFs	120.0	0
	26.715(b)(4): Retain superseded procedures (LTFs and collection sites)	24 programs	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	0 LTFs	240.0	0
	26.715(b)(6): LTF test reports	0 LTFs	240.0	0
	26.715(b)(7): LTF performance testing records	0 LTFs	80.0	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	4 programs	40.0	160.0	Number of Recordkeepers - 26.715(b)(8). It is estimated that 4 reports on testing errors or unsatisfactory performance at HHS labs will be received each year. This value is the average number of 26.719(c) reports received by the NRC from CY 2019 through CY 2021. The previous clearance estimated 6 reports per year.
	26.715(b)(9): Performance records on HHS-certified lab inspections.	Burden accounted for under 26.41(f) and (g)
	26.715(b)(10): Records of preventative maintenance on LTF instruments	0 LTFs	40.0	0
	26.715(b)(11): Retain records that summarize any test results the MRO determined to be scientifically insufficient for further action	0 programs	3.0	0
	26.715(b)(12): LTF retains computer-generated data	0 LTFs	120.0	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 26.129(a)
	26.715(b)(14): Retain records of the inspection, maintenance and calibration of EBTs (collection sites)	60 sites	8.0	480.0
	26.717(a) and (b): Collect FFD performance data for D&A testing programs	60 sites	40.0	2,400.0
	26.717(a) and (b): Collect FFD performance data for fatigue management programs	53 sites	40.0	2,120.0
	26.717(c): Analyze D&A testing program FFD performance data annually	60 sites	16.0	960.0
	26.717(c): Analyze fatigue management program data annually	53 sites	16.0	848.0
	26.717(d): D&A test results leading to termination	1 site	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 26.717(a) and (b)
	26.719(b): Prepare information to make a 24-hour event report to the NRC	30 sites	1.0	30.0	Number of Recordkeepers - 26.719(b). It is estimated that licensee and other entities will submit 30 reports per year under 26.719(b). This value is the average number of 26.719(b) reports received from CY 2019 through CY 2021 (31 reports in 2019, 29 reports in 2020, and 30 reports in 2021). The previous clearance estimated 36 reports per year.
	26.719(c): Prepare 30-day event report documentation.	4 sites	40.0	160.0	Number of Recordkeepers - 26.719(c). It is estimated that 4 reports will be received per year under 26.719(c). This value is the average number of 26.719(c) reports received per CY 2019 through CY 2021 (5 reports in 2019, 4 reports in 2020, 4 reports in 2021). The previous clearance estimated 6 reports per year.
	26.719(d): Document non-reportable indicators of FFD program weaknesses	24 programs	20.0	480.0
	26.821(a): Provide NRC with access to records (to inspect, copy, or take away copies of records)	28 programs	4.0	112.0
	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 C/V	4.0	4.0
	Total			167,554.1

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Sheet 3: T3_AnnRpting

	Table 3: Annual Reporting	Extension (October 2024 - September 2027)
	Section	Number of Respondents	Responses per Respondent	Total Responses	Burden Hours per Response	Total Annual Burden Hours	Notes
	26.9: Application to NRC for exemption (D&A testing program)	0 sites	1.0	0	40.0	0
	26.9: Application to NRC for exemption (Fatigue management program)	0 sites	1.0	0	2.0	0	Number of Respondents - 26.9. No licensing exemption requests for fatigue management program requirements are anticipated for the current clearance period. The previous clearance estimated that 40 operating nuclear power reactor sites would seek work hour controls exemptions due to the COVID-19 public health emergency (PHE) (i.e., using a COVID-19 Work Hour Controls Exemption Request form). The COVID-19 PHE declaration ended on May 11, 2023. As a result, the annual burden associated with these COVID-19 exemption requests has been eliminated from the current clearance period.
	26.77(c) Report impaired NRC employee	0 sites	0	0	1.0	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 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	53 sites	1.0	53.0	16.0	848.0	Number of Respondents - 26.203(e)(1). Annually, an average of 53 operating nuclear power reactor sites will be subject to the fatigue management program requirements. This assumption also applies to the requirements in Table 3 for 26.203(e)(2) and 26.717 (Fatigue Management). In the previous clearance, the number of operating reactor sites was estimated to decrease from 54 in the first year of the clearance period to 51 in the second and third years of the clearance period (i.e., the average number of operating reactor sites per year for that clearance was 52). Two of those operating reactor sites did not shutdown, thus the return to 53 operating reactor sites for the current clearance period.
	26.203(e)(2): Prepare summary of fatigue corrective actions for inclusion in the annual FFD program performance report for fatigue management programs	53 sites	1.0	53.0	2.0	106.0
	26.417(b)(1): Report to NRC by telephone within 24 hours of identifying a programmatic failure in a reactor construction site D&A testing program	Burden accounted for under 26.719(b)
	26.417(b)(2): Prepare annual FFD program performance report (reactor construction site D&A testing program)	1.3 sites	1.0	1.3	80.0	106.7	Number of Respondents - 26.417(b)(2). The NRC staff estimates that construction activities will begin at four (4) SMR construction sites in year 3 of this clearance period. (4 SMR sites in year 3 / 3 years to annualize the value = 1.3 sites / year)
	26.717: Annual FFD program performance report information (fatigue management programs)	53 sites	1.0	53.0	8.0	424.0	Number of Respondents - 26.717 (Fatigue Management). Annually, each operating nuclear power reactor site will submit an FFD program performance report to the NRC on fatigue management using NRC Form 892. The reporting burden to develop the content of the fatigue management reports is accounted for under 26.203(e)(1) and (e)(2). This line item only pertains to the burden hours to produce the report and submit it to the NRC.
	26.717: Annual FFD program performance report information (D&A testing programs)	60 sites	1.0	60.0	60.0	3,600.0	Number of Respondents - 26.717 (D&A Testing). Annually, an average of 60 sites (53 operating nuclear power reactor sites; 2 Category 1 special nuclear material (SNM) sites, 4 corporate FFD programs, and 1 C/V) each submit FFD program performance report information to the NRC on D&A test results using NRC Forms 890 and 891. The previous clearance reported the same 60 sites per year average, but the mix of sites was different (54 operating nuclear power reactor sites in the first year of the clearance period and 51 sites in years two and three of the clearance period due to three sites permanently ceasing operations; 2 Category 1 SNM sites, 5 corporate FFD programs, and 1 C/V).
	26.719(b): Report to the NRC by telephone within 24 hours of identifying a significant D&A testing violation	30 sites	1.0	30.0	4.0	120.0	Number of Respondents - 26.719(b). NRC estimates that licensee and other entities will submit 30 reports per year under 26.719(b). This value is the average number of 26.719(b) reports received from CY 2019 through CY 2021 (31 reports in 2019, 29 reports in 2020, 30 reports in 2021). The previous clearance estimated 36 reports per year.
	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	4 sites	1.0	4.0	24.0	96.0	Number of Respondents - 26.719(c)(1). NRC estimates that licensee and other entities will submit 4 reports per year under 26.719(c)(1). This value is the average number of 26.719(c)(1) reports received from CY 2019 through CY 2021 (5 reports in 2019, 4 reports in 2020, 4 reports in 2021). The previous clearance estimated 6 reports year.
	26.719(c)(2): Notify the NRC by telephone within 24 hours of receiving notice of a false positive on a BPTS test result	0 sites	1.0	0	4.0	0
	26.719(c)(3): Notify the NRC by telephone within 24 hours of receiving a false negative test result on a QA check of a validity screening test (only applies to LTFs)	0 sites	1.0	0	4.0	0
	Total			254.3		5,300.7

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Sheet 4: T4_Ann_3rdParty

	Table 4: Annual Third-Party Disclosure	Extension (October 2024 - September 2027)
	Section	Number of Responses	Burden Hours per Response	Total Annual Burden Hours	Notes
	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	30.0	2.0	60.0	Number of Responses - 26.4(j). It is estimated that 50 percent of the 60 sites with a D&A testing program grant authorization to offsite response personnel subject to a State or Federal agency D&A testing program (e.g., emergency fire and medical response personnel, SSNM transporters).
	26.29(b): Complete initial training on FFD policy and take comprehensive examination	60,257.0	2.0	120,514.0	Burden Hours per Response - 26.29(b). Each individual spends 1.5 hours to complete the standard web-based training used by industry (National Academy for Nuclear Training e-Learning (NANTeL) Generic FFD and Behavioral Observation training or equivalent) + 0.5 hours per individual to complete the comprehensive examination. It is estimated that 60,257 individuals complete initial training each year (i.e., the average annual number of individuals receiving a pre-access test in CYs 2019, 2020, and 2021). The previous clearance estimated training completion by 68,285 individuals per year.
	26.29(c)(2): Complete annual refresher training on FFD policy	76,528.0	1.5	114,792.0	Burden Hours per Response - 26.29(c)(2). Each individual spends 1.5 hours to complete annual refresher training (i.e., NANTeL Generic FFD and Behavioral Observation training, or equivalent). It is estimated that 76,528 individuals will complete annual refresher training each year (i.e., the average number of individuals subject to a random testing program from CY 2019 through CY 2021). This assumption overestimates the burden for annual refresher training because some individuals in the random testing program will have received initial training each year. However, no data were available to improve this estimate. The previous clearance estimated 85,917 individuals completed retraining each year.
	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	300.0	1.0	300.0	Number of Responses - 26.31(b)(1)(i). The NRC staff estimates that an average of 5 individuals each year per site with a D&A testing program will apply for authorization to serve as FFD program personnel (i.e., 5 individuals x 60 sites = 300 responses).
	26.35(a): Employee assistance program (EAP) records	24.0	32.0	768.0	Number of Responses - 26.35(a). It is estimated that each D&A testing program utilizes 1 EAP provider under contract.
	26.35(c): Individual completes and provides the EAP with a written waiver of right to privacy to share information with FFD management	766.0	0.25	191.5	Number of Responses - 26.35(c). It is estimated that 766 individuals per year will provide written consent to an EAP to release information to FFD management (i.e., 1 percent of 76,527 individuals -- the average number of individuals subject to a random testing program from CY 2019 through CY 2021). The previous clearance estimated 860 individuals per year (i.e., 1 percent of 85,916).
	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): Individual provides signed consent to release information collected and maintained under Part 26 by a D&A testing program	231.0	0.25	57.8	Number of Responses - 26.37(b). It is estimated that only those individuals that have been granted access would provide written consent to release information on an FFD related matter (i.e., a testing violation on a random, for-cause, post-event, or followup test). The average number of individuals with a non-pre-access testing violation from CY 2019 through CY 2021 is 231 per year. The previous clearance estimated 209 individuals per year. This assumption also applies to 26.37(b)(1).
	26.37(b)(1): Individual provides signed consent to the licensee or other entity to disclose personal information on an FFD matter to a representative	231.0	0.25	57.8
	26.37(d): Request by donor or donor’s representative to the D&A testing program to provide personal records collected under Part 26	24.0	0.25	6.0
	26.53(h): Applicant provides written consent before any actions are initiated under Subpart C of Part 26	60,257.0	0.25	15,064.3	Number of Responses - 26.53(h). It is estimated that each applicant spends 15 minutes (0.25 hour) to review and sign a written consent form. The previous clearance estimated 68,285 individuals per year. It is estimated that 60,257 individuals apply for authorization each year at D&A testing programs (i.e., the average number of individuals that were pre-access tested from CY 2019 through CY 2021).
	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 26.61(a) and 26.63(a),(c) and (e)			No. Actions/Year - 26.719(c). It is estimated that the NRC will receive 4 reports per year under 26.719(c), which is the average number of reports received from CY 2019 through CY 2021. The previous clearance estimated 6 reports per year.
	26.59(c)(1): Applicant prepares self-disclosure (for authorization reinstatement period of interruption of no more than 30 days)	Burden accounted for under 26.61(a)
	26.61(a): Applicant prepares self-disclosure and employment history	60,257.0	1.0	60,257.0
	26.63(a), (c), and (e): Former employer(s) provide information to the licensee or other entity to verify an applicant’s suitable inquiry information on previous authorization(s)	60,257.0	0.75	45,192.8
	26.63(c)(2): U.S. Department of Defense (DOD) provides licensee or other entity with form DD 214 which details an applicant’s military service record	Burden of supplying DD 214 affects DOD, or is accounted for under 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 applicant’s prior employment history	120.0	0.1	10.0	Number of Responses - 26.63(c)(2). It is estimated that 2 percent of former employers refuse to provide information (i.e., 2 percent of the 60,257 pre-access tests conducted annually).
	26.67: Records of random D&A testing of persons who have applied for authorization, but who have not been granted unescorted access authorization	302.0	0.5	151.0	Number of Responses - 26.67. It is estimated that D&A testing programs will randomly test 302 individuals per year that have applied for authorization, but before authorization had been granted (i.e., 0.5 percent of the 60,257 individuals pre-access tested each year). The previous clearance estimated 341 individuals per year (i.e., 0.5 percent of 68,285 pre-access tests).
	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 26.61(a)
	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	603.0	2.0	1,206.0	Number of Responses - 26.69(c)(2). It is estimated that D&A testing programs will identify potentially disqualifying FFD information (PDI) in the applications of 603 individuals per year (i.e., 1 percent of the 60,257 individuals pre-access tested each year). The previous clearance estimated 683 individuals per year (i.e., 1 percent of 68,285 individuals).
	26.85(b): Alternative collectors not employed by licensee provide proof of qualification	24.0	1.0	24.0	The 2022 Part 26 final rule renumbered the alternate collector requirements (i.e., changing from 26.85(c) to 26.85(b)). This change did not affect estimated burden.
	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	Number of Responses - 26.93(a)(6). It is estimated that 10 individuals per D&A testing program each year (24 programs x 10 individuals = 240) are FFD program personnel not located at the reactor site, Category I SNM site, or C/V site where collections are typically made and will be tested at a U.S. Department of Transportation compliant collection site as permitted by 26.31(b)(2). This assumption also applies to 26.95(b)(5), and 26.117(c) - (e) in Table 4.
	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 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 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 the Federal CCF (non-licensee collection site)	Burden accounted for under 26.111(b)
	26.109(b)(3): Collector documents on the Federal CCF a shy-bladder situation and notifies FFD management (non-licensee collection site)	0	0.25	0
	26.109(b)(4): Collector documents on the Federal CCF confirmation from FFD management to conduct an observed collection (non-licensee collection site)	0	0.25	0
	26.111(b): Collector documents on the Federal 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 the Federal 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
	26.113(b)(3): Collector completes the Federal CCF for split-specimen collection (non-licensee collection site)	Burden accounted for under 26.117(c) - (e)
	26.115(b): Collector documents on the Federal 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 the Federal CCF directly observed collection performed and the reason for the observed collection (non-licensee collection site)	Burden accounted for under 26.115(b)
	26.115(f)(3): Record name of observer on the Federal CCF (non-licensee collection site)	0	0.25	0
	26.117(c) - (e): Collector prepares ID labels and Federal CCFs 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 and sends a memorandum to the LTF documenting investigation of discrepancies between specimen bottles and Federal CCF (non-licensee collection site)	0	1.0	0
	26.135(b): Donor request 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 (initial specimen testing performed at an LTF)	Burden accounted for under 26.165(b)(1)
	26.153(g): Supply memorandum to HHS lab explaining use of non-Federal CCF (non-licensee collection site)	2.0	0.5	1.0
	26.157(a): Implement and maintain written HHS lab procedures specific to 10 CFR Part 26 that document the accession, receipt, shipment, and testing of specimens	24.0	2.0	48.0	The 2022 Part 26 final rule eliminated duplicative records maintenance requirements (i.e., HHS lab procedures already maintained under the HHS Guidelines) and revised 26.157(a) to clarify that the HHS lab only must maintain written procedures specific to Part 26 for specimen accession, receipt, shipment, and testing. It is estimated that an HHS lab will spend 2.0 hour per D&A testing program to maintain procedures specific to Part 26.
	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 hours of identifying evidence of specimen tampering	0	1.0	0
	26.159(c) - (e): Use and storage of Federal CCFs at an HHS lab	Burden accounted for under 26.715(b)(2)
	26.159(f): Send a copy of the Federal CCF with the specimen that an HHS lab ships to another HHS lab	Burden accounted for under 26.165(b)(1)
	26.165(b)(1): At the direction of the MRO, the initial HHS lab that conducted testing sends a donor’s specimen (i.e., aliquot of a single specimen or Bottle B of the split specimen) to a second HHS lab for further testing	37.0	1.0	37.0	Number of Responses - 26.165(b)(1). It is estimated that 5 percent of the 738 confirmed drug positive, adulterated, and substituted test results each year will be processed by the initial HHS lab and sent for retesting at a second HHS lab at the direction of the MRO.
	26.165(b)(3): Donor provides the MRO with an oral or written request to retest an aliquot of a single specimen or to test the Bottle B split specimen at a second HHS lab	37.0	1.0	37.0	Number of Responses - 26.165(b)(3). It is estimated that for 5 percent of the 738 specimens with a drug positive, adulterated, and substituted test result each year the donor will provide the MRO with a request to perform specimen retesting at a second HHS lab.
	26.165(b)(4): Donor provides documentation to the MRO on the reason for the inability to make a timely retest request	Burden accounted for under 26.185(e)
	26.165(b)(6) HHS lab provides quantitative test results report to the MRO on the retesting of aliquot of a single specimen or the testing of the Bottle B split specimen	Burden accounted for under 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(g): Blind performance test sample (BPTS) supplier provides HHS lab certification letter of BPTS formulation to licensee or other entity	60.0	1.0	60.0	Burden Hours per Response and Number of Responses - 26.168(g). It is estimated that a BPTS supplier spends 1 hour per site with an FFD D&A testing program per year to provide an HHS lab certification letter for each BPTS (60 sites x 1 hour = 60 hours/year). The previous clearance (2021-2024) estimated a total of 8 hours for this BPTS supplier requirement. Also note that the previous clearance referenced 26.168(a), which was incorrect, this clearance now references 26.168(g). This assumption change more accurately captures burden for this activity and also applies to 26.168(h)(2) in Table 4.
	26.168(h)(2): BPTS supplier provides expiration date on each BPTS	60.0	1.0	60.0
	26.169(a): HHS lab reports test results to the MRO of the D&A testing program	Burden accounted for under 26.169(c)(1)
	26.169(c)(1): HHS lab report to the MRO for each drug positive, dilute and drug positive, adulterated, substituted, and invalid test result	738.0	0.25	184.5	Number of Responses - 26.169(c)(1). It is estimated that 738 drug positive, adulterated, and substituted test results will be reported by HHS labs to MROs each year. The 738 value is the average number of drug positive (including dilute positive), adulterated, and substituted test results from CY 2019 through CY 2021 for all D&A testing programs, adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule. The previous clearance estimated 559 results per year.
	26.169(c)(2): HHS lab reports quantitative test result for positive drug tests (at MRO request)	Burden accounted for under 26.169(c)(1)
	26.169(c)(3): HHS lab reports quantitative test result for adulterated and substituted tests (at MRO request)	Burden accounted for under 26.169(c)(1)
	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 the Federal CCF for specimens (negative test results)	Burden accounted for under 26.715(b)(2)
	26.169(g): HHS lab transmits to the MRO a copy of the original Federal CCF signed by the certifying scientist (positive, adulterated, substituted, dilute, and invalid test results)	Burden accounted for under 26.169(c)(1)
	26.169(h): HHS lab prepares and submits annual statistical summary report of testing results	60.0	2.0	120.0
	26.185(c): Donor discussion with MRO about HHS lab test result (applies to drug positive, dilute and drug positive, adulterated, and substituted results determined to be an FFD program violation)	738.0	0.25	184.5	Burden Hours per Response - 26.185(c). It is estimated that a donor spends an average of 15 minutes (0.25 hour) discussing an HHS lab test result with the MRO. The previous clearance estimated an average of 30 minutes (0.5 hour) per discussion, which is too high. For the MRO to verify a drug or validity test result as an FFD policy violation, no legitimate medical explanation is provided by the donor. The discussion with the donor in these instances is limited in duration. For instances where a legitimate medical explanation exists, the donor discussion is longer (see 26.185(j)). The average annual number of drug positive, adulterated, and substituted test results from CY 2019 through CY 2021 is 738. The previous clearance estimated 559 results per year.
	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 the MRO to determine if additional specimen testing should be performed at a second HHS lab for a specimen with an invalid test results	24.0	0.5	12.0
	26.185(f)(2): Donor discussion with the MRO regarding an invalid test result	Burden accounted for under 26.185(c)
	26.185(h)(1): Donor discussion with the MRO regarding a substituted test result	Burden accounted for under 26.185(c)
	26.185(i)(1): Donor discussion with the MRO regarding an adulterated test result	Burden accounted for under 26.185(c)
	26.185(j) Donor discussion with the MRO regarding a positive drug test result (from prescription medication use), and the donor obtains and provides to the MRO documentation on medication use (e.g., prescription bottle information, dispensing pharmacy, prescribing physician)	92.0	1.0	92.0	Burden Hours per Recordkeeper - 26.185(j). For a positive drug test result due to a legitimate medical use, it is estimated that a donor spends an average of 1 hour discussing the test result with the MRO and then obtaining and providing requested information to the MRO on medication use. The NRC staff estimates 92 positive results each year associated with legitimate medical use, which is adjusted for the estimated increase in detection as a result of the 2022 Part 26 final rule changes. The previous clearance estimated 60 positive results per year.
	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)	37.0	0.25	9.3	Number of Responses - 26.185(n). It is estimated that 5 percent of the 738 specimens with a drug positive, adulterated, or substituted test result each year will be retested at a second HHS lab at the request of the donor.
	26.185(o): HHS lab provides quantitative test results report for the testing of a specimen from a donor applying for reauthorization following a 1st positive drug test result (at MRO request)	Burden accounted for under 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	0.5	5.0
	26.411(b): Applicant provides written consent to the reactor construction site D&A testing program	1,343.0	0.25	335.8	Number of Responses - 26.411(b). It is estimated that each applicant will spend 15 minutes (0.25 hour) to review and sign a written consent. The only reactor construction activity estimated to occur during this clearance period is construction starting at four SMR reactor construction sites in the third year of this clearance period. The NRC estimates that in year three of the clearance, 4,028 individuals will be pre-assignment tested. Because the burden in this table is annualized, the number of responses is 1,343 (i.e., 0 individuals in year 1 + 0 individuals in year 2 + 4,028 individuals in year 3 / 3 years = 1,343 individual responses per year). The previous clearance accounted for construction activity at the Vogtle Unit 4 site (which was estimated to be complete under Subpart K of Part 26 in the first year of the clearance).
	26.715(a): Documentation of all aspects of HHS lab testing process, not specified elsewhere in 26.715(b)	Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
	26.715(b)(1): Retain HHS lab staff personnel files	No longer applicable to HHS labs (updated requirement in 2022 Part 26 Final Rule). Remaining burden accounted for in Table 2			The 2022 Part 26 final rule eliminated the duplicative requirements in 26.155, "Laboratory personnel." As a result, this personnel file retention requirement applicable to HHS labs has been removed.
	26.715(b)(2): Retain HHS lab chain-of-custody documents	9.0	240.0	2,160.0
	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	9.0	40.0	360.0
	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	9.0	240.00	2,160.0
	26.715(b)(7): HHS lab performance testing records	Burden covered by HHS lab certification requirements OMB Clearance No. 0930-0158
	26.715(b)(9): HHS lab performance records on certification inspections	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 detailing the results of an investigation on a testing error (information for 30-day event report to NRC)	4.0	8.0	32.0
	26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/V’s documents, records, and reports	1.0	4.0	4.0
	Total	324,343.0		365,003.0

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Sheet 5: T5_Ann_NRC

	Table 5: Annualized NRC Burden	Extension (October 2024 - September 2027)
	NRC ACTION	No. Actions/ Year	Burden Hours / Action	Total Annual Burden Hours	Notes
	26.9: Review exemption request (D&A testing program)	0	40.0	0
	26.9: Review exemption request (Fatigue management program)	0	12.0	0	No. Actions/Year - 26.9 (Fatigue Management). The NRC staff does not anticipate receiving any exemption requests for the current clearance period. The previous clearance estimated that 40 operating power reactor sites would seek work hour controls exemptions due to the COVID-19 public health emergency (PHE) (i.e., using a COVID-19 Work Hour Controls Exemption Request form). The COVID-19 PHE declaration ended on May 11, 2023. As a result, the annual burden associated with the review of these COVID-19 exemption requests has been eliminated from the current clearance.
	26.27(d): Review FFD policies and procedures (performed during periodic NRC inspections)	20.0	8.0	160.0	No. Actions/Year - 26.27(d). Every 3 years, the NRC inspects the FFD program of each operating nuclear power reactor site, Category I SNM site, and reactor construction site.
	26.27(h): Review records to ensure only appropriate records maintained by the D&A testing program for administratively withdrawing access for initial positive drug tests for marijuana or cocaine (only applicable to LTFs) (performed during periodic NRC inspections)	0	4.0	0
	26.77(c): Review and evaluate report made on an NRC employee or contractor being unfit for duty	0	4.0	0
	26.187(f): Review documentation provided by SAE (upon request by the NRC)	1.0	4.0	4.0
	26.417(b)(1): Review and evaluate 24-hour report to the NRC Operations Center on a significant FFD program failure, degradation, or vulnerability (reactor construction site D&A testing programs)	Burden accounted for under 26.719(b)
	26.417(b)(2): Annual FFD program performance report – Review, analyze, and summarize information (reactor construction site D&A testing programs)	1.3	25.0	33.3	No. Actions/Year - 26.417(b)(2). An annual FFD program performance report is submitted by each reactor construction site D&A testing program. In the first two years of this clearance period, no reports will be submitted because no reactors will be under construction. In year three of this clearance period, the NRC estimates that 4 SMR construction site D&A testing programs will submit a report. Because the values in this table are annualized, 4 reports in clearance year 3 / 3 years of the clearance = 1.3 reports / year. The prior clearance estimated 0.3 actions per year, consistent with the assumption that the reactor construction at Vogtle Unit 4 would be complete in the first year of the clearance period (1 report / 3 years = 0.3 reports / year)
	26.717: Annual fatigue management performance report – Review, analyze, and summarize fatigue management data specified in 26.203(e)	53.0	0.75	39.8	No. Actions/Year - 26.717. A fatigue management performance report is submitted by each operating nuclear power reactor site on an annual basis. Annually, an average of 53 operating nuclear power reactor sites will be subject to the fatigue management program requirements and submit a performance report to the NRC. In the previous clearance, the number of operating reactor sites was estimated to decrease from 54 in the first year of the clearance period, to 51 in the second and third years of the clearance period (i.e., the average number of operating reactor sites per year for that clearance was 52). Two of those operating reactor sites did not shutdown, thus the return to 53 operating reactor sites for this clearance period.
	26.717: Annual FFD program performance report – Review, analyze, and summarize information (D&A testing programs)	60.0	12.0	720.0	No. Actions/Year - 26.717. It is estimated that 60 sites each submit FFD program performance report information to the NRC (i.e., 53 operating nuclear power reactor sites; 2 Category I SNM sites, 4 corporate FFD programs, and 1 C/V). The previous clearance also reported that 60 sites per year would submit report information; however, the mix of sites was different (54 operating nuclear power reactor sites in the first year of the clearance period and 51 sites in years two and three of the clearance period due to three sites permanently ceasing operations; 2 Category I SNM sites, 5 corporate FFD programs, and 1 C/V).
	26.719(b): 24-hour report – Review, evaluate, and respond to a report made to the NRC Operations Center on a significant FFD policy violation or programmatic failure	30.0	8.0	240.0	No. Actions/Year - 26.719(b). It is estimated that the NRC will receive 30 reports per year under 26.719(b), which is the average number reports received from CY 2019 through CY 2021. The previous clearance estimated 36 reports per year.
	26.719(c): 30-day report – Review, evaluate, and respond to a report made to the NRC detailing the investigation of any testing errors or unsatisfactory performance discovered at an LTF or HHS lab	4.0	4.0	16.0	No. Actions/Year - 26.719(c). It is estimated that the NRC will receive four (4) reports per year under 26.719(c), which is the average number of reports received from CY 2019 through CY 2021. The previous clearance estimated 6 reports per year.
	Total	169.3		1,213.1

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Sheet 6: TOTALS

						Previous ROCIS Total	2024-2027
Summary of Estimated Burden Hours and Costs (2024-2027)
Table	Description	Responses	Annualized Burden Hours	Cost at $300/hour		Annualized Burden Hours	Annualized Burden Hours	Change Hours	Change %
1	Recordkeeping (One-Time)	7.0	2,192.0	$657,600		466.7	2,192.0	1,725.3	369.7%
2	Recordkeeping (Annual)	49.0	167,554.1	$50,266,226		181,815.5	167,554.1	(14,261.4)	-7.8%
3	Annual Reporting	254.3	5,300.7	$1,590,200		5,409.7	5,300.7	(109.0)	-2.0%
4	Third Party Disclosure (Annual)	324,343.0	365,003.0	$109,500,900		411,956.1	365,003.0	(46,953.1)	-11.4%
TOTAL		324,646.3	540,049.8	$162,014,926		599,647.9	540,049.8	(59,598.2)	-9.9%
		Tables 1 + 2 Burden >>>	169,746.1
		Records storage costs >>>	$20,369.53
Table	Description	Actions	Annualized Burden Hours	Cost at $300/hour
5	NRC Action	169.3	1,213.1	$363,925
	Total Number of Respondents					Previous ROCIS Total	2024-2027
	D&A testing programs					24	24
	Reactor construction sites D&A testing programs					1	4
	Fatigue management programs					21	21
	Third-Party Respondents					70,514	64,343
				Pre-access testing (D&A testing programs)		68,285	60,257
				Pre-access testing (reactor construction site D&A testing programs		2,171	4,028
				HHS labs		9	9
				BPTS suppliers		1	1
				EAPs		24	24
				Non-licensee collection sites		24	24
				Total Respondents		70,560	64,392
	Total Number of Responses					Previous ROCIS Total	2024-2027
	Recordkeepers (Table 2)					30.0	49.0
	Reporting Responses (Table 3)					398.3	254.3
	Third-Party Disclosure Responses (Table 4)					368,274.3	324,343
				Total Responses		368,702.6	324,646.3