| Table 1: One Time Recordkeeping | ||||||||
| 2011 | 2014 | |||||||
| Section | Number of Programs | Burden Hours per Program (Annualized) | Total Burden Hours (Annualized) | Number of Programs | Burden Hours per Program (Annualized) | Total Burden Hours (Annualized) | Change | |
| 26.27(a): Prepare FFD policy statement | 1.0 | 107.0 | 107.0 | - | 107.0 | - | (107.0) | |
| 26.27(a): Prepare FFD procedures | 1.0 | 213.0 | 213.0 | - | 213.0 | - | (213.0) | |
| 26.29(a): Prepare FFD training course | 1.0 | 83.0 | 83.0 | - | 83.0 | - | (83.0) | |
| 26.29(b): Prepare FFD exam | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.29(b): All current staff take FFD exam | 1.0 | 200.2 | 200.0 | - | 200.2 | - | (200.0) | |
| 26.29(b): FFD staff mgmt grade FFD exam | 1.0 | 200.2 | 200.0 | - | 200.2 | - | (200.0) | |
| 26.29(c)(1): FFD training for current staff | 1.0 | 4,710.7 | 4,711.0 | - | 4,710.7 | - | (4,711.0) | |
| 26.31(b)(1)(v): Prepare behavioral observation procedures for FFD program personnel | Burden shown under 26.27 | Burden accounted for under 26.27 (0 programs) |
- | |||||
| 26.31(d)(1)(iii): Document additional drugs being tested | 1.0 | 0.3 | - | - | 0.3 | - | - | |
| 26.37(a): Confirm files and procedures protect personal information | 1.0 | 2.7 | 3.0 | - | 2.7 | - | (3.0) | |
| 26.37(b): Obtain signed consent for release of information | 1.0 | 98.1 | 98.0 | - | 98.1 | - | (98.0) | |
| 26.39(a) and (b): Prepare procedure for review of determination of FFD violation | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.85(a): Prepare and deliver qualification training for urine collectors | 1.0 | 5.3 | 5.0 | - | 5.3 | - | (5.0) | |
| 26.85(b): Prepare and deliver qualification training for alcohol collectors | 1.0 | 5.3 | 5.0 | - | 5.3 | - | (5.0) | |
| 26.127(a): Prepare procedures for handling specimens at licensee testing facility | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.127(b): Prepare written chain-of-custody procedures for licensee testing facility | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.127(c): Prepare written procedures for assays performed by licensee testing facility | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.127(d): Prepare written procedures for instrument and test setup by licensee testing facility | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.127(e): Prepare written procedures for remedial actions for systems and tests at licensee testing facility | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.137(a): Develop QA/QC program and procedures for licensee testing facility | 1.0 | 13.3 | 13.0 | - | 13.3 | - | (13.0) | |
| 26.155(a)(1), (3), (4), (5); (b),(c), (e), and (f): Confirm that HHS requirements for laboratory personnel qualifications and procedures already in place pursuant to HHS requirements also meet Part 26 requirements | - | 2.7 | - | - | 2.7 | - | - | |
| 26.157(b), (c), (d), and (e): Confirm that laboratory procedures already in place pursuant to HHS requirements also meet Part 26 requirements | - | 2.7 | - | - | 2.7 | - | - | |
| 26.159(a), (c), (e), (f): Confirm that specimen security, chain of custody, and preservation procedures already in place pursuant to HHS requirements also meet Part 26 requirements | - | 2.7 | - | - | 2.7 | - | - | |
| 26.203(a): Prepare fatigue management policy (In addition to 26.27 burden) | 1.0 | 13.3 | 13.0 | 2.0 | 7.3 | 14.6 | 1.6 | |
| 26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden) | 1.0 | 26.6 | 27.0 | 2.0 | 1.7 | 3.4 | (23.6) | |
| 26.203(c): Prepare training on fatigue management. | 1.0 | 22.7 | 23.0 | 2.0 | 2.0 | 4.0 | (19.0) | |
| 26.205(b): Develop work hour tracking system | 1.0 | 133.3 | 133.0 | 2.0 | 7.7 | 15.4 | (117.6) | |
| 26.205(c): Develop individual work scheduling system | 1.0 | 33.3 | 33.0 | 2.0 | 2.0 | 4.0 | (29.0) | |
| 26.205(d)(7): Implementation of voluntary alternative to minimum days off | 22.0 | 11.7 | 257.4 | - | (257.4) | |||
| 26.401(b): Prepare Subpart K program plan | 1.0 | 60.0 | 60.0 | - | 60.0 | - | (60.0) | |
| 26.403(a): Prepare written Subpart K FFD policy statement | 1.0 | 107.0 | 107.0 | - | 107.0 | - | (107.0) | |
| 26.403(a): Distribute Subpart K FFD policy statement to all individuals | 1.0 | 5.0 | 5.0 | - | 5.0 | - | (5.0) | |
| 26.403(b): Prepare written Subpart K FFD procedures | 1.0 | 213.0 | 213.0 | - | 213.0 | - | (213.0) | |
| 26.406(a), (b), and (d): Establish a fitness monitoring program | - | 26.7 | - | - | 26.7 | - | - | |
| 26.406(c): Establish procedures for fitness monitors | - | 40.0 | - | - | 40.0 | - | - | |
| 26.407: Establish procedures for behavioral observation | - | 40.0 | - | - | 40.0 | - | - | |
| 26.413: Develop procedures for review of determinations of FFD violations | 1.0 | 120.0 | 120.0 | - | 120.0 | - | (120.0) | |
| Table 1: Total | 6,720.4 | 41.4 | (6,679.0) | (6,679.0) | ||||
| Table 2: Annual Recordkeeping | ||||||||
| 2011 | 2014 | |||||||
| Section | Number of Recordkeepers | Burden Hours per Recordkeeper | Total Annual Burden Hours | Number of Recordkeepers | Burden Hours per Recordkeeper | Total Annual Burden Hours | Change | |
| 26.4: Requires training be provided to persons subject to a drug and alcohol testing program regulated by another Federal agency or State but who are not covered by these training elements of a Part 26 FFD program. Further, these State and Federal entities are required to ensure that the licensee granting authorization is notified of any FFD policy violation. | 30.5 | 2.0 | 61.0 | 61.0 | ||||
| 26.27(b): Make FFD policy statement available to staff subject to FFD reqs. | 31.0 | 4.0 | 124.0 | 28.0 | 4.0 | 112.0 | (12.0) | |
| 26.27(c): Record updates to policy & procedures | 31.0 | 8.0 | 248.0 | 28.0 | 8.0 | 224.0 | (24.0) | |
| 26.27(d): Provide policy and procedures for NRC review | 31.0 | 4.0 | 124.0 | 28.0 | 4.0 | 112.0 | (12.0) | |
| 26.29(b): Maintain records of FFD exams | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.29(c)(2): Maintain records of refresher FFD training and testing | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.29(d): Record acceptance of FFD training from other licensees' programs | 31.0 | 4.0 | 124.0 | 28.0 | 4.0 | 112.0 | (12.0) | |
| 26.31(b)(1)(i): Record results of background checks for FFD personnel | 31.0 | 17.5 | 542.5 | 28.0 | 17.5 | 490.0 | (52.5) | |
| 26.31(b)(1)(v): Record results of behavioral observation for FFD program personnel | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.31(d)(1)(i)(D): Document analysis and certification for unlisted drugs | 8.0 | 4.0 | 32.0 | 2.3 | 4.0 | 9.2 | (22.8) | |
| 26.31(d)(1)(ii): Document licensee additions to tested drugs | 31.0 | 8.0 | 248.0 | 2.3 | 8.0 | 18.4 | (229.6) | |
| 26.31(d)(3)(iii)(A): Document more stringent cutoff levels | 8.0 | 8.0 | 64.0 | 2.0 | 8.0 | 16.0 | (48.0) | |
| 26.31(d)(3)(iii)(C): Document evaluation and certification of more stringent cutoff levels | 8.0 | 8.0 | 64.0 | 2.0 | 8.0 | 16.0 | (48.0) | |
| 26.31(d)(6): Document written permission of donor to conduct another analysis or test with specimen | 8.0 | 1.0 | 8.0 | - | 1.0 | - | (8.0) | |
| 26.33: Records of behavioral observations | 31.0 | 400.0 | 12,400.0 | 28.0 | 400.0 | 11,200.0 | (1,200.0) | |
| 26.35(a): Employee assistance program records | 31.0 | 16.0 | 496.0 | 28.0 | 16.0 | 448.0 | (48.0) | |
| 26.35(c): Maintain record of written waivers of right to privacy from individuals given to EAP | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.35(c): Record of EAP disclosure to FFD mgt. | 16.0 | 1.0 | 16.0 | 14.0 | 1.0 | 14.0 | (2.0) | |
| 26.37(b)(1): Record of signed designations of personal representative for FFD matters | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.37(c): Record of disclosures to other licensees | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.37(d): Record of lab results and provide result to individual | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.39(a): Maintain procedures for review of determinations of FFD | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.39(d): Update records to reflect outcome of review of determination of fitness | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.39(e): Record that review procedure provided to individual | 31.0 | 15.5 | 480.5 | - | 0.5 | - | (480.5) | |
| 26.41(a), (b), and (c): Record of audits | Burden shown under 26.41(f) | Burden accounted for under section 26.41(f) | - | |||||
| 26.41(d): Record of review of C/V audit results | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.41(f): Document and report audit results | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.41(g): Record that audit results shared with mgmt and with other FFD programs | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.53(e)(2): Record that C/Vs informed licensee of the termination of an individual's authorization | 2.0 | 120.0 | 240.0 | 1.0 | 120.0 | 120.0 | (120.0) | |
| 26.53(g): Record that CVs and other licensees informed of Part 26 violations | 8.0 | 8.0 | 64.0 | 7.0 | 8.0 | 56.0 | (8.0) | |
| 26.53(h): Record that written consent obtained from the subject individual before initiating any actions under Subpart C | 31.0 | 1,411.0 | 43,741.0 | 28.0 | 1,677.0 | 46,956.0 | 3,215.0 | |
| 26.53(i): Record that all individuals applying for authorization informed, in writing, of the causes for denial or termination of authorization | 31.0 | 21.4 | 663.4 | 28.0 | 23.3 | 652.4 | (11.0) | |
| 26.55(a)(1) and (a)(2): Record that obtained and reviewed self-disclosure & employment history and completed suitable inquiry | Burden shown under 26.61 and 26.63 | Burden accounted for under sections 26.61 and 26.63 | - | |||||
| 26.57(a)(1) and (a)(2): Record that obtained and reviewed self-disclosure & employment history & completed suitable inquiry | Burden shown under 26.61 and 26.63 | Burden accounted for under sections 26.61 and 26.63 | - | |||||
| 26.59(a)(1) and (a)(2): Record that obtained and reviewed self-disclosure & employment history & completed suitable inquiry | Burden shown under 26.61 and 26.63 | Burden accounted for under sections 26.61 and 26.63 | - | |||||
| 26.59(c)(1): Record that obtained and reviewed self-disclosure | Burden shown under 26.61 | Burden accounted for under section 26.61 | - | |||||
| 26.61(a): Record of written self-disclosure and employment history | 31.0 | 1,197.0 | 37,107.0 | 28.0 | 1,197.0 | 33,516.0 | (3,591.0) | |
| 26.63(a), (c), and (e): Record of suitable inquiry | 31.0 | 1,197.0 | 37,107.0 | 28.0 | 1,197.0 | 33,516.0 | (3,591.0) | |
| 26.63(c)(2): File DD 214 | 31.0 | 4.0 | 124.0 | 28.0 | 4.0 | 112.0 | (12.0) | |
| 26.63(c)(3): Document refusal of past employer to supply employment information | 31.0 | 2.7 | 83.7 | 28.0 | 2.7 | 75.6 | (8.1) | |
| 26.63(d) & (e): Maintain documentation of denial or unfavorable termination of authorization from other FFD programs | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.65(d) and (e): Record of reinstatement or administrative withdrawal of authorization | 31.0 | 4.0 | 124.0 | 28.0 | 4.0 | 112.0 | (12.0) | |
| 26.65(f): Administrative withdrawal of authorization | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.67 Record of random drug and alcohol testing of persons who have applied for authorization | 31.0 | 4.3 | 133.3 | 28.0 | 5.5 | 154.0 | 20.7 | |
| 26.69(b) and (c)(1): Record of written self-disclosure and employment history | Burden shown under 26.713(a)(1) | Burden accounted for under section 26.713(a)(1) | - | |||||
| 26.69(c)(2): Record that licensee confirmed potentially disqualifying FFD situation resolved | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.69(c)(3): Record that licensee verified that qualified professional indicated individual is fit for duty. | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.69(c)(4): Record of verification that drug/alcohol treatment & testing completed | 31.0 | 3.0 | 93.0 | 28.0 | 3.0 | 84.0 | (9.0) | |
| 26.69(c)(5): Record of verification that pre-access drug/alcohol testing completed | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.69(d): Record that reviewing officer's review completed | 31.0 | 24.0 | 744.0 | 28.0 | 24.0 | 672.0 | (72.0) | |
| 26.69(e): Record of testing and treatment plans accepted from other FFD programs | 31.0 | 8.0 | 248.0 | 28.0 | 8.0 | 224.0 | (24.0) | |
| 26.69(e)(1): Record that information transmitted on testing and treatment plans to other FFD programs | 31.0 | 8.0 | 248.0 | 28.0 | 8.0 | 224.0 | (24.0) | |
| 26.75(a), (b), (c), (d), (e), and (g): Record of sanctions for FFD violation | 31.0 | 12.0 | 372.0 | 28.0 | 12.0 | 336.0 | (36.0) | |
| 26.75(h): Record additional evidence indicating impairment | 31.0 | 18.0 | 558.0 | 28.0 | 18.0 | 504.0 | (54.0) | |
| 26.75(i): Record of positive initial test result and temporary administrative action | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.75(i)(3): Eliminate from record references to temporary administrative action | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.85(a), (b), & (c): Training collectors | 31.0 | 4.0 | 124.0 | 28.0 | 4.0 | 112.0 | (12.0) | |
| 26.85(e): Maintain personnel files | 31.0 | 4.0 | 124.0 | 28.0 | 4.0 | 112.0 | (12.0) | |
| 26.87(d)(3) and (f)(1): Signage/security at test sites | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.87(f)(3), (f)(4), and (f)(5): Record of custody-and-control forms | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.89(a): Record of absence of donor reported | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.89(b)(1), (b)(2), and (b)(4): Record that ID and consent-to-testing form obtained | 31.0 | 1.5 | 46.5 | 28.0 | 1.5 | 42.0 | (4.5) | |
| 26.89(b)(3): Record that FFD program management informed that individual did not present identification | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.89(c): Record of donor's refusal to cooperate in collection procedures | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.91(c)(1), (c)(2), and (c)(3): Record of EBT test results | Burden shown under 26.715(b)(12) | Burden accounted for under section 26.715(b)(2) | - | corrected section reference from (b)(12) to (b)(2) | ||||
| 26.91(e)(4): Record that results cancelled after EBT calibration check failure | 8.0 | 6.0 | 48.0 | - | 6.0 | - | (48.0) | |
| 26.91(e)(5): Prepare record of EBT maintenance | 31.0 | 6.0 | 186.0 | 28.0 | 6.0 | 168.0 | (18.0) | |
| 26.93(a)(6): Document alcohol pre-test questions asked and answered | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.95(b)(5): Record donor identity for initial alcohol breath test | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.97(b)(2): Record reason for new oral fluid alcohol test | 31.0 | 5.0 | 155.0 | - | 5.0 | - | (155.0) | |
| 26.97(c)(1): Document reason for failure of 2nd collection attempt | 31.0 | 2.5 | 77.5 | - | 2.5 | - | (77.5) | |
| 26.97(d): Record results and alcohol screening device used | 31.0 | 0.3 | 7.8 | - | 0.25 | - | (7.8) | |
| 26.99(b): Record test time of initial test with 0.02% or higher BAC | 31.0 | 0.3 | 7.8 | Burden accounted for under section 26.715(b)(2) | (7.8) | updated to more accurately reflect that burden is accounted for elsewhere | ||
| 26.101(b)(7): Record time on EBT printout of alcohol test result | 31.0 | 0.3 | 7.8 | - | - | - | (7.8) | |
| 26.103(b): Record that FFD mgmt informed of result between 0.01 and 0.02 when donor in work status 3 or more hours | 8.0 | 0.3 | 2.0 | 8.0 | 0.25 | 2.0 | - | |
| 26.107(b): Document tampering attempt on CCF form | 31.0 | 0.1 | 3.1 | 28.0 | 0.1 | 2.8 | (0.3) | |
| 26.109(b)(3): Record that FFD mgt. or MRO notified of Ashy bladder@ problem | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.109(b)(4): Record that FFD management notified if observed collection required | 31.0 | 0.3 | 9.3 | 28.0 | 0.3 | 8.4 | (0.9) | |
| 26.111(b): Note unusual findings on CCF form | 31.0 | 1.4 | 43.4 | 4.0 | 0.25 | 1.0 | (42.4) | |
| 26.111(c): Record that tampering attempts reported to FFD mgr. | 31.0 | 0.3 | 9.3 | 28.0 | 0.3 | 8.4 | (0.9) | |
| 26.113(b)(3): Record of CCF forms for both parts of split sample | 31.0 | 0.3 | 9.3 | 28.0 | 0.3 | 8.4 | (0.9) | |
| 26.115(b): Record that approval obtained for collection under direct observation from FFD mgr. or MRO | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.115(d): Record of CCF form for directly observed collection | 31.0 | 0.3 | 9.3 | 28.0 | 0.3 | 8.4 | (0.9) | |
| 26.115(f)(3): Record of name of observer | 31.0 | 0.3 | 9.3 | 28.0 | 0.3 | 8.4 | (0.9) | |
| 26.117(c), (d), and (e): Prepare ID labels and CCF forms for specimen shipment | 31.0 | 60.0 | 1,860.0 | 28.0 | 60.0 | 1,680.0 | (180.0) | |
| 26.119(a), (e), and (f): Record that evaluation obtained from MRO or physician evaluating Ashy bladder@ claim | 31.0 | 6.0 | 186.0 | 28.0 | 6.0 | 168.0 | (18.0) | |
| 26.119(b): Record that MRO provided information to physician as background for evaluation of Ashy bladder@ claim | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.125(b) and (c): Proficiency and qualifications records of testing facility personnel | 31.0 | 16.0 | 496.0 | 7.0 | 16.0 | 112.0 | (384.0) | |
| 26.127(a): Procedures for handling specimens by licensee testing facilities | 31.0 | 40.0 | 1,240.0 | 7.0 | 40.0 | 280.0 | (960.0) | |
| 26.127(b): Written chain-of-custody procedures for licensee testing facilities | 31.0 | 40.0 | 1,240.0 | 7.0 | 40.0 | 280.0 | (960.0) | |
| 26.127(c): Written procedures for assays performed by licensee testing facilities | 31.0 | 40.0 | 1,240.0 | 7.0 | 40.0 | 280.0 | (960.0) | |
| 26.127(d): Written procedures for instrument and device setup by licensee testing facilities | 31.0 | 40.0 | 1,240.0 | 7.0 | 40.0 | 280.0 | (960.0) | |
| 26.127(e): Written procedures for remedial actions for systems and testing devices at licensee testing facilities | 31.0 | 40.0 | 1,240.0 | 7.0 | 40.0 | 280.0 | (960.0) | |
| 26.129(a): Records associated with limiting access to testing site | 31.0 | 2.5 | 77.5 | 7.0 | 2.5 | 17.5 | (60.0) | |
| 26.129(b): Inspect specimen packages, custody control forms, and obtain memorandum from specimen collector | 31.0 | 0.5 | 15.5 | 7.0 | 0.5 | 3.5 | (12.0) | |
| 26.129(b)(1): Record of report to senior management of attempts to tamper with specimens in transit | 31.0 | 1.0 | 31.0 | 7.0 | 1.0 | 7.0 | (24.0) | |
| 26.129(d): Procedures for tracking CCF of specimens | 31.0 | 80.0 | 2,480.0 | 7.0 | 80.0 | 560.0 | (1,920.0) | |
| 26.135(b): Record of donor's written permission for retest second part of split sample | 31.0 | 2.2 | 68.2 | 7.0 | 2.2 | 15.4 | (52.8) | |
| 26.137(a): Record of QA/QC program and procedures for licensee testing facility | 31.0 | 4.0 | 124.0 | 7.0 | 4.0 | 28.0 | (96.0) | |
| 26.137(b)(1)(ii): Document performance of testing device not on SAMHSA list | 2.0 | 40.0 | 80.0 | 2.0 | 40.0 | 80.0 | - | |
| 26.137(b)(1)(iii): Document results of annual test of device not on SAMHSA list | 2.0 | 20.0 | 40.0 | 2.0 | 20.0 | 40.0 | - | |
| 26.137(b)(3): Record that 1 in 10 negative specimens submitted for validity screening | 31.0 | 40.0 | 1,240.0 | 7.0 | 40.0 | 280.0 | (960.0) | |
| 26.137(e)(7): Document procedures to protect against carryover material | 31.0 | 2.0 | 62.0 | 7.0 | 2.0 | 14.0 | (48.0) | |
| 26.137(f)(5): Record finding of testing errors | 31.0 | 24.0 | 744.0 | 7.0 | 24.0 | 168.0 | (576.0) | |
| 26.137(h): Label standards and controls | 31.0 | 65.0 | 2,015.0 | 7.0 | 65.0 | 455.0 | (1,560.0) | |
| 26.139(d): Record that information prepared for FFD annual report on activities of licensee testing facility | 31.0 | 40.0 | 1,240.0 | 7.0 | 40.0 | 280.0 | (960.0) | |
| 26.153(e): Record of inspection of HHS-certified labs | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.153(f): Include specified requirements in contracts with HHS labs | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.153(g): Record of memo to HHS labs explaining use of non-federal CCF form | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.159(b)(1): Record of report of evidence of tampering with specimens in transit to FFD program mgr. of licensee or other entity | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.159(i): Record of written authorization to store specimens other than 1 year | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.163(a)(2): Record that licensee informed of dilute specimen and report confirmatory validity test result to MRO | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.165(b)(1): Record of donor request for the retest of an aliquot of a single specimen or testing of Bottle B of split specimen at a second HHS lab | 31.0 | 1.4 | 43.4 | 28.0 | 1.0 | 28.0 | (15.4) | |
| 26.165(b)(2): Record that MRO informed donor of opportunity for re-test of aliquot or test of Bottle B of split sample | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.165(b)(3): Record that donor gave written permission for re-test of aliquot or test of Bottle B of split sample | Burden shown under 26.165(b)(1) | Burden accounted for under section 26.165(b)(1) | - | |||||
| 26.165(b)(4): Record that donor presented documentation for reason for inability to complete timely retest request | 31.0 | 0.2 | 6.2 | 6.0 | 0.2 | 1.2 | (5.0) | |
| 26.165(b)(6): Record that results of re-test of aliquot or test of Bottle B provided to MRO and to donor | 31.0 | 3.0 | 93.0 | 28.0 | 3.0 | 84.0 | (9.0) | |
| 26.165(c)(4): Record that retesting results provided to MRO | 10.0 | 2.5 | 25.0 | 12.0 | 2.5 | 30.0 | 5.0 | |
| 26.165(f)(1): Adjustments to personnel files and written notifications regarding test results, including temporary administrative action | 31.0 | 6.0 | 186.0 | 28.0 | 6.0 | 168.0 | (18.0) | |
| 26.165(f)(1)(iv) and (f)(2): Written record and notice that records purged of references to temporary administrative action | 31.0 | 8.0 | 248.0 | 28.0 | 8.0 | 224.0 | (24.0) | |
| 26.167(f)(3): Record of certification by HHS lab that retesting requested by licensee or other entity has occurred | 10.0 | 1.0 | 10.0 | 12.0 | 1.0 | 12.0 | 2.0 | |
| 26.169(a): Records of reports of test results by HHS lab | Burden covered under 26.169 (c)(1) through (c)(5) | Burden accounted for under sections 26.169 (c)(1) through (c)(5) | - | |||||
| 26.169(c)(1): Records of HHS lab reports of positive, adulterated, substituted, dilute, and invalid test results to the MRO | 10.0 | 80.0 | 800.0 | 12.0 | 80.0 | 960.0 | 160.0 | |
| 26.169(c)(2): Records of HHS lab reports of quantitative test results as requested by MRO | 2.0 | 1.0 | 2.0 | 12.0 | 1.0 | 12.0 | 10.0 | |
| 26.169(c)(2): Records of HHS lab reports of quantitative test results for opiates to MRO | 10.0 | 0.5 | 5.0 | 12.0 | 0.5 | 6.0 | 1.0 | |
| 26.169(c)(3): Records of HHS lab reports of quantitative test results for adulterated or substituted test results | 10.0 | 2.5 | 25.0 | 12.0 | 2.5 | 30.0 | 5.0 | |
| 26.169(c)(4): Record of HHS lab contact with MRO to discuss whether testing by another HHS lab should be done | 10.0 | 2.0 | 20.0 | 12.0 | 2.0 | 24.0 | 4.0 | |
| 26.169(c)(5): Record of HHS lab reports of concentrations exceeding linear range | 2.0 | 1.0 | 2.0 | 2.0 | 1.0 | 2.0 | - | |
| 26.169(f): Records of HHS lab transmittals of copies of the CCF form for negative results to the MRO | 10.0 | 125.8 | 1,258.0 | 12.0 | 109.5 | 1,314.0 | 56.0 | |
| 26.169(g): Records of HHS lab transmittals of original of CCF form for positive, adulterated, substituted, dilute or invalid results to the MRO | 10.0 | 42.3 | 423.0 | 12.0 | 44.7 | 536.4 | 113.4 | |
| 26.169(h): Record that HHS lab prepared and submitted annual statistical summary report of urinalysis testing results | 10.0 | 40.0 | 400.0 | 12.0 | 40.0 | 480.0 | 80.0 | |
| 26.183(a): Documentation of MRO qualifications | 31.0 | 3.5 | 108.5 | 28.0 | 3.5 | 98.0 | (10.5) | |
| 26.183(c)(1): MRO review of records for positive, adulterated, substituted, invalid, or, at the licensees or other entitys discretion, dilute test results | 31.0 | 26.0 | 806.0 | 28.0 | 19.1 | 534.8 | (271.2) | |
| 26.183(d)(1)(ii)(D): Record of MRO report of drug test results to licensees designated reviewing official | 31.0 | 26.0 | 806.0 | 28.0 | 19.1 | 534.8 | (271.2) | |
| 26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results | 31.0 | 213.0 | 6,603.0 | 28.0 | 292.2 | 8,181.6 | 1,578.6 | |
| 26.183(d)(2)(ii): Record of MRO staff review of CCF forms and forwarding of changes to MRO | 31.0 | 2.6 | 80.6 | 28.0 | 1.9 | 53.2 | (27.4) | |
| 26.185(a) Record of MRO review of all positive, adulterated, substituted, dilute, or invalid test results and report to licensee or other entity | 31.0 | 26.0 | 806.0 | 28.0 | 26.0 | 728.0 | (78.0) | |
| 26.185(c): Record of MRO discussion of test results with the donor and report to licensee, following discussion with donor, of FFD violation | 31.0 | 26.0 | 806.0 | 28.0 | 26.0 | 728.0 | (78.0) | |
| 26.185(d)(1): Documentation that donor declined to discuss test results | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.185(e): Documentation that donor was unavoidably prevented from discussing test results and request to reopen proceeding | 31.0 | 0.3 | 9.3 | 28.0 | 0.3 | 8.4 | (0.9) | |
| 26.185(f)(1): Record of MRO consultation with HHS lab to determine whether additional testing needed | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.185(f)(2): Record of MRO contact with donor regarding medical explanation for test result | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.185(h)(1): Record of MRO contact with donor to offer opportunity to provide medical evidence regarding substituted specimen | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(h)(1): Record that donor presented medical explanation for substituted result | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(h)(2): Record of MRO notification to licensee that no valid medical explanation presented | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.185(h)(3): Record of MRO notification to licensee that valid medical explanation presented | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(i)(1): Record of MRO contact with donor to offer opportunity to provide medical evidence regarding adulterated specimen | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(i)(1): Record that donor presented medical explanation for adulterated result | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(i)(2): Record of MRO notification to licensee that no valid medical explanation presented | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.185(i)(3): Record of MRO notification to licensee that valid medical explanation presented | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(j)(3): Record of MRO notification to licensee where evidence of drug abuse | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(j)(3): Record of MRO report to licensee that donor has violated FFD policy by use of another individual's prescription medication | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.185(k): Record of MRO report to licensee that no FFD policy violation has occurred | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(m): Record of MRO review of inspection and audit reports, quality control data, multiple specimens, and other data to determine if positive, adulterated, substituted, or invalid result is scientifically insufficient for determination of FFD policy violation | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(n): Record of MRO report to licensee on result of analysis by second HHS lab | 31.0 | 2.0 | 62.0 | 28.0 | 2.0 | 56.0 | (6.0) | |
| 26.185(o): Record of MRO request for quantitation of test results | 31.0 | 0.5 | 15.5 | 28.0 | 0.5 | 14.0 | (1.5) | |
| 26.185(o): Record that lab provided quantitation of test results | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.185(p): Record of MRO notice to licensee of determination of FFD policy violation | 31.0 | 8.0 | 248.0 | 28.0 | 8.0 | 224.0 | (24.0) | |
| 26.187(d): SAE training requirements | 31.0 | 20.0 | 620.0 | 28.0 | 20.0 | 560.0 | (60.0) | |
| 26.187(f): Documentation of SAE credentials and training | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.189(a): Written record of determination of fitness | 31.0 | 80.2 | 2,486.2 | 28.0 | 80.2 | 2,245.6 | (240.6) | |
| 26.189(c): Written record of Afor cause@ determination of fitness | 31.0 | 57.5 | 1,782.5 | 28.0 | 16.3 | 456.4 | (1,326.1) | |
| 26.189(d): Record of modification of an initial determination of fitness | 31.0 | 1.0 | 31.0 | 28.0 | 1.0 | 28.0 | (3.0) | |
| 26.203(a): Prepare fatigue management policy (In addition to 26.27 burden) | 2.0 | 7.3 | 14.6 | 14.6 | ||||
| 26.203(b): Prepare fatigue management procedures (in addition to 26.27 burden) | 2.0 | 1.7 | 3.4 | 3.4 | ||||
| 26.203(c): Prepare training on fatigue management. | 2.0 | 2.0 | 4.0 | 4.0 | ||||
| 26.203(d)(1): Records of work hours | Burden shown under 26.205(c), (d)(1), and (e)(4) | Burden accounted for under 26.205(c), (d)(1), and (e)(4) | - | |||||
| 26.203(d)(2): Records of shift schedules and shift cycles | Burden shown under 26.205(c), (d)(1), and (e)(4) | Burden accounted for under 26.205(c), (d)(1), and (e)(4) | - | |||||
| 26.203(d)(3): Documentation of waivers | Burden shown under 26.207(a)(4) | Burden accounted for under section 26.207(a)(4) | - | |||||
| 26.203(d)(4): Documentation of work hour reviews | Burden shown under 26.205(d)(2), (e)(3) and (e)(4) | Burden accounted for under 26.205(d)(2), (e)(3) and (e)(4) | - | |||||
| 26.203(d)(5): Documentation of fatigue assessment | Burden shown under 26.211(f) | Burden accounted for under section 26.211(f) | - | |||||
| 26.205(b): Record of calculation of work hours | 29.0 | 160.0 | 4,640.0 | 23.0 | 160.0 | 3,680.0 | (960.0) | |
| 26.205(c): Schedule work hours | 29.0 | 2,080.0 | 60,320.0 | 23.0 | 2,080.0 | 47,840.0 | (12,480.0) | |
| 26.205(d)(1): Record of implementation of work hour controls | 29.0 | 50.0 | 1,450.0 | 23.0 | 50.0 | 1,150.0 | (300.0) | |
| 26.205(d)(2): Record of adequate rest breaks | 29.0 | 50.0 | 1,450.0 | 23.0 | 50.0 | 1,150.0 | (300.0) | |
| 26.205(e)(1) and (2): Record of review of control of work hours twice per calendar year | 29.0 | 40.0 | 1,160.0 | 23.0 | 40.0 | 920.0 | (240.0) | |
| 26.205(e)(3): Document methods for reviews | 29.0 | 20.0 | 580.0 | 23.0 | 20.0 | 460.0 | (120.0) | |
| 26.205(e)(4): Record and trend problems in regarding work hours | 29.0 | 20.0 | 580.0 | 23.0 | 20.0 | 460.0 | (120.0) | |
| 26.207(a)(4): Document basis for waiver | 3.0 | 6.0 | 18.0 | 3.0 | 6.0 | 18.0 | - | |
| 26.211(f): Document results of fatigue assessments | 29.0 | 50.0 | 1,450.0 | 23.0 | 50.0 | 1,150.0 | (300.0) | |
| 26.405(a): Record of random drug and alcohol testing | 1.0 | 500.0 | 500.0 | 2.0 | 705.0 | 1,410.0 | 910.0 | |
| 26.405(c)(1): Document pre-assignment testing | 1.0 | 2,000.0 | 2,000.0 | 2.0 | 2,338.0 | 4,676.0 | 2,676.0 | |
| 26.405(c)(2) and (c)(3): Document for-cause and post accident testing | 1.0 | 38.0 | 38.0 | 2.0 | 197.0 | 394.0 | 356.0 | |
| 26.405(c)(4): Document follow up testing | 1.0 | 190.0 | 190.0 | 2.0 | 34.5 | 69.0 | (121.0) | |
| 26.405(d): Record of testing for specified drugs, adulterants, and alcohol, at Part 26 specified cutoff levels | Burden shown under 26.405(a) - (c)(4) | Burden accounted for under section 26.405(a) - (c)(4) | - | |||||
| 26.405(e): Record of methods to ensure privacy and quality control | 1.0 | 40.0 | 40.0 | 2.0 | 40.0 | 80.0 | 40.0 | |
| 26.405(f): Record that testing conducted at an HHS lab | 1.0 | 40.0 | 40.0 | 2.0 | 40.0 | 80.0 | 40.0 | |
| 26.405(g): Record of MRO review of positive, adulterated, substituted, and invalid drug and validity test results | 1.0 | 50.0 | 50.0 | 2.0 | 50.0 | 100.0 | 50.0 | |
| 26.406(c): Record of fitness monitoring procedures (programs that do not adopt random testing and behavioral observation) | - | 80.0 | - | - | 80.0 | - | - | |
| 26.411(a): Record of system of files and procedures to protect personal information | 1.0 | 4.0 | 4.0 | 2.0 | 4.0 | 8.0 | 4.0 | |
| 26.411(a): Collection of personal information | 1.0 | 2,000.0 | 2,000.0 | 2.0 | 2,189.0 | 4,378.0 | 2,378.0 | |
| 26.411(b): Record that signed consent forms obtained | 1.0 | 1.5 | 1.5 | 2.0 | 1.5 | 3.0 | 1.5 | |
| 26.413: Document results of review process | 1.0 | 80.0 | 80.0 | 2.0 | 80.0 | 160.0 | 80.0 | |
| 26.415: Document and report audit results | 1.0 | 40.0 | 40.0 | 2.0 | 40.0 | 80.0 | 40.0 | |
| 26.417(a): Retain program records | 1.0 | 20.0 | 20.0 | 2.0 | 20.0 | 40.0 | 20.0 | |
| 26.417(b)(2) Collect FFD program performance data for Subpart K reactor construction site programs | - | - | - | 2.0 | 100.0 | 200.0 | 200.0 | new entry for 2014 clearance. The requirement existed previously but was not capture in the clearance package. |
| 26.713(a)(1): Retain records of self-disclosure | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.713(a)(2): Retain records on FFD violations | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.713(a)(3): Retain records of authorization | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.713(a)(4): Retain records of FFD determinations | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.713(b)(1): Retain records of FFD training | 31.0 | 160.0 | 4,960.0 | 28.0 | 160.0 | 4,480.0 | (480.0) | |
| 26.713(b)(2): Retain records of audits | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.713(c): Retain records on 5-year authorization denial and permanent denial | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.713(d): Retain superseded FFD policy | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.713(e): Retain written agreements for services under Part 26 | 31.0 | 16.0 | 496.0 | 28.0 | 16.0 | 448.0 | (48.0) | |
| 26.713(f): Retain records of background investigations | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.713(g): Retain documentation regarding additional drugs tested | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.715(a): Maintain documentation of all aspect of testing process (not otherwise specified in 26.715(b)) | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.715(b)(1): Retain personal files | 31.0 | 20.0 | 620.0 | 28.0 | 20.0 | 560.0 | (60.0) | |
| 26.715(b)(2): Retain chain-of-custody documents | 31.0 | 240.0 | 7,440.0 | 28.0 | 240.0 | 6,720.0 | (720.0) | |
| 26.715(b)(3): Retain quality assurance records | 31.0 | 120.0 | 3,720.0 | 28.0 | 120.0 | 3,360.0 | (360.0) | |
| 26.715(b)(4): Retain superseded procedures | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.715(b)(5): Retain all test data | 31.0 | 240.0 | 7,440.0 | 28.0 | 240.0 | 6,720.0 | (720.0) | |
| 26.715(b)(6): Retain test reports | 31.0 | 240.0 | 7,440.0 | 28.0 | 240.0 | 6,720.0 | (720.0) | |
| 26.715(b)(7): Retain performance test records | 31.0 | 80.0 | 2,480.0 | 28.0 | 80.0 | 2,240.0 | (240.0) | |
| 26.715(b)(8): Retain testing error investigation records | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.715(b)(9): Retain certification inspection records | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.715(b)(10): Retain records on preventative maintenance | 31.0 | 40.0 | 1,240.0 | 28.0 | 40.0 | 1,120.0 | (120.0) | |
| 26.715(b)(11): Retain records summarizing scientific insufficiency | 31.0 | 20.0 | 620.0 | 28.0 | 20.0 | 560.0 | (60.0) | |
| 26.715(b)(12): Retain computer-generated data | 31.0 | 120.0 | 3,720.0 | 28.0 | 120.0 | 3,360.0 | (360.0) | |
| 26.715(b)(13): Retain records on visitors | 31.0 | 20.0 | 620.0 | 28.0 | 20.0 | 560.0 | (60.0) | |
| 26.715(b)(14): Retain records on EBT maintenance | 31.0 | 20.0 | 620.0 | 28.0 | 20.0 | 560.0 | (60.0) | |
| 26.717(a) and (b): Collect FFD performance data for drug and alcohol testing | 31.0 | 200.0 | 6,200.0 | 28.0 | 100.0 | 2,800.0 | (3,400.0) | split original into separate rows for D&A and fatigue |
| 26.717(a) and (b): Collect FFD performance data for fatigue management pgorams | 23.0 | 100.0 | 2,300.0 | 2,300.0 | split original into separate rows for D&A and fatigue | |||
| 26.717(c): Analyze drug and alcohol testing program FFD data annually | 31.0 | 80.0 | 2,480.0 | 28.0 | 40.0 | 1,120.0 | (1,360.0) | split original into separate rows for D&A and fatigue |
| 26.717(c): Analyze fatigue management program data annually | - | - | - | 23.0 | 40.0 | 920.0 | 920.0 | split original into separate rows for D&A and fatigue |
| 26.717(d): Drug and alcohol test results leading to termination | 2.0 | 1.0 | 2.0 | 1.0 | 1.0 | 1.0 | (1.0) | |
| 26.717(g): Record that required FFD drug and alcohol information shared by C/V with licensee to ensure information is reported completely and is not duplicated in reports submitted to the NRC | 2.0 | 120.0 | 240.0 | 1.0 | 120.0 | 120.0 | (120.0) | |
| 26.719(b): Prepare 24-hour event report to submit to the NRC | 1.2 | 1.0 | 1.2 | 1.2 | ||||
| 26.719 (c): Prepare 30-day event report documentation. | 0.2 | 40.0 | 8.0 | 8.0 | ||||
| 26.719(d): Document non-reportable indicators of FFD program weaknesses | 31.0 | 20.0 | 620.0 | 30.0 | 20.0 | 600.0 | (20.0) | |
| 26.821(a): Allow NRC to inspect and copy records | 31.0 | 4.0 | 124.0 | 30.0 | 4.0 | 120.0 | (4.0) | |
| 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 | 2.0 | 4.0 | 8.0 | 1.0 | 4.0 | 4.0 | (4.0) | |
| Table 2 Total | 351,889.6 | 314,177.4 | (37,712.2) | |||||
| [1] The 2007-2010 clearance estimated 33 FFD programs, which included one mixed-oxide (MOX) fuel fabrication facility. The 2010-2013 clearance estimates 31 FFD programs. The number of FFD programs has been reduced from 33 to 31 because one FFD program was combined with an existing FFD program (28 to 27 FFD programs) and because an FFD program is not required for the MOX facility until after it receives its NRC license. The MOX facility not expected to be licensed until after the period of the clearance. | ||||||||
| [2] The estimate is based on 991 positive, adulterated, and substituted test results (this includes both alcohol and drug test results) from NRC’s CY 2008 FFD program performance data. One-half burden hour is estimated for each test. | ||||||||
| [3] The estimate is based on 87,468 pre-access tests from NRCs CY 2008 FFD program performance data. One-half burden hour is estimated for each test. | ||||||||
| [4] The estimate is based on 664 positive, adulterated, and substituted pre-access test results (this includes both alcohol and drug test results) from NRC=s CY 2008 FFD program performance data. One burden hour is estimated for each test result. | ||||||||
| [5] NRCs CY 2008 FFD program performance data reported 54,759 total random drug tests. Of these, this estimate assumes that approximately 0.5% of individuals who have applied for authorization and who have received a pre-access test also will be randomly tested. One-half burden hour is estimated for each test. The 2007-2010 clearance reported that all persons received random drug and alcohol testing during the period prior to clearance being approved; that estimate therefore was conservatively high. | ||||||||
| [6] The estimate is based on 846 positive, adulterated, and substituted drug test results from NRCs CY 2008 FFD program performance report data. The assumption is that 10% of all donors will request a retest/split specimen test be performed at a second HHS-certified laboratory. The burden is estimated at one-half burden hour per event. | ||||||||
| [7] This estimate is based on 6 donors and one-burden hour per donor. | ||||||||
| [8] The 2007-2010 clearance estimated that 26 HHS-certified laboratories would provide services under Part 26. The clearance uses updated information obtained from a 2009 industry survey that reported that only 10 laboratories support all Part 26 programs. | ||||||||
| [9] Electronic reporting is allowed by the regulations and assumed for all laboratories. Each laboratory would process a record into their electronic reporting system at 15,095 records per year at a burden-hour estimate of 30 seconds per record. | ||||||||
| [10] NRCs CY 2008 FFD program performance data reported 846 positive, adulterated, and substituted drug test results. It is estimated that an MRO staff spend one burden hour to review each test result and communicate results. | ||||||||
| [11] The estimate assumes that 151,937 tests were conducted in 2008, minus 846 positive, adulterated, and substituted drug tests, equals the total number of negative drug test results reviewed by MROs and MRO staff. Of these, it is estimated that 90% are reviewed by MRO staff at 3 minutes per record. | ||||||||
| [12] NRCs CY 2008 FFD program performance data reported 846 positive, adulterated, and substituted drug test results. It is estimated that MRO staff spend 6 minutes to review each record. | ||||||||
| [13] Based on 1,783 for-cause tests from NRC’s CY 2008 FFD program performance report and one burden hour to prepare a record. | ||||||||
| [14] This quantity is based on an estimate of one construction program choosing to conduct random testing (rather than fitness monitoring), 2,000 workers per construction site subject to the FFD program (based on a 2009 NRC site visit and information presented by the site construction contractor), a 50% test rate, and one-half burden hour per test. | ||||||||
| [15] Estimate based on one burden hour per person to document pre-assignment testing for 2,000 workers at the construction site subject to the FFD program. | ||||||||
| [16] Estimate based on one burden hour per person to collect personal information for 2,000 workers at the construction site subject to the FFD program. | ||||||||
| Table 3: Annual Reporting | ||||||||||||
| 2011 | 2014 | |||||||||||
| Section | Number of Respondents |
Responses per Respondent | Total Responses | Burden per Response (hours) | Total Burden Hours | Number of Respondents |
Responses per Respondent | Total Responses | Burden per Response (hours) | Total Burden Hours |
Burden change | |
| 26.9: Application to NRC for exemption | 2.0 | 1.0 | 2.0 | 16.0 | 32.0 | - | 1.0 | - | - | - | (32.0) | |
| 26.77(c) Report FFD- impaired NRC employee | 31.0 | - | - | 1.0 | - | 30.0 | - | - | 1.0 | - | - | |
| 26.137(b)(3): Report false negative QC test result from LTF | Burden shown under 26.719(c)(3) | Burden accounted for under section 26.719(c)(3) | - | |||||||||
| 26.139(d): Prepare information from LTF for annual FFD program performance report | Burden shown under 26.717(e) and (f) | Burden accounted for under section 26.717(e) and (f) | - | updated text description | ||||||||
| 26.187(f): Provide SAE qualifications documentation to NRC upon request | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | - | |
| 26.203(e)(1): Prepare information on waivers of work hour controls for inclusion in FFD program performance report to NRC required by 26.717(e) and (f) | 29.0 | 1.0 | 29.0 | 50.0 | 1,450.0 | 23.0 | 1.0 | 23.0 | 50.0 | 1,150.0 | (300.0) | |
| 26.203(e)(2): Prepare summary of fatigue corrective actions for inclusion in FFD program performance report to NRC required by 26.717(e) and (f) | 29.0 | 1.0 | 29.0 | 6.0 | 174.0 | 23.0 | 1.0 | 23.0 | 6.0 | 138.0 | (36.0) | |
| 26.417(b)(1): Report to NRC by telephone within 24 hours programmatic failures under Subpart K FFD program | 1.0 | 1.0 | 1.0 | 4.0 | 4.0 | 2.0 | 1.0 | 2.0 | 4.0 | 8.0 | 4.0 | |
| 26.417(b)(2): Prepare annual program performance report for Subpart K FFD program | 1.0 | 1.0 | 1.0 | 80.0 | 80.0 | 2.0 | 1.0 | 2.0 | 80.0 | 160.0 | 80.0 | |
| 26.717(d): Report termination test results in the annual summary by processing stage | Burden shown under 26.717(e) and (f). NRC's 2008 FFD program performance data indicates 991 positive test results. |
Burden accounted for under section 26.717(e) and (f). NRC’s 2012 FFD program performance data indicate 1,089 positive, adulterated, substituted, and refusal to test results. |
- | |||||||||
| 26.717(e) and (f): Annual report of FFD program performance fatigue management programs | - | - | - | - | - | 62.0 | 1.0 | 62.0 | 8.0 | 496.0 | 496.0 | split original into separate rows for D&A and fatigue |
| 26.717(e) and (f): Annual report of FFD program performance for drug and alcohol programs | 31.0 | 1.0 | 31.0 | 150.0 | 4,650.0 | 65.0 | 1.0 | 65.0 | 60.0 | 3,900.0 | (750.0) | split original into separate rows for D&A and fatigue |
| 26.719(a): Reports of significant FFD violations, program failures, and errors in testing | Burden reported under 26.719(b) and (c) | Burden accounted for under section 26.719(b) and (c) | - | |||||||||
| 26.719(b): Report significant FFD violations by phone with in 24 hrs | 15.0 | 1.0 | 15.0 | 4.0 | 60.0 | 15.0 | 2.5 | 37.1 | 4.0 | 148.2 | 88.2 | |
| 26.719(c)(1): Report results of testing error investigation to NRC with in 30 days | 6.0 | 1.0 | 6.0 | 24.0 | 144.0 | 6.0 | 1.0 | 6.0 | 24.0 | 144.0 | - | |
| 26.719(c)(2): Notify NRC of false positives on blind performance sample with in 24 hrs | 1.0 | 1.0 | 1.0 | 4.0 | 4.0 | 1.0 | 1.0 | 1.0 | 4.0 | 4.0 | - | |
| 26.719(c)(3): Notify NRC of false negative test result on QA check within 24 hrs | 4.0 | 1.0 | 4.0 | 4.0 | 16.0 | 4.0 | 1.0 | 4.0 | 4.0 | 16.0 | - | |
| Table 3 Total | 120.0 | 6,615.0 | 226.1 | 6,165.2 | (449.8) | (449.8) | ||||||
| [1] Based on an assumption that programs submit consolidated reports, but that the reports summarize data by site as required by § 26.717(f). | ||||||||||||
| [2] Experience in reviewing licensee reports indicates that most errors reported are associated with false negative results from blind performance sample testing that requires investigation and coordination between the specimen suppliers and the testing laboratories. | ||||||||||||
| Table 4: Annual Third-Party Disclosure | ||||||||
| 2011 | 2014 | |||||||
| Section | Number of Responses |
Burden Hours per Response | Total Annual Burden Hours | Number of Responses |
Burden Hours per Response | Total Annual Burden Hours | Burden change |
|
| 26.4: Requires that training be provided to persons subject to a drug and alcohol testing program regulated by another Federal agency or State but who are not covered by these training elements of a Part 26 FFD program. Further, these State and Federal entities are required to ensure that the licensee granting authorization is notified of any FFD policy violation. | 14.0 | 2.0 | 28.0 | 28.0 | ||||
| 26.31(b)(1)(i): Individuals provide responses to background checks for FFD personnel | 87,468.0 | 1.0 | 87,468.0 | 93,890.0 | 1.0 | 93,890.0 | 6,422.0 | |
| 26.31(d)(6): Donors provide written permission to conduct another analysis or test with specimen | 8.0 | 1.0 | 8.0 | 8.0 | 1.0 | 8.0 | - | |
| 26.35(a): Employee assistance program records (independent non-licensee EAP programs) | 16.0 | 32.0 | 512.0 | 14.0 | 32.0 | 448.0 | (64.0) | |
| 26.35(c): Individuals give written waiver of right to privacy to EAP | 5,476.0 | 0.3 | 1,643.0 | 5,636.0 | 0.3 | 1,690.8 | 47.8 | |
| 26.35(c): Record of disclosure by independent EAP to FFD mgt. | 16.0 | 1.0 | 16.0 | 15.0 | 1.0 | 15.0 | (1.0) | |
| 26.37(b): Individuals provide signed consent for release of information | 54,400.0 | 0.3 | 16,320.0 | 1,127.0 | 0.3 | 338.1 | (15,981.9) | |
| 26.37(b)(1): Individuals provide signed designation of personal representative for FFD matters | 991.0 | 1.0 | 991.0 | 961.0 | 1.0 | 961.0 | (30.0) | |
| 26.37(d): Record that FFD program personnel provided records to individual | 991.0 | 1.0 | 991.0 | 961.0 | 1.0 | 961.0 | (30.0) | |
| 26.53(h): Individuals provide written consent before any actions are initiated under Subpart C | 87,468.0 | 0.3 | 26,240.0 | 93,890.0 | 0.3 | 28,167.0 | 1,927.0 | |
| 26.55(a)(1) and (a)(2): Individual applicants for initial authorization prepare self-disclosure and employment history | Burden shown under 26.61 and 26.63 | Burden accounted for under sections 26.61 and 26.63 | - | |||||
| 26.57(a)(1) and (a)(2): Individual applicants for authorization update prepare self-disclosure and employment history | Burden shown under 26.61 and 26.63 | Burden accounted for under sections 26.61 and 26.63 | - | |||||
| 26.59(a)(1) and (a)(2): Individual applicants for authorization reinstatement prepare self-disclosure and employment history | Burden shown under 26.61 and 26.63 | Burden accounted for under sections 26.61 and 26.63 | - | |||||
| 26.59(c)(1): Individual applicants for authorization reinstatement after period of interruption of no more than 30 days prepare self-disclosure | Burden shown under 26.61 | Burden accounted for under section 26.61 | - | |||||
| 26.61(a): Individuals prepare written self-disclosure and employment history | 87,468.0 | 1.0 | 87,468.0 | 93,890.0 | 1.0 | 93,890.0 | 6,422.0 | |
| 26.63(a), (c), and (e): Verification from former employers through suitable inquiry that information provided by individual on previous authorization(s) is accurate and complete | 87,468.0 | 0.8 | 69,974.0 | 93,890.0 | 0.8 | 75,112.0 | 5,138.0 | |
| 26.63(c)(2): Receive form DD 214 regarding previous military service | Burden of supplying DD 214 affects DOD | Burden of supplying DD 214 affects DOD | - | |||||
| 26.63(c)(3): Past employer refuses to supply employment information | 180.0 | 0.5 | 90.0 | 180.0 | 0.5 | 90.0 | - | |
| 26.67: Records of random drug and alcohol testing of persons who have applied for authorization | 274.0 | 0.5 | 137.0 | 335.0 | 0.5 | 167.5 | 30.5 | |
| 26.69(b) and (c)(1): Applicant provides written self-disclosure and employment history | Burden shown under 26.63 | Burden accounted for under section 26.63 | - | |||||
| 26.69(c)(2): Record that licensee confirmed potentially disqualifying FFD situation resolved | 186.0 | 2.0 | 372.0 | 939.0 | 2.0 | 1,878.0 | 1,506.0 | |
| 26.85(c): Alternative collectors not employed by licensee provide proof of qualification | 22.0 | 1.0 | 22.0 | 22.0 | 1.0 | 22.0 | - | |
| 26.85(e): Maintain personnel files for alternative collectors | 22.0 | 4.0 | 88.0 | 22.0 | 4.0 | 88.0 | - | |
| 26.87(f)(3), (f)(4), and (f)(5): Record of information from non-designated (emergency) test site | 2.0 | 1.0 | 2.0 | 2.0 | 1.0 | 2.0 | - | |
| 26.89(a): Record that absence of donor reported by non-licensee collection site | 2.0 | 1.0 | 2.0 | 2.0 | 1.0 | 2.0 | - | |
| 26.89(b)(3): Record that non-licensee collection site informed FFD program management that individual did not present identification | 2.0 | 1.0 | 2.0 | 2.0 | 1.0 | 2.0 | - | |
| 26.89(c): Record that non-licensee collection site reported donor's refusal to cooperate in the collection procedures. | 2.0 | 1.0 | 2.0 | 2.0 | 1.0 | 2.0 | - | |
| 26.91(e)(4): Record that results cancelled after EBT calibration check failure (non-licensee collection site) | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | - | |
| 26.91(e)(5): Prepare record of EBT maintenance (non-licensee collection site) | 22.0 | 4.0 | 88.0 | 22.0 | 4.0 | 88.0 | - | |
| 26.93(a)(6): Document alcohol pre-test questions asked and answered (non-licensee collection site) | 310.0 | 0.3 | 93.0 | 280.0 | 0.3 | 84.0 | (9.0) | |
| 26.95(b)(5): Record donor identity for initial alcohol breath test (non-licensee collection site) | 310.0 | 0.3 | 93.0 | 280.0 | 0.3 | 84.0 | (9.0) | |
| 26.97(b)(2): Record reason for new oral fluid alcohol test (non-licensee collection site) | 8.0 | 0.5 | 4.0 | 8.0 | 0.5 | 4.0 | - | |
| 26.97(c)(1): Document reason for failure of 2nd collection attempt (non-licensee collection site) | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | - | |
| 26.97(d): Record results and alcohol screening device used (non-licensee collection site) | 8.0 | 0.3 | 2.0 | 8.0 | 0.3 | 2.4 | 0.4 | |
| 26.99(b): Record test time of initial test with 0.02% or higher BAC (non-licensee collection site) | 1.0 | 0.3 | - | 1.0 | 0.3 | 0.3 | 0.3 | |
| 26.101(b)(7): Indicate time on EBT printout of confirmatory alcohol test result (non-licensee collection site) | 1.0 | 0.3 | - | 1.0 | 0.3 | 0.3 | 0.3 | |
| 26.103(b): Non-licensee collector informs FFD mgmt of result between 0.01 and 0.02 when donor in work status 3 or more hours | - | 0.5 | - | - | 0.5 | - | - | |
| 26.107(b): Document tampering attempt on CCF form (non-licensee collection site) | - | 1.0 | - | - | 1.0 | - | - | |
| 26.109(b)(3): Record that non-licensee collector notified FFD management or MRO notified of Ashy bladder@ problem | - | 0.5 | - | - | 0.5 | - | - | |
| 26.109(b)(4): Record that non-licensee collector notified FFD management if observed collection required | - | 0.3 | - | - | 0.3 | - | - | |
| 26.111(b): Non-licensee collector notes unusual findings on CCF form | 2.0 | 0.5 | 1.0 | 2.0 | 0.5 | 1.0 | - | |
| 26.111(c): Record that non-licensee collector notified FFD mgr. of tampering attempts | - | 0.4 | - | - | 0.4 | - | - | |
| 26.113(b)(3): Record of CCF forms for both parts of split urine sample (non-licensee collection site) | - | 0.3 | - | - | 0.3 | - | - | |
| 26.115(b): Record that approval obtained for collection under direct observation from FFD mgr. or MRO (non-licensee collection site) | - | 0.3 | - | - | 0.3 | - | - | |
| 26.115(d): Record of CCF form for directly observed collection (non-licensee collection site) | - | 0.3 | - | - | 0.3 | - | - | |
| 26.115(f)(3): Record of name of observer (non-licensee collection site) | - | 0.3 | - | - | 0.3 | - | - | |
| 26.117(c), (d), and (e): Prepare ID labels and CCF forms for specimen shipment (non-licensee collection site) | 310.0 | 0.3 | 93.0 | 280.0 | 0.3 | 84.0 | (9.0) | |
| 26.119(a), (e), and (f): Record that evaluation obtained from MRO or physician evaluating Ashy bladder@ claim (non-licensee collection site) | - | 6.0 | - | - | 6.0 | - | - | |
| 26.119(b): MRO provides information to physician as background for evaluation of Ashy bladder@ claim | - | 2.0 | - | - | 2.0 | - | - | |
| 26.129(b): Non-licensee specimen collector prepares memorandum to licensee testing facility personnel documenting investigation of discrepancies between bottles and CCF forms | - | 1.0 | - | - | 1.0 | - | - | |
| 26.135(b): Donor prepares written permission for retest second part of split sample | 1.0 | 0.5 | 1.0 | 1.0 | 0.5 | 0.5 | (0.5) | |
| 26.137(b)(3): Submit 1 in 10 negative specimens for validity screening to HHS lab | - | 40.0 | - | - | 40.0 | - | - | |
| 26.153(g): Supply memo to HHS labs explaining use of non-federal CCF form | 2.0 | 0.5 | 1.0 | 2.0 | 0.5 | 1.0 | - | |
| 26.155(a)(1): Document qualifications for lab mgr of HHS-certified lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.155(a)(3): Lab manager documents training of lab personnel | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.155(a)(4): Lab manager reviews and signs lab procedures | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.155(a)(5): Lab manager maintains QA program | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.155(b): Certifying scientist to certify test results from HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.155(c): Supervise technical analysts at HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.155(e): Continuing education for staff at HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.155(f): Lab personnel records | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.157(a): Written procedures for accession, receipt, shipment, and testing of urine specimens at the HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.157(b): Written chain-of-custody procedures for HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.157(c): Written procedures manual for each assay performed by HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.157(d): Written procedures for device set-up and operation | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.157(e): Written procedures for remedial actions to address systems and instrument errors | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.159(a): Documented restriction to access to HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.159(c), (d), and (e): Use and storage of CCF forms | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.159(f): Use of CCF form when shipping specimen to another HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.165(b)(1): Donor requests aliquot or split specimen to be tested by a second HHS lab | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | - | |
| 26.165(b)(2): Record that non-licensee MRO informed donor of opportunity for re-test of aliquot or test of Bottle B of split sample | 1.0 | 0.3 | 0.3 | 1.0 | 0.3 | 0.3 | - | |
| 26.165(b)(3): Written permission by donor for re-test of aliquot or test of Bottle B of split sample | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | - | |
| 26.165(b)(4): Donor presents documentation for reason unable to complete timely retest request | - | 1.0 | - | - | 1.0 | - | - | |
| 26.165(b)(6): HHS lab provides results of re-test of aliquot or test of Bottle B to MRO and to donor | 1.0 | 0.5 | 0.5 | 1.0 | 0.5 | 0.5 | - | |
| 26.167(a): Document quality assurance program of HHS lab | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.167(c)(2)(i): Refractometer at the HHS lab must display specific gravity to 4 decimals and be interfaced with laboratory information management system or computer and/or document result by hard copy or electronic display | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.167(f)(3): Certification by HHS lab that retesting requested by licensee or other entity has occurred | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.167(h): Labeling of standards and controls | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.168(a): Certification of contents of blind performance test samples submitted to HHS lab | Burden covered by HHS lab certification requirements | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.168(h)(2): Ensure supplier provides expiration date for test sample | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.168(i)(2): Use CCF form, place fictional initials on specimen labels, and indicate blind performance test samples | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.169(a): Reports of test results by HHS lab | Burden covered under 26.169(c)(1) through (c)(5) | Burden covered by HHS lab certification requirements OMB Clearance # 0930-0158 |
- | |||||
| 26.169(c)(1): HHS lab record of reports of positive, adulterated, substituted, dilute, and invalid test results to the MRO | 846.0 | 0.3 | 211.5 | 686.0 | 0.3 | 171.5 | (40.0) | |
| 26.169(c)(2): HHS lab record of quantitative test results as requested by MRO | 5.0 | 1.0 | 5.0 | 5.0 | 1.0 | 5.0 | - | |
| 26.169(c)(2): HHS lab record of quantitative test results for opiates to MRO | 16.0 | 1.0 | 16.0 | 16.0 | 1.0 | 16.0 | - | |
| 26.169(c)(3): HHS lab record of quantitative test results for adulterated or substituted test results | 51.0 | 1.0 | 51.0 | 5.0 | 1.0 | 5.0 | (46.0) | |
| 26.169(c)(4): HHS lab record of contact with MRO to discuss whether testing by another HHS lab should be done | 10.0 | 0.5 | 5.0 | 10.0 | 0.5 | 5.0 | - | |
| 26.169(f): HHS lab transmits copy of the CCF form for negative results to the MRO | Electronic transmission | Electronic transmission | - | |||||
| 26.169(g): HHS lab transmits original of CCF form for positive, adulterated, substituted, dilute or invalid results to the MRO | 846.0 | 0.5 | 423.0 | 686.0 | 0.5 | 343.0 | (80.0) | |
| 26.169(h): HHS lab prepares and submits annual statistical summary report of urinalysis testing results | 10.0 | 40.0 | 400.0 | 10.0 | 40.0 | 400.0 | - | |
| 26.183(a): Documentation of MRO qualifications | 23.0 | 1.0 | 23.0 | 28.0 | 1.0 | 28.0 | 5.0 | |
| 26.183(c)(1): MRO review of records for positive, adulterated, substituted, invalid, or, at the licensees or other entity's discretion, dilute test results | Burden covered by 26.185(a) | Burden accounted for under section 26.185(a) | - | |||||
| 26.183(d)(2)(i): Record of MRO staff review and reporting of negative test results | 101,986.0 | 0.1 | 5,099.3 | 16,383.0 | 0.1 | 819.2 | (4,280.2) | |
| 26.183(d)(2)(ii): Record of MRO staff review of CCF forms and forward changes to MRO | 635.0 | 0.1 | 63.5 | 54.0 | 0.1 | 5.4 | (58.1) | |
| 26.185(a) Record of MRO review of all positive, adulterated, substituted, or invalid test results and report to licensee or other entity | 635.0 | 1.0 | 635.0 | 635.0 | 1.0 | 635.0 | - | |
| 26.185(c): Record of MRO discussion of test results with the donor and record of report to licensee, following discussion with donor, of FFD violation | 635.0 | 1.0 | 635.0 | 635.0 | 1.0 | 635.0 | - | |
| 26.185(d)(1): Documentation that donor declined to discuss test results | 81.0 | 1.0 | 81.0 | 81.0 | 1.0 | 81.0 | - | |
| 26.185(e): Documentation that donor was unavoidably prevented from discussing test results and request to reopen proceeding | 8.0 | 1.0 | 8.0 | 8.0 | 1.0 | 8.0 | - | |
| 26.185(f)(1): MRO consultation with HHS lab to determine whether additional testing needed | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(f)(2): MRO contact with donor regarding medical explanation for test result | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(h)(1): MRO contact with donor to provide medical evidence regarding substituted specimen | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(h)(2): MRO notification to licensee that no valid medical explanation presented | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(h)(3): MRO notification to licensee that valid medical explanation presented | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(i)(1): MRO contact with donor to provide medical evidence regarding adulterated specimen | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(i)(2): MRO notification to licensee that no valid medical explanation presented | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(i)(3): MRO notification to licensee that valid medical explanation presented | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(j)(3): MRO notification to licensee where evidence of drug abuse | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(j)(3): MRO report to licensee that donor has violated FFD policy by use of another individual's prescription medication | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.185(k): MRO report to licensee that no FFD policy violation has occurred | 24.0 | 1.0 | 24.0 | 24.0 | 1.0 | 24.0 | - | |
| 26.185(m): MRO review of inspection and audit reports, quality control data, multiple specimens, and other data to determine if positive, adulterated, substituted, or invalid result is scientifically insufficient for determination of FFD policy violation | 24.0 | 1.0 | 24.0 | 24.0 | 1.0 | 24.0 | - | |
| 26.185(n): Record of MRO report to licensee on result of analysis by second laboratory | 64.0 | 1.0 | 64.0 | 54.0 | 1.0 | 54.0 | (10.0) | |
| 26.185(o): Record of MRO request for quantitation of test results | 8.0 | 0.5 | 4.0 | 8.0 | 0.5 | 4.0 | - | |
| 26.185(o): Lab provides quantitation of test results | 8.0 | 1.0 | 8.0 | 8.0 | 1.0 | 8.0 | - | |
| 26.185(p): MRO notice to licensee of determination of FFD policy violation | Burden covered by 26.185(c) | Burden accounted for under section 26.185(c) | - | |||||
| 26.187(d): SAE training requirements | 24.0 | 20.0 | 480.0 | 24.0 | 20.0 | 480.0 | - | |
| 26.187(f): Documentation of SAE credentials and training | 24.0 | 1.0 | 24.0 | 24.0 | 1.0 | 24.0 | - | |
| 26.189(a): Written record of determination of fitness | 245.0 | 0.5 | 122.5 | 69.0 | 1.0 | 69.0 | (53.5) | |
| 26.189(c): Written record of a For-cause determination of fitness | 76.0 | 1.0 | 76.0 | 6.9 | 1.0 | 6.9 | (69.1) | |
| 26.189(d): Modification of an initial determination of fitness based on information from other sources | 24.0 | 1.0 | 24.0 | 24.0 | 1.0 | 24.0 | - | |
| 26.209(a): Persons must self declare whether they are fatigued | 23.0 | 0.3 | 6.9 | 6.9 | ||||
| 26.405(g): MRO report of positive, adulterated, substituted, and invalid drug test results | - | 1.0 | - | 90.0 | 1.0 | 90.0 | 90.0 | |
| 26.411(b): Obtain signed consent form | 2,000.0 | 0.3 | 600.0 | 4,675.0 | 0.3 | 1,402.5 | 802.5 | |
| 26.719(c): Respond to a request for information associated with a 30-day event report due to a LTF or HHS-certified laboratory testing error | 6.0 | 8.0 | 48.0 | 48.0 | ||||
| 26.821(b): Written agreement between C/Vs and licensees to permit authorized NRC representatives to inspect, copy, or take away copies of C/V’s documents, records, and reports | 5.0 | 4.0 | 20.0 | 5.0 | 4.0 | 20.0 | - | |
| Table 4 Total | 521,756.0 | 301,855.6 | 410,999.9 | 303,559.1 | 1,703.5 | 1,703.5 | ||
| Reason for Change in Burden or Cost Table | ||||
| Table | Description | Clearance Period | Difference between the 2011-2014 and 2014-2017 Collections (hours) | |
| 2011-2014 (hours) |
2014-2017 (hours) |
|||
| 1 | One-Time Recordkeeping | 6,720.4 | 41.4 | -6,679.0 |
| 2 | Recordkeeping | 351,889.6 | 314,177.4 | -37,712.2 |
| 3 | Reporting | 6,615.0 | 6,165.2 | -449.8 |
| 4 | Third Party Disclosure | 301,855.6 | 303,559.1 | 1,703.5 |
| TOTAL | 667,080.6 | 623,943.1 | -43,137.5 | |
| Estimate of Industry Burden and Costs | |||||||
| Table | Description | Responses | Burden Hours |
Cost at $272/hr |
|||
| 1 | One-Time Recordkeeping* | - | 41.4 | $11,261 | |||
| 2 | Recordkeeping | 65.0 | 314,177.4 | $85,456,253 | 314,218.8 | ||
| 3 | Reporting | 226.1 | 6,165.2 | $1,676,934 | |||
| 4 | Third Party Disclosure | 410,999.9 | 303,559.1 | $82,568,062 | |||
| TOTAL | 411,291.0 | 623,943.1 | $169,712,510 | ||||
| *All one-time recordkeepers are also annual recordkeepers and are included in the recordkeeping responses total. | |||||||
| File Type | application/vnd.openxmlformats-officedocument.spreadsheetml.sheet |
| File Modified | 0000-00-00 |
| File Created | 0000-00-00 |