ML23136B177
| ML23136B177 | |
| Person / Time | |
|---|---|
| Issue date: | 05/16/2023 |
| From: | NRC/NMSS/DMSST/MSEB |
| To: | |
| S Spence | |
| References | |
| OMB 3150-0010 | |
| Download: ML23136B177 (1) | |
Text
Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)
Burden per Number of Responses Per Total Number Total Annual Cost @
Section Description Response Respondents Respondent of Responses Burden (Hours) $290/Hr (Hours)
Research application information needed if the research is conducted, funded, 35.6(b) 61 1 61 4 244 $ 70,760 supported, or regulated by another Federal agency.
Research application information needed for ammendment to NRC medical use license, 35.6(c) if the research is not conducted, 6 1 6 4 24 $ 6,960 funded,supported or regulated by another Federal agency.
35.12(b), (c), &
OMB Clearance 3150-0120 (d) 35.13 OMB Clearance 3150-0120 Describes the requirements that need to be satisfied to notify the Commission, to function as an authorized user (AU),
35.14(a) & (b) 105 2 210 0.25 52.5 $ 15,225 authorized medical physicist (AMP),
ophthalmic physicist (OP), or authorized nuclear pharmacist (ANP).
Requires a licensee to notify the 35.14(b)(1) Commission within 30 days of when an 48 1 48 0.25 12 $ 3,480 ARSO discontinues performance of duties under the license or has a name change.
Requires a licensee to notify the NRC if it 35.14(b)(6) receives certain sealed sources without first 464 2 928 0.25 232 $ 67,280 obtaining a license amendment.
Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)
Burden per Number of Responses Per Total Number Total Annual Cost @
Section Description Response Respondents Respondent of Responses Burden (Hours) $290/Hr (Hours)
Provides that upon application of any interested person or upon its own initiative, the Commission may grant exemptions from 35.19 the regulations in Part 35 that it determines 4 1 4 1 4 $ 1,160 are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
Provides that a licensee may permit an individual qualified to be a RSO, to function 35.24(c) 5 1 5 1 5 $ 1,450 as a temporary RSO and to perform the functions of a RSO.
Requires licensees to file a report with the NRC within 5 days in accordance with § 35.67(e)(2) Burden covered in 35.3067 35.3067 if leakage of a sealed source is detected.
35.204(e) Burden covered in 35.3204(a) & (b)
Requires that the licensee promptly notify the RSO, or his or her designee, and the AU 35.315(b) 2 1 2 1 2 $ 580 as soon as possible if the patient has a medical emergency or dies.
Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)
Burden per Number of Responses Per Total Number Total Annual Cost @
Section Description Response Respondents Respondent of Responses Burden (Hours) $290/Hr (Hours)
Requires that the licensee notify the RSO, 35.415(c) or his or her designee, and AU as soon as 8 1 8 1 8 $ 2,320 possible if the patient or human research subject has a medical emergency or dies.
Requires a licensee to notify the RSO, or his/her designee, and an AU as soon as possible if the patient or human research subject has a medical emergency or dies.
35.615(f)(4) 15 1 15 1 15 $ 4,350 This notification is required so that the RSO, or his/her designee, or AU can take whatever actions are necessary for radiation safety.
Requires that the AMP review the results of 35.642(c) each spot-check and notify the licensee in 1 12 12 0.25 3 $ 870 writing of the results of each spot checks.
With regards to periodic spot-checks for remote afterloader units this section requires licensees to have the AMP review the results of each spot-check required by 35.643(c) 144 155 22320 0.25 5580 $ 1,618,200 paragraph (a) within 15 days of the check and to notify the licensee as soon as possible in writing of the results of each spot check.
Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit within 15 days 35.645(b)(2) 15 260 3900 0.25 975 $ 282,750 of each spot-check and to notify the licensee as soon as possible in writing the results of each spot-check.
Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)
Burden per Number of Responses Per Total Number Total Annual Cost @
Section Description Response Respondents Respondent of Responses Burden (Hours) $290/Hr (Hours) 35.1000() OMB Clearance 3150-0120 35.3045(a) & (b) Burden covered in 35.3045(c) & (d)
Requires licensees to notify the NRC by 35.3045(c) telephone no later than the next calendar 5 1 5 0.5 2.5 $ 725 day after discovery of the medical event.
Requires licensees to submit a written 35.3045(d) report to NRC within 15 days of the 5 1 5 8 40 $ 11,600 discovery of the medical event.
Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)
Burden per Number of Responses Per Total Number Total Annual Cost @
Section Description Response Respondents Respondent of Responses Burden (Hours) $290/Hr (Hours)
Requires the licensee to: (1) annotate a copy of the medical event report provided to 35.3045(g) 5 1 5 0.5 2.5 $ 725 the NRC with spicific infromation outlined in thi section.
35.3047(a) & (b) Burden covered in 35.3047(c) & (d)
Requires the licensee to notify by telephone the NRC Operation Center no later than the 35.3047(c) next calendar day after discovery of a dose 1 1 1 0.5 0.5 $ 145 to the embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).
Requires the licensee to submit a written report to the appropriate NRC Regional Office no later than 15 days after discovery 35.3047(d) 1 1 1 8 8 $ 2,320 of a dose to the embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).
Requires the licensee to notify the referring physician and also notify the pregnant individual or mother (both hereafter referred 35.3047(e) to as the mother) no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 1 1 1 2 2 $ 580 after discovery of an event that would require reporting under paragraph § 35.3047(a) or (b).
Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)
Burden per Number of Responses Per Total Number Total Annual Cost @
Section Description Response Respondents Respondent of Responses Burden (Hours) $290/Hr (Hours)
Requires the licensee to: (1) annotate a copy of the report provided to the NRC with the: (a) name of the pregnant individual or 35.3047(f) the nursing child who is the subject of the 1 1 1 0.5 0.5 $ 145 event; and (b) social security number or other identification number, if one has been assigned.
This section requires licensees to report detection of a leaking source by submitting a written report within 5 days after a leakage 35.3067 1 1 1 1 1 $ 290 test required by § 35.67 reveal the presence of 185 Bq (0.005 microcurie) or more of removable contamination.
Requires radiopharmacy and medical use licensees to notify both the NRC Operations 35.3204(a) Center and the distributor of the generator 1 1 1 0.25 1 $ 290 by telephone within 7 days after discovery that an eluate exceeds the permissible concentration listed in § 35.204(a).
Requires radiopharmacy and medical use licensees to submit a written report to the appropriate NRC Regional Office listed in § 35.3204(b) 1 1 1 2.00 1 $ 290 30.6 within 30 days after discovery of an eluate exceeding the permissible concentration listed in § 35.204(a).
Total 27,541 7,216 $ 2,092,495
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Approval in writing by 35.24(a) management of other 862 5 0.50 2,155.00 $ 624,950 5 years administrative changes.
Appointment of associate RSOs 35.24(b) 89 2 0.25 44.50 $ 12,905 in writing.
Authority, duties, and 35.24(e) responsibilities of the RSO in Burden covered in 35.2024 writing.
Requirement to establish a Radiation Safety Committee to 35.24(f) 227 1 0.50 113.50 $ 32,915 Industry practice oversee the radiation protection programs.
Requires that a licensee record and retain actions taken pursuant 35.24(h) to the authority and Burden covered in 35.2024 responsibilities within the radiation protection program.
Requires the revision has been reviewed and approved by the Radiation Safety Officer and 35.26(a)(3)&(4) licensee management; and the 862 1 0.50 431.00 $ 124,990 5 years affected individuals are instructed on the revised program before the changes are implemented.
Requires a record of each change 35.26(b) to be retained in accordance with Burden covered in 35.2026 35.2026.
Requires a licensee that permits the receipt, possession, use, or 35.27(a) transfer of byproduct material by 862 1 1 862 $ 249,980 an individual under the supervision of an AU as allowed by § 35.11(b).
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR A licensee that permits the preparation of byproduct material for medical use by an individual 35.27(b) under the supervision of an 162 1 1.00 162.00 $ 46,980 authorized nuclear pharmacist or physician who is an authorized user.
Requires the information in the oral directive to be documented as soon as possible in writing in 35.40(a)(1) 425 7 0.25 743.75 $ 215,688 3 years the patients record and a written directive must be prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral directive.
Permits a written revision to an existing written directive if the 35.40(c)(1) revision is dated and signed by an 425 10 0.25 1062.50 $ 308,125 3 years AU before the administration or the next fractional dose.
Requires the licensee to retain a 35.40(d) copy of the written directive in Burden covered in 35.2040 accordance with § 35.2040.
Requires licensees to develop, implement and maintain written procedures for any administration requiring a written directive to provide high confidence that the 35.41(a)&(b) patient or human research 474 1 0.50 237.00 $ 68,730 Duration of license subject's identity is verified prior to each administration and that each administration is in accordance with the written directive (WD).
35.41(c) Burden covered in 35.2041
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR 35.50(a) 35.50(b)(2) OMB Clearance 3150-0120 35.51(a) 35.51(b)(2) 35.55(a) 35.55(b)(2) 35.60(c) Burden covered in 35.2060 Requires that the licensee conspicuously note on a survey instrument the date that the 35.61(a)(3) instrument was calibrated. This 862 1 0.03 25.86 $ 7,499 Equipment duration information is necessary to show that survey instruments are calibrated and operational.
35.61(c) Burden covered in 35.2061 35.63(e) Burden covered in 35.2063 Prohibits the bundling or aggregating of single sealed sources to create a sealed source Inventory and leak 35.65(b)(2) 2 2 2.50 5.00 $1,390 with an activity greater than the testing 3 years maximum activity authorized by
§ 35.65.
35.67(a) Burden covered in 35.2067 35.67 (d) Burden covered in 35.2067
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires that each syringe and vial that contains unsealed byproduct material must be labeled, and that each syringe 35.69 776 2126 0.02 32,995.52 $ 9,568,701 Equipment duration shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.
35.70(c) Burden covered in 35.2070 35.75(c) Burden covered in 35.2075(a) 35.75(d) Burden covered in 35.2075(b)
Requires a licensee providing mobile service to obtain a letter signed by the management of each client that permits the use of 3 years after last 35.80(a)(1) 25 20 1.00 500.00 $ 145,000 byproduct material at the client's service address and delineates the authority and responsibility of the licensee and the client.
35.80(c) Burden covered in 35.2080 35.92(b) Burden covered in 35.2092 35.190(c)(2)
OMB Clearance 3150-0120 35.190(a)
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR 35.204(d) Burden covered in 35.2204 35.290(a)
OMB Clearance 3150-0120 35.290(c)(2)
Requires that licensees provide safety instruction, initially and at least annually, to personnel caring for patients or human research 35.310(a) 22 1 1.00 22 $ 6,380 Annual subjects that have received therapy with unsealed byproduct material and cannot be released in accordance with § 35.75.
35.310(b) Burden covered in 35.2310 Requires a licensee to note on the door or in the patient's chart indicating where and how long visitors may stay in the patient's 35.315(a)(3) 22 12 0.10 26.4 $ 7,656 Duration of treatment room. This posting and note are required so that employees and visitors receive information necessary for radiation safety.
35.390(a) 35.390(b)(2) 35.392(a) 35.392(c)(3)
OMB Clearance 3150-0120 35.394(a) 35.394(c)(3)
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR 35.396 (c) 35.396 (d) 35.404(c) Burden covered in 35.2404 35.406(c) Burden covered in 35.2406 Requires licensees to provide safety instruction, initially and at least annually, to personnel caring 35.410(a) for patients or human research 43 1 1.00 43 $ 12,470 subjects that are receiving brachytherapy and cannot be released in accordance with § 35.75.
35.67(a) Burden covered in 35.2067 35.410(b) Burden covered in 35.2310 Requires a note on the door or in the patient's or human research subject's chart where and how 35.415(a)(3) 43 5 0.10 21.5 $ 6,235 Duration of treatment long visitors may stay in the patient's or human research subject's room.
35.432(d) Burden covered in 35.2432 35.433(b) Burden covered in 35.2433 35.490(a) 35.490(b)(3)
OMB Clearance 3150-0120
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR OMB Clearance 3150-0120 35.491 (c) 35.590(a) 35.604(b) Burden covered in 35.2404 35.605(d) Burden covered in 35.2605 Requires licensees to develop, implement, and maintain written 35.610(a)(4) 160 1 1.00 160.00 $ 46,400 Possession of unit procedures for responding to an abnormal situation.
Requires licensees to physically 35.610(b) locate a copy of the procedures at 160 1 0.03 4.80 $ 1,392 Possession of unit the unit console.
Requires licensees to post instructions for individuals who operate the devices at the device 35.610(c) 160 1 0.50 80.00 $ 23,200 Possession of unit console providing the location of the procedures and emergency names and telephone numbers.
Requires all individuals who will operate remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units to receive vendor operational and 35.610(d)(1) safety training prior to the first use 160 1 1.00 160.00 $ 46,400 Possession of unit for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit.
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires licensees to provide initial instruction and annual refresher instruction to all 35.610(d)(2) individuals who operate the unit in 160 1 1.00 160.00 $ 46,400 Possession of unit the procedures identified in § 35.610(a) and the operating procedures for the unit.
Requires licensees to ensure that operators, AMPs, and AUs 35.610(e) participate in drills of the 160 1 0.50 80.00 $ 23,200 emergency procedures, initially and at least annually.
35.610(f) Burden covered in 35.2310 35.610(g) Burden covered in 35.2610 35.630(c) Burden covered in 35.2630 35.632(g) Burden covered in 35.2632 35.633(i) Burden covered in 35.2632 36.635(g) Burden covered in 35.2632 Requires licensees to perform spot check measurements in 35.642(b) accordance with written 1 1 4.00 4.00 $ 1,160 Possession of unit procedures established by the AMP.
Requires that the AMP review the results of each spot-check and 35.642(c) 1 12 0.25 3.00 $ 870 3 years notify the licensee in writing of the results of each spot checks.
35.642(f) Burden covered in 35.2642
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires licensees to perform spot check measurements in 35.643(b) accordance with written 144 1 4.00 576.00 $ 167,040 Possession of unit procedures established by the AMP.
Requires licensees to have the AMP review the results of each spot-check required by paragraph 35.643(c) (a) within 15 days of the check 144 155 0.25 5580.00 $ 1,618,200 3 years and to notify the licensee as soon as possible in writing of the results of each spot check.
35.643(f) Burden covered in 35.2643 Requires licensees to perform spot-check measurements in 35.645(b)(1) accordance with written 15 1 4.00 60.00 $ 17,400 Possession of unit procedures established by the AMP.
Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit 35.645(b)(2) 15 260 0.25 975.00 $ 282,750 3 years within 15 days of each spot-check and to notify the licensee as soon as possible in writing the results of each spot-check.
35.645(g) Burden covered in 35.2645 35.647(e) Burden covered in 35.2647 35.652(c) Burden covered in 35.2652 35.655(c) Burden covered in 35.2655
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR 35.690(a)
OMB Clearance 3150-0120 35.690(b)(3)
Requires licensees to retain a record of actions taken by the 35.2024(a) licensees management in 862 5 0.25 1,077.50 $ 312,475 5 years accordance with § 35.24(a) for 5 years.
Requires licensees to retain a 35.2024(b) copy of both the authority, duties, 862 2 0.10 172.40 $ 49,996 Duration of license and responsibilities of the RSO Requires the licensee to keep the written documents signed by the licensees management for each 5 years after ARSO is 35.2024(c) 88 1 1.00 88.00 $ 25,520 ARSO appointed under § 35.24(b) removed from license for 5 years after the ARSO is removed from the license.
Requires licensees to retain a record of each radiation protection 35.2026 program change made in 862 1 0.25 215.50 $ 62,495 5 years accordance with § 35.26(a) for 5 years.
Requires licensees to retain a 35.2040 () 425 104 0.05 2,210.00 $ 640,900 3 years copy of each written directive.
Requires licensees to retain a copy of the procedures for 35.2041 425 1 0.05 21.25 $ 6,163 Duration of license administrations requiring a written directive Requires licensees to maintain a 35.2060() record of instrument calibrations 161 255 0.02 821.10 $ 238,119 3 years required by § 35.60 for 3 years.
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires licensees to maintain a record of radiation survey 35.2061 862 1.5 0.25 323.25 $ 93,743 3 years instrument calibrations required by § 35.61 for 3 years.
Requires licensees to maintain a 35.2063 record of dosage determinations 776 2126 0.02 32,995.52 $ 9,568,701 3 years required by § 35.63 for 3 years.
Requires licensees to retain 35.2067(a) records of leak tests required by 862 3 0.06 155.16 $ 44,996 3 years 35.67 (b) for 3 years.
Requires that licensees retain records of the semi-annual physical inventory of sealed 35.2067(b) 862 2 0.06 103.44 $ 29,998 3 years sources and brachytherapy sources required by § 35.67(g) for 3 years.
Requires a licensee to retain a 35.2070() record of each survey required by 300 43 0.02 258.00 $ 74,820 3 years
§ 35.70 for 3 years.
Requires licensees to retain a record of the basis for authorizing 35.2075(a) 425 14 0.25 1,487.50 $ 431,375 3 years the release of an individual in accordance with § 35.75.
Requires licensees to retain a record that the instructions required by § 35.75(b) were provided to a breast-feeding 35.2075(b) female if the radiation dose to the 425 2 0.20 170.00 $ 49,300 3 years infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisievert (0.5 rem).
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires licensees providing mobile medical services to retain a copy of each letter that permits 3 years after last 35.2080(a) 25 20 0.03 15.00 $ 4,350 the use of byproduct material at a service clients address, as required by
§ 35.80(a) (1).
Requires licensees to maintain a 35.2080(b) record of each survey required by 25 260 0.10 650.00 $ 188,500 3 years
§ 35.80(a) (4) for 3 years.
Requires licensees to retain records of the disposal of licensed 35.2092 862 52 0.02 896.48 $ 259,979 3 years materials, as required by § 35.92 for 3 years.
Requires licensees to maintain records of molybdenum-99, 35.2204 strontium-82, and strontium-85 40 108 0.08 345.60 $ 100,224 3 years concentration tests required by § 35.204(b) for 3 years.
Requires licensees to maintain a record of safety instructions required by §§ 35.310 and 35.410 35.2310 225 1 0.10 22.50 $ 6,525 3 years and the operational and safety instructions required by § 35.610 for 3 years.
Requires licensees to maintain a 35.2404 record of the surveys required by 215 97 0.02 417.10 $ 120,959 3 years
§§ 35.404 and 35.604 for 3 years.
Requires licensees to maintain 35.2406 95 15 0.20 285.00 $ 82,650 3 years records of brachytherapy source accountability required by § 35.406 for 3 years.
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires licensees to maintain a record of calibrations of 35.2432 brachytherapy sources required 95 15 0.20 285.00 $ 82,650 3 years by § 35.432 for 3 years after the last use of the source.
Requires licensees to maintain a record of the activity of a 35.2433 12 70 0.50 420.00 $ 121,800 Life of source strontium-90 source required by § 35.433 for the life of the source.
Requires licensees to retain records of installation, maintenance, adjustment, and 35.2605 repair of remote afterloader units, 160 5 2.00 1,600.00 $ 464,000 3 years teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years.
Requires licensees to maintain records of procedures required by§ 35.610(a) (4) and (d) (2) until 35.2610() the licensee no longer possesses 160 2 0.05 16.00 $ 4,640 Possession of unit the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.
Requires licensees to retain a record of the calibration, intercomparison, and 35.2630() comparisons of its dosimetry 163 1 0.50 81.50 $ 23,635 3 years equipment done in accordance with § 35.630 for the duration of the license.
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires licensees to maintain records of the teletherapy unit, remote afterloader unit, and 35.2632 gamma stereotactic radiosurgery 160 4.6 4.00 2,944.00 $ 853,760 3 years unit full calibrations required by §§ 35.632, 35.633, and 35.635 for 3 years.
Requires licensees to retain a record of each periodic spot-35.2642(a) 1 12 0.50 6.00 $ 1,740 3 years check for teletherapy units required by § 35.642 for 3 years.
Requires licensees to retain a copy of the written procedures for 35.2642(c) periodic spot-checks for 1 1 0.05 0.05 $ 15 Possession of unit teletherapy units established by the AMP.
Requires licensees to retain records of each spot-check for 35.2643(a) 125 155 1.00 19,375.00 $ 5,618,750 3 years remote afterloader units required by §§ 35.643 for 3 years.
Requires licensees to retain a copy of the written procedures for 35.2643(c) periodic spot-checks for remote 125 1 0.05 6.25 $ 1,813 Possession of unit afterloader units established by the AMP.
Requires licensees to retain records of each spot-check for 35.2645(a) gamma stereotactic radiosurgery 15 260 2.00 7,800.00 $ 2,262,000 3 years units required by § 35.645 for 3 years.
Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)
No of Records per Burden per Total Annual Cost @
Section Description Record Retention Recordkeepers Licensee record Burden $290/HR Requires licensees to retain a copy of the written procedures for 35.2645(c) periodic spot-checks for gamma 15 1 0.05 0.75 $ 218 Possession of unit stereotactic radiosurgery units established by the AMP.
Requires licensees to retain records of each check for mobile 35.2647 1 260 0.50 130.00 $ 37,700 3 years remote afterloader units required by § 35.647 for 3 years.
Requires licensees to maintain records of radiation surveys of 35.2652 treatment units made in 160 1 0.50 80.00 $ 23,200 Duration of use of unit accordance with § 35.652 for the duration of use of the unit.
Requires licensees to maintain a record of the 5-year inspections for teletherapy and gamma 35.2655 16 0.2 1.00 3.20 $ 928 Duration of use of unit stereotactic radiosurgery units required by § 35.655 for the duration of use of the unit.
Total 862 122,771.38 $ 35,603,700
Table 3 - Annual Third Party Disclosure Requirements NRC Licensees (3150-0010)
Total Number of Responses Total Burden per Annual Cost @
Section Description Respondent Per Number of Response Burden $290/Hr s Respondent Responses (Hours)
(Hours)
Requires licensees to provide an individual who has been administered unsealed byproduct material or implants containing byproduct material and who is being released from the licensee's control in accordance with § 35.75(b) 425 20 8500 0.17 1445 $ 419,050 35.75(a) with instructions on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem).
Notification of medical event to the referring physician and individual 35.3045(e) 5 2 10 2 20 $ 5,800 who is the subject of the medical event within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />
Table 3 - Annual Third Party Disclosure Requirements NRC Licensees (3150-0010)
Requires radiopharmacy and medical use licensees to notify both the NRC Operations Center and the distributor of the generator by 35.3204(a) 1 1 1 0.25 0.25 $ 73 telephone within 7 days after discovery that an eluate exceeds the permissible concentration listed in
§ 35.204(a).
Total 8511 1465.25 $ 424,923
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)
Description Number of Responses Burden per Total Annual Cost @
Section Per Total Responses Response Burden
$290/HR Respondents Respondent (Hours) (Hours)
Research application information needed if the research is conducted, 35.6(b) 458 1 458 4 1,832 $ 531,280 funded, supported, or regulated by another Federal agency.
Provides the criteria needed in amendment request if the research will not be conducted, funded, 35.6(c) 45 1 45 4 180 $ 52,200 supported, or regulated by another Federal agency that has implemented the Federal Policy.
35.12(b), (c), &
(d) OMB Clearance 3150-0120 35.13 Describes the requirements that need to be satisfied to notify the Commission, to function as an 35.14(a) & (b) authorized user (AU), authorized 788 2 1576 0.25 394 $ 114,260 medical physicist (AMP), ophthalmic physicist (OP), or authorized nuclear pharmacist (ANP).
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)
Requires a licensee to notify the Commission within 30 days of when 35.14(b)(1) an ARSO discontinues performance 360 1 360 0.25 90.00 $ 26,100 of duties under the license or has a name change.
Requires a licensee to notify the NRC if it receives certain sealed 35.14(b)(6) 3480 2 6,960 0.25 1,740.00 $ 504,600 sources without first obtaining a license amendment.
Provides that upon application of any interested person or upon its own initiative, the Commission may grant 35.19 exemptions from the regulations in 30 1 30 1 30 $ 8,700 Part 35 that it determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.
Provides that a licensee may permit an individual qualified to be a RSO, 35.24(c) 38 1 38 1 38 $ 11,020 to function as a temporary RSO and to perform the functions of a RSO.
Requires licensees to file a report with the NRC within 5 days in 35.67(e)(2) accordance with § 35.3067 if Burden covered in 35.3067 leakage of a sealed source is detected.
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010) 35.204(e) Burden covered in 35.3204(a) & (b)
Requires that the licensee promptly notify the RSO, or his or her 35.315(b) designee, and the AU as soon as 15 1 15 1 15 $ 4,350 possible if the patient has a medical emergency or dies.
Requires that the licensee notify the RSO, or his or her designee, and AU 35.415(c) as soon as possible if the patient or 60 1 60 1 60 $ 17,400 human research subject has a medical emergency or dies.
Requires a licensee to notify the RSO, or his/her designee, and an AU as soon as possible if the patient or human research subject has a 35.615(f)(4) medical emergency or dies. This 113 1 113 1 113 $ 32,770 notification is required so that the RSO, or his/her designee, or AU can take whatever actions are necessary for radiation safety.
Requires that the AMP review the results of each spot-check and notify 35.642(c) 8 12 96 0.25 24 $ 6,960 the licensee in writing of the results of each spot checks.
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)
With regards to periodic spot-checks for remote afterloader units this section requires licensees to have the AMP review the results of each 35.643(c) spot-check required by paragraph 1080 155 167400 0.25 41,850 $ 12,136,500 (a) within 15 days of the check and to notify the licensee as soon as possible in writing of the results of each spot check.
Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit within 15 days of 35.645(b)(2) 113 260 29380 0.25 7,345 $ 2,130,050 each spot-check and to notify the licensee as soon as possible in writing the results of each spot-check.
35.1000() OMB Clearance 3150-0120 35.3045(a) & (b) Burden covered in 35.3045(c)(d)&(e)
Requires licensees to notify the NRC by telephone no later than the next 35.3045(c) 52 1 52 0.5 26 $ 7,540 calendar day after discovery of the medical event.
Requires licensees to submit a written report to NRC within 15 days 35.3045(d) 52 1 52 8 416 $ 120,640 of the discovery of the medical event.
Requires the licensee to: (1) annotate a copy of the medical event 35.3045(g) report provided to the NRC with 38 1 38 0.5 19 $ 5,510 spicific infromation outlined in thi section.
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010) 35.3047(a) & (b) Burden covered in 35.3047(c) & (d)
Requires the licensee to notify by telephone the NRC Operation Center no later than the next 35.3047(c) calendar day after discovery of a 8 1 8 0.5 4 $ 1,160 dose to the embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).
Requires the licensee to submit a written report to the appropriate NRC Regional Office no later than 15 35.3047(d) days after discovery of a dose to the 8 1 8 8 64 $ 18,560 embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).
Requires the licensee to notify the referring physician and also notify the pregnant individual or mother (both hereafter referred to as the 35.3047(e) 8 1 8 2 16 $ 4,640 mother) no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery of an event that would require reporting under paragraph § 35.3047(a) or (b).
Requires the licensee to annotate a copy of the report provided to the 35.3047(f) 8 1 8 0.5 4 $ 1,160 NRC with specific details of the affected individual.
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)
Requires licensees to report detection of a leaking source by submitting a written report within 5 35.3067 days after a leakage test required by 8 1 8 1 8 $ 2,320
§ 35.67 reveal the presence of 185 Bq (0.005 microcurie) or more of removable contamination.
Requires radiopharmacy and medical use licensees to notify both the NRC Operations Center and the distributor of the generator by 35.3204(a) 8 1 8 0.25 2.00 $ 580 telephone within 7 days after discovery that an eluate exceeds the permissible concentration listed in
§ 35.204(a).
Requires radiopharmacy and medical use licensees to submit a written report to the appropriate NRC 35.3204(b) Regional Office listed in § 30.6 within 8 1 8 2.00 16.00 $ 4,640 30 days after discovery of an eluate exceeding the permissible concentration listed in § 35.204(a).
Total 206,729 54,286 $ 15,742,940
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention Approval in writing by management of 35.24(a) 6465 5 0.50 16,162.50 $ 4,687,125 5 years other administrative changes.
Appointment of associate RSOs in 35.24(b) 668 2 0.25 334.00 $ 96,860 writing.
Authority, duties, and responsibilities of 35.24(e) Burden covered in 35.2024 the RSO in writing.
Requirement to establish a Radiation 35.24(f) Safety Committee to oversee the 1703 1 0.50 851.50 $ 246,935 Industry practice radiation protection programs.
Requires that a licensee record and retain actions taken pursuant to the 35.24(h) Burden covered in 35.2024 authority and responsibilities within the radiation protection program.
Requires the revision has been reviewed and approved by the Radiation Safety Officer and licensee 35.26(a)(3)&(4) management; and the affected 6465 1 0.50 3,232.50 $ 937,425 5 years individuals are instructed on the revised program before the changes are implemented.
Requires a record of each change to be 35.26(b) Burden covered in 35.2026 retained in accordance with 35.2026.
Requires a licensee that permits the receipt, possession, use, or transfer of 35.27(a) byproduct material by an individual 6163 1 1.00 6,163.00 $ 1,787,270 under the supervision of an AU as allowed by § 35.11(b).
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention A licensee that permits the preparation of byproduct material for medical use by 35.27(b) an individual under the supervision of an 1215 1 1.00 1,215.00 $ 352,350 authorized nuclear pharmacist or physician who is an authorized user.
Requires the information in the oral directive to be documented as soon as 35.40(a)(1) possible in writing in the patients record 3188 7 0.25 5,579.00 $ 1,617,910 3 years and a written directive must be prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral directive.
Permits a written revision to an existing written directive if the revision is dated 35.40(c)(1) and signed by an AU before the 3188 10 0.25 7,970.00 $ 2,311,300 3 years administration or the next fractional dose.
Requires the licensee to retain a copy of 35.40(d) the written directive in accordance with Burden covered in 35.2040
§ 35.2040.
Requires licensees to develop, implement and maintain written procedures for any administration requiring a written directive to provide high confidence that the patient or Duration of 35.41(a)&(b) 3555 1 0.50 1,777.50 $ 515,475 human research subject's identity is license verified prior to each administration and that each administration is in accordance with the written directive (WD).
35.41(c) Burden covered in 35.2041 35.50(a) 35.50(b)(2) 35.51(a) OMB Clearance 3150-0120 35.51(b)(2)
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention 35.55(a) 35.55(b)(2) 35.60(c) Burden covered in 35.2060 Requires that the licensee conspicuously note on a survey instrument the date that the instrument Equipment 35.61(a)(3) was calibrated. This information is 6465 1 0.03 193.95 $ 56,246 duration necessary to show that survey instruments are calibrated and operational.
35.61(c) Burden covered in 35.2061 35.63(e) Burden covered in 35.2063 Prohibits the bundling or aggregating of Inventory and single sealed sources to create a sealed 35.65(b)(2) 15 1 2.50 37.50 $10,875 leak testing 3 source with an activity greater than the years maximum activity authorized by § 35.65.
35.67(d) Burden covered in 35.2067 35.67(g) Burden covered in 35.2067 Requires that each syringe and vial that contains unsealed byproduct material must be labeled, and that each syringe Equipment 35.69 5820 2126 0.02 247,466.40 $ 71,765,256 shield and vial shield must also be duration labeled unless the label on the syringe or vial is visible when shielded.
35.70(c) Burden covered in 35.2070 35.75(c) Burden covered in 35.2075(a) 35.75(d) Burden covered in 35.2075(b)
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention Requires a licensee providing mobile service to obtain a letter signed by the management of each client that permits 3 years after 35.80(a)(1) the use of byproduct material at the 188 20 1.00 3,760.00 $ 1,090,400 last service client's address and delineates the authority and responsibility of the licensee and the client.
35.80(c) Burden covered in 35.2080 35.92(b) Burden covered in 35.2092 35.190(a)
OMB Clearance 3150-0120 35.190(c)(2) 35.204(b) Covered under 35.2204 35.204(c) Burden covered in 35.2204 35.290(a)
OMB Clearance 3150-0120 35.290(c)(2)
Requires that licensees provide safety instruction, initially and at least annually, to personnel caring for patients or 35.310(a) human research subjects that have 165 1 1.00 165.00 $ 47,850 Annual received therapy with unsealed byproduct material and cannot be released in accordance with § 35.75.
35.310(b) Burden covered in 35.2310 Requires a licensee to note on the door or in the patient's chart indicating where and how long visitors may stay in the Duration of 35.315(a)(3) patient's room. This posting and note 165 12 0.10 198.00 $ 57,420 treatment are required so that employees and visitors receive information necessary for radiation safety.
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention 35.390(a) 35.390(b)(2) 35.392(a) 35.392(c)(3) OMB Clearance 3150-0120 35.394(a) 35.394(c)(3) 35.396 (c) 35.396 (d) 35.404(c) Burden covered in 35.2404 35.406(c) Burden covered in 35.2406 Requires licensees to provide safety instruction, initially and at least annually, 35.410(a) to personnel caring for patients or 323 1 1.00 323.00 $ 93,670 human research subjects that are receiving brachytherapy and cannot be released in accordance with § 35.75.
35.410(b) Burden covered in 35.2310 Requires a note on the door or in the patient's or human research subject's Duration of 35.415(a)(3) chart where and how long visitors may 323 5 0.10 161.50 $ 46,835 treatment stay in the patient's or human research subject's room.
35.432(d) Burden covered in 35.2432 35.433(b) Burden covered in 35.2433 35.490(a) 35.490(b)(3) OMB Clearance 3150-0120 35.491 (c) 35.590(a) 35.604(b) Burden covered in 35.2404
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention 35.605(d) Burden covered in 35.2605 Requires licensees to develop, implement, and maintain written Possession of 35.610(a)(4) 1200 1 1.00 1200.00 $ 348,000 procedures for responding to an unit abnormal situation.
Requires licensees to physically locate Possession of 35.610(b) a copy of the procedures at the unit 1200 1 0.03 36.00 $ 10,440 unit console.
Requires licensees to post instructions for individuals who operate the devices at the device console providing the Possession of 35.610(c) 1200 1 0.50 600.00 $ 174,000 location of the procedures and unit emergency names and telephone numbers.
Requires all individuals who will operate remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units to receive vendor Possession of 35.610(d)(1) operational and safety training prior to 1200 1 1.00 1200.00 $ 348,000 unit the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit.
Requires licensees to provide initial instruction and annual refresher instruction to all individuals who operate Possession of 35.610(d)(2) 1200 1 1.00 1200.00 $ 348,000 the unit in the procedures identified in § unit 35.610(a) and the operating procedures for the unit.
Requires licensees to ensure that operators, AMPs, and AUs participate in 35.610(e) 1200 1 0.50 600.00 $ 174,000 drills of the emergency procedures, initially and at least annually.
35.610(f) Burden covered in 35.2310 35.610(g) Burden covered in 35.2610 35.630(c) Burden covered in 35.2630
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention 35.632(g) Burden covered in 35.2632 35.633(i) Burden covered in 35.2632 36.635(g) Burden covered in 35.2632 Requires licensees to perform spot check measurements in accordance Possession of 35.642(b) 8 1 4.00 32.00 $ 9,280 with written procedures established by unit the AMP.
Requires that the AMP review the results of each spot-check and notify the 35.642(c) 8 12 0.25 24.00 $ 6,960 3 years licensee in writing of the results of each spot checks.
35.642(f) Burden covered in 35.2642 Requires licensees to perform spot check measurements in accordance Possession of 35.643(b) 1080 1 4.00 4320.00 $ 1,252,800 with written procedures established by unit the AMP.
Requires licensees to have the AMP review the results of each spot-check required by paragraph (a) within 15 days 35.643(c) 1080 155 0.25 41850.00 $ 12,136,500 3 years of the check and to notify the licensee as soon as possible in writing of the results of each spot check.
35.643(f) Burden covered in 35.2643 Requires licensees to perform spot-check measurements in accordance Possession of 35.645(b)(1) 113 1 4.00 452.00 $ 131,080 with written procedures established by unit the AMP.
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit 35.645(b)(2) within 15 days of each spot-check and 113 260 0.25 7345.00 $ 2,130,050 3 years to notify the licensee as soon as possible in writing the results of each spot-check.
35.645(g) Burden covered in 35.2645 35.647(e) Burden covered in 35.2647 35.652(c) Burden covered in 35.2652 35.655(c) Burden covered in 35.2655 35.690(a)
OMB Clearance 3150-0120 35.690(b)(3)
Requires licensees to retain a record of actions taken by the licensees 35.2024(a) 6465 5 0.25 8081.25 $ 2,343,563 5 years management in accordance with § 35.24(a) for 5 years.
Requires licensees to retain a copy of Duration of 35.2024(b) both the authority, duties, and 6465 2 0.10 1293.00 $ 374,970 license responsibilities of the RSO Requires the licensee to keep the written documents signed by the 5 years after licensees management for each ARSO ARSO is 35.2024(c ) 660 2 1.00 1320.00 $ 382,800 appointed under § 35.24(b) for 5 years removed from after the ARSO is removed from the license license.
Requires licensees to retain a record of each radiation protection program 35.2026 6465 1 0.25 1616.25 $ 468,713 5 years change made in accordance with § 35.26(a) for 5 years.
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention Requires licensees to retain a copy of 35.2040() 3188 104 0.05 16577.60 $ 4,807,504 3 years each written directive.
Requires licensees to retain a copy of Duration of 35.2041 the procedures for administrations 3188 1 0.05 159.40 $ 46,226 license requiring a written directive Requires licensees to maintain a record 35.2060() of instrument calibrations required by 1208 255 0.02 6160.80 $ 1,786,632 3 years
§ 35.60 for 3 years.
Requires licensees to maintain a record of radiation survey instrument 35.2061 6465 1.5 0.25 2424.38 $ 703,069 3 years calibrations required by § 35.61 for 3 years.
Requires licensees to maintain a record 35.2063 of dosage determinations required by 5820 2126 0.02 247466.40 $ 71,765,256 3 years
§ 35.63 for 3 years.
Requires licensees to retain records of 35.2067(a) leak tests required by 35.67 (b) for 3 6465 3 0.06 1163.70 $ 337,473 3 years years.
Requires that licensees retain records of the semi-annual physical inventory of 35.2067(b) sealed sources and brachytherapy 6465 2 0.06 775.80 $ 224,982 3 years sources required by § 35.67(g) for 3 years.
Requires a licensee to retain a record of 35.2070() each survey required by § 35.70 for 3 2250 43 0.02 1935.00 $ 561,150 3 years years.
Requires licensees to retain a record of the basis for authorizing the release of 35.2075(a) 3188 14 0.25 11158.00 $ 3,235,820 3 years an individual in accordance with § 35.75.
Requires licensees to retain a record that the instructions required by
§ 35.75(b) were provided to a breast-feeding female if the radiation dose to 35.2075(b) 3188 2 0.20 1275.20 $ 369,808 3 years the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisievert (0.5 rem).
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention Requires licensees providing mobile medical services to retain a copy of 3 years after 35.2080(a) each letter that permits the use of 188 20 0.03 112.80 $ 32,712 last service byproduct material at a clients address, as required by § 35.80(a) (1).
Requires licensees to maintain a record 35.2080(b) of each survey required by § 35.80(a) 188 260 0.10 4888.00 $ 1,417,520 3 years (4) for 3 years.
Requires licensees to retain records of 35.2092 the disposal of licensed materials, as 6465 52 0.02 6723.60 $ 1,949,844 3 years required by § 35.92 for 3 years.
Requires licensees to maintain records 35.2204 of molybdenum-99 concentration tests 300 108 0.08 2592.00 $ 751,680 3 years required by § 35.204(b) for 3 years.
Requires licensees to maintain a record of safety instructions required by 35.2310 §§ 35.310 and 35.410 and the 1688 1 0.10 168.80 $ 48,952 3 years operational and safety instructions required by § 35.610 for 3 years.
Requires licensees to maintain a record 35.2404 of the surveys required by §§ 35.404 1613 61 0.02 1967.86 $ 570,679 3 years and 35.604 for 3 years.
Requires licensees to maintain records 35.2406 of brachytherapy source accountability 713 15 0.20 2139.00 $ 620,310 3 years required by § 35.406 for 3 years.
Requires licensees to maintain a record of calibrations of brachytherapy sources 35.2432 713 15 0.20 2139.00 $ 620,310 3 years required by § 35.432 for 3 years after the last use of the source.
Requires licensees to maintain a record of the activity of a strontium-90 source 35.2433 90 70 0.50 3150.00 $ 913,500 Life of source required by § 35.433 for the life of the source.
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention Requires licensees to retain records of installation, maintenance, adjustment, and repair of remote afterloader units, 35.2605 1200 5 2.00 12000.00 $ 3,480,000 3 years teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years.
Requires licensees to maintain records of procedures required by§ 35.610(a)
(4) and (d) (2) until the licensee no Possession of 35.2610() longer possesses the remote 1200 2 0.05 120.00 $ 34,800 unit afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.
Requires licensees to retain a record of the calibration, intercomparison, and 35.2630() comparisons of its dosimetry equipment 1223 1 0.50 611.50 $ 177,335 3 years done in accordance with § 35.630 for the duration of the license.
Requires licensees to retain a record of the calibration, intercomparison, and 35.2632 comparisons of its dosimetry equipment 1200 4.6 4.00 22080.00 $ 6,403,200 3 years done in accordance with § 35.630 for the duration of the license.
Requires licensees to maintain records of the teletherapy unit, remote afterloader unit, and gamma stereotactic 35.2642 (a) 8 12 0.50 48.00 $ 13,920 3 years radiosurgery unit full calibrations required by §§ 35.632, 35.633, and 35.635 for 3 years.
Requires licensees to retain a record of Possession of 35.2642 (c) each periodic spot-check for teletherapy 8 1 0.05 0.40 $ 116 unit units required by § 35.642 for 3 years.
Requires licensees to retain a copy of the written procedures for periodic spot-35.2643 (a) 938 155 1.00 145390.00 $ 42,163,100 3 years checks for teletherapy units established by the AMP.
Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $290/HR Licensee record Burden Retention Requires licensees to retain records of Possession of 35.2643 (c) each spot-check for remote afterloader 938 1 0.05 46.90 $ 13,601 unit units required by §§ 35.643 for 3 years.
Requires licensees to retain a copy of the written procedures for periodic spot-35.2645 (a) 113 260 2.00 58760.00 $ 17,040,400 3 years checks for remote afterloader units established by the AMP.
Requires licensees to retain a copy of the written procedures for periodic spot-Possession of 35.2645 (c) checks for gamma stereotactic 113 1 0.05 5.65 $ 1,639 unit radiosurgery units established by the AMP.
Requires licensees to retain records of each check for mobile remote 35.2647 8 260 0.50 1040.00 $ 301,600 3 years afterloader units required by § 35.647 for 3 years.
Requires licensees to maintain records of radiation surveys of treatment units Duration of use 35.2652 1200 1 0.50 600.00 $ 174,000 made in accordance with § 35.652 for of unit the duration of use of the unit.
Requires licensees to maintain a record of the 5-year inspections for teletherapy and gamma stereotactic Duration of use 35.2655 120 0.2 1.00 24.00 $ 6,960 radiosurgery units required by § of unit 35.655 for the duration of use of the unit.
Total 6465 920,464 $ 266,934,454
Table 7 - Annual Reporting Requirements AS Licensees (3150-0010)
Responses Total Number of Total Burden per Per Annual Section Description Responde Number of Response Cost @ $290/hr Responde Burden nts Responses (Hours) nt (Hours)
Requires licensees to provide an individual who has been administered unsealed byproduct material or implants containing byproduct material and who is being released from the licensee's control in accordance with § 35.75(a) with 35.75(b) 3188 20 63760 0.17 10,839 $ 3,143,368 instructions on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem).
Requires the licensee to notify the referring physician and the individual who is the subject of the medical event, or that individual's responsible relative 35.3045(e) 52 2 104 2 208 $ 60,320 or guardian, no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after its discovery, or as soon as possible, if the patient or the referring physician cannot be reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.
Table 7 - Annual Reporting Requirements AS Licensees (3150-0010)
Requires radiopharmacy and medical use licensees to notify both the NRC Operations Center and the distributor of the 35.3204(a) generator by telephone within 7 8 1 8 2 16 $ 4,640 days after discovery that an eluate exceeds the permissible concentration listed in
§ 35.204(a).
Total 63872 11,063 $ 3,208,328
Burden Responses Cost @ $290/hr NRC licensee reporting 7,216 27,541 $ 2,092,495 NRC licensee recordkeeping 122,771 862 $ 35,603,700 NRC third party 1,465 8,511 $ 424,923 AS reporting 54,286 206,729 $ 15,742,940 AS recordkeeping 920,464 6,465 $ 266,934,454 AS third party 11,063 63,872 $ 3,208,328 Specialty certifying entities 4 2 $ 1,160 Total 1,117,269 313,982 $ 324,008,000 Burden Responses Cost @ $290/hr NRC licensees TOTAL 131,452 36,914 $ 38,121,118 AS licensees TOTAL 985,813 277,066 $ 285,885,722 Specialty certifying entities 4 2 $ 1,160 TOTAL 1,117,269 313,982 $ 324,008,000 Part 35 Totals Burden Responses Cost @ $290/hr Reporting 61,506 234,272 $ 17,836,595 Recordkeeping 1,043,235 7,327 $ 302,538,154 Third Party Disclosure 12,528 72,383 $ 3,633,251 Total 1,117,269 313,982 $ 324,008,000 Part 35 Respondents NRC licensees 862 Agreement State licensees 6465 Specialty certifying entities 2 Total 7329 Other costs (item #13) $ 121,015
Previous Part 35 Burden Totals submission Current Request Change Reporting 69,391 61,506 (7,886)
Recordkeeping 1,097,177 1,043,235 (53,942)
Third Party Disclosure 127 12,528 12,401 Total 1,166,695 1,117,269 (49,426)