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