ML20128J891
| ML20128J891 | |
| Person / Time | |
|---|---|
| Issue date: | 06/30/2020 |
| From: | Figueroa Said Daibes NRC/NMSS/DMSST/MSEB |
| To: | |
| DAIBES S/NMSS/MSST | |
| Shared Package | |
| ML20128J888 | List: |
| References | |
| OMB-3150-0010 | |
| Download: ML20128J891 (49) | |
Text
Section Description Number of Respondents Responses Per Respondent Total Number of Responses Burden per
Response
(Hours)
Total Annual Burden (Hours)
Cost @
$278/Hr 35.6(b)
Research application information needed if the research is conducted, funded, supported, or regulated by another Federal agency.
44 1
44 4
176 $ 48,928 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 $ 6,672 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).
123 2
246 0.25 61.5 $ 17,097 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.
32 1
32 0.25 8 $ 2,224 35.14(b)(6)
Requires a licensee to notify the NRC if it receives certain sealed sources without first obtaining a license amendment.
471 2
942 0.25 235.5 $ 65,469 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 @
$278/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 $ 1,112 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.
9 1
9 1
9 $ 2,502 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.
35.75(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).
462 20 9240 0.17 1570.8 $ 436,682 Burden covered in 35.3067
Section Description Number of Respondents Responses Per Respondent Total Number of Responses Burden per
Response
(Hours)
Total Annual Burden (Hours)
Cost @
$278/Hr Table 1 - Annual Reporting Requirements NRC 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.
2 1
2 1
2 $ 556 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 $ 2,224 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.
12 1
12 1
12 $ 3,336 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 $ 834 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.
138 155 21390 0.25 5347.5 $ 1,486,605 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 @
$278/Hr Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010) 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.
14 260 3640 0.25 910 $ 252,980 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.
8 1
8 0.5 4 $ 1,112 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 @
$278/Hr Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010) 35.3045(d)
Requires licensees to submit a written report to NRC within 15 days of the discovery of the medical event.
8 1
8 8
64 $ 17,792 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.
9 1
9 0.5 4.5 $ 1,251 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 $ 139 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 $ 2,224 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 @
$278/Hr Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010) 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 $ 556 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 $ 139 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 $ 278 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 $ 278 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 $ 278 Total 35,619 8,458 $ 2,351,268
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/HR Record Retention 35.24(a)
Approval in writing by management of other administrative changes.
936 5
0.50 2,340.00 $ 650,520 5 years 35.24(b)
Appointment of associate RSOs in writing.
87 2
0.25 43.50 $ 12,093 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.
247 1
0.50 123.50 $ 34,333 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.
856 1
0.50 428.00 $ 118,984 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).
856 1
1 856 $ 237,968 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 @
$278/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.
157 1
1.00 157.00 $ 43,646 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.
503 7
0.25 880.25 $ 244,710 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.
503 10 0.25 1257.50 $ 349,585 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).
511 1
0.50 255.50 $ 71,029 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 @
$278/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.
856 1
0.03 25.68 $ 7,139 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 @
$278/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.
819 2126 0.02 34,823.88 $ 9,681,039 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.
38 20 1.00 760.00 $ 211,280 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 @
$278/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 24 1
1.00 24 $ 6,672 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.
24 12 0.10 28.8 $ 8,006 Duration of treatment 35.390(a) 35.390(b)(2) 35.392(a) 35.392(c)(3) 35.394(a) 35.394(c)(3)
OMB Clearance 3150-0120 Burden covered in 35.2204 OMB Clearance 3150-0120 Burden covered in 35.2310
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/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.
45 1
1.00 45 $ 12,510 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.
45 5
0.10 22.5 $ 6,255 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 @
$278/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.
152 1
1.00 152.00 $ 42,256 Possession of unit 35.610(b)
Requires licensees to physically locate a copy of the procedures at the unit console.
152 1
0.03 4.56 $ 1,268 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.
152 1
0.50 76.00 $ 21,128 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.
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 @
$278/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.
152 1
1.00 152.00 $ 42,256 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.
152 1
0.50 76.00 $ 21,128 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 $ 1,112 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 $ 834 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 @
$278/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.
136 1
4.00 544.00 $ 151,232 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.
136 155 0.25 5270.00 $ 1,465,060 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.
14 1
4.00 56.00 $ 15,568 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.
14 260 0.25 910.00 $ 252,980 3 years 35.645(g) 35.647(e) 35.652(c) 35.655(c)
Burden covered in 35.2655 Burden covered in 35.2645 Burden covered in 35.2647 Burden covered in 35.2652 Burden covered in 35.2643
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/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.
856 5
0.25 1,070.00 $ 297,460 5 years 35.2024(b)
Requires licensees to retain a copy of both the authority, duties, and responsibilities of the RSO 856 2
0.10 171.20 $ 47,594 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.
31 1
1.00 31.00 $ 8,618 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.
856 1
0.25 214.00 $ 59,492 5 years 35.2040 ()
Requires licensees to retain a copy of each written directive.
511 104 0.05 2,657.20 $ 738,702 3 years 35.2041 Requires licensees to retain a copy of the procedures for administrations requiring a written directive 564 1
0.05 28.20 $ 7,840 Duration of license 35.2060()
Requires licensees to maintain a record of instrument calibrations required by §35.60 for 3 years.
156 255 0.02 795.60 $ 221,177 3 years OMB Clearance 3150-0120
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/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.
856 1.5 0.25 321.00 $ 89,238 3 years 35.2063 Requires licensees to maintain a record of dosage determinations required by §35.63 for 3 years.
830 2126 0.02 35,291.60 $ 9,811,065 3 years 35.2067(a)
Requires licensees to retain records of leak tests required by 35.67 (b) for 3 years.
856 3
0.06 154.08 $ 42,834 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.
856 2
0.06 102.72 $ 28,556 3 years 35.2070()
Requires a licensee to retain a record of each survey required by
§ 35.70 for 3 years.
321 43 0.02 276.06 $ 76,745 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.
451 14 0.25 1,578.50 $ 438,823 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).
451 2
0.20 180.40 $ 50,151 3 years
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/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).
38 20 0.03 22.80 $ 6,338 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.
56 260 0.10 1,456.00 $ 404,768 3 years 35.2092 Requires licensees to retain records of the disposal of licensed materials, as required by
§ 35.92 for 3 years.
856 52 0.02 890.24 $ 247,487 3 years 35.2204 Requires licensees to maintain records of molybdenum-99 concentration tests required by § 35.204(b) for 3 years.
72 108 0.08 622.08 $ 172,938 3 years 35.2204 Requires licensees to maintain records of molybdenum-99 concentration tests required by § 35.204(b) for 3 years.
36 1
13.00 468.00 $ 130,104 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.
211 1
0.10 21.10 $ 5,866 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.
18 1
1.00 18.00 $ 5,004 3 years
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/HR Record Retention Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010) 35.2404 Requires licensees to maintain a record of the surveys required by
§§ 35.404 and 35.604 for 3 years.
213 97 0.02 413.22 $ 114,875 3 years 35.2406 Requires licensees to maintain records of brachytherapy source accountability required by § 35.406 for 3 years.
81 15 0.20 243.00 $ 67,554 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.
81 15 0.20 243.00 $ 67,554 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.
15 70 0.50 525.00 $ 145,950 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.
153 5
2.00 1,530.00 $ 425,340 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.
152 2
0.05 15.20 $ 4,226 Possession of unit
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/HR Record Retention Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010) 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.
154 1
0.50 77.00 $ 21,406 3 years 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.
142 4.6 4.00 2,612.80 $ 726,358 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 $ 1,668 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 $ 14 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.
132 155 1.00 20,460.00 $ 5,687,880 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.
132 1
0.05 6.60 $ 1,835 Possession of unit
Section Description No of Recordkeepers Records per Licensee Burden per record Total Annual Burden Cost @
$278/HR Record Retention Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010) 35.2645(a)
Requires licensees to retain records of each spot-check for gamma stereotactic radiosurgery units required by § 35.645 for 3 years.
13 260 2.00 6,760.00 $ 1,879,280 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.
13 1
0.05 0.65 $ 181 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.
2 260 0.50 260.00 $ 72,280 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.
153 1
0.50 76.50 $ 21,267 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.
15 0.2 1.00 3.00 $ 834 Duration of use of unit Total 856 128,925.47 $ 35,841,281
Section Description No of Recordkeepers Records per Licensee Total Number of Records Burden per record Total Annual Burden Cost @
$278/HR Record Retention 35.24(b) 35.41(a) 35.41(b)(5) 35.41(b)(6) 35.41(c) 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.
8 1
8 2.00 16.00
$4,448 Inventory and leak testing 3 years 35.2024(c)
Copy of the written document appointing the Associate RSO signed by the licensee's management 856 1
856 1.00 856.00
$229,408 5 years after ARSO is removed from license Covered in 35.41(a) (454)
Covered in 35.2041 Table 4 - NRC Licensee Burden for One-time Implementation Requirements from Medical Use of Byproduct Material, Medical Event Definitions, Training and Experience, and Clarifying Amendments Final Rule NRC Licensees (3150-0010)
Burden covered in 35.2024(c)
Burden covered in 35.2041 Covered in 35.41(a) (570)
Section Description No of Recordkeepers Records per Licensee Total Number of Records Burden per record Total Annual Burden Cost @
$278/HR Record Retention Table 4 - NRC Licensee Burden for One-time Implementation Requirements from Medical Use of Byproduct Material, Medical Event Definitions, Training and Experience, and Clarifying Amendments Final Rule NRC Licensees (3150-0010) 35.2041 Requires licensees to retain a copy of the procedures for administrations requiring a written directive, required by § 35.41, for the duration of the license.
856 1
856 9.00 7,704.00
$2,064,672 Duration of the license Total 856 8,576.00
$2,384,128 Annualized Total 285 2,858.67
$766,123
Section Description Number of Respondent s
Responses Per Respondent Total Number of Responses Burden per
Response
(Hours)
Total Annual Burden (Hours)
Cost @
$278/Hr 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 /> 6
1 6
2 12 $ 3,336 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).
2 1
2 0.25 0.5 $ 139 Total 8
12.5 $ 3,475 Table 3 - Annual Third Party Disclosure Requirements NRC Licensees (3150-0010)
Description Number of Respondents 35.6(b)
Research application information needed if the research is conducted, funded, supported, or regulated by another Federal agency.
317 1
317 4
1,268
$ 98,904 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.
44 1
44 4
176
$ 13,728 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).
886 2
1772 0.25 443
$ 123,154 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 @
$278/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.
230 1
230 0.25 57.50
$ 15,985 35.14(b)(6)
Requires a licensee to notify the NRC if it receives certain sealed sources without first obtaining a license amendment.
3391 2
6,782 0.25 1,695.50
$ 471,349 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.
29 1
29 1
29 $ 8,062 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.
65 1
65 1
65
$ 18,070 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) 35.75(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).
3326 20 66520 0.17 11,308
$ 3,143,735 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.
14 1
14 1
14 $ 3,892 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.
58 1
58 1
58
$ 16,124 Burden covered in 35.3204(a) & (b)
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010) 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.
86 1
86 1
86
$ 23,908 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.
7 12 84 0.25 21 $ 5,838 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.
994 155 154070 0.25 38,518
$ 10,707,865 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.
101 260 26260 0.25 6,565
$ 1,825,070 35.1000()
OMB Clearance 3150-0120
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010) 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.
58 1
58 0.5 29 $ 8,062 35.3045(d)
Requires licensees to submit a written report to NRC within 15 days of the discovery of the medical event.
58 1
58 8
464
$ 128,992 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.
65 1
65 0.5 33 $ 9,035 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).
7 1
7 0.5 4 $ 973 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).
7 1
7 8
56
$ 15,568 Burden covered in 35.3045(c)(d)&(e)
Burden covered in 35.3047(c) & (d)
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010) 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).
7 1
7 2
14 $ 3,892 35.3047(f)
Requires the licensee to annotate a copy of the report provided to the NRC with specific details of the affected individual.
7 1
7 0.5 4 $ 973 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.
7 1
7 1
7 $ 1,946 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).
7 1
7 0.25 1.75 $ 487
Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010) 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).
7 1
7 2.00 14.00 $ 3,892 Total 256,561 60,929
$ 16,938,304
Section Description Recordkeepers Records per Licensee Burden hours per record Total Annual Burden Cost @ $278/HR Record Retention 35.24(a)
Approval in writing by management of other administrative changes.
6163 5
0.50 15,407.50 $ 4,283,285 5 years 35.24(b)
Appointment of associate RSOs in writing.
626 2
0.25 313.00 $ 87,014 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.
1779 1
0.50 889.50 $ 247,281 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.
6163 1
0.50 3,081.50 $ 856,657 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 $ 1,713,314 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 @ $278/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.
1130 1
1.00 1,130.00 $ 314,140 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.
3622 7
0.25 6,338.50 $ 1,762,103 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.
3622 10 0.25 9,055.00 $ 2,517,290 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).
3680 1
0.50 1,840.00 $ 511,520 Duration of license 35.41(c) 35.50(a) 35.50(b)(2) 35.51(a)
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 @ $278/HR Record Retention Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees 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.
6163 1
0.03 184.89 $ 51,399 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 37.50 562.50 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.
5897 2126 0.02 250,740.44 $ 69,705,842 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 @ $278/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.
274 20 1.00 5,480.00 $ 1,523,440 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.
173 1
1.00 173.00 $ 48,094 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.
173 12 0.10 207.60 $ 57,713 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 @ $278/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.
324 1
1.00 324.00 $ 90,072 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.
324 5
0.10 162.00 $ 45,036 Duration of treatment 35.432(d) 35.433(b) 35.490(a) 35.490(b)(3) 35.491 (c) 35.590(a)
Burden covered in 35.2310 Burden covered in 35.2433 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 @ $278/HR Record Retention Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees 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.
1095 1
1.00 1095.00 $ 304,410 Possession of unit 35.610(b)
Requires licensees to physically locate a copy of the procedures at the unit console.
1095 1
0.03 32.85 $ 9,132 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.
1095 1
0.50 547.50 $ 152,205 Possession of unit 35.610(d)
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.
1095 1
1.00 1095.00 $ 304,410 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.
1095 1
0.50 547.50 $ 152,205 35.610(f) 35.610(g) 35.630(c) 35.632(g)
Burden covered in 35.2632 Burden covered in 35.2404 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 @ $278/HR Record Retention Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees 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 $ 8,896 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 $ 6,672 3 years 35.642(f) 35.643(b)
Requires licensees to perform spot check measurements in accordance with written procedures established by the AMP.
980 1
4.00 3920.00 $ 1,089,760 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.
980 155 0.25 37975.00 $ 10,557,050 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.
101 1
4.00 404.00 $ 112,312 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.
101 260 0.25 6565.00 $ 1,825,070 3 years Burden covered in 35.2643 Burden covered in 35.2642 Burden covered in 35.2632 Burden covered in 35.2632
Section Description Recordkeepers Records per Licensee Burden hours per record Total Annual Burden Cost @ $278/HR Record Retention Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees 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.
6163 5
0.25 7703.75 $ 2,141,643 5 years 35.2024(b)
Requires licensees to retain a copy of both the authority, duties, and responsibilities of the RSO 6163 2
0.10 1232.60 $ 342,663 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.
224 2
1.00 448.00 $ 124,544 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.
6163 1
0.25 1540.75 $ 428,329 5 years 35.2040()
Requires licensees to retain a copy of each written directive.
3680 104 0.05 19136.00 $ 5,319,808 3 years 35.2041 Requires licensees to retain a copy of the procedures for administrations requiring a written directive 4061 1
0.05 203.05 $ 56,448 Duration of license 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 @ $278/HR Record Retention Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees 35.2041 Requires licensees to retain a copy of the procedures for administrations requiring a written directive 183 1
183 9.00 $ 2,502 35.2060()
Requires licensees to maintain a record of instrument calibrations required by
§35.60 for 3 years.
1124 255 0.02 5732.40 $ 1,593,607 3 years 35.2061 Requires licensees to maintain a record of radiation survey instrument calibrations required by § 35.61 for 3 years.
6163 1.5 0.25 2311.13 $ 642,493 3 years 35.2063 Requires licensees to maintain a record of dosage determinations required by
§35.63 for 3 years.
5976 2126 0.02 254099.52 $ 70,639,667 3 years 35.2067(a)
Requires licensees to retain records of leak tests required by 35.67 (b) for 3 years.
6163 3
0.06 1109.34 $ 308,397 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.
6163 2
0.06 739.56 $ 205,598 3 years 35.2070()
Requires a licensee to retain a record of each survey required by § 35.70 for 3 years.
2312 43 0.02 1988.32 $ 552,753 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.
3248 14 0.25 11368.00 $ 3,160,304 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).
3248 2
0.20 1299.20 $ 361,178 3 years
Section Description Recordkeepers Records per Licensee Burden hours per record Total Annual Burden Cost @ $278/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).
274 20 0.03 164.40 $ 45,703 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.
404 260 0.10 10504.00 $ 2,920,112 3 years 35.2092 Requires licensees to retain records of the disposal of licensed materials, as required by § 35.92 for 3 years.
6163 52 0.02 6409.52 $ 1,781,847 3 years 35.2204 Requires licensees to maintain records of molybdenum-99 concentration tests required by § 35.204(b) for 3 years.
519 108 0.08 4484.16 $ 1,246,596 3 years 35.2204 Requires licensees to maintain records of molybdenum-99 concentration tests required by § 35.204(b) for 3 years.
260 1
13 3380.00 $ 939,640 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.
1520 1
0.10 152.00 $ 42,256 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.
130 142 1
18460.00 $ 5,131,880 3 years 35.2404 Requires licensees to maintain a record of the surveys required by §§ 35.404 and 35.604 for 3 years.
1534 61 0.02 1871.48 $ 520,271 3 years 35.2406 Requires licensees to maintain records of brachytherapy source accountability required by § 35.406 for 3 years.
584 15 0.20 1752.00 $ 487,056 3 years
Section Description Recordkeepers Records per Licensee Burden hours per record Total Annual Burden Cost @ $278/HR Record Retention Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees 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.
584 15 0.20 1752.00 $ 487,056 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.
108 70 0.50 3780.00 $ 1,050,840 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.
1102 5
2.00 11020.00 $ 3,063,560 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.
1095 2
0.05 109.50 $ 30,441 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.
1109 1
0.50 554.50 $ 154,151 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.
1023 4.6 4.00 18823.20 $ 5,232,850 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 $ 13,344 3 years
Section Description Recordkeepers Records per Licensee Burden hours per record Total Annual Burden Cost @ $278/HR Record Retention Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees 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 $ 111 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.
951 155 1.00 147405.00 $ 40,978,590 3 years 35.2643 (c)
Requires licensees to retain records of each spot-check for remote afterloader units required by §§ 35.643 for 3 years.
951 1
0.05 47.55 $ 13,219 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.
94 260 2.00 48880.00 $ 13,588,640 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.
94 1
0.05 4.70 $ 1,307 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.
15 260 0.50 1950.00 $ 542,100 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.
1102 1
0.50 551.00 $ 153,178 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.
108 0.2 1.00 21.60 $ 6,005 Duration of use of unit Total 6163 944,811 $ 262,657,432
Section Description Number of Responde nts Responses Per Responde nt Total Number of Responses Burden per
Response
(Hours)
Total Annual Burden (Hours)
Cost @ $278/hr 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 />.
43 1
43 2
86 $ 23,908 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).
14 1
14 2
28 $ 7,784 Total 57 114 31,692 Table 7 - Annual Reporting Requirements AS Licensees (3150-0010)
Section Description No of Recordkeepers Records per Licensee Total Number of Records Burden per record Total Annual Burden Cost @
$278/HR Record Retention 35.24(b)
Requires that a licensee's management appoint a RSO who agrees, in writing, to be responsible for implementing the radiation protection program.
35.41(a)
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).
35.41(b)(5)
Requires licensees to develop, implement, and maintain written procedures for any administration requiring a WD to determine if a medical event, as defined in
§35.3045, has occurred.
Table 8 - One-time Implementation Requirements from Medical Use of Byproduct Material, Medical Event Definitions, Training and Experience, and Clarifying Amendments Final Rule AS Licensees (3150-0010)
Burden covered in 35.2024(c)
Burden covered in 35.2041 Covered in 35.41(a)
Table 8 - One-time Implementation Requirements from Medical Use of Byproduct Material, Medical Event Definitions, Training and Experience, and Clarifying Amendments Final Rule AS Licensees (3150-0010) 35.41(b)(6)
Requires licensees to develop, implement, and maintain written procedures for permanent implant brachytherapy.
35.41(c)
Requires the licensee to retain a copy of the procedures required by
§35.41(a) in accordance with § 35.2041 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.
58 1
58 2.00 116.00
$32,248 Inventory and leak testing 3 years 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.
6163 1
6,163 1.00 6,163.00
$1,713,314 5 years after ARSO is removed from license 35.2041 Requires licensees to retain a copy of the procedures for administrations requiring a written directive, required by
§ 35.41, for the duration of the license.
6163 1
6,163 9.00 55,467.00
$15,419,826 Duration of the license Covered in 35.41(a)
Covered in 35.2041
Table 8 - One-time Implementation Requirements from Medical Use of Byproduct Material, Medical Event Definitions, Training and Experience, and Clarifying Amendments Final Rule AS Licensees (3150-0010)
Total 6163 12,384.00 61,746.00
$17,165,388 Annualized Total 6163 20,582.00
$5,721,796
Burden Responses Cost @ $278/hr NRC licensee reporting 8,458 35,619 2,351,268 NRC licensee recordkeeping 131,784 856 36,635,990 NRC third party 13 8
3,475 AS reporting 60,929 256,561 16,938,304 AS recordkeeping 965,393 6,163 268,379,228 AS third party 114 57 31,692 Specialty certifying entities 4
2 1,112 Total 1,166,694 299,266 324,341,069 Burden Responses Cost @ $278/hr NRC licensees TOTAL 140,254 36,483 38,990,733 AS licensees TOTAL 1,026,436 262,781 285,349,223 Specialty certifying entities 4
2 1,112 TOTAL 1,166,694 299,266 324,341,069 Part 35 Totals Burden Responses Cost @ $278/hr Reporting 69,391 292,182 19,290,684 Recordkeeping 1,097,177 7,019 305,015,218 Third Party Disclosure 127 65 35,167 Total 1,166,694 299,266 324,341,069 NRC licensees 856 Agreement State licensees 6,163 Specialty certifying entities 2
Total 7,021 Other costs (item #13) 122,006 Part 35 Respondents
Part 35 Burden Totals Previous submission Current Request Change Reporting 65,571 69,391 3,820 Recordkeeping 1,038,933 1,097,177 58,244 Third Party Disclosure 80 127 47 Total 1,104,583 1,166,694 62,111