| Table 1 – Annual Reporting Requirements |
|
| NRC Licensees (3150-0010) |
|
| 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) |
|
OMB Clearance 3150-0120 |
| 35.13 |
|
OMB Clearance 3150-0120 |
| 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 |
| 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. |
Burden covered in 35.3067 |
| 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 |
| 35.204(e) |
|
Burden covered in 35.3204(a) & (b) |
| 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 |
| 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() |
|
Cullison, David:
This section is not mentioned in the Form 313 Clearance
OMB Clearance 3150-0120 |
| 35.3045(a) & (b) |
|
Burden covered in 35.3045(c) & (d) |
| 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 |
| 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) |
|
Burden covered in 35.3047(c) & (d) |
| 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 |
| 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 hours 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 |
| Table 2 – Annual Recordkeeping Requirements |
| NRC Licensees (3150-0010) |
| 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. |
Burden covered in 35.2024 |
| 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. |
Burden covered in 35.2024 |
| 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. |
Burden covered in 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 |
|
| 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 patient’s record and a written directive must be prepared within 48 hours 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. |
Burden covered in 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 35.2041 |
| 35.50(a) |
|
OMB Clearance 3150-0120 |
| 35.50(b)(2) |
|
| 35.51(a) |
|
| 35.51(b)(2) |
|
| 35.55(a) |
|
| 35.55(b)(2) |
|
| 35.60(c) |
|
Burden covered in 35.2060 |
| 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) |
|
Burden covered in 35.2061 |
| 35.63(e) |
|
Burden covered in 35.2063 |
| 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) |
|
Burden covered in 35.2067 |
| 35.67 (d) |
|
Burden covered in 35.2067 |
| 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) |
|
Burden covered in 35.2070 |
| 35.75(c) |
|
Burden covered in 35.2075(a) |
| 35.75(d) |
|
Burden covered in 35.2075(b) |
| 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) |
|
Burden covered in 35.2080 |
| 35.92(b) |
|
Burden covered in 35.2092 |
| 35.190(c)(2) |
|
OMB Clearance 3150-0120 |
| 35.190(a) |
|
| 35.204(d) |
|
Burden covered in 35.2204 |
| 35.290(a) |
|
OMB Clearance 3150-0120 |
| 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) |
|
Burden covered in 35.2310 |
| 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) |
|
OMB Clearance 3150-0120 |
| 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) |
|
Burden covered in 35.2404 |
| 35.406(c) |
|
Burden covered in 35.2406 |
| 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) |
|
Burden covered in 35.2067 |
| 35.410(b) |
|
Burden covered in 35.2310 |
| 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) |
|
Burden covered in 35.2432 |
| 35.433(b) |
|
Burden covered in 35.2433 |
| 35.490(a) |
|
OMB Clearance 3150-0120 |
| 35.490(b)(3) |
|
| 35.491 (c) |
|
| 35.590(a) |
|
| 35.604(b) |
|
Burden covered in 35.2404 |
| 35.605(d) |
|
Burden covered in 35.2605 |
| 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. |
|
| 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) |
|
Burden covered in 35.2310 |
| 35.610(g) |
|
Burden covered in 35.2610 |
| 35.630(c) |
|
Burden covered in 35.2630 |
| 35.632(g) |
|
Burden covered in 35.2632 |
| 35.633(i) |
|
Burden covered in 35.2632 |
| 36.635(g) |
|
Burden covered in 35.2632 |
| 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 35.2642 |
| 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) |
|
Burden covered in 35.2643 |
| 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) |
|
Burden covered in 35.2645 |
| 35.647(e) |
|
Burden covered in 35.2647 |
| 35.652(c) |
|
Burden covered in 35.2652 |
| 35.655(c) |
|
Burden covered in 35.2655 |
| 35.690(a) |
|
OMB Clearance 3150-0120 |
| 35.690(b)(3) |
|
| 35.2024(a) |
Requires licensees to retain a record of actions taken by the licensee’s 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 licensee’s 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 |
| 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 |
| 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 client’s 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 |
| 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 |
| 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 |
| 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 |
|
| Table 5 – Annual Reporting Requirements |
|
| Agreement State Licensees (3150-0010) |
|
| Section |
Description |
Number of |
Responses Per Respondent |
Total Responses |
Burden per Response (Hours) |
Total Annual Burden (Hours) |
Cost @ $278/HR |
|
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) |
|
OMB Clearance 3150-0120 |
| 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 |
| 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 |
| 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) |
Burden covered in 35.3204(a) & (b) |
| 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 |
| 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 |
| 35.3045(a) & (b) |
|
Burden covered in 35.3045(c)(d)&(e) |
| 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) |
|
Burden covered in 35.3047(c) & (d) |
| 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 |
| 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 hours 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 |
| 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 |
| 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 |
| 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. |
Burden covered in 35.2024 |
| 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. |
Burden covered in 35.2024 |
| 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. |
Burden covered in 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 |
|
| 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 patient’s record and a written directive must be prepared within 48 hours 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. |
Burden covered in 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) |
|
Burden covered in 35.2041 |
| 35.50(a) |
|
OMB Clearance 3150-0120 |
| 35.50(b)(2) |
|
| 35.51(a) |
|
| 35.51(b)(2) |
|
| 35.55(a) |
|
| 35.55(b)(2) |
|
| 35.60(c) |
|
Burden covered in 35.2060 |
| 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) |
|
Burden covered in 35.2061 |
| 35.63(e) |
|
Burden covered in 35.2063 |
| 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) |
|
Burden covered in 35.2067 |
| 35.67(g) |
|
Burden covered in 35.2067 |
| 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) |
|
Burden covered in 35.2070 |
| 35.75(c) |
|
Burden covered in 35.2075(a) |
| 35.75(d) |
|
Burden covered in 35.2075(b) |
| 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) |
|
Burden covered in 35.2080 |
| 35.92(b) |
|
Burden covered in 35.2092 |
| 35.190(a) |
|
OMB Clearance 3150-0120 |
| 35.190(c)(2) |
|
| 35.204(b) |
|
Covered under 35.2204 |
| 35.204(c) |
|
Burden covered in 35.2204 |
| 35.290(a) |
|
OMB Clearance 3150-0120 |
| 35.290(c)(2) |
|
| 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) |
|
Burden covered in 35.2310 |
| 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 |
| 35.390(a) |
|
OMB Clearance 3150-0120 |
| 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) |
|
Burden covered in 35.2404 |
| 35.406(c) |
|
Burden covered in 35.2406 |
| 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) |
|
Burden covered in 35.2310 |
| 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) |
|
Burden covered in 35.2432 |
| 35.433(b) |
|
Burden covered in 35.2433 |
| 35.490(a) |
|
OMB Clearance 3150-0120 |
| 35.490(b)(3) |
|
| 35.491 (c) |
|
| 35.590(a) |
|
| 35.604(b) |
|
Burden covered in 35.2404 |
| 35.605(d) |
|
Burden covered in 35.2605 |
| 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) |
|
Burden covered in 35.2310 |
| 35.610(g) |
|
Burden covered in 35.2610 |
| 35.630(c) |
|
Burden covered in 35.2630 |
| 35.632(g) |
|
Burden covered in 35.2632 |
| 35.633(i) |
|
Burden covered in 35.2632 |
| 36.635(g) |
|
Burden covered in 35.2632 |
| 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) |
|
Burden covered in 35.2642 |
| 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) |
|
Burden covered in 35.2643 |
| 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 |
| 35.645(g) |
|
Burden covered in 35.2645 |
| 35.647(e) |
|
Burden covered in 35.2647 |
| 35.652(c) |
|
Burden covered in 35.2652 |
| 35.655(c) |
|
Burden covered in 35.2655 |
| 35.690(a) |
|
OMB Clearance 3150-0120 |
| 35.690(b)(3) |
|
| 35.2024(a) |
Requires licensees to retain a record of actions taken by the licensee’s 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 licensee’s 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 |
| 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 |
| 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 client’s 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 |
| 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 |
| 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 |
|