Difference between revisions of "ML20128J891"

From kanterella
Jump to navigation Jump to search
(StriderTol Bot insert)
 
(No difference)

Latest revision as of 01:02, 2 August 2020

OMB-3150-0010 - Master Tables - 10 CFR Part 35 Medical Use Byproduct Material
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

Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)

Burden per Number of Responses Per Total Number Total Annual Cost @

Section Description Response Respondents Respondent of Responses Burden (Hours) $278/Hr (Hours)

Research application information needed if the research is conducted, funded, 35.6(b) 44 1 44 4 176 $ 48,928 supported, or regulated by another Federal agency.

Research application information needed for ammendment to NRC medical use 35.6(c) license, if the research is not conducted, 6 1 6 4 24 $ 6,672 funded,supported or regulated by another Federal agency.

35.12(b), (c), &

OMB Clearance 3150-0120 (d) 35.13 OMB Clearance 3150-0120 Describes the requirements that need to be satisfied to notify the Commission, to function as an authorized user (AU),

35.14(a) & (b) 123 2 246 0.25 61.5 $ 17,097 authorized medical physicist (AMP),

ophthalmic physicist (OP), or authorized nuclear pharmacist (ANP).

Requires a licensee to notify the 35.14(b)(1) Commission within 30 days of when an 32 1 32 0.25 8 $ 2,224 ARSO discontinues performance of duties under the license or has a name change.

Requires a licensee to notify the NRC if it 35.14(b)(6) receives certain sealed sources without first 471 2 942 0.25 235.5 $ 65,469 obtaining a license amendment.

Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)

Burden per Number of Responses Per Total Number Total Annual Cost @

Section Description Response Respondents Respondent of Responses Burden (Hours) $278/Hr (Hours)

Provides that upon application of any interested person or upon its own initiative, the Commission may grant exemptions 35.19 from the regulations in Part 35 that it 4 1 4 1 4 $ 1,112 determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

Provides that a licensee may permit an individual qualified to be a RSO, to function 35.24(c) 9 1 9 1 9 $ 2,502 as a temporary RSO and to perform the functions of a RSO.

Requires licensees to file a report with the NRC within 5 days in accordance with § 35.67(e)(2) Burden covered in 35.3067 35.3067 if leakage of a sealed source is detected.

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 35.75(b) accordance with § 35.75(a) with instructions 462 20 9240 0.17 1570.8 $ 436,682 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).

Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)

Burden per Number of Responses Per Total Number Total Annual Cost @

Section Description Response Respondents Respondent of Responses Burden (Hours) $278/Hr (Hours) 35.204(e) Burden covered in 35.3204(a) & (b)

Requires that the licensee promptly notify the RSO, or his or her designee, and the 35.315(b) 2 1 2 1 2 $ 556 AU as soon as possible if the patient has a medical emergency or dies.

Requires that the licensee notify the RSO, 35.415(c) or his or her designee, and AU as soon as 8 1 8 1 8 $ 2,224 possible if the patient or human research subject has a medical emergency or dies.

Requires a licensee to notify the RSO, or his/her designee, and an AU as soon as possible if the patient or human research subject has a medical emergency or dies.

35.615(f)(4) 12 1 12 1 12 $ 3,336 This notification is required so that the RSO, or his/her designee, or AU can take whatever actions are necessary for radiation safety.

Requires that the AMP review the results of 35.642(c) each spot-check and notify the licensee in 1 12 12 0.25 3 $ 834 writing of the results of each spot checks.

With regards to periodic spot-checks for remote afterloader units this section requires licensees to have the AMP review the results of each spot-check required by 35.643(c) 138 155 21390 0.25 5347.5 $ 1,486,605 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.

Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)

Burden per Number of Responses Per Total Number Total Annual Cost @

Section Description Response Respondents Respondent of Responses Burden (Hours) $278/Hr (Hours)

Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit within 15 days 35.645(b)(2) 14 260 3640 0.25 910 $ 252,980 of each spot-check and to notify the licensee as soon as possible in writing the results of each spot-check.

35.1000() OMB Clearance 3150-0120 35.3045(a) &

Burden covered in 35.3045(c) & (d)

(b)

Requires licensees to notify the NRC by 35.3045(c) telephone no later than the next calendar 8 1 8 0.5 4 $ 1,112 day after discovery of the medical event.

Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)

Burden per Number of Responses Per Total Number Total Annual Cost @

Section Description Response Respondents Respondent of Responses Burden (Hours) $278/Hr (Hours)

Requires licensees to submit a written 35.3045(d) report to NRC within 15 days of the 8 1 8 8 64 $ 17,792 discovery of the medical event.

Requires the licensee to: (1) annotate a copy of the medical event report provided to 35.3045(g) 9 1 9 0.5 4.5 $ 1,251 the NRC with spicific infromation outlined in thi section.

35.3047(a) &

Burden covered in 35.3047(c) & (d)

(b)

Requires the licensee to notify by telephone the NRC Operation Center no later than the 35.3047(c) next calendar day after discovery of a dose 1 1 1 0.5 0.5 $ 139 to the embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).

Requires the licensee to submit a written report to the appropriate NRC Regional Office no later than 15 days after discovery 35.3047(d) 1 1 1 8 8 $ 2,224 of a dose to the embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).

Table 1 - Annual Reporting Requirements NRC Licensees (3150-0010)

Burden per Number of Responses Per Total Number Total Annual Cost @

Section Description Response Respondents Respondent of Responses Burden (Hours) $278/Hr (Hours)

Requires the licensee to notify the referring physician and also notify the pregnant individual or mother (both hereafter referred 35.3047(e) to as the mother) no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 1 1 1 2 2 $ 556 after discovery of an event that would require reporting under paragraph § 35.3047(a) or (b).

Requires the licensee to: (1) annotate a copy of the report provided to the NRC with the: (a) name of the pregnant individual or 35.3047(f) the nursing child who is the subject of the 1 1 1 0.5 0.5 $ 139 event; and (b) social security number or other identification number, if one has been assigned.

This section requires licensees to report detection of a leaking source by submitting a written report within 5 days after a 35.3067 1 1 1 1 1 $ 278 leakage test required by § 35.67 reveal the presence of 185 Bq (0.005 microcurie) or more of removable contamination.

Requires radiopharmacy and medical use licensees to notify both the NRC Operations 35.3204(a) Center and the distributor of the generator 1 1 1 0.25 1 $ 278 by telephone within 7 days after discovery that an eluate exceeds the permissible concentration listed in § 35.204(a).

Requires radiopharmacy and medical use licensees to submit a written report to the appropriate NRC Regional Office listed in § 35.3204(b) 1 1 1 2.00 1 $ 278 30.6 within 30 days after discovery of an eluate exceeding the permissible concentration listed in § 35.204(a).

Total 35,619 8,458 $ 2,351,268

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Approval in writing by 35.24(a) management of other 936 5 0.50 2,340.00 $ 650,520 5 years administrative changes.

Appointment of associate RSOs 35.24(b) 87 2 0.25 43.50 $ 12,093 in writing.

Authority, duties, and 35.24(e) responsibilities of the RSO in Burden covered in 35.2024 writing.

Requirement to establish a Radiation Safety Committee to 35.24(f) 247 1 0.50 123.50 $ 34,333 Industry practice oversee the radiation protection programs.

Requires that a licensee record and retain actions taken pursuant 35.24(h) to the authority and Burden covered in 35.2024 responsibilities within the radiation protection program.

Requires the revision has been reviewed and approved by the Radiation Safety Officer and 35.26(a)(3)&(4) licensee management; and the 856 1 0.50 428.00 $ 118,984 5 years affected individuals are instructed on the revised program before the changes are implemented.

Requires a record of each 35.26(b) change to be retained in Burden covered in 35.2026 accordance with 35.2026.

Requires a licensee that permits the receipt, possession, use, or 35.27(a) transfer of byproduct material by 856 1 1 856 $ 237,968 an individual under the supervision of an AU as allowed by § 35.11(b).

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR A licensee that permits the preparation of byproduct material for medical use by an individual 35.27(b) under the supervision of an 157 1 1.00 157.00 $ 43,646 authorized nuclear pharmacist or physician who is an authorized user.

Requires the information in the oral directive to be documented as soon as possible in writing in 35.40(a)(1) 503 7 0.25 880.25 $ 244,710 3 years the patients record and a written directive must be prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral directive.

Permits a written revision to an existing written directive if the 35.40(c)(1) revision is dated and signed by 503 10 0.25 1257.50 $ 349,585 3 years an AU before the administration or the next fractional dose.

Requires the licensee to retain a 35.40(d) copy of the written directive in Burden covered in 35.2040 accordance with § 35.2040.

Requires licensees to develop, implement and maintain written procedures for any administration requiring a written directive to provide high confidence that the 35.41(a)&(b) patient or human research 511 1 0.50 255.50 $ 71,029 Duration of license subject's identity is verified prior to each administration and that each administration is in accordance with the written directive (WD).

35.41(c) Burden covered in 35.2041

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR 35.50(a) 35.50(b)(2) OMB Clearance 3150-0120 35.51(a) 35.51(b)(2) 35.55(a) 35.55(b)(2) 35.60(c) Burden covered in 35.2060 Requires that the licensee conspicuously note on a survey instrument the date that the 35.61(a)(3) instrument was calibrated. This 856 1 0.03 25.68 $ 7,139 Equipment duration information is necessary to show that survey instruments are calibrated and operational.

35.61(c) Burden covered in 35.2061 35.63(e) Burden covered in 35.2063 Prohibits the bundling or aggregating of single sealed sources to create a sealed source Inventory and leak 35.65(b)(2) 2 2 2.50 5.00 $1,390 with an activity greater than the testing 3 years maximum activity authorized by

§ 35.65.

35.67(a) Burden covered in 35.2067 35.67 (d) Burden covered in 35.2067

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires that each syringe and vial that contains unsealed byproduct material must be labeled, and that each syringe 35.69 819 2126 0.02 34,823.88 $ 9,681,039 Equipment duration shield and vial shield must also be labeled unless the label on the syringe or vial is visible when shielded.

35.70(c) Burden covered in 35.2070 35.75(c) Burden covered in 35.2075(a) 35.75(d) Burden covered in 35.2075(b)

Requires a licensee providing mobile service to obtain a letter signed by the management of each client that permits the use of 3 years after last 35.80(a)(1) 38 20 1.00 760.00 $ 211,280 byproduct material at the client's service address and delineates the authority and responsibility of the licensee and the client.

35.80(c) Burden covered in 35.2080 35.92(b) Burden covered in 35.2092 35.190(c)(2)

OMB Clearance 3150-0120 35.190(a)

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR 35.204(d) Burden covered in 35.2204 35.290(a)

OMB Clearance 3150-0120 35.290(c)(2)

Requires that licensees provide safety instruction, initially and at least annually, to personnel caring for patients or human 35.310(a) research subjects that have 24 1 1.00 24 $ 6,672 Annual received therapy with unsealed byproduct material and cannot be released in accordance with § 35 75 35.310(b) Burden covered in 35.2310 Requires a licensee to note on the door or in the patient's chart indicating where and how long visitors may stay in the patient's 35.315(a)(3) 24 12 0.10 28.8 $ 8,006 Duration of treatment room. This posting and note are required so that employees and visitors receive information necessary for radiation safety.

35.390(a) 35.390(b)(2) 35.392(a) 35.392(c)(3)

OMB Clearance 3150-0120 35.394(a) 35.394(c)(3)

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR 35.396 (c) 35.396 (d) 35.404(c) Burden covered in 35.2404 35.406(c) Burden covered in 35.2406 Requires licensees to provide safety instruction, initially and at least annually, to personnel 35.410(a) caring for patients or human 45 1 1.00 45 $ 12,510 research subjects that are receiving brachytherapy and cannot be released in accordance with § 35.75.

35.67(a) Burden covered in 35.2067 35.410(b) Burden covered in 35.2310 Requires a note on the door or in the patient's or human research subject's chart where and how 35.415(a)(3) 45 5 0.10 22.5 $ 6,255 Duration of treatment long visitors may stay in the patient's or human research subject's room.

35.432(d) Burden covered in 35.2432 35.433(b) Burden covered in 35.2433 35.490(a) 35.490(b)(3)

OMB Clearance 3150-0120

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR OMB Clearance 3150-0120 35.491 (c) 35.590(a) 35.604(b) Burden covered in 35.2404 35.605(d) Burden covered in 35.2605 Requires licensees to develop, implement, and maintain written 35.610(a)(4) 152 1 1.00 152.00 $ 42,256 Possession of unit procedures for responding to an abnormal situation.

Requires licensees to physically 35.610(b) locate a copy of the procedures 152 1 0.03 4.56 $ 1,268 Possession of unit at the unit console.

Requires licensees to post instructions for individuals who operate the devices at the device 35.610(c) 152 1 0.50 76.00 $ 21,128 Possession of unit console providing the location of the procedures and emergency names and telephone numbers.

Requires all individuals who will operate remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units to receive vendor operational and 35.610(d)(1) safety training prior to the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit.

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires licensees to provide initial instruction and annual refresher instruction to all 35.610(d)(2) individuals who operate the unit 152 1 1.00 152.00 $ 42,256 Possession of unit in the procedures identified in § 35.610(a) and the operating procedures for the unit.

Requires licensees to ensure that operators, AMPs, and AUs 35.610(e) participate in drills of the 152 1 0.50 76.00 $ 21,128 emergency procedures, initially and at least annually.

35.610(f) Burden covered in 35.2310 35.610(g) Burden covered in 35.2610 35.630(c) Burden covered in 35.2630 35.632(g) Burden covered in 35.2632 35.633(i) Burden covered in 35.2632 36.635(g) Burden covered in 35.2632 Requires licensees to perform spot check measurements in 35.642(b) accordance with written 1 1 4.00 4.00 $ 1,112 Possession of unit procedures established by the AMP.

Requires that the AMP review the results of each spot-check and 35.642(c) 1 12 0.25 3.00 $ 834 3 years notify the licensee in writing of the results of each spot checks.

35.642(f) Burden covered in 35.2642

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires licensees to perform spot check measurements in 35.643(b) accordance with written 136 1 4.00 544.00 $ 151,232 Possession of unit procedures established by the AMP.

Requires licensees to have the AMP review the results of each spot-check required by paragraph 35.643(c) (a) within 15 days of the check 136 155 0.25 5270.00 $ 1,465,060 3 years and to notify the licensee as soon as possible in writing of the results of each spot check.

35.643(f) Burden covered in 35.2643 Requires licensees to perform spot-check measurements in 35.645(b)(1) accordance with written 14 1 4.00 56.00 $ 15,568 Possession of unit procedures established by the AMP.

Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit 35.645(b)(2) 14 260 0.25 910.00 $ 252,980 3 years within 15 days of each spot-check and to notify the licensee as soon as possible in writing the results of each spot-check.

35.645(g) Burden covered in 35.2645 35.647(e) Burden covered in 35.2647 35.652(c) Burden covered in 35.2652 35.655(c) Burden covered in 35.2655

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR 35.690(a)

OMB Clearance 3150-0120 35.690(b)(3)

Requires licensees to retain a record of actions taken by the 35.2024(a) licensees management in 856 5 0.25 1,070.00 $ 297,460 5 years accordance with § 35.24(a) for 5 years.

Requires licensees to retain a 35.2024(b) copy of both the authority, duties, 856 2 0.10 171.20 $ 47,594 Duration of license and responsibilities of the RSO Requires the licensee to keep the written documents signed by the licensees management for each 5 years after ARSO is 35.2024(c ) ARSO appointed under 31 1 1.00 31.00 $ 8,618 removed from license

§ 35.24(b) for 5 years after the ARSO is removed from the license.

Requires licensees to retain a record of each radiation 35.2026 protection program change made 856 1 0.25 214.00 $ 59,492 5 years in accordance with § 35.26(a) for 5 years.

Requires licensees to retain a 35.2040 () 511 104 0.05 2,657.20 $ 738,702 3 years copy of each written directive.

Requires licensees to retain a copy of the procedures for 35.2041 564 1 0.05 28.20 $ 7,840 Duration of license administrations requiring a written directive Requires licensees to maintain a 35.2060() record of instrument calibrations 156 255 0.02 795.60 $ 221,177 3 years required by § 35.60 for 3 years.

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires licensees to maintain a record of radiation survey 35.2061 856 1.5 0.25 321.00 $ 89,238 3 years instrument calibrations required by § 35.61 for 3 years.

Requires licensees to maintain a 35.2063 record of dosage determinations 830 2126 0.02 35,291.60 $ 9,811,065 3 years required by § 35.63 for 3 years.

Requires licensees to retain 35.2067(a) records of leak tests required by 856 3 0.06 154.08 $ 42,834 3 years 35.67 (b) for 3 years.

Requires that licensees retain records of the semi-annual physical inventory of sealed 35.2067(b) 856 2 0.06 102.72 $ 28,556 3 years sources and brachytherapy sources required by § 35.67(g) for 3 years.

Requires a licensee to retain a 35.2070() record of each survey required by 321 43 0.02 276.06 $ 76,745 3 years

§ 35.70 for 3 years.

Requires licensees to retain a record of the basis for authorizing 35.2075(a) 451 14 0.25 1,578.50 $ 438,823 3 years the release of an individual in accordance with § 35.75.

Requires licensees to retain a record that the instructions required by § 35.75(b) were provided to a breast-feeding 35.2075(b) female if the radiation dose to the 451 2 0.20 180.40 $ 50,151 3 years infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisievert (0.5 rem).

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires licensees providing mobile medical services to retain a copy of each letter that permits 3 years after last 35.2080(a) 38 20 0.03 22.80 $ 6,338 the use of byproduct material at a service clients address, as required by

§ 35.80(a) (1).

Requires licensees to maintain a 35.2080(b) record of each survey required by 56 260 0.10 1,456.00 $ 404,768 3 years

§ 35.80(a) (4) for 3 years.

Requires licensees to retain records of the disposal of 35.2092 856 52 0.02 890.24 $ 247,487 3 years licensed materials, as required by

§ 35.92 for 3 years.

Requires licensees to maintain records of molybdenum-99 35.2204 72 108 0.08 622.08 $ 172,938 3 years concentration tests required by § 35.204(b) for 3 years.

Requires licensees to maintain records of molybdenum-99 35.2204 36 1 13.00 468.00 $ 130,104 3 years concentration tests required by § 35.204(b) for 3 years.

Requires licensees to maintain a record of safety instructions required by §§ 35.310 and 35.410 35.2310 211 1 0.10 21.10 $ 5,866 3 years and the operational and safety instructions required by § 35.610 for 3 years.

Requires licensees to maintain a record of safety instructions 35.2310 required by §§ 35.310 and 35.410 18 1 1.00 18.00 $ 5,004 3 years and the operational and safety instructions required by § 35.610 for 3 years.

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires licensees to maintain a 35.2404 record of the surveys required by 213 97 0.02 413.22 $ 114,875 3 years

§§ 35.404 and 35.604 for 3 years.

Requires licensees to maintain 35.2406 81 15 0.20 243.00 $ 67,554 3 years records of brachytherapy source accountability required by § 35.406 for 3 years.

Requires licensees to maintain a record of calibrations of 35.2432 brachytherapy sources required 81 15 0.20 243.00 $ 67,554 3 years by § 35.432 for 3 years after the last use of the source.

Requires licensees to maintain a record of the activity of a 35.2433 15 70 0.50 525.00 $ 145,950 Life of source strontium-90 source required by § 35.433 for the life of the source.

Requires licensees to retain records of installation, maintenance, adjustment, and 35.2605 repair of remote afterloader units, 153 5 2.00 1,530.00 $ 425,340 3 years teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years.

Requires licensees to maintain records of procedures required by§ 35.610(a) (4) and (d) (2) until 35.2610() the licensee no longer possesses 152 2 0.05 15.20 $ 4,226 Possession of unit the remote afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires licensees to retain a record of the calibration, intercomparison, and 35.2630() comparisons of its dosimetry 154 1 0.50 77.00 $ 21,406 3 years equipment done in accordance with § 35.630 for the duration of the license.

Requires licensees to maintain records of the teletherapy unit, remote afterloader unit, and 35.2632 gamma stereotactic radiosurgery 142 4.6 4.00 2,612.80 $ 726,358 3 years unit full calibrations required by

§§ 35.632, 35.633, and 35.635 for 3 years.

Requires licensees to retain a record of each periodic spot-35.2642(a) 1 12 0.50 6.00 $ 1,668 3 years check for teletherapy units required by § 35.642 for 3 years.

Requires licensees to retain a copy of the written procedures for 35.2642(c) periodic spot-checks for 1 1 0.05 0.05 $ 14 Possession of unit teletherapy units established by the AMP.

Requires licensees to retain records of each spot-check for 35.2643(a) 132 155 1.00 20,460.00 $ 5,687,880 3 years remote afterloader units required by §§ 35.643 for 3 years.

Requires licensees to retain a copy of the written procedures for 35.2643(c) periodic spot-checks for remote 132 1 0.05 6.60 $ 1,835 Possession of unit afterloader units established by the AMP.

Table 2 - Annual Recordkeeping Requirements NRC Licensees (3150-0010)

No of Records per Burden per Total Annual Cost @

Section Description Record Retention Recordkeepers Licensee record Burden $278/HR Requires licensees to retain records of each spot-check for 35.2645(a) gamma stereotactic radiosurgery 13 260 2.00 6,760.00 $ 1,879,280 3 years units required by § 35.645 for 3 years.

Requires licensees to retain a copy of the written procedures for 35.2645(c) periodic spot-checks for gamma 13 1 0.05 0.65 $ 181 Possession of unit stereotactic radiosurgery units established by the AMP.

Requires licensees to retain records of each check for mobile 35.2647 2 260 0.50 260.00 $ 72,280 3 years remote afterloader units required by § 35.647 for 3 years.

Requires licensees to maintain records of radiation surveys of Duration of use of 35.2652 treatment units made in 153 1 0.50 76.50 $ 21,267 unit accordance with § 35.652 for the duration of use of the unit.

Requires licensees to maintain a record of the 5-year inspections for teletherapy and gamma Duration of use of 35.2655 15 0.2 1.00 3.00 $ 834 stereotactic radiosurgery units unit required by § 35.655 for the duration of use of the unit.

Total 856 128,925.47 $ 35,841,281

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)

Records Total Total No of Burden per Cost @ Record Section Description per Number of Annual Recordkeepers record $278/HR Retention Licensee Records Burden 35.24(b)

Burden covered in 35.2024(c) 35.41(a) Burden covered in 35.2041 35.41(b)(5) Covered in 35.41(a) (570) 35.41(b)(6) Covered in 35.41(a) (454) 35.41(c) Covered in 35.2041 Prohibits the bundling or aggregating of single sealed Inventory sources to create a sealed and leak 35.65(b)(2) 8 1 8 2.00 16.00 $4,448 source with an activity greater testing 3 than the maximum activity years authorized by § 35.65.

5 years Copy of the written document after appointing the Associate RSO ARSO is 35.2024(c) 856 1 856 1.00 856.00 $229,408 signed by the licensee's removed management from license

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)

Records Total Total No of Burden per Cost @ Record Section Description per Number of Annual Recordkeepers record $278/HR Retention Licensee Records Burden Requires licensees to retain a copy of the procedures for administrations requiring a Duration of 35.2041 856 1 856 9.00 7,704.00 $2,064,672 written directive, required by § the license 35.41, for the duration of the license.

Total 856 8,576.00 $2,384,128 Annualized 285 2,858.67 $766,123 Total

Table 3 - Annual Third Party Disclosure Requirements NRC Licensees (3150-0010)

Total Number of Responses Total Burden per Annual Cost @

Section Description Respondent Per Number of Response Burden $278/Hr s Respondent Responses (Hours)

(Hours)

Notification of medical event to the referring physician and individual 35.3045(e) 6 1 6 2 12 $ 3,336 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 /> Requires radiopharmacy and medical use licensees to notify both the NRC Operations Center and the distributor of the generator by 35.3204(a) 2 1 2 0.25 0.5 $ 139 telephone within 7 days after discovery that an eluate exceeds the permissible concentration listed in

§ 35.204(a).

Total 8 12.5 $ 3,475

Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)

Description Number of Responses Burden per Total Annual Cost @

Section Per Total Responses Response Burden

$278/HR Respondents Respondent (Hours) (Hours)

Research application information needed if the research is conducted, 35.6(b) 317 1 317 4 1,268 $ 98,904 funded, supported, or regulated by another Federal agency.

Provides the criteria needed in amendment request if the research will not be conducted, funded, 35.6(c) 44 1 44 4 176 $ 13,728 supported, or regulated by another Federal agency that has implemented the Federal Policy.

35.12(b), (c), &

(d) OMB Clearance 3150-0120 35.13 Describes the requirements that need to be satisfied to notify the Commission, to function as an 35.14(a) & (b) authorized user (AU), authorized 886 2 1772 0.25 443 $ 123,154 medical physicist (AMP), ophthalmic physicist (OP), or authorized nuclear pharmacist (ANP).

Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)

Requires a licensee to notify the Commission within 30 days of when 35.14(b)(1) an ARSO discontinues performance 230 1 230 0.25 57.50 $ 15,985 of duties under the license or has a name change.

Requires a licensee to notify the NRC if it receives certain sealed 35.14(b)(6) 3391 2 6,782 0.25 1,695.50 $ 471,349 sources without first obtaining a license amendment.

Provides that upon application of any interested person or upon its own initiative, the Commission may grant exemptions from the 35.19 regulations in Part 35 that it 29 1 29 1 29 $ 8,062 determines are authorized by law and will not endanger life or property or the common defense and security and are otherwise in the public interest.

Provides that a licensee may permit an individual qualified to be a RSO, 35.24(c) 65 1 65 1 65 $ 18,070 to function as a temporary RSO and to perform the functions of a RSO.

Requires licensees to file a report with the NRC within 5 days in 35.67(e)(2) accordance with § 35.3067 if Burden covered in 35.3067 leakage of a sealed source is detected.

Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)

Requires licensees to provide an individual who has been administered unsealed byproduct material or implants containing byproduct material and who is being released from the licensee's control in accordance with § 35.75(a) with 35.75(b) 3326 20 66520 0.17 11,308 $ 3,143,735 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).

35.204(e) Burden covered in 35.3204(a) & (b)

Requires that the licensee promptly notify the RSO, or his or her 35.315(b) designee, and the AU as soon as 14 1 14 1 14 $ 3,892 possible if the patient has a medical emergency or dies.

Requires that the licensee notify the RSO, or his or her designee, and 35.415(c) AU as soon as possible if the patient 58 1 58 1 58 $ 16,124 or human research subject has a medical emergency or dies.

Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)

Requires a licensee to notify the RSO, or his/her designee, and an AU as soon as possible if the patient or human research subject has a 35.615(f)(4) medical emergency or dies. This 86 1 86 1 86 $ 23,908 notification is required so that the RSO, or his/her designee, or AU can take whatever actions are necessary for radiation safety.

Requires that the AMP review the results of each spot-check and 35.642(c) 7 12 84 0.25 21 $ 5,838 notify the licensee in writing of the results of each spot checks.

With regards to periodic spot-checks for remote afterloader units this section requires licensees to have the AMP review the results of 35.643(c) each spot-check required by 994 155 154070 0.25 38,518 $ 10,707,865 paragraph (a) within 15 days of the check and to notify the licensee as soon as possible in writing of the results of each spot check.

Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit within 15 days of 35.645(b)(2) 101 260 26260 0.25 6,565 $ 1,825,070 each spot-check and to notify the licensee as soon as possible in writing the results of each spot-check.

35.1000() OMB Clearance 3150-0120

Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010) 35.3045(a) & (b) Burden covered in 35.3045(c)(d)&(e)

Requires licensees to notify the NRC by telephone no later than the 35.3045(c) 58 1 58 0.5 29 $ 8,062 next calendar day after discovery of the medical event.

Requires licensees to submit a written report to NRC within 15 days 35.3045(d) 58 1 58 8 464 $ 128,992 of the discovery of the medical event.

Requires the licensee to: (1) annotate a copy of the medical 35.3045(g) event report provided to the NRC 65 1 65 0.5 33 $ 9,035 with spicific infromation outlined in thi section.

35.3047(a) & (b) Burden covered in 35.3047(c) & (d)

Requires the licensee to notify by telephone the NRC Operation Center no later than the next 35.3047(c) calendar day after discovery of a 7 1 7 0.5 4 $ 973 dose to the embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).

Requires the licensee to submit a written report to the appropriate NRC Regional Office no later than 35.3047(d) 15 days after discovery of a dose to 7 1 7 8 56 $ 15,568 the embryo/fetus or nursing child that requires a report under § 35.3047(a) or (b).

Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)

Requires the licensee to notify the referring physician and also notify the pregnant individual or mother (both hereafter referred to as the 35.3047(e) 7 1 7 2 14 $ 3,892 mother) no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery of an event that would require reporting under paragraph § 35.3047(a) or (b).

Requires the licensee to annotate a copy of the report provided to the 35.3047(f) 7 1 7 0.5 4 $ 973 NRC with specific details of the affected individual.

Requires licensees to report detection of a leaking source by submitting a written report within 5 35.3067 days after a leakage test required by 7 1 7 1 7 $ 1,946

§ 35.67 reveal the presence of 185 Bq (0.005 microcurie) or more of removable contamination.

Requires radiopharmacy and medical use licensees to notify both the NRC Operations Center and the distributor of the generator by 35.3204(a) 7 1 7 0.25 1.75 $ 487 telephone within 7 days after discovery that an eluate exceeds the permissible concentration listed in § 35.204(a).

Table 5 - Annual Reporting Requirements Agreement State Licensees (3150-0010)

Requires radiopharmacy and medical use licensees to submit a written report to the appropriate 35.3204(b) NRC Regional Office listed in § 30.6 7 1 7 2.00 14.00 $ 3,892 within 30 days after discovery of an eluate exceeding the permissible concentration listed in § 35.204(a).

Total 256,561 60,929 $ 16,938,304

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention Approval in writing by management of 35.24(a) 6163 5 0.50 15,407.50 $ 4,283,285 5 years other administrative changes.

Appointment of associate RSOs in 35.24(b) 626 2 0.25 313.00 $ 87,014 writing.

Authority, duties, and responsibilities of 35.24(e) Burden covered in 35.2024 the RSO in writing.

Requirement to establish a Radiation Industry 35.24(f) Safety Committee to oversee the 1779 1 0.50 889.50 $ 247,281 practice radiation protection programs.

Requires that a licensee record and retain actions taken pursuant to the 35.24(h) Burden covered in 35.2024 authority and responsibilities within the radiation protection program.

Requires the revision has been reviewed and approved by the Radiation Safety Officer and licensee 35.26(a)(3)&(4) management; and the affected 6163 1 0.50 3,081.50 $ 856,657 5 years individuals are instructed on the revised program before the changes are implemented.

Requires a record of each change to be 35.26(b) Burden covered in 35.2026 retained in accordance with 35.2026.

Requires a licensee that permits the receipt, possession, use, or transfer of 35.27(a) byproduct material by an individual 6163 1 1.00 6,163.00 $ 1,713,314 under the supervision of an AU as allowed by § 35.11(b).

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention A licensee that permits the preparation of byproduct material for medical use by 35.27(b) an individual under the supervision of 1130 1 1.00 1,130.00 $ 314,140 an authorized nuclear pharmacist or physician who is an authorized user.

Requires the information in the oral directive to be documented as soon as possible in writing in the patients 35.40(a)(1) 3622 7 0.25 6,338.50 $ 1,762,103 3 years record and a written directive must be prepared within 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> of the oral directive.

Permits a written revision to an existing written directive if the revision is dated 35.40(c)(1) and signed by an AU before the 3622 10 0.25 9,055.00 $ 2,517,290 3 years administration or the next fractional dose.

Requires the licensee to retain a copy 35.40(d) of the written directive in accordance Burden covered in 35.2040 with § 35.2040.

Requires licensees to develop, implement and maintain written procedures for any administration requiring a written directive to provide high confidence that the patient or Duration of 35.41(a)&(b) 3680 1 0.50 1,840.00 $ 511,520 human research subject's identity is license verified prior to each administration and that each administration is in accordance with the written directive (WD).

35.41(c) Burden covered in 35.2041 35.50(a) 35.50(b)(2) 35.51(a) OMB Clearance 3150-0120

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention 35.51(b)(2) 35.55(a) 35.55(b)(2) 35.60(c) Burden covered in 35.2060 Requires that the licensee conspicuously note on a survey instrument the date that the instrument Equipment 35.61(a)(3) was calibrated. This information is 6163 1 0.03 184.89 $ 51,399 duration necessary to show that survey instruments are calibrated and operational.

35.61(c) Burden covered in 35.2061 35.63(e) Burden covered in 35.2063 Prohibits the bundling or aggregating of single sealed sources to create a Inventory and 35.65(b)(2) sealed source with an activity greater 15 1 2.50 37.50 562.50 leak testing 3 than the maximum activity authorized years by § 35.65.

35.67(d) Burden covered in 35.2067 35.67(g) Burden covered in 35.2067 Requires that each syringe and vial that contains unsealed byproduct material must be labeled, and that each syringe Equipment 35.69 5897 2126 0.02 250,740.44 $ 69,705,842 shield and vial shield must also be duration labeled unless the label on the syringe or vial is visible when shielded.

35.70(c) Burden covered in 35.2070 35.75(c) Burden covered in 35.2075(a) 35.75(d) Burden covered in 35.2075(b)

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention Requires a licensee providing mobile service to obtain a letter signed by the management of each client that permits 3 years after 35.80(a)(1) the use of byproduct material at the 274 20 1.00 5,480.00 $ 1,523,440 last service client's address and delineates the authority and responsibility of the licensee and the client.

35.80(c) Burden covered in 35.2080 35.92(b) Burden covered in 35.2092 35.190(a)

OMB Clearance 3150-0120 35.190(c)(2) 35.204(b) Covered under 35.2204 35.204(c) Burden covered in 35.2204 35.290(a)

OMB Clearance 3150-0120 35.290(c)(2)

Requires that licensees provide safety instruction, initially and at least annually, to personnel caring for 35.310(a) patients or human research subjects 173 1 1.00 173.00 $ 48,094 Annual that have received therapy with unsealed byproduct material and cannot be released in accordance with § 35.75.

35.310(b) Burden covered in 35.2310 Requires a licensee to note on the door or in the patient's chart indicating where and how long visitors may stay in the Duration of 35.315(a)(3) patient's room. This posting and note 173 12 0.10 207.60 $ 57,713 treatment are required so that employees and visitors receive information necessary for radiation safety.

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention 35.390(a) 35.390(b)(2) 35.392(a) 35.392(c)(3) OMB Clearance 3150-0120 35.394(a) 35.394(c)(3) 35.396 (c) 35.396 (d) 35.404(c) Burden covered in 35.2404 35.406(c) Burden covered in 35.2406 Requires licensees to provide safety instruction, initially and at least annually, to personnel caring for 35.410(a) patients or human research subjects 324 1 1.00 324.00 $ 90,072 that are receiving brachytherapy and cannot be released in accordance with

§ 35.75.

35.410(b) Burden covered in 35.2310 Requires a note on the door or in the patient's or human research subject's Duration of 35.415(a)(3) chart where and how long visitors may 324 5 0.10 162.00 $ 45,036 treatment stay in the patient's or human research subject's room.

35.432(d) Burden covered in 35.2432 35.433(b) Burden covered in 35.2433 35.490(a) 35.490(b)(3) OMB Clearance 3150-0120 35.491 (c) 35.590(a)

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention 35.604(b) Burden covered in 35.2404 35.605(d) Burden covered in 35.2605 Requires licensees to develop, implement, and maintain written Possession of 35.610(a)(4) 1095 1 1.00 1095.00 $ 304,410 procedures for responding to an unit abnormal situation.

Requires licensees to physically locate Possession of 35.610(b) a copy of the procedures at the unit 1095 1 0.03 32.85 $ 9,132 unit console.

Requires licensees to post instructions for individuals who operate the devices at the device console providing the Possession of 35.610(c) 1095 1 0.50 547.50 $ 152,205 location of the procedures and unit emergency names and telephone numbers.

Requires all individuals who will operate remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units to receive vendor Possession of 35.610(d) operational and safety training prior to 1095 1 1.00 1095.00 $ 304,410 unit the first use for patient treatment of a new unit or an existing unit with a manufacturer upgrade that affects the operation and safety of the unit.

Requires licensees to ensure that operators, AMPs, and AUs participate 35.610(e) 1095 1 0.50 547.50 $ 152,205 in drills of the emergency procedures, initially and at least annually.

35.610(f) Burden covered in 35.2310 35.610(g) Burden covered in 35.2610 35.630(c) Burden covered in 35.2630 35.632(g) Burden covered in 35.2632

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention 35.633(i) Burden covered in 35.2632 36.635(g) Burden covered in 35.2632 Requires licensees to perform spot check measurements in accordance Possession of 35.642(b) 8 1 4.00 32.00 $ 8,896 with written procedures established by unit the AMP.

Requires that the AMP review the results of each spot-check and notify 35.642(c) 8 12 0.25 24.00 $ 6,672 3 years the licensee in writing of the results of each spot checks.

35.642(f) Burden covered in 35.2642 Requires licensees to perform spot check measurements in accordance Possession of 35.643(b) 980 1 4.00 3920.00 $ 1,089,760 with written procedures established by unit the AMP.

Requires licensees to have the AMP review the results of each spot-check required by paragraph (a) within 15 35.643(c) 980 155 0.25 37975.00 $ 10,557,050 3 years days of the check and to notify the licensee as soon as possible in writing of the results of each spot check.

35.643(f) Burden covered in 35.2643 Requires licensees to perform spot-check measurements in accordance Possession of 35.645(b)(1) 101 1 4.00 404.00 $ 112,312 with written procedures established by unit the AMP.

Requires licensees to have the AMP review the results of each spot-check of a gamma stereotactic radiosurgery unit 35.645(b)(2) within 15 days of each spot-check and 101 260 0.25 6565.00 $ 1,825,070 3 years to notify the licensee as soon as possible in writing the results of each spot-check.

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention 35.645(g) Burden covered in 35.2645 35.647(e) Burden covered in 35.2647 35.652(c) Burden covered in 35.2652 35.655(c) Burden covered in 35.2655 35.690(a)

OMB Clearance 3150-0120 35.690(b)(3)

Requires licensees to retain a record of actions taken by the licensees 35.2024(a) 6163 5 0.25 7703.75 $ 2,141,643 5 years management in accordance with § 35.24(a) for 5 years.

Requires licensees to retain a copy of Duration of 35.2024(b) both the authority, duties, and 6163 2 0.10 1232.60 $ 342,663 license responsibilities of the RSO Requires the licensee to keep the written documents signed by the 5 years after licensees management for each ARSO ARSO is 35.2024(c ) 224 2 1.00 448.00 $ 124,544 appointed under § 35.24(b) for 5 years removed from after the ARSO is removed from the license license.

Requires licensees to retain a record of each radiation protection program 35.2026 6163 1 0.25 1540.75 $ 428,329 5 years change made in accordance with § 35.26(a) for 5 years.

Requires licensees to retain a copy of 35.2040() 3680 104 0.05 19136.00 $ 5,319,808 3 years each written directive.

Requires licensees to retain a copy of Duration of 35.2041 the procedures for administrations 4061 1 0.05 203.05 $ 56,448 license requiring a written directive

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention Requires licensees to retain a copy of 35.2041 the procedures for administrations 183 1 183 9.00 $ 2,502 requiring a written directive Requires licensees to maintain a record 35.2060() of instrument calibrations required by 1124 255 0.02 5732.40 $ 1,593,607 3 years

§ 35.60 for 3 years.

Requires licensees to maintain a record of radiation survey instrument 35.2061 6163 1.5 0.25 2311.13 $ 642,493 3 years calibrations required by § 35.61 for 3 years.

Requires licensees to maintain a record 35.2063 of dosage determinations required by 5976 2126 0.02 254099.52 $ 70,639,667 3 years

§ 35.63 for 3 years.

Requires licensees to retain records of 35.2067(a) leak tests required by 35.67 (b) for 3 6163 3 0.06 1109.34 $ 308,397 3 years years.

Requires that licensees retain records of the semi-annual physical inventory of 35.2067(b) sealed sources and brachytherapy 6163 2 0.06 739.56 $ 205,598 3 years sources required by § 35.67(g) for 3 years.

Requires a licensee to retain a record of 35.2070() each survey required by § 35.70 for 3 2312 43 0.02 1988.32 $ 552,753 3 years years.

Requires licensees to retain a record of the basis for authorizing the release of 35.2075(a) 3248 14 0.25 11368.00 $ 3,160,304 3 years an individual in accordance with § 35.75.

Requires licensees to retain a record that the instructions required by

§ 35.75(b) were provided to a breast-feeding female if the radiation dose to 35.2075(b) 3248 2 0.20 1299.20 $ 361,178 3 years the infant or child from continued breast-feeding could result in a total effective dose equivalent exceeding 5 millisievert (0.5 rem).

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention Requires licensees providing mobile medical services to retain a copy of 3 years after 35.2080(a) each letter that permits the use of 274 20 0.03 164.40 $ 45,703 last service byproduct material at a clients address, as required by § 35.80(a) (1).

Requires licensees to maintain a record 35.2080(b) of each survey required by § 35.80(a) 404 260 0.10 10504.00 $ 2,920,112 3 years (4) for 3 years.

Requires licensees to retain records of 35.2092 the disposal of licensed materials, as 6163 52 0.02 6409.52 $ 1,781,847 3 years required by § 35.92 for 3 years.

Requires licensees to maintain records 35.2204 of molybdenum-99 concentration tests 519 108 0.08 4484.16 $ 1,246,596 3 years required by § 35.204(b) for 3 years.

Requires licensees to maintain records 35.2204 260 1 13 3380.00 $ 939,640 of molybdenum-99 concentration tests required by § 35.204(b) for 3 years.

Requires licensees to maintain a record of safety instructions required by 35.2310 §§ 35.310 and 35.410 and the 1520 1 0.10 152.00 $ 42,256 3 years operational and safety instructions required by § 35.610 for 3 years.

Requires licensees to maintain a record of safety instructions required by 35.2310 §§ 35.310 and 35.410 and the 130 142 1 18460.00 $ 5,131,880 3 years operational and safety instructions required by § 35.610 for 3 years.

Requires licensees to maintain a record 35.2404 of the surveys required by §§ 35.404 1534 61 0.02 1871.48 $ 520,271 3 years and 35.604 for 3 years.

Requires licensees to maintain records 35.2406 of brachytherapy source accountability 584 15 0.20 1752.00 $ 487,056 3 years required by § 35.406 for 3 years.

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention Requires licensees to maintain a record of calibrations of brachytherapy sources 35.2432 584 15 0.20 1752.00 $ 487,056 3 years required by § 35.432 for 3 years after the last use of the source.

Requires licensees to maintain a record of the activity of a strontium-90 source 35.2433 108 70 0.50 3780.00 $ 1,050,840 Life of source required by § 35.433 for the life of the source.

Requires licensees to retain records of installation, maintenance, adjustment, and repair of remote afterloader units, 35.2605 1102 5 2.00 11020.00 $ 3,063,560 3 years teletherapy units, and gamma stereotactic radiosurgery units as required by § 35.605 for 3 years.

Requires licensees to maintain records of procedures required by§ 35.610(a)

(4) and (d) (2) until the licensee no Possession of 35.2610() 1095 2 0.05 109.50 $ 30,441 longer possesses the remote unit afterloader, teletherapy unit, or gamma stereotactic radiosurgery unit.

Requires licensees to retain a record of the calibration, intercomparison, and 35.2630() comparisons of its dosimetry equipment 1109 1 0.50 554.50 $ 154,151 3 years done in accordance with § 35.630 for the duration of the license.

Requires licensees to retain a record of the calibration, intercomparison, and 35.2632 comparisons of its dosimetry equipment 1023 4.6 4.00 18823.20 $ 5,232,850 3 years done in accordance with § 35.630 for the duration of the license.

Requires licensees to maintain records of the teletherapy unit, remote afterloader unit, and gamma 35.2642 (a) 8 12 0.50 48.00 $ 13,344 3 years stereotactic radiosurgery unit full calibrations required by §§ 35.632, 35.633, and 35.635 for 3 years.

Table 6 - Annual Recordkeeping Requirements for Agreement State Licensees Records per Burden hours per Total Annual Record Section Description Recordkeepers Cost @ $278/HR Licensee record Burden Retention Requires licensees to retain a record of Possession of 35.2642 (c) each periodic spot-check for teletherapy 8 1 0.05 0.40 $ 111 unit units required by § 35.642 for 3 years.

Requires licensees to retain a copy of the written procedures for periodic spot-35.2643 (a) 951 155 1.00 147405.00 $ 40,978,590 3 years checks for teletherapy units established by the AMP.

Requires licensees to retain records of Possession of 35.2643 (c) each spot-check for remote afterloader 951 1 0.05 47.55 $ 13,219 unit units required by §§ 35.643 for 3 years.

Requires licensees to retain a copy of the written procedures for periodic spot-35.2645 (a) 94 260 2.00 48880.00 $ 13,588,640 3 years checks for remote afterloader units established by the AMP.

Requires licensees to retain a copy of the written procedures for periodic spot-Possession of 35.2645 (c) checks for gamma stereotactic 94 1 0.05 4.70 $ 1,307 unit radiosurgery units established by the AMP.

Requires licensees to retain records of each check for mobile remote 35.2647 15 260 0.50 1950.00 $ 542,100 3 years afterloader units required by § 35.647 for 3 years.

Requires licensees to maintain records of radiation surveys of treatment units Duration of use 35.2652 1102 1 0.50 551.00 $ 153,178 made in accordance with § 35.652 for of unit the duration of use of the unit.

Requires licensees to maintain a record of the 5-year inspections for teletherapy and gamma stereotactic Duration of use 35.2655 108 0.2 1.00 21.60 $ 6,005 of unit radiosurgery units required by § 35.655 for the duration of use of the unit.

Total 6163 944,811 $ 262,657,432

Table 7 - Annual Reporting Requirements AS Licensees (3150-0010)

Responses Total Number of Total Burden per Per Annual Section Description Responde Number of Response Cost @ $278/hr Responde Burden nts Responses (Hours) nt (Hours)

Requires the licensee to notify the referring physician and the individual who is the subject of the medical event, or that individual's responsible relative 35.3045(e) 43 1 43 2 86 $ 23,908 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 />.

Requires radiopharmacy and medical use licensees to notify both the NRC Operations Center and the distributor of the 35.3204(a) generator by telephone within 7 14 1 14 2 28 $ 7,784 days after discovery that an eluate exceeds the permissible concentration listed in

§ 35.204(a).

Total 57 114 $ 31,692

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)

Records Total Total No of Burden per Cost @ Record Section Description per Number of Annual Recordkeepers record $278/HR Retention Licensee Records Burden Requires that a licensee's management appoint a RSO who agrees, in writing, 35.24(b) to be responsible for implementing the radiation protection program.

Burden covered in 35.2024(c)

Requires licensees to develop, implement and maintain written procedures for any administration requiring a written directive to provide high confidence 35.41(a) that the patient or human Burden covered in 35.2041 research subject's identity is verified prior to each administration and that each administration is in accordance with the written directive (WD).

Requires licensees to develop, implement, and maintain written procedures for any administration 35.41(b)(5) Covered in 35.41(a) 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)

Requires licensees to develop, implement, and 35.41(b)(6) maintain written procedures Covered in 35.41(a) for permanent implant brachytherapy.

Requires the licensee to retain a copy of the 35.41(c) procedures required by Covered in 35.2041

§ 35.41(a) in accordance with § 35.2041 Prohibits the bundling or aggregating of single sealed Inventory sources to create a sealed and leak 35.65(b)(2) source with an activity 58 1 58 2.00 116.00 $32,248 testing 3 greater than the maximum years activity authorized by

§ 35.65.

Requires the licensee to keep the written documents signed by the licensees 5 years after management for each ARSO is 35.2024(c) 6163 1 6,163 1.00 6,163.00 $1,713,314 ARSO appointed under removed

§ 35.24(b) for 5 years after from license the ARSO is removed from the license.

Requires licensees to retain a copy of the procedures for administrations requiring a Duration of 35.2041 6163 1 6,163 9.00 55,467.00 $15,419,826 written directive, required by the license

§ 35.41, for the duration of the license.

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 6163 20,582.00 $5,721,796 Total

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 Part 35 Respondents NRC licensees 856 Agreement State licensees 6,163 Specialty certifying entities 2 Total 7,021 Other costs (item #13) $ 122,006

Previous Part 35 Burden Totals 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