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pdfTable 1 – Annual Reporting Requirements
NRC Licensees (3150-0010)
Section
Description
35.6(b)
Research application information needed if
the research is conducted, funded,
supported, or regulated by another Federal
agency.
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.
Number of
Respondents
Responses Per
Respondent
Total Number
of Responses
Burden per
Response
(Hours)
1
61
4
244 $
70,760
6
1
6
4
24 $
6,960
OMB Clearance 3150-0120
35.13
OMB Clearance 3150-0120
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.
35.14(b)(6)
Requires a licensee to notify the NRC if it
receives certain sealed sources without first
obtaining a license amendment.
Cost @
$290/Hr
61
35.12(b), (c), &
(d)
Describes the requirements that need to be
satisfied to notify the Commission, to
function as an authorized user (AU),
35.14(a) & (b)
authorized medical physicist (AMP),
ophthalmic physicist (OP), or authorized
nuclear pharmacist (ANP).
Total Annual
Burden (Hours)
105
2
210
0.25
52.5 $
15,225
48
1
48
0.25
12 $
3,480
464
2
928
0.25
232 $
67,280
Table 1 – Annual Reporting Requirements
NRC Licensees (3150-0010)
Section
35.19
Description
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.
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.
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.
Number of
Respondents
Responses Per
Respondent
Burden per
Response
(Hours)
Total Annual
Burden (Hours)
Cost @
$290/Hr
4
1
4
1
4 $
1,160
5
1
5
1
5 $
1,450
2 $
580
Burden covered in 35.3067
Burden covered in 35.3204(a) & (b)
35.204(e)
35.315(b)
Total Number
of Responses
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
Table 1 – Annual Reporting Requirements
NRC Licensees (3150-0010)
Section
35.415(c)
35.615(f)(4)
Description
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.
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.
Number of
Respondents
Responses Per
Respondent
Total Number
of Responses
Burden per
Response
(Hours)
Total Annual
Burden (Hours)
Cost @
$290/Hr
8
1
8
1
8 $
2,320
15
1
15
1
15 $
4,350
1
12
12
0.25
3 $
870
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.
35.643(c)
With regards to periodic spot-checks for
remote afterloader units this section
requires licensees to have the AMP review
the results of each spot-check required by
paragraph (a) within 15 days of the check
and to notify the licensee as soon as
possible in writing of the results of each
spot check.
144
155
22320
0.25
5580 $
1,618,200
35.645(b)(2)
Requires licensees to have the AMP review
the results of each spot-check of a gamma
stereotactic radiosurgery unit within 15 days
of each spot-check and to notify the
licensee as soon as possible in writing the
results of each spot-check.
15
260
3900
0.25
975 $
282,750
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)
35.1000()
OMB Clearance 3150-0120
35.3045(a) &
(b)
Burden covered in 35.3045(c) & (d)
Total Annual
Burden (Hours)
Cost @
$290/Hr
35.3045(c)
Requires licensees to notify the NRC by
telephone no later than the next calendar
day after discovery of the medical event.
5
1
5
0.5
2.5 $
725
35.3045(d)
Requires licensees to submit a written
report to NRC within 15 days of the
discovery of the medical event.
5
1
5
8
40 $
11,600
Table 1 – Annual Reporting Requirements
NRC Licensees (3150-0010)
Section
35.3045(g)
Description
Requires the licensee to: (1) annotate a
copy of the medical event report provided to
the NRC with spicific infromation outlined in
thi section.
Number of
Respondents
Responses Per
Respondent
5
35.3047(a) &
(b)
Total Number
of Responses
1
5
Burden per
Response
(Hours)
Total Annual
Burden (Hours)
0.5
Cost @
$290/Hr
2.5 $
725
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 $
145
35.3047(d)
Requires the licensee to submit a written
report to the appropriate NRC Regional
Office no later than 15 days after discovery
of a dose to the embryo/fetus or nursing
child that requires a report under §
35.3047(a) or (b).
1
1
1
8
8 $
2,320
35.3047(e)
Requires the licensee to notify the referring
physician and also notify the pregnant
individual or mother (both hereafter referred
to as the mother) no later than 24 hours
after discovery of an event that would
require reporting under paragraph §
35.3047(a) or (b).
1
1
1
2
2 $
580
Table 1 – Annual Reporting Requirements
NRC Licensees (3150-0010)
Section
35.3047(f)
35.3067
35.3204(a)
35.3204(b)
Total
Description
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.
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.
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).
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).
Number of
Respondents
Responses Per
Respondent
Total Number
of Responses
Burden per
Response
(Hours)
Total Annual
Burden (Hours)
Cost @
$290/Hr
1
1
1
0.5
0.5 $
145
1
1
1
1
1 $
290
1
1
1
0.25
1 $
290
1
1
1
2.00
1 $
290
7,216 $
2,092,495
27,541
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
35.24(a)
35.24(b)
35.24(e)
Description
Approval in writing by
management of other
administrative changes.
Appointment of associate RSOs
in writing.
Authority, duties, and
responsibilities of the RSO in
writing.
35.24(f)
Requirement to establish a
Radiation Safety Committee to
oversee the radiation protection
programs.
35.24(h)
Requires that a licensee record
and retain actions taken pursuant
to the authority and
responsibilities within the radiation
protection program.
35.26(a)(3)&(4)
Requires the revision has been
reviewed and approved by the
Radiation Safety Officer and
licensee management; and the
affected individuals are instructed
on the revised program before the
changes are implemented.
35.26(b)
Requires a record of each change
to be retained in accordance with
35.2026.
35.27(a)
Requires a licensee that permits
the receipt, possession, use, or
transfer of byproduct material by
an individual under the
supervision of an AU as allowed
by § 35.11(b).
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
862
5
0.50
2,155.00 $
624,950
89
2
0.25
44.50 $
12,905
Record Retention
5 years
Burden covered in 35.2024
227
1
0.50
113.50 $
32,915
Industry practice
124,990
5 years
Burden covered in 35.2024
862
1
0.50
431.00 $
Burden covered in 35.2026
862
1
1
862 $
249,980
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Section
Description
35.27(b)
A licensee that permits the
preparation of byproduct material
for medical use by an individual
under the supervision of an
authorized nuclear pharmacist or
physician who is an authorized
user.
162
1
1.00
162.00 $
46,980
35.40(a)(1)
Requires the information in the
oral directive to be documented
as soon as possible in writing in
the patient’s record and a written
directive must be prepared within
48 hours of the oral directive.
425
7
0.25
743.75 $
215,688
3 years
35.40(c)(1)
Permits a written revision to an
existing written directive if the
revision is dated and signed by an
AU before the administration or
the next fractional dose.
425
10
0.25
1062.50 $
308,125
3 years
68,730
Duration of license
35.40(d)
Requires the licensee to retain a
copy of the written directive in
accordance with § 35.2040.
35.41(a)&(b)
Requires licensees to develop,
implement and maintain written
procedures for any administration
requiring a written directive to
provide high confidence that the
patient or human research
subject's identity is verified prior
to each administration and that
each administration is in
accordance with the written
directive (WD).
35.41(c)
Record Retention
Burden covered in 35.2040
474
1
0.50
237.00 $
Burden covered in 35.2041
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Record Retention
35.50(a)
35.50(b)(2)
35.51(a)
35.51(b)(2)
35.55(a)
35.55(b)(2)
OMB Clearance 3150-0120
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.
862
1
0.03
25.86 $
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
35.67(a)
Burden covered in 35.2067
35.67 (d)
Burden covered in 35.2067
7,499
$1,390
Equipment duration
Inventory and leak
testing 3 years
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
35.69
Description
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.
No of
Recordkeepers
776
Records per
Licensee
Burden per
record
2126
0.02
Total Annual
Burden
32,995.52 $
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.
25
20
1.00
500.00 $
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)
Cost @
$290/HR
9,568,701
145,000
Record Retention
Equipment duration
3 years after last
service
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
record
35.290(a)
35.310(a)
Requires that licensees provide
safety instruction, initially and at
least annually, to personnel caring
for patients or human research
subjects that have received
therapy with unsealed byproduct
material and cannot be released
in accordance with § 35.75.
22
1
1.00
22 $
Requires a licensee to note on the
door or in the patient's chart
indicating where and how long
visitors may stay in the patient's
room. This posting and note are
required so that employees and
visitors receive information
necessary for radiation safety.
22
12
0.10
26.4 $
35.390(b)(2)
35.392(a)
35.392(c)(3)
35.394(c)(3)
6,380
Annual
Burden covered in 35.2310
35.390(a)
35.394(a)
Record Retention
OMB Clearance 3150-0120
35.310(b)
35.315(a)(3)
Cost @
$290/HR
Burden covered in 35.2204
35.204(d)
35.290(c)(2)
Total Annual
Burden
OMB Clearance 3150-0120
7,656 Duration of treatment
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Record Retention
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)
35.67(a)
35.410(b)
35.415(a)(3)
Requires licensees to provide
safety instruction, initially and at
least annually, to personnel caring
for patients or human research
subjects that are receiving
brachytherapy and cannot be
released in accordance with §
35.75.
43
1
1.00
43 $
12,470
Burden covered in 35.2067
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
long visitors may stay in the
patient's or human research
subject's room.
43
5
0.10
21.5 $
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
6,235 Duration of treatment
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
Total Annual
record
Burden
OMB Clearance 3150-0120
Cost @
$290/HR
Record Retention
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)
35.610(b)
35.610(c)
35.610(d)(1)
Requires licensees to develop,
implement, and maintain written
procedures for responding to an
abnormal situation.
Requires licensees to physically
locate a copy of the procedures at
the unit console.
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.
Requires all individuals who will
operate remote afterloader units,
teletherapy units, and gamma
stereotactic radiosurgery units to
receive vendor operational and
safety training prior to the first use
for patient treatment of a new unit
or an existing unit with a
manufacturer upgrade that affects
the operation and safety of the
unit.
160
1
1.00
160.00 $
46,400
Possession of unit
160
1
0.03
4.80 $
1,392
Possession of unit
160
1
0.50
80.00 $
23,200
Possession of unit
160
1
1.00
160.00 $
46,400
Possession of unit
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
35.610(d)(2)
Requires licensees to provide
initial instruction and annual
refresher instruction to all
individuals who operate the unit in
the procedures identified in §
35.610(a) and the operating
procedures for the unit.
160
1
1.00
160.00 $
46,400
35.610(e)
Requires licensees to ensure that
operators, AMPs, and AUs
participate in drills of the
emergency procedures, initially
and at least annually.
160
1
0.50
80.00 $
23,200
35.610(f)
Burden covered in 35.2310
35.610(g)
35.630(c)
35.632(g)
35.633(i)
36.635(g)
Burden covered in 35.2610
Burden covered in 35.2630
Burden covered in 35.2632
Burden covered in 35.2632
Burden covered in 35.2632
35.642(b)
Requires licensees to perform
spot check measurements in
accordance with written
procedures established by the
AMP.
1
1
4.00
4.00 $
1,160
35.642(c)
Requires that the AMP review the
results of each spot-check and
notify the licensee in writing of the
results of each spot checks.
1
12
0.25
3.00 $
870
35.642(f)
Burden covered in 35.2642
Record Retention
Possession of unit
Possession of unit
3 years
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
35.643(b)
Requires licensees to perform
spot check measurements in
accordance with written
procedures established by the
AMP.
144
1
4.00
576.00 $
167,040
35.643(c)
Requires licensees to have the
AMP review the results of each
spot-check required by paragraph
(a) within 15 days of the check
and to notify the licensee as soon
as possible in writing of the
results of each spot check.
144
155
0.25
5580.00 $
1,618,200
Record Retention
Possession of unit
3 years
Burden covered in 35.2643
35.643(f)
35.645(b)(1)
Requires licensees to perform
spot-check measurements in
accordance with written
procedures established by the
AMP.
15
1
4.00
60.00 $
17,400
Possession of unit
35.645(b)(2)
Requires licensees to have the
AMP review the results of each
spot-check of a gamma
stereotactic radiosurgery unit
within 15 days of each spot-check
and to notify the licensee as soon
as possible in writing the results
of each spot-check.
15
260
0.25
975.00 $
282,750
3 years
35.645(g)
Burden covered in 35.2645
35.647(e)
35.652(c)
Burden covered in 35.2647
Burden covered in 35.2652
35.655(c)
Burden covered in 35.2655
35.690(a)
OMB Clearance 3150-0120
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
35.690(b)(3)
No of
Recordkeepers
Records per
Licensee
Burden per
Total Annual
record
Burden
OMB Clearance 3150-0120
Cost @
$290/HR
Record Retention
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.
862
5
0.25
1,077.50 $
312,475
5 years
35.2024(b)
Requires licensees to retain a
copy of both the authority, duties,
and responsibilities of the RSO
862
2
0.10
172.40 $
49,996
Duration of license
35.2024(c)
Requires the licensee to keep the
written documents signed by the
licensee’s management for each
ARSO appointed under § 35.24(b)
for 5 years after the ARSO is
removed from the license.
88
1
88.00 $
25,520
5 years after ARSO is
removed from license
35.2026
Requires licensees to retain a
record of each radiation protection
program change made in
accordance with § 35.26(a) for 5
years.
862
1
0.25
215.50 $
62,495
5 years
Requires licensees to retain a
copy of each written directive.
425
104
0.05
2,210.00 $
640,900
3 years
35.2041
Requires licensees to retain a
copy of the procedures for
administrations requiring a written
directive
425
1
0.05
21.25 $
6,163
35.2060()
Requires licensees to maintain a
record of instrument calibrations
required by § 35.60 for 3 years.
161
255
0.02
821.10 $
238,119
3 years
35.2061
Requires licensees to maintain a
record of radiation survey
instrument calibrations required
by § 35.61 for 3 years.
862
1.5
0.25
323.25 $
93,743
3 years
35.2040 ()
1.00
Duration of license
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Section
Description
Record Retention
35.2063
Requires licensees to maintain a
record of dosage determinations
required by § 35.63 for 3 years.
776
2126
0.02
32,995.52 $
9,568,701
3 years
35.2067(a)
Requires licensees to retain
records of leak tests required by
35.67 (b) for 3 years.
862
3
0.06
155.16 $
44,996
3 years
35.2067(b)
Requires that licensees retain
records of the semi-annual
physical inventory of sealed
sources and brachytherapy
sources required by § 35.67(g) for
3 years.
862
2
0.06
103.44 $
29,998
3 years
35.2070()
Requires a licensee to retain a
record of each survey required by
§ 35.70 for 3 years.
300
43
0.02
258.00 $
74,820
3 years
35.2075(a)
Requires licensees to retain a
record of the basis for authorizing
the release of an individual in
accordance with § 35.75.
425
14
0.25
1,487.50 $
431,375
3 years
35.2075(b)
Requires licensees to retain a
record that the instructions
required by § 35.75(b) were
provided to a breast-feeding
female if the radiation dose to the
infant or child from continued
breast-feeding could result in a
total effective dose equivalent
exceeding 5 millisievert (0.5 rem).
425
2
0.20
170.00 $
49,300
3 years
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
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).
35.2080(b)
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Record Retention
3 years after last
service
25
20
0.03
15.00 $
4,350
Requires licensees to maintain a
record of each survey required by
§ 35.80(a) (4) for 3 years.
25
260
0.10
650.00 $
188,500
3 years
35.2092
Requires licensees to retain
records of the disposal of licensed
materials, as required by § 35.92
for 3 years.
862
52
0.02
896.48 $
259,979
3 years
35.2204
Requires licensees to maintain
records of molybdenum-99,
strontium-82, and strontium-85
concentration tests required by §
35.204(b) for 3 years.
40
108
0.08
345.60 $
100,224
3 years
35.2310
Requires licensees to maintain a
record of safety instructions
required by §§ 35.310 and 35.410
and the operational and safety
instructions required by § 35.610
for 3 years.
225
1
0.10
22.50 $
6,525
3 years
35.2404
Requires licensees to maintain a
record of the surveys required by
§§ 35.404 and 35.604 for 3 years.
215
97
0.02
417.10 $
120,959
3 years
95
15
0.20
285.00 $
82,650
3 years
35.2406
Requires licensees to maintain
records of brachytherapy source
accountability required by §
35.406 for 3 years.
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Section
Description
Record Retention
35.2432
Requires licensees to maintain a
record of calibrations of
brachytherapy sources required
by § 35.432 for 3 years after the
last use of the source.
95
15
0.20
285.00 $
82,650
3 years
35.2433
Requires licensees to maintain a
record of the activity of a
strontium-90 source required by §
35.433 for the life of the source.
12
70
0.50
420.00 $
121,800
Life of source
35.2605
Requires licensees to retain
records of installation,
maintenance, adjustment, and
repair of remote afterloader units,
teletherapy units, and gamma
stereotactic radiosurgery units as
required by § 35.605 for 3 years.
160
5
2.00
1,600.00 $
464,000
3 years
35.2610()
Requires licensees to maintain
records of procedures required
by§ 35.610(a) (4) and (d) (2) until
the licensee no longer possesses
the remote afterloader,
teletherapy unit, or gamma
stereotactic radiosurgery unit.
160
2
0.05
16.00 $
4,640
Possession of unit
35.2630()
Requires licensees to retain a
record of the calibration,
intercomparison, and
comparisons of its dosimetry
equipment done in accordance
with § 35.630 for the duration of
the license.
163
1
0.50
81.50 $
23,635
3 years
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
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.
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Record Retention
160
4.6
4.00
2,944.00 $
853,760
3 years
35.2642(a)
Requires licensees to retain a
record of each periodic spotcheck for teletherapy units
required by § 35.642 for 3 years.
1
12
0.50
6.00 $
1,740
3 years
35.2642(c)
Requires licensees to retain a
copy of the written procedures for
periodic spot-checks for
teletherapy units established by
the AMP.
1
1
0.05
0.05 $
15
35.2643(a)
Requires licensees to retain
records of each spot-check for
remote afterloader units required
by §§ 35.643 for 3 years.
125
155
1.00
19,375.00 $
5,618,750
35.2643(c)
Requires licensees to retain a
copy of the written procedures for
periodic spot-checks for remote
afterloader units established by
the AMP.
125
1
0.05
6.25 $
1,813
35.2645(a)
Requires licensees to retain
records of each spot-check for
gamma stereotactic radiosurgery
units required by § 35.645 for 3
years.
15
260
2.00
7,800.00 $
2,262,000
Possession of unit
3 years
Possession of unit
3 years
Table 2 – Annual Recordkeeping Requirements
NRC Licensees (3150-0010)
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Record Retention
35.2645(c)
Requires licensees to retain a
copy of the written procedures for
periodic spot-checks for gamma
stereotactic radiosurgery units
established by the AMP.
15
1
0.05
0.75 $
218
35.2647
Requires licensees to retain
records of each check for mobile
remote afterloader units required
by § 35.647 for 3 years.
1
260
0.50
130.00 $
37,700
35.2652
Requires licensees to maintain
records of radiation surveys of
treatment units made in
accordance with § 35.652 for the
duration of use of the unit.
160
1
0.50
80.00 $
23,200 Duration of use of unit
35.2655
Requires licensees to maintain a
record of the 5-year inspections
for teletherapy and gamma
stereotactic radiosurgery units
required by § 35.655 for the
duration of use of the unit.
16
0.2
1.00
3.20 $
928 Duration of use of unit
Total
862
122,771.38 $
35,603,700
Possession of unit
3 years
Table 3 – Annual Third Party Disclosure Requirements
NRC Licensees (3150-0010)
Section
Description
Requires licensees to
provide an individual who
has been administered
unsealed byproduct
material or implants
containing byproduct
material and who is being
released from the
licensee's control in
accordance with §
35.75(b)
35.75(a) with instructions
on actions recommended
to maintain doses to
other individuals as low
as is reasonably
achievable if the total
effective dose equivalent
to any other individual is
likely to exceed 1 mSv
(0.1 rem).
Notification of medical
event to the referring
physician and individual
35.3045(e)
who is the subject of the
medical event within 24
hours
Number of Responses
Total
Burden per
Respondent
Per
Number of Response
s
Respondent Responses (Hours)
Total
Annual
Burden
(Hours)
Cost @
$290/Hr
425
20
8500
0.17
1445 $
419,050
5
2
10
2
20 $
5,800
Table 3 – Annual Third Party Disclosure Requirements
NRC Licensees (3150-0010)
Requires radiopharmacy
and medical use
licensees to notify both
the NRC Operations
Center and the distributor
of the generator by
35.3204(a)
telephone within 7 days
after discovery that an
eluate exceeds the
permissible
concentration listed in
§ 35.204(a).
Total
1
1
1
8511
0.25
0.25 $
73
1465.25 $
424,923
Table 5 – Annual Reporting Requirements
Agreement State Licensees (3150-0010)
Description
Section
Number of
Responses
Per
Respondent
Respondents
35.6(b)
Research application information
needed if the research is conducted,
funded, supported, or regulated by
another Federal agency.
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.
Total Responses
Burden per
Response
(Hours)
Total Annual
Burden
(Hours)
Cost @
$290/HR
458
1
458
4
1,832
$
531,280
45
1
45
4
180
$
52,200
0.25
394
$
114,260
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
medical physicist (AMP), ophthalmic
physicist (OP), or authorized nuclear
pharmacist (ANP).
788
2
1576
Table 5 – Annual Reporting Requirements
Agreement State Licensees (3150-0010)
35.14(b)(1)
Requires a licensee to notify the
Commission within 30 days of when
an ARSO discontinues performance
of duties under the license or has a
name change.
35.14(b)(6)
Requires a licensee to notify the
NRC if it receives certain sealed
sources without first obtaining a
license amendment.
35.19
35.24(c)
35.67(e)(2)
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.
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.
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.
360
1
360
0.25
90.00
$
26,100
3480
2
6,960
0.25
1,740.00
$
504,600
30
1
30
1
30
$
8,700
38
1
38
1
38
$
11,020
Burden covered in 35.3067
Table 5 – Annual Reporting Requirements
Agreement State Licensees (3150-0010)
Burden covered in 35.3204(a) & (b)
35.204(e)
35.315(b)
Requires that the licensee promptly
notify the RSO, or his or her
designee, and the AU as soon as
possible if the patient has a medical
emergency or dies.
15
1
15
1
15
$
4,350
35.415(c)
Requires that the licensee notify the
RSO, or his or her designee, and AU
as soon as possible if the patient or
human research subject has a
medical emergency or dies.
60
1
60
1
60
$
17,400
35.615(f)(4)
Requires a licensee to notify the
RSO, or his/her designee, and an
AU as soon as possible if the patient
or human research subject has a
medical emergency or dies. This
notification is required so that the
RSO, or his/her designee, or AU can
take whatever actions are necessary
for radiation safety.
113
1
113
1
113
$
32,770
35.642(c)
Requires that the AMP review the
results of each spot-check and notify
the licensee in writing of the results
of each spot checks.
8
12
96
0.25
24
$
6,960
Table 5 – Annual Reporting Requirements
Agreement State Licensees (3150-0010)
35.643(c)
35.645(b)(2)
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.
Requires licensees to have the AMP
review the results of each spotcheck 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 spotcheck.
$ 12,136,500
1080
155
167400
0.25
41,850
113
260
29380
0.25
7,345
$
2,130,050
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.
52
1
52
0.5
26
$
7,540
35.3045(d)
Requires licensees to submit a
written report to NRC within 15 days
of the discovery of the medical
event.
52
1
52
8
416
$
120,640
35.3045(g)
Requires the licensee to: (1)
annotate a copy of the medical event
report provided to the NRC with
spicific infromation outlined in thi
section.
38
1
38
0.5
19
$
5,510
35.3047(a) & (b)
Burden covered in 35.3047(c) & (d)
Table 5 – Annual Reporting Requirements
Agreement State Licensees (3150-0010)
35.3047(c)
Requires the licensee to notify by
telephone the NRC Operation
Center no later than the next
calendar day after discovery of a
dose to the embryo/fetus or nursing
child that requires a report under §
35.3047(a) or (b).
8
1
8
0.5
4
$
1,160
35.3047(d)
Requires the licensee to submit a
written report to the appropriate NRC
Regional Office no later than 15
days after discovery of a dose to the
embryo/fetus or nursing child that
requires a report under § 35.3047(a)
or (b).
8
1
8
8
64
$
18,560
35.3047(e)
Requires the licensee to notify the
referring physician and also notify
the pregnant individual or mother
(both hereafter referred to as the
mother) no later than 24 hours after
discovery of an event that would
require reporting under paragraph §
35.3047(a) or (b).
8
1
8
2
16
$
4,640
35.3047(f)
Requires the licensee to annotate a
copy of the report provided to the
NRC with specific details of the
affected individual.
8
1
8
0.5
4
$
1,160
35.3067
Requires licensees to report
detection of a leaking source by
submitting a written report within 5
days after a leakage test required by
§ 35.67 reveal the presence of 185
Bq (0.005 microcurie) or more of
removable contamination.
8
1
8
1
8
$
2,320
Table 5 – Annual Reporting Requirements
Agreement State Licensees (3150-0010)
35.3204(a)
Requires radiopharmacy and
medical use licensees to notify both
the NRC Operations Center and the
distributor of the generator by
telephone within 7 days after
discovery that an eluate exceeds the
permissible concentration listed in
§ 35.204(a).
8
1
8
0.25
2.00
$
580
35.3204(b)
Requires radiopharmacy and
medical use licensees to submit a
written report to the appropriate NRC
Regional Office listed in § 30.6
within 30 days after discovery of an
eluate exceeding the permissible
concentration listed in § 35.204(a).
8
1
8
2.00
16.00
$
4,640
Total
206,729
54,286
$ 15,742,940
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
35.24(a)
Approval in writing by management of
other administrative changes.
35.24(b)
Appointment of associate RSOs in
writing.
35.24(e)
Authority, duties, and responsibilities of
the RSO in writing.
35.24(f)
Requirement to establish a Radiation
Safety Committee to oversee the
radiation protection programs.
35.24(h)
Requires that a licensee record and
retain actions taken pursuant to the
authority and responsibilities within the
radiation protection program.
35.26(a)(3)&(4)
Requires the revision has been
reviewed and approved by the Radiation
Safety Officer and licensee
management; and the affected
individuals are instructed on the revised
program before the changes are
implemented.
35.26(b)
Requires a record of each change to be
retained in accordance with 35.2026.
35.27(a)
Requires a licensee that permits the
receipt, possession, use, or transfer of
byproduct material by an individual
under the supervision of an AU as
allowed by § 35.11(b).
Recordkeepers
Records per
Licensee
Burden hours per
record
Total Annual
Burden
Cost @ $290/HR
Record
Retention
6465
5
0.50
16,162.50
$
4,687,125
5 years
668
2
0.25
334.00
$
96,860
851.50
$
246,935 Industry practice
3,232.50
$
937,425
6,163.00
$
1,787,270
Burden covered in 35.2024
1703
1
0.50
Burden covered in 35.2024
6465
1
0.50
Burden covered in 35.2026
6163
1
1.00
5 years
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Burden hours per
record
Total Annual
Burden
35.27(b)
A licensee that permits the preparation
of byproduct material for medical use by
an individual under the supervision of an
authorized nuclear pharmacist or
physician who is an authorized user.
1215
1
1.00
1,215.00
$
352,350
35.40(a)(1)
Requires the information in the oral
directive to be documented as soon as
possible in writing in the patient’s record
and a written directive must be prepared
within 48 hours of the oral directive.
3188
7
0.25
5,579.00
$
1,617,910
3 years
35.40(c)(1)
Permits a written revision to an existing
written directive if the revision is dated
and signed by an AU before the
administration or the next fractional
dose.
3188
10
0.25
7,970.00
$
2,311,300
3 years
35.40(d)
Requires the licensee to retain a copy of
the written directive in accordance with
§ 35.2040.
35.41(a)&(b)
Requires licensees to develop,
implement and maintain written
procedures for any administration
requiring a written directive to provide
high confidence that the patient or
human research subject's identity is
verified prior to each administration and
that each administration is in
accordance with the written directive
(WD).
1,777.50
$
515,475
Duration of
license
Burden covered in 35.2040
3555
1
0.50
Burden covered in 35.2041
35.50(a)
35.50(b)(2)
35.51(a)
35.51(b)(2)
35.55(a)
Cost @ $290/HR
Record
Retention
Description
35.41(c)
Recordkeepers
Records per
Licensee
Section
OMB Clearance 3150-0120
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
Recordkeepers
35.55(b)(2)
Records per
Licensee
Burden hours per
record
Requires that the licensee
conspicuously note on a survey
instrument the date that the instrument
was calibrated. This information is
necessary to show that survey
instruments are calibrated and
operational.
6465
1
0.03
193.95
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
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
shield and vial shield must also be
labeled unless the label on the syringe
or vial is visible when shielded.
5820
2126
0.02
$
Record
Retention
247,466.40
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)
56,246
Equipment
duration
Inventory and
$10,875 leak testing 3
years
37.50
35.67(d)
35.69
Cost @ $290/HR
Burden covered in 35.2060
35.60(c)
35.61(a)(3)
Total Annual
Burden
$
71,765,256
Equipment
duration
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
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.
Recordkeepers
188
Records per
Licensee
Burden hours per
record
20
Total Annual
Burden
1.00
35.80(c)
Burden covered in 35.2080
35.92(b)
Burden covered in 35.2092
35.190(a)
35.204(b)
Covered under 35.2204
35.204(c)
Burden covered in 35.2204
35.290(a)
3,760.00
$
1,090,400
3 years after
last service
165.00
$
47,850
Annual
198.00
$
57,420
Duration of
treatment
OMB Clearance 3150-0120
35.290(c)(2)
Requires that licensees provide safety
instruction, initially and at least annually,
to personnel caring for patients or
human research subjects that have
received therapy with unsealed
byproduct material and cannot be
released in accordance with § 35.75.
165
1
1.00
Burden covered in 35.2310
35.310(b)
35.315(a)(3)
Record
Retention
OMB Clearance 3150-0120
35.190(c)(2)
35.310(a)
Cost @ $290/HR
Requires a licensee to note on the door
or in the patient's chart indicating where
and how long visitors may stay in the
patient's room. This posting and note
are required so that employees and
visitors receive information necessary
for radiation safety.
165
12
0.10
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
Recordkeepers
Records per
Licensee
Burden hours per
record
Total Annual
Burden
Cost @ $290/HR
Record
Retention
35.390(a)
35.390(b)(2)
35.392(a)
35.392(c)(3)
35.394(a)
35.394(c)(3)
35.396 (c)
35.396 (d)
OMB Clearance 3150-0120
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.
323
1
323.00
$
93,670
161.50
$
46,835
Burden covered in 35.2310
35.410(b)
35.415(a)(3)
1.00
Requires a note on the door or in the
patient's or human research subject's
chart where and how long visitors may
stay in the patient's or human research
subject's room.
323
5
0.10
35.432(d)
Burden covered in 35.2432
35.433(b)
Burden covered in 35.2433
35.490(a)
35.490(b)(3)
35.491 (c)
35.590(a)
OMB Clearance 3150-0120
35.604(b)
Burden covered in 35.2404
Duration of
treatment
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
Recordkeepers
Records per
Licensee
Burden hours per
record
35.610(b)
35.610(c)
35.610(d)(1)
35.610(d)(2)
35.610(e)
Cost @ $290/HR
Record
Retention
Burden covered in 35.2605
35.605(d)
35.610(a)(4)
Total Annual
Burden
Requires licensees to develop,
implement, and maintain written
procedures for responding to an
abnormal situation.
Requires licensees to physically locate
a copy of the procedures at the unit
console.
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.
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.
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.
Requires licensees to ensure that
operators, AMPs, and AUs participate in
drills of the emergency procedures,
initially and at least annually.
1200
1
1.00
1200.00
$
348,000
Possession of
unit
1200
1
0.03
36.00
$
10,440
Possession of
unit
1200
1
0.50
600.00
$
174,000
Possession of
unit
1200
1
1.00
1200.00
$
348,000
Possession of
unit
1200
1
1.00
1200.00
$
348,000
Possession of
unit
1200
1
0.50
600.00
$
174,000
35.610(f)
Burden covered in 35.2310
35.610(g)
Burden covered in 35.2610
35.630(c)
Burden covered in 35.2630
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
Records per
Licensee
Recordkeepers
Burden hours per
record
Total Annual
Burden
35.632(g)
Burden covered in 35.2632
35.633(i)
Burden covered in 35.2632
36.635(g)
Burden covered in 35.2632
Cost @ $290/HR
Record
Retention
35.642(b)
Requires licensees to perform spot
check measurements in accordance
with written procedures established by
the AMP.
8
1
4.00
32.00
$
9,280
Possession of
unit
35.642(c)
Requires that the AMP review the
results of each spot-check and notify
the licensee in writing of the results of
each spot checks.
8
12
0.25
24.00
$
6,960
3 years
Burden covered in 35.2642
35.642(f)
35.643(b)
Requires licensees to perform spot
check measurements in accordance
with written procedures established by
the AMP.
1080
1
4.00
4320.00
$
1,252,800
Possession of
unit
35.643(c)
Requires licensees to have the AMP
review the results of each spot-check
required by paragraph (a) within 15 days
of the check and to notify the licensee
as soon as possible in writing of the
results of each spot check.
1080
155
0.25
41850.00
$
12,136,500
3 years
$
131,080
Possession of
unit
Burden covered in 35.2643
35.643(f)
35.645(b)(1)
Requires licensees to perform spotcheck measurements in accordance
with written procedures established by
the AMP.
113
1
4.00
452.00
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
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.
Recordkeepers
113
Records per
Licensee
Burden hours per
record
260
Total Annual
Burden
0.25
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)
Cost @ $290/HR
Record
Retention
7345.00
$
2,130,050
3 years
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.
6465
5
0.25
8081.25
$
2,343,563
5 years
35.2024(b)
Requires licensees to retain a copy of
both the authority, duties, and
responsibilities of the RSO
6465
2
0.10
1293.00
$
374,970
Duration of
license
35.2024(c )
Requires the licensee to keep the
written documents signed by the
licensee’s management for each ARSO
appointed under § 35.24(b) for 5 years
after the ARSO is removed from the
license.
660
2
35.2026
Requires licensees to retain a record of
each radiation protection program
change made in accordance with §
35.26(a) for 5 years.
6465
1
1.00
0.25
1320.00
$
382,800
5 years after
ARSO is
removed from
license
1616.25
$
468,713
5 years
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
Requires licensees to retain a copy of
each written directive.
Recordkeepers
Records per
Licensee
Burden hours per
record
Total Annual
Burden
Cost @ $290/HR
Record
Retention
3188
104
0.05
16577.60
$
4,807,504
3 years
3188
1
0.05
159.40
$
46,226
Duration of
license
1208
255
0.02
6160.80
$
1,786,632
3 years
35.2061
Requires licensees to maintain a record
of radiation survey instrument
calibrations required by § 35.61 for 3
years.
6465
1.5
0.25
2424.38
$
703,069
3 years
35.2063
Requires licensees to maintain a record
of dosage determinations required by
§ 35.63 for 3 years.
5820
2126
0.02
247466.40
$
71,765,256
3 years
6465
3
0.06
1163.70
$
337,473
3 years
6465
2
0.06
775.80
$
224,982
3 years
35.2040()
35.2041
35.2060()
35.2067(a)
35.2067(b)
Requires licensees to retain a copy of
the procedures for administrations
requiring a written directive
Requires licensees to maintain a record
of instrument calibrations required by
§ 35.60 for 3 years.
Requires licensees to retain records of
leak tests required by 35.67 (b) for 3
years.
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.
35.2070()
Requires a licensee to retain a record of
each survey required by § 35.70 for 3
years.
2250
43
0.02
1935.00
$
561,150
3 years
35.2075(a)
Requires licensees to retain a record of
the basis for authorizing the release of
an individual in accordance with §
35.75.
3188
14
0.25
11158.00
$
3,235,820
3 years
35.2075(b)
Requires licensees to retain a record
that the instructions required by
§ 35.75(b) were provided to a breastfeeding female if the radiation dose to
the infant or child from continued breastfeeding could result in a total effective
dose equivalent exceeding 5 millisievert
(0.5 rem).
3188
2
0.20
1275.20
$
369,808
3 years
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Recordkeepers
Records per
Licensee
Burden hours per
record
Total Annual
Burden
Cost @ $290/HR
Record
Retention
Section
Description
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).
188
20
0.03
112.80
$
32,712
3 years after
last service
35.2080(b)
Requires licensees to maintain a record
of each survey required by § 35.80(a)
(4) for 3 years.
188
260
0.10
4888.00
$
1,417,520
3 years
35.2092
Requires licensees to retain records of
the disposal of licensed materials, as
required by § 35.92 for 3 years.
6465
52
0.02
6723.60
$
1,949,844
3 years
35.2204
Requires licensees to maintain records
of molybdenum-99 concentration tests
required by § 35.204(b) for 3 years.
300
108
0.08
2592.00
$
751,680
3 years
35.2310
Requires licensees to maintain a record
of safety instructions required by
§§ 35.310 and 35.410 and the
operational and safety instructions
required by § 35.610 for 3 years.
1688
1
0.10
168.80
$
48,952
3 years
35.2404
Requires licensees to maintain a record
of the surveys required by §§ 35.404
and 35.604 for 3 years.
1613
61
0.02
1967.86
$
570,679
3 years
35.2406
Requires licensees to maintain records
of brachytherapy source accountability
required by § 35.406 for 3 years.
713
15
0.20
2139.00
$
620,310
3 years
35.2432
Requires licensees to maintain a record
of calibrations of brachytherapy sources
required by § 35.432 for 3 years after
the last use of the source.
713
15
0.20
2139.00
$
620,310
3 years
35.2433
Requires licensees to maintain a record
of the activity of a strontium-90 source
required by § 35.433 for the life of the
source.
90
70
0.50
3150.00
$
913,500
Life of source
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Section
Description
Records per
Licensee
Recordkeepers
Burden hours per
record
Total Annual
Burden
Cost @ $290/HR
Record
Retention
35.2605
Requires licensees to retain records of
installation, maintenance, adjustment,
and repair of remote afterloader units,
teletherapy units, and gamma
stereotactic radiosurgery units as
required by § 35.605 for 3 years.
1200
5
2.00
12000.00
$
3,480,000
3 years
35.2610()
Requires licensees to maintain records
of procedures required by§ 35.610(a)
(4) and (d) (2) until the licensee no
longer possesses the remote
afterloader, teletherapy unit, or gamma
stereotactic radiosurgery unit.
1200
2
0.05
120.00
$
34,800
Possession of
unit
35.2630()
Requires licensees to retain a record of
the calibration, intercomparison, and
comparisons of its dosimetry equipment
done in accordance with § 35.630 for
the duration of the license.
1223
1
0.50
611.50
$
177,335
3 years
35.2632
Requires licensees to retain a record of
the calibration, intercomparison, and
comparisons of its dosimetry equipment
done in accordance with § 35.630 for
the duration of the license.
1200
4.6
4.00
22080.00
$
6,403,200
3 years
35.2642 (a)
Requires licensees to maintain records
of the teletherapy unit, remote
afterloader unit, and gamma stereotactic
radiosurgery unit full calibrations
required by §§ 35.632, 35.633, and
35.635 for 3 years.
8
12
0.50
48.00
$
13,920
3 years
35.2642 (c)
Requires licensees to retain a record of
each periodic spot-check for teletherapy
units required by § 35.642 for 3 years.
8
1
0.05
0.40
$
116
Possession of
unit
938
155
1.00
145390.00
$
42,163,100
3 years
938
1
0.05
46.90
$
13,601
Possession of
unit
35.2643 (a)
35.2643 (c)
Requires licensees to retain a copy of
the written procedures for periodic spotchecks for teletherapy units established
by the AMP.
Requires licensees to retain records of
each spot-check for remote afterloader
units required by §§ 35.643 for 3 years.
Table 6 – Annual Recordkeeping Requirements for Agreement State Licensees
Records per
Licensee
Total Annual
Burden
35.2645 (a)
Requires licensees to retain a copy of
the written procedures for periodic spotchecks for remote afterloader units
established by the AMP.
113
260
2.00
58760.00
$
17,040,400
3 years
35.2645 (c)
Requires licensees to retain a copy of
the written procedures for periodic spotchecks for gamma stereotactic
radiosurgery units established by the
AMP.
113
1
0.05
5.65
$
1,639
Possession of
unit
8
260
0.50
1040.00
$
301,600
3 years
1200
1
0.50
600.00
$
174,000
Duration of use
of unit
120
0.2
1.00
24.00
$
6,960
Duration of use
of unit
920,464
$
266,934,454
35.2647
35.2652
35.2655
Total
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.
6465
Cost @ $290/HR
Record
Retention
Description
Requires licensees to retain records of
each check for mobile remote
afterloader units required by § 35.647
for 3 years.
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.
Recordkeepers
Burden hours per
record
Section
Table 7 – Annual Reporting Requirements
AS Licensees (3150-0010)
Section
Description
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)
instructions on actions
recommended to maintain
doses to other individuals as low
as is reasonably achievable if
the total effective dose
equivalent to any other individual
is likely to exceed 1 mSv (0.1
rem).
Requires the licensee to notify
the referring physician and the
individual who is the subject of
the medical event, or that
individual's responsible relative
35.3045(e)
or guardian, no later than 24
hours after its discovery, or as
soon as possible, if the patient
or the referring physician cannot
be reached within 24 hours.
Responses
Number of
Total
Burden per
Per
Responde
Number of Response
Responde
Responses (Hours)
nts
nt
Total
Annual
Burden
(Hours)
Cost @ $290/hr
3188
20
63760
0.17
10,839
$
3,143,368
52
2
104
2
208
$
60,320
Table 7 – Annual Reporting Requirements
AS Licensees (3150-0010)
Requires radiopharmacy and
medical use licensees to notify
both the NRC Operations
Center and the distributor of the
35.3204(a) generator by telephone within 7
days after discovery that an
eluate exceeds the permissible
concentration listed in
§ 35.204(a).
Total
8
1
8
63872
2
16
$
11,063 $
4,640
3,208,328
Table 8 – Annual Recordkeeping Requirements
Specialty Boards (3150-0010)
NMSS Office Procedure MSST–70–03–2, “Procedures for Recognizing, Monitoring, and Terminating the Certification Process of Specialty Boards,”
(ML20351A389) establishes procedures for the specialty boards seeking to apply for or maintain an NRC-recognized certification program. The record
Section
Description
No of
Recordkeepers
Records per
Licensee
Burden per
record
Total Annual
Burden
Cost @
$290/HR
Record Retention
3.1 Applications for
Recognition of a
Specialty Board
Certification Process
A specialty board should request
NRC recognition of its certification
process by applying to the NRC
(i.e., application letter).
1
1
80.00
80.00 $
23,200
No requirement.
3.1.1(j) Certificate
Include a copy of the certificate(s)
with any special terms or phrases
that must appear on the
certificate(s) and a “not valid” or
“sample” watermark across the
text of each certificate.
1
1
3.00
3.00 $
870
No requirement.
3.7 Notification of
Change
Specialty boards should contact
the NRC, in writing, regarding a
change in certification
procedures, change in certificate,
name change, or other change
2
1
4.00
8.00 $
2,320
No requirement.
8
2
8.00
128.00 $
37,120
No requirement.
3.11 Monitoring
Continued
Satisfaction of
Recognition
Requirements
The reviewers should contact
each of the specialty boards
with a written request that the
specialty board confirm that it
still satisfies the board
recognition criteria, if the
specialty board did not submit
a notification of change,
revised certificate, or any other
communication within the last
five years. The reviewers
should request verification in
writing on whether it has
changed its name, the name of
Table 8 – Annual Recordkeeping Requirements
Specialty Boards (3150-0010)
NMSS Office Procedure MSST–70–03–2, “Procedures for Recognizing, Monitoring, and Terminating the Certification Process of Specialty Boards,”
(ML20351A389) establishes procedures for the specialty boards seeking to apply for or maintain an NRC-recognized certification program. The record
Section
Description
3.12 Terminating The board requests, in writing,
NRC Recognition of that the NRC no longer
Specialty Boards recognize it.
Total
No of
Recordkeepers
1
13
Records per
Licensee
Burden per
record
1
Total Annual
Burden
6
Cost @
$290/HR
6 $
1,740
225.00 $
65,250
Record Retention
No requirement.
NRC licensee reporting
NRC licensee recordkeeping
NRC third party
AS reporting
AS recordkeeping
AS third party
AS approving specialty board application letter
Specialty Board
Total
Burden
7,216
122,771
1,465
54,286
920,464
11,063
80
225
1,117,570
Responses
27,541
862
8,511
206,729
6,465
63,872
1
13
313,994
$
$
$
$
$
$
$
$
$
Cost @ $290/hr
2,092,495
35,603,700
424,923
15,742,940
266,934,454
3,208,328
23,200
65,250
324,095,290
NRC licensees TOTAL
AS licensees TOTAL
Specialty Board TOTALS
TOTAL
Burden
131,452
985,893
225
1,117,570
Responses
36,914
277,067
13
313,994
$
$
$
$
Cost @ $290/hr
38,121,118
285,908,922
65,250
324,095,290
Part 35 Totals
Reporting
Recordkeeping
Third Party Disclosure
Total
NRC licensees
Agreement State licensees
Specialty certifying entities
Total
Other costs (item #13)
Burden
61,807
1,043,235
12,528
1,117,570
Part 35 Respondents
862
6465
2
7329
$
121,015
Responses
Cost @ $290/hr
234,284 $
17,923,885
7,327 $
302,538,154
72,383 $
3,633,251
313,994 $
324,095,290
Part 35 Burden Totals
Reporting
Recordkeeping
Third Party Disclosure
Total
Previous
submission Current Request
69,391
61,807
1,097,177
1,043,235
127
12,528
1,166,695
1,117,570
Change
(7,585)
(53,942)
12,401
(49,125)
| File Type | application/pdf |
| Author | fxm |
| File Modified | 2023-11-30 |
| File Created | 2023-11-30 |