Final Supporting Statement NRC Form 313A 2019

Final Supporting Statement NRC Form 313A 2019.pdf

NRC Form 313, Application for Material License, NRC Form 313A, Medical Use Training and Experience and Preceptor Attestation

OMB: 3150-0120

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FINAL OMB SUPPORTING STATEMENT
FOR
NRC FORM 313, “APPLICATION FOR MATERIALS LICENSE,”
AND NRC FORMS 313A (RSO), 313A (AMP), 313A (ANP), 313A (AUD), 313A (AUT),
AND 313A (AUS)
(3150-0120)
---REVISION
Description of the Information Collection
The U.S. Nuclear Regulatory Commission (NRC) is responsible for licensing and regulating
nuclear facilities and material and for conducting research in support of the licensing and
regulatory process, as mandated by the Atomic Energy Act (AEA) of 1954, as amended, and
other related Acts such as the Energy Reorganization Act of 1974, as amended, and the Energy
Policy Act of 2005. Under the aforementioned Acts, the NRC licenses and regulates medical,
industrial, and academic uses of nuclear materials through a combination of regulatory
requirements and safety oversight programs (including inspection). In addition, Section 274 of
the AEA provides statutory bases under which NRC relinquishes to States portions of its
regulatory authority to license and regulate byproduct materials (radioisotopes), source
materials (uranium and thorium), and certain quantities of special nuclear materials. These
states are called Agreement States.
In order for a person to be licensed to possess, use, or distribute licensed material, the person
must submit an application that will permit the NRC to determine whether the applicant has
training, experience, equipment, facilities, and procedures for the use of radioactive material
that are adequate to protect the public health and safety, as applicable. NRC Form 313,
“Application for Materials License,” is used to provide the information required.
The different versions of Form 313A are being revised to better reflect recent changes in the
requirements in 10 CFR Parts 30 and 35. The revisions minimize or eliminate unnecessary
information requests and assist applicants in complying with rule requirements. The revisions
do this by clarifying the minimum information that is needed to demonstrate adequate training
and education for various disciplines.”
Medical use and commercial nuclear pharmacy applicants and licensees may use following
NRC Form 313A series of optional supplemental forms to provide the required training and
experience information required under Item 7 of the NRC Form 313:
•

NRC Form 313A (RSO), “Radiation Safety Officer or Associate Radiation Safety Officer
Training, Experience and Preceptor Attestation [10 CFR 35.57, 35.50]”

•

NRC Form 313A (AMP), “Authorized Medical Physicist and Ophthalmic Physicist, Training,
Experience and Preceptor Attestation [10 CFR 35.51, 35.57(a)(3), and 35.433]”

•

NRC Form 313A (ANP), “Authorized Nuclear Pharmacist Training, Experience, and
Preceptor Attestation [10 CFR 35.55]”
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•

NRC Form 313A (AUD), “Authorized User Training, Experience and Preceptor Attestation
(for uses defined under 35.100, 35.200, and 35.500) [10 CFR 35.57, 35.190, 35.290, and
35.590]”

•

NRC Form 313A (AUT), “Authorized User Training, Experience, and Preceptor Attestation
(for uses defined under 35.300) [10 CFR 35.57, 35.390, 35.392, 35.394, and 35.396]”

•

NRC Form 313A (AUS), “Authorized User Training, Experience and Preceptor Attestation
(for uses defined under 35.400 and 35.600) [10 CFR 35.57, 35.490, 35.491, and 35.690]”

The NRC issues a materials license, if the information as part of the NRC Form 313 (which for
medical and commercial nuclear pharmacy applicants only includes the NRC Form 313A series
of forms) fulfills the substantive requirements stated elsewhere in the regulations.
Between 1997 and 2007, NRC produced the original versions of a series of technical reports
(NUREG-1556 series, “Consolidated Guidance About Materials Licenses”) to provide program
specific guidance for materials applicants. These guidance documents were intended to
facilitate the process of developing new license applications, license amendments, and license
renewals. They provide a comprehensive source of reference information about materials
regulation for the applicant, the licensee, and the NRC staff and are updated, as appropriate.
The documents also apply NRC’s risk informed performance based approach to materials
licensing which simplifies the information collection burden on applicants and licensees. The
effect of the NUREG-1556 series is factored into this and previous versions of this clearance.
On July 16, 2018, the NRC published the Final Rule “10 CFR Parts 30, 32, and 35 Medical uses
of Byproduct Material – Medical Event Definitions and Training and Experience,” related to the
possession, use, and distribution of byproduct material for medical uses. The rule changed
the training and experience requirements that affect the specific information needed to complete
item 7 of the NRC Form 313 for medical use and commercial nuclear pharmacy applicants and
licensees. Therefore, all of the NRC form 313A series of forms need to be revised to conform to
appropriate rule changes. The revised forms were not ready at the time the changes to
information collections due to the rule were submitted to OMB. The revised forms are being
submittal as part of this clearance renewal. These changes include: adding the training and
experience information needed for the Associate Radiation Safety Officer to the NRC Form 313A
(RSO); adding the training and experience information needed for the ophthalmic physicist to the
NRC Form 313A (AMP); adding the training and experience information needed for all individuals
board certified prior to October 24, 2005, to all the NRC Form 131A series of forms except the
NRC Form 313A (ANP); deleting the need to submit the preceptor information for most board
certified individuals from all the NRC Form 313A series of forms; revising the preceptor attestation
statement for all the NRC Form 313A series of forms; adding the information needed for the
residency program director to sign the attestation on NRC Forms 313A (AUD), 313A (AUT) and
313A (AUS); and clarifying the clinical category experience information needed for the NRC Form
313A (AUT). These rule changes require modifications to all of the NRC Form 313A series of
forms. The new rule did not affect NRC Form 313 or the information submitted for the other items
on the form for any materials applicants and licensees. This clearance addresses the changes in
the reporting burden, due primarily to the reduction in the number of all materials NRC licensees
and all NRC materials licensing actions, and in the submission of the NRC Form 313 (including
the NRC Form 313A series by some licensees) by all licensees.
NRC changed the frequency for its materials license renewals from a ten year to fifteen year
frequency since the last OMB clearance. The Agreement States have not adopted this change in
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the renewal frequency.
JUSTIFICATION
1.

Need for and Practical Utility of the Collection of Information
The filing of an application for a specific license for possession, use, and
distribution of byproduct or source material on NRC Form 313, "Application for
Materials License," for a specific license is provided in 10 CFR 30.14, 30.15, 30.18,
30.19, 30.20, 30.21, 30.32, 30.37, 30.38, 32.11, 32.14, 32.18, 32.21, 32.22, 32.26,
32.30, 32.51, 32.53, 32.57, 32.61, 32.72, 32.74, 33.12, 34.11, 35.12, 36.11, 39.11,
40.31, 40.43, and 40.44. The filing of training and experience information on NRC
Form 313 (which may include the NRC Form 313A series of forms) is provided in
10 CFR 35.12. The information required under training and experience for the
medical use and commercial nuclear pharmacy applicant or licensee is found in
10 CFR 32.72, 35.50, 35.51, 35.55, 35.190, 35.290, 35.390, 35.392, 35.394,
35.396, 35.433, 35.490, 35.491, 35.590, and 35.690.
The information submitted as part of the NRC Form 313 (which may include the
NRC Form 313A series of forms) is reviewed by the NRC staff to determine
whether the applicant is qualified by training and experience. Also, the NRC staff
assesses whether the applicant has equipment, facilities, and procedures which are
adequate to protect the health and safety of the public and minimize danger to life
or property, as applicable.

2.

Agency Use of Information
The NRC reviews the information submitted in order to determine whether the
applicant's training, personnel experience, equipment, facilities, and procedures for
the use of byproduct or source material are adequate to protect the public health
and safety as required by the Atomic Energy Act, as amended, the Energy
Reorganization Act of 1974, as amended, and the Energy Policy Act of 2005 so that
the Commission may determine whether to issue, amend, or renew a license.
The NRC uses the information submitted to develop reports on licenses issued.
The NRC also uses the information to respond to public and congressional
inquiries, develop and guide its policies, and formulate its budgets. The NRC can
use initial license information along with additional documentation to aid in the
inspections, identifying compliance violations, and enforcement activities.

3.

Reduction of Burden through Information Technology
The NRC has issued Guidance for Electronic Submissions to the NRC which
provides direction for the electronic transmission and submittal of documents to
the NRC. Electronic transmission and submittal of documents can be
accomplished via the following avenues: the Electronic Information Exchange
(EIE) process, which is available from the NRC's “Electronic Submittals” Web
page, by Optical Storage Media (OSM) (e.g.

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CD-ROM, DVD), by facsimile or by e-mail. It is estimated that approximately
25% of the responses are filed electronically.
4.

Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no duplication of
requirements.

5.

Effort to Reduce Small Business Burden
While a number of licensees are considered small businesses, the health and safety
consequences of improper use of radioactive material are the same for large and small
entities. There is a minimum amount of information that must be provided in order for
the NRC to determine if an applicant's facilities, equipment, and procedures are
adequate to protect the public health and safety. Therefore, it is not possible to reduce
the burden on small businesses by less frequent submission or less complete
applications.

6.

Consequences to Federal Program or Policy Activities if the Collection is not
Conducted or is Conducted Less Frequently
Applications for a new license are submitted only once, while applications for renewal
of a license are submitted every fifteen years. Amendments are submitted as needed
by the licensee. This is the minimum frequency necessary to assure that licensees will
continue to conduct programs in a manner that will assure adequate protection of the
public health and safety. If the information is not collected, the NRC will have no way
to determine the adequacy of licensees' programs to protect the public health and
safety.

7.

Circumstances which Justify Variation from OMB Guidelines
There are no variations from OMB guidelines.

8.

Consultations outside the NRC
Opportunity for public comment on the information collection requirements for this
clearance package was published in the Federal Register in February 13, 2019 (84
FR 3834). Eight NRC licensees were contacted by email as part of the public
consultation process and requested to provide for feedback on this information
collection. Comments were received from four of the eight licensees but no other
comments were received from other members of the public. The respondents did
not comment on every question in the Federal Register. The questions and a
summary of the responses are as follows.
1. Is the proposed collection of information necessary for the NRC to properly
perform its functions?
a. Comment: The two responders to this question agreed that the proposed
collection of information is foundational to the NRC’s responsibility to license
and regulate nuclear facilities and material. The information required by
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these forms is the minimum necessary for the NRC to evaluate and approve
such requests. The information collected also documents the licensee’s
commitments, qualifications, and methods which are then subject to NRC
inspection and enforcement activities. The gauge user licensee concluded
the information is necessary to maintain safety for users of the gauge and
helps ensure a level of oversight into storage and use of gauges.
Response: NRC agrees with the commenters’ affirmation of the need and
usefulness of the forms.
2. Is the estimate of the burden of the information collection accurate?
Four responders addressed this question.
a. Comment: The estimate appeared to be accurate but it was not his area of
expertise.
Response: No response necessary
b. Comment: One responder agreed the total number (1049) of licensing
actions NRC used to estimate the burden of the information collection was
reasonably justified. This responder, however, wanted more detailed
information, such as number of hours required to prepare new license
applications vs. license renewals vs. license amendments, and broad scope
vs. limited scope licenses, to evaluate the 4.3 hour average burden per
licensing action.
Response: As discussed in the supporting statement the burden hours are
an average over all licensees. The NRC initially estimated the average
burden based on the number and types of licensees and the complication of
the licensees’ programs. The low burden hours reflects the few large
licensees the NRC has with complex programs and a large number of small
licensees with simple programs. Later, with the introduction of the NUREG1556 series and the shift of the NRC licensing policy from prescriptive
requirements to performance-based programs there was a reduction in the
amount of information that needs to be submitted with the form 313. This
reduction reduced the burden to 4.3 hours and was accounted for in an
earlier OMB clearance. After the NRC established the 4.3 hour average
burden per licensee, the NRC now looks to see if there were regulatory
changes for licensees that would change the information submitted on the
NRC Form 313 and 313A series to see if the number of hours needs to be
adjusted. During this cycle the changes to the medical use requirements in
10 CFR Part 35 were the only applicable regulatory changes and they did not
affect the 4.3 hour average. Therefore, the NRC’s accounting structure does
not differentiate between the types of licensing reviews but considers the
burden hours to be an average over all types of licensing reviews.
c. Comment: One responder, from a broad scope medical use license, thought
the $275 hourly rate may be appropriate for the NRC staff burden, but
overestimated the licensee cost and suggested the U.S. Department of
Labor, Bureau of Labor Statistics news release, “Employer Costs for
Employee Compensation – December 2018” (USDL-19-0449). This provided
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an average hourly rate for the management/professional occupational group
of $60.70 for state/government workers and $59.57 for private industry
workers.
Response: The NRC’s use of the $275 hourly rate in the burden estimate is
based on the NRC’s current fee for hourly rates as noted in 10 CFR 170.20
“Average cost per professional staff-hour. Using the NRC’s fee rate in
burden cost estimates provides a conservative, consistent approach which
bounds the costs of the wide range of potential respondents to an information
collection. The staff recognizes that the actual licensee hourly rates (and
therefore overall financial burdens) for reporting and record keeping for an
individual respondent may be significantly different than those estimated by
the NRC.
d. Comment: One responder, from a major medical broad scope licensee,
estimated 1 or 2 amendment requests per year at approximately 4 labor
hours to complete and submit (electronically) approximately, 150 hours to
prepare a new license and 75 hours to prepare a renewal application
involving primarily professional or management labor hours. The responder
used the minimum necessary information prescribed in NUREG-1556,
Volume 11 to develop the estimates. The conclusion was 8.7 hours per
licensing action (270 hours, 31 licensing actions) for the first 15 years, and
6.3 hours per licensing action (195 hours, 31 licensing actions) for each
subsequent 15 year renewal period.
Response: See the consolidated response to the next comment.
e. Comment: One responder with a 10 CFR Part 70 license with Type A Broad
scope license aspects had only amended the license 4 times in 6 years. This
licensee found the amendment and use of the NRC Form 313 to be
straightforward. Some of the categories of the 313A were used as guidance
to develop a letter of RSO qualifications along with a résumé and those
documents were attached to the 313 requesting the amendment.
Response: These two comments show the difference in experiences for
different licensees. One estimated 2 licensing actions per year and the other
estimated 0.6 licensing actions per year over 6 years. The NRC’s experience
from its 3,120 licensees and Master Material License (MML) permittees was
1049 licensing actions per year for a frequency of 0.3 licensing actions per
year per licensee. Both respondents are from larger licensees and expected
to provide more information in filling out the NRC Form 313 than the smaller
simpler licensees. Further, the NRC has very few new licenses per year and
the burden from new licensees becomes a small part of the average burden.
There were only 41 new licenses out of the total of 1049 licensing actions in
2018.
No response is needed for the commenter’s observation that the use of the
NRC Form 313 was straight forward.
f.

Comment: One responder concluded that the proposed changes will not
greatly impact his information collection time or process. Generally speaking,
he often only identifies a single onsite RSO and do not have a need for
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Associate Radiation Safety Officers or other “Authorized” persons to be
spelled out on license applications. Additionally, much of the employees
training, certifications, and experience are captured in internal corporate
databases. The largest time consumption is gathering this data internally
and compiling into a single curriculum vitae or application. That process
would not go away.
Response: None needed. This is an observation of the licensee’s
experience.
3. Is there a way to enhance the quality, utility, and clarity of the information to be
collected?
Comment: One responder concluded implementation of standardized forms for
information gathered is helpful to both parties.
Response: The NRC agrees and uses one form, the NRC Form 313, for license
submissions.
4. How can the burden of the information collection on respondents be minimized,
including the use of automated collection techniques or other forms of information
technology?
a. Comment: One responder reiterated that standardized forms and automated
collection would help and suggested there be a central location for
downloaded required forms.
Response: The NRC provides access to its forms on the NRC public web
site under https://www.nrc.gov/reading-rm/doc-collections/#forms. The
forms are also accessible under each Licensing Toolkit on the NRC public
website for example on the Medical Products Distribution Licensee Toolkit
(https://www.nrc.gov/materials/miau/product-manufac/med-toolkit.html) under
forms.
b. Another respondent concluded that for any “Reduction of Burden” through
Information Technology, any initiative, program, or standard would be
welcome. However, because the respondent has to deal with numerous
Agreement States at varying levels of implementation, he continues to create
hard copy documents and scans. He maintains both of these centrally via
“Correspondence Binders” as well as archives them on an internal
SharePoint site. This causes minimal additional time but greatly reduces the
burden and time to search a traditional filing system.
Response: No response necessary the responder is commenting on the
differences between the NRC and different Agreement States in the ability to
automate information collection.
9. Payment or Gift to Respondents
Not applicable.
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10. Confidentiality of the Information
Confidential and proprietary information is protected in accordance with NRC
regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).
11. Justification for Sensitive Questions
Sensitive information is not requested under these regulations.
12. Estimated Burden and Burden Hour Cost
The $275 hourly rate used in the burden estimates is based on the Nuclear
Regulatory Commission’s fee for hourly rates as noted in 10 CFR 170.20 “Average
cost per professional staff-hour.” For more information on the basis of this rate, see
the Revision of Fee Schedules; Fee Recovery for Fiscal Year 2018 (83 FR 29622,
June 25, 2018).
A. NRC Licensees
The burden associated with the use of NRC Form 313 and NRC Form 313A
series of forms for new licenses, amendments and renewals for all materials
licensees is based on the total number of licensing actions processed by the
NRC and NRC’s Master Material License licensees during fiscal year 2018 and
estimated increase in amendments for the associate Radiation Safety Officer and
ophthalmic physicist to medical use licenses, approximately 1049 licensing
actions (including all new licenses, amendments, and renewals, and the
assumed increase of amendments based on just adding new Associate
Radiation Safety Officers and ophthalmic physicist to medical use licenses).
There were 197 total amendment request in 2018 from medical use licensees.
Some licensees are projected to include amendment request to add Associate
Radiation Safety Officers and ophthalmic physicists with other changes to their
programs so it is estimated that there will be an additional 100 amendment
request per year as a result of the new rule. Based on this number of licensing
actions, the industry burden for licensing is estimated to be 4,510 hours (4.3
hours per licensing action x 1049 licensing actions). The annual cost to all
affected NRC licensees is estimated to be $1,240,250 (4,510 hours x $275 per
hour). The estimate of 4.3 hours per licensing action factors in the guidance given
in the NUREG-1556 series, because it reduces the time needed to complete the
application.
B. Agreement State Licensees
Section 274 of the Atomic Energy Act of 1954 provides a statutory basis under
which NRC relinquishes to the States portions of its regulatory authority to
license and regulate byproduct materials (radioisotopes); source materials
(uranium and thorium); and certain quantities of special nuclear materials. The
mechanism for the transfer of NRC’s authority to a State is an agreement signed
by the Governor of the State and the Chairman of the Commission, in
accordance with section 274b of the Act. A map of Agreement States and nonAgreement States is located on NRC’s Web site: https://scp.nrc.gov/.
Licensees operating in these “Agreement States” are referred to in this
supporting statement as “Agreement State Licensees.”
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The NRC has established compatibility requirements for Agreement States to
implement their own regulations in a manner consistent with NRC regulations.
Annually, the NRC requests that all Agreement States provide the number of
specific radioactive material licenses currently active under their jurisdiction.
The total number of Agreement State licensees is based on the data provided
by the Agreement States. For this renewal, the NRC used an estimate of 16,531
Agreement State material licensees.
The number of Agreement State licensees who submit required information on
Agreement State forms equivalent to NRC Form 313 is not known to the NRC
and must be estimated. NRC uses two ratios to provide this estimate. The first is
the ratio of the sum of the total number of NRC licensees and NRC MML
permittees to the total number of Agreement State licensees to estimate the
number of Agreement State amendment licensing actions. This ratio is 1:5.3. It
is based on 3,120 total NRC licensees and NRC MML permittees and 16,531
Agreement State licensees. Based on this ratio, the estimated number of
Agreement State amendment licensing actions is 3,683 (695 NRC amendment
licensing actions x 5.3). The second ratio is ratio of the total number of NRC
licensees (excluding NRC MML permittees) to the total number of Agreement
State licensees to estimate the number of Agreement State new licensing. The
NRC MML licensees do not add new permittees. This ratio is 1:5.9 and is based
on 2,795 NRC licensees and 16,531 Agreement State licensees. Based
on this ratio, the estimated number of Agreement State new licensing actions is
242 (41 NRC new licensing actions x 5.9). The Agreement State renewal periods
are different from that of the NRC and the Agreement State estimate was based
on a five year renewal frequency. The estimate for the Agreement States renewal
licensing action 3,306 is based on dividing the total number of Agreement State
licensee by the 5 year renewal frequency (16,531/5).
Therefore the total Agreement State estimated number of licensing actions is
7,231 (3,683 amendment + 3,306 renewal + 242 new licensing actions).
Additionally, the NRC estimates that the amount of time that the Agreement
States will need to prepare an application and the associated costs will be the
same as for NRC licensees.
Therefore, the total burden for Agreement State licensees is estimated to be
31,093 hours (4.3 hours per licensing action x 7,231 licensing actions).
The estimated annual cost to the Agreement State licensees to prepare
applications and submit required information on forms equivalent to NRC
Form 313 (which may include the NRC Form 313A series of forms) is
estimated to be $8,550,575 (31,093 hours x $275 per hour).
C. Third party
The medical use applicant and licensee is the only one that requires information
need to complete the NRC Form 313 be provided from a third party. The
medical use licensees must provide preceptor attestation for certain individuals
seeking to be recognized as authorized users, authorized medical physicist,
authorized nuclear pharmacists, and Radiation Safety Officers for the first time
and for certain additional authorizations at a later time. The preceptor providing
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the attestation is not a licensee and it is estimated the preceptor will need 0.05
hour to complete the attestation. The total number of attestations, 624, is
estimated to be a third of the annual estimated medical use license
amendments submitted [(297 for NRC and 1574 for Agreement States) /3]. The
total estimated burden is 31.2 hours (624 responses x 0.05 hours). The
estimated annual cost to the third party is
$8,580 (31.2 hours x $275).
D. Total
The total burden for NRC and Agreement State licensees and third parties
combined is 35,634 hours (4,510 hours for NRC licensees + 31,093 hours for
Agreement State licensees + 31.2 hours for third parties). The estimated total
cost is 9,790,825 ($1,240,250 NRC + 8,550,575 AS + 8,580 3rd party).
13. Estimate of Other Additional Costs
There are no additional costs.
14. Estimated Annualized Cost to the Federal Government
The staff has developed estimates of annualized costs to the Federal Government
related to the conduct of this collection of information. These estimates are based on
staff experience and subject matter expertise and include the burden needed to
review, analyze, and process the collected information and any relevant operational
expenses.
It is estimated that the review of the information on NRC Forms 313 (which for
medical use and commercial nuclear pharmacy applicants and licensees may include
the NRC Form 313A series of optional forms) will take an average of approximately
4.3 hours/application. Based on an anticipated 1049 licensing actions at a cost of
$275 per hour, the cost to perform the licensing review would be
$1,240,442 (1049 licensing actions x 4.3 hours per licensing action x $275 per hour
hour). This cost is fully recovered through license fees charged to NRC licensees
pursuant to 10 CFR Parts 170 and/or 171.
15. Reasons for Changes in Burden or Cost
The burden for NRC licensees is expected to decrease by 3,192 hours from 7,702
to 4,510 hours as a result of the decrease in licensing actions received by 1,664
from 2,713 to 1,049. The NRC expects the number of submitted licensing
actions to remain at the fiscal year 2018 levels.
There are fewer licensing actions expected for Agreement States due to a decrease
in the number of Agreement State respondents. The estimated number of licensing
actions received will decrease by 8,189 from 15,420 to 7,231.
Overall, the burden for Agreement States will decrease by 20,417 hours from
51,510 to 31,093 hours.
The total estimated burden for completing NRC Form 313 and 313A will decrease
by 25,100 hours, from 60,703 to 35,603 hours.
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The total burden for completing NRC Form 313 and 313A is as follows:
35,603 burden hours for 8,280 responses (4,510 burden hours for 1,049 NRC
licensing actions plus 31,093 Agreement State licensee burden hours for 7,231
estimated Agreement State licensing actions.)
8,280 respondents (1,049 NRC licensee respondents plus 7,231 Agreement State
licensee respondents.)
The burden decreased due to a reduction in the actual number of licensing actions
received (downward adjustment of 25,100 hours).
The burden for the third parties was not included in the last OMB clearance. The
burden is expected to decrease because board certified individuals will no longer
be required to have preceptor attestations.
For background on NRC Form 313 and the calculation of estimated burden, all
applicable applicants and licensees need to consider and address Items 1 through
13 of NRC Form 313, as appropriate. Also, the NRC developed the optional
supplemental NRC Form 313A series to make it easier for medical use and
commercial nuclear pharmacy licensees and applicants to provide information to be
submitted as part of Item 7 (“Individual(s) Responsible for Radiation Safety
Program and Their Training and Experience”) and Item 8 (“Training for Individuals
Working In or Frequenting Restricted Areas”) of NRC Form 313. This estimated
burden for NRC Form 313 (calculated above) includes the burden for the optional
supplemental NRC Form 313A series due to the supplementary nature of the NRC
Form 313A. Therefore, the burden for the NRC Form 313A series is not presented
separately. Any burden changes related to the revisions to the NRC Form 313A
series forms as a result of the final rule published July 26, 2018 were included in
the information collection changes submitted with that final rule.
In addition, the fee rate increased from $268 to $275 per hour.
16. Publication for Statistical Use
This information will not be published for statistical use.
17. Reason for Not Displaying the Expiration Date
The expiration date is displayed on NRC Forms 313 and NRC Form 313A series of
forms.
18. Exceptions to the Certification Statement
There are no exceptions.
B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Not applicable.

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TABLE 1
Annualized Reporting Burden for NRC Licensees

Section
NRC Form 313
and 313A Series
Licensing Actions

Number of
Respondents

Responses/
Respondent

Total
Responses

Burden/
Response

Total
Annual
Burden
Hours

1,049

1

1,049

4.3

4,510

1,049

TOTAL

12

4,510

TABLE 2
Annualized Reporting Burden for Agreement States

Section
NRC Form 313
and 313A Series
Licensing Actions

Number of
Respondents

Responses/
Respondent

Total
Responses

Burden/
Response

Total
Annual
Burden
Hours

7,231

1

7,231

4.3

31,093

7,231

TOTAL

31,093

TABLE 3
Annualized Third Party Burden

Section
NRC Form 313
and 313A Series
Licensing Actions

Number of
Respondents

Responses/
Respondent

Total
Responses

Burden/
Response

Total
Annual
Burden
Hours

624

1

624

0.05

31.2

624

TOTAL

31.2

Total Responses:

8,904 (1,049 reporting/NRC Licensees) +
(7,231 reporting/Agreement States) + (624 Third Party)

Total Respondents:
Party)

8,904 (1,049 NRC Licensees + 7,231 Agreement States + 624 Third

Total Burden Hours: 35,634 (4,510 NRC Licensees hours reporting) +
(31,093 Agreement States hours reporting) + 31 Third Party

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