Supporting Statement A

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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 byproduct 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 is granted authority to license and regulate medical, industrial, and academic uses of nuclear byproduct materials through a combination of regulatory requirements and safety oversight programs (including inspection). 

In order for an entity to be licensed to possess, use, or distribute licensed material, the entity must submit an application with information such that the NRC can determine whether the entity’s applicant designees have adequate training, experience, equipment, facilities, and procedures for the use of radioactive material that protects public health and safety. NRC Form 313, “Application for Materials License,” is used to aggregate the necessary information for NRC review.

    • To supplement the information within NRC Form 313, applicants may be required to also submit appropriate NRC 313A form(s) to detail training and experience to hold a specific position(s) required by the license. The following are available NRC Form 313As that can be used to document training and experience to request authorization for different license mandated positions. The specific 313A Form(s) available for submission is listed below:

    • NRC Form 313A (AMP)—Authorized Medical Physicist or Ophthalmic Medical Physicist
    • NRC Form 313A (ANP)—Authorized Nuclear Pharmacist
    • NRC Form 313A (AUD)—Authorized User requesting authorization for diagnostic uses defined under 10 CFR 35.100, 10 CFR 35.200, or 10 CFR 35.500.
    • NRC Form 313A (AUS)—Authorized User requesting authorization for use of sealed sources defined under 10 CFR 35.400 or 10 CFR 35.600.
    • NRC Form 313A (AUT)—Authorized User requesting authorization for use of unsealed radioactive material for therapy defined under 10 CFR 35.300.
    • NRC Form 313A (RSO)—Radiation Safety Officer or Associate Radiation Safety Officer.

The NRC utilizes the Web-Based Licensing (WBL) System to store and manage information collected through Forms 313 and 313A associated with licensing, amendments, and renewals of byproduct or source material authorizations. The NRC offers printable and online editable Form 313 and 313A to be used by applicants submitting a license request, amendment, or renewal, for byproduct or source material authorizations. The printable 313 and 313A Forms can be submitted vial postal mail or as attachments to emailed application submissions. The online portal offers an editable Form 313 that can be submitted directly to NRC licensing. This portal allows for submission of Form 313A attachments only.

The NRC approves materials licenses, amendments, and renewals if the information contained within NRC Form 313 (and related NRC Form 313A) fulfills the substantive requirements stated elsewhere in guidance and regulations.

NRC issued a series of technical reports (NUREG-1556 series, “Consolidated Guidance About Materials Licenses”) to provide program specific guidance for materials application submission. These documents provided guidance to prospective licensees for submission of new license applications, license amendments, and license renewals. The guidance documents also reference applicable regulations for the applicant to assure compliance. 

Each guidance document provides templates and examples to provide approved processes that applicants can adopt to show compliance to NRC’s risk informed performance-based approach to materials licensing. These resources aim to reduce the information collection burden on the applicant and hasten NRC reviews. Efficiencies gained through the licensing aids within NUREG-1556 series is factored into this clearance burden estimation. A link to the NUREG-1556 series is included in the list of guidance materials at the end of this document.

NRC and Agreement State applicants use Form 313 and 313A (or Agreement State equivalent) as primary documents to submit required information to their regulatory Agency for review. NRC radioactive material license renewals are currently submitted every 15 years. Agreement State licensees using NRC 313 Forms or state equivalent forms, submit license renewals at varying frequencies. The total number of license renewals, amendments and initial licensing requests occur at variable frequencies and numbers throughout the national Nuclear Materials Program.

Furthermore, entities regulated by Agreement States must also send applications to the NRC if they wish to distribute exempt quantities of radioactive material or possess and use licensed material in state locations subject to Federal control, i.e., NRC jurisdiction. These special situations utilize use of Form 313 and 313A among Federal and State Agencies.

JUSTIFICATION

    1. Need for and Practical Utility of the Collection of Information

The information needed within the application submission of an application for possession, use, and distribution of byproduct or source material 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 information needed within the application submission for training and experience is provided in10 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.

This information may be submitted by NRC Form 313 (which may include any of the NRC 313A series of Forms) which organizes relevant information for review. Applicants are afforded the ability to submit information not by NRC Form 313 but this does not occur often. Nearly all applicants (~99%) utilize Form 313 and 313A series to submit information for regulatory review. This review determines whether an applicant’s safety program complies to requirements and staff are qualified through training and experience. Therefore, the National Materials Program finds it useful to recommend that applicants use NRC Forms (or the state equivalent) that detail all needed information for acceptability review. 

    2. Agency Use of Information

Regulating Agencies review information submitted 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 presiding regulatory code.

The NRC (as well as Agreement states) use the applicant’s information within Form 313 to develop reports of license issues, responses to public and congressional inquiries, to develop oversight policies, and to formulate budgets. The NRC (and Agreement states) also use this information to aid in inspections and enforcement activities.

    3. Reduction of Burden through Information Technology

The NRC has issued Guidance for Electronic Submissions to the NRC (Revision 9) 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.CD-ROM, DVD), or by e-mail. It is estimated that approximately 95 percent 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

It is estimated that approximately 33 percent of materials licensees are considered small businesses. While a minority of licensees are considered small businesses, the health and safety consequences of improper use of radioactive material are similar regardless of the entity size. 

The NRC Form 313 requests a minimum amount of information to determine if an applicant's facilities, equipment, and procedures are adequate to protect the public health and safety. Therefore, these forms elicit the minimum information needed for the NRC to make a safety determination. Reducing this burden on small businesses through less frequent submission or less complete applications does not align with NRC’s safety mission. 


    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 once, while NRC applications for renewal of a license are currently submitted every fifteen years (periodicity varies for Agreement State licensees), throughout the existence of the license. Amendments are submitted as needed by the licensee. This frequency is optimal when there is a need to balance business considerations with NRC’s requirement to approve and document processes that assure adequate protection of the public health and safety. If the information is collected less frequently, the NRC will have limited capacity to determine the adequacy of licensees' programs that intend to protect the public health and environment.

    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 on April 21, 2026 (91FR 21332).  Potential respondents were 4 NRC licensees who recently submitted Form 313 through the online portal and 2 NRC licensees who are soon to be submitting Form 313 to the NRC. These potential respondents were sent email requests on May 4, 2026 to comment. No comments were received. 

    9. Payment or Gift to Respondents

Not applicable.

    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 Effort and Annual Burden Hour Cost

All applicants for materials licenses need to consider and address Items 1 through 13 of NRC Form 313, as appropriate. The NRC developed supplemental NRC Form 313A series to detail the necessary information to be submitted for response to 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. 

The estimated effort for completing NRC Form 313 was calculated to be 4.3 hours per response, on average. This estimate was used to calculate the annual effort attributed to Form 313 usage. These Form 313 metrics include the effort for completing the related NRC Form 313A series forms as well. Therefore, the effort estimates associated with the NRC Form 313A series are not presented separately but is factored into the NRC Form 313 completion effort estimate. 

The Form 313 (and related 313A series) average and annual effort was calculated for this 2025 clearance for the 1824 NRC licenses comprising 238 unique license types (ML22278A183) and differing renewal dates. The calculation assigned each individual license type an effort value, depending on the requirement for their unique combination of Forms 313 and 313A series submission, as illustrated in the chart of sample license types below. 

License type
 Code
313 Form 
313A (AUS)
313A (AUT)
313A (AUD)
313A (ANP)
313A (AMP)
313A (RSO)
Broadscope
2110
X
X
X
X
X
X
X
Irradiator
3510
X
 
 
 
 
 
X
Industrial Radiography
3310
X
 
 
 
 
 
X
In-vitro Testing
2410
 
 
X
X
 
 
 
Nuclear Imaging
2200
X
 
X
 
 
 
 
Nuclear Pharmacy
2500
X
 
 
 
X
 
X
Exempt Distribution
3257
 
 
 
 
 
 
X

The license type effort was estimated as follows: 
    1) Effort value associated with completing each Form 313 (i.e., NRC Form 313 only) ranged from 200 hours for the Broadscope or Master Material License (MML) type to 0.25 hours for a possession-only license type. 
    2) The effort value associated with completing each Form 313A series (i.e., each NRC Form 313A individually) was estimated to be consistent at 1 hour for each. 
    3) The range of total efforts to complete Form 313 (and related 313A series) was from 1.25 hours (simple possession license) to 206 hours (Broadscope/MML license). 

The distribution of all NRC licensing efforts skewed to the lower values showing a mean of 4.5 hours and a median of 5 hr. This was due to the majority of NRC’s 1824 active licenses requiring approximately 5 hours or less of effort, only 6 NRC licenses require more than 200 hours effort. 

The calculation assumed not all licenses were renewed annually and calculations were run per expected number of licensing actions (i.e., # of new license applications, # of renewed license applications, and # of amendment license applications). The analysis produced a mean value for Form 313 (and related 313A series) effort of 4.5 hours with an uncertainty error that encompassed the 4.3 hours (2021 clearance) estimate. For this reason, the 4.3 hour estimate was not changed as it was determined not to be significantly (in a statistical sense) different than the current 2025 estimate.

In the current submission, the NRC staff had updated the estimated burden to submit an amendment from 4.3 hours to 2 hours due the new 2026 implementation of a submission portal and elimination of pre-licensing engagement with licensees, which reduces licensee burden.

A.	NRC Licensees

The 2026-2029 annual effort estimate associated with the use of NRC Form 313 (and related NRC Form 313A) for new licenses, amendments and renewals for all material licensees is based on the most recent year of complete licensing data, i.e., total number of licensing actions processed during fiscal year 2024. 

Table 1a: Licensing Actions NRC Licensees (FY 2024)

2024
HQ 
Region 1
Region 3
Region 4
Total
New 
4
10
12
15
41
Renew
4
78
88
45
215
Amend
51
232
464
289
1036

Table 1b: Burden per NRC Licensing Action (FY 2024)

 
 Number of Respondents 
 Responses per Respondent 
 Responses 
 Burden per Response (hrs) 
 Burden Total (hrs) 
 New License Applications 
41.0
1.0
41.0
4.3
176.3
 Amendments 
1,036.0
1.5
1,554.0
2.0
3,108.0
 Renewals 
215.0
1.0
215.0
4.3
924.5
 Total 
1,292.0
 
1,810.0
 
4,208.8

Based on the expected number licensing actions, the total effort for NRC licensees seeking licensing actions is estimated to be 4,209 hours (sum of licensing actions hours). 

B.	Agreement State Licensees

Section 274 of the Atomic Energy Act of 1954, as amended, provides the statutory basis under which NRC relinquishes to the States its regulatory authority to license and regulate byproduct materials; source materials; and certain quantities of special nuclear materials. A map of Agreement States and non-Agreement 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 Licensee.”
 
The number of Agreement State licensees who submit information through NRC Form 313 or forms equivalent to NRC Form 313 is not known to the NRC and must be estimated. NRC uses a ratio method to provide this estimate. This ratio is defined as the total number of NRC licensees to the total number of Agreement State licensees. This ratio is used to estimate the number of Agreement State licensing actions. This ratio was calculated as 1:8.2 is based on Results of the Annual Count of Active Radioactive Materials Licenses in the National Materials Program 2026 (ML26085A506) 1,824 total NRC licensees and 14,916 Agreement State licensees.

Table 2: Burden per Agreement State Licensing Action (FY 2024)

 
Number of Respondents
 Responses per Respondent 
 Responses 
Burden per Response (hrs)
Burden Total
New License Applications
336.0
1.0
336.0
4.3
1,444.8
Amendments
8,495.0
1.5
12,742.5
2.0
25,485.0
Renewals
1,763.0
1.0
1,763.0
4.3
7,580.9
Total
10,594.0
 
14,841.5
 
34,510.7

The reporting burden for Agreement State licensees is estimated to be 34,511 hours.

C.	Third party

The medical use applicant or licensee requires third party information to complete the NRC Form 313A. These medical use licensees must provide preceptor attestation for individuals seeking to be recognized as authorized users, authorized Medical Physicist, authorized Nuclear Pharmacists, and Radiation Safety Officers for each authorization and additional authorizations being sought later as amendments. 

The preceptor providing attestation is usually not a licensee and their burden to complete the attestation is estimated to be 0.5 hours. The total number of third-party attestations is estimated to be equivalent to a fourth of the annual estimated medical use amendments. Medical use amendments are estimated to comprise three quarters of amendment requests. The total estimated third party annual burden is 1,171 hours [(1,036+11,458) responses x 0.25 x 0.75 x 0.5 hours)].

 D.	Total

Respondents to the collection are as follows:


Respondents
NRC licensees
1,292.0
AS licensees
10,594.0
3rd Part attestations
2,343.0
Total
14,229.0



Table 3. Total Annualized Burden Cost to Licensee

 
Responses
Burden
Cost ($154/hr)
NRC licensees reporting
1,810.0
4,209
$648,186 
Agreement State licensee reporting
14,841.5
34,511
$5,314,648 
3rd Party Attestations
2,343.0
1,171.00
$180,334 
Total
18,994.5
39,891
$6,143,168 

The NRC’s average labor rate of $154 per hour for FY 2026 was used to calculate burden costs to the public because it aligns with 2024 Bureau of Labor Statistics data showing comparable hourly mean wages across five key occupational groups (executives, management, technical staff, licensing staff, and physicists) within the nuclear industry.

    13. Estimate of Other Additional Costs

There are no additional costs.

    14. Estimated Annualized Cost to the Federal Government

NRC licensing staff has developed an estimate of annualized costs to the Federal Government related to the conduct of this collection of information. These estimates are based on staff’s experience with review, analysis, and process of information submitted through Form 313 and 313A.

It is relevant to note that use of NRC Forms increase government efficiency by receiving relevant data organized for efficient review. The use of NRC Forms reduces NRC’s information collection effort through minimizing follow-up requests for missing information.

It is estimated that the review of the information on NRC Forms 313 which for most applicants (approximately 3/4 of all applicants) will include NRC Form 313A submissions and will take an average of approximately 3.0 hours/application to review. Based on an anticipated 3,876 (3 x 1292) hour burden at a cost of $154 per hour, the cost to perform the licensing review would be $596,904. 

    15. Reasons for Changes in Burden or Cost  

The estimated burden has increased from 49,359 hours and 12,222 responses to 39,891 hours and 18,995 responses, a decrease of 9,468 hours and and increase of 6,773 responses. Burden differences are seen as 1) an increase in form 313 use, and 2) a decrease in effort per amendment, and 3) an increase in the number of licensee submissions to the regulator. 
The NRC staff has reduced the estimated burden to submit amendments from 4.3 hours to 2 hours due to amendments not requiring pre-licensing work. However, there has been an increase in the number of estimated Agreement State amendments from 6,862 to 8,495, resulting in an overall increase in the number of responses. The increase in licensing actions resulted from an increase in the number of licensees. 
Furthermore, the NRC has implemented a process to reduce inefficient paperwork through an online submission portal for Materials License Applications. Screenshots for the portal have been included in this submission. The online submission portal will allow NRC material licensees to submit licensing actions directly to the Web-based Licensing (WBL) system. This aims to reduce reliance on email, mailed, and faxed submissions. This online portal aims to improve the speed and accuracy of data transition to WBL. This clearance assumes the online application submission portal does not affect the burden or cost estimates for this effort calculation.

    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.

    18. Exceptions to the Certification Statement

There are no exceptions.

B.	COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

Not applicable.



 


GUIDANCE DOCUMENTS 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)


Title
Accession number or link
Nureg-1556, "Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Use Licenses" Final Report.

https://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/index.html