ML20104B698

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LIC-116, Pre-application Readiness Assessment
ML20104B698
Person / Time
Issue date: 07/31/2020
From:
NRC/NRR/DNRL/NRLB
To:
Office of Nuclear Reactor Regulation
Tabatabai O
References
LIC-116, Y020200016
Download: ML20104B698 (24)
v • d • e


Text

OFFICE OF NUCLEAR REACTOR REGULATION LIC-116 Preapplication Readiness Assessment Volume 100 Licensing Processes Approved By: Anna H. Bradford Date Approved: July 31, 2020 Effective Date: August 3, 2020 Certification Date: August 3, 2025 Responsible Organization: DNRL Primary

Contact:

Omid Tabatabai Omid.Tabatabai@nrc.gov 301-415-6616 Summary: Initial issuance. NRR-LIC-116 incorporates and rescinds NRO-REG-104, Pre-application Readiness Review. It also incorporates insights from the Environmental Center of Expertise, License Renewal Program, and Advanced Reactor Program.

Training: None ADAMS Accession Number: ML20104B698 TABLE OF CONTENTS

1. POLICY ................................................................................................................................. 2
2. OBJECTIVES ........................................................................................................................ 2
3. BACKGROUND .................................................................................................................... 2
4. BASIC REQUIREMENTS ..................................................................................................... 3
5. RESPONSIBILITIES AND AUTHORITIES ........................................................................... 7
6. PERFORMANCE MEASURES ............................................................................................. 7
7. PRIMARY CONTACT ...........................................................................................................8
8. RESPONSIBLE ORGANIZATION ........................................................................................ 8
9. EFFECTIVE DATE ................................................................................................................ 8
10. CERTIFICATION DATE ........................................................................................................ 8
11. REFERENCES...................................................................................................................... 8

ML20104B698 *via-email LIC-116 OFFICE NRR/DNRL: PM NRR/DNRL: BC OGC/GCHA/AGCNRP NMSS/REFS: DD NAME OTabatabai MDudek* RWeisman* KCoyne*

DATE 6/15/2020 6/18/2020 7/27/2020 6/23/2020 OFFICE NRR/DNRL: D NRR/DRMA: DD NRR/DNRL: D NAME ABradford* TGorham* ABradford*

DATE 7/6/2020 7/30/2020 7/31/2020 NRR Office Instruction LIC-116, Revision 0 Page 2 of 8

1. POLICY It is the policy of the U.S. Nuclear Regulatory Commissions (NRCs) Office of Nuclear Reactor Regulation (NRR) to develop office instructions (OIs) for the staffs review of licensing applications submitted under Title 10 of the Code of Federal Regulations (10 CFR) Parts 50, 51, 52, and 54 that involve two or more NRR divisions or other NRC program offices. NRR staff is encouraged to use this OI to plan and conduct preapplication readiness assessments in order to advocate for early engagement with potential applicants, which will set NRC staffs expectations regarding the quality of applications for an efficient review.
2. OBJECTIVES The purpose of this OI is to provide guidance to the NRR staff, and other NRC staff supporting NRRs licensing activities, to assess the readiness of a draft application, such as a design certification, combined license, early site permit, construction permit, or license renewal, before it is formally submitted for the staffs review. The readiness assessment will allow the staff to (1) identify any required information that is missing from the application, (2) identify technical or regulatory issues that may complicate the acceptance or technical reviews of the application, and (3) become familiar with the content of the application, particularly in areas where applicants plan to propose new concepts or novel design features. Implementing and improving procedures for permit (licensing) streamlining is consistent with the directives of the Office of Management and Budget and Executive orders as documented annually by the NRCs submission of best practices in an annual report to Congress.
3. BACKGROUND In April 2013, the NRC issued New Reactor Licensing Process Lessons Learned Report (Agencywide Documents Access and Management System (ADAMS) Accession No. ML13059A239), in which the staff identified the quality of an application as a significant contributor to the overall efficiency of a review. The report also concluded that the NRC staffs performance of a readiness assessment before an applicants formal submission of an application would enhance the quality of the application.

Specifically, a readiness assessment would provide an opportunity for applicants to address major technical and policy issues and significant information gaps before submitting their applications and would assist the NRC staff to better plan for the resources needed for an effective and efficient review once the applications were formally submitted. With regard to environmental reviews, 10 CFR 51.40, Consultation with NRC staff, states that A prospective applicant [for licensing actions] or petitioner for rulemaking is encouraged to confer with NRC staff as early as possible in their planning process and before submitting environmental information or filing an environmental report.

In December 2017, the NRC staff published, A Regulatory Review Roadmap for Non-Light Water Reactors, (ADAMS Accession No. ML17312B567) to provide a regulatory review roadmap of the options available for NRC review of pre-application information and of formal applications for non-light-water reactor designs.

NRR Office Instruction LIC-116, Revision 0 Page 3 of 8 This OI describes the process for initiating, conducting, and documenting a readiness assessment. It also provides guidance for effective implementation of a readiness assessment. While the readiness assessment is a voluntary licensee preapplication interaction with the staff, experience has shown that this preapplication interaction contributes to achieving higher quality applications, as stated in the lessons learned report. The readiness assessment is not part of the staffs formal acceptance review and does not predetermine whether the application will be docketed. The NRC describes the process for performing an acceptance review in NRR-LIC-109, Acceptance Review Procedures, (ADAMS Accession No. ML16144A521), and NRO-REG-100, Acceptance Review Process for Early Site Permit, Design Certification, and Combined License Applications, (ADAMS Accession No. ML14078A152.) The readiness assessment is intended to inform and benefit both the prospective applicant and the staff.

In view of the foregoing, the staff should engage with prospective applicants to schedule a preapplication readiness assessment. If the prospective applicant agrees to a voluntary readiness assessment, the staff recommends conducting it at least 6 months before the expected date of formal application submittal. This would allow time for applicants to consider the results from the readiness assessment as they finalize their applications and to reevaluate the application submission date to take into account the time needed to address the readiness assessment results. Prospective applicants that choose to have a readiness assessment should submit a request, which the staff should acknowledge by e-mail or letter. If, for any reason, a readiness assessment did not occur before submittal of an application, the staff should document the circumstances for this decision in an internal memorandum. The staff may also wish to acknowledge the decision in correspondence to the prospective applicant.

4. BASIC REQUIREMENTS 3.1 RESPONSIBILITIES Safety Project Manager1 The safety project manager (PM) is the lead PM within NRR and is supported by other PMs as needed. The role of the safety PM is as follows:
  • Engage the prospective applicant and management to agree on the dates and scope of the readiness assessment and communicate these to the technical staff;
  • Develop the readiness assessment plan and the agreed scope of the readiness assessment in coordination with the technical staff. The lead PM should transmit the readiness assessment plan to the prospective applicant at least 30 days before the starting date of the readiness assessment review. The readiness assessment plan should be made publicly available (see Appendix A);
  • Coordinate the logistics of the readiness assessment, including a list of documents the prospective applicant should provide, agendas, and interactions between the NRC and prospective applicant personnel; 1 For readiness assessment activities related to the environmental report, the lead safety PM will coordinate with the Environmental Center of Expertise PM to ensure the successful performance of these activities.

Appendix B to NRR-COM-101 describes the roles and responsibilities of the environmental staff with regard to activities supporting the environmental review.

NRR Office Instruction LIC-116, Revision 0 Page 4 of 8

  • Ensure that a fee-billable cost activity code number is obtained before the technical staff conducts any fee-billable activity;
  • Schedule a planning meeting with all the NRC staff involved in the readiness assessment to discuss individual responsibilities and logistics of the readiness assessment, including how to document the observations, issues, and concerns;
  • Support the technical staff during the readiness assessment;
  • Compile technical staff observations;
  • Lead the entrance, exit, and daily status meetings during the readiness assessment;
  • Brief management on the results of the readiness assessment;
  • Prepare and issue a readiness assessment report within 45 calendar days of completion of the readiness assessment (see Appendix B). A nonproprietary version of the readiness assessment report will be made publicly available; and
  • Coordinate with the technical staff to determine the level of detail of the results to be shared with the prospective applicant in the report (i.e., general observations, no requests for additional information (RAIs)).

Technical Staff Technical staff in NRR and other NRC offices, as assigned, are responsible for the following:

  • Participate in the planning meeting that the safety PM schedules;
  • Become familiar with applicable regulatory requirements and guidance documents pertaining to review of the potential application (e.g., requirements for content of applications, applicable sections of any applicable Design Specific Review Standard, applicable sections of NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, interim staff guidance, and regulatory guides);
  • Develop an assessment strategy for the area of review by considering lessons learned from previous application reviews, guidance, regulations, and requirements. For example, a reviewer can create a list of the information that should be part of the application (such as requirements, general design criteria, drawings, graphs, and analysis inputs/outputs values), to be used in assessing the technical content of the draft application within the time constraints of the readiness assessment schedule;
  • Identify information gaps or other concerns in the technical reviewer area(s) that may pose challenges during the acceptance review process;
  • Communicate issues and concerns to the prospective applicant and PMs during the readiness assessment;
  • Document the results of the readiness assessment in a memorandum (see Attachment C) or an e-mail addressed to the responsible Licensing Branch Chief (BC). The memorandum or e-mail should identify (1) areas where the level of detail is not sufficient and (2) areas where significant information gaps or technical and policy issues might negatively impact the application review schedule. The memo or e-mail should cite the regulatory requirements for which the information is lacking or not sufficient. A significant information gap exists when the missing information the staff needs to conduct the detailed technical review is not expected to be addressed through one or two rounds of RAIs.

A minor information gap exists when missing information can be addressed

NRR Office Instruction LIC-116, Revision 0 Page 5 of 8 through one round of RAIs. A minor information gap, however, does not necessarily indicate a minor technical issue; and

  • Place the branch memorandum or e-mail in ADAMS as a nonpublicly available (sensitive internal informationno periodic review) document and provide it to the Projects BC within 2 weeks of completing the readiness assessment.

Branch Chiefs (BCs)

BCs have the following roles:

  • Ensure that the staffs assessment strategy has considered risk insights. Office Instruction, NRR-LIC-206, Integrated Risk-Informed Decision-Making for Licensing Reviews, (ADAMS Accession No. ML19031C861) provides a basic framework for considering risk insights in licensing activities;
  • Document the results of the technical staffs readiness assessment in a memorandum to the responsible Licensing BC;
  • Support staff briefings to upper management on the results of the readiness assessment, as needed;
  • Lead the staffs briefing of the prospective applicant on the results of the readiness assessment; and
  • Review and concur on the readiness assessment report before it is publicly issued.

4.2 INTERFACE GUIDANCE FOR THE NRC STAFF As stated earlier, the readiness assessment will allow the NRC staff to identify major issues or information gaps between the draft application and the technical content the applicant is required to include in the application submitted to the NRC. Guidance below will aid the staff in focusing the readiness assessment on the appropriate topics.

Dos Before the readiness assessment, the staff should do the following:

  • Review the latest documentation related to the design available in ADAMS under the project number; and
  • Develop an assessment strategy that considers risk insights, consistent with guidance in NRR-LIC-206, for each area of expertise that is part of the readiness assessment scope.

During the readiness assessment, the staff should do the following:

  • Identify aspects of the draft application that may be inconsistent with applicable review guidance and regulations (other than where the application indicates it is proposing an alternative to an approach contemplated by review guidance);
  • Identify areas that appear to be incomplete to support a complete technical review, such as where the level of detail appears to be different than what is described in regulatory guidance;
  • Identify documents referenced in the application that the staff would need to review to support the detailed technical review, if the application were to be docketed;

NRR Office Instruction LIC-116, Revision 0 Page 6 of 8

  • Identify regulations and current guidance that may be related to an identified issue or information gap;
  • Perform a preliminary categorization of the identified issues based on the impact of the issue on docketing or technical review of the application (e.g., a significant issue is one that could negatively impact the docketing and/or is an obviously significant technical issue; however, an issue that can be addressed through the RAI process is not necessarily a minor technical issue). The categorization of observation provides an efficient method of preparing the readiness assessment report and communicating the identified issues to the prospective applicant; and
  • As a general practice, information reviewed by the staff should not be removed from the readiness assessment site. Information must be handled in accordance to federal records requirements and applicable NRC guidance, including Management Directive (MD) 3.53, NRC Records and Document Management Program.

Donts During the readiness assessment, the staff should NOT do the following:

  • Provide any guidance to the prospective applicant on what to write to make the information acceptable or provide written revisions for the prospective applicants consideration; and
  • Discuss or make actual regulatory determinations (i.e., safety findings) on the draft application.

4.3 SCOPE OF THE READINESS ASSESSMENT The readiness assessment may focus on either the whole application or selected parts identified in early interactions between the staff and prospective applicant. For new and novel reactor designs such as non-light-water reactors (non-LWRs), a full-scope readiness assessment is recommended. The environmental PM coordinates the appropriate scope of readiness assessment for an environmental review. If the prospective applicant requests a partial readiness assessment, the staff should encourage assessment of the review topics below, which have proven challenging during previous application reviews.

Safety Topics:

  • seismic analysis;
  • long-term cooling and Generic Safety Issue 191;
  • instrumentation and controls;
  • radioactive effluents, radiation protection, and radiation-related (e.g., shielding) portions of equipment qualification;
  • severe accident analysis and probabilistic risk analysis; and
  • human factors engineering.

Environmental Topics:

  • consideration of other environmental permits required for the project/action (including any water use permits) and the required consultations that the NRC must perform under other laws (see Nuclear Energy Institute 10-07, Industry

NRR Office Instruction LIC-116, Revision 0 Page 7 of 8 Guideline for Effective Pre-Application Interactions with Agencies Other Than NRC During the Early Site Permit Process, Revision 1, issued January 2013);

  • alternatives to the action, including, if applicable, alternative site selection process documentation; and
  • unique or novel methodologies or issues (such as a unique purpose and need for the project).

The readiness assessment plan (see Appendix A) should list the sections/topics for staff review during the readiness assessment.

4.4 INFORMATION AND OTHER MATERIAL NECESSARY FOR THE READINESS ASSESSMENT During the readiness assessment, the prospective applicant should make available full copies of the draft application, all supporting topical and technical reports, examples of important calculations, and personnel who can answer questions for the areas selected for review. Supporting technical reports include reports referenced in the application that will require the NRCs review as part of the detailed review.

4.5 COMMUNICATING THE OBSERVATIONS OF THE READINESS ASSESSMENT

  • Daily Briefs with the Prospective Applicant: A summary of the preliminary observations should take place at the end of each day, along with confirmation with the prospective applicant of the topics that will be assessed the next day;
  • Exit Meeting with the Prospective Applicant: An exit meeting should take place on the last day of the readiness assessment to summarize the most significant preliminary observations identified by the NRC staff;
  • NRC Staff: The PM(s) will discuss staff observations with the branch-level management in order to gain alignment on the content of the readiness assessment report; and
  • Letter to the Prospective Applicant: The staff should send the readiness assessment report to the prospective applicant by letter (Appendix B) within 45 calendar days of completion of the readiness assessment.
5. RESPONSIBILITIES AND AUTHORITIES Section 4.1 of this OI describes roles and responsibilities of the staff involved in preapplication readiness assessments.
6. PERFORMANCE MEASURES None
7. PRIMARY CONTACT Omid Tabatabai 301-415-6616 Omid.Tabatabai@nrc.gov

NRR Office Instruction LIC-116, Revision 0 Page 8 of 8

8. RESPONSIBLE ORGANIZATION DNRL
9. EFFECTIVE DATE August 3, 2020
10. CERTIFICATION DATE August 3, 2025
11. REFERENCES
1. Nuclear Energy Institute 10-07, Industry Guideline for Effective Pre-Application Interactions with Agencies Other Than NRC During the Early Site Permit Process, Revision 1, January 2013 (ADAMS Accession No. ML13028A392)
2. NRC, NRR Office Instruction COM-101, NRR Interfaces with NMSS, Revision 1, August 2020 (ADAMS Accession No. ML20041D873)
3. NRC, RG 1.206, Applications for Nuclear Power Plants, Revision 1, October 2018

Enclosures:

1. Appendix A: Preapplication Readiness Assessment Plan
2. Appendix B: Template of Letter to the Prospective Applicant Documenting the Preapplication Readiness Assessment Observations
3. Appendix C: Template of Branch Memorandum Documenting Preapplication Readiness Assessment Observations
4. Appendix D: Change History

Appendix A Preapplication Readiness Assessment Plan Enclosure 1

[Date]

[Name], [Title]

[Company]

[Address]

Dear Mr./Ms. [Last Name]:

On [Day, Date], [Name of Prospective Applicant] submitted a letter notifying the U.S. Nuclear Regulatory Commission (NRC) that it plans to submit an application for the [Application Name] on [Date of Submittal]. The NRC, through discussions with [Name of Prospective Applicant], has determined that [Date] would be an appropriate date to conduct preapplication readiness assessment (hereinafter readiness assessment) as part of preapplication interactions on the [Application Name] draft application.

The readiness assessment is not part of the NRCs official acceptance review process. The readiness assessment of the [Application Name] draft application will allow the NRC staff to understand the level of detail in the draft application and identify any major issues or information gaps between the draft application and the technical content required to be included in the application submitted to the NRC. Therefore, the observations from the readiness assessment do not predetermine whether the application will be docketed.

The attached readiness assessment plan provides the details and logistics of the readiness assessment activities.

If you have any questions or concerns, please contact [Name of Project Manager] at [Phone Number] or [E-Mail].

Sincerely,

[Name], Division Director

[Division]

[Office]

Project No. [Project Number]

Attachment:

Readiness Assessment Plan cc: Distribution via listserv 2

MLxxxxxxxxx [Template #]

OFFICE PM: Office/Division/Branch BC: Office/Division/Branch DD: Office/Division NAME DATE PREAPPLICATION READINESS ASSESSMENT PLAN OF THE [APPLICATION NAME]

[TYPE OF APPLICATION] DRAFT APPLICATION

[Dates]

[Application Name]

[Name of Prospective Applicant]

Project No. PROJXXXX LOCATION [Name of Location]

[Street Address]

PURPOSE The [Name of Applicant] has voluntarily agreed to engage with the NRC staff in a preapplication readiness assessment (hereinafter readiness assessment) of the [Application Name] draft [Type of Application] application before the application is submitted for a formal U.S. Nuclear Regulatory Commission (NRC) review. The readiness assessment will allow the NRC staff to (1) identify information gaps between the draft application and the technical content required in the application submitted to the NRC, (2) identify major technical or policy issues that may adversely impact the docketing or technical review of the application, and (3) become familiar with the application, particularly in areas where [Name of Prospective Applicant] is proposing new concepts or novel design features. The observations from the readiness assessment will inform the prospective applicant in finalizing the application and also will assist the NRC staff in planning NRC resources in preparation for the review once the application is formally submitted.

BACKGROUND In a letter dated [Date] (Agencywide Documents Access and Management System (ADAMS)

Accession No. MLxxxxxxxxx), [Name of Prospective Applicant] stated that it plans to submit the application on [Date of Submittal]. In agreement with [Name of Prospective Applicant],

the NRC has scheduled a readiness assessment of the [Application Name] draft application on

[Date] at [Location].

SCOPE OF THE READINESS ASSESSMENT The readiness assessment of the [Application Name] draft application will focus on the

[choose one of the following: major areas identified from past reviews of applications to be challenging review areas. or areas identified from past reviews of applications to pose a challenge and areas identified based on preapplication interactions with [Name of Prospective Applicant].]

4

[The following are the recommended minimum topics to consider for a readiness assessment.]

seismic analysis (e.g., DSRS/SRP Chapter 3)

  • long-term cooling and Generic Safety Issue 191 (Chapters 4 and 6)
  • instrumentation and controls (Chapter 7)
  • radioactive effluents (Chapter 11), radiation protection (Chapter 12 and radiation-related portions of equipment qualification (Section 3.11))
  • severe accident analysis and probabilistic risk analysis (Chapters 15 and 19)
  • human factors engineering (Chapter 18)
  • [add other review topics as desired]

INFORMATION AND OTHER MATERIAL NECESSARY FOR THE READINESS ASSESSMENT As previously discussed with [Name of Prospective Applicant], the following should be available to support the readiness assessment: full copies of the draft application, all supporting topical reports, all major supporting technical reports, examples of important calculations, and staff who can answer questions related to these documents.

READINESS ASSESSMENT TEAM The following table shows the technical review areas and the responsible technical staff.

Review Area Reviewer(s)

LOGISTICS The readiness assessment will take place at the [Name of Location] located in [City, State]. It is scheduled to begin with an entrance meeting upon the arrival of the team on [Date] and to end with an exit meeting on [Date]. Daily debriefings will take place as needed.

The NRC technical staff will charge time to the following fee-billable cost activity code number:

XXXXXX.

5

SPECIAL REQUESTS

    • This section may document any requests of the licensee by the team to support the readiness assessment.*** The staff will observe appropriate handling and protection of proprietary or safeguards information, or both, throughout the readiness assessment.

READINESS ASSESSMENT OBSERVATIONS The NRC will send the readiness assessment observations, including any identified technical concerns or major information gaps, to [Name of Prospective Applicant] in a publicly available report that will also summarize the scope of the readiness assessment. To protect the applicants proprietary information, if needed, the staff will issue a Proprietary version of the readiness assessment report to [Name of Prospective Applicant]. The staffs expectation is that [Name of Prospective Applicant] will consider the observations from the readiness assessment while finalizing the application and will reevaluate the application submission date based on its evaluation of the time to address the readiness assessment observations.

REFERENCES (Update as needed)

1. [IF APPLICABLE:] U.S. Nuclear Regulatory Commission (NRC), [Name of Design]

Design Specific Review Standard, [Document Number], [Date], ADAMS Accession No. MLxxxxxxxxx. [present the accession number as a hyperlink if possible]

2. NRC, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, NUREG-0800. (Link)
3. NRC, Combined License Applications for Nuclear Power Plants (LWR Edition),

Regulatory Guide 1.206. (Link)

4. 10 CFR Part 50, Domestic licensing of production and utilization facilities. (Link)
5. 10 CFR Part 52, Licenses, certifications, and approvals for nuclear power plants.

(Link) 6

Appendix B Template of Letter to the Prospective Applicant Documenting the Preapplication Readiness Assessment Observations Enclosure 2

[Date]

[Name], [Title]

[Company]

[Address]

Dear Mr./Ms. [Last Name]:

On [Day, Date], members of the staff of the U.S. Nuclear Regulatory Commission (NRC) completed a preapplication readiness assessment (hereinafter readiness assessment) of the draft application and supporting documents that [Name of Prospective Applicant] intends to submit as part of the [Application Name] [Type of Application] application. The staff conducted the readiness assessment at [Name of Location] in [City, State]. The readiness assessment plan used for the [Application Name] [Type of Application] application can be found in the Agencywide Documents Access and Management System (ADAMS) under Accession No. MLxxxxxxxxx.

The readiness assessment is not part of the NRCs official acceptance review process. The staff performed the readiness assessment to understand the level of detail of the [Application Name] draft application and to identify any major issues or information gaps between the draft application and the technical content required to be included in the final application submitted to the NRC. Therefore, the observations from the readiness assessment do not predetermine whether the application will be docketed.

The attached document provides the NRC staff observations of the [Application Name] [Type of Application] draft application.

2

Please consider the observations from the readiness assessment while finalizing your application and reevaluate the application submission date based on your evaluation of the time needed to address the readiness assessment observations.

If you have any questions, please contact [Name of Project Manager] at [Phone Number] or

[E-mail].

Sincerely,

[Name], Division Director

[Division]

[Office]

Project No. [Project Number]

Attachment:

NRC Staff Observations cc: Distribution via listserv DISTRIBUTION:

RidsNrr/Division (Project)

RidsNrr/Division (Technical)

ADAMS Accession: MLxxxxxxxxx [Template #]

OFFICE PM: Office/Division/Branch BC: Office/Division/Branch DD: Office/Division*

NAME DATE OFFICE DD: Office/Division* OGC DD: Office/Division NAME DATE OFFICIAL RECORD COPY

  • Technical Division Director 3

Preapplication Readiness Assessment of the [Application Name] [Type of Application] Draft Application NRC Staff Observations

[The following examples illustrate how the issue or information gap could be described.]

Chapter X

  • Does not identify the results of the assessment of the standard design for the effects of seismic interaction, or Category II/I.
  • Does not describe sensitivity studies for addressing uncertainties in seismic analysis.
  • Etc.
  • Cite the regulatory basis for identifying the major issues and information gaps.

Chapter X

  • does not provide a functional description of the plant protection system and the engineered safety feature-component control system.
  • Etc.

4

Appendix C Template of Branch Memorandum Documenting Preapplication Readiness Assessment Observations Enclosure 3

Date MEMORANDUM TO: [NameResponsible Licensing Branch], Chief

[Branch]

[Division]

[Office]

FROM: [NameTechnical Branch], Chief

[Branch]

[Division]

[Office]

SUBJECT:

PREAPPLICATION READINESS ASSESMENT OBSERVATIONS FOR

[SECTION NUMBER(S)] OF THE [FACILITY NAME] [TYPE OF APPLICATION] APPLICATION FOR THE [APPLICATION NAME]

During [Date], the [Branch Name(s)] conducted a preapplication readiness assessment of the draft application and supporting documents that [Name of Prospective Applicant] intends to submit as part of the [Application Name] [Type of Application] application. The preapplication readiness assessment plan can be found in the Agencywide Documents Access and Management System (ADAMS) under Accession No. MLxxxxxxxxx.

The attached document identifies the major technical and policy issues or significant information gaps in the draft application that the staff recognized through the preapplication readiness assessment related to [topic(s)/section(s) reviewed]. The applicant should revise the technical content of the application to address, or provide, the identified information . This report is designed to serve as input to an overall preapplication readiness assessment report that the project manager will prepare. As such, this reports content is limited to a description of the sections reviewed and the insights and observations that will support development of the overall preapplication readiness assessment report.

Enclosure:

See attached CONTACT: [Name], [Office/Division/Branch]

[Phone Number]

2

DISTRIBUTION:

RidsNrr/Division (Project)

RidsNrr/Division (Technical)

RidsNrr/DE ADAMS Accession: MLxxxxxxxxx [Template #]

OFFICE Lead Technical Reviewer: Technical Branch BC:

Office/Division/Branch Office/Division/Branch NAME DATE OFFICIAL RECORD COPY 3

Purpose:

The purpose of the readiness assessment is to understand the level of detail of the

[Application Name] draft application and to identify any major issues or information gaps between the draft application and the technical content expected to be included in the final application submitted to the U.S. Nuclear Regulatory Commission (NRC).

Scope:

This preapplication readiness assessment input provides the NRC staffs observations on the portion of the review scope related to [topic(s) reviewed].

Observations:

The staff identified the following significant issues or information gaps between the draft application and the technical content expected to be included in the final application submitted to the NRC.

[The following examples illustrate how the issue or information gap could be described. The regulatory basis for each observation must be provided.]

  • Section XX does not describe sensitivity studies for addressing uncertainties in the seismic analysis. Sensitivity studies are typically performed to address modeling assumptions pertaining to water table effects, foundation uplift, location of model boundaries, element discretization, and other factors.
  • Section XX does not provide a detailed functional description of the plant protection system and the engineered safety feature-component control system.
  • Section XX does not identify the results of the assessment of the standard design for the effects of seismic interaction, or Category II/I.
  • etc.

4

Appendix DChange History Office Instruction LIC-116 LIC-116Change HistoryPage 1 of 1 Date Description of Changes Method Training Used to Announce &

Distribute July 31, 2020 Initial issuance. NRR-LIC-116 incorporates and E-mail to all None rescinds NRO-REG-104, Pre-application NRR staff Readiness Review. It also incorporates insights from the Environmental Center of Expertise, License Renewal Program, and Advanced Reactor Program.

Enclosure 4

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