ML20036C829

LIC-109, Revision 3, Acceptance Review Procedures for Licensing Basis Changes

ML20036C829
Person / Time
Issue date:	07/13/2020
From:	Gregory Suber NRC/NRR/DORL/LPL2-2
To:	Office of Nuclear Reactor Regulation
Wentzel M
References
LIC-109, Y020190372
Download: ML20036C829 (54)

Text

OFFICE OF NUCLEAR REACTOR REGULATION LIC-109, Revision 3 Acceptance Review Procedures for Licensing Basis Changes Volume 100 Licensing Processes Approved By:

Gregory F Suber Date Approved:

July 13, 2020 Effective Date:

July 20, 2020 Certification Date:

July 20, 2025 Responsible Organization:

DORL Primary

Contact:

Michael Wentzel Michael.Wentzel@nrc.gov 301-415-6459 Summary:

Revision 3 of LIC-109 is renamed and revised to clarify that the scope of the office instruction applies to licensee-requested changes to a plants licensing basis. Additional revisions were made to reflect current processes, to clarify how to count working days for the purposes of the acceptance review, and to clarify and make consistent the language used in the example letters.

Training:

None ADAMS Accession Number: ML20036C829 TABLE OF CONTENTS 1.

POLICY............................................................................................................................... 2 2.

OBJECTIVES..................................................................................................................... 3 3.

BACKGROUND.................................................................................................................. 3 4.

BASIC REQUIREMENTS................................................................................................... 4 5.

RESPONSIBILITIES AND AUTHORITIES......................................................................... 4 6.

PERFORMANCE MEASURES........................................................................................... 9 7.

PRIMARY CONTACT......................................................................................................... 9 8.

RESPONSIBLE ORGANIZATION...................................................................................... 9 9.

EFFECTIVE DATE........................................................................................................... 10 10.

CERTIFICATION DATE.................................................................................................... 10 11.

REFERENCES................................................................................................................. 10

ML20036C829 OFFICE NRR/DORL/LPL2-2/PM NRR/DORL/LPL2-2/LA NRR/DORL/LPL2-2/BC NRR/DEX/D NAME MWentzel BAbeywickrama UShoop EBenner DATE 02/10/2020 02/10/2020 05/13/2020 05/27/2020 OFFICE NRR/DRO/D(A)

NRR/DNRL/D NRR/DRA/D NRR/DSS/D NAME MFerdas RCaldwell GBowman MRoss-Lee DATE 06/02/2020 06/09/2020 06/08/2020 06/08/2020 OFFICE NSIR/DPR/D OGC (NLO w/edits)

NRR/DRMA NRR/DORL/D NAME KBrock MYoung TGorham CErlanger (GSuber for)

DATE 06/08/2020 06/24/2020 06/25//2020 07/13/2020

NRR Office Instruction LIC-109, Revision 3 Page 2 of 11

1.

POLICY It is the policy of the Office of Nuclear Reactor Regulation (NRR) to review an application to amend a license for completeness and acceptability for docketing. The regulations in Title 10 of the Code of Federal Regulations (10 CFR), Part 2, Agency Rules of Practice and Procedure, prescribe the procedure for: issuance of a license; amendment of a license at the request of the licensee; and transfer and renewal of a license. Activities covered by this Office Instruction (OI) are those changes to a plants licensing basis that require U.S. Nuclear Regulatory Commission (NRC) approval prior to implementation (e.g., license amendments, relief requests, exemptions, etc.).

The regulations that are applicable to this OI are contained in 10 CFR 2.101, Filing of Application, 10 CFR 2.102, Administrative Review of Application, 10 CFR 2.107, Withdrawal of Application, and 10 CFR 2.108, Denial of Application for Failure to Supply Information.

Section 2.101 of 10 CFR allows the NRC staff to determine whether a request for licensing action (RLA) is complete and acceptable for docketing. Additionally, the NRC staff may return an application found to be incomplete, and therefore not acceptable for review, to a licensee to address any identified insufficiencies. This authority may be utilized before an opportunity for a hearing has been noticed in the Federal Register.

Section 2.107 of 10 CFR provides the opportunity for a licensee to request to withdraw an RLA prior to the issuance of a notice of a hearing.

Section 2.102 of 10 CFR allows the NRC staff to request that the licensee supply additional information in the course of the review of the proposed action. The staff may request any one party to the proceeding to confer with the NRC staff informally. If a licensee fails to respond to a request for additional information (RAI) in the requested time frame, 10 CFR 2.108 allows the NRC staff to deny an application.

NRR will consider an RLA to be acceptable for review upon the NRC staffs conclusion that the application reasonably appears to contain sufficient technical information, both in scope and depth, for the NRC staff to complete the detailed technical review and render, in an appropriate time frame for the associated action, an independent assessment of the proposed action with regard to applicable regulatory requirements and the protection of public health, safety, and security.

While the goal of the acceptance review process is to facilitate submittal of acceptable RLAs, resulting in fewer RAIs, the acceptance of an RLA in no way implies that RAIs may not be raised during the detailed review process, that these RAIs may not identify serious insufficiencies in the application (possibly resulting in denial of the RLA), or that the application will be or must be approved. Rather, the acceptance review is a tool used by the NRC staff to identify unacceptable RLAs early in the review process, so that they can be returned to the licensee.

Use of This Office Instruction for Other Processes The regulations cited in this OI do not apply to submittals that are not considered licensing applications, such as topical reports (TRs) or Technical Specifications Task Force (TSTF) travelers. The regulations cited in this OI are not intended to address

NRR Office Instruction LIC-109, Revision 3 Page 3 of 11 submittals by non-licensees and may not apply to entities other than licensees (e.g.,

contractors to a licensee). Entities preparing such submittals or NRC staff and process owners reviewing such submittals may use the guidance in this OI as a best practice for the preparation and processing of such submittals. However, the NRC staff and process owners may want to consult with the Office of the General Counsel (OGC) to understand how the legal aspects of the regulations apply to the submittal. For a more detailed description of the TRs review process, see LIC-500, Processing Requests for Reviews of Topical Reports. For a more detailed description of the TSTF traveler review process, see LIC-600, Standard Technical Specifications Change Traveler Review and Adoption Process.

This OI does not apply to early site permit, design certification, or combined license applications; research and test reactor activities; or RLAs that require a regulatory decision in such a limited time that performance of an acceptance review would not be feasible (e.g., emergency or exigent amendment requests, or quality assurance program changes). The acceptance reviews for these activities are covered in other OIs or staff guidance documents.

2.

OBJECTIVES This OI, along with Enclosure 1, Guide for Performing Acceptance Reviews, provides all NRR staff (and other NRC staff supporting NRR licensing activities) a basic framework for performing an acceptance review upon receipt of an RLA.

These procedures should enhance NRR's efficiency in responding to the needs of the licensees and the public. Specific objectives include the following:

Provide general guidance to NRC staff, licensees, and the public defining acceptable RLAs; Promote the submission of acceptable RLAs by licensees; Promote an effective and consistent application of NRC resources in performing acceptance reviews; Establish the acceptance review process as an integral part of an effective licensing review, thus reducing unnecessary delays in the review of RLAs; Establish the priority of acceptance reviews and schedule for completion; and Ensure effective internal and external communications.

3.

BACKGROUND The quality of an RLA has a significant impact on the amount of NRC staffs resources expended in the review process. RLAs that include information of a sufficient scope and depth allow the NRC staff to focus its efforts on reviewing the safety, technical, and regulatory merits of the arguments put forth by the licensee. When an application lacks critical information necessary (e.g., analyses/calculations, unjustified use of unapproved methodologies, etc.) for the NRC staff to complete its review, an excessive amount of

NRR Office Instruction LIC-109, Revision 3 Page 4 of 11 NRC staff time is spent gathering this information. Additionally, time spent on RLAs that are unacceptable for review results in longer review periods for the RLA and adversely impacts the resources and schedules of other acceptable RLAs.

A thorough acceptance review is integral to the efficient review of an RLA. The early identification of insufficient information benefits both the NRC staff and the licensee.

The NRC staff benefits by identifying informational needs earlier and expending fewer resources in completing its review. The licensee benefits by understanding potential NRC staff concerns and needs earlier, in addition to getting faster decisions on RLAs.

NOTE: Given the lesser scope and depth of the acceptance review as compared to the detailed technical review, there may be instances in which significant issues that impact the NRC staffs ability to complete the review are identified despite completion of an adequate acceptance review. When such issues are identified, management will be promptly informed so that appropriate action can be taken, which may involve denying the application.

For the purposes of this procedure, the RLA will be considered received by the NRC the day that it is declared an Official Agency Record (OAR) in the Agencywide Documents Access and Management System (ADAMS).

NOTE: Unless otherwise noted, all time frames are defined as working days. Working days exclude weekends and all Federal holidays (including holidays granted by Executive Order). Additionally, any day the NRC headquarters office is closed will not be counted as a working day for acceptance review timeliness purposes, but a partial day closure will be counted as a working day.

4.

BASIC REQUIREMENTS The attached guidance describes a procedure for performing acceptance reviews of requested RLAs. The process includes the following sub-processes:

Establish schedule and resources for the acceptance review; Review of the application for administrative and technical sufficiency; Resolve any informational insufficiencies; and Implement and document results.

5.

RESPONSIBILITIES AND AUTHORITIES All NRC staff who support the review of applicable RLAs are responsible for reading, understanding, and applying the guidance contained in Enclosure 1. They are also responsible for identifying possible improvements to the guidance and submitting suggestions for such improvements to their management or to the assigned contact for this OI. The responsibilities listed below are applicable to NRC staff from other offices performing all or part of the review of an RLA.

NRR Office Instruction LIC-109, Revision 3 Page 5 of 11 Throughout the process, NRR management is responsible for ensuring the consistent application of the process, communicating the process objectives, and providing the status to internal and external stakeholders. NRR management is responsible for clearly communicating the rationale for decisions on challenging RLAs to stakeholders, as appropriate. They are also responsible for tracking and reporting statistics for implementation of this procedure and establishing criteria for identifying overall progress and success of the acceptance review program.

The sections that follow describe specific responsibilities and authorities within each sub-process in performing an acceptance review.

5.1 Project Managers (PMs)

A. ESTABLISH SCHEDULES AND RESOURCES FOR ACCEPTANCE REVIEW Oversee and coordinate activities related to RLA; Establish a schedule (for both the acceptance and technical review) and identify appropriate technical branches using the NRR workload management tool; Ensure work requests are submitted in a timely manner to minimize the challenges to completing the acceptance review within established schedules; Coordinate any necessary interfaces with other offices (e.g., OGC, Office of Nuclear Security and Incident Response, etc.);

Provide oversight on achieving NRR Office performance goals related to the acceptance review process, discussed later in this OI; and Confirm the RLA is entered into ADAMS in a timely manner.

B. REVIEW OF THE APPLICATION FOR TECHNICAL AND ADMINISTRATIVE SUFFICIENCY Review the submittal for administrative sufficiency in accordance with Section 3.1, Acceptance Review Criteria, of Enclosure 1 of this OI; Collect and review the input provided by the technical branches; Determine the significance of any information insufficiencies identified by the NRC staff and make recommendations to Division management; Notify Division management and the associated technical branches of the overall results of the acceptance review after collecting information from all the technical branches;

NRR Office Instruction LIC-109, Revision 3 Page 6 of 11 Ensure implementation or revision of the acceptance review schedule in a timely manner; Communicate the results of this review to the licensee no later than 25 working days from the date the RLA is declared an Official Agency Record in ADAMS; Communicate any information insufficiencies to their Branch Chiefs (BCs) and the associated technical staff as soon as possible; and Notify Division management of potential failures to meet an acceptance review schedule.

C. RESOLVE INFORMATION INSUFFICIENCIES Ensure the acceptance review criteria are being applied consistent with all regulatory policies, guidance, and requirements; Contact the licensee to communicate the information needed and understand their course of action; Establish, during a conference call, the date-specific deadline by which the licensee must submit the information (no more than 13 working days);

Issue a letter to the licensee identifying the information needed and the verbally established deadline; Notify Division management and technical branches whether the licensee intends to supplement its RLA within 13 working days; Coordinate timely communication of the status of the overall review and any adverse impacts on office resources to higher management; Notify Division management and technical branches of any change in the schedule; and Coordinate the dissemination of any RLA supplement to the technical branches.

D. IMPLEMENT AND DOCUMENT RESULTS Document the decision regarding the technical and administrative sufficiency of the RLA using examples in Enclosure 2, Guide for Performing Acceptance Reviews - Example Letters; Record the date that the results of the RLAs acceptance review was issued and the status of its acceptance in the NRR workload management tool; and

NRR Office Instruction LIC-109, Revision 3 Page 7 of 11 Notify the appropriate stakeholders, including the licensee, the public and the technical staff, of the results of the acceptance review activities.

5.2 Technical Branch Staff A. ESTABLISH AND SCHEDULE RESOURCES FOR ACCEPTANCE REVIEW Confirm that the proposed schedule is acceptable; if not, provide recommended revision.

B. REVIEW OF THE APPLICATION FOR ADMINISTRATIVE AND TECHNICAL SUFFICIENCY Review the RLA for technical sufficiency in accordance with Enclosure 1 of this OI; Provide a recommendation to their BC and the PM regarding the significance of any information insufficiencies; Communicate the results of this review to their BCs and the PM as soon as possible, but no later than 20 working days from the date the RLA is declared an OAR in ADAMS; Notify their BCs of workload conflicts associated with performing an acceptance review. The BC is responsible for the resolution of workload conflicts; and Notify their Division management of potential failures to meet an acceptance review schedule.

C. RESOLVE INFORMATION INSUFFICIENCIES

• Provide prompt notification of the information insufficiency to their management and the PM both verbally and in writing;

• Provide written input to the PM documenting information insufficiencies (an e-mail with BC concurrence is acceptable);

• Support the PM with discussions with the licensee to explain the requested supplemental information;

• Review the supplemental information for responsiveness to the NRC staffs concerns within 5 working days of receipt by the NRC; and

• Inform their BC and the PM of any conflicting responsibilities that may adversely impact the schedule.

NRR Office Instruction LIC-109, Revision 3 Page 8 of 11 D. IMPLEMENT AND DOCUMENT RESULTS Communicate the adequacy of the supplemental information to management and the PM within 5 working days of receipt by the NRC; Support the PM with briefing NRR management; and Support the PM with documenting the results of the acceptance review by providing technical input.

5.3 Branch Chiefs A. RESOLVE INFORMATION INSUFFICIENCIES Support and guide the staff in determining the appropriate course of resolution for the information insufficiencies; Maintain an awareness of agency priorities and how these may affect the RLA review schedule; Provide oversight of and direct the implementation of acceptance review activities; Support the PM and technical staff, when appropriate, with informing senior management; Ensure consistency in the administration of acceptance reviews; Facilitate peer reviews, when appropriate, to confirm the information insufficiency prior to the PM contacting the licensee; and Ensure timely communication of the status of these reviews and any adverse impacts on office resources to higher management.

5.4 Division Management A. RESOLVE INFORMATION INSUFFICIENCIES Maintain an awareness of other agency activities and how these may affect the RLA review schedule and other resources; Work collaboratively to revise schedules and resources, as appropriate, to effectively support agency priorities; Ensure effective communication to internal and external stakeholders including staff and senior management on challenging RLAs; and Provide rationale for the final decisions on challenging RLAs.

NRR Office Instruction LIC-109, Revision 3 Page 9 of 11 B. IMPLEMENT AND DOCUMENT RESULTS Ensure all applicable regulatory guidance, policy, and requirements are accurately and consistently documented; Ensure consistency in the conduct of acceptance reviews; Oversee the achievement of NRR Office performance goals discussed later in this OI or ensure there is adequate justification for not achieving them; and Monitor the effectiveness of the acceptance review process.

6.

PERFORMANCE MEASURES RLAs may require more or less acceptance review time depending on the nature of the technical issues. The NRC staff will continue to ensure that the goal of protecting public health and safety, promoting common defense and security, and protecting the environment, is not compromised to meet the timeliness goals. The following statistics of program implementation will be tracked:

Number of RLAs accepted after 25 working days; Number of RLAs non-accepted without opportunity to supplement; Number of RLAs non-accepted with an opportunity to supplement, and subsequently accepted for review after the 13-day period afforded to the licensee to provide supplemental information (53 working days total); and Number of RLAs denied for failure to provide sufficient information during the detailed technical review.

The established performance timeliness goal is to complete 95 percent within 25 working days (53 working days if an opportunity to supplement is offered).

As stated previously, the RLA will be considered received by the NRC the day that it is declared an OAR in ADAMS. The aforementioned metrics will be measured from this date, with the next working day counted as day one of the acceptance review timeline.

Other existing metrics (such as the 12-and 24-month metrics) will be measured from the date the NRC staff notifies the licensee of the acceptance of the RLA.

7.

PRIMARY CONTACT Michael Wentzel 301-415-6459 michael.wentzel@nrc.gov

8.

RESPONSIBLE ORGANIZATION DORL

NRR Office Instruction LIC-109, Revision 3 Page 10 of 11

9.

EFFECTIVE DATE July 20, 2020

10.

CERTIFICATION DATE July 20, 2025

11.

REFERENCES 10 CFR 2.101, 10 CFR 2.102, 10 CFR 2.107, and 10 CFR 2.108 LIC-101, LIC-102, LIC-103, COM-109, LIC-500, and LIC-600

Enclosures:

1. Guide for Performing Acceptance Reviews

2. Example Letters

3. Information Insufficiency

4. Acceptance Review Milestones

5. Appendix A - Change History

Office of Nuclear Reactor Regulation Guide for Performing Acceptance Reviews

Guide for Performing Acceptance Reviews Page 2 of 18 Acronyms ADAMS Agencywide Documents Access and Management System ASME American Society of Mechanical Engineers BC Branch Chief CLIIP Consolidated Line-Item Improvement Process DD Division Director DORL Division of Operating Reactor Licensing EDO Executive Director for Operations EPID Enterprise Project Identification EPU extended power uprate FR Federal Register NRC Nuclear Regulatory Commission NRR Office of Nuclear Reactor Regulation OAR Official Agency Record OGC Office of the General Counsel OI Office Instruction PM project manager RAI request for additional information RLA requested licensing action STS Standard Technical Specifications TR topical report TS technical specification TSTF Technical Specification Task Force

Guide for Performing Acceptance Reviews Page 3 of 18

1.0 INTRODUCTION

This guide provides staff in the U.S. Nuclear Regulatory Commissions (NRCs) Office of Nuclear Reactor Regulation (NRR) with a basic framework for performing an acceptance review of a requested licensing action (RLA) for a change to a plants licensing basis.

The guide is for use by project managers (PMs), technical staff, and their respective management. Additionally, this guide is for use by NRC staff in other offices when they are performing a review of an RLA at the request of NRR (e.g., emergency plan changes). The PM shall follow the appropriate procedure for requesting work from another office. This guide provides a general description of the process to be followed.

However, it is recognized that RLAs are reviewed and issued under various conditions that require flexibility in the planning and execution of application reviews. This guide is intended to allow that necessary measure of flexibility.

1.1 RLAs to Which Acceptance Review Process Described in this Guide May Not Apply This Office Instruction (OI) does not apply to early site permit, design certification, or combined license applications; research and test reactor activities; or RLAs that require a regulatory decision in such a limited time that performance of an acceptance review would not be feasible (e.g., emergency or exigent amendment requests, or quality assurance program changes). The acceptance reviews for these activities are covered in other OIs or staff guidance documents.

The regulations cited in this OI do not apply to submittals that are not considered licensing applications, such as topical reports (TRs) or technical specification task force (TSTF) travelers. The regulations cited in this OI are not intended to address submittals by non-licensees and may not apply to entities other than licensees (e.g.,

contractors to a licensee). Entities preparing such submittals, NRC staff and process owners reviewing such submittals may use the guidance in this OI as a best practice for the preparation and processing of such submittals. However, NRC staff and process owners may want to consult with the Office of the General Counsel (OGC) to understand how the legal aspects of the regulations apply to the submittal. For a more detailed description of the TRs review process, see LIC-500, Processing Requests for Reviews of Topical Reports. For a more detailed description of the TSTF traveler review process, see LIC-600, Standard Technical Specifications Change Traveler Review and Adoption Process.

Other regulatory guidance and associated standard review plan guidance are sufficient to resolve any completeness deficiencies for these types of actions during the course of a license review.

1.2 Process Overview The NRR process for the review of RLAs begins with the acceptance review. The performance of an acceptance review is an important part of the NRCs overall RLA review process. When properly implemented, acceptance reviews allow for a more efficient use of NRC staff resources and foster the submittal of RLAs that are acceptable for NRCs review. The acceptance, non-acceptance, requests for additional information (RAI), approval, or denial (for insufficient information or merit) of an RLA is part of a continuous process of managing issues related to nuclear power facilities. PMs,

Guide for Performing Acceptance Reviews Page 4 of 18 technical staff, and licensees should be in regular contact to discuss NRC's ongoing reviews and other regulatory matters requiring NRCs review and approval.

Frequent and early communications between the NRC staff and the licensee can help avoid unnecessary delays in the processing of submittals. Pre-application review meetings or conference calls (discussions regarding future RLAs prior to the request being submitted) between the licensee and NRC staff members can be beneficial and are encouraged when the NRC staffs workload is not adversely impacted.

The level of effort expended in the review of RLAs is based on many factors and varies significantly. Therefore, in performing the acceptance review, the expectation is that an individual NRC staff member should expect to expend no more than approximately 10 percent of the level of effort that would normally be expended performing the detailed technical review. For large or complex reviews, 10 percent of the overall effort may be excessive (e.g., an extended power uprate (EPU) or voluntary risk-informed fire protection submittals where 10 percent of the overall effort could suggest over 100 hours0.00116 days <br />0.0278 hours <br />1.653439e-4 weeks <br />3.805e-5 months <br /> be expended on the acceptance review). In such cases, the technical staff should consult with their branch chiefs (BCs) and coordinate with the PM to determine an appropriate level of effort.

If a more significant effort than 10 percent of the detailed review is needed to complete the acceptance review, this may indicate that a too detailed review is being performed, that the RLA is more complex than expected, or that the RLA does not contain sufficient information to be accepted for review. Prior to expending this significant effort, the NRC staff should consult with their management.

The acceptance review consists of the following high-level processes:

Establish schedule and resources for the acceptance review; Review of the application for administrative and technical sufficiency; Resolve any information insufficiencies; and, Implement and document result.

Each of these sub-processes is described in detail in the following sections:

Section 2.0, Distribution and Involvement, discusses scheduling and resources; Section 3.0, Review of Application for Completeness and Acceptability, discusses the PMs and technical staffs review of administrative criteria and technical sufficiency of the document, and identification of issues to management; Section 4.0, Resolution of Information Insufficiencies, discusses the process for resolving information insufficiencies;

Guide for Performing Acceptance Reviews Page 5 of 18 Section 5.0, Non-Acceptance of the RLA, discusses non-acceptance of the application; and Section 6.0, Documentation of an Application Found Acceptable, discusses documentation of an RLA found acceptable for review.

1.3 Frequently Used Terms 1.3.1 Acceptable for Review A determination made by the NRC staff that the application reasonably appears to contain sufficient technical information, both in scope and depth, for the NRC staff to complete the detailed technical review and render, in an appropriate time frame for the associated action, an independent assessment of the proposed action with regard to applicable regulatory requirements and the protection of public health, safety, and security.

1.3.2 Complex Review A licensing action may be considered complex if any of the following criteria are satisfied: (1) it is a first of a kind; (2) it is especially voluminous; (3) it involves a large number of branches in the review (i.e., will require extensive coordination to determine scope for each branch and development of the safety evaluation); (4) it will require Advisory Committee on Reactor Safeguards (ACRS) review; (5) it relates to an unresolved generic issue; (6) it involves issues with parameters that have a limited margin of acceptable values (e.g., ultimate heat sink, steam dryer stresses, etc.) or (7) the initial schedule developed, if not related to lack of resources, indicates the review will take longer than 1 year.

1.3.3 Linked RLA These are RLAs where approval of one RLA is contingent upon the approval of (an)other RLA(s) currently under review. This definition evaluates the independence of an RLA with respect to all other RLAs currently under review.

1.3.4 Non-Accept Non-acceptance derives from certain provisions in 10 CFR 2.101, Filing of application, and is the conclusion that the tendered application is not acceptable for review because it is incomplete or technically inadequate and it is unlikely that the NRC staff could complete its detailed technical review in an appropriate time frame given the information insufficiencies. A decision to non-accept does not have hearing rights associated with it, and the licensee is free to augment the application and reapply for the same change.

1.3.5 Rare Circumstances In certain circumstances, there may be situations where, although evaluation of an RLA against the criteria provided by the guidance would suggest one action, another may be more appropriate, based on NRC staffs recommendations to management. In these situations, the basis for decisions different from the criteria should be well understood and clearly documented.

Guide for Performing Acceptance Reviews Page 6 of 18 1.3.6 Receipt by the NRC Receipt by the NRC will be considered as the date the submittal is declared an Official Agency Record (OAR) in the Agencywide Documents Access and Management System (ADAMS).

1.3.7 Readily Available Information that can be provided by the licensee within a reasonable time frame such that the NRCs review resources and schedules will not be adversely affected and the review, in its entirety, can proceed. Considerations regarding adverse effects include, but are not limited to, availability and complexity of the outstanding items, work priorities, and PM and technical staff availability. Information that is readily available should be able to be submitted within 13 working days to the NRC staff.

1.3.8 Requested Licensing Action An RLA is defined as a licensing action requiring NRC approval prior to implementation, with the exclusion of license renewal applications, research and test reactor activities, early site permits, design certifications, combined license applications or RLAs that require a regulatory decision in such a limited time that performance of an acceptance review would not be feasible.

1.3.9 Sufficiency Item A sufficiency item is information that should have been provided as part of the analysis and represents an omission or oversight in the submittal. The failure to address NRC-identified concerns or issues will also be considered a sufficiency item. The suggested regulatory scope for RLAs can be (shall be for Part 52 submittals) reflected in the applicable section of NUREG-0800, Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition, or through NRC regulatory guidance (e.g., Regulatory Guides, NUREGs, Interim Staff Guidance). Often the technical scope is defined by an NRC-endorsed industry standard. However, the failure to have sufficient technical detail or depth should not be considered a sufficiency item but may be identified as part of the acceptance review.

2.0 DISTRIBUTION AND INVOLVEMENT Upon receipt of an RLA, the PM will open a project in the NRR workload management tool to generate an Enterprise Project Identification (EPID) number, specify those technical branches that are to be involved in the review, assign the project priority, and develop the proposed schedule, among other work planning aspects.

The PM is responsible for verification that all other interested parties have received the document, while the technical staff is responsible for informing the PM of any information needs (including access to the initial submittal).

The technical staff is then notified of the opportunity to confirm or revise the schedule and assigned priority after the project has been opened in the work planning system.

Licensees may submit an electronic courtesy copy of the submittal to facilitate this

Guide for Performing Acceptance Reviews Page 7 of 18 process. If circumstances exist that would delay distribution of the submittal, the PM should include the submittal in an e-mail to the associated BCs to ensure timely distribution.

In limited cases, (e.g., lengthy applications or complex reviews) the PM may choose to initiate the acceptance review process via e-mail to facilitate the acceptance review process. However, the PM should consult with his or her BC before adopting this approach. The technical staff may begin the acceptance review process using the advanced copy of the application provided by the PM. However, the metric regarding the acceptance review does not start until the RLA is declared an OAR in ADAMS.

Once a project has been opened in the NRR workload management tool, the technical staff will address the proposed schedule and priority information and begin reviewing the RLA in accordance with Section 3.0 of this enclosure, Review of Application for Completeness and Acceptability. Time spent performing the acceptance review should be charged to the same EPID number associated with the overall review.

Note: The PM shall not publish the no significant hazards consideration (NSHC) determination until the RLA has been found acceptable and proprietary determinations made. However, this does not preclude generating the document internally and obtaining the necessary concurrences.

In some cases, the PM may have cause to split an RLA into multiple, independent reviews. For example, other guidance directs the NRC staff on how to process relief requests that are submitted under one letter but contains multiple, independent requests.

In this case, the independent requests should be reviewed against this procedure and acted upon, separately.

3.0 REVIEW OF APPLICATION FOR COMPLETENESS AND ACCEPTABILITY The PM must notify the licensee within 25 working days of receipt of the RLA by the NRC. Enclosure 4, Guide for Performing Acceptance Reviews - Acceptance Review Milestones, of this OI provides general acceptance review process milestones. The PM should identify to the technical staff any information insufficiencies within 15 working days of the date of receipt of the RLA by the NRC. Likewise, the technical staff should identify to the PM any information insufficiencies within 20 working days of the date of receipt of the RLA by the NRC. The NRC staff should ensure that the application reasonably appears to contain sufficient technical information, both in scope and depth, for the NRC staff to complete its detailed technical review and render, in an appropriate timeframe, an independent assessment of the RLA with regard to applicable regulatory requirements and the protection of public health, safety, and security (i.e., acceptable for review).

To meet the acceptance review process milestones for identifying information insufficiencies, the PM and technical staff should review the RLA in parallel against their respective criteria (as listed in Section 3.1, Acceptance Review Criteria).

Note: Due to the limited time available to perform the review, the NRC staff should recognize that other, in-process reviews may be impacted by performance of the acceptance review. If other work efforts have the potential to be impacted by the performance of the

Guide for Performing Acceptance Reviews Page 8 of 18 acceptance review, the appropriate BC shall assign priority or reassign work, as appropriate.

If there are factors that would justify a longer review period for the acceptance review, the PM and technical staff must obtain approval of their Division management and respective technical Division Director (DD).

The minimal content for RLAs are contained in associated regulations (e.g.,

10 CFR 50.90, Application for amendment of license, construction permit, or early site permit). Non-binding guidance is also available in regulatory guides, NUREGs, Interim Staff Guidance, etc. Often the technical scope is defined by an NRC-endorsed industry standard.

3.1 Acceptance Review Criteria The following sections highlight key elements that should be contained in an RLA and potential issues that should be addressed during the acceptance review. The PMs and technical staff should make the following determinations about the RLA. Failure of an RLA to meet one or more of the following criteria is indicative of an unacceptable application. However, the criteria are not all-inclusive or absolute, and NRC staffs discretion and judgement should be used in the process. Application of the criteria should not replace sound technical and regulatory judgement. The list of criteria is divided into groups by which the reviewer (PM or technical staff) would likely be utilizing them.

, Information Insufficiency Examples, to this OI contains examples of information insufficiencies that may occur and a discussion of each as to whether it would or would not cause an RLA to be unacceptable for review. The examples are provided as a guide and are not dispositive to the results of the acceptance review.

3.1.1 PM Criteria Regulatory and Completeness Criteria: Determine whether the RLA satisfies all appropriate regulatory and completeness criteria, such as those listed in Section 2.2 of LIC-101 (e.g., addressed to the Document Control Desk, submitted under Oath and Affirmation, an NSHC provided, etc.). These criteria, though often easily corrected, should be met prior to acceptance for review.

Additionally, PMs should be mindful of the timeliness guidelines for RLAs. For example, as discussed in LIC-102, Relief Requests, the licensee should submit the proposed alternatives/relief requests to the NRC and obtain NRC approval prior to implementation of said alternatives or after the interval for reliefs.

Alternatives submitted after the fact will not be evaluated by the staff (e.g.,

alternatives performed during the 10-year inservice inspection (ISI) interval without prior authorization, or relief requests submitted after the end of the subject 10-year ISI interval) and will not be approved retroactively. As discussed in LIC-102, submittals from licensees that do not comply with 10 CFR 50.55a(z),

10 CFR 50.55a(f)(5)(iv) and 10 CFR 50.55a(g)(5)(iv) are not required by regulation to be accepted for approval.

When a licensees submittal is determined to be not in compliance with the timeliness provisions mentioned above, the issue of the licensees

Guide for Performing Acceptance Reviews Page 9 of 18 noncompliance with specific American Society of Mechanical Engineers (ASME)

Code requirements shall be forwarded to the appropriate Regional Office for enforcement action. Where NRR elects not to review a submittal that does not meet the timeliness requirement, NRR will provide an assessment of the safety significance of the inspection for which relief would have been requested to the appropriate Regional Office for its consideration within the scope of the enforcement action.

Use of Approved Guidance: Determine whether the RLA cites any unapproved guidance such as draft TRs, TRs not yet approved by the NRC, TSTF travelers not yet approved, or draft ASME Code cases. Unapproved guidance may be used as the basis for a proposed change; however, the licensee must supply all information necessary (i.e., plant-specific justification and technical basis) to support the change. Simply citing unapproved guidance may not be acceptable.

The NRC staff should also ensure that the safety evaluation of the RLA is clear and that it has only been evaluated for the plant-specific application. A licensee may reference a TR once the NRCs draft safety evaluation for generic use has been issued, recognizing that the review of the TR is near completion.

Unapproved TSTF travelers cannot be used as the basis for a change. While discouraged, a licensee may request a change similar to a traveler under review but cannot cite the unapproved traveler in the RLA.

Additionally, consideration should be given to the submittal of multiple unapproved methodologies or unapproved TRs for review as part of an RLA.

Given that these unapproved methodologies or unapproved TRs may require their own review and approval, which can take upwards of 18 months, this may impact the schedule of or path forward for the RLA. In such instances, the licensee may need to identify their chosen path forward (e.g., methodology review followed by an amendment to adopt the approved methodologies, plant specific methodology review for the given licensee).

Additional Criteria: For certain RLAs, ensure that the licensee or industry addresses any specific criteria associated with a particular action. These criteria are typically identified either in 10 CFR Part 50, Domestic Licensing of Production and Utilization Facilities, 10 CFR Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants, 10 CFR Part 73, Physical Protection of Plants and Materials, or in the associated guidance document. An example is an exemption request in which the licensee must not only justify the acceptability of the proposed action but must demonstrate that there are special circumstances present that justify the issuance of an exemption.

Linked RLAs: Determine whether the approval of the RLA is contingent upon the approval of other RLAs or TRs currently under review. It is important to note that multiple RLAs can affect the same systems or technical specifications (TSs) without being linked. As such, it may be possible to issue RLAs in any order and without regard to the results of the review of the others. An RLA should not be accepted for NRC review and approval until all requisite RLAs have been reviewed and approved by the NRC.

Guide for Performing Acceptance Reviews Page 10 of 18 Promised Information: Determine whether the RLA commits to submit required information at a later date. Not all information associated with the RLA, such as calculations performed, needs to be submitted for complete review. However, if the licensee identifies a calculation or other information that is needed, but has yet to be performed or completed, the RLA is unlikely to be acceptable for review.

Need for an Exemption: Determine whether any exemptions are needed to support the RLA. Generally, the licensee will submit the exemption request with the associated RLA. If submitted separately, the NRC staff should ensure that the licensee understands that an exemption is necessary for acceptance of the associated RLA and agrees to submit the exemption request in parallel with the associated RLA.

Consolidated Line-Item Improvement Process (CLIIP): In the case of RLAs utilizing the CLIIP to adopt an approved TSTF traveler, determine whether the application varies in any way from the model license amendment or model safety evaluation. See LIC-600, Revision 1, Appendix D, Items 2, 3 and 10 for further information on identifying and dispositioning variations. This is a shared criterion against which both the PM and the Technical Specifications Branch staff should evaluate the application. If there are variations from the approved CLIIP traveler, the PM and the Technical Specifications Branch staff should evaluate the complexity of those variations. There will likely still be sufficient information to perform the review; however, the application may be removed from the CLIIP, including possible longer review time and involvement of technical staff in addition to the Technical Specifications Branch.

3.1.2 Technical Staff Criteria Completeness of Scope: Determine if there are significant analyses or evaluations missing from the RLA (e.g., an application is missing a loss-of-coolant accident analysis when it appears that the proposed change would impact that analysis). Often, the appropriate analyses are designated in industry codes and standards, NRC regulatory guides, regulatory issue summaries, etc. An RLA lacking an analysis necessary for the NRC staffs review is unacceptable.

Sufficiency of Information: Determine if there are significant, obvious problems with the information and analyses provided. Technical staff may use various measures for this criterion, such as the volume and magnitude of questions that could be generated based simply on the initial reading of the application. The information provided should support a comparison of the RLA to the licensees existing processes or programs, if applicable, with justification for the change. If significant, obvious problems are identified, the RLA should be considered unacceptable.

Regulatory Basis: Determine whether the applicable regulations and criteria are properly applied. The licensee should identify the regulatory criteria used to determine that the RLA is acceptable. The NRC staff may utilize guidance documents such as the standard review plan or any specific review standards for

Guide for Performing Acceptance Reviews Page 11 of 18 specific RLAs (e.g., EPUs). When the licensee proposes an alternative to an approved approach described in a guidance document, the NRC staff should verify the completeness of the scope and logic of the alternate methodology.

From the information contained in the application, the NRC staff should be able to identify the applicable criteria by which to evaluate the proposed action.

Use of Approved Guidance: Determine whether any approved codes or TRs cited in the application are used in accordance with the limitations and conditions imposed by the NRC staff. A licensees use of unapproved codes or TRs (or the use of codes and TRs outside the limitations imposed by the NRC staff) may be acceptable if the licensee has provided a full analysis to justify that the proposed use satisfies NRC regulations and is appropriately conservative. However, simply referencing an unapproved TR or code is not acceptable. Additionally, deviations from guidance should not be considered acceptable unless fully justified.

It should be noted that the generic use of a Code Case that has received final approval by the ASME and is currently under review by the NRC, shall not be accepted for review. This avoids inefficiencies by preventing the NRC staff from expending resources to review the same issue in two separate processes.

Use of Precedent: Determine whether cited precedents are justified and used appropriately and whether any deviations from the precedent appear to be justified. A previous precedent of approval itself is not a justification for a proposed change but can facilitate a resource savings by allowing the technical staff to make appropriate use of information from previously-approved reviews.

The technical staff should be aware that, in addition to inappropriate use of a cited precedent, there may also be an applicable precedent that was not cited.

Although the licensee is not required to cite a precedent, the technical staff should remain cognizant of other applicable licensing information and operational experience. Evaluation against this criterion is not meant to initiate an exhaustive search of all operational experience, but instead promote awareness of any readily-available information or knowledge pertinent to the RLA.

CLIIP: Applicable to the Technical Specifications Branch staff only. Other technical branches do not review RLAs adopting a CLIIP traveler. In the case of RLAs utilizing the CLIIP to adopt an approved traveler, determine whether the application varies, in any from the model license amendment or model safety evaluation. See LIC-600, Revision 1, Appendix D, Items 2, 3 and 10 for further information on identifying and dispositioning variations. This is a shared criterion against which both the PM and the Technical Specifications Branch staff should evaluate the application. If there are variations from the approved CLIIP traveler, the PM and Technical Specifications Branch staff should evaluate the complexity of those variations. There will likely still be sufficient information to perform the review; however, the application should be removed from the CLIIP, including possible longer review time and involvement of technical staff in addition to the Technical Specifications Branch.

Guide for Performing Acceptance Reviews Page 12 of 18 3.1.3 Rare Circumstances In certain rare circumstances, there may be situations where, although evaluation of an RLA against the criteria provided by this guidance would suggest one action, another action may be more appropriate, based on the NRC staffs recommendations to Division management. In the rare instances when such circumstances occur, the basis for decisions different from the criteria should be well understood and clearly documented.

RLAs that are novel or first of a kind, and are in the interest of public health, safety, and security may be subjected to this provision by the NRC staff. The final decision to invoke the rare circumstance provision will be made by NRR Division management and must be agreed to by all the reviewing NRR Divisions.

3.2 Acceptance Review Results 3.2.1 Unacceptable with No Opportunity to Supplement If, during the acceptance review of the RLA, the NRC staff finds deficiencies so significant that they impede completion of the acceptance review, the RLA should be returned to the licensee as unacceptable for review, pursuant to 10 CFR 2.101.

Otherwise, at the completion of the review, the NRC staff may identify major deficiencies that would be better addressed by terminating the review and returning the RLA to the licensee for resolution. In these cases, the PM, with input from the technical staff, will ensure communication with the licensee (e.g., conference call to discuss the major deficiencies) and will send a formal letter (not an e-mail) to the licensee that identifies the deficiencies and states that the review has been terminated.

NOTE: The letter should identify that other aspects of the RLA may be insufficient but were not reviewed due to the significance of the aforementioned information insufficiency, when appropriate. While due diligence is expected, both NRC staff and management should be aware that the appropriate level and scope of the documentation for a non-acceptance letter is less than that for a denial.

The associated BCs and Division management need to agree with this action and concur on the letter. With the issuance of the letter, the PM should then close the EPID and cease review activities. An example of a non-acceptance letter for an RLA is provided in Enclosure 2, Example 2, Non-Acceptance of RLA. An electronic version of this letter is available in ADAMS (Accession No. ML073240328). While the RLA non-acceptance letter is typically signed by the PM, there may be cases (e.g., an RLA related to emergency planning) where the signature authority is not the PM. In all cases, ADM-200, Delegation of Signature Authority, shall be followed.

3.2.2 Unacceptable with Opportunity to Supplement If, after review of the RLA, either the PM or the technical staff concludes that the submittal is not acceptable for review, described in Section 1.3 of this enclosure, they should promptly contact (as discussed in Section 5.0, Responsibilities and Authorities) the other parties involved in the review to discuss the impact of the information insufficiencies. The PM and the technical staff (and associated management, if appropriate) should discuss the information insufficiencies. This discussion should focus on ensuring that all parties understand the information insufficiencies, identifying

Guide for Performing Acceptance Reviews Page 13 of 18 whether the insufficiencies are within the scope of the review of the proposed action, and if they should be addressed using the acceptance review process (i.e., the issues are not appropriate for the RAI process).

If it is determined that the information insufficiencies are appropriately acceptance review issues, and do not warrant a determination that the RLA is Unacceptable with No Opportunity to Supplement, Section 4.0, Resolution of Information Insufficiencies, of this enclosure should be followed.

Both the PM and technical staff should consider the generic implications of information insufficiencies. If the potential exists for an issue to be generically applicable, the involved parties should decide on the appropriate way to resolve the issue.

Should the PM opt to not accept a determination of the technical staff, that decision must be communicated by the PMs BC to the technical BC within 5 working days before issuance of an acceptance.

3.2.3 Acceptable for Review If the RLA is found to be acceptable for review, or if it is determined that the information needs identified during the acceptance review are not significant enough to fail the acceptance review criteria and should be addressed in the technical review process (i.e.,

via the RAI process), the acceptance of the RLA for review should be communicated to the licensee per Section 6.0, Documentation of an Application Found Acceptable for NRC Staffs Review, of this enclosure.

3.3 Follow-up In addition to the more immediate communications with the PM via telephone or e-mail, the technical staff may indicate the results of the acceptance review in the NRR workload management tool in the comments section. If the technical branch sends the results to the PM with acceptable for review in the comments section, this will inform the PM that the indicated technical branch recommends the RLA as acceptable for review without the need for supplementation by the licensee. Otherwise, the technical staff will provide the results of the acceptance review to the PM via an e-mail by the agreed upon date.

4.0 RESOLUTION OF INFORMATION INSUFFICIENCIES If the NRC staff determines that an RLA is Unacceptable with Opportunity to Supplement, the PM (with input from technical staff) will compile a list of the insufficiencies and the associated time frames to support the review schedule. The communication of the information may be via an informal path such as an e-mail from the technical staff to the PM. However, communications meeting the definition of an OAR should be entered into ADAMS. The NRC staff shall ensure that the associated BCs are informed of the insufficiencies and any other mitigating factors influencing the determination (e.g., workload and availability issues). The applicable BCs shall be consulted should there be a difference concerning whether the identified information constitutes a sufficiency item. For complex or high-visibility issues, and if consistent with the acceptance review schedule, the technical BC should consider a peer review to confirm the information insufficiencies prior to the PM contacting the licensee. The peer

Guide for Performing Acceptance Reviews Page 14 of 18 review is not intended to be another full acceptance review, but rather an independent assessment of the issues identified. If the issues are agreed upon, the PM shall notify the associated Division management (Division of Operating Reactor Licensing (DORL) and non-accepting divisions) via e-mail, briefly summarizing the issues. For RLAs that have an associated process PM, such as the Power Uprate coordinator, the process coordinator should also be notified.

4.1 Discussion of Information Insufficiencies with the Licensee The PM will inform the licensee that its application has been found unacceptable for review and set up a conference call to discuss the required information. The PM should avoid lengthy discussions with the licensee in setting up the call. Instead, the PM should simply provide enough information such that the licensee can have the appropriate technical staff on the call. The conference call should occur as soon as possible, but no later than 5 working days from the date of the discussion with the licensee. Also, the PM will provide the identified insufficiencies to the licensee in draft form prior to the call.

Regardless of the method used to transmit the identified insufficiencies to the licensee, the PM should ensure documents are properly captured as OARs.

During the conference call, the NRC staff will identify the omitted or insufficient information to the licensee, discuss the appropriate course of action, and establish the specific date the information will be submitted. It is important that the conference call result in a clear communication to the licensee of the information needed and that the NRC staff gain an understanding of whether the licensee plans to submit the information within the NRC staffs deadline established during the call (no more than 13 working days). However, the licensee does not need to agree with the need for the information or the deadline.

Note: During the call, the licensee should be provided the opportunity to justify the apparent omission of sufficient information by identifying to the NRC staff where the responsive information is contained in the RLA or elsewhere on the docket. The NRC staff will evaluate this justification to determine whether the information identified resolves the NRC staff's concerns.

Following the call, the PM should confer with the technical staff on the results to determine if the information is likely to be submitted within 13 working days of the call. If it is unlikely, in the NRC staffs judgement, that the information is readily available, the PM will generate a letter documenting the non-acceptance of the RLA and process it through concurrence. This action will facilitate a timely issuance of the letter at a later date, if necessary. Should the licensee request greater than 13 working days to respond, the PM should discuss the proposed extension with the BC. The BC should discuss all significant extensions beyond 13 working days with the applicable Deputy Director.

Regardless of whether the licensee indicates a desire to withdraw the RLA, the PM will prepare a letter requesting the information in accordance with Section 4.2, Licensee Supplements to RLA. The associated technical BCs need to concur with the final letter or with the technical input provided for preparing the letter.

Guide for Performing Acceptance Reviews Page 15 of 18 If a hearing has been granted regarding an RLA, the PM should be aware that additional rules and guidance govern the NRC staffs actions. In this case, the NRC staff should interface closely with the OGC to determine the proper course of action. OI COM-109, NRR Interfaces with the Office of the General Counsel, provides guidance on this interface.

4.2 Licensee Supplements to RLA Regardless of whether the NRC staff believes that the RLA can be supplemented with readily available information, or if the licensee indicated a preference to withdraw the application, a letter requesting supplemental information shall be sent to the licensee that clearly identifies:

The information needed for the NRC staff to complete its review; The time frame for the submission of the information. This time frame shall not be more than 13 working days from the date of the conference call with the technical staff (unless approved by management); and a statement identifying that failure to submit the information within the time frame will result in non-acceptance of the application and cessation of the NRCs review activities pursuant to 10 CFR 2.101.

Notification (via phone call, e-mail, or letter) that the RLA must be supplemented should be given to the licensee no later than 25 working days from the date of receipt of the RLA by the NRC. If telephone or e-mail is used for notification, a formal letter must be placed in ADAMS as an OAR. An example letter is provided in Enclosure 2 as Example 1. An electronic version of this letter is available in ADAMS (Accession No. ML073240323).

The PM will track the submission of the information by the licensee. If the information is provided within the agreed-upon time frame, the PM should ensure that the supplement is provided to all technical staff assigned to the RLA review. Within 5 working days of receipt of the supplement by the NRC, the technical staff should review the supplementary information to ensure that it is responsive to its concerns. The technical staff is responsible for identifying any issues (e.g., staff reassignments or other high priority work) that may impact the review schedule to the PM and their BC. The same criteria used in the initial acceptance review shall be applied, although the review should be focused on the areas previously identified as non-acceptable.

If it appears that the licensee is not able to submit the information in the established time frame (or the information to be submitted is unlikely to be responsive to the NRC staffs concerns), the associated Division management (BCs and DDs) shall be informed of the NRC staffs intent to non-accept the application and cease review activities pursuant to 10 CFR 2.101 at the expiration of the time frame.

If the licensee does not provide the requested information within the time frame, or if the provided information is not responsive to the NRC staffs concerns (i.e., insufficient),

Section 5.0, Non-Acceptance of the RLA, should be used to proceed with non-acceptance of the application pursuant to 10 CFR 2.101.

Guide for Performing Acceptance Reviews Page 16 of 18 If the information provided is both timely and responsive, notify the licensee in accordance with Section 6.0, Documentation of an Application Found Acceptable, and transition into the detailed technical review.

5.0 NON-ACCEPTANCE OF THE RLA For acceptance reviews where the NRC staff determines that the RLA is (1) Unacceptable Without Opportunity to Supplement or (2) Unacceptable With Opportunity to Supplement, and the licensee has been unable or untimely in providing sufficient information for the NRC staff to find the application acceptable for review, the NRC staff shall not accept the RLA and should terminate the review. Upon determination to terminate the review and with concurrence from the associated BCs and DDs, the PM should involve OGC. OGC should be briefed on the situation and the proposed action. Additionally, while not required, OGC should be afforded the opportunity to determine whether there is no legal objection to the NRC staffs action.

Upon the determination that a more significant, complex, or challenging RLA is not acceptable for NRC review, the associated BCs should communicate this decision to NRR management, including the NRR Executive Leadership Team (as appropriate) and the Executive Director for Operations (EDOs) office (via an EDO daily note), informing them of the issues warranting non-acceptance, prior to contacting the licensee.

The PM shall then communicate the reason for non-acceptance to the licensee.

Note: When communicating the non-acceptance of an RLA to the licensee, the NRC staff should avoid debating the issue with the licensee. Instead, the NRC staff should ensure that the reasons for the NRC staffs actions are clearly communicated.

Upon notification of the NRC staffs decision to non-accept the RLA, pursuant to 10 CFR 2.101, the licensee should also be made aware that it may withdraw the application pursuant to 10 CFR 2.107. The licensee should be encouraged to fully document the reasons for withdrawal in its letter and understand that the NRC staff will likewise document the information insufficiencies in the letter of non-acceptance of the RLA or the withdrawal acknowledgement letter.

Regardless of whether the licensee intends to withdraw the RLA, PM activities associated with processing the non-acceptance of the RLA should continue. If the RLA non-acceptance is a result of insufficiencies, the cognizant branch(es) will provide written input to the PM clearly documenting the issues. This input should be formally captured as an OAR. OARs for this purpose can include memoranda from the technical BC to the DORL BC or e-mails describing the insufficiencies. If an e-mail is used, concurrence with the insufficiencies by the technical BC must be documented and the e-mail from the technical branch shall be added to ADAMS as an OAR (non-publicly available).

If the licensee fails to supplement the RLA within the agreed upon time frame, the letter of non-acceptance of the RLA should be issued within 5 working days of the milestone established for supplementing the RLA. If the supplement is found to be unresponsive to the NRC staff's concerns, the letter of non-acceptance of the RLA should be issued within 5 working days after the completion of the staffs review of the supplement (which

Guide for Performing Acceptance Reviews Page 17 of 18 is within 5 working days following receipt of the supplement, per Section 4.2 of this enclosure).

If the licensee, prior to issuance of the non-acceptance letter, submits a written request to withdraw the RLA, the NRC staff should modify the letter to accept the withdrawal and terminate the review. The documentation of the insufficiencies that led to the withdrawal needs to be maintained in the letter. This action is both supportive of a clear public record and informative to other licensees that may be preparing similar RLAs. Examples of both non-acceptance of an RLA and withdrawal acknowledgement letters are provided in Enclosure 2, as Examples 2 and 3, Withdrawal Acknowledgement Letter, respectively. Electronic versions of these letters are available in ADAMS (Accession Nos. ML073240328 and ML080100019), respectively.

In implementation of these actions, the PM should be sensitive to the visibility and nature of the action. For actions associated with an operating plant, the planned actions should be communicated to the regional plant BC and resident inspector staff. Additionally, the PM should consider generating an EDO Daily Note describing the action taken. In some cases, it may be prudent to inform the Office of Public Affairs of the NRC staffs planned course of action.

Upon issuance of the letter of non-acceptance for the RLA, or the withdrawal acknowledgement letter, the PM will close the associated EPID number using the ADAMS accession number of the letter and ensure that the appropriate status is selected (i.e., Withdrawn or Closed).

Requests to discuss a non-accepted RLA with the NRC staff should be treated as pre-application meetings and will be entertained only if they do not adversely impact the NRC staffs review of RLAs accepted for review. The NRC staff should treat these discussions as they would a pre-application discussion for the re-submission of the RLA.

6.0 DOCUMENTATION OF AN APPLICATION FOUND ACCEPTABLE If the RLA is acceptable for review, the licensee should be notified. The formality of this communication will depend on the specific circumstances surrounding the RLA. In determining the formality of the communication, the PM should consider:

Visibility, complexity, and contentiousness of the proposed action. To foster openness, highly visible RLAs typically warrant use of a letter to document the acceptance.

Whether the RLA required supplementation prior to acceptance. If the application was originally found to be Unacceptable with Opportunity to Supplement, the PM shall use a letter to document that the RLA is now acceptable for review.

Whether other procedural requirements exist for certain RLAs. For example, power uprates require a letter documenting the acceptance for review.

Guide for Performing Acceptance Reviews Page 18 of 18 Management and technical staff input (if provided). Additional considerations may be raised that would benefit from a formal documentation of the acceptance for review.

Typically, if the licensees submittal was found to be acceptable without any supplements, an e-mail to the PMs licensing contact would be sufficient to document the completion of the acceptance review. An example acceptance letter is provided in, Example 4, Acceptance Letter. An electronic version of this letter is available in ADAMS (Accession No. ML073240325). An example e-mail is provided in, Example 5, Acceptance E-Mail. The PM should ensure that the e-mail contains the same information as the formal letter, however, no further concurrence is necessary.

Note: It is important that the PM ensure that e-mail documentation to the licensee of the acceptance for review is documented in ADAMS as an OAR (publicly available) and distributed via listserv.

One way to add the e-mail to ADAMS is to forward the e-mail as an attachment to the office e-mail capture resource. The established timeframe for public release is 14 calendar days after the e-mail is captured as an OAR in ADAMS. If the e-mail and its attachments need to be released prior to the 14-day hold, please include that information in your transmittal e-mail to the resource.

At the conclusion of the acceptance review, the PM and technical staff will continue the detailed technical review in accordance with the appropriate process.

Should acceptance of the application conflict with a recommendation of the technical staff, the associated BC shall send an e-mail to the technical staff BC identifying the basis for overturning the technical staff recommendation and identifying the intended date of submittal of the acceptance review. The acceptance review shall be issued no earlier than 5 working days after technical staff notification.

Office of Nuclear Reactor Regulation Example Letters

Example Letters Page 2 of 14 EXAMPLE 1: UNACCEPTABLE WITH OPPORTUNITY TO SUPPLEMENT

[DATE]

[ADDRESSEE]

SUBJECT:

[PLANT NAME, UNIT NO.] - SUPPLEMENTAL INFORMATION NEEDED FOR ACCEPTANCE OF REQUESTED LICENSING ACTION RE:

[AMENDMENT/RELIEF REQUEST] (EPID NO(S). )

Dear [Addressee]:

By letter dated [DATE], [LICENSEE] submitted a [license amendment/relief] request for

[FACILITY]. The proposed [amendment/relief request] would [INSERT DESCRIPTION OF PROPOSED AMENDMENT OR RELIEF REQUEST AS APPLICABLE]. The purpose of this letter is to provide the results of the U.S. Nuclear Regulatory Commission (NRC) staffs acceptance review of this [amendment/relief] request. The acceptance review was performed to determine if there is sufficient technical information in scope and depth to allow the NRC staff to complete its detailed technical review. The acceptance review is also intended to identify whether the application has any readily apparent information insufficiencies in its characterization of the regulatory requirements or the licensing basis of the plant.

[FOR LICENSE AMENDMENT USE THIS PARAGRAPH]

Consistent with Section 50.90 of Title 10 of the Code of Federal Regulations (10 CFR), an application for an amendment to a license (including the technical specifications) [or construction permit] must fully describe the changes requested, and following as far as applicable, the form prescribed for original applications. Section 50.34 of 10 CFR addresses the content of technical information required. This section stipulates that the submittal address the design and operating characteristics, unusual or novel design features, and principal safety considerations.

[FOR RELIEF REQUEST USE THIS PARAGRAPH]

Pursuant to Sections 50.55a(z)(1) and 50.55a(z)(2) of Title 10 of the Code of Federal Regulations (10 CFR), the applicant shall demonstrate that the proposed alternatives would provide an acceptable level of quality and safety, or that compliance with the specified requirements of Section 50.55a would result in hardship or unusual difficulty without a compensating increase in the level of quality or safety.

[FOR OTHER RLAs, CITE APPLICABLE REGULATORY CRITERIA]

The NRC staff has reviewed your application and concluded that the information delineated in the enclosure to this letter is necessary to enable the staff to make an independent assessment regarding the acceptability of the proposed [amendment/relief request] in terms of regulatory requirements for the protection of public health and safety and the environment.

In order to make the application complete, the NRC staff requests that [LICENSEE] supplement the application to address the information requested in the enclosure by [DATE]. This will enable the NRC staff to begin its detailed technical review. If the information responsive to the NRC staffs request is not received by the above date, the application will not be accepted for

Example Letters Page 3 of 14 review pursuant to 10 CFR 2.101, and the NRC will cease its activities associated with the application. If the application is subsequently accepted for review, you will be advised of any further information needed to support the staffs detailed technical review by separate correspondence.

The information requested and associated time frame in this letter were discussed with

[CONTACT] of your staff on [DATE].

If you have any questions, please contact the [FACILITY] Project Manager, [NAME], at (301) 415-XXXX.

Sincerely,

[Name], Project Manager Plant Licensing Branch X-X Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No(s).

cc: Distribution via Listserv

Enclosure:

As stated (ADAMS Accession No. ML073240323)

Concurrence is needed by PM, LA, Technical BC(s), and DORL BC

Example Letters Page 4 of 14 EXAMPLE 2: NON-ACCEPTANCE OF RLA

[DATE]

[ADDRESSEE]

SUBJECT:

[PLANT NAME, UNIT NO.] - NONACCEPTANCE OF REQUESTED LICENSING ACTION RE: [AMENDMENT/RELIEF REQUEST] (EPID NO(S). )

Dear [Addressee]:

By letter dated [DATE], [LICENSEE] submitted a [license amendment/relief request] for

[FACILITY]. The proposed [amendment/relief request] would [INSERT DESCRIPTION OF PROPOSED AMENDMENT OR RELIEF REQUEST AS APPLICABLE]. The purpose of this letter is to provide the results of the U.S. Nuclear Regulatory Commission (NRC) staffs acceptance review of this [amendment/relief request]. The acceptance review was performed to determine if there is sufficient technical information in scope and depth to allow the NRC staff to complete its detailed technical review. The acceptance review is also intended to identify whether the application has any readily apparent information insufficiencies in its characterization of the regulatory requirements or the licensing basis of the plant.

[FOR LICENSE AMENDMENT USE THIS PARAGRAPH]

Consistent with Section 50.90 of Title 10 of the Code of Federal Regulations (10 CFR), an application for an amendment to a license (including the technical specifications) [or construction permit] must fully describe the changes requested, and following as far as applicable, the form prescribed for original applications. Section 50.34 of 10 CFR addresses the content of technical information required. This section stipulates that the submittal address the design and operating characteristics, unusual or novel design features, and principal safety considerations.

[FOR RELIEF REQUEST USE THIS PARAGRAPH]

Pursuant to Sections 50.55a(z)(1) and 50.55a(z)(2) of Title 10 of the Code of Federal Regulations (10 CFR), the applicant shall demonstrate that the proposed alternatives would provide an acceptable level of quality and safety, or that compliance with the specified requirements of Section 50.55a would result in hardship or unusual difficulty without a compensating increase in the level of quality or safety.

[FOR OTHER RLAs CITE APPLICABLE REGULATORY CRITERIA]

[IF THE LICENSEE WAS REQUESTED TO SUPPLEMENT THE RLA, USE THESE PARAGRAPHS]

The NRC staff has reviewed your application and concluded that it did not provide technical information in sufficient detail to enable the staff to complete its detailed review and make an independent assessment regarding the acceptability of the proposed amendment in terms of regulatory requirements for the protection of public health and safety and the environment. This informational need was conveyed to you [cite method (e.g., phone call, e-mail, etc.)] followed by letter dated [DATE]. In this letter, the NRC staff identified that the following information was needed to begin its technical review:

LIST INFORMATION NEEDED

Example Letters Page 5 of 14

[IF THE LICENSEE DID NOT PROVIDE A SUPPLEMENT, USE THIS PARAGRAPH]

As of the date of this letter, the NRC staff has not received any communications from you regarding this informational need. Therefore, the NRC staff finds the request for approval of the proposed action to be unacceptable for docketing for NRC review pursuant to 10 CFR 2.101.

NRC staff activities have ceased, and the associated Enterprise Project Identifier number has been closed.]

[IF THE LICENSEE PROVIDED AN UNRESPONSIVE SUPPLEMENT, USE THIS PARAGRAPH]

By letter dated [DATE], you provided a supplement to this submittal. The NRC staff has found the supplement unresponsive to the cited informational needs. Therefore, the NRC staff finds the request for approval of the proposed action to be unacceptable for docketing for NRC review pursuant to 10 CFR 2.101. NRC staff activities on the review have ceased and the associated Enterprise Project Identifier number has been closed.]

[IF THE LICENSEE IS NOT BEING ALLOWED TO SUPPLEMENT THE RLA DUE TO INSUFFICIENCT INFORMATION, USE THESE PARAGRAPHS]

The NRC staff has reviewed your application and concluded that it did not provide technical information in sufficient detail to enable the staff to complete its detailed review and make an independent assessment regarding the acceptability of the proposed amendment in terms of regulatory requirements for the protection of public health and safety and the environment. This informational need was conveyed to you [cite method (e.g., phone call, e-mail, etc.)] followed by letter dated [DATE]. In this letter, the NRC staff identified that the following information was needed to begin its technical review:

LIST INFORMATION INSUFFICIENCY Because of the extensive nature of the information needed, the NRC staff finds the request for approval of the proposed action unacceptable for NRC review pursuant to 10 CFR 2.101.

[Additionally, other aspects of the RLA may also be insufficient but were not reviewed or identified due to the significance of the aforementioned information insufficiency.] NRC staff activities on the review have ceased and the associated Enterprise Project Identifier number has been closed.]

[IF THE LICENSEE IS NOT BEING ALLOWED TO SUPPLEMENT THE RLA DUE TO ANY OTHER REASON, DESCRIBE THE BASIS FOR NON-ACCEPTANCE]. NRC staff activities on the review have ceased and the associated Enterprise Project Identifier number has been closed.

Example Letters Page 6 of 14 If you have any questions, please contact the [FACILITY] Project Manager, [NAME], at (301) 415-XXXX.

Sincerely,

[Name], Project Manager Plant Licensing Branch X-X Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No(s).

cc: Distribution via Listserv (ADAMS Accession No. ML073240328)

Concurrence is needed by PM, LA, Technical BC(s), and DORL BC, Technical Division Director(s) and DORL Division Director

Example Letters Page 7 of 14 EXAMPLE 3: WITHDRAWAL ACKNOWLEDGEMENT LETTER

[DATE]

[ADDRESSEE]

SUBJECT:

[PLANT NAME, UNIT NO] - WITHDRAWAL OF REQUESTED LICENSING ACTION RE: [LICENSE AMENDMENT/RELIEF REQUEST] SUBMITTED TO NRC FOR ACCEPTANCE REVIEW (EPID NO(S). )

Dear [ADDRESSEE]:

By letter dated [DATE], [LICENSEE] submitted a [LICENSE AMENDMENT/RELIEF REQUEST]

for [FACILITY]. The proposed [amendment/relief request] would [INSERT DESCRIPTION OF PROPOSED AMENDMENT OR RELIEF REQUEST AS APPLICABLE]. The purpose of this letter is to provide the results of the U.S. Nuclear Regulatory Commission (NRC) staffs acceptance review of this [AMENDMENT/RELIEF REQUEST]. The acceptance review was performed to determine if there is sufficient technical information in scope and depth to allow the NRC staff to complete its detailed technical review. The acceptance review is also intended to identify whether the application has any readily apparent information insufficiencies in its characterization of the regulatory requirements or the licensing basis of the plant.

[FOR LICENSE AMENDMENT USE THIS PARAGRAPH]

Consistent with Section 50.90 of Title 10 of the Code of Federal Regulations (10 CFR), an application for an amendment to a license (including the Technical Specifications) [or construction permit] must fully describe the changes requested, and following as far as applicable, the form prescribed for original applications. Section 50.34 of 10 CFR addresses the content of technical information required. This section stipulates that the submittal address the design and operating characteristics, unusual or novel design features, and principal safety considerations.

[FOR RELIEF REQUEST USE THIS PARAGRAPH]

Pursuant to Sections 50.55a(z)(1) and 50.55a(z)(2) of Title 10 of the Code of Federal Regulations (10 CFR), the applicant shall demonstrate that the proposed alternatives would provide an acceptable level of quality and safety, or that compliance with the specified requirements of Section 50.55a would result in hardship or unusual difficulty without a compensating increase in the level of quality or safety.

[FOR OTHER RLAs CITE APPLICABLE REGULATORY CRITERIA]

By letter dated [DATE], you requested to withdraw the application from NRC review. The NRC acknowledges your request to withdraw the application. NRC staff activities on the review have ceased and the associated Cost Activity Code number has been closed.

The NRC staff notes that its review to date has identified that your application did not provide the following technical information in sufficient detail to enable the staff to complete its detailed

Example Letters Page 8 of 14 review. Therefore, should you decide to re-submit the request, it must include the following information:

LIST INFORMATION NEEDED If you have any questions, please contact the [FACILITY] Project Manager, [NAME], at (301) 415-XXXX.

Sincerely,

[Name], Project Manager Plant Licensing Branch X-X Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No(s).

cc: Distribution via Listserv (ADAMS Accession No. ML080100019)

Concurrence is needed by PM, LA, Technical BC(s), and DORL BC

Example Letters Page 9 of 14 EXAMPLE 4: ACCEPTANCE LETTER

[DATE]

[ADDRESSEE]

SUBJECT:

[PLANT NAME, UNIT NO] - ACCEPTANCE OF REQUESTED LICENSING ACTION RE: [LICENSE AMENDMENT/RELIEF REQUEST] (EPID NO(S). )

Dear [Addressee]:

By letter dated [DATE], [LICENSEE] submitted a [license amendment/relief request] for

[FACILITY]. The proposed [amendment/relief request] would [INSERT DESCRIPTION OF PROPOSED AMENDMENT OR RELIEF REQUEST AS APPLICABLE]. The purpose of this letter is to provide the results of the U.S. Nuclear Regulatory Commission (NRC) staffs acceptance review of this [amendment/relief] request. The acceptance review was performed to determine if there is sufficient technical information in scope and depth to allow the NRC staff to complete its detailed technical review. The acceptance review is also intended to identify whether the application has any readily apparent information insufficiencies in its characterization of the regulatory requirements or the licensing basis of the plant.

[FOR LICENSE AMENDMENT USE THIS PARAGRAPH]

Consistent with Section 50.90 of Title 10 of the Code of Federal Regulations (10 CFR), an application for an amendment to a license (including the technical specifications) [or construction permit] must fully describe the changes requested, and following as far as applicable, the form prescribed for original applications. Section 50.34 of 10 CFR addresses the content of technical information required. This section stipulates that the submittal address the design and operating characteristics, unusual or novel design features, and principal safety considerations.

[FOR RELIEF REQUEST USE THIS PARAGRAPH]

Pursuant to Sections 50.55a(z)(1) and 50.55a(z)(2) of Title 10 of the Code of Federal Regulations (10 CFR), the applicant shall demonstrate that the proposed alternatives would provide an acceptable level of quality and safety, or that compliance with the specified requirements of Section 50.55a would result in hardship or unusual difficulty without a compensating increase in the level of quality or safety.

[FOR OTHER RLAs CITE APPLICABLE REGULATORY CRITERIA]

The NRC staff has reviewed your application and concluded that it does provide technical information in sufficient detail to enable the NRC staff to complete its detailed technical review and make an independent assessment regarding the acceptability of the proposed amendment in terms of regulatory requirements and the protection of public health and safety and the environment. Given the lesser scope and depth of the acceptance review as compared to the detailed technical review, there may be instances in which issues that impact the NRC staffs ability to complete the detailed technical review are identified despite completion of an adequate acceptance review. You will be advised of any further information needed to support the NRC staffs detailed technical review by separate correspondence.

Example Letters Page 10 of 14 Based on the information provided in your submittal [and discussions during the pre-licensing meeting on <insert date>], the NRC staff has estimated that this licensing request will take approximately <insert forecasted hours here from the NRR workload management tool> hours to complete. The NRC staff expects to complete this review in approximately <insert number>

months, which is <insert Month, Year>. {Note: Insert forecasted completion date (actual requested date by licensee (ex. outage date), if we agree; stated metric - most will be 12 months from acceptance; or actual forecasted completion date based on complexity.)} If there are emergent complexities or challenges in our review that would cause changes to the initial forecasted completion date or significant changes in the forecasted hours, the reasons for the changes, along with the new estimates, will be communicated during the routine interactions with the assigned project manager.

<For LARs use: These estimates are based on the NRC staffs initial review of the application and they could change, due to several factors including requests for additional information, unanticipated addition of scope to the review, and review by NRC advisory committees or hearing-related activities. For Relief Requests and other RLAs use: These estimates are based on the NRC staffs initial review of the application and they could change, due to several factors including requests for additional information, and unanticipated addition of scope to the review.>

Additional delay may occur if the submittal is provided to the NRC in advance or in parallel with industry program initiatives or pilot applications.

If you have any questions, please contact the [FACILITY] Project Manager, [NAME], at (301) 415-XXXX.

Sincerely,

[NAME], Project Manager

[BRANCH]

Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No(s).

cc: Distribution via Listserv (ADAMS Accession No. ML073240325)

Concurrence is needed by PM, LA, and DORL BC

Example Letters Page 11 of 14 EXAMPLE 5: ACCEPTANCE E-MAIL

SUBJECT:

By letter dated [DATE], [LICENSEE] submitted a [license amendment/relief request] for

[FACILITY]. The purpose of this e-mail is to provide the results of the U.S. Nuclear Regulatory Commission (NRC) staffs acceptance review of this [amendment/relief] request. The acceptance review was performed to determine if there is sufficient technical information in scope and depth to allow the NRC staff to complete its detailed technical review. The acceptance review is also intended to identify whether the application has any readily apparent information insufficiencies in its characterization of the regulatory requirements or the licensing basis of the plant.

[FOR LICENSE AMENDMENT USE THIS PARAGRAPH]

Consistent with Section 50.90 of Title 10 of the Code of Federal Regulations (10 CFR), an application for an amendment to a license (including the technical specifications) [or construction permit] must fully describe the changes requested, and following as far as applicable, the form prescribed for original applications. Section 50.34 of 10 CFR addresses the content of technical information required. This section stipulates that the submittal address the design and operating characteristics, unusual or novel design features, and principal safety considerations.

[FOR RELIEF REQUEST USE THIS PARAGRAPH]

Pursuant to Sections 50.55a(z)(1) and 50.55a(z)(2) of Title 10 of the Code of Federal Regulations (10 CFR), the applicant shall demonstrate that the proposed alternatives would provide an acceptable level of quality and safety, or that compliance with the specified requirements of Section 50.55a would result in hardship or unusual difficulty without a compensating increase in the level of quality or safety.

[FOR OTHER RLAs CITE APPLICABLE REGULATORY CRITERIA]

The NRC staff has reviewed your application and concluded that it does provide technical information in sufficient detail to enable the NRC staff to complete its detailed technical review and make an independent assessment regarding the acceptability of the proposed amendment in terms of regulatory requirements and the protection of public health and safety and the environment. Given the lesser scope and depth of the acceptance review as compared to the detailed technical review, there may be instances in which issues that impact the NRC staffs ability to complete the detailed technical review are identified despite completion of an adequate acceptance review. If additional information is needed, you will be advised by separate correspondence.

Based on the information provided in your submittal [and discussions during the pre-licensing meeting on <insert date>], the NRC staff has estimated that this licensing request will take approximately <insert forecasted hours here from the NRR workload management tool> hours to complete. The NRC staff expects to complete this review in approximately <insert number>

months, which is <insert Month, Year>. {Note: Insert forecasted completion date (actual requested date by licensee (ex. outage date), if we agree; stated metric - most will be 12 months from acceptance; or actual forecasted completion date based on complexity.)} If there are emergent complexities or challenges in our review that would cause changes to the initial forecasted completion date or significant changes in the forecasted hours, the reasons for

Example Letters Page 12 of 14 the changes, along with the new estimates, will be communicated during the routine interactions with the assigned project manager.

<For LARs use: These estimates are based on the NRC staffs initial review of the application and they could change, due to several factors including requests for additional information, unanticipated addition of scope to the review, and review by NRC advisory committees or hearing-related activities. For Relief Requests and other RLAs use: These estimates are based on the NRC staffs initial review of the application and they could change, due to several factors including requests for additional information, and unanticipated addition of scope to the review.>

Additional delay may occur if the submittal is provided to the NRC in advance or in parallel with industry program initiatives or pilot applications.

If you have any questions, please contact me.

[NAME], Project Manager

[BRANCH]

Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation (ADAMS Accession No. ML16323A247)

Example Letters Page 13 of 14 EXAMPLE 6: ACCEPTANCE OF RLA FOR LATE ALTERNATIVE/RELIEF

[DATE]

[ADDRESSEE]

SUBJECT:

[PLANT NAME, UNIT NO] - ACCEPTANCE OF REQUESTED LICENSING ACTION FOR [LATE SUBMISSION OF ALTERNATIVE/RELIEF REQUEST] RE:

(EPID NO(S). )

Dear [Addressee]:

By letter dated [DATE], [LICENSEE] submitted an alternative/relief request under Section [CITE REQUIREMENT] to Title 10 of the Code of Federal Regulations (10 CFR) for [FACILITY]. The proposed [alternative/relief request] would [INSERT DESCRIPTION OF PROPOSED ALTERNATIVE/RELIEF REQUEST]. The purpose of this letter is to provide the results of the U.S. Nuclear Regulatory Commission (NRC) staffs acceptance review of this request. The acceptance review was performed to determine if there is sufficient technical information in scope and depth to allow the NRC staff to complete its detailed technical review. The acceptance review is also intended to identify whether the application has any readily apparent information insufficiencies in its characterization of the regulatory requirements or the licensing basis of the plant.

Pursuant to Sections [INSERT CITATION] of Title 10 of the Code of Federal Regulations (10 CFR), the applicant shall demonstrate that the proposed alternatives/relief requests would provide an acceptable level of quality and safety, or that compliance with the specified requirements of Section 50.55a would result in hardship or unusual difficulty without a compensating increase in the level of quality or safety.

The NRC staff has reviewed your application and notes that the [proposed alternative/relief request] was submitted [during the current 10-year interval, but after implementation OR after the ten-year interval, but not during the 12-month submittal period as required by [INSERT CITATION]. While the NRC staff concludes that it does provide technical information in sufficient detail to enable the NRC staff to complete its detailed technical review and make an independent assessment. The NRC staff will not be able to approve the [alternative/relief request] as requested. However, the NRC staff will assess the technical justification provided in terms of regulatory requirements and the protection of public health and safety and the environment to support enforcement related activities. Given the lesser scope and depth of the acceptance review as compared to the detailed technical review, there may be instances in which issues that impact the NRC staffs ability to complete the detailed technical review are identified despite completion of an adequate acceptance review. You will be advised of any further information needed to support the NRC staffs detailed technical review by separate correspondence.

Based on the information provided in your submittal [and discussions during the pre-licensing meeting on <insert date>], the NRC staff has estimated that this licensing request will take approximately <insert forecasted hours here from the NRR workload management tool> hours to complete. The NRC staff expects to complete this review in approximately <insert number>

months, which is <insert Month, Year>. {Note: Insert forecasted completion date (actual requested date by licensee (ex. outage date), if we agree; stated metric - most will be

Example Letters Page 14 of 14 12 months from acceptance; or actual forecasted completion date based on complexity.)} If there are emergent complexities or challenges in our review that would cause changes to the initial forecasted completion date or significant changes in the forecasted hours, the reasons for the changes, along with the new estimates, will be communicated during the routine interactions with the assigned project manager.

These estimates are based on the NRC staffs initial review of the application and they could change, due to several factors including requests for additional information, and unanticipated addition of scope to the review. Additional delay may occur if the submittal is provided to the NRC in advance or in parallel with industry program initiatives or pilot applications.

If you have any questions, please contact the [FACILITY] Project Manager, [NAME], at (301) 415-XXXX.

Sincerely,

[NAME], Project Manager

[BRANCH]

Division of Operating Reactor Licensing Office of Nuclear Reactor Regulation Docket No(s).

cc: Distribution via Listserv (ADAMS Accession No. ML16294A058)

Concurrence is needed by PM, LA, Technical BC(s), and DORL BC, Technical Division Director(s) and DORL Division Director

Office of Nuclear Reactor Regulation Information Insufficiency Examples

Information Insufficiency Examples Page 1 of 5 Examples of Informational Insufficiencies The purpose of the examples included in this Enclosure is to better delineate the threshold where an informational insufficiency would result in a requested licensing action (RLA) being unacceptable for review versus it being more appropriately dealt with via the request for additional information (RAI) process. In each example, the corresponding project manager (PM) or technical staff criteria are identified, whether the insufficiency would cause the RLA to be unacceptable for review, or, if appropriate, any changes to the situation that may change this determination.

Example 1 Criteria PM, Promised Information; and Technical Staff, Completeness of Scope Situation A licensee for a multi-unit site requests the full-scope implementation of a revised methodology for accident source term in accordance with Regulatory Guide (RG) 1.183, Alternative Radiological Source Terms for Evaluating Design Basis Accidents at Nuclear Power Reactors.

Compliance with RG 1.183 requires the analyses of four specific design basis accidents to be submitted; however, the licensee has performed only three of the four for Unit No. 1 and provides a commitment to provide the others at a later date.

Acceptable for Review?

No, because the licensee failed to include analyses that are critical to the Nuclear Regulatory Commission (NRC) staffs review (Completeness of Scope) as is evidenced by the promise to submit it at a later date (Promised Information). Without having the analyses (either the missing Unit No. 1 analysis or the remaining units), the NRC staff does not have sufficient information to complete the review. This situation is not appropriate for the RAI process and the RLA should not be accepted for review.

May be Acceptable for Review If:

If the original submittal provided by the licensee included adequate justification for why the omitted analyses are not needed, due to plant-specific considerations, omission of the analyses may be appropriate. Additionally, the application may be acceptable if the licensee submitted all necessary analyses for Unit No. 1 and provided detailed comparison of the remaining units sufficient to demonstrate similarity in design such that the analyses are applicable to all units.

Alternately, if the licensee had performed all the necessary analyses and they were readily available (i.e., able to be provided to the NRC staff within 13 working days), but simply failed to include them, the RLA may be acceptable for review if the information is provided within the prescribed time frame.

Information Insufficiency Examples Page 2 of 5 Example 2 Criteria PM and Technical Staff, Use of Approved Guidance Situation A licensee requests the approval for a change to a fuel type which requires changes to the safety limits. The application references a topical report (TR) methodology that is currently under review for generic use, for determining the safety limits.

Acceptable for Review?

No, because the licensee has cited an unapproved TR in support of the proposed change (Use of Approved Guidance). Although the licensee may be able to cite the TR after it receives generic approval, the NRC staff should not accept the RLA for review until the generic review is completed.

May be Acceptable for Review If:

If the TR was not currently under NRC review for generic use and the licensee provided a full justification (versus a simple reference to the TR) for why use of the method described in the unapproved TR results in a conservative safety limit, the application may be acceptable for review.

Also, if the licensee has an urgent need for the change to the safety limit and the generic review of the TR would not be complete in time for the licensees need, using the TR as a plant-specific justification may be acceptable. Again, the licensee would need to provide a full justification and it should be recognized that the approval is specific only to this singular application of the TR.

Example 3 Criteria PM, Linked RLAs; and Technical Staff, Regulatory Basis Situation While the NRC staff is reviewing a licensees request to change the accident analyses for a loss-of-coolant accident (LOCA), the licensee submits an application for an extended power uprate (EPU). The analysis and supporting justification for the EPU are based, in part, on the proposed LOCA analysis currently under review.

Acceptable for Review?

No, because the EPU should not begin until all prerequisite reviews have been completed (Linked RLAs). Additionally, the regulatory basis cited in the EPU application (i.e., the currently unapproved LOCA analysis) is not the current licensing basis for the plant (Regulatory Basis).

Information Insufficiency Examples Page 3 of 5 May be Acceptable for Review If:

Review and approval of the EPU was not contingent upon the outcome of the NRC staffs review of the LOCA analysis.

Example 4 Criteria PM, Additional Criteria Situation The PM for a site receives a request for NRC approval of an exemption from a section of Title 10 of the Code of Federal Regulations Part 50, Domestic Licensing of Production and Utilization Facilities. While the exemption request contains sufficient information to justify that the proposed exemption will maintain safety, the licensee fails to identify any special circumstances that necessitate granting an exemption.

Acceptable for Review?

No, because for exemptions, the licensee must also justify that special circumstances exist (see Title 10 of the Code of Federal Regulations, Exceptions and exemptions from licensing requirements).

May be Acceptable for Review If:

Special circumstances exist, but the licensee omitted them from the application. If the justification is readily available (i.e., able to be provided to the NRC staff within 13 working days), the licensee may be able to supplement the application to make it acceptable for the NRC staffs review.

Example 5 Criteria PM, Use of Approved Guidance; and Technical Staff, Sufficiency of Information Situation A licensee requests an increased ultimate heat sink (UHS) temperature limit based on reducing measurement uncertainty. The RLA indicates that Regulatory Guide (RG) 1.105, Setpoints for Safety-Related Instrumentation, was followed in developing the submittal. RG 1.105 describes a method acceptable to the NRC staff for complying with the NRCs regulations for ensuring that setpoints for safety-related instrumentation are initially within and remain within the technical specification limits. For non-safety related instrumentation such as UHS instrumentation, the setpoint methodology can include a graded approach; however, the RG indicates that the grading technique chosen should be consistent with ISA-S67.04-1994, Setpoints for Nuclear Safety-Related Instrumentation, and should consider applicable uncertainties regardless of the

Information Insufficiency Examples Page 4 of 5 setpoint application. The RLA simply references a graded setpoint methodology that has not been approved by the NRC, nor has the RLA addressed treatment of applicable uncertainties.

Acceptable for Review?

No, because the licensee failed to include the setpoint methodology and an evaluation of all applicable uncertainties as indicated by the RG (Use of Approved Guidance). If the licensee had not cited RG 1.105, but still omitted the information, it would likely fail the technical staff sufficiency of information criteria as the NRC staff would still need the information to complete its review.

May be Acceptable for Review If:

The setpoint methodology was provided with justification for its use as well as an evaluation of all applicable uncertainties. Alternately, it may also be acceptable for review if the graded approach had been previously approved for generic use and the licensee used it in accordance with all limitations and conditions of NRC approval.

Example 6 Criteria Technical Staff, Use of Precedent Situation The licensee for a multi-unit site previously received NRC approval to add 3 months to the 5-year extension already in place for the containment integrated leak rate test (ILRT) for Unit 1.

Subsequently, the licensee requests to add 8 months to the 5-year extension already in place for the containment ILRT for Unit 2, referencing the approval of an extension for the Unit 1 ILRT as precedent.

Acceptable for Review?

No, because the precedent for the extension, by itself, is not sufficient justification for the change.

May be Acceptable for Review If:

If the licensees RLA for Unit 2 had provided a full justification for the extension to the containment ILRT. The use of precedent in this case may provide a time and resource savings, however, if the licensee addressed previous NRC staff questions associated with the Unit 1 review and reconciled any salient technical differences between the construction and/or operation of the units.

Additional Considerations Situation Operating experience, gained subsequent to having approved the extension for Unit 1, showed that extension beyond 5 years was potentially inappropriate in certain circumstances.

Information Insufficiency Examples Page 5 of 5 Result The NRC staff should (in addition to evaluating backfit actions for previously approved extensions) ensure that the RLA for Unit 2 addresses and appropriately resolves the concerns generated by the emergent operating experience. The magnitude of the operating experience would dictate whether the issue should result in immediate non-acceptance, allowing the licensee to supplement during the acceptance review, or RAIs during the full technical review (see Enclosure 1, Guide for Performing Acceptance Reviews, Section 3.2, Acceptance Review Results).

Office of Nuclear Reactor Regulation Acceptance Review Milestones

Acceptance Review Milestones Page 1 of 2 GENERIC ACCEPTANCE REVIEW MILESTONES T = Time from date when requested licensing action (RLA) is declared an Official Agency Record in ADAMS (in working days)

A. RLA is Acceptable for Review MILESTONES Schedule 1

PM distribute RLA to technical staff T = 0 2

PM review for information sufficiency

< T = 15 days 3

Technical staff provide results of technical sufficiency review to PM

< T = 20 days 4

PM notify licensee (e.g., via call, e-mail or letter) that RLA is acceptable < T = 25 days 5

PM records the date of acceptance in the NRR workload management tool

< T = 25 days B. RLA is Unacceptable for Review with Opportunity to Supplement MILESTONES Schedule 1

PM distribute RLA to technical staff T = 0 2

PM review for information sufficiency

< T = 15 days 3

Technical staff provide results of technical sufficiency review to PM

< T = 20 days 4

PM coordinate discussion with technical staff and raise issue to appropriate management

< T = 25 days 5

PM notify licensee (e.g., via call, e-mail or letter) that RLA is insufficient and schedule call to discuss results

< T = 25 days 6

PM records the date that the licensee was notified that the RLA is insufficient in the NRR workload management tool

< T = 25 days 7

Conference call held with the licensee and the NRC staff regarding RLA insufficiencies; response date established

< T = 30 days 8

Licensee provide requested information to address information insufficiency

< T = 43 days 9

NRC staff review supplemental information

< T = 48 days 10 PM notify licensee (e.g., via call, e-mail or letter) that RLA is acceptable < T = 53 days 11 PM records the date of acceptance in the NRR workload management tool

< T = 53 days

Acceptance Review Milestones Page 2 of 2 C. RLA is Unacceptable for Review with Opportunity to Supplement, and Supplement is Unresponsive MILESTONES Schedule 1

RLA is declared an Official Agency Record in ADAMS T = 0 2

PM review for information sufficiency

< T = 15 days 3

Technical staff provide results of technical sufficiency review to PM

< T = 20 days 4

PM coordinate discussion with technical staff and raise issue to appropriate management

< T = 20 days 5

PM notify licensee (e.g., via call, e-mail or letter) that RLA is insufficient and schedule call to discuss results

< T = 25 days 6

PM records the date that the licensee was notified that the RLA is insufficient in the NRR workload management tool

< T = 25 days 7

Conference call held with the licensee and the NRC staff regarding RLA insufficiencies; response date established

< T = 30 days 8

Licensee provide requested information to address information insufficiency

< T = 43 days 9

NRC staff review supplemental information

< T = 48 days 10 Supplement is unresponsive, PM coordinate further discussion with technical staff and appropriate management (e.g., Division Directors, NRR ET, and/or EDO, as appropriate)

< T = 53 days 11 PM notify licensee (via letter) that RLA is unacceptable

< T = 53 days 12 PM records the date of non-acceptance in the NRR workload management tool and closes the EPID

< T = 53 days D. RLA is Unacceptable for Review Without Opportunity to Supplement MILESTONES Schedule 1

RLA is declared an Official Agency Record in ADAMS T = 0 2

PM review for information sufficiency

< T = 15 days 3

Technical staff provide results of technical sufficiency review to PM

< T = 20 days 4

PM coordinate discussion with technical staff and receive concurrence from appropriate Division management; brief OGC on situation and proposed action

< T = 24 days 5

PM/BC to communicate decision to ET and notify EDO via daily note

< T = 24 days 6

PM notify licensee (e.g., via call or e-mail, followed by letter) that RLA is insufficient and schedule call to discuss results, if appropriate

< T = 25 days 7

PM records the date of non-acceptance in the NRR workload management tool and closes the EPID

< T = 25 days

Appendix A - Change History Office Instruction LIC-109 Acceptance Review Procedures LIC-109 Change History Date Description of Changes Method Used to Announce &

Distribute Training 05/02/2008 Initial Document E-mail to NRR staff Division-wide training sessions 07/16/2009 Revision 1 of LIC-109, Acceptance Review Procedures, includes enhancements to the guidelines and criteria to the staff in performing acceptance reviews.

E-mail to NRR staff Division-wide training sessions 01/09/2017 Revision 2 of LIC-109, Acceptance Review Procedures, better defines the concept of a sufficiency item, and complex review clarifies the applicability of the process to plants post-52.103(g) finding, and ensures appropriate managerial concurrences are documented on any action needing to be supplemented, or the decision to not accept a document initially found unacceptable to the technical staff. Also adds guidance to reflect actions to be taken for late reliefs/alternatives. This revision clarifies the applicability of the regulations and guidance to non-applications such as topical reports and TSTFs and to non-applicants such as entities other than licensees or applicants for a license.

E-mail to NRR staff Division-wide training sessions

LIC-109 Change History Date Description of Changes Method Used to Announce &

Distribute Training 07/13/2020 Revision 3 of LIC-109 is renamed and revised to clarify that the scope of the office instruction applies to licensee-requested changes to a plants licensing basis. Additional revisions were made to reflect current processes, to clarify how to count working days for the purposes of the acceptance review, and to clarify and make consistent the language used in the example letters.

E-mail to NRR staff None