The NRC Staff's Topical Report Role
Office Instruction LIC-500, describes the role of the NRC staff in the topical report process. The NRC uses one of four review pathways: (1) Standard Review, (2) Compressed Review, (3) Uncomplicated Review, or (4) Safety Evaluation (SE) Confirmation Review. There are seven phases in the standard topical review process which are discussed in detail in LIC-500. The phases, as summarized on this page, are:
Phase 1: Submittal
Much of this phase is focused on those activities which occur before the submittal of the topical report, namely any pre-submittal meetings. While these meeting are optional, most organizations choose to at least one pre-submittal meeting for the efficiencies that is added to the process. These meetings can be a valuable tool in obtaining staff feedback or helping the staff determine the topical report priority. This phase ends when the TR has been submitted to the NRC and is placed on the docket.
Phase 2: Work Plan Development
This phase begins once the topical report has been submitted for NRC staff review and ends when the priority has been determined. Most of the steps in this phase are focused on planning the review schedule and determining the priority of the review. The planning and scheduling is done among the Project Manager and all technical reviewers assigned to the topical report evaluation.
Priority is assigned for the topical report against other agency work as well as among the different topical reports under NRC staff review with the same subject matter.
Phase 3: Completeness and Decision Letter
The beginning of this phase is based on the priority of the topical report and it starts when the NRC staff is scheduled to begin the technical review. This phase determines if the topical report is technically complete enough to allow for an NRC staff review. It also means that all proprietary and non-proprietary information has been appropriately marked. The phase ends with the issuance of the decision letter.
Phase 4: Draft SE with Holes and Requests for Additional Information
This phase marks the formal beginning of the detailed technical review. It begins immediately upon a staff decision to docket a TR and ends when the Request for Additional Information (RAI) questions have been sent. The goal of this phase is the generation of the Draft SE with “holes” to support the development and issuance of the RAI questions, as appropriate, in accordance with LIC-115, “Processing Requests for Additional Information.” The staff will maintain the Draft SE with “holes” as an internal pre-decisional document for use in tracking issues and sponsor submissions to close them. When all issues are closed, the staff may convert the Draft SE with “holes” into a complete Draft SE for proprietary review or public disclosure in connection with Advisory Committee on Reactor Safeguards (ACRS) review or other reasons, as discussed below.
Phase 5: Draft Safety Evaluation
For the Standard Review pathway, this phase begins after the RAI responses have been received and ends when the “holes” in the Draft SE are closed. For the Compressed, Uncomplicated, or SE Confirmation reviews, this phase begins upon receipt of the TR. The staff will update the Draft SE with information from the RAI response. Then, the technical staff will provide concurrence. Advisory committee on Reactor Safeguards (ACRS) is provided the opportunity the review the TR and the associated SE. After the licensing assistant review, a draft SE will be provided to the applicant to identify any proprietary information.
Phase 6: Final Safety Evaluation
For the Standard Review pathway, this phase begins after the Draft SE is complete and ends once the Final SE has been issued. Technical staff will update the Draft SE as necessary with relevant comments from the sponsor (i.e., identification of proprietary information) from the Draft SE, the staffs concurrence review, and any ACRS comments, as appropriate. Then the PM will issue the final SE by the scheduled date via file-sharing method established by Office of the Chief Information Officer.
Phase 7: "-A" Version
This is the final phase of the process and occurs if the NRC staff has found the topical report acceptable for use. It begins after the final safety evaluation has been placed on the docket and transmitted to the submitting organization. Once the final safety evaluation is issued, the submitting organization has 60 days, or any other negotiated time, to provide the "-A" version. It ends once the "-A" verification letter is issued by the NRC staff.
During this phase, the NRC will determine if the topical report is considered a rule under the Congressional Review Act (CRA). If it is, the NRC will consult with the Office of Management and Budget (OMB) as required under the CRA to determine if the topical report is considered a major rule.
Part of the information the NRC staff provides to OMB is the anticipated costs of using the topical report. In preparing that portion of the OMB information, the NRC staff may consult with the submitting organization to obtain detailed costs information for using the topical report.
If the NRC staff verifies that the "-A" version of the topical report does not change any of the SE conclusions, and OMB determines it is not a major rule, the NRC staff will issue its verification letter. If OMB determines the topical report is a major rule, then further consultation will be needed.
Review Pathways and Timelines
The four review pathways are:
- Standard Review: This is for a highly complex new or revised TR. It involves all the steps in conducting an evaluation including an acceptance review, RAI questions, a Draft SE, Final SE, and -A TR with staff verification. A typical schedule for this review type could be up to two years, but it may be shorter or longer depending on circumstances.
- Compressed Review: Use of this review is appropriate for TRs that are less complicated and for which a detailed set of RAI questions is not expected to be necessary (e.g., due to simplicity of topic area, similarity to previous reviews, etc.). Simple or minor RAI questions may nonetheless be necessary to place information on the TR docket. The Compressed Review is intended to be completed within one year.
- Uncomplicated TR Review: This review process is used when there are minor revisions to an existing TR and the staff has determined based on information at the pre-submittal meeting that no RAI questions or open items are anticipated. A 6-month review schedule is the nominal planning time, but it may take up to 12 months to complete.
- SE Confirmation Review: The SE Confirmation Review is intended for minimal revisions of TRs where the existing SE does not need to be revised (e.g., administrative transfer of a TR to new vendor). (Refer to Uncomplicated TR Review Process Diagram).