ML18199A235
| ML18199A235 | |
| Person / Time | |
|---|---|
| Issue date: | 09/05/2019 |
| From: | Patricia Vokoun NRC/NRO/DLSE/LB3 |
| To: | |
| Vokoun P / 3470 | |
| Shared Package | |
| ML18199A232 | List: |
| References | |
| LIC-115 | |
| Download: ML18199A235 (3) | |
Text
Request for Additional Information Job Aid Revision 2 Office of New Reactors Summer 2018 Do you need to write an RAI? Best Practices When insufficient information has been docketed, such that
- Offer a converse or contrarian statement to clearly point out what the staff is unable to reach a reasonable assurance information is missing from the specific portion of the text determination related to a licensing application or provided by the entity to assist both the reviewers and the entity in determining what specific information is being requested.
amendment, the staff member should compose an RAI.
- Review the regulations statements of consideration, as necessary, To assess whether sufficient information has been docketed, to ensure that the application of the regulation(s) is consistent adequate alternatives should be considered, such as with the Commissions intended interpretation.
discussions with fellow reviewers and supervisors, public
- For follow-up questions, describe the preceding question at the meetings, focused audits, or e-mail correspondence from start of the new question. Then discuss how the preceding the Project Manager to the entity. This is especially true response answered part of the question, but did not resolve the when addressing complex or detailed subject areas where part you are again asking about and enter the preceding RAI and question number in the relates to question field in eRAI.
issuing an RAI as a first step may not be as efficient in resolving staff concerns.
- For Multiple Question RAIs follow these points:
o If the regulatory basis is the same for all questions in the RAI, it is acceptable to only include the regulatory basis at the start of the first question and state that it applies to all questions in the RAI o Each question must meet the Six Qualities for RAIs (except Six Qualities for RAIs: for regulatory basis) o Each question should provide enough information that it Necessity- RAIs are necessary when the information being does not require referencing another question within the requested is (1) not available through another docketed RAI (except for regulatory basis).
source and (2) technically relevant to the discussion and
- Simply state the facts. Take emotion out of the question.
conclusions in the safety evaluation.
Regulatory Basis- The regulatory basis and underlying relevant guidance should be clearly stated in the body of the RAI. Things to Avoid Clarity- Ensure that the RAI states what information is Do not use the term requirement when asking for information related to guidance contained in the SRP or Regulatory Guides (RG).
required or what information has been omitted or Only regulations and orders are requirements. The SRP and RGs are presented in an unclear fashion and the context guidance and the applicant may propose an alternate means to surrounding it so that the applicant can fully respond to meet regulations.
the issue.
RAIs should not make determinations on the adequacy of the application. Staff evaluations/conclusions belong in the SER.
Conciseness- Ensure the RAI is succinct.
Do not provide the answer to your RAIs. However, explanatory Comprehensiveness- Ensure the RAI asks the entire examples of the kind of information you need may be included to provide context for the RAI.
question. Is there other relevant subject matter or topical material related to the RAI that must also be considered? Do not request reports. Rather, request relevant, specific information from reports or a summary report, as appropriate.
Significance- Ensure the information requested in the RAI Do not phrase the RAI in a way that could be answered with a yes clearly documents the safety, security, risk, or or no answer.
environmental significance of the issue with respect to the licensing acceptance criteria that must be met to provide The use of subquestions within an RAI is discouraged.
a reasonable assurance determination.
Do not put SGI, SUNSI, CEII, or ECI in eRAI.
RAI Quality Control Checklist: Part 50/52 Review Process Information To ensure that an RAI is of sufficient quality, confirm that the RAI NRO will continue to use the eRAI workflow accessed through has the following attributes: EPM/SharePoint for processing RAIs regarding licensing The regulatory basis is clearly stated at the beginning of the application submitted under Parts 50 or 52. The eRAI RAI. Workflow uses Questions, which are transmitted in RAI If applicable, relevant guidance document(s) are provided letters.
that help clarify the information being requested (e.g., SRPs, Use statements to identify your information needs.
etc.)
For COLA reviews, RAIs related to concerns you may have The RAI clearly identifies the location of the issue in the about the DC should be asked in the ongoing DC review.
document being reviewed (e.g., FSAR Section X.Y).
Note that certified designs have design finality and can only The RAI clearly explains why the information provided does not meet the requirements cited in the regulatory basis be changed under the provisions of 10 CFR 52.63.
The RAI clearly specifies potential impacts of the missing Any follow-up RAIs should identify the original RAI within the information (such as the safety, security, risk, or text, identify what additional information is needed and use environmental significance of the question). the relates to question field in eRAI.
The RAI clearly specifies the specific information being Do not request that report(s) be provided in a response to an requested from the applicant or licensee to support the RAI, rather request specific information within a report or a reasonable assurance determination. summary of the report(s).
Additional considerations for Branch Chief Reivew:
Ensure that the context of the RAI has a clear logical basis, information sought is provided in plain and all acronyms are Where can you find more information?
defined.
Confirm that the RAI is objective, factual and written for an Talk to your Branch Chief or a senior technical reviewer audience of suitably qualified safety and environmental NRO-REG-101 Revision 2, Processing Requests for Addtional reviewers. Information (ML14091A802)
Determine if any questions are duplicative of other questions eRAI guidance documents - eRAI Guidance Documents generated by the branch Quality RAI Examples (ML18199A234)
Determine if coordination with other technical Branches is NRO RAI Audit Report (ML18096B419) needed. Memo from NRO Office Director on the effective use of RAIs Ensure the RAI uses the appropriate format for multiple or (ML18110A398) follow-up questions.
Additional considerations for Technical Division Manager Review:
Determine if RAI could potentially introduce new policy issues and coordinate issuance with Office management as necessary.
Abbreviations BC - Branch Chief RG - Regulatory Guide Determine if question has been consistently addressed across COLA - Combined SGI - Safeguards Information all projects as appropriate. License Application SRP - Standard Review Plan Determine if Office or other Division level alignment is needed CEII - Critical Electrical SUNSI - Sensitive Unclassified prior to issuance. Infrastructure Information Non-Safeguards Information Confirm that the scope and level of detail of questions across FSAR - Final Safety Analysis Report TBC - Technical Branch Chief technical Branches in the Division are appropriately uniform, LBC - Licensing Branch Chief TBR - Technical Branch given consideration of the relative importance of technical OGC - Office of General Counsel Reviewer topics and unique aspects of the design. RAI - Request for Additional TDM - Technical Division Information Management