Pre-Application White Papers and Technical Reports
The U.S. Nuclear Regulatory Commission (NRC) provides a path to receive feedback on any technical, programmatic, regulatory, or administrative topic to support the development of future applications. Pre-application white papers and technical reports can be submitted by prospective applicants, applicants, licensees, vendors, utilities, or industry organizations[1].
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Pre-Application White Papers
General Information
Pre-application white papers are documents that request NRC feedback on technical, programmatic, regulatory, or administrative topics and may document a proposed position, describe new/novel approaches, or involve policy issues that require Commission involvement. Pre-application white papers are most often used to identify any new/novel design features or methodologies to allow for NRC staff familiarization. If a submitter intends to use novel design features (such as passive systems, inherent safety features, or simplified control features), early identification of these features or approaches to the NRC staff can facilitate timely identification and resolution of any unique regulatory issues.
Pre-application white papers are used to request feedback from the NRC staff on a specific topic. The NRC staff reviews the information in the pre-application white paper and provides feedback that can be used to inform future licensing applications (e.g., construction permits, license amendment requests, combined licenses, etc.) or topical reports. The feedback will be in the form of NRC staff observations; no safety evaluation is issued for a pre-application white paper. Pre-application white paper feedback does not contain regulatory findings and is not an official agency position; therefore, it cannot be cited as pre-approval of the identified topic in future licensing submittals. Once submitters receive the NRC feedback, they may incorporate it into a subsequent submittal (e.g., a topical report or permit or license application) or revised white paper.
The feedback may be delivered via two methods: verbally in a public meeting (and subsequently documented in a meeting summary) and/or in a letter response. Submitters may choose one or both feedback methods. A common approach is for the NRC staff to send draft written feedback and hold a subsequent public meeting to discuss the feedback with the submitter. Afterward, any feedback modifications discussed during the meeting are incorporated and the final written feedback is issued to the submitter as a separate document or contained within the public meeting summary.
When submitting a pre-application white paper to the NRC, it is helpful if the request includes a review schedule, review hours, specific questions to be addressed, and the preferred feedback method (public meeting or written documentation or both). Submitters are able to request the approximate schedule for the review and the approximate number of fee-billed hours for the review. This information will help the NRC staff understand the depth of the review requested. The NRC staff will strive to remain within the schedule and hours boundaries requested by the submitter for the review. When no review hours or schedule are specified, typical pre-application white papers can generally take approximately 3-4 months and 100-150 total hours for technical review and project management processing; however, a more in-depth review and more detailed feedback will result from a longer review time and more review hours. Providing specific questions to be answered by the NRC staff during the review will make the most efficient use of the NRC staff’s time by focusing their review. Identifying the feedback method(s) will let the NRC staff know whether they will need to plan for any public meeting(s) on the topic.
When submitting a pre-application white paper to the NRC, submitter should not provide multiple approaches to a topic and request that the NRC choose or recommend one approach over another because, as a regulator, it is inappropriate for the NRC to act as a consulting organization.
Submittal Procedure
A prospective applicant, applicant, licensee, vendor, utility, or industry organization may, on its own initiative or at the recommendation of the NRC staff, submit a pre-application white paper.
Communication and Correspondence
Prospective applicants are encouraged to provide advanced notice of a forthcoming white paper to the NRC through their regulatory engagement plan. For vendors and industry organizations, notice should be provided to the NRC’s cognizant project manager when a white paper is being developed for submittal to the NRC for review.
When a refined date (i.e., the specific month) for the submittal of a white paper becomes known by the submitting party, they should consult the NRC's cognizant project manager so that the NRC staff can allocate resources and begin preparing for the review. A pre-submittal meeting may be held to discuss the proposed pre-application white paper and may support a timely and thorough review but is not required.
The pre-application white paper transmittal letter and enclosures should be addressed to the Document Control Desk, U.S. Nuclear Regulatory Commission Washington, DC 20555-0001. Hardcopy submittals (e.g., paper, CD-ROM, DVD) are acceptable, but electronic submittals through the Electronic Information Exchange (EIE) are highly encouraged. See Electronic Submittals and Hardcopy Submittals for more information on each type of submission.
Review Fees
Pre-application white paper reviews are normally subject to fees based on the full cost of the review, as set forth in 10 CFR Part 170.
Exemptions to the fee recovery requirements are made on a case-by-case basis, as set forth in 10 CFR 170.11.
Handling of Proprietary information
The regulations in 10 CFR 2.390 require, in part, that the NRC make public NRC records and documents, including correspondence to and from the NRC. If pre-application white papers contain proprietary or other sensitive information, italics, marginal lines, underscoring, or bracketing with yellow highlighting are various methods that can be used to identify this material. Submitters are to provide both a nonproprietary and proprietary copy of a pre-application white paper to the NRC. If the entire white paper is proprietary to the level that a non-proprietary version would provide no value to the public, then submittal of a nonproprietary copy is not necessary.
The nonproprietary version should indicate where proprietary information has been deleted. For example, if brackets and yellow highlighting are used in the proprietary version to show what portion of the information is considered proprietary, the nonproprietary version should leave blank the portion between the brackets to show that information was removed.
Upon receiving a properly marked, proprietary pre-application white paper and the supporting justification for why it is proprietary under 10 CFR 2.390 (i.e., an affidavit), the NRC staff will perform a review to determine whether the information should be withheld from public disclosure and notify the submitting organization of its determination. Nonproprietary versions of pre-application white papers should contain the maximum amount of information possible. Designating an entire page as proprietary when just a few numbers or design factors are proprietary is a basis for the NRC staff to reject the request for withholding.
Pre-Application Technical Reports
General Information
A prospective applicant may, at its option, submit technical reports for the NRC staff’s review in advance of the application submittal. Technical reports may also be submitted in parallel with, or subsequent to, the application submittal, but those submittal timings are not covered here. Technical reports typically address application-specific technical safety topics and are generally intended to support and augment information contained in the permit or license application, typically in the preliminary or final safety analysis reports. Technical reports may contain a level of detail (e.g., test data) beyond that considered appropriate for inclusion in a permit or license application and may be incorporated by reference into the permit or license application to support its completeness. For example, a technical report may include design-specific features to address a regulatory issue, discuss the safety/security interface, or address the design-specific vibration assessment program. A technical report may be used for sections of the permit or license application that contain proprietary information.
The NRC staff will typically review technical reports submitted prior to the permit or license application as part of the pre-application process. Any NRC feedback provided on a technical report prior to submission of a permit or license application will be in the form of observations (i.e., similar to white papers). If NRC approval is requested, then a topical report should be submitted instead, or the prospective applicant should submit the technical report for review as a component of the permit or license application.
The prospective applicant should discuss the desired feedback method (e.g. written documentation or public meeting) or other desired outcome and the desired schedule with the NRC staff prior to submittal to ensure mutual understanding. The desired outcome and proposed feedback schedule should also be included within the submittal.
Submittal Procedure
Submittal procedure is the same as pre-application white papers discussed above.
[1] The NRC staff also has the option to issue white papers as a path to obtain early stakeholder feedback on new or revised guidance that is being developed or on policy or rulemaking topics that the NRC staff plans to subsequently submit in a SECY paper for Commission consideration. NRC-issued white papers are not covered in this discussion.