Pre-Application Topical Reports
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General Information
For new reactor applicants, new and novel components, methodologies, programs, etc.[1] are often the critical components of the NRC review due to the lack of precedent and previous operational experience. To minimize the risk and to enhance efficiency and predictability in an application review, a prospective applicant may, at its option, submit topical reports for the NRC staff’s review and approval of singular, but critical, technical issues.
A pre-application topical report should meet all the following criteria:
- Addresses a specific safety-related subject that requires a safety evaluation by the NRC staff and that can be evaluated independently of a specific license application.
- Is expected to improve regulatory efficiency for new reactors or novel designs by addressing singular critical technical issues.
- Contains complete and detailed information on the specific subject presented.
Prospective applicants may incorporate by reference into a permit or license application any applicable approved topical reports (i.e., those that have received an NRC safety evaluation). If all limitations and conditions contained within the topical report’s safety evaluation are met by the application, the NRC staff will not re-review the subject matter during the application review. Unapproved, but accepted by the NRC for review, topical reports may be incorporated by reference into a submitted permit or license application; however, these topical reports must be approved prior to issuance of the license or permit.
The schedule for the NRC staff’s review depends on the scope and complexity of the topical report. Applicants may request a review timeline for a topical report and identify when it is needed for a forthcoming application, but the NRC staff will discuss and set a review schedule and provide an estimated number of review hours with the prospective applicant once the topical report is accepted for review.
Submittal Procedure
A prospective applicant, vendor, or industry organization may, on its own initiative submit a pre-application topical report.
Communication and Correspondence
Prospective applicants are encouraged to provide advanced notice of a forthcoming topical report 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 topical report is being developed for submittal to the NRC for review.
Three to six months prior to the planned submittal, a pre-submittal meeting should be held on the proposed topical report with the NRC staff.
The pre-application topical report 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 submittal through the Electronic Information Exchange (EIE) is highly encouraged. See Electronic Submittals and Hardcopy Submittals for more information on each type of submission."
Review Fees
Pre-application topical report 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.
Topical Report Identifier
Each submitting organization assigns a unique alphanumeric identifier to each pre-application topical report for filing and reference purposes, and places it in the upper right-hand corner of the first page or cover page of all documents related to the report. Consult the cognizant NRC project manager to ensure that the selected identifier does not conflict with that of another organization. In general, however, the following guidance applies:
- For all proprietary reports, place "-P" or "(P)" at the end of the identifier.
- For the corresponding nonproprietary report, place "-NP" or "(NP)" at the end of the identifier, rather than "-P" or "(P)".
- For all approved proprietary reports, place "-P-A" or "(P-A)" after the identifier, where the A indicates NRC approval.
- For all approved nonproprietary reports, place "-NP-A" or "(NP-A)" after the identifier, where the A indicates NRC approval.
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 topical reports 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. Applicants are to submit both a nonproprietary and proprietary copy of a pre-application topical report to the NRC. Nonproprietary versions of pre-application topical reports 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.
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 topical report and an affidavit justifying why it is considered 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.
The NRC Staff’s Pre-Application Topical Report Role
The phases for a pre-application topical report can be found as part of the Standard Review schedule as detailed on the NRC Staff’s topical report role page
[1] For example, for new reactors, the principal design criteria, instrument set point methodology, severe accident evaluation, new materials qualification, etc. could be unique for a new technology or design and NRC pre-approval may benefit the prospective applicant.