ML16259A085
| ML16259A085 | |
| Person / Time | |
|---|---|
| Issue date: | 09/15/2016 |
| From: | Hayes B NRC/NRO/DEIA/NRGB |
| To: | |
| Hayes B 415-7442 | |
| References | |
| Download: ML16259A085 (4) | |
Text
DRAFT RG 1.206 C.2.3 for public meeting on September 26, 2016 Page l1 C.2 Application Regulatory Topics C.2.3 Application Electronic Submittal Overview An applicant for a combined license (COL), standard design certification (DC), or early site permit (ESP) shall submit all correspondence, reports, applications, and other written communications to the NRC in accordance with the provisions of 10 CFR Part 52.3, Written communications. Where practicable, the communications are by electronic submission; and, the electronic submissions must be made in a manner that enables the NRC to receive, read, authenticate, distribute, and archive the submission, and process and retrieve it a single page at a time.
Electronic Submission Guidance The NRCs specific guidance on acceptable procedures for electronic submissions is provided on the public web site at http://www.nrc.gov/site-help/e-submittals.html. Users new to the process should select the getting started link to http://www.nrc.gov/site-help/e-submittals/getting-started.html and access reference materials for electronic submissions (http://www.nrc.gov/site-help/electronic-sub-ref-mat.html). The reference materials for electronic submissions link also provides a link to the current version of the primary guidance document entitled, Guidance for Electronic Submissions to the NRC. The NRC staff plans to update the guidance periodically to reflect changes in technology and agency experience and post the latest version of the document. Applicants should use the most recent processes and guidance when submitting documents in electronic format. The public meeting presentation entitled Electronic Document Submittal Process from March 18, 2014 is also a useful reference and can be found at ADAMS ML14071A344.
In accordance with the provisions of 10 CFR 52.3, all correspondence, reports, applications, and other written communications from an applicant, licensee, or holder of a standard design approval to the NRC concerning regulations, individual license conditions, or the terms and conditions of an ESP or standard design approval must be sent either by mail to the NRCs Document Control Desk; by hand delivery; or, where practicable, by electronic submission (e.g.,
CD-ROM). Table C.2.3-1 summarizes the distribution requirements for specific correspondence, given in 10 CFR 52.3(b).
Table C.2.3-1 Submission of Documentation per 10 CFR 52.3 Type of Submission Addressees and Copies (CD-ROM or Regulation(s) paper)
Application for NRC Document Control Desk 10 CFR 52.3(b)(1) amendments of permits (if on paper, signed original) 10 CFR 50.30 and licenses, reports, 1 copy to the appropriate regional office and other communications 1 copy to the resident inspector, if applicable (to be provided under oath or affirmation)
DRAFT RG 1.206 C.2.3 for public meeting on September 26, 2016 Page l2 Application NRC Document Control Desk 10 CFR 52.3(b)(2) and amendment (if on paper, signed original) 10 CFR 50.30 to application 1 copy to the appropriate regional office 1 copy to the resident inspector, if applicable (to be provided under oath or affirmation)
Acceptance review NRC Document Control Desk 10 CFR 52.3(b)(3) application (if on paper, signed original) 1 copy to the appropriate regional office Security plan NRC Document Control Desk 10 CFR 52.3(b)(4) and related submissions (if on paper, signed original) 1 copy to the appropriate regional office Emergency plan NRC Document Control Desk 10 CFR 52.3(b)(5) and related submissions (if on paper, signed original) 1 copy to the appropriate regional office 1 copy to the resident inspector, if applicable Updated FSAR NRC Document Control Desk 10 CFR 52.3(b)(6)
(if on paper, signed original) 1 copy to the appropriate regional office 1 copy to the resident inspector, if applicable QA-related submissions NRC Document Control Desk 10 CFR 52.3(b)(7)
(if on paper, signed original) 10 CFR 50.54(a)(3) 1 copy to the appropriate regional office or 1 copy to the Resident Inspector, if 10 CFR 50.55(f)(3) applicable Certification of permanent NRC Document Control Desk 10 CFR 52.3(b)(8) cessation of operations (to be provided under oath or affirmation)
Certification of permanent NRC Document Control Desk 10 CFR 52.3(b)(9) fuel removal (to be provided under oath or affirmation)
Referencing a Design Certification Rule or Early Site Permit In accordance with the applicable DCR, the COL applicant must include the plant-specific DCD in its applications FSAR. The plant-specific DCD, as defined in the Section II.C of the DCRs, consists of the information in the generic DCD, as modified and supplemented by the plant-specific departures and exemptions. The COL applicant should also include the generic DCD in the application. However, in accordance with 10 CFR 52.79(d)(1), the plant-specific DCD portion of the COL applicants FSAR must incorporate by reference the generic DCD. Any incorporation by reference should be clear and should specify the section number(s) containing the relevant information to be incorporated by reference. To facilitate staff review and support features such as hyperlinks between electronic files, the applicant should identify the actual generic DCD (complete and current to the revision referenced in the COL application) as a reference document when an electronic medium is used for the COL application. When an application includes hyperlinks to the DCD and other reference documents, these files should be the files within the NRC electronic recordkeeping system, the Agencywide Documents
DRAFT RG 1.206 C.2.3 for public meeting on September 26, 2016 Page l3 Access and Management System (ADAMS). Likewise, a COL application may incorporate by reference documents related to an ESP, and the electronic applications may include hyperlinks to the ESP references in ADAMS.
The NRC recommends that COL applicants facilitate NRC review of COL applications.
For example, the applicant should integrate the plant-specific DCD into the FSAR included in the COL application. This can be accomplished by inserting the information in the generic DCD into the FSAR or, if using electronic submittals, by providing hyperlinks from the COL application to the appropriate section of the generic DCD. While an applicant may use other means to include the plant-specific DCD in the COL application, this method will provide the NRC technical reviewer with a complete description of the area of review in the COL application and ready access to the related discussions in the generic DCD. Regardless of the incorporation approach selected for providing the information in the generic DCD in the FSAR, the agency strongly encourages the applicant to clearly distinguish information quoted directly from the generic DCD from the plant-specific departures and exemptions to the generic DCD that the NRC will review in the COL application. In addition, site-specific information and operational programs should also be distinguished from information in the generic DCD. Applicants are encouraged to clearly identify the information provided in the application, including the FSAR, in terms of its role in addressing COL information items, proposing departures or variances, replacing conceptual design information, and supplementing information provided in a generic DCD or ESP. Likewise, the agency encourages applicants to clearly identify information that is specific to the subject application and information that is referencing or will be referenced by another COL application (e.g., reference or standard information).
The staff anticipates that, as described in 10 CFR 52.55(c), some COL applications will reference a design for which a design certification application has been docketed but not granted. Such COL applications may use the above guidance to incorporate by reference the generic DCD under review by the NRC and clearly indicate relevant departures, COL information items, and other information correlating the application to the proposed design. The NRC staff, design certification applicant, and COL applicant will need to closely coordinate their activities related to the reviews of the proposed design and COL applications. In some cases, it may be appropriate for a COL applicant to submit a revision of major COL documents (e.g., the FSAR) to reflect intermediate revisions to the generic DCD. The COL applicant should at least submit a letter following each revision of the referenced generic DCD to supplement the COL application and acknowledge the related activities in the design review. In all cases, the COL applicant should submit a revision to its application, including the FSAR and other affected documents, upon the completion of the NRCs review and certification of the referenced design.
The agency expects some COL applications to reference DCRs for which an amendment to the applicable design certification has been requested but not yet granted by the NRC. There are three options available to COL applicants in such cases and the decision on which option to choose will depend on the specific circumstances related to the DCR and COL applications:
- The COL applications may be prepared based on the expected outcome of the rulemaking related to the proposed changes to the generic DCD under review by the NRC. This approach is similar to the above approach for cases involving a new design certification application.
- The COL applications may be prepared independent from the petition to revise the DCR. The outcome of the rulemaking could then be addressed by a revision to the COL
DRAFT RG 1.206 C.2.3 for public meeting on September 26, 2016 Page l4 application or as otherwise required by the provisions of change processes related to maintaining the relationship between generic and plant-specific DCDs.
- COL applications may include within the identified departures from the existing DCR those changes related to the requested amendment to the DCR. The report regarding departures from the certified design may refer to the request for a revision to the certified design. In this way, the COL application may then incorporate by reference the DCD under review by the NRC. Within the FSAR and other parts of the application, the COL applicant may correlate the proposed departures, COL information items, and other information to the version of generic DCD under review by the NRC.
As mentioned above, there are several ways to handle the coordination of activities related to the reviews of the DCD and COL applications. The COL applicant should submit a revision to its application, including the FSAR and other affected documents, upon the NRC issuing a decision on the request to amend the referenced design certification.
Revised or Additional Information During the application review process, the applicant may submit revisions of applications, or portions thereof, as the review progresses. The electronic submissions guidance includes information regarding the process to submit changes to electronic documents. For example, applicants submit a complete revised document (e.g., a FSAR) even if it has only revised portions of the document. If the revised document includes hyperlinks to other documents within the application and those documents are not being revised (e.g., revised FSAR with hyperlinks to same generic DCD), the referenced documents may be identified as reference documents on the CD-ROM or DVD and are not to be entered as new records into ADAMS (even if the CD-ROM or DVD includes the reference documents). The updated version of a document should include a list of changes from the previous version. Each page should include a change indicator (e.g., a bold vertical line at the margin adjacent to the portion that has been changed) and a page change identification including either the date of change, revision number, or both. Alternative means may be acceptable when designating changes to drawings and pictures.
The licensing process will likely involve general correspondence, responses to requests for additional information, and other submittals. The agency expects that the supplemental submittals will involve a combination of electronic information exchange, additional CDs or DVDs, and paper correspondence. Applicants should ensure that these various submittals are addressed in accordance with 10 CFR 52.3 and include the docket number and subject, and that copies are provided to the NRC project manager.