ML070390473
| ML070390473 | |
| Person / Time | |
|---|---|
| Issue date: | 02/08/2007 |
| From: | William Reckley NRC/NRO/DNRL/NGIF |
| To: | |
| References | |
| DG-1145, RG-1.206 | |
| Download: ML070390473 (4) | |
Text
Preliminary Work Product to support February 13. 2007 Public Meeting RG 1.206 Section C.IV.2 Rewrite C.IV.2. Submittal Guidance for Combined Licenses (COLs)
The purpose of this section is to provide information to combined license (COL) applicants on methods of submitting COL applications. COL applicants are also referred to U.S. Nuclear Regulatory Commission (NRC) guidance for submitting electronic documentation. The electronic submission guidance found on the NRCs public Web site will be updated as appropriate to reflect new conventions and best practices for the electronic submittal of COL applications.
C.IV.2.1 Background 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 early site permit or standard design approval, must be sent either by mail to the NRCs Document Control Desk, or where practicable by electronic submission (e.g., CD-ROM). Distribution requirements for specific correspondence is described in 10 CFR 52.3(b) and summarized in Table C.IV.2.2-1.
Table C.IV.2.2-1. Submission of Documentation per 10 CFR 52.3 Type of Submission Addressees and Copies (CD-ROM or paper) Regulation Application for amendments NRCs Document Control Desk 52.3(b)(1) of permits and licenses; (if on paper, signed original) 50.30 reports; and other 1 copy to the appropriate Regional Office communications 1 copy to the Resident Inspector, if applicable (to be provided under oath or affirmation)
Applications and amendments NRCs Document Control Desk 52.3(b)(2) to applications (if on paper, signed original) 50.30 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable (to be provided under oath or affirmation)
Acceptance review application NRCs Document Control Desk 52.3(b)(3)
(if on paper, signed original) 1 copy to the appropriate Regional Office Security plan NRCs Document Control Desk 52.3(b)(4) and related submissions (if on paper, signed original) 1 copy to the appropriate Regional Office Emergency plan and related NRCs Document Control Desk 52.3(b)(5) submissions (if on paper, signed original) 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable Updated FSAR NRCs Document Control Desk 52.3(b)(6)
(if on paper, signed original) 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable RG 1.206, Page C.IV.2-1
Preliminary Work Product to support February 13. 2007 Public Meeting RG 1.206 Section C.IV.2 Rewrite Type of Submission Addressees and Copies (CD-ROM or paper) Regulation Quality assurance-related NRCs Document Control Desk 52.3(b)(7) submissions (if on paper, signed original) [50.54(a)(3) or 1 copy to the appropriate Regional Office 50.55(f)(3)]
1 copy to the Resident Inspector, if applicable Certification of permanent NRCs Document Control Desk 52.3(b)(8) cessation of operations (to be provided under oath or affirmation)
Certification of permanent NRCs Document Control Desk 52.3(b)(9) fuel removal (to be provided under oath or affirmation)
C.IV.2.2 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 application. The plant-specific DCD, as defined in the design certification rules which are set forth in the DCR II.C, is a combination of the generic DCD and the plant specific departures and exemptions from the generic DCD. The COL applicant must include the generic DCD in the application. However, per 10 CFR 52.79(b), the generic DCD may be included in the plant specific DCD using incorporation by reference. To facilitate staff review and support features such as hyperlinks between electronic files, the actual generic DCD (complete and current to the revision referenced in the COL application) should be identified as a reference document when an electronic media is used for the COL application. The DCD and other reference documents to which the application includes hyperlinks should be the files within the NRC electronic recordkeeping system, ADAMS. Documents related to an ESP may likewise be incorporated by reference within a COL application 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. One acceptable method to facilitate NRC review is to integrate the generic DCD into the FSAR included in the COL application. This can be accomplished by inserting actual portions of the generic DCD into the FSAR or, if using electronic submittals, by providing hyperlinks from the COL application to the appropriate section of generic DCD. While these are not the only means to include the generic DCD in the COL application, they will provide the NRC technical reviewer with a complete description of the area of review in the COL application with ready access to the related discussions in the generic DCD.
Regardless of the incorporation approach selected for referencing the generic DCD in the FSAR, the applicant is strongly encouraged to clearly distinguish information quoted directly from the generic DCD from the plant-specific departures and exemptions to the DCD that the NRC will review in the COL application. In addition, site specific information and operational programs should also be distinguished from the generic DCD. Applicants are encouraged to clearly identify the information being 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 DCD or ESP. Applicants are likewise encouraged to clearly identify that 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).
It is anticipated 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 RG 1.206, Page C.IV.2-2
Preliminary Work Product to support February 13. 2007 Public Meeting RG 1.206 Section C.IV.2 Rewrite use the above guidance in terms of incorporating by reference the DCD under review by the NRC and clearly indicating relevant departures, COL information items, and other information correlating the application to the proposed design. The NRC staff, design certificate 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 DCD. The COL applicant should at least submit a letter following each revision of the referenced 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 NRC completing its review and certification of the referenced design.
Some COL applications are expected to reference DCRs for which an amendment to the applicable design certification has been requested but not yet granted by the NRC. The COL applicant is required by Section X.B, Reporting, of the applicable appendix to10 CFR 52 to submit a report to the NRC describing departures from the certified design documents. The report regarding departures from the certified design may refer to the request for an amendment to the certified design. The COL application may then be presented in terms of incorporating 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 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.
C.IV.2.3 Electronic Submissions Effective January 1, 2004 (68 FR 58792), the NRC amended its rules regarding electronic submissions in order to implement the Government Paperwork Elimination Act (GPEA). As stated in this final rule, entitled Electronic Maintenance and Submission of Information (e-rule), the NRC issued specific guidance on acceptable procedures for electronic submissions. Since electronic technology is evolving, the staff laid out specific guidance in a document that can be updated as necessary to reflect new technology and experience. This guidance, entitled Appendix A: United States Nuclear Regulatory Commission (NRC) Guidance for Electronic Submissions to the Commission (Appendix A)
(from now on referred to as the Guidance Document), which is posted on the NRCs public Web site at http://www.nrc.gov/site-help/eie/guid-elec-submission.pdf, supersedes previous information for electronic submissions under 10 CFR Part 50 and the proposed 10 CFR Part 52. Forms used to submit information electronically are available on the NRCs public Web site at http://www.nrc.gov/site-help/eie.html.
10 CFR 52.3 addresses electronic submissions in a general manner for COL applicants. The NRC guidance document for electronic submittals will specifically address COL applications and describes an acceptable protocol to provide new or revised documents, reference documents available in ADAMS, and a companion file to describe the content of the CD-ROM or DVD. COL applicants should use the process described in the Guidance Document to the final e-rule when submitting documents to the NRC in electronic format.
RG 1.206, Page C.IV.2-3
Preliminary Work Product to support February 13. 2007 Public Meeting RG 1.206 Section C.IV.2 Rewrite C.IV.2.4 Submission of Revised or Additional Information During the licensing process, the applicant may submit various revisions of COL applications, or portions thereof, as the review progresses. The Guidance Document to the e-rule provides information regarding the process to submit changes to electronic documents. For electronic submittals, a complete revised document (e.g., a FSAR) is submitted even if only portions of the document are being revised. If the revised document includes hyperlinks to other documents within the COL 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 would not be input as new records into ADAMS (whether or not the reference documents are included on the CD-ROM or DVD). The updated version of a document should include a list of changes to 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, or both. Alternative means may be acceptable when designating changes to drawings and pictures.
In addition to the initial COL application and the revision of major parts of the application such as the FSAR, the licensing process will likely involve general correspondence, responses to requests for additional information, and other submittals. It is expected that the supplemental submittals will involve a combination of electronic information exchange, additional CDs or DVDs, and paper correspondence.
Applicants should follow established requirements and practices to ensure these various submittals are addressed in accordance with 10 CFR 52.3, include the docket number and subject, and copies are provided to the NRC project manager. Specific requirements for submitting documents directly related to the hearing process are provided in 10 CFR Part 2.
RG 1.206, Page C.IV.2-4