ML061360240
| ML061360240 | |
| Person / Time | |
|---|---|
| Issue date: | 09/01/2006 |
| From: | NRC/NRR/ADRA/DNRL/NGDB |
| To: | |
| Oesterle, E,ADRA/DNRL/NRBA, 301-415-1365 | |
| Shared Package | |
| ML061800499 | List: |
| References | |
| DG-1145 | |
| Download: ML061360240 (7) | |
Text
DG-1145, Page C.IV.2-1 C.IV.2. Submittal Guidance for Combined Licenses (COLs)
The purpose of this section is to provide summarized information to combined license (COL) applicants who reference a design certification rule (DCR) as well as on the existing U.S. Nuclear Regulatory Commission (NRC) guidance for submitting electronic documentation. The information on electronic submissions discussed in this section supplements the electronic submission guidance found on the NRCs public Web site at http://www.nrc.gov/site-help/eie/ guid-elec-submission.pdf.
C.IV.2.1 Background The NRC staff is issuing this guidance to provide additional information on the procedures that an applicant should follow to submit documentation necessary for the licensing process. This section includes guidance on referencing a certified design in the COL application as well as a brief description of the documentation needed in a COL application if a DCR is not referenced (See Figure C.IV.2.1-1), if a DCR is referenced (See Figure C.IV.2.1-2), and if a DCR and an early site permit (ESP) are referenced (See Figure C.IV.2.1-3). This section also addresses electronic submissions of license applications, related documentation, and submission of subsequent revisions.
In accordance with the provisions of Title 10, Part 52, of the Code of Federal Regulations (10 CFR Part 52), an applicant, licensee, or holder of a standard design approval (person) shall submit licensing documentation to the NRC by mail or electronically, where applicable. Table C.IV.2.2-1 depicts the documents required by regulation and their respective addressees.
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 of permits and licenses; reports; and other communications NRCs Document Control Desk (if on paper, signed original) 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable 52.3(b)(1)
Applications and amendments to applications NRCs Document Control Desk (if on paper, signed original) 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable 52.3(b)(2)
Acceptance review application NRCs Document Control Desk (if on paper, signed original) 1 copy to the appropriate Regional Office 52.3(b)(3)
Security plan and related submissions NRCs Document Control Desk (if on paper, signed original) 1 copy to the appropriate Regional Office 52.3(b)(4)
Type of Submission Addressees and Copies (CD-ROM or paper)
Regulation DG-1145, Page C.IV.2-2 Emergency plan and related submissions NRCs Document Control Desk (if on paper, signed original) 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable 52.3(b)(5)
Updated FSAR NRCs Document Control Desk (if on paper, signed original) 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable 52.3(b)(6)
Quality assurance-related submissions NRCs Document Control Desk (if on paper, signed original) 1 copy to the appropriate Regional Office 1 copy to the Resident Inspector, if applicable 52.3(b)(7)
[50.54(a)(3) or 50.55(f)(3)]
Certification of permanent cessation of operations NRCs Document Control Desk (Submission must be under oath or affirmation) 52.3(b)(8)
Certification of permanent fuel removal NRCs Document Control Desk (Submission must be under oath or affirmation) 52.3(b)(9)
C.IV.2.2 Referencing a Design Certification Rule The plant-specific design control document (DCD), as defined in the design certification rules which are set forth in the appendices to 10 CFR Part 52, 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. Included in the application means that the actual document is provided with the application. For example, when a COL applicant is required to include the DCD for the certified design that it references in its application, the NRC expects that the COL applicant provide a copy of this DCD with its COL application upon submittal.
For certain DCRs, the COL applicant must include the plant-specific DCD in its application.
This means that the COL applicant should include a copy of the generic DCD (updated to include all revision pages), the plant-specific departures and exemptions from the generic DCD, as well as the plant-specific information, siting information, and operational programs in the FSAR of the COL application.
COL applicants should not expect the NRC to use the generic DCD submitted to support the design certification review in their COL application.
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. While this is not the only means to include the generic DCD in the COL application, it will provide the NRC technical reviewer with a complete description of the area of review in context with the complete discussion on the subject. If a COL applicant does integrate the generic DCD into the FSAR submitted with the COL application, the applicant is strongly encouraged to clearly distinguish information extracted 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. While integration of the generic DCD into the FSAR of the COL application may present some challenges to the applicant, the NRC believes that the review of the FSAR included in the COL application will be more efficient. In addition, for requirements on submitting information to the NRC regarding updates to
DG-1145, Page C.IV.2-3 a DCD that has been referenced in a COL application, COL applicants are directed to Section X.B.3 of the appendix to 10 CFR 52 that is applicable to the referenced certified design.
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. The purpose of this section is to address file format, file size, submission of revised information, submission using CD-ROM, and submission of portable document file (PDF) documents, which specific guidance information is included in the e-rule issued in 68 FR 58792. The applicant or licensee should refer to the e-rule when submitting information electronically.
For persons applying for a COL for nuclear power plants, the proposed 10 CFR 52.3 addresses electronic submissions in a general manner. The applicant can submit documentation via Electronic Information Exchange, e-mail, or CD-ROM and these submissions should be in a manner that allows the NRC staff to receive, read, authenticate, distribute, and archive the information. The documentation should be submitted in a manner that allows the NRC to process and retrieve the submission one page at a time. 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.
C.IV.2.3.1 File Format The applicant should submit documents using the file format guidelines provided in the Guidance Document. The NRC has standardized the use of Portable Document Format (PDF) files to store official agency records. The NRC staff performs a review before accepting electronic submissions to verify that the files conform to the published guidance.
C.IV.2.3.2 File Size The Guidance Document to the e-rule summarizes size limitations for submitting electronic files.
These limitations primarily relate to the end users ability to access or download files from the NRCs Agencywide Documents Access and Management System (ADAMS) or the Internet.
DG-1145, Page C.IV.2-4 C.IV.2.3.3 Submission of Revised Information During the licensing process, the NRC may receive 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. If the applicant elects to submit changes, each document (including all of the electronic files and electronic objects that comprise the document) should be submitted in its entirety, preferably on a CD-ROM. The updated version 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.
C.IV.2.3.4 Submission Using CD-ROM Electronic submittals on CD-ROM are acceptable to the NRC staff. The Guidance Document provides instructions for CD-ROM submissions to the NRC. The files on the CD-ROM must not be locked or password protected. The applicant may submit the COL FSAR, design control document (DCD), and site SAR (SSAR) as separate PDF files on the same CD-ROM.
C.IV.2.3.5 Submission of PDF Documents In order to decrease the possibility of rejection of an application, or related documentation, when it is submitted electronically, the applicant should open the PDF document and verify that the PDF document meets NRCs submission requirements. The applicant may use the verification process delineated in http://www.nrc.gov/site-help/eie/pdf-doc-submittal-checklist.pdf.
C.IV.2.4 References Federal Register, Electronic Maintenance Submission of Information; Final Rule (e-rule),
68 FR 58792, October 10, 2003, available on the NRCs public Web site at http://www.nrc.gov/site-help/eie/10cfr1.pdf.
Federal Register, Licenses, Certifications, and Approvals for Nuclear Power Plants; Proposed Rules, 71 FR 12782, March 13, 2006. U.S. Nuclear Regulatory Commission, Electronic Submittals Electronic Information Exchange, Washington, DC, available on the NRCs public Web site at http://www.nrc.gov/site-help/eie.html.
U.S. Nuclear Regulatory Commission, Appendix A: United States Nuclear Regulatory Commission (NRC) Guidance for Electronic Submissions to the Commission Washington, DC, available on the NRCs public Web site at http://www.nrc.gov/site-help/ eie/guid-elec-submission.pdf.
DG-1145, Page C.IV.2-5 Figure C.IV.2.1-1. Information Requirements for an Application Referencing Neither a Design Certification Rule nor an Early Site Permit
DG-1145, Page C.IV.2-6 Figure C.IV.2.1-2. Information Requirements for an Application Referencing a Design Certification Rule
DG-1145, Page C.IV.2-7 Figure C.IV.2.1-3. Information Requirements for an Application Referencing a Design Certification Rule and an Early Site Permit