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Category:Letter
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2024-01-22
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Text
June 15, 2004 Mr. Alex Marion, Director Engineering Nuclear Energy Institute Suite 400 1776 I Street, NW Washington, DC 20006-3708
SUBJECT:
GUIDANCE ON PRE-SUBMITTAL MEETING ON TOPICAL REPORTS
Dear Mr. Marion:
The topical report (TR) review process provides for a pre-submittal meeting between the staff and the vendor or owners group, when appropriate, preferably during the formative stage and before finalization of the TR. Based on our recent experience with these meetings, we believe their effectiveness and value, both to you and us, can be improved in line with our continuing efforts to improve the efficiency and effectiveness of the overall TR review process. This letter explains and clarifies the purpose of the pre-submittal meetings and their scope, content, expectations, and conduct.
The principal objectives of the pre-submittal meeting are to: (1) identify, at an early stage and based on the information exchanged at the meeting, proposed TRs that are not likely to satisfy our acceptance criteria, and/or aspects of a proposed TR that appear to be incomplete, deficient, or not addressed at all and which should be corrected before the submittal of the TR for our acceptance review, and (2) identify resource needs to support reviews of planned submittals. These objectives will require additional focus and effort by you and us but should minimize wasted effort and save subsequent schedule time and resources.
The following cooperative actions are necessary to maximize the benefits of this effort.
- 1. Pre-submittal meetings should be held unless you and your TR project manager (PM),
in consultation with the cognizant technical staff, are satisfied that a meeting is not needed.
- 2. Meetings should be scheduled as early as possible once the proposed TR concept and supporting bases are finalized. You should engage your PM sufficiently well in advance of the meeting to enable him/her to conduct a proprietary review and finding, if needed, arrange participation of appropriate staff, and have enough time for noticing the meeting. A draft of the TR, if available, should be submitted prior to the meeting. If a draft is not yet available, provide as much information as possible about the proposed TR when requesting the meeting. You can also assist your PM by identifying needed staff disciplines.
- 3. At the meeting, you should be prepared to present as much information as possible on the concept, purpose, scope, supporting bases, relationship to other ongoing or planned
A. Marion industry activities, and coordination with other industry groups and activities, as appropriate. You should identify any issues you believe could affect our acceptance (or subsequent approval) of the proposed TR and how you would have addressed and resolved such issues. To the extent possible, based on this information and our experience, we will identify any concerns we have about the viability or completeness of the report for you to consider before submitting the TR. However, the pre-submittal meeting is not intended to replace our subsequent formal acceptance review, and no decision about the acceptability of the proposed TR will be made at this stage. You should also tell us your planned submittal date and your desired approval date.
Recognize that, notwithstanding this additional effort prior to submittal, technical issues can emerge during the staff acceptance and technical reviews that were not apparent at the pre-submittal stage which could result in the TR either not being accepted or not being approved.
- 4. The PM will assure that all issues are adequately addressed and that the success criteria for the meeting are satisfied. At the conclusion of the meeting and after a staff caucus, if necessary, the PM will summarize any identified concerns about the acceptability or completeness of the TR and these will be documented in the meeting summary.
Section 170.21 of Title 10 of the Code of Federal Regulations requires that TRs be subject to fees based on the full cost of the review. Therefore, staff time spent on pre-submittal meetings will be billed accordingly.
If you have any questions about what is outlined in this letter, please call me at 301-415-1838. I also welcome your feedback on the conduct and effectiveness of future pre-submittal meetings, and your suggestions for further improvement.
Sincerely,
/RA/
Herbert N. Berkow, Director Project Directorate IV Division of Licensing Project Management Office of Nuclear Reactor Regulation Project No. 689
A. Marion June 15, 2005 industry activities, and coordination with other industry groups and activities, as appropriate. You should identify any issues you believe could affect our acceptance (or subsequent approval) of the proposed TR and how you would have addressed and resolved such issues. To the extent possible, based on this information and our experience, we will identify any concerns we have about the viability or completeness of the report for you to consider before submitting the TR. However, the pre-submittal meeting is not intended to replace our subsequent formal acceptance review, and no decision about the acceptability of the proposed TR will be made at this stage. You should also tell us your planned submittal date and your desired approval date.
Recognize that, notwithstanding this additional effort prior to submittal, technical issues can emerge during the staff acceptance and technical reviews that were not apparent at the pre-submittal stage which could result in the TR either not being accepted or not being approved.
- 4. The PM will assure that all issues are adequately addressed and that the success criteria for the meeting are satisfied. At the conclusion of the meeting and after a staff caucus, if necessary, the PM will summarize any identified concerns about the acceptability or completeness of the TR and these will be documented in the meeting summary.
Section 170.21 of Title 10 of the Code of Federal Regulations requires that TRs be subject to fees based on the full cost of the review. Therefore, staff time spent on pre-submittal meetings will be billed accordingly.
If you have any questions about what is outlined in this letter, please call me at 301-415-1838. I also welcome your feedback on the conduct and effectiveness of future pre-submittal meetings, and your suggestions for further improvement.
Sincerely,
/RA/
Herbert N. Berkow, Director Project Directorate IV Division of Licensing Project Management Office of Nuclear Reactor Regulation Project No. 689 DISTRIBUTION:
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