ML18275A046

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Request NRR Concurrence on Generic Issue Non-acceptance Memo (Package Accession No. ML18201A565
ML18275A046
Person / Time
Issue date: 10/01/2018
From: Mirela Gavrilas
NRC/NRR/DSS
To: Stanley Gardocki
NRC/RES/DE/RGDB
Beaton R, NRR/DSS/SRXB, 415-2952
Shared Package
ML18201A565 List:
References
Download: ML18275A046 (2)


Text

From: Beaton, Robert Sent: Monday, October 01, 2018 2:03 PM To: Betancourt, Luis Cc: Whitman, Jennifer

Subject:

FW: request NRR concurrence on generic issue non acceptance memo (package accession no. ML18201A565

Luis, Mirela concurred on this last Friday (see below). Robert From: Gavrilas, Mirela Sent: Friday, September 28, 2018 10:27 AM To: Gardocki, Stanley <Stanley.Gardocki@nrc.gov>; Boyce (RES), Tom <Tom.Boyce@nrc.gov>;

Thomas, Brian <Brian.Thomas@nrc.gov>

Cc: Beaton, Robert <Robert.Beaton@nrc.gov>; Whitman, Jennifer

<Jennifer.Whitman@nrc.gov>; Marshall, Jane <Jane.Marshall@nrc.gov>; Perkins, Leslie

<Leslie.Perkins@nrc.gov>; Lund, Louise <Louise.Lund@nrc.gov>

Subject:

RE: request NRR concurrence on generic issue non acceptance memo (package accession no. ML18201A565

Stan, Robert has just briefed me, and NRR/DSS concurs with the comments noted on the attached documents. Please let us know if you have any questions.

Brian, Tom, and Stan, This is a great example of using risk insights to decide if regulatory action is needed. I particularly appreciate the fact that safety significance is the first criterion used to decide if something enters the GI process.

Thanks, M.

From: Beaton, Robert Sent: Friday, September 28, 2018 9:19 AM To: Gavrilas, Mirela <Mirela.Gavrilas@nrc.gov>

Cc: Whitman, Jennifer <Jennifer.Whitman@nrc.gov>

Subject:

FW: request NRR concurrence on generic issue non acceptance memo (package accession no. ML18201A565

Mirela, I have reviewed the package and recommend concurrence assuming my comments are addressed. I have attached the files with my comments. Some of my comments are editorial in nature while others are technical that have to be addressed.

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Robert From: Whitman, Jennifer Sent: Tuesday, September 18, 2018 12:43 PM To: Beaton, Robert <Robert.Beaton@nrc.gov>

Subject:

FW:request NRR concurrence on generic issue non acceptance memo (package accession no. ML18201A565 From: Gardocki, Stanley Sent: Tuesday, September 18, 2018 12:38 PM To: Perkins, Leslie <Leslie.Perkins@nrc.gov>; Whitman, Jennifer <Jennifer.Whitman@nrc.gov>

Cc: Boyce (RES), Tom <Tom.Boyce@nrc.gov>

Subject:

request NRR concurrence on generic issue non acceptance memo (package accession no.

ML18201A565

Leslie, We are requesting NRR concurrence on this memorandum of non-acceptance for generic issue PRE-GI-020. Normally we do not request NRR concurrence on such a memo. However, this issue has been discussed in meeting with NRR and RES management at division level, they directed such action. Therefore, we are asking for NRR concurrence due to their direct involvement.

The documents are in adams, see link below. Tom Boyce has reviewed the documents and is prepared to concur on them, but first we are requesting NRR concurrence. We have worked with DSS, mainly Jennifer Whitman on this issue. She is aware of the issue.

Attached is a copy of the documents Also attached is Jennifer Whitmans comments on the former draft document sent by her and her team.

Also, attached is NRR immediate safety determination (ML18081A936), which is non-public, and we request NRR make it publicly available.

Thanks Request response within two weeks. Stan Gardocki View ADAMS Properties ML18201A565 Open ADAMS Package (Initial acceptance review Generic Issue for procedures to address anticipated operational occurences (AOOs))

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