ML15161A345

Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Revisions Resulting from Request for Additional Information Responses - Summary of Preliminary Safety Analysis Report Changes Public Version

ML15161A345
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/21/2015
From:	SHINE Medical Technologies
To:	Office of Nuclear Reactor Regulation
Shared Package
ML15161A336	List: ML15161A343 ML15161A345 ML15161A346
References
SMT-2015-019
Download: ML15161A345 (2)

Text

ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. PRELIMINARY SAFETY ANALYSIS REPORT REVISIONS RESULTING FROM REQUEST FOR ADDITIONAL INFORMATION RESPONSES

SUMMARY

OF PRELIMINARY SAFETY ANALYSIS REPORT CHANGES PUBLIC VERSION SHINE has determined that Preliminary Safety Analysis Report (PSAR) changes described in letters dated October 15, 2014; December 3, 2014, February 6, 2015; April 3, 2015; and May 1, 2015 can be incorporated. The following table provides a listing of the requests for additional information (RAIs) in which SHINE provided a response describing a change to the PSAR. In addition, the table provides reference to submittal information containing the applicable SHINE Response and the affected PSAR pages for each change.

A mark-up of the PSAR changes is provided in Attachment 1. The non-public (proprietary) version of the PSAR, incorporating the changes provided in Attachment 1, is provided in Enclosure 4. The public (non-proprietary) version of the PSAR, incorporating the changes provided in Attachment 1, is provided in Enclosure 5.

SHINE Letter Accession Affected Preliminary Safety RAI Number Number Letter Date Number Analysis Report Page(s)

RAI 1.3-1 SMT-2014-033 October 15, 2014 ML14296A189 Figure 1.3-3 RAI 2.4-5 SMT-2014-040 December 3, 2014 ML14356A527 2.4-18 and 2.4-32 RAI 2.5-6 SMT-2014-040 December 3, 2014 ML14356A527 3-29 RAI 2.2-3 SMT-2015-004 February 6, 2015 ML15043A404 2-iv, 2.2-18, 2.2-18a, 2.2-18b, 2.2-18c, 2.2-18d, 2.2-18e, 2.2-18f, 2.2-24, 2.2-40a, 2.2-40b, 2.2-40c, 2.6-2, and 2.6-3 RAI 2.2-4 SMT-2015-004 February 6, 2015 ML15043A404 2-iii, 2.2-5, 2.2-6, 2.2-7, 2.2-8, 2.2-25, 2.2-28, 2.2-29, 2.2-30, 2.2-33, 2.2-34, 2.2-35, 2.6-2, and 2.6-3 RAI 3.2-1 SMT-2014-040 December 3, 2014 ML14356A527 2.3-12 RAI 3.5b-2 SMT-2015-012 April 10, 2015 ML15120A248 3-104 and 3-104a RAI 4a2.6-2 SMT-2014-033 October 15, 2014 ML14296A189 4a2-38 RAI 4b-1 SMT-2014-033 October 15, 2014 ML14296A189 4b-9 RAI 4a2.8-2 SMT-2014-040 December 3, 2014 ML14356A527 4a2-26 and 4a2-27 RAI 6a2.2-5 SMT-2014-033 October 15, 2014 ML14296A189 6a2-6 RAI 6a2.2-6 SMT-2014-033 October 15, 2014 ML14296A189 6a2-7 RAI 6a2.2-10 SMT-2014-033 October 15, 2014 ML14296A189 1-10, 6-ii, 6a2-4, 6a2-5, 6a2-8a, and 6a2-9 RAI 6b.2-2 SMT-2014-033 October 15, 2014 ML14296A189 6b-5 Page 1 of 2

SHINE Letter Accession Affected Preliminary Safety RAI Number Number Letter Date Number Analysis Report Page(s)

RAI 6b.2-3 SMT-2014-033 October 15, 2014 ML14296A189 6b-6 RAI 6b.2-5 SMT-2014-033 October 15, 2014 ML14296A189 1-10, 6-ii, 6b-3, 6b-4, 6b-9a, and 6b-10 RAI 6b.2-6 SMT-2014-040 December 3, 2014 ML14356A527 6b-2 and 6b-3 RAI 6b.3-24(a) SMT-2015-014 May 1, 2015 ML15131A464 6b-12 RAI 6b.3-27(b) SMT-2015-014 May 1, 2015 ML15131A464 6b-17 and 6b-18 RAI 11.1-5 SMT-2014-033 October 15, 2014 ML14296A189 11-20 RAI 11.2-3 SMT-2014-033 October 15, 2014 ML14296A189 11-54 RAI 11.2-4 SMT-2015-004 February 6, 2015 ML15043A404 9b-48, 9b-49, 9b-50, Figure 9b.7-5, and 11-50 RAI 12.1-1 SMT-2014-033 October 15, 2014 ML14296A189 11-6, 11-7, 11-8, 11-10, 11-11, 11-22, Figure 11.1-1, 11-58, 12-iii, 12-1, 12-3, 12-4, and Figure 12.1-1 RAI 12.1-2a SMT-2014-033 October 15, 2014 ML14296A189 12-3 RAI 12.1-2b SMT-2014-033 October 15, 2014 ML14296A189 12-3 RAI 12.2-1a SMT-2014-033 October 15, 2014 ML14296A189 12-5 RAI 12.2-1b SMT-2014-033 October 15, 2014 ML14296A189 12-5 RAI 12.2-2 SMT-2014-033 October 15, 2014 ML14296A189 12-6 RAI 12.2-3 SMT-2014-033 October 15, 2014 ML14296A189 12-6 RAI 12.3-1b SMT-2014-033 October 15, 2014 ML14296A189 12-7 and 12-7a RAI 12C.1-3b SMT-2015-004 February 6, 2015 ML15043A404 12-13 RAI 13a2.1-2 SMT-2014-033 October 15, 2014 ML14296A189 4a2-59 and 4a2-60 RAI 13a2.1-8 SMT-2014-040 December 3, 2014 ML14356A527 13a2-3 a) PSAR Revision originally described in the SHINE Response to RAI 6b.3-10 (SMT-2014-040), but modified based on the SHINE Response to RAI 6b.3-24.

b) PSAR Revision originally described in the SHINE Response to RAI 6b.3-6 (SMT-2014-040), but modified based on the SHINE Response to RAI 6b.3-27.

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