ML15236A127

Shine Medical Technologies, Inc. Application for Construction Permit Submittal of Atkins-NS-TR-SHN-15-06, Revision 1

ML15236A127
Person / Time
Site:	SHINE Medical Technologies
Issue date:	08/07/2015
From:	Bynum R V SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
SMT-2015-037 NS-TR-SHN-15-06, Rev. 1
Download: ML15236A127 (7)

Text

Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390August 7, 2015SMT-201 5-03710 CFR 50.30U.S. Nuclear Regulatory Commission

-r-LL-O-

&'ATTN: Document Control DeskWashington, DC 20555

References:

(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013,Part One of the SHINE Medical Technologies, Inc. Application forConstruction Permit (ML1 30880226)

(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013,Part Two of the SHINE Medical Technologies, Inc. Application forConstruction Permit (ML13172A324)

(3) NRC letter to SHINE Medical Technologies, Inc., dated March 25, 2015,SHINE Medical Technologies, Inc. -Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305,MF2307, and MF2308) (ML15055A116)

(4) SHINE Medical Technologies, Inc. letter to NRC, dated July 23, 2015,SHINE Medical Technologies, Inc. Application for Construction Permit,Response to Request for Additional Information 6b.3-30SHINE Medical Technologies, Inc. Application for Construction PermitSubmittal of Atkins-NS-TR-SHN-1 5-06, Revision 1Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI(References 1 and 2). The NRC staff determined that additional information was required toenable the staff's continued review of the SHINE construction permit application (Reference 3).Via the SHINE Response to RAI 6b.3-30 (Reference 4), SHINE stated a nuclear criticality safetyevaluation (NCSE) covering criticality safety in the uranyl sulfate preparation tank would beprovided to the NRC at a later date.Enclosure 1 provides the non-public (proprietary) version of Atkins-NS-TR-SHN-15-06, Revision 1, "Criticality Safety Evaluation for the SHINE Target Solution Preparation System."Enclosure 1 is being provided via optical storage media (OSM) as OSM#1. In addition toproprietary information, Enclosure 1 contains security-related information which was identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31.

SHINErequests that the NRC withhold Enclosure 1 frorn public disclosure under 10 CFR 2.390.Enclosure 1 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 1, this letter is uncontrolled.

AD0-2555 Industrial Drive I Monona, WI 53713J P (608) 210-1060 I F (608) 210-2504 1 www.shinemed.corn Document Control DeskPage 2THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390Enclosure 2 provides the public (non-proprietary) version of Atkins-NS-TR-SHN-15-06, Revision 1, "Criticality Safety Evaluation for the SHINE Target Solution Preparation System."Enclosure 2 is being provided via OSM as OSM#2.Enclosure 3 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information pursuant to 10 CFR 2.390. Enclosure 1 contains information proprietary to SHINE.Upon removal of Enclosure 1, this letter is uncontrolled.

If you have any questions, please contact Mr. Jim Costedio, Licensing Manager,at 608/210-1730.

I declare under the penalty of perjury that the foregoing is true and correct.Executed on August 7, 2015.Very truly yours,VanByum, Ph.D. V z Chief Operating OfficerSHINE Medical Technologies, Inc.Docket No. 50-608Enclosures cc: Administrator, Region IlI, USNRCProject Manager, USNRCEnvironmental Project Manager, USNRCSupervisor, Radioactive Materials

Program, Wisconsin Division of Public Health(w/o Enclosure 1)Enclosure 1 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 1, this letter is uncontrolled.

ENCLOSURE 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390ENCLOSURE 1SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITSUBMITT-IAL OF ATKINS-NS-TR-SHN-1 5-06, REVISION 1ATKINS-NS-TR-SHN-15-06, REVISION 1CRITICALITY SAFETY EVALUATION FOR THESHINE TARGET SOLUTION PREPARATION SYSTEMNON-PUBLIC VERSION(OSM#1)/ 1 Me TchnoTlogies

'SMT-2015-037 (7\ /Atkins-NS-TR-SHN-1 5-06, Revision 1~Criticality Safety Evaluation for i~the SHINE Target Solution~Preparation System"%%._ Non-Public (OSM#1)Enciosure 1 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 1, this letter is uncontrolled.

[ I ENCLOSURE 2SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITSUBMITT-AL OF ATKINS-NS-TR-SHN-15-06, REVISION 1ATKINS-NS-TR-SHN-1 5-06, REVISION 1CRITICALITY SAFETY EVALUATION FOR THESHINE TARGET SOLUTION PREPARATION SYSTEMPUBLIC VERSION(OSM#2)SMVT-201 5-037()

ENCLOSURE 3SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITSUBMITT-AL OF ATKINS-NS-TR-SHN-1 5-06, REVISION 1AFFIDAVIT OF RICHARD VANN BYNUM2 pages follow SSHiINMedical Technologies AFFIDAVIT OF RICHARD VANN BYNUMSTATE OF WISCONSIN

)) ss.COUNTY OF DANE)I, Richard Vann Bynum, Chief Operating Officer of SHINE Medical Technologies, Inc. (SHINE),do hereby affirm and state:1. I am authorized to execute this affidavit on behalf of SHINE. I am authorized toreview information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from publicdisclosure.

The purpose of this affidavit is to provide the information required by10 CFR 2.390(b) in support of SHINE's request for proprietary treatment ofcertain confidential commercial and financial information submitted in the SHINEresponse to the NRC staff's requests for additional information transmitted byletter SMT-2015-037 with enclosures.

SHINE requests that the confidential information contained in Enclosure 1 be withheld from public disclosure in itsentirety.

2. I have knowledge of the criteria used by SHINE in designating information assensitive, proprietary, or confidential.

3. Pursuant to the provisions of paragraph (a)(4) of 10 CFR 2.390, the following isfurnished for consideration by the NRC in determining whether the information sought to be withheld from public disclosure should be withheld.

a. The information sought to be withheld from public disclosure contained inEnclosure 1 of SMT-2015-037 is owned by SHINE, its affiliates, or thirdparties to whom SHINE has an obligation to maintain its confidentiality.

Thisinformation is and has been held in confidence by SHINE.b. The information sought to be protected in Enclosure 1 is not available to thepublic to the best of my knowledge and belief.1

c. The information contained in Enclosure 1 is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. Theinformation that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial financial information, commercial information, or information that is subject to export controls.

SHINE limitsaccess to these elements to those with a "need to know," and subject tomaintaining confidentiality.

d. The proprietary information sought to be withheld from public disclosure inEnclosure 1 includes, but is not limited to: structural configuration, primaryand supporting systems of the medical isotope facility, process and systemlocations, and process details.

This would include information regarding thetypes, quantities, and locations of materials stored on site as would bereferenced in facility configuration drawings.

Public disclosure of theinformation in Enclosure 1 would create substantial harm to SHINE because itwould reveal trade secrets owned by SHINE, its affiliates, or third parties towhom SHINE has an obligation to maintain its confidentiality.

e. The information contained in Enclosure 1 of SMT-2015-037 is transmitted tothe NRC in confidence and under the provisions of 10 CFR 2.390; it is to bereceived in confidence by the NRC. The information is properly marked.I declare under the penalty of perjury that the foregoing is true and correct.Executed on August 7, 2015.CC oh Medicalh Te c~hnolo g ies, Inc.2