ML15147A203

Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information

ML15147A203
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/14/2015
From:	Bynum R V SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML15147A211	List: ML15147A196 ML15147A197 ML15147A203
References
SMT-2015-018
Download: ML15147A203 (9)

Text

jSHINEThMedical TechnologiesTHIS LETTER CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390May 14, 2015SMT-2015-01810 CFR 50.3050- 606U.S. Nuclear Regulatory CommissionATTN: 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 (ML130880226)(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 April 15, 2015, SHINEMedical Technologies, Inc. -Request for Additional Information RegardingApplication for Construction Permit (TAC Nos. MF2305, MF2307, andMF2308) (ML15099A607)SHINE Medical Technologies, Inc. Application for Construction PermitResponse to Request for Additional InformationPursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an applicationfor a construction permit to construct a medical isotope facility to be located in Janesville, WI(References 1 and 2). Via Reference (3), the NRC staff determined that additional informationwas required to enable the staff's continued review of the SHINE construction permitapplication.Enclosure 1 provides the non-public (proprietary) version of the SHINE response to theNRC staff's request for additional information. Enclosure 1 is being provided via optical storagemedia (OSM) as OSM#1. Enclosure 1 contains security-related information which wasidentified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31.SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.Enclosure 2 provides the public (non-proprietary) version of the SHINE response to theNRC staff's request for additional information. Enclosure 2 is being provided via OSM asOSM#2.Enclosure 1 contains security-related information.Enclosure 3 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.2555 Industrial Drive I Monona, WI 53713 1 P (608) 210-1060 1 F (608) 210-2504 1 www.shinemed.com Document Control DeskPage 2THIS LETTER CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390Enclosure 3 provides a non-public (proprietary) revision to the SHINE Preliminary SafetyAnalysis Report (PSAR), incorporating changes based on the SHINE responses to theNRC staff's request for additional information. Enclosure 3 is provided via OSM as OSM#3.In addition to proprietary information, Enclosure 3 contains security-related information whichwas identified utilizing the guidance contained RIS 2005-31. SHINE requests that the NRCwithhold Enclosure 3 from public disclosure under 10 CFR 2.390.Enclosure 4 provides a public (non-proprietary) revision to the SHINE PSAR, incorporatingchanges based on the SHINE responses to the NRC staff's request for additional information.Enclosure 4 is provided via OSM as OSM#4.Enclosure 5 provides an affidavit supporting the proprietary treatment of the SHINE proprietaryinformation pursuant to 10 CFR 2.390. Enclosure 3 contains information proprietary to SHINE.Upon removal of Enclosures 1 and 3, 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 May 14, 2015.Very truly yours,m, Ph.D.Chief Operating OfficerSHINE Medical Technologies, Inc.Docket No. 50-608Enclosurescc: Administrator, Region Ill, USNRCProject Manager, USNRCEnvironmental Project Manager, USNRCSupervisor, Radioactive Materials Program, Wisconsin Division of Public Health(w/o Enclosures 1 and 3)Enclosure 1 contains security-related information.Enclosure 3 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

ENCLOSURE1SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATIONNON-PUBLIC VERSION(OSM#1),%ISHINEMdcal TechnologiesSMT-201 5-018SHINE Medical Technologies, Inc.Application for Construction PermitResponse to Request forAdditional InformationN~. Non-Public Version(OSM#1)Enclosure 1 contains security-related information.Enclosure 3 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

ENCLOSURE 2SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATIONPUBLIC VERSION(OSM#2)HN SHINEMedical TechnologiesSMT-201 5-018SHINE Medical Technologies, Inc.Application for Construction PermitResponse to Request forAdditional Information'K Public Version(OSM#2)

ENCLOSURE 3 CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390ENCLOSURE 3SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATIONPRELIMINARY SAFETY ANALYSIS REPORTNON-PUBLIC VERSION(OSM#3)Enclosure 1 contains security-related information.Enclosure 3 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

ENCLOSURE 4SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATIONPRELIMINARY SAFETY ANALYSIS REPORTPUBLIC VERSION(OSM#4)

ENCLOSURE 5SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATIONAFFIDAVIT OF RICHARD VANN BYNUM2 pages follow

• SHINEMedical TechnologiesAFFIDAVIT 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 RegulatoryCommission (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-2015-018 with enclosures. SHINE requests that the confidentialinformation contained in Enclosure 3 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 informationsought to be withheld from public disclosure should be withheld.a. The information sought to be withheld from public disclosure contained inEnclosure 3 of SMT-2015-018 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 3 is not available to thepublic to the best of my knowledge and belief.1

c. The information contained in Enclosure 3 is of the type that is customarilyheld in confidence by SHINE, and there is a rational basis for doing so. Theinformation that SHINE is requesting to be withheld from public disclosureincludes trade secret, commercial financial information, commercialinformation, 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 3 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 3 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. Public disclosure of the information in Enclosure 3 would create substantialharm to SHINE because it would reveal valuable business informationregarding SHINE's competitive expectations, assumptions, processes, andcurrent position. Its use by a competitor could substantially improve theircompetitive position in the design, manufacture, shipment, installation,assurance of quality, or licensing of a similar product.f. The information contained in Enclosure 3 of SMT-2015-018 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 May 14, 2015.Va~n~nBynum, Ph.D.COO -SHINE Medical Technologies, Inc.2