ML15092A407

Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information 11.1-9

ML15092A407
Person / Time
Site:	SHINE Medical Technologies
Issue date:	03/23/2015
From:	Bynum R V SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML15092A397	List: ML15092A367 ML15092A369 ML15092A371 ML15092A407
References
SMT-2015-008
Download: ML15092A407 (9)

Text

ThiSSHINETMedical TechnologiesTHIS LETTER CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390March 23, 2015 SMT-2015-00810 CFR 50.305"o-. GO'U.S. Nuclear Regulatory CommissionATTN: Document Control DeskWashington, DC 20555

References:

See BelowSHINE Medical Technologies, Inc. Application for Construction PermitResponse to Request for Additional Information 11.1-9Pursuant 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. SHINE responded to the NRC staff's requests via References (4) and (5).In the course of reviewing the SHINE responses submitted via Reference (4), the NRC staffdetermined that additional information was required (Reference 6) to complete the review of theSHINE construction permit application. SHINE responded to the NRC staff's additional requestsvia Reference (7), with the exception of Request for Additional Information (RAI) 11.1-9.Enclosure 1 provides the SHINE response to RAI 11.1-9. Enclosure 1 is being provided viaoptical storage media (OSM) as OSM#1.Enclosure 2 provides a non-public (proprietary) revision to the SHINE Preliminary SafetyAnalysis Report (PSAR), incorporating changes based on the SHINE response to RAI 11.1-9.Enclosure 2 is provided via OSM as OSM#2. In addition to proprietary information, Enclosure 2contains security-related information which was identified utilizing the guidance contained inRegulatory Information Summary (RIS) 2005-31. SHINE requests that the NRC withholdEnclosure 2 from public disclosure under 10 CFR 2.390.Enclosure 3 provides a public (non-proprietary) revision to the SHINE PSAR, incorporatingchanges based on the SHINE response to RAI 11.1-9. Enclosure 3 is provided via OSM asOSM#3.Enclosure 2 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 2, 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 100 i Document Control DeskPage 2THIS LETTER CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390Enclosure 4 provides an affidavit supporting the proprietary treatment of the SHINE proprietaryinformation pursuant to 10 CFR 2.390. Enclosure 2 contains information proprietary to SHINE.Upon removal of Enclosure 2, 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 March 23, 2015.Very truly yours,R. Vann Bynum, Ph.D.Chief Operating OfficerSHINE Medical Technologies, Inc.Docket No. 50-608Enclosurescc: Administrator, Region III, USNRCProject Manager, USNRCEnvironmental Project Manager, USNRCSupervisor, Radioactive Materials Program, Wisconsin Division of Public Health(w/o Enclosure 2)Enclosure 2 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 2, this letter is uncontrolled.

Document Control DeskPage 3THIS LETTER CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390

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 September 19, 2014,SHINE Medical Technologies, Inc. -Request for Additional InformationRegarding Application for Construction Permit (TAC Nos. MF2305, MF2307,and MF2308) (ML14195A159)(4) SHINE Medical Technologies, Inc. letter to NRC, dated October 15, 2014,SHINE Medical Technologies, Inc. Application for Construction Permit,Response to Request for Additional Information (ML1 4296A1 90)(5) SHINE Medical Technologies, Inc. letter to NRC, dated December 3, 2014,SHINE Medical Technologies, Inc. Application for Construction Permit,Response to Request for Additional Information (ML1 4356A528)(6) NRC letter to SHINE Medical Technologies, Inc., dated January 8, 2015,SHINE Medical Technologies, Inc. -Request for Additional InformationRegarding Application for Construction Permit (TAC Nos. MF2305, MF2307,and MF2308) (ML15005A407)(7) SHINE Medical Technologies, Inc. letter to NRC, dated February 6, 2015,SHINE Medical Technologies, Inc. Application for Construction Permit,Response to Request for Additional InformationEnclosure 2 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 2, this letter is uncontrolled.

ENCLOSURE 1SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 11.1-9SHINE RESPONSE TO RAI 11.1-9(OSM#1)

ENCLOSURE 2 CONTAINS PROPRIETARY INFORMATIONIN ACCORDANCE WITH 10 CFR 2.390ENCLOSURE 2SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 11.1-9PRELIMINARY SAFETY ANALYSIS REPORTNON-PUBLIC VERSION(OSM#2)Enclosure 2 contains both proprietary and security-related information.Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 2, this letter is uncontrolled.

ENCLOSURE 3SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 11.1-9PRELIMINARY SAFETY ANALYSIS REPORTPUBLIC VERSION(OSM#3)

ENCLOSURE 4SHINE MEDICAL TECHNOLOGIES, INC.SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMITRESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 11.1-9AFFIDAVIT OF RICHARD VANN BYNUM2 pages follow fSHINETPMedical 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-2015-008 with enclosures. SHINE requests that the confidentialinformation contained in Enclosure 2 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 2 of SMT-2015-008 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 2 is not available to thepublic to the best of my knowledge and belief.1

c. The information contained in Enclosure 2 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 2 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 2 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 2 of SMT-2015-008 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 March 23, 2015.CO0x -SHE MedRichard Vann &ynu hDCOO -SHINE Medical Technologies, Inc.2