Letter Sequence Supplement |
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EPID:L-2019-NEW-0004, Shine Medical Technologies, LLC Application for an Operating License (Approved, Closed) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance, Acceptance
- Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement, Supplement
Results
Other: ML19235A308, ML19324F963, ML20057F950, ML20114E315, ML20126G523, ML20226A262, ML21029A103, ML21053A261, ML21089A228, ML21089A334, ML21096A250, ML21130A314, ML21145A060, ML21161A115, ML21209A997, ML21210A438, ML22042A018, ML22075A331, ML22075A336, ML22095A067, ML22124A073, ML22125A040, ML22152A108, ML22187A134, ML22206A208, ML22216A112, ML22220A261, ML22308A233, ML22322A212, ML22322A223, ML22347A177, ML22347A214, ML22348A067, ML22348A070, ML22348A072, ML23006A185
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MONTHYEARML19211C0442019-07-17017 July 2019 Shine Medical Technologies, LLC Application for an Operating License Project stage: Request ML19211C1432019-07-17017 July 2019 Shine Medical Technologies, LLC Application for an Operating License Project stage: Request ML19235A3082019-09-0505 September 2019 Shine Medical Technologies, LLC - Cover Letter for Notice of Receipt and Availability of Operating License Application Project stage: Other ML19276D4112019-10-0808 October 2019 Shine Medical Technologies, LLC - Acceptance for Docketing Letter Project stage: Acceptance Review ML19276D4092019-10-0808 October 2019 Shine Medical Technologies, LLC - Operating License Application Acceptance Review Results Project stage: Request ML19276D4102019-10-0808 October 2019 Shine Medical Technologies, LLC - Acceptance for Docketing Federal Register Notice Project stage: Acceptance Review ML19337A2752019-11-14014 November 2019 Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report Project stage: Request ML19331A6472019-11-14014 November 2019 Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report, Chapter 18, Highly Enriched to Low Enriched Uranium Conversion Project stage: Request ML19353C6872019-12-19019 December 2019 Environmental Site Audit Regarding Shine Medical Technologies, LLC - Proposed Medical Isotope Production Facility Project stage: Request ML19324F9632020-01-0202 January 2020 Shine Medical Technologies, LLC - Cover Letter for Notice of Opportunity for Hearing and Petition for Leave to Intervene Project stage: Other ML19324F9622020-01-0202 January 2020, 6 January 2020 Shine Medical Technologies, LLC - Notice of Opportunity for Hearing and Petition for Leave to Intervene Project stage: Request ML20057F9502020-03-0606 March 2020 Shine Medical Technologies, LLC - Instrumentation and Control Regulatory Audit Plan Project stage: Other ML20105A2952020-03-27027 March 2020 Shine Medical Technologies, LLC, Supplement 2 to License Application, Rev.2 to Final Safety Analysis Report Project stage: Supplement ML20114E3152020-04-30030 April 2020 Shine Medical Technologies, LLC - Operating License Application Technical Review Schedule Project stage: Other ML20126G5232020-05-0707 May 2020 Shine Medical Technologies, LLC - Regulatory Audit Plan Related to Electrical Power Systems Project stage: Other ML20226A2622020-08-14014 August 2020 Shine Medical Technologies, LLC - Accident Analysis and Criticality Safety Audit Plan Project stage: Other ML20255A0272020-08-28028 August 2020 Shine Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3 Project stage: Supplement ML21309A0192020-10-16016 October 2020 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 2, 3, and 8 Project stage: RAI ML20311A1242020-10-30030 October 2020 Shine Medical Technologies, LLC, Operating License Application Supplement No. 4 Submittal of a Revision to the Shine Physical Security Plan Project stage: Supplement ML21309A0232020-11-10010 November 2020 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 6 and 13 Project stage: RAI ML20325A0262020-11-13013 November 2020 Submittal of a Mark-Up to the Draft NRG-Proposed SHINE-Specific Security Measures Project stage: Request ML20357A0862020-12-10010 December 2020 Enclosure 1 - Final Safety Analysis Report Change Summary Project stage: Request ML21011A2242020-12-15015 December 2020 Shine Medical Technologies, LLC - Operating License Application Supplement No. 6 and Response to Request for Additional Information Project stage: Supplement ML20352A2252020-12-18018 December 2020 Shine Environmental RAIs - Cumulative Impacts Project stage: RAI ML21019A1592021-01-27027 January 2021 Public Meeting Summary January 12 2021 Project stage: Meeting ML21309A0442021-01-27027 January 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 9 and 11 Project stage: RAI ML21029A1022021-01-29029 January 2021 Shine Medical Technologies, LLC Operating License Application Response to Request for Additional Information Project stage: Response to RAI ML21029A0382021-01-29029 January 2021 Request for Exemption from Criticality Accident Alarm System Monitoring Requirements for the Shine Irradiation Unit Cells and Material Staging Building Project stage: Request ML21029A1032021-01-29029 January 2021 Enclosure 1 - Response to Final Safety Analysis Report Chapters 2, 3, and 8 Requests for Additional Information Project stage: Other ML21057A0052021-02-26026 February 2021 Shine Medical Technologies. LLC Application for an Operating License Commitment Change Related to the Submission of a Revision to the Technical Specifications Project stage: Request ML21053A2612021-03-11011 March 2021 Shine Medical Technologies - Geotechnical Audit Plan Project stage: Other ML21075A0122021-03-16016 March 2021 Shine Medical Technologies, LLC - Application for an Operating License, Revision 1 of Shine Response to Request for Additional Information 2.4-1 Project stage: Response to RAI ML21095A2292021-03-23023 March 2021 Shine Medical Technologies, LLC, Response to Request for Additional Information and Supplement No. 7 Project stage: Supplement ML21095A2222021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 5, Cooling Systems Project stage: Request ML21095A2142021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 6, Engineered Safety Features Project stage: Request ML21095A2352021-03-23023 March 2021 Shine Medical Technologies, LLC, Cover Letter for Response to Request Tor Additional Information and Supplement No. 7 Project stage: Supplement ML21089A3342021-04-0707 April 2021 Shine Medical Technologies, LLC - Summary of Audit Related to Geotechnical Topics Project stage: Other ML21089A0012021-04-0808 April 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Meteorological Data, Cooling Systems, and Physical Security Project stage: RAI ML21096A2502021-04-0808 April 2021 Shine Medical Technologies - Fire Protection Audit Plan Project stage: Other ML21106A1362021-04-16016 April 2021 Shine Medical Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 3.4-6 Project stage: Response to RAI ML21089A2282021-04-21021 April 2021 Shine Medical Technologies, LLC - Physical Security Plan Audit Summary Project stage: Other ML21130A3142021-05-12012 May 2021 Shine Medical Technologies, LLC - Instrumentation and Control Systems Audit Plan Project stage: Other ML21130A3132021-05-12012 May 2021 Shine Medical Technologies, LLC - Instrumentation and Control Systems Audit Topics Enclosure 2 Project stage: Request ML21145A0602021-06-0202 June 2021 Shine Medical Technologies - Ch 6 8 13 and Exemption RAI Project stage: Other ML21161A1162021-06-10010 June 2021 Shine Medical Technologies, LLC - Cyber Security Audit Plan W/ 2 Encl Project stage: Request ML21161A1152021-06-10010 June 2021 Shine Medical Tech Ltr - Cyber Security Audit Plan Enclosure 1 Project stage: Other ML21172A1952021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Instrumentation and Control Systems Project stage: RAI ML21162A3182021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Fire Protection Project stage: RAI ML21208A1352021-07-27027 July 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information Project stage: Response to RAI ML21209A9972021-08-0303 August 2021 Shine Medical Technologies, LLC - Update to Operating License Application Technical Review Schedule Project stage: Other 2020-08-14
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Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report ML23229A0202023-08-17017 August 2023 Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23087A2272023-05-0505 May 2023 Shine Technologies, LLC - Issuance of Amendment No. 4 to Construction Permit No. CPMIF-001 for the Receipt and Possession of Contained Special Nuclear Material ML23086C0502023-04-27027 April 2023 Shine Technologies, LLC - Letter, Environmental Assessment and Finding of No Significant Impact ML23088A3382023-04-0505 April 2023 Shine Technologies, LLC - Review of the Physical Security Plan in Support of an Operating License for a Medical Radioisotope Production Facility ML23010A1982023-02-24024 February 2023 Shine Technologies, LLC - Letter: Safety Evaluation Report for the Shine Medical Radioisotope Production Facility Operating License Application ML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter ML23034A1872023-02-0303 February 2023 Shine Medical Technologies, LLC Notice of Availability of Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility (Docket Number: 50-608) ML23023A0942023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0922023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0862023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23024A1682023-02-0101 February 2023 Letter to Ken Westlake, EPA Region 5 - Issuance of Final EIS Supplement Related to the Operating License ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement ML22308A2332023-01-0909 January 2023 Shine Technologies LLC - Regulatory Audit Report for Chapter 8 - Irradiation Facility and Radioisotope Production Facility Electrical Power Systems ML22347A2142023-01-0404 January 2023 Shine Technologies LLC - Regulatory Audit Report for I&C Combined Sessions ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22347A1772022-12-14014 December 2022 Shine Technologies LLC - Regulatory Audit Report for Programmable Logic Lifecycle ML22301A1492022-12-0707 December 2022 Shine Technologies, LLC - Regulatory Audit Report for Chapter 13 - Accident Analysis and Criticality Safety ML22322A2122022-12-0202 December 2022 Shine Medical Technologies - Cybersecurity Audit Summary Report ML22322A2232022-12-0202 December 2022 Shine Medical Technologies - Fire Protection Audit Summary Report ML22348A0672022-12-0101 December 2022 Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22292A3192022-11-30030 November 2022 Shine Medical Technologies, LLC Issuance of Order and Amendment No. 3 to Construction Permit No. CPMIF-001 ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22279A9512022-10-0606 October 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML22271A9632022-09-28028 September 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 31 Revision to the Phased Startup Operations Application Supplement ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22220A2612022-09-12012 September 2022 Shine Technologies LLC - Regulatory Report on the Audit Chapter 14, Technical Specifications ML22251A3272022-09-0808 September 2022 Shine Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Requests for Additional Information 7-38, 7-40, and 7-48 ML22249A1252022-08-31031 August 2022 Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach ML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule ML22206A2082022-07-27027 July 2022 Shine Medical Technologies, LLC - Request for Confirmatory Information Related to Radiation Protection Program and Waste Management ML22207A0062022-07-26026 July 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 29 ML22202A4492022-07-21021 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 28 - Submittal of a Revision to the Shine Emergency Plan ML22188A2412022-07-14014 July 2022 Meeting with Shine Medical Technologies, LLC (EPID No. L-2019-NEW-0004), to Discuss Development of Shine'S Cybersecurity Program for It'S Medical Isotope Production Facility ML22175A0392022-07-11011 July 2022 Letter to Reid Nelson, Achp Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0542022-07-0808 July 2022 Letter to Gregory Piefer - Notice of Availability of the Draft EIS Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22175A0912022-07-0808 July 2022 Notice of Availability and Request for Comments on the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine (Multiple Tribal Letters) ML22175A0772022-07-0808 July 2022 Letter to Daina Penkiunas - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0632022-07-0808 July 2022 Letter to Ken Westlake, EPA Region 5 - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22188A1942022-07-0707 July 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 27 ML22188A0562022-07-0707 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 26 Submittal of a Revision to the Shine Material Control and Accounting Plan ML22223A0662022-07-0606 July 2022 Shine Technologies, LLC, Application for an Operating License, Revision 1 of the Response to Requests for Additional Information Related to Cyber Security 2024-05-07
[Table view] Category:Response to Request for Additional Information (RAI)
MONTHYEARML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22178A0352022-06-27027 June 2022 Enclosure 2 - Shine Technologies, LLC Application for an Operating License Revision 1 of the Shine Response to Requests for Additional Information 9-8 and 9-9 ML22143A8142022-05-23023 May 2022 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML22112A1952022-04-22022 April 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22094A0452022-04-0404 April 2022 Shine Technologies, LLC - Application for an Operating License Revision 1 of Shine Response to Part (C) of Request for Additional Information 7-9 ML22077A0862022-03-18018 March 2022 Shine Technologies, LLC Application for an Operating License - Supplement No. 20 and Response to Request for Additional Information ML22059A0202022-02-28028 February 2022 Enclosure 2: Shine Technologies, LLC - Response to Request to Additional Information ML22032A3422022-02-0101 February 2022 Shine Technologies, LLC, Application for an Operating License Revision 1 of the Shine Response to Request for Additional Information 11-2 ML22028A2242022-01-28028 January 2022 Shine Technologies, LLC, Response to Request for Additional Information on Application for an Operating License ML21364A0552021-12-30030 December 2021 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML21350A1912021-12-16016 December 2021 Shine Technologies, LLC - Application for an Operating License Response to Request for Additional Information ML21326A2092021-11-22022 November 2021 Enclosure 3: Response to Request for Additional Information - Public Version ML21307A3062021-11-0303 November 2021 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML21272A3442021-09-29029 September 2021 Shine Medical Technologies, LLC - Response to Request for Additional Information (Public Version) ML21271A0762021-09-28028 September 2021 Shine Medical Technologies, LLC, Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 3.4-12 ML21243A2692021-08-31031 August 2021 Enclosure 2 - Response to Request for Additional Information Public Version ML21239A0492021-08-27027 August 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21232A5872021-08-20020 August 2021 Shine Medical Technologies, LLC - Application for an Operating License Response to Request for Additional Information ML21232A6202021-08-20020 August 2021 Shine Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 - Response to Request for Additional Information ML21232A6232021-08-20020 August 2021 Enclosure 3: Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML21232A6212021-08-20020 August 2021 Enclosure 1: Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML21208A1352021-07-27027 July 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21183A1282021-07-0202 July 2021 Enclosure 2: Shine Medical Technologies, LLC, Application for an Operating License, Response to Request for Additional Information Public Version ML21154A3032021-06-0303 June 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information 4a-15 ML21127A0512021-05-0707 May 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21095A2352021-03-23023 March 2021 Shine Medical Technologies, LLC, Cover Letter for Response to Request Tor Additional Information and Supplement No. 7 ML21095A2292021-03-23023 March 2021 Shine Medical Technologies, LLC, Response to Request for Additional Information and Supplement No. 7 ML21075A0122021-03-16016 March 2021 Shine Medical Technologies, LLC - Application for an Operating License, Revision 1 of Shine Response to Request for Additional Information 2.4-1 ML21029A1032021-01-29029 January 2021 Enclosure 1 - Response to Final Safety Analysis Report Chapters 2, 3, and 8 Requests for Additional Information ML21029A1052021-01-29029 January 2021 Enclosure 3 - Response to Final Safety Analysis Report Chapters 6 and 13 Requests for Additional Information ML21022A0272021-01-22022 January 2021 Shine Medical Technologies, LLC Application for an Operating License, Response to Environmental Requests for Additional Information ML21011A2402020-12-15015 December 2020 Shine Medical Technologies, LLC - Operating License Application Supplement No. 6 and Response to Request for Additional Information ML20357A0872020-12-10010 December 2020 Enclosure 3 - Response to Request for Additional Information ML20255A0282020-08-28028 August 2020 Enclosure 1 - Response to Request for Additional Information ML20188A3022020-06-17017 June 2020 Shine Medical Technologies, LLC - Response to Request for Additional Information on Operating License Application ML20129J9202020-05-0808 May 2020 Shine Medical Technologies, LLC, Application for an Operating License Response to Supplemental Environmental Requests for Additional Information ML20073E8802020-03-13013 March 2020 Shine Medical Technologies, LLC Application for an Operating License Response to Environmental Requests for Additional Information ML19071A0562019-03-0808 March 2019 Shine Medical Technologies, Inc., Affidavit & Response to Request for Additional Information to Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information ML17040A1382017-02-0707 February 2017 Shine Medical Technologies, Inc. Safeguards Information (SGI) Protection Program Response to Request for Additional Information ML15259A0242015-09-15015 September 2015 Shine Medical Technologies, Inc. - Application for Construction Permit, Revision 1 of Shine Response to Request for Additional Information 6b.3-34 ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information ML15258A5982015-08-27027 August 2015 Enclosure 2 - Revision 1 of the Shine Response to RAI 12.1-1 and RAI 12.2-1 ML15222A2422015-07-23023 July 2015 Enclosure 2 - Attachment 3 - Atkins-NS-DAC-SHN-15-02, Revision 0 ML15222A2442015-07-23023 July 2015 Enclosure 2 - Attachment 2 - Atkins-NS-DAC-SHN-15-04, Revision 0 2023-02-17
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Ii SHINE Medical Technologies THIS LETTER CONTAINS PROPRJETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10'CFR 2.390 March 23, 2021 2021-SMT-0032 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) SHINE Medical Technologies, LLC letter to the NRC, *SHINE Medical Technologies, LLC Applicatlon for an Operating License," dated July 17, 2019 (ML19211C143)
(2) NRC letter to SHINE Medlcal Technologles, LLC, *issuance of Request for Additlonaf Information Related to the SHINE Medical Technologies, LLC Operating License Applicatlon (EPID No. L-2019-NEW-0004)," dated January 27, 2021 (3) SHINE Medical Technologies, LLC letter to the NRC, aSHINE Medical Technologles, LLC Operating License Application Supplement No. 5 and Response to Requa.st for Additional Information," dated December 10, 2020 (4) SHINE Medical Technologies, LLC letter to the NRC, aSHINE Medlcal Technologies, LLC Operating License Application Supplement No. 6 and Response to Request for Additional Information," dated December 15, 2020 (5) SHINE Medical Technologies, LLC letter to the NRC, *sHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information," dated January 29, 2021 (6) SHINE Medlcal Technologies, LLC letter to the NRC, aSHINE Medical Technologies, LLC Operating License Application Revision 1 of SHINE Response to Request for Additional Information 2.4-1," dated March 16, 2021 (7) SHINE Medical Technologies, LLC letter to the NRC, aSHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3," dated August 28, 2020 SHINE Medical Technologies. LLC Operating License AppUcatton Response to Request tor Additional Information and Supplement No. Z Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHINE) submitted an application for an operating license for a medical Isotope production faclllty to be located in Janesville, V\11 via Reference 1. Via Reference 2, the NRC staff determined that additional information was required to enable the staff's continued review of the SHINE operating license application. SHINE has determined that a supplement to the operating license application Is necessary to address facility design changes and to provide administrative revisions. y (s--D }
rJfZf.__
Enclosures 1, 3, 5, and 9 contain security-related information.
Withhold from public disclosure under 10 CFR 2.390.
Uoon removal of Enclosures 1. 3 5 7 and 9 this letter Is urfcontroned:
101 E. MIiwaukee Street, Sulte 600 I JanesvlBe, WI 535451 P (608) 210-1060 IF (608) 210-25041 www.shinemed.com
Document Control Desk Page2 This submittal contains information which SHINE requests to be withheld from publlc disclosure, Including proprietary information in accordance with 10 CFR 2.390(a)(4), export controlled information (ECI) In accordance with 10 CFR 2.390(a)(3), and security-related information (SRI)
In accordance 10 CFR 2.390(d). SRI was Identified utilizing the guidance contained in Regulatory Issue Summary (RIS) 2005-31, Revision 1. The revised application documents are provided via optlcal storage media (OSM). provides the non-public version of the SHINE response to the NRC staffs request for addltlonal Information. Enclosure 1 contains proprietary Information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. provides a publlc version of the SHINE response to the NRC staff's request for addltlonal Information. provides a non-publlc version of the SHINE Final Safety Analysis Report (FSAR)
Change Summary, Including a markup of affected FSAR pages. Enclosure 3 contains proprietary Information, a subset of which has been determined to be ECI, as well as SRI.
SHINE requests that the NRC withhold Enclosure 3 from public disclosure under 10 CFR 2.390. provides a publlc version of the SHINE FSAR Change Summary. provides a non-public revision to the SHINE FSAR. In addition to incorporating the changes described in Enclosures 1 and 3, this revision Incorporates the changes described in References 3, 4, 5, and 6. Enclosure 5 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold Enclosure 5 from publlc disclosure under 10 CFR 2.390. provides a public revision to the SHINE FSAR. provides a non-publlc revision to the SHINE Technical Spectflcatlons. In addition to incorporating the changes described In Enclosure 1, this revision Incorporates the changes described in References 3, 4, and 5. Enclosure 7 contains proprietary information, a subset of which has been determined to be ECI. SHINE requests that the NRC withhold Enclosure 7 from public disclosure under 10 CFR 2.390. provides a public revision to the SHINE Technical Specifications. provides a non-publlc revision to the SHINE Emergency Plan. Enclosure 9 contains proprietary information, a subset of which has been determined to be ECI, as welt as SRI.
SHINE requests that the NRC withhold Enclosure 9 from public disclosure under 10 CFR 2.390.
\ 0 provides a public revision to the SHINE Emergency Plan. 1 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained In Enclosures 1, 3, 5, 7, and 9, pursuant to 10 CFR 2.390. SHINE requests that the NRC wlthhold Enclosures 1, 3, 5, 7, and 9 from public disclosure under 10 CFR 2.390. Upon removal of Enclosures 1, 3, 5, 7, and 9, this letter is uncontrolled.
Document Control Desk Page3 The SHINE FSAR is provided in Its entirety in Enclosures 5 (Non-Public) and 6 (Public);
however, not every FSAR chapter has been revised. Revision bars within Enclosures 5 and 6 Indicate the changes incorporated into the FSAR via this supplement. The followlng table Identifies which FSAR chapter flies, submitted within the enclosed OSM, have been modified from the files previously submitted In Reference 7.
Enclosure Title Modified 5 FSAR Chapter 01 - The Facility Yes 5 FSAR Chapter 02 - Site Characteristics Yes 5 FSAR Chapter 03 - Design of Structures, Systems, and Yes Components 5 FSAR Chapter 04 - Irradiation Unit and Radioisotope Production Yes Facilltv Descrictlon 5 FSAR Chapter 05 - Cooling Systems Yes 5 FSAR Chapter 06 - Engineered Safetv Features Yes 5 FSAR Chacter 07 - Instrumentation and Control Svstems Yes 5 FSAR Chapter 09 - Auxiliary Systems Yes 5 FSAR Chapter 11 - Radiation Protection Program and Waste Yes Management 5 FSAR Chapter 13 - Accident Analvsls Yes 5 FSAR Chacter 15 - Flnancial Quallficatlons Yes 6 FSAR Chapter 01 - The Facility Yes 6 FSAR Chapter 02 - Site Characteristics Yes 6 FSAR Chapter 03 - Design of Structures, Systems, and Yes Components 6 FSAR Chapter 04- Irradiation Unit and Radioisotope Production Yes Facilltv Description r 6 FSAR Chacter 05 - Coolina Systems Yes 6 FSAR Chacter 06 - Enaineered Safetv Features Yes 6 FSAR Chapter 07 - Instrumentation and Control Systems Yes 6 FSAR Chapter 08 - Electrical Power Svstems Yes 6 FSAR Chapter 09 - Auxiliary Systems Yes 6 FSAR Chapter 10 - Exoerlmental Fadlitles No 6 FSAR Chapter 11 - Radiation Protection Program and Waste Yes Management 6 FSAR Chacter 12 - Conduct of Operations ' Yes 6 FSAR Chapter 13 - Accident Analysis Yes 6 FSAR Chapter 14 -Technical Specifications No 6 FSAR Chacter 15 - Flnancial Qualifications Yes 6 FSAR Chapter 16 - Other License Considerations No 6 FSAR Chapter 17 - Decommissioning and Possession-Only No License Amendments 6 FSAR Chapter 18 - Highly Enriched to Low Enriched Uranium No Conversion
DocuSlgn Envelope ID: 31 A30966-8FAM 1DS-8532-7420630CD1 D7 Document Control Desk Page4 If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.
I declare under the penalty of perjury that the foregoing Is ~ and correct Executed on March 23, 2021.
Very truly yours, James Costedlo Vice President of Regulatory Affairs and Quality SHINE Medlcal Technologies, LLC Docket No. 50-608 Enclosures cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Progra.m, Wisconsin Division of Public Health (w/o Enclosures 1, 3, 5, 7, and 9)
ENCLOSURE11 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC OPERATING LICENSE APPLICATION RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION AND SUPPLEMENT NO. 7 AFFIDAVIT OF JAMES COSTEDIO 2 pages follow
AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN )
) ss.
COUNTY OF ROCK )
1 I, James Costedio, Vice President of Regulatory Affairs and Quallty of SHINE Medlcal Technologies, LLC (SHINE), do hereby affirm and state:
- 1. I am authorized to execute this affidavit on behalf of SHINE. I am authorized to review Information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of Information from public disclosure. The purpose of this affidavit is to provide the Information required by 10 CFR 2.390(b) In support of SHINE's request for proprietary treatment of certain confidential commercial and financial Information submitted in the operating license application supplement by letter 2021-SMT-0032 with enclosures. SHINE requests that the confidential Information contained in Enclosures 1, 3, 5, 7, and 9 be withheld from public disclosure in their entirety.
- 2. I have knowledge of the criteria used by SHINE In designating information as sensitive, proprietary, or confidential.
- 3. Pursuant to the provisions of paragraph ,(a)(4) of 10 CFR 2.390, the following is furnished 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 In Enclosures 1, 3, 5, 7, and 9 of 2021-SMT-0032 is owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its
' .confidentiality. This Information Is and has been held in confidence by r SHINE.
- b. The Information sought to be protected in Enclosures 1, 3, 5, 7, and 9 Is not available to the publlc to the best of my knowledge and belief.
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Docu6lgn Envelope ID: 31A3D966-BF~ 1D5-8532-742063DC01D7
- c. The Information contained In Enclosures 1, 3, 5, 7, and 9 Is of the type that is customarily held in confidence by SHINE, and I/
there Is a rational basis for doing so. The Information 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 limits access to these elements to those with a aneed to know/ and 1 subject to maintaining confidentiality.
- d. The proprietary Information sought to be withheld from public disclosure in Enclosures 1, 3, 5, 7, and 9 includes, but Is not llmlted to: structural configuration, primary and supporting systems of the medlcal isotope production faclllty, process and system locations, and process details. This would include information regarding the types, quantlties,,and locations of materials stored on site as would be referenced in facility configuration drawings. Public disclosure of the information In Enclosures 1, 3, 5, 7, and 9 would create substantial harm to SHINE because It would reveal trade
~ owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality. *
- e. Publlc disclosure of the information In Enclosures 1, 3, 5, 7, and 9 would create substantial harm to SHINE because it would reveal valuable business information regarding SHINE's competitive expectations, assumptions,
, processes, and current position. Its use by a competitor could substantially Improve their competitive position In the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.
- f. The Information contained In Enclosures 1, 3, 5, 7, and 9 of 2021-SMT-0032 Is ~nsmitted to the NRC In confidence and under the provisions of 10 CFR 2.390; It is to be received in confidence by the NRC. The Information Is property marked.
I declare under the penalty of perjury that the foregoing Is true and correct.
Executed on March 23, 2021.
James Costedlo Vice President of Regulatory .Affairs and Quality SHINE Medical Technologies, LLC Page 2 of 2