Letter Sequence Meeting |
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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
- 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 ML19353C6872019-12-19019 December 2019 Environmental Site Audit Regarding Shine Medical Technologies, LLC - Proposed Medical Isotope Production Facility Project stage: Request 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 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 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 ML21309A0442021-01-27027 January 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Chapters 9 and 11 Project stage: RAI ML21019A1592021-01-27027 January 2021 Public Meeting Summary January 12 2021 Project stage: Meeting 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 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 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 ML21095A2142021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 6, Engineered Safety Features Project stage: Request ML21095A2222021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 5, Cooling Systems Project stage: Request ML21095A2292021-03-23023 March 2021 Shine Medical Technologies, LLC, Response to Request for Additional Information and Supplement No. 7 Project stage: Supplement 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 ML21130A3132021-05-12012 May 2021 Shine Medical Technologies, LLC - Instrumentation and Control Systems Audit Topics Enclosure 2 Project stage: Request ML21130A3142021-05-12012 May 2021 Shine Medical Technologies, LLC - Instrumentation and Control Systems Audit Plan Project stage: Other 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 ML21162A3182021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Fire Protection Project stage: RAI ML21172A1952021-07-0101 July 2021 Shine Medical Technologies, LLC - Request for Additional Information Related to Instrumentation and Control Systems 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 ML21210A4382021-08-13013 August 2021 Shine Medical Technologies, LLC - Cyber Security RAI Project stage: Other 2020-08-14
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Category:Meeting Agenda
MONTHYEARPMNS20230480, Meeting with Shine Technologies LLC to Discuss Change in Seismic Approach for the Installation of Process Equipment2023-04-27027 April 2023 Meeting with Shine Technologies LLC to Discuss Change in Seismic Approach for the Installation of Process Equipment ML22279B0542022-10-21021 October 2022 Agenda - Shine - Sc - October 21, 2022 PMNS20220959, Public Meeting with Shine Medical Technologies, LLC - Discussion of Phased Approach to Construction and Operation2022-09-12012 September 2022 Public Meeting with Shine Medical Technologies, LLC - Discussion of Phased Approach to Construction and Operation PMNS20220659, Public Meeting to Discuss the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility2022-07-0606 July 2022 Public Meeting to Discuss the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility PMNS20220448, Public Meeting with Shine Medical Technologies, LLC - Discussion of Cybersecurity Program2022-06-29029 June 2022 Public Meeting with Shine Medical Technologies, LLC - Discussion of Cybersecurity Program PMNS20220313, Public Meeting with Shine Medical Technologies, LLC - Discussion of Cyber Security Program2022-05-0202 May 2022 Public Meeting with Shine Medical Technologies, LLC - Discussion of Cyber Security Program PMNS20211565, Public Meeting with Shine Medical Technologies, LLC - Discussion of Phased Approach to Construction and Operation2021-12-13013 December 2021 Public Meeting with Shine Medical Technologies, LLC - Discussion of Phased Approach to Construction and Operation PMNS20211212, Shine Medical Technologies, LLC - Discussion on Engineered Safety Features and Auxiliary Systems2021-09-17017 September 2021 Shine Medical Technologies, LLC - Discussion on Engineered Safety Features and Auxiliary Systems PMNS20211033, Shine Medical Technologies, LLC - Radiation Damage Topics Related to Operating License Application2021-08-17017 August 2021 Shine Medical Technologies, LLC - Radiation Damage Topics Related to Operating License Application PMNS20210629, Shine Medical Technologies, LLC - Discussion on Structural Analysis Associated with Operating License Application2021-05-10010 May 2021 Shine Medical Technologies, LLC - Discussion on Structural Analysis Associated with Operating License Application PMNS20210334, Shine Medical Technologies, LLC - Discussion of Staggered Approach to Construction, Operation, and Licensing2021-04-0606 April 2021 Shine Medical Technologies, LLC - Discussion of Staggered Approach to Construction, Operation, and Licensing PMNS20210231, Shine Medical Technologies, LLC - Follow-up Discussion on Electrical Power Systems RAI Responses2021-03-15015 March 2021 Shine Medical Technologies, LLC - Follow-up Discussion on Electrical Power Systems RAI Responses PMNS20210229, Shine Medical Technologies, LLC - Proposed Amendment to Construction Permit for Possession of Materials2021-02-25025 February 2021 Shine Medical Technologies, LLC - Proposed Amendment to Construction Permit for Possession of Materials PMNS20210134, Shine Medical Technologies, LLC Instrumentation and Control System Open Item Discussion2021-02-0909 February 2021 Shine Medical Technologies, LLC Instrumentation and Control System Open Item Discussion ML21019A1592021-01-27027 January 2021 Public Meeting Summary January 12 2021 PMNS20210068, Shine Instrumentation and Control Systems Open Items Discussion2021-01-15015 January 2021 Shine Instrumentation and Control Systems Open Items Discussion PMNS20201420, Shine Medical Technologies, LLC Operating License Application Environmental Technical Discussion2020-12-23023 December 2020 Shine Medical Technologies, LLC Operating License Application Environmental Technical Discussion ML20010D1692020-01-16016 January 2020 Memo to R. Elliott from J. Davis Summary of Public Scoping Meeting Conducted for the Shine Medical Technologies, LLC Operating License Application Review (Docket 50-608)w/Enclosures 1 and 2 ML17086A5662017-03-30030 March 2017 Notice of Closed Meeting with Shine Medical Technologies, Inc. to Discuss Physical Security Requirements ML16133A0942016-05-12012 May 2016 Shine Medical Technologies, Inc. Discussion on Eligible Facilities List and Construction Inspection ML14063A5882014-03-0606 March 2014 & 03/20/2014 - Notice of Forthcoming Public Meeting with Shine Medical Technologies, Inc to Discuss Topics Associated with Design Changes Related to the Proposed Shine Facility and Preliminary Safety Analysis Report ML13227A3912013-09-23023 September 2013 Summary of Public Meetings Conducted Related to the Review of the Proposed Shine Radioisotope Production Facility ML13178A3142013-07-0303 July 2013 7/17/13- Notice of Forthcoming Category 3 Public Meetings with Shine Medical Technologies, Inc. on the Environmental Scoping Process 2023-04-27
[Table view] Category:Meeting Summary
MONTHYEARML23156A6122023-06-0707 June 2023 Summary of Public Meeting with Shine Technologies ML22258A3132022-09-27027 September 2022 Meeting Summary to Discuss Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22258A3122022-09-27027 September 2022 July 27, 2022, Shine Draft Supplemental Environmental Impact Statement Public Meeting - Summary 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 ML22118A8542022-05-0303 May 2022 Shine January 20, 2022 Public Meeting Summary ML21313A4282021-11-15015 November 2021 Summary of September 27, 2021 Meeting with Shine Medical Technologies, LLC ML21019A1592021-01-27027 January 2021 Public Meeting Summary January 12 2021 ML19071A1812019-03-22022 March 2019 Shine Medical Technologies, Inc. - January 31, 2019 Public Meeting Summary ML18221A4542018-08-17017 August 2018 Summary of Meeting with Shine Medical Technologies, Inc. ML18162A0552018-06-18018 June 2018 Shine Medical Technologies April 3, 2018 Public Meeting Summary ML17025A4172017-01-27027 January 2017 12/01/2016 Summary of SHINE Medical Technologies, Inc. Public Meeting on Design Changes and Operating License Structure ML16215A4082016-08-0404 August 2016 05/26/2016 - Public Meeting Summary - SHINE Medical Technologies on Eligible Facilities List and Construction Inspection ML15169B1352015-07-0101 July 2015 June 10, 2015, Summary of Public Meeting to Discuss the Draft Environmental Impact Statement for the Construction Permit for the Proposed Shine Medical Radioisotope Production Facility ML14120A4732014-05-0202 May 2014 03/19 & 20/2014 Summary of Category 1 Public Meeting with Shine Medical Technologies, Inc ML13227A3912013-09-23023 September 2013 Summary of Public Meetings Conducted Related to the Review of the Proposed Shine Radioisotope Production Facility 2023-06-07
[Table view] Category:Memoranda
MONTHYEARML22258A3132022-09-27027 September 2022 Meeting Summary to Discuss Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22258A3102022-09-27027 September 2022 Input for ACRS Review of Shine Operating License Application - Safety Evaluation Report for Chapter 12, Conduct of Operations (Operator Training and Requalification, and Startup Plan) ML22258A3082022-09-26026 September 2022 Input for ACRS Review of Shine Operating License Application - Safety Evaluation Report for Chapter 3, Design of Structures, Systems, and Components ML22258A3052022-09-26026 September 2022 Input for ACRS Review of Shine Operating License Application - Safety Evaluation Report for Chapter 7, Instruments and Control Systems, Section 7.4.9, Human Factors Engineering ML22258A3072022-09-23023 September 2022 Input for ACRS Review of Shine Operating License Application - Safety Evaluation Report for Chapter 9, Auxiliary Systems, Section 9A.2.3, Fire Protection Systems and Programs ML22216A1122022-08-0808 August 2022 Shine Technologies LLC - Regulatory Audit Plan of Logic Lifecycle Described in Operating License ML21019A1592021-01-27027 January 2021 Public Meeting Summary January 12 2021 ML20010D1692020-01-16016 January 2020 Memo to R. Elliott from J. Davis Summary of Public Scoping Meeting Conducted for the Shine Medical Technologies, LLC Operating License Application Review (Docket 50-608)w/Enclosures 1 and 2 ML14139A5412014-05-22022 May 2014 Shine Medical Technologies, Inc. - Memo to Adm Regarding Correction to the Federal Register Notice Related to the Acceptance for Docketing of Part Two of the Application for Construction Permit ML14063A5882014-03-0606 March 2014 & 03/20/2014 - Notice of Forthcoming Public Meeting with Shine Medical Technologies, Inc to Discuss Topics Associated with Design Changes Related to the Proposed Shine Facility and Preliminary Safety Analysis Report ML13227A3912013-09-23023 September 2013 Summary of Public Meetings Conducted Related to the Review of the Proposed Shine Radioisotope Production Facility ML13178A3142013-07-0303 July 2013 7/17/13- Notice of Forthcoming Category 3 Public Meetings with Shine Medical Technologies, Inc. on the Environmental Scoping Process 2022-09-27
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Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 27, 2021 MEMORANDUM TO: Robert B. Elliott, Chief Environmental Review License Renewal Branch Division of Division of Rulemaking, Environmental, and Financial Support Office of Nuclear Material Safety and Safeguards Signed by Davis, FROM: Jennifer A. Davis, Senior Project Manager on 01/27/21 Environmental Review New Reactor Branch Division of Division of Rulemaking, Environmental, and Financial Support Office of Nuclear Material Safety and Safeguards
SUBJECT:
SUMMARY
OF PUBLIC MEETING CONDUCTED FOR THE SHINE MEDICAL TECHNOLOGIES, LLC OPERATING LICENSE APPLICATION ENVIRONMENTAL REVIEW (EPID NUMBER: L-2019-NEW-0004)
The U.S. Nuclear Regulatory Commission (NRC) staff conducted a public meeting (teleconference) related to the review of an operating license for the proposed SHINE Medical Technologies, LLC (SHINE) Medical Isotope Production Facility in Janesville, Wisconsin. The teleconference was conducted on January 12, 2021. The purpose of this meeting was to discuss NRC requests for additional information (RAI) dated December 18, 2020 (Agencywide Documents Access and Management System Accession Number ML20352A225). Specifically, the NRC staff requested information related to new or revised project plans occurring adjacent to the SHINE facility with respect to the production of lutetium-177, and the construction and operation of the proposed SHINE headquarters and therapeutics facility.
SHINE described its approach on how it will respond to the RAIs and asked clarifying questions.
NRC staff also asked clarifying questions related to the site layout, changes in staffing, transportation impacts, and characterization of waste streams. No sensitive or proprietary information was discussed during the teleconference.
CONTACT: Jennifer Davis, NMSS/REFS 301-415-3835
R. Elliott 2 Sixteen people participated in the public teleconference including representatives from the NRC and SHINE, and members of the public. A list of public meeting attendees is provided in . Enclosure 2 is a copy of the meeting agenda.
Action Items SHINE will submit responses to RAIs dated December 18, 2020 by February 1, 2021.
Docket Number: 50-608
Enclosures:
As stated
PUBLIC MEETING ATTENDEES January 12, 2021 PARTICIPANTS AFFILIATION Jennifer Davis U.S. Nuclear Regulatory Commission (NRC)
Nancy Martinez NRC Donald Palmrose NRC Steve Lynch NRC Phyllis Clark NRC William Rautzen NRC Robert Hoffman NRC Kevin Folk NRC Greg Casto NRC Mary Woods NRC Duane White NRC Jeff Bartelme SHINE Medical Technologies, LLC (SHINE)
Jim Costedio SHINE Eric Van Abel SHINE Robert S. No affiliation Jakub Simecek No affiliation
PUBLIC MEETING AGENDA
SHINE Medical Technologies, LLC Operating License Application Environmental Technical Discussion January 12, 2021, 09:00 AM to 10:00 AM Teleconference Time Topic Speaker 9:00 am Welcome and Purpose of Meeting NRC 9:05 am Technical Discussion NRC/SHINE 9:45 am Public Questions/Comments Public/NRC 9:55 am Closing NRC ENCLOSURE 1
Memo ML21019A159 NMSS/REFS NMSS/REFS NMSS/REFS OFFICE NMSS/REFS/ERLRB
/ERNRB /ERLRB /ERNRB NAME JDavis JD NMartinez NM RElliott RE JDavis JD DATE Jan 22, 2021 Jan 25, 2021 Jan 26, 2021 Jan 27, 2021