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 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] |
Text
May 3, 2022 LICENSEE: SHINE Medical Technologies, LLC
SUBJECT:
SUMMARY
OF JANUARY 20, 2022, MEETING WITH SHINE MEDICAL TECHNOLOGIES, LLC (EPID NO. L-2019-NEW-0004)
On January 20, 2022, an Observation public meeting was held between the U.S. Nuclear Regulatory Commission (NRC) staff and representatives of SHINE Medical Technologies, LLC (SHINE). The purpose of this meeting was to discuss licensing and technical topics associated with SHINE's proposed phased approach to construction and operation of its Medical Isotope Production Facility. Portions of this meeting were closed to public participation to discuss proprietary information. The meeting notice and agenda, dated December 13, 2021, are available in the Agencywide Documents Access and Management System (ADAMS) at Accession No. ML21347A082. SHINEs presentation is also available in ADAMS at Accession No. ML22110A209. A list of meeting attendees is provided as an enclosure to this summary.
During the meeting, SHINE provided an overview of the proposed phased startup operations.
SHINE described each phase of the proposed approach, including the systems installed within each phase. SHINE discussed its approach to developing the operating license application supplement. SHINE also presented which final safety analysis report chapters would be impacted by the proposed phased approach. In addition, SHINE stated its proposed licensing path for the phased approach. Throughout the meeting, the NRC staff asked clarifying questions to better understand the phased approach. During the closed portion of the meeting, SHINE provided additional proprietary detail related to the impact of the phased approach.
Please direct any inquiries to me at 301-415-0293, or at Molly-Kate.Gavello@nrc.gov.
Signed by Gavello, Molly-Kate on 05/03/22 Molly-Kate Gavello, Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Docket No. 50-608
Enclosure:
As stated cc w/enclosure: See next page
Shine Medical Technologies, LLC Docket No. 50-608 cc:
Jeff Bartelme Test, Research and Training Licensing Manager Reactor Newsletter SHINE Technologies, LLC Attention: Amber Johnson 3400 Innovation Court Dept of Materials Science Janesville, WI 53546 and Engineering University of Maryland Nathan Schleifer 4418 Stadium Drive General Counsel College Park, MD 20742-2115 SHINE Technologies, LLC 3400 Innovation Court Mark Freitag Janesville, WI 53546 City Manager P.O. Box 5005 Christopher Landers Janesville, WI 53547-5005 Director, Office of Conversion National Nuclear Security Administration, Bill McCoy NA 23 1326 Putnam Avenue U.S. Department of Energy Janesville, WI 53546 1000 Independence Ave SW Washington, DC 20585 Alfred Lembrich 541 Miller Avenue Mark Paulson, Supervisor Janesville, WI 53548 Radiation Protection Section Wisconsin Department of Health Services Gregory Piefer, Ph.D.
P.O. Box 2659 Chief Executive Officer Madison, WI 53701-2659 SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546
ML21347A082 Public Meeting Notice; ML22110A209 Public Meeting Presentation; ML22118A854 Public Meeting Summary; ML22110A208 Package NRC-001 OFFICE NRR/DANU/UNPL/PM NRR/DANU/UNPL/LA NRR/DANU/UNPL/BC NRR/DANU/UNPL/PM NAME MGavello NParker JBorromeo MGavello DATE 4/28/2022 4/28/2022 5/3/2022 5/3/2022 LIST OF ATTENDEES JANUARY 20, 2022, MEETING WITH SHINE MEDICAL TECHNOLOGIES, LLC 1:00 P.M. - 3:00 P.M.
Name Organization Adam Rau U.S. Nuclear Regulatory Commission Andrea Kock U.S. Nuclear Regulatory Commission Beth Reed U.S. Nuclear Regulatory Commission Brannen Adkins U.S. Nuclear Regulatory Commission Brian Green U.S. Nuclear Regulatory Commission Brian Wittick U.S. Nuclear Regulatory Commission Caroline Hsu U.S. Nuclear Regulatory Commission Charles Kreuzberger U.S. Nuclear Regulatory Commission Charles Teal U.S. Nuclear Regulatory Commission Christopher Brown U.S. Nuclear Regulatory Commission Dan Warner U.S. Nuclear Regulatory Commission David Heeszel U.S. Nuclear Regulatory Commission Dinesh Taneja U.S. Nuclear Regulatory Commission Duane Hardesty U.S. Nuclear Regulatory Commission Edward Robinson U.S. Nuclear Regulatory Commission Elijah Dickson U.S. Nuclear Regulatory Commission Glenn Tuttle U.S. Nuclear Regulatory Commission Gordon Curran U.S. Nuclear Regulatory Commission Holly Cruz U.S. Nuclear Regulatory Commission Ian Tseng U.S. Nuclear Regulatory Commission James Chang U.S. Nuclear Regulatory Commission James Hammelman U.S. Nuclear Regulatory Commission James Maltese U.S. Nuclear Regulatory Commission Jason White U.S. Nuclear Regulatory Commission Jay Robinson U.S. Nuclear Regulatory Commission Jennifer Davis U.S. Nuclear Regulatory Commission Jennifer Tobin U.S. Nuclear Regulatory Commission Jeremy Munson U.S. Nuclear Regulatory Commission Jeremy Wachutka U.S. Nuclear Regulatory Commission Jesse Seymour U.S. Nuclear Regulatory Commission Jessie Quichocho U.S. Nuclear Regulatory Commission Jorge Cintron-Rivera U.S. Nuclear Regulatory Commission Joseph Colaccino U.S. Nuclear Regulatory Commission Joseph McManus U.S. Nuclear Regulatory Commission Joseph Staudenmeier U.S. Nuclear Regulatory Commission Joshua Borromeo U.S. Nuclear Regulatory Commission Kerri Kavanagh U.S. Nuclear Regulatory Commission Kevin Folk U.S. Nuclear Regulatory Commission Lance Rakovan U.S. Nuclear Regulatory Commission Michael Balazik U.S. Nuclear Regulatory Commission Michael Salay U.S. Nuclear Regulatory Commission Michael Waters U.S. Nuclear Regulatory Commission Michelle Romano U.S. Nuclear Regulatory Commission Enclosure
2 Mike Call U.S. Nuclear Regulatory Commission Molly-Kate Gavello U.S. Nuclear Regulatory Commission Naeem Iqbal U.S. Nuclear Regulatory Commission Nancy Martinez U.S. Nuclear Regulatory Commission Nathanael Hudson U.S. Nuclear Regulatory Commission Nicolas Mertz U.S. Nuclear Regulatory Commission Norbert Carte U.S. Nuclear Regulatory Commission Phyllis Clark U.S. Nuclear Regulatory Commission Robert Hoffman U.S. Nuclear Regulatory Commission Robert Williams U.S. Nuclear Regulatory Commission Shaun Anderson U.S. Nuclear Regulatory Commission Sheila Ray U.S. Nuclear Regulatory Commission Steve Jones U.S. Nuclear Regulatory Commission Steven Lynch U.S. Nuclear Regulatory Commission Tarek Zaki U.S. Nuclear Regulatory Commission Tim Harris U.S. Nuclear Regulatory Commission Trent Wertz U.S. Nuclear Regulatory Commission William Rautzen U.S. Nuclear Regulatory Commission Yawar Faraz U.S. Nuclear Regulatory Commission Zachary Gran U.S. Nuclear Regulatory Commission Abbey Donahue SHINE Medical Technologies, LLC Alexander Newell SHINE Medical Technologies, LLC Alisa McClelland SHINE Medical Technologies, LLC Bobby Slater SHINE Medical Technologies, LLC Daniel Arizaga SHINE Medical Technologies, LLC Ian Soderling SHINE Medical Technologies, LLC Jamie Getchius SHINE Medical Technologies, LLC Jeff Bartelme SHINE Medical Technologies, LLC Jim Costedio SHINE Medical Technologies, LLC Mark Johnson SHINE Medical Technologies, LLC Ryan Wendling SHINE Medical Technologies, LLC Thomas Drury SHINE Medical Technologies, LLC Tracy Radel SHINE Medical Technologies, LLC Anthony Palumbo SHINE Medical Technologies, LLC Gregg Clarkson Rock Creek Innovations Michael Grochowski Atomic Alchemy, Inc.
Thomas Eiden Atomic Alchemy, Inc.