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Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024
Shine Technologies, LLC, Submittal of Annual Financial Report
ML24047A0392024-02-16016 February 2024
Shine Technologies, LLC - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001
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)
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
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
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
ML22287A1852023-02-0101 February 2023
Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement
ML23024A1742023-02-0101 February 2023
Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License
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
ML22187A1342022-08-0101 August 2022
Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule
ML22213A0492022-08-0101 August 2022
Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information
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 Shines Cybersecurity Program for Its 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
2024-05-07
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Text
September 28, 2015 SMT-2015-052 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555
References:
(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)
(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A361)
SHINE Medical Technologies, Inc. Application for Construction Permit SHINE-Definition of Safety-Related Activities Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2).
SHINE has determined it is appropriate to define safety-related activities, as follows:
safety-related activities - those activities affecting the safety-related functions of structures, systems, and components, including siting, designing, purchasing, fabricating, handling, shipping, receiving, storing, cleaning, erecting, installing, repairing, maintaining, modifying, inspecting, testing, and operating.
SHINE will update Section 1.3 of the Quality Assurance Program Description (QAPD) to include the above definition of safety-related activities, and provide the updated QAPD as part of the SHINE Operating License (OL) Application. An Issues Management Report (IMR) has been initiated to track the inclusion of the SHINE-definition of safety-related activity in the QAPD.
If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.
2555 Industrial Drive l Monona, WI 53713 l P (608) 210-1060 l F (608) 210-2504 l www.shinemed.com
Document Control Desk Page 2 I declare under the penalty of perjury that the foregoing is true and correct.
Executed on September 28, 2015.
Very truly yours, Gregory Piefer, Ph.D.
Chief Executive Officer SHINE Medical Technologies, Inc.
Docket No. 50-608 cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health