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{{#Wiki_filter:October 15, 2021  
{{#Wiki_filter:3400 Innovation Ct.
 
* Janesville, WI 53546
U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555  
* 877.512.6554
* info@shinemed.com
* www.SHINEtechnologies.com October 15, 2021 2021-SMT-0149 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555  


==References:==
==References:==
 
(1) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Application for an Operating License, dated July 17, 2019 (ML19211C143)
2021-SMT-0149 10 CFR 50.30
(2) NRC letter to SHINE Medical Technologies, LLC, SHINE Medical Technologies, LLC - Update to Operating License Application Technical Review Schedule (EPID No. L-2019-NEW-0004), dated August 3, 2021 (ML21209A997)
 
(3) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Schedule Update, dated September 2, 2021 (ML21245A055)
(1) SHINE Medical Technologies, LLC letter to the NRC, âSHINE Medical  
(4) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Overview of Phased Approach to Initial Facility Operations, dated February 26, 2021 (ML21057A340)
 
SHINE Technologies, LLC Schedule Update - Expected Dates for Completion of Construction and Request for Receipt of Additional Radioactive Material Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, WI (Reference 1). Via Reference 2, the NRC staff requested SHINE provide updated submission dates for the phased approach supplement and subsequent request to receive and possess radioactive material, as well as the current expected completion dates for each phase of construction, to enable the staff to establish a revised review schedule for the SHINE application. SHINE previously provided the estimated submission date for the application supplement for the phased approach to initial facility operations (Reference 3).
Technologies, LLC Application for an Operating License,â dated July 17, 2019 (ML19211C143)  
 
(2) NRC letter to SHINE Medical Technologies, LLC, âSHINE Medical  
 
Technologies, LLC â Update to Operating License Application Technical Review Schedule (EPID No. L-2019-NEW-0004),â dated August 3, 2021 (ML21209A997)  
 
(3) SHINE Medical Technologies, LLC letter to the NRC, âSHINE Medical  
 
Technologies, LLC Schedule Update,â dated September 2, 2021 (ML21245A055)  
 
(4) SHINE Medical Technologies, LLC letter to the NRC, âSHINE Medical  
 
Technologies, LLC Overview of Phased Approach to Initial Facility Operations,â dated February 26, 2021 (ML21057A340)  
 
SHINE Technologies, LLC Schedule Update â Expected Dates for Completion of Construction and Request for Receipt of Additional Radioactive Material Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, WI (Reference 1). Via Reference 2, the NRC staff requested SHINE provide updated submission dates for the phased approach supplement and subsequent request to receive and possess radioactive material, as well as the current expected completion dates for each phase of construction, to enable the staff to establish a revised review schedule for the SHINE application. SHINE previously provided the estimated submission date for the application supplement for the phased approach to initial facility operations (Reference 3).
An overview of the phased approach to initial facility operations, including identification of the four phases of process equipment installation and operation, was provided via Reference 4.
An overview of the phased approach to initial facility operations, including identification of the four phases of process equipment installation and operation, was provided via Reference 4.
SHINE estimates the following construction completion dates for each of the four phases:  
SHINE estimates the following construction completion dates for each of the four phases:
 
Phase 1 construction substantially complete: May 2023 Phase 2 construction substantially complete: May 2023 Phase 3 construction substantially complete: May 2024 Phase 4 construction substantially complete: August 2025 SHINE estimates the submission date for the request to license certain byproduct, source, and special nuclear material to support initial facility operations to be April 2022.  
⢠ Phase 1 construction substantially complete: May 2023  
⢠ Phase 2 construction substantially complete: May 2023  
⢠ Phase 3 construction substantially complete: May 2024  
⢠ Phase 4 construction substantially complete: August 2025  
 
SHINE estimates the submission date for the request to license certain byproduct, source, and special nuclear material to support initial facility operations to be April 2022.  
 
3400 Innovation Ct. ⢠Janesville, WI 53546 ⢠877.512.6554 ⢠info@shinemed.com ⢠www.SHINEtechnologies.com


Document Control Desk Page 2 If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.
Document Control Desk Page 2 If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.
Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 cc:  
Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 cc:
 
Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health}}
Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health}}

Latest revision as of 21:33, 27 November 2024

Shine Technologies, LLC Schedule Update - Expected Dates for Completion of Construction and Request for Receipt of Additional Radioactive Material
ML21288A543
Person / Time
Site: SHINE Medical Technologies
Issue date: 10/15/2021
From: Jim Costedio
SHINE Health. Illuminated, SHINE Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
2021-SMT-0149
Download: ML21288A543 (2)
v • d • e


Text

3400 Innovation Ct.

  • Janesville, WI 53546
  • 877.512.6554
  • info@shinemed.com
  • www.SHINEtechnologies.com October 15, 2021 2021-SMT-0149 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 Application for an Operating License, dated July 17, 2019 (ML19211C143)

(2) NRC letter to SHINE Medical Technologies, LLC, SHINE Medical Technologies, LLC - Update to Operating License Application Technical Review Schedule (EPID No. L-2019-NEW-0004), dated August 3, 2021 (ML21209A997)

(3) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Schedule Update, dated September 2, 2021 (ML21245A055)

(4) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Overview of Phased Approach to Initial Facility Operations, dated February 26, 2021 (ML21057A340)

SHINE Technologies, LLC Schedule Update - Expected Dates for Completion of Construction and Request for Receipt of Additional Radioactive Material Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, WI (Reference 1). Via Reference 2, the NRC staff requested SHINE provide updated submission dates for the phased approach supplement and subsequent request to receive and possess radioactive material, as well as the current expected completion dates for each phase of construction, to enable the staff to establish a revised review schedule for the SHINE application. SHINE previously provided the estimated submission date for the application supplement for the phased approach to initial facility operations (Reference 3).

An overview of the phased approach to initial facility operations, including identification of the four phases of process equipment installation and operation, was provided via Reference 4.

SHINE estimates the following construction completion dates for each of the four phases:

Phase 1 construction substantially complete: May 2023 Phase 2 construction substantially complete: May 2023 Phase 3 construction substantially complete: May 2024 Phase 4 construction substantially complete: August 2025 SHINE estimates the submission date for the request to license certain byproduct, source, and special nuclear material to support initial facility operations to be April 2022.

Document Control Desk Page 2 If you have any questions, please contact Mr. Jeff Bartelme, Director of Licensing, at 608/210-1735.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Technologies, LLC Docket No. 50-608 cc:

Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health

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