Letter Sequence Response to RAI |
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EPID:L-2021-LLA-0104, Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 1, the Facility (Approved, Closed) |
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MONTHYEARML21095A2252021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 9, Auxiliary Systems Project stage: Request ML21095A2262021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 4, Irradiation Unit and Radioisotope Production Facility Description Project stage: Request ML21095A2212021-03-23023 March 2021 Shine Medical Technologies, LLC, Revisions to Final Safety Analysis Report, Chapter 1, the Facility Project stage: Request ML21119A1662021-04-29029 April 2021 Shine Medical Technologies, LLC, Request to Amend Construction Permit No. CPMIF-001 Project stage: Request ML21119A1652021-04-29029 April 2021 Shine Medical Technologies, LLC, Request to Amend Construction Permit No. CPMIF-001 Project stage: Request ML21119A1682021-04-29029 April 2021 Enclosure 2: Request to Amend Construction Permit No. CPMIF-001 Project stage: Request ML21158A0702021-06-0808 June 2021 Shine Medical Technologies, LLC - Acceptance of the Application for a Construction Permit Amendment Related to the Receipt and Possession of Certain Radioactive Materials Project stage: Acceptance Review ML21232A5872021-08-20020 August 2021 Shine Medical Technologies, LLC - Application for an Operating License Response to Request for Additional Information Project stage: Response to RAI ML21242A0282021-08-20020 August 2021 Shine Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information Project stage: Request ML21245A2172021-09-13013 September 2021 Shine Medical Technologies, LC - Individual Notice of Consideration of Issuance of Amendment to Construction Permit, Opportunity to Request a Hearing, and Order Imposing Procedures Federal Register Notice (Letter) Project stage: Other ML21245A2202021-09-13013 September 2021, 20 September 2021 Shine Medical Technologies, LLC - Federal Register Notice for Construction Permit Amendment Application; Opportunity to Request a Hearing; and Order Imposing Procedures Federal Register Notice Project stage: Request ML21245A2162021-09-20020 September 2021 Shine Medical Technologies, LLC - Federal Register Notice for Construction Permit Amendment Application Project stage: Other ML21320A2242021-12-0202 December 2021 Shine Medical Technologies, LLC - Issuance of Amendment No 2 to Construction Permit No CPMIF-001 Project stage: Approval ML21320A2252021-12-0202 December 2021 Shine Medical Technologies, LLC - Federal Register Notice for Construction Permit Amendment Application Project stage: Request ML21326A0192021-12-13013 December 2021 Shine Medical Technologies, LLC - Environmental Assessment and Finding of No Significant Impact Related to the Receipt and Possession of Certain Radioactive Materials Project stage: Other 2021-04-29
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101 E. Milwaukee Street, Suite 600 l Janesville, WI 53545 l P (608) 210-1060 l F (608) 210-2504 l www.shinemed.com August 20, 2021 2021-SMT-0106 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 - Request for Additional Information Related to Fire Protection (EPID No. L-2019-NEW-0004), dated June 23, 2021 (ML21162A318)
SHINE Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, WI (Reference 1). The NRC staff determined that additional information was required to enable the staffs continued review of the SHINE operating license application (Reference 2).
Additional time is needed to prepare responses to the Reference 2 requests for additional information (RAIs). SHINE will submit responses to the Reference 2 RAIs by December 31, 2021.
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 Medical Technologies, LLC Docket No. 50-608 cc:
Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health