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| {{#Wiki_filter:}} | | {{#Wiki_filter:June 8, 2021 Dr. Gregory Piefer, Chief Executive Officer SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 |
| | |
| | ==SUBJECT:== |
| | SHINE MEDICAL TECHNOLOGIES, LLC - ACCEPTANCE OF THE APPLICATION FOR A CONSTRUCTION PERMIT AMENDMENT RELATED TO THE RECEIPT AND POSSESSION OF CERTAIN RADIOACTIVE MATERIALS (EPID NO. L-2021-LLA-0104) |
| | |
| | ==Dear Dr. Piefer:== |
| | |
| | By {{letter dated|date=April 29, 2021|text=letter dated April 29, 2021}} (Agencywide Documents Access and Management System Accession No. ML21119A166), SHINE Medical Technologies, LLC (SHINE) applied for an amendment to Construction Permit No. CPMIF-001 for its Medical Isotope Production Facility. |
| | The license amendment request (LAR) proposes to receive and possess certain radioactive materials necessary for the continued construction of the SHINE Medical Isotope Production Facility. Consistent with Title 10 of the Code of Federal Regulations (10 CFR) 50.90, Application for amendment of license, construction permit, or early site permit, an application to amend the construction permit must fully describe the changes desired and follow, as far as applicable, the form prescribed for original applications. The requirements in 10 CFR 50.34, Contents of applications; technical information, cover the technical information to be included in the application and stipulate that it address design and operating characteristics, unusual or novel design features, and principal safety considerations. |
| | The U.S. Nuclear Regulatory Commission (NRC) staff performed an acceptance review of the LAR and concluded that it includes sufficient information for the NRC staff to begin its detailed technical review. Notwithstanding the acceptance review, the NRC staff may require additional information to complete the detailed technical review. If needed, the NRC staff will request this information by separate correspondence within approximately 30 days of the date of this letter. |
| | Based on the acceptance review, the NRC staff expects to complete its review and make a final determination on the LAR by August 31, 2021. This date could change due to several factors, including requests for additional information, unanticipated changes to the scope of the review, unsolicited supplements to the LAR, and others. If the forecasted date changes, the NRC staff will notify SHINE in writing of the new date and an explanation of the reason for the change. |
| | |
| | G. Piefer If you or other SHINE representatives have any questions, please contact me at (301) 415-1524, or by electronic mail at Steven.Lynch@nrc.gov. |
| | Sincerely, Signed by Lynch, Steven on 06/08/21 Steven T. Lynch, Senior 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 cc: See next page |
| | |
| | SHINE Medical Technologies, LLC Docket No. 50-608 cc: |
| | Jeff Bartelme Licensing Manager SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Nathan Schleifer General Counsel SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept. of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 |
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| | ML21158A070 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA RIII/DNMS/BC NAME SLynch NParker ROrlikowski DATE 6/7/2021 6/7/2021 6/7/2021 OFFICE NMSS/REFS/BC NRR/DANU/BC NRR/DANU/PM NAME RElliott JBorromeo SLynch DATE 6/7/2021 6/8/2021 6/8/2021}} |
Revision as of 13:45, 22 June 2021
Letter Sequence Acceptance Review |
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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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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 Shine'S Cybersecurity Program for It'S 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
[Table view] |
Text
June 8, 2021 Dr. Gregory Piefer, Chief Executive Officer SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, LLC - ACCEPTANCE OF THE APPLICATION FOR A CONSTRUCTION PERMIT AMENDMENT RELATED TO THE RECEIPT AND POSSESSION OF CERTAIN RADIOACTIVE MATERIALS (EPID NO. L-2021-LLA-0104)
Dear Dr. Piefer:
By letter dated April 29, 2021 (Agencywide Documents Access and Management System Accession No. ML21119A166), SHINE Medical Technologies, LLC (SHINE) applied for an amendment to Construction Permit No. CPMIF-001 for its Medical Isotope Production Facility.
The license amendment request (LAR) proposes to receive and possess certain radioactive materials necessary for the continued construction of the SHINE Medical Isotope Production Facility. Consistent with Title 10 of the Code of Federal Regulations (10 CFR) 50.90, Application for amendment of license, construction permit, or early site permit, an application to amend the construction permit must fully describe the changes desired and follow, as far as applicable, the form prescribed for original applications. The requirements in 10 CFR 50.34, Contents of applications; technical information, cover the technical information to be included in the application and stipulate that it address design and operating characteristics, unusual or novel design features, and principal safety considerations.
The U.S. Nuclear Regulatory Commission (NRC) staff performed an acceptance review of the LAR and concluded that it includes sufficient information for the NRC staff to begin its detailed technical review. Notwithstanding the acceptance review, the NRC staff may require additional information to complete the detailed technical review. If needed, the NRC staff will request this information by separate correspondence within approximately 30 days of the date of this letter.
Based on the acceptance review, the NRC staff expects to complete its review and make a final determination on the LAR by August 31, 2021. This date could change due to several factors, including requests for additional information, unanticipated changes to the scope of the review, unsolicited supplements to the LAR, and others. If the forecasted date changes, the NRC staff will notify SHINE in writing of the new date and an explanation of the reason for the change.
G. Piefer If you or other SHINE representatives have any questions, please contact me at (301) 415-1524, or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely, Signed by Lynch, Steven on 06/08/21 Steven T. Lynch, Senior 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 cc: See next page
SHINE Medical Technologies, LLC Docket No. 50-608 cc:
Jeff Bartelme Licensing Manager SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Nathan Schleifer General Counsel SHINE Medical Technologies, LLC 101 East Milwaukee Street, Suite 600 Janesville, WI 53545 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Avenue, SW Washington, DC 20585 Mark Paulson Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept. of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548
ML21158A070 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA RIII/DNMS/BC NAME SLynch NParker ROrlikowski DATE 6/7/2021 6/7/2021 6/7/2021 OFFICE NMSS/REFS/BC NRR/DANU/BC NRR/DANU/PM NAME RElliott JBorromeo SLynch DATE 6/7/2021 6/8/2021 6/8/2021