Letter Sequence Withholding Request Acceptance |
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EPID:L-2018-LLM-0154, Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 (Approved, Closed) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance...
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MONTHYEARML16238A0342016-08-25025 August 2016 Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML17055A5732017-02-24024 February 2017 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML17235A1102017-08-23023 August 2017 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML18054A0022018-02-23023 February 2018 Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML18166A1782018-06-13013 June 2018 Shine Medical Technologies, Inc., Submittal of Annual Financial Report Project stage: Request ML18234A0202018-08-22022 August 2018 Shine Medical Technologies, Inc. - Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Request ML18347A2152018-12-11011 December 2018 Shine Medical Technologies - Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment Project stage: Request ML19024A5302019-02-13013 February 2019 Shine Medical Technologies, Inc. - Request for Additional Information Regarding the Application for Indirect License Transfer and Conforming Amendment Project stage: RAI ML19010A1722019-02-13013 February 2019 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML19010A0952019-02-13013 February 2019, 14 February 2019 Shine Medical Technologies, Inc. Application for Indirect License Transfer Project stage: Request ML19010A0962019-02-13013 February 2019 Shine Medical Technologies, Inc. - Notice of Consideration of Approval of Indirect License Transfer and Conforming Amendment and Opportunity for a Hearing and Petition for Leave to Intervene Project stage: Other ML19010A0972019-02-14014 February 2019 Shine Medical Technologies, Inc. - Federal Register Notice Related to Consideration of Approval of Transfer of License and Conforming Amendment Project stage: Other ML19053A2782019-02-22022 February 2019 Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001 Project stage: Request ML19071A0562019-03-0808 March 2019 Shine Medical Technologies, Inc., Affidavit & Response to Request for Additional Information to Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML19071A0552019-03-0808 March 2019 Shine Medical Technologies, Inc., Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML19102A3482019-05-0202 May 2019 Shine Medical Technologies, Inc. - Response to Withholding Request Related to Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Other ML19102A3212019-05-0202 May 2019, 20 May 2019, 30 May 2019 Shine Medical Technologies, Inc. - Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Request ML19102A3242019-05-20020 May 2019 Shine Medical Technologies, Inc. - Order Approving Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Request ML19102A3232019-05-20020 May 2019 Shine Medical Technologies, Inc. - Cover Letter for Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 Project stage: Other ML19162A0262019-07-0101 July 2019 Shine Medical Technologies, LLC - Amendment No. 1 to Shine Medical Isotope Production Facility Construction Permit No. CPMIF-001 Project stage: Other ML19162A0242019-07-0101 July 2019 Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001 Project stage: Request ML19162A0252019-07-0101 July 2019 Shine Medical Technologies, LLC - Issuance of Amendment Reflecting Indirect Transfer of Construction Permit No. CPMIF-001 Project stage: Approval ML19234A0472019-08-22022 August 2019 Shine Medical Technologies - Periodic Report Required by the License Conditions in Section 3.0.(1) of CPMIF-001 Project stage: Request ML19331A8322019-11-14014 November 2019 Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report Project stage: Request ML20052C7942020-02-21021 February 2020 Shine Medical Technologies, Inc., Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 Project stage: Other 2019-02-13
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Category:Letter
MONTHYEARML24128A2162024-05-0707 May 2024 Shine Technologies, LLC, Submittal of Annual Financial Report 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) 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 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 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 ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - 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 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 ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule 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 ML22223A0662022-07-0606 July 2022 Shine Technologies, LLC, Application for an Operating License, Revision 1 of the Response to Requests for Additional Information Related to Cyber Security 2024-05-07
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Text
February 13, 2019 Gregory Piefer, Ph.D.
Chief Executive Officer SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545
SUBJECT:
SHINE MEDICAL TECHNOLOGIES, INC. - REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE (EPID NO. L-2018-LLM-0154)
Dear Dr. Piefer:
By letter dated December 11, 2018 (Agencywide Documents Access and Management System Accession No. ML18347A215), SHINE Medical Technologies, Inc. (SHINE) submitted an affidavit executed by James Costedio, which requested that information contained in the following document be withheld from public disclosure pursuant to Title 10 of the Code of Federal Regulations (10 CFR), Section 2.390:
SHINE Medical Technologies, Inc. Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment (Enclosure 1 of 2018-SMT-0133)
The affidavit stated that the submitted information should be considered exempt from mandatory public disclosure for the following reasons:
- a. The information sought to be withheld from public disclosure contained in Enclosure 1 of 2018-SMT-0133 is owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality. This information is and has been held in confidence by SHINE.
- b. The information sought to be protected in Enclosure 1 is not available to the public to the best of my knowledge and belief.
- c. The information contained in Enclosure 1 is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial financial information, commercial information, or information that is subject to export controls. SHINE limits access to these elements to those with a need to know, and subject to maintaining confidentiality.
- d. Public disclosure of the information in Enclosure 1 would create substantial harm to SHINE because it would reveal valuable business information regarding SHINEs competitive expectations, assumptions, processes, and current position.
Its use by a competitor could substantially improve their competitive position in
G. Piefer the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.
- e. The information contained in Enclosure 1 of 2018-SMT-0133 is transmitted to the NRC in confidence and under the provisions of 10 CFR 2.390; it is to be received in confidence by the NRC. The information is properly marked.
The U.S. Nuclear Regulatory Commission (NRC) staff has reviewed your submittal in accordance with the requirements of 10 CFR 2.390 and, on the basis of the statements in the affidavit, has determined that the submitted information sought to be withheld contains proprietary commercial information and should be withheld from public disclosure.
Therefore, the submitted information marked as proprietary, will be withheld from public disclosure pursuant to 10 CFR 2.390(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended.
Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.
If the basis for withholding information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.
If you have any questions regarding this matter, I may be reached at (301) 415-1524 or by electronic mail at Steven.Lynch@nrc.gov.
Sincerely,
/RA/
Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Licensing Projects Office of Nuclear Reactor Regulation Docket No. 50-608 cc: See next page
SHINE Medical Technologies, Inc. Docket No. 50-608 cc:
Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.
101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Jeff Chamberlin National Nuclear Security Administration, NA-231 U.S. Department of Energy 1000 Independence Ave 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 Dr.
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 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546
PKG ML19010A095; LTR (NRR-106) ML19010A096; FRN (ADM-012)
ML19010A097; Withholding LTR: ML19010A172 OFFICE NRR/DLP/PRLB/PM NRR/DLP/PRLB/LA* NRR/DLP/PRLB/A/BC NRR/DLP/PRLB/PM NAME SLynch NParker WKennedy SLynch DATE 1/17/19 1/17/19 2/12/19 2/13/19