Letter Sequence Withholding Request Acceptance |
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EPID:L-2017-PMP-0014, Shine Medical Technologies, Inc., Submittal of Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 (Open) |
Initiation
- Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request, Request
- Acceptance...
Results
Other: ML18054A077, ML18087A340, ML18127B706, ML18128A034, ML18155A603, ML18162A117, ML18162A118, ML18162A129, ML18193A141, ML18268A344, ML18340A171, ML18340A276, ML19015A352, ML19071A185
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MONTHYEARML18030A7422017-07-14014 July 2017 Irrevocable Standby Letter of Credit (Redacted) Project stage: Request ML18054A0772018-03-0808 March 2018 Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Other ML18092A0872018-03-27027 March 2018 Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Request ML18087A3892018-03-28028 March 2018 Meeting Slides for the April 3, 2018, Public Meeting Between Shine Medical Technologies. Inc. and the NRC Project stage: Request ML18162A0542018-03-28028 March 2018, 29 March 2018, 3 April 2018, 18 June 2018 Shine Medical Technologies, Inc. April 3, 2018 Public Meeting Project stage: Request ML18096A6882018-04-0303 April 2018 Confirmatory Action Letter (CAL) No. NRR-2011-001 Project stage: Request ML18096A4552018-04-0303 April 2018 Shine Operating License Pre-Application Meeting (Environmental Presentation Slides) Project stage: Request ML18087A3402018-04-0303 April 2018 Response to Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Other ML18096A6892018-04-0303 April 2018 Arrr Restart Plan (4/3/2018) Approach to Critical, Control Rod and Power Calibrations Project stage: Request ML18130A5782018-05-0707 May 2018 Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Request ML18162A1362018-05-11011 May 2018, 18 June 2018 Shine Medical Technologies, Inc. May 23, 2018 Public Meeting Project stage: Request ML18138A2912018-05-16016 May 2018 Shine Medical Technologies, Inc. - Submittal of Meeting Slides for the May 23 and 24, 2018 with NRC Project stage: Request ML18128A0342018-05-16016 May 2018 Response to Second Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Other ML18156A1302018-06-0101 June 2018 Inc. - Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Request ML18155A6032018-06-0707 June 2018 Response to Third Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Other ML18162A1172018-06-18018 June 2018 Shine Medical Technologies Acknowledgment of Receipt of 2016 Annual Financial Report Project stage: Other ML18162A0552018-06-18018 June 2018 Shine Medical Technologies April 3, 2018 Public Meeting Summary Project stage: Meeting ML18162A1162018-06-18018 June 2018 Shine Medical Technologies Annual Financial Report Project stage: Request ML18162A1182018-06-18018 June 2018 Shine Medical Technologies Response to Request for Withholding Letter for 2016 Annual Financial Report Project stage: Other ML18162A1292018-06-18018 June 2018 Shine Medical Technologies, Inc. - Acknowledgment of Receipt of Periodic Reports on Construction Permit Conditions Project stage: Other ML18162A1382018-06-18018 June 2018 May 23-24, 2018, Summary of Meeting with Shine Medical Technologies, Inc Project stage: Meeting ML18127B7062018-06-21021 June 2018 Closure of NRC Confirmatory Action Letter No. NRR-2011-001 Project stage: Other ML18221A4532018-06-27027 June 2018, 17 August 2018 Shine Medical Technologies, Inc. June 2018 Public Meeting Project stage: Request ML18187A2162018-07-0202 July 2018 Resubmittal of Meeting Slides for the June 28, 2018, Public Meeting Between Shine Medical Technologies, Inc. and the NRC Project stage: Request ML18197A0802018-07-10010 July 2018 Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Request ML18193A1412018-07-16016 July 2018 Response to Fourth Request for Extension of Time to Respond to Letter Regarding Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Other ML18277A1962018-07-17017 July 2018 Amendment to Standby Letter of Credit (Redacted) Project stage: Request ML18206A7262018-07-18018 July 2018 Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor (Redacted) Project stage: Request ML18221A4542018-08-17017 August 2018 Summary of Meeting with Shine Medical Technologies, Inc. Project stage: Meeting ML18239A2192018-08-27027 August 2018 Request for Confirmation of the 10 CFR Part 140 Financial Protection Requirements for the Shine Facility Project stage: Request ML18268A3442018-10-0202 October 2018 Letter of Appreciation for the Tour of the Research Test Reactor Fuel Fabrication Facility Provided to the U.S. Nuclear Regulatory Commission on August 21, 2018 EPID No. L-2017-PMP-0014 Project stage: Other ML18340A1712018-12-10010 December 2018 Shine Medical Technologies, Inc. - Acknowledgement of Receipt of Periodic Report on Construction Permit Conditions Project stage: Other ML18340A2762018-12-19019 December 2018 Shine Medical Technologies, Inc. - Acknowledgment of Receipt of Request for Confirmation of Applicable Financial Protection Requirements Project stage: Other ML19025A2642019-01-22022 January 2019 Shine Medical Technologies, Inc. Submittal of Meeting Slides for the January 29 and 30, 2019 Meeting with the NRC Project stage: Request ML19024A3522019-01-22022 January 2019 Shine Medical Technologies - Meeting Slides for the January 31, 2019 Public Meeting Between Shine Medical Technologies, Inc. and the NRC Project stage: Request ML19025A2752019-01-22022 January 2019 Shine Medical Technologies, Inc. Submittal of Meeting Slides for the January 29 and 30, 2019 Meeting with the NRC Project stage: Request ML19015A3522019-02-15015 February 2019 Irrevocable Standby Letter of Credit for the Aerotest Radiography and Research Reactor Project stage: Other ML19071A1852019-03-22022 March 2019 Shine Medical Technologies, Inc. - Request for Withholding from Public Disclosure Project stage: Other ML19071A1812019-03-22022 March 2019 Shine Medical Technologies, Inc. - January 31, 2019 Public Meeting Summary Project stage: Meeting ML19071A1792019-03-22022 March 2019 Shine Medical Technologies, Inc. January 31, 2019 Public Meeting Project stage: Request ML19071A1802019-03-22022 March 2019 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance 2018-06-18
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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
[Table view] Category:Proprietary Information Review
MONTHYEARML19102A3482019-05-0202 May 2019 Shine Medical Technologies, Inc. - Response to Withholding Request Related to Indirect Transfer of and Conforming Amendment to Construction Permit No. CPMIF-001 ML19071A1802019-03-22022 March 2019 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure ML19071A1852019-03-22022 March 2019 Shine Medical Technologies, Inc. - Request for Withholding from Public Disclosure ML18162A1182018-06-18018 June 2018 Shine Medical Technologies Response to Request for Withholding Letter for 2016 Annual Financial Report ML17142A4342017-07-14014 July 2017 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure ML15267A2672016-01-0606 January 2016 July 23, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure ML15267A2912016-01-0606 January 2016 June 19, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure ML15219A2632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure ML15219A1822015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure ML15219A3032015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure ML15219A3852015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure ML15219A4252015-08-27027 August 2015 Shine Medical Technologies Inc. - Request for Withholding Information from Public Disclosure ML15140A7312015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure ML15140A7262015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure ML15140A7252015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure ML15140A7242015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure ML15140A7232015-05-21021 May 2015 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure ML15140A7222015-05-21021 May 2015 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure ML14121A5342014-05-0808 May 2014 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure ML14120A4922014-05-0202 May 2014 Shine Request for Withholding Letter 2019-05-02
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Text
March 22, 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-2017-PMP-0014)
Dear Dr. Piefer:
By letter dated January 22, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19024A352), SHINE Medical Technologies, Inc. (SHINE) submitted an affidavit executed by James Costedio, which requested that information contained in the following enclosures of SHINE document 2019-SMT-0007 and associated meeting discussions be withheld from public disclosure pursuant to the Title 10 of the Code of Federal Regulations (10 CFR), Section 2.390:
Enclosure 1, Meeting Slides for the January 31, 2019, Public Meeting Between SHINE Medical Technologies, Inc. and the U.S. Nuclear Regulatory Commission (NRC), SHINE Technology Overview, Non-Public Version Enclosure 3, Meeting Slides for the January 31, 2019, Public Meeting Between SHINE Medical Technologies, Inc. and the NRC, SHINE Structural Design, Non-Public Version SHINE also requested that security-related information contained in Enclosures 1 and 3 be withheld from public disclosure pursuant to 10 CFR 2.390. Nonproprietary versions of these enclosures, designated as Enclosures 2 and 4, respectively, submitted by SHINE in the January 22, 2019, letter referenced above have been placed in NRC Public Document Room and added to the NRC Library in ADAMS for public inspection (ADAMS Accession No. ML19024A352).
The affidavit requesting withholding of Enclosures 1 and 3, and the related meeting discussions, 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 Enclosures 1 and 3, and the related meeting discussion, 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.
G. Piefer b. The information sought to be protected in Enclosures 1 and 3, and the related meeting discussion, is not available to the public to the best of [SHINEs]
knowledge and belief.
- c. The information contained in Enclosures 1 and 3, and the related meeting discussion, 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 individuals with a need to know, and subject to maintaining confidentiality.
- d. The proprietary information sought to be withheld from public disclosure in Enclosures 1 and 3, and the related meeting discussion, includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope production facility, process and system locations, and process details. This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings. Public disclosure of the information in Enclosures 1 and 3, and the related meeting discussion, would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality.
- e. Public disclosure of the information in Enclosures 1 and 3, and the related meeting discussion, 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 the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.
- f. The information contained in Enclosures 1 and 3, and the related meeting discussion, 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 NRC staff has reviewed SHINEs 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 and associated meeting discussions sought to be withheld contains proprietary trade secret, commercial financial information, and commercial information, and, as such, should be withheld from public disclosure.
Therefore, the submitted information marked as proprietary in Enclosures 1 and 3, including the related meeting discussions, will be withheld from public disclosure pursuant to 10 CFR 2.390(b)(5). Information marked as security-related in Enclosures 1 and 3, will also be withheld from public disclosure pursuant to 10 CFR 2.390(d)(1).
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, the NRC staff may send copies of this information to its consultants working in this area. The NRC staff will ensure that the consultants have signed the appropriate agreements for handling proprietary information.
G. Piefer 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, SHINE should promptly notify the NRC. SHINE also should understand that the NRC staff may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes SHINEs information. In all review situations, if the NRC makes a determination adverse to the above, SHINE 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 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 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 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
ML19071A179, Pkg; ML19029B344, Notice; ML19071A181, Mtg.
Summary; ML1907A180, Withholding Ltr.; ML19024A352, Slides *concurred via email NRR-084 OFFICE NRR/DLP/PRLB/PM NRR/DLP/PROB/LA* NRR/DLP/PRLB/ABC NRR/DLP/PRLB/PM NAME SLynch NParker WKennedy SLynch DATE 03/11/19 03/13/19 03/21/19 03/22/19