|
---|
Category:Legal-Affidavit
MONTHYEARML24128A2182024-05-0707 May 2024 Shine Technologies, LLC, Annual Financial Report - Affidavit of Jeff Bartelme ML22271A9672022-09-28028 September 2022 Enclosure 4: Affidavit of James Costedio ML22249A1252022-08-31031 August 2022 Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter ML22202A4522022-07-21021 July 2022 Enclosure 3: Shine Technologies, LLC - Affidavit of James Costedio ML22188A0582022-07-0707 July 2022 Enclosure 2 - Affidavit of James Costedio ML22188A1972022-07-0707 July 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 27 - Affidavit of James Costedio ML22164A8182022-06-13013 June 2022 Shine Technologies, LLC: Affidavit of James Costedio ML22161A9782022-06-10010 June 2022 Shine Technologies, LLC - Affidavit of James Costedio ML22032A3432022-02-0101 February 2022 Shine Technologies, LLC, Application for an Operating License Revision 1 of the Shine Response to Request for Additional Information 11-2 - Affidavit of James Costedio ML22028A2252022-01-28028 January 2022 Shine Technologies, LLC, Response to Request for Additional Information on Application for an Operating License - Affidavit ML22027A6682022-01-27027 January 2022 Shine Technologies, LLC, Operating License Application Supplement No. 16 Submittal of a Revision to the Shine Emergency Plan - Affidavit ML22027A3572022-01-27027 January 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 15 Submittal of the Phased Startup Operations Application Supplement - Affidavit of James Costedio ML22027A6722022-01-27027 January 2022 Shine Technologies, LLC Operating License Application Supplement No. 17 Submittal of a Revision to the Shine Material Control and Accounting Plan - Affidavit ML22034A6132022-01-26026 January 2022 Shine Technologies, LLC, Application for Operating License Supplement 14, Revision to Final Safety Analysis Report ML21326A2102021-11-22022 November 2021 Enclosure 4: Affidavit of James Costedio ML21272A3452021-09-29029 September 2021 Shine Medical Technologies, LLC - Affidavit of James Costedio ML21271A0772021-09-28028 September 2021 Shine Medical Technologies, LLC, Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 3.4-12 - Affidavit of James Costedio ML21243A2702021-08-31031 August 2021 Enclosure 3 - Affidavit of James Costedio ML21183A1292021-07-0202 July 2021 Enclosure 3: Shine Medical Technologies, LLC, Application for an Operating License, Response to Request for Additional Information, Affidavit of James Costedio ML21011A2242020-12-15015 December 2020 Shine Medical Technologies, LLC - Operating License Application Supplement No. 6 and Response to Request for Additional Information ML20357A0892020-12-10010 December 2020 Shine Medical Technologies, LLC Operating License Application Supplement No. 5 and Response to Request for Additional Information ML20255A0272020-08-28028 August 2020 Shine Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 3 ML20188A3012020-06-17017 June 2020 Shine Medical Technologies, LLC - Response to Request for Additional Information on Operating License Application ML20115E5422020-04-24024 April 2020 Shine Medical Technologies, LLC Submittal of Annual Financial Report ML20105A2952020-03-27027 March 2020 Shine Medical Technologies, LLC, Supplement 2 to License Application, Rev.2 to Final Safety Analysis Report ML20069B1612020-02-24024 February 2020 Transmittal of Meeting Slides for the March 4 and 5, 2020 Public Meeting Between Shine Medical Technologies, LLC and the NRC ML19339E7212019-12-0202 December 2019 Transmittal of Meeting Slides for the December 4 and 5, 2019 Public Meeting Between Shine Medical Technologies, LLC and the NRC ML19337A2752019-11-14014 November 2019 Shine Medical Technologies, LLC Supplement 1 to Final Safety Analysis Report ML19211C0442019-07-17017 July 2019 Shine Medical Technologies, LLC Application for an Operating License ML19163A1322019-06-10010 June 2019 Shine Medical Technologies, Inc. Submittal of Annual Financial Report 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 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 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 ML18166A1782018-06-13013 June 2018 Shine Medical Technologies, Inc., Submittal of Annual Financial Report ML17079A4762017-03-17017 March 2017 Shine Medical Technologies, Inc. - Request for Confirmation Re Proposed Demonstration Project ML16308A2212016-11-0101 November 2016 Shine Medical Technologies, Inc., Submittal of Annual Financial Report ML15222A2012015-07-23023 July 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information 6b.3-30 ML15131A4622015-05-0101 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information ML15043A3952015-02-0606 February 2015 Shine Medical Technologies, Inc. - Application for Construction Permit - Response to Request for Additional Information ML14119A0432014-03-17017 March 2014 Affidavit for Shine Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting 2024-05-07
[Table view] |
Text
SHINE MEDICAL TECHNOLOGIES, LLC
ENCLOSURE 4
SHINE MEDICAL TECHNOLOGIES, LLC APPLICATION FOR AN OPERATING LICENSE SUPPLEMENT NO. 8 AND RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION
AFFIDAVIT OF JAMES COSTEDIO
AFFIDAVIT OF JAMES COSTEDIO
STATE OF WISCONSIN COUNTY OF ROCK I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, LLC (SHINE), do hereby affirm and state:
)
) ss.
)
- 1.
I am authorized to execute this affidavit on behalf of SHINE. I am authorized to review information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from public disclosure. The purpose of this affidavit is to provide the information required by 10 CFR 2.390(b) in support of SHINEâs request for proprietary treatment of certain confidential commercial and financial information submitted in the response to request for additional information by letter 2021-SMT-0125 with enclosures. SHINE requests that the confidential information contained in be withheld from public disclosure in their entirety.
- 2.
- 3.
I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential.
Pursuant to the provisions of paragraph (a)(4) of 10 CFR 2.390, the following is furnished for consideration by the NRC in determining whether the information sought to be withheld from public disclosure should be withheld.
- a. The information sought to be withheld from public disclosure contained in of 2021-SMT-0125 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 2 is not available to the
public to the best of my knowledge and belief.
Page 1 of 2
- c. The information contained in Enclosure 2 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 âneed to know,â and subject to maintaining confidentiality.
- d. The proprietary information sought to be withheld from public disclosure in 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 Enclosure 2 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 Enclosure 2 would create substantial
harm to SHINE because it would reveal valuable business information regarding SHINE's 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 Enclosure 2 of 2021-SMT-0125 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.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on September 29, 2021.
James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC
Page 2 of 2