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{{#Wiki_filter:}} | {{#Wiki_filter:ENCLOSURE 3 | ||
SHINE MEDICAL TECHNOLOGIES, LLC | |||
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 | |||
2 pages follow AFFIDAVIT OF JAMES COSTEDIO | |||
STATE OF WISCONSIN ) | |||
)ss. | |||
COUNTY OF ROCK ) | |||
I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, LLC (SHINE), do hereby affirm and state: | |||
: 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 SHINEs request for proprietary treatment of certain confidential commercial and financial information submitted in the operating license application supplement by letter 2021-SMT-0123 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 be withheld from public disclosure in their entirety. | |||
: 2. I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential. | |||
: 3. 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 Enclosure 1 of 2021-SMT-0123 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. | |||
Page 1 of 2 | |||
: 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. The proprietary information sought to be withheld from public disclosure in Enclosure 1 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 1 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 1 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 1 of 2021-SMT-0123 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 28, 2021. | |||
James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC | |||
Page 2 of 2}} | |||
Latest revision as of 20:10, 19 November 2024
| ML21271A077 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 09/28/2021 |
| From: | Jim Costedio SHINE Medical Technologies |
| To: | Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML21271A073 | List: |
| References | |
| 2021-SMT-0123 | |
| Download: ML21271A077 (3) | |
Text
ENCLOSURE 3
SHINE MEDICAL TECHNOLOGIES, LLC
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
2 pages follow AFFIDAVIT OF JAMES COSTEDIO
STATE OF WISCONSIN )
)ss.
COUNTY OF ROCK )
I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, LLC (SHINE), do hereby affirm and state:
- 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 SHINEs request for proprietary treatment of certain confidential commercial and financial information submitted in the operating license application supplement by letter 2021-SMT-0123 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 be withheld from public disclosure in their entirety.
- 2. I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential.
- 3. 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 Enclosure 1 of 2021-SMT-0123 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.
Page 1 of 2
- 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. The proprietary information sought to be withheld from public disclosure in Enclosure 1 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 1 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 1 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 1 of 2021-SMT-0123 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 28, 2021.
James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC
Page 2 of 2