ML16308A221: Difference between revisions

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                                    *-          Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 November 1, 2016                                                                                      SMT-2016-051 10 CFR 50.71 (b)
U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 SHINE Medical Technologies, Inc. Submittal of Annual Financial Report SHINE Medical Technologies, Inc. (SHINE) hereby submits its annual financial report, including certified financial statements, in accordance with the requirements of 10 CFR 50.71 (b).
Enclosure 1 provides the SHINE annual financial report. SHINE requests that the NRG withhold Enclosure 1, in its entirety, from public disclosure under 10 CFR 2.390.
Enclosure 2 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1, pursuant to 10 CFR 2.390. SHINE requests that the NRG withhold Enclosure 1, in its entirety, from public disclosure under 10 CFR 2.390. Upon removal of Enclosure 1, this letter is uncontrolled.
If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on November 1, 2016.
Very truly yours,
  ~~*
A  ames Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosures cc:      Administrator, Region Ill, USNRC Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1)
Enclosure 1 contains proprietary information.
Withhold from public disclosure under 10 CFR 2.390.
Upon removal of Enclosure 1, this letter is uncontrolled.
2555 Industrial Drive I Monona, WI 53713 \ P (608) 210-1060 IF (608) 210-2504 I www.shinemed.com
ENCLOSURE 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
SHINE MEDICAL TECHNOLOGIES, INC. SUBMITTAL OF ANNUAL FINANCIAL REPORT SHINE MEDICAL TECHNOLOGIES, INC.
FINANCIAL STATEMENTS YEARS ENDED DECEMBER 31, 2015 AND 2014 Enclosure 1 contains proprietary information.
Withhold from public disclosure under 10 CFR 2.390.
Uoon removal of Enclosure 1, this letter is uncontrolled.
26 pages follow
ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC.
SHINE MEDICAL TECHNOLOGIES, INC. SUBMITTAL OF ANNUAL FINANCIAL REPORT AFFIDAVIT OF JAMES COSTEDIO 2 pages follow
AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN            )
                              ) SS.
COUNTY OF DANE                )
I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, Inc. (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 SHIN E's request for proprietary treatment of certain confidential commercial and financial information submitted in the annual financial report by letter SMT-2016-051 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 be withheld from public disclosure in its 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 SMT-2016-051 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.
1
: 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 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.
: e. The information contained in Enclosure 1 of SMT-2016-051 is transmitted to the NRC in confide.nee 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 November 1, 2016.
                                      ~ames Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.
2}}

Latest revision as of 15:01, 10 November 2019

Shine Medical Technologies, Inc., Submittal of Annual Financial Report
ML16308A221
Person / Time
Site: SHINE Medical Technologies
Issue date: 11/01/2016
From: Jim Costedio
SHINE Medical Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
References
SMT-2016-051
Download: ML16308A221 (5)
v • d • e


Text

ZJ

  • - Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 November 1, 2016 SMT-2016-051 10 CFR 50.71 (b)

U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 SHINE Medical Technologies, Inc. Submittal of Annual Financial Report SHINE Medical Technologies, Inc. (SHINE) hereby submits its annual financial report, including certified financial statements, in accordance with the requirements of 10 CFR 50.71 (b).

Enclosure 1 provides the SHINE annual financial report. SHINE requests that the NRG withhold Enclosure 1, in its entirety, from public disclosure under 10 CFR 2.390.

Enclosure 2 provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1, pursuant to 10 CFR 2.390. SHINE requests that the NRG withhold Enclosure 1, in its entirety, from public disclosure under 10 CFR 2.390. Upon removal of Enclosure 1, this letter is uncontrolled.

If you have any questions, please contact Mr. Jeff Bartelme, Licensing Manager, at 608/210-1735.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on November 1, 2016.

Very truly yours,

~~*

A ames Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.

Docket No. 50-608 Enclosures cc: Administrator, Region Ill, USNRC Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1)

Enclosure 1 contains proprietary information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 1, this letter is uncontrolled.

2555 Industrial Drive I Monona, WI 53713 \ P (608) 210-1060 IF (608) 210-2504 I www.shinemed.com

ENCLOSURE 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. SUBMITTAL OF ANNUAL FINANCIAL REPORT SHINE MEDICAL TECHNOLOGIES, INC.

FINANCIAL STATEMENTS YEARS ENDED DECEMBER 31, 2015 AND 2014 Enclosure 1 contains proprietary information.

Withhold from public disclosure under 10 CFR 2.390.

Uoon removal of Enclosure 1, this letter is uncontrolled.

26 pages follow

ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. SUBMITTAL OF ANNUAL FINANCIAL REPORT AFFIDAVIT OF JAMES COSTEDIO 2 pages follow

AFFIDAVIT OF JAMES COSTEDIO STATE OF WISCONSIN )

) SS.

COUNTY OF DANE )

I, James Costedio, Vice President of Regulatory Affairs and Quality of SHINE Medical Technologies, Inc. (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 SHIN E's request for proprietary treatment of certain confidential commercial and financial information submitted in the annual financial report by letter SMT-2016-051 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 be withheld from public disclosure in its 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 SMT-2016-051 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.

1

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 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.
e. The information contained in Enclosure 1 of SMT-2016-051 is transmitted to the NRC in confide.nee 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 November 1, 2016.

~ames Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.

2

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