ML19163A132

Shine Medical Technologies, Inc. Submittal of Annual Financial Report

ML19163A132
Person / Time
Site:	SHINE Medical Technologies
Issue date:	06/10/2019
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML19163A131	List: ML19163A132
References
2019-SMT-0052
Download: ML19163A132 (4)

Text

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SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 June 10, 2019 201 9-SMT-0052 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 1 0 CFR 50.71 (b). provides the SHINE annual financial report. SHINE requests that the NRC withhold in its entirety, from public disclosure under 1 0 CFR 2.390.

, provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1 pursuant to 1 0 CFR 2.390. SHINE requests that the NRC withhold Enclosure 1 in its entirety, from public disclosure under 1 0 CFR 2.390. Upon removal of Enclosure 1 this letter is uncontrolled.

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

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

Executed on June 10, 2019.

Very truly yours, mes Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.

Docket No. 50-608 Enclosures cc: 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.

101 E. Milwaukee Street, Suite 600 I Janesville, WI 53545 I P (608) 210-1060 I F (608) 210-2504 I www.shinemed.com

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 ROCK )

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 SHINEs request for proprietary treatment of certain confidential commercial and financial information submitted in the annual financial report by letter 2019-SMT-0052 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 2019-SMT-0052 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.

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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 the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.

e. The information contained in Enclosure 1 of 201 9-SMT-0052 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 June 10, 2019.

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

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