ML17135A337

Shine Medical Technologies, Inc., Submittal of Annual Financial Report

ML17135A337
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/11/2017
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML17135A352	List: ML17135A337
References
SMT-2017-017
Download: ML17135A337 (5)

Text

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TM THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 May 11, 2017 SMT-2017-017 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). provides the SHINE annual financial report. SHINE requests that the NRC withhold , in its entirety, from public disclosure under 10 CFR 2.390. 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 NRC 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 May 11 , 2017.

Very truly yours, k.~

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 IJanesville, WI 53545 I P (608) 210-1060 I F (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, 2016 AND 2015 Enclosure 1 contains proprietary information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 1, this letter is uncontrolled.

27 pages follow

ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC.

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

SHINE'"

Medical Technologies 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 SHIN E's request for proprietary treatment of certain confidential commercial and financial information submitted in the annual financial report by letter SMT-2017-017 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-2017-017 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 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-2017-017 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.

EJ<ecuted on May 11, 2017.

£1d/SP V:e P:sident of Regulatory Affairs and Quality SHINE Medical Technologies, Inc.

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