ML17101A802

Shine Medical Technologies, Inc., - Request for Withholding Information from Public Disclosure

ML17101A802
Person / Time
Site:	SHINE Medical Technologies
Issue date:	04/19/2017
From:	Lynch S T NRC/NRR/DPR/PRLB
To:	Piefer G SHINE Medical Technologies
Lynch S T, NRR/DPR/PRLB, 301-415-1524
Shared Package
ML17101A800	List: ML17101A802
References
Download: ML17101A802 (3)

Text

April 19. 2017

Gregory Piefer, Ph.D.

Chief Executive Officer SHINE Medical Technologies, Inc. 101 E. Milwaukee Street, Suite 600 Janesville, WI 53545

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, INC. - REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE

Dear Dr. Piefer:

By letter dated November 1, 2016 (Agencywide Documents Access and Management System [ADAMS] Accession No. ML16308A221), SHINE Medical Technologies, Inc. (SHINE) submitted an affidavit executed by James Costedio, which requested that information contained in the following document be withheld from public disclosure pursuant to the Title 10 of the Code of Federal Regulations (10 CFR), Section 2.390: SHINE Medical Technologies, Inc., Submittal of Annual Financial Report, Enclosure 1 of SMT-2016-051 SHINE Medical Technologies, Inc. Financial Statements Years Ended December 31, 2015 and 2014 The affidavit stated that the submitted information should be considered exempt from mandatory public disclosure for the following reasons: 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.

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 information or information that is subject to export controls. SHINE limits access to these elements to those individuals 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.

G. Piefer 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. The U.S. Nuclear Regulatory Commission (NRC) staff has reviewed your submittal in accordance with the requirements of 10 CFR 2.390 and, on the basis of the statements in the affidavit, has determined that the submitted information sought to be withheld contains proprietary commercial information and should be withheld from public disclosure.

Therefore, the submitted information marked as proprietary, will be withheld from public disclosure pursuant to 10 CFR 2.390(b)(5) as well as Section 103(b) of the Atomic Energy Act of 1954, as amended.

Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.

If the basis for withholding information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.

If you have any questions regarding this matter, I may be reached at (301) 415-1524 or by electronic mail at Steven.Lynch@nrc.gov. Sincerely, /RA/ Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-608

Pkg.: ML17101A800; Ltr.: ML17101A802; *concurred via email OFFICE NRR/DPR/PRLB/PM* NRR/DPR/PROB/LA* NRR/DPR/PRLB/BC NAME SLynch NParker AAdams DATE 4/13/17 4/13/17 4/19/17