ML19010A172

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

ML19010A172
Person / Time
Site:	SHINE Medical Technologies
Issue date:	02/13/2019
From:	Steven Lynch Research and Test Reactors Licensing Projects Branch
To:	Piefer G SHINE Medical Technologies
Lynch S, NRR/DLP, 415-1524
References
EPID L-2018-LLM-0154
Download: ML19010A172 (4)

Text

February 13, 2019 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 (EPID NO. L-2018-LLM-0154)

Dear Dr. Piefer:

By letter dated December 11, 2018 (Agencywide Documents Access and Management System Accession No. ML18347A215), 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 Title 10 of the Code of Federal Regulations (10 CFR), Section 2.390:

SHINE Medical Technologies, Inc. Application for Order Approving Indirect Transfer of Control of Construction Permit and Conforming Administrative Construction Permit Amendment (Enclosure 1 of 2018-SMT-0133)

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 2018-SMT-0133 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 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

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

e. The information contained in Enclosure 1 of 2018-SMT-0133 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.

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) and 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 Licensing Projects Office of Nuclear Reactor Regulation Docket No. 50-608 cc: See next page

SHINE Medical Technologies, Inc. Docket No. 50-608 cc:

Jeff Bartelme Licensing Manager SHINE Medical Technologies, Inc.

101 E. Milwaukee Street, Suite 600 Janesville, WI 53545 Jeff Chamberlin National Nuclear Security Administration, NA-231 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson, Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Dr.

College Park, MD 20742-2115 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546

PKG ML19010A095; LTR (NRR-106) ML19010A096; FRN (ADM-012)

ML19010A097; Withholding LTR: ML19010A172 OFFICE NRR/DLP/PRLB/PM NRR/DLP/PRLB/LA* NRR/DLP/PRLB/A/BC NRR/DLP/PRLB/PM NAME SLynch NParker WKennedy SLynch DATE 1/17/19 1/17/19 2/12/19 2/13/19