ML19071A180

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

ML19071A180
Person / Time
Site:	SHINE Medical Technologies
Issue date:	03/22/2019
From:	Steven Lynch Research and Test Reactors Licensing Projects Branch
To:	Piefer G SHINE Medical Technologies
Lynch S, NRR/DLP, 415-1524
Shared Package
ML19071A179 -Pkg.	List: ML19071A180
References
EPID L-2017-PMP-0014
Download: ML19071A180 (5)

Text

March 22, 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-2017-PMP-0014)

Dear Dr. Piefer:

By letter dated January 22, 2019 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19024A352), SHINE Medical Technologies, Inc. (SHINE) submitted an affidavit executed by James Costedio, which requested that information contained in the following enclosures of SHINE document 2019-SMT-0007 and associated meeting discussions be withheld from public disclosure pursuant to the Title 10 of the Code of Federal Regulations (10 CFR), Section 2.390:

Enclosure 1, Meeting Slides for the January 31, 2019, Public Meeting Between SHINE Medical Technologies, Inc. and the U.S. Nuclear Regulatory Commission (NRC), SHINE Technology Overview, Non-Public Version Enclosure 3, Meeting Slides for the January 31, 2019, Public Meeting Between SHINE Medical Technologies, Inc. and the NRC, SHINE Structural Design, Non-Public Version SHINE also requested that security-related information contained in Enclosures 1 and 3 be withheld from public disclosure pursuant to 10 CFR 2.390. Nonproprietary versions of these enclosures, designated as Enclosures 2 and 4, respectively, submitted by SHINE in the January 22, 2019, letter referenced above have been placed in NRC Public Document Room and added to the NRC Library in ADAMS for public inspection (ADAMS Accession No. ML19024A352).

The affidavit requesting withholding of Enclosures 1 and 3, and the related meeting discussions, 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 Enclosures 1 and 3, and the related meeting discussion, 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.

G. Piefer b. The information sought to be protected in Enclosures 1 and 3, and the related meeting discussion, is not available to the public to the best of [SHINEs]

knowledge and belief.

c. The information contained in Enclosures 1 and 3, and the related meeting discussion, 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 individuals with a need to know, and subject to maintaining confidentiality.

d. The proprietary information sought to be withheld from public disclosure in Enclosures 1 and 3, and the related meeting discussion, includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope production facility, process and system locations, and process details. This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings. Public disclosure of the information in Enclosures 1 and 3, and the related meeting discussion, would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality.

e. Public disclosure of the information in Enclosures 1 and 3, and the related meeting discussion, 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.

f. The information contained in Enclosures 1 and 3, and the related meeting discussion, 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 NRC staff has reviewed SHINEs 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 and associated meeting discussions sought to be withheld contains proprietary trade secret, commercial financial information, and commercial information, and, as such, should be withheld from public disclosure.

Therefore, the submitted information marked as proprietary in Enclosures 1 and 3, including the related meeting discussions, will be withheld from public disclosure pursuant to 10 CFR 2.390(b)(5). Information marked as security-related in Enclosures 1 and 3, will also be withheld from public disclosure pursuant to 10 CFR 2.390(d)(1).

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, the NRC staff may send copies of this information to its consultants working in this area. The NRC staff will ensure that the consultants have signed the appropriate agreements for handling proprietary information.

G. Piefer 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, SHINE should promptly notify the NRC. SHINE also should understand that the NRC staff may have cause to review this determination in the future, for example, if the scope of a Freedom of Information Act request includes SHINEs information. In all review situations, if the NRC makes a determination adverse to the above, SHINE 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 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 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 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005

ML19071A179, Pkg; ML19029B344, Notice; ML19071A181, Mtg.

Summary; ML1907A180, Withholding Ltr.; ML19024A352, Slides *concurred via email NRR-084 OFFICE NRR/DLP/PRLB/PM NRR/DLP/PROB/LA* NRR/DLP/PRLB/ABC NRR/DLP/PRLB/PM NAME SLynch NParker WKennedy SLynch DATE 03/11/19 03/13/19 03/21/19 03/22/19