ML20357A089

Shine Medical Technologies, LLC Operating License Application Supplement No. 5 and Response to Request for Additional Information

ML20357A089
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/10/2020
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
2020-SMT-0125
Download: ML20357A089 (5)

Text

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SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 December 10, 2020 2020-SMT-0125 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, LLC letter to the NRC, *sHINE Medical Technologies, LLC Application for an Operating License,* dated July 17, 2019 (ML19211C143)

(2) NRC letter to SHINE Medical Technologies, LLC, "Issuance of Request for Additional Information Related to the SHINE Medical Technologies, LLC Operating License Application (EPID No. L-2019-NEW-0004)," dated November 10, 2020 SHINE Medical Technologies, LLC Operating License Application Supplement No. 5 and Response to Request for Additional Information Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located In Janesville, ~ via Reference 1. Via Reference 2, the NRC staff determined that additional Information was required to enable the staff's continued review of the SHINE operating license I\

application.

This submittal contains information which SHINE requests to be withheld from public disclosure, Including proprietary lnfonnatlon In accordance with 10 CFR 2.390(a)(4) and export controlled Information (ECI) In accordance with 10 CFR 2.390(a)(3). Enclosures 1 through 3 are provided via optical storage media (OSM).

Enclosure 1 provides the SHINE Final Safety Analysis Report (FSAR) Change Summary, identifying changes to the SHINE FSAR not related to the SHINE responses to the NRC staff's request for additional Information.

Enclosure 2 provides the non-public version of the SHINE response to the NRC staffs request for additional Information. Enclosure 2 contains proprietary Information, a subset of which has been determined to be ECI. SHINE requests that the NRC withhold Enclosure 2 from public disclosure under 10 CFR 2.390.

Enclosure 3 provides a public version of the SHINE response to the NRC staffs request for additional information.

Enclosure 4 provides an affidavit supporting the proprietary treatment of the SHINE proprietary Information contained in Enclosure 2, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold Enclosures 2 public disclosure under 10 CFR 2.390. Upon removal of Enclosure 2, this letter Is uncontrolled.

101 E. Mflwaukee Street Suite 600 I Janesville, WI 535451 P (608) 210-1060 IF (608) 210-2504 I www.shlnemed.com

DocuSlgn Envelope ID: 627DEAOE-22FS-413A-8583-00492-4246929 Document Control Desk Page2 Enclosure 2 provides the SHINE response to Reference 2 requests for additional Information (RAls), with the exception of RAI 6b.3-10, RAI 6b.3-12, RAI 6b.3-14, RAI 13-5, RAI 13-7, RAI 13-8, RAI 13-9, and RAI 13-10. The SHINE response to these remaining RAls will be provided by January 31, 2021.

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 December 10, 2020. ,

Very truly yours, Doou81gnedby:

QJ"' ~

~4FF James Costedlo Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Docket No. 50-608 Enclosures cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin DMslon of Public Health (w/o Enclosure 2)

ENCLOSURE 4 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL TECHNOLOGIES, LLC OPERATING LICENSE APPLICATION SUPPLEMENT NO. 6 AND RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION 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, LLC (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 wlthholding 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 SHINE's request for proprietary treatment of certain confidential commercial and financial information submitted In the operating license application supplement by letter 2020-SMT-0125 with enclosures. SHINE requests that the confidential information contained in Enclosure 2 be withheld from public disclosure in their 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 detemilning 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 2 of 2020-SMT-0125 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 2 is not available to the public to the best of my knowledge and belief.

Page 1 of 2

DocuSlgn Envelope ID: 627DEAOE-22F5-413A-85~924246929

c. The Information contained In Enclosure 2 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 disdosure 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. The proprietary information sought to be withheld from public disclosure in Enclosure 2 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 stte as would be referenced In facility configuration drawings. Public disclosure of the information in Enclosure 2 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 Enclosure 2 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 slmllar product

f. The Information contained In Endosure 2 of 202~MT-0126 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 property marked.

I declare under the penalty of perjury that the foregoing Is true and~-

Executed on December 10, 2020.

l&Dooulllglled by.

~~' ~4FF.

James Costedlo Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Page 2 of 2