ML21011A224

Shine Medical Technologies, LLC - Operating License Application Supplement No. 6 and Response to Request for Additional Information

ML21011A224
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/15/2020
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
2020-SMT-0131
Download: ML21011A224 (5)

Text

Ii SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 December15,2020 2020-SMT-0131 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 Llcense,"-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 October 16, 2020 SHINE Medical Technologies, LLC Operating License AppUcatlon Supplement No. 6 and Response to Request for Additional Information Pursuant to 10 CFR Part 50.30, SHINE Medical Technologies, LLC (SHINE) submitted an appllcatlon for an operating license for a medical isotope prcxf uction facility to be located In Janesvllle, WI via Reference 1. Via Reference 2, the NRC staff determined that additional information was required to enable the staffs continued review of the SHINE operating license appllcatlon.

This submittal contains Information which SHINE requests to be withheld from publlc disclosure, Including proprietary Information in accordance with 10 CFR 2.390(a)(4), export controlled information (ECI) In accordance with 10 CFR 2.390(a)(3), and security-related information (SRI)

In accordance 10 CFR 2.390(d). SRI was Identified utilizing the guidance contained In Regulatory Issue Summary (RIS) 2005-31, Revision 1. Enclosures 1 through 3 are provided via optical storage media (OSM). provides the SHINE Final Safety Analysts Report (FSAR) Change Summary, Identifying changes to the SHINE FSAR not related to the SHINE responses to the NRC staffs request for additional Information. provides the non-public version of the SHINE response to the NRC staff's request for additional information. Enclosure 2 contains proprietary Information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold Enclosure 2 from publlc disclosure under 10 CFR 2.390. provides a public version of the SHINE response to the NRC staffs request for 1/ G-D l addltlonal information.

AD6 2-J

~ - - - - - - Enclosure - - - -2 contains

- - -security-related

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information.

Withhold from publlc disclosure under 10 CFR 2.390.

Upon removal of Enclosure 2, this letter is uncontrolled.

Jfi.R..

101 E. MIIWcU<ee Street, Suite 600 I Janesville, WI 535451 P (608) 210-1080 IF (608) 210-25041 www.shinemed.com

DocuSlgn Envelope ID: 511A01EB-3387-4BB0-89FC-25BF9042232F Document Control Desk Page2 Enclosure 4 provides an affidavit supporting the proprietary treatment of the SHINE proprietary lnfonnation contained in Enclo8Ure 2, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold Enclosure 2 public disclosure under 10 CFR 2.390. Upon removal of Enclosure 2, this letter Is uncontrolled.

Enclosure 2 provides the SHINE response to Reference 2 requests for additional lnfonnatlon (RAls), with the exception of RAI 2.2-1, RAI 2.2-2, RAI 2.2-3, RAI 3.2-1, RAI 3.4-13, RAI 3.4-17, RAI 8-1, and RAI 8-3. 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 15, 2020.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologles, LLC Docket No. 50-608 Enclosures cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioadive Materials Program, \Nisconsln Division of Public Health (w/o Enclosure 2)

ENCLOSURE4 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

AFFIQA\IIT OF JAMES COSTEDIQ 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 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 SHINE's request for proprietary treatment of certain confidential commercial and financial information submitted In the operating license application supplement by letter 2020-SMT-0131 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 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 2 of 2020-SMT-0131 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.

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DocuSlgn Envelope ID: 611A01EB-3387-4BBD-89FC-25BF9D42232F

c. The infonnation 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 lnfonnation that SHINE Is requesting to be wfthheld from public disclosure includes trade secret, commercial financial lnfonnation, commercial lnfonnation, or infonnation that Is subject to export controls. SHINE limits access to these elements to those with a Mneed to know,* and subject to maintaining confidentiality.

d. The proprietary lnfonnatlon 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 facillty, 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. Publlc disclosure of the lnfonnatlon 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 lnfonnatlon In Enclosure 2 would create substantial hann to SHINE because it would reveal valuable business lnfonnatlon 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.

f. The infonnatlon contained in Enclosure 2 of 2020-SMT-0131 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.

Executed on December 15, 2020.

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

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