ML21326A206

Submittal of Shine Technologies, LLC Application for an Operating License Supplement No. 13 and Response to Request for Additional Information

ML21326A206
Person / Time
Site:	SHINE Medical Technologies
Issue date:	11/22/2021
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML21326A205	List: ML21326A206 ML21326A207 ML21326A209 ML21326A210
References
2021-SMT-0164
Download: ML21326A206 (2)

Text

THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 November 22, 2021 2021-SMT-0164 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, SHINE Medical Technologies, LLC - Request for Additional Information Related to Instrumentation and Control Systems (EPID No. L-2019-NEW-0004), dated September 27, 2021 (ML21252A753)

SHINE Technologies, LLC Application for an Operating License Supplement No. 13 and Response to Request for Additional Information Pursuant to 10 CFR Part 50.30, SHINE Technologies, LLC (SHINE) submitted an application for an operating license for a medical isotope production facility to be located in Janesville, Wisconsin 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 application.

This submittal contains information which SHINE requests to be withheld from public 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 with 10 CFR 2.390(d). SRI was identified utilizing the guidance contained in Regulatory Issue Summary (RIS) 2005-31, Revision 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 staffs request for additional information. 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, as well as SRI. SHINE requests that the NRC withhold Enclosure 2 from public disclosure under 10 CFR 2.390.

Enclosure 2 contains security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 2, this letter is uncontrolled.

3400 Innovation Ct.

• Janesville, WI 53546

• 877.512.6554

• info@shinemed.com

• www.SHINEtechnologies.com




         

Document Control Desk Page 2 Enclosure 3 provides the 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 Enclosure 2 from public disclosure under 10 CFR 2.390. Upon removal of Enclosure 2, this letter is uncontrolled.

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 November 22, 2021.

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