ML21272A341

Shine Medical Technologies, LLC Application for an Operating License Supplement No. 8 and Response to Request for Additional Information

ML21272A341
Person / Time
Site:	SHINE Medical Technologies
Issue date:	09/29/2021
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML21272A340	List: ML21272A341 ML21272A342 ML21272A344 ML21272A345
References
2021-SMT-0125
Download: ML21272A341 (2)

Text

THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION

IN ACCORDANCE WITH 10 CFR 2.390

2021-SMT-0125 10 CFR 50.30

September 29, 2021

U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, LLC letter to the NRC, âSHINE Medical

Technologies, LLC Application for an Operating License,â dated July 17, 2019 (ML19211C143)

(2) NRC letter to SHINE Medical Technologies, LLC, âSHINE Medical Technologies, LLC â Request for Additional Information Related to Instrumentation and Control Systems (EPID No. L-2019-NEW-0004),â dated July 1, 2021 (ML21172A195)

(3) SHINE Medical Technologies, LLC letter to the NRC, âApplication for an

Operating License Response to Request for Additional Information,â dated August 27, 2021 (ML21239A049)

SHINE Medical Technologies, LLC Application for an Operating License Supplement No. 8 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, Wisconsin via Reference 1. Via Reference 2, the NRC staff determined that additional information was required to enable the staffâs continued review of the SHINE operating license application. SHINE responded to a portion of the NRC staffâs requests via Reference 3.

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) and export controlled information (ECI) in accordance with 10 CFR 2.390(a)(3).

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 staffâs request for additional information.

provides the non-public version of the remaining SHINE responses to the NRC staffâs Reference 2 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.

101 E. Milwaukee Street, Suite 600 l Janesville, WI 53545 l P (608) 210-1060 l F (608) 210-2504 l www.shinemed.com

Document Control Desk Page 2 provides the public version of the remaining SHINE responses to the NRC staffâs request for additional information.

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 September 29, 2021.

Very truly yours, James Costedio 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 Division of Public Health (w/o Enclosure 2)