ML21243A267

Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information

ML21243A267
Person / Time
Site:	SHINE Medical Technologies
Issue date:	08/31/2021
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML21243A266	List: ML21243A267 ML21243A269 ML21243A270
References
2021-SMT-0095
Download: ML21243A267 (2)

Text

THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION

IN ACCORDANCE WITH 10 CFR 2.390

2021-SMT-0095 10 CFR 50.30

August 31, 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 Accident Analysis, Criticality Safety, and Electrical Power Systems (EPID No. L-2019-NEW-0004),â dated June 2, 2021 (ML21145A060)

(3) SHINE Medical Technologies, LLC letter to the NRC, âSHINE Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information,â dated July 2, 2021

SHINE Medical Technologies, LLC Application for an Operating License 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, WI (Reference 1). The NRC staff determined that additional information was required to enable the staffâs continued review of the SHINE operating license application (Reference 2).

SHINE responded to a portion of the NRC staffâs request 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), 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.

provides the non-public version of the remaining SHINE responses to the NRC staff's request for additional information. Enclosure 1 contains proprietary information, a subset of which has been determined to be ECI, as well as SRI. SHINE requests that the NRC withhold from public disclosure under 10 CFR 2.390.

provides the public version of the remaining SHINE responses to the NRC staff's request for additional information.

contains security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 1, this letter is uncontrolled.

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 an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1, pursuant to 10 CFR 2.390. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. Upon removal of Enclosure 1, 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 August 31, 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 1)