ML21271A074

Shine Medical Technologies, LLC, Submittal of Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 3.4-12

ML21271A074
Person / Time
Site:	SHINE Medical Technologies
Issue date:	09/28/2021
From:	Jim Costedio SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML21271A073	List: ML21271A074 ML21271A076 ML21271A077
References
2021-SMT-0123
Download: ML21271A074 (2)

Text

THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 September 28, 2021 2021-SMT-0123 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 October 16, 2020 (3) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Operating License Application Supplement No. 6 and Response to Request for Additional Information, dated December 15, 2020 (ML21011A264)

SHINE Medical Technologies, LLC Application for an Operating License Revision 1 of SHINE Response to Request for Additional Information 3.4-12 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 staffs continued review the SHINE operating license application (Reference 2).

SHINE provided the response to the NRC staffs request for additional information (RAI) via Reference (3). SHINE has determined that the SHINE Response to RAI 3.4-12, provided via Reference (3), required revision to correct an administrative error.

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).

Enclosure 1 provides the non-public version of Revision 1 of the SHINE Response to RAI 3.4-12. Revision 1 supersedes the previously provided SHINE Response to RAI 3.4-12, provided via Reference (3), in its entirety. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.

Enclosure 2 provides the public version of Revision 1 of the SHINE Response to RAI 3.4-12.

101 E. Milwaukee St., 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 Enclosure 3 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 September 28, 2021.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Docket No. 50-608 Enclosure cc: Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1)