ML22032A340

Shine Technologies, LLC, Submittal of Application for an Operating License Revision 1 of the Shine Response to Request for Additional Information 11-2

ML22032A340
Person / Time
Site:	SHINE Medical Technologies
Issue date:	02/01/2022
From:	Jim Costedio SHINE Health. Illuminated, SHINE Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML22032A339	List: ML22032A340 ML22032A342 ML22032A343
References
022-SMT-0022
Download: ML22032A340 (2)

Text



THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 3400 Innovation Ct.

• Janesville, WI 53546

• 877.512.6554

• info@shinemed.com

• www.SHINEtechnologies.com

February 1, 2022 2022-SMT-0022 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 January 27, 2021 (ML21309A044)

(3) SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Operating License Application Response to Request for Additional Information and Supplement No. 7, dated March 23, 2021 (ML21095A241)

SHINE Technologies, LLC Application for an Operating License Revision 1 of the SHINE Response to Request for Additional Information 11-2 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, WI (Reference 1). The NRC staff determined that additional information was required to enable the staffs continued review of 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 11-2, provided via Reference 3, requires revision.

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 non-public version of Revision 1 of the SHINE Response to RAI 11-2.

Revision 1 supersedes the previously provided SHINE Response to RAI 11-2, provided via Reference 3, in its entirety. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.

provides the public version of Revision 1 of the SHINE Response to RAI 11-2.






  

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 February 1, 2022.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE 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)