ML22028A222

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

ML22028A222
Person / Time
Site:	SHINE Medical Technologies
Issue date:	01/28/2022
From:	Jim Costedio SHINE Health. Illuminated, SHINE Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML22028A221	List: ML22028A222 ML22028A224 ML22028A225
References
2022-SMT-0018
Download: ML22028A222 (2)

Text




      



THIS LETTER CONTAINS PROPRIETARY AND EXPORT CONTROLLED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 January 28, 2022 2022-SMT-0018 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 Radiation Damage (EPID No. L-2019-NEW-0004), dated December 23, 2021 (ML21355A360)

SHINE Technologies, LLC Application for an Operating License 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, 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).

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 the SHINE responses to the NRC staffs request for additional information. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.

Enclosure 2 provides the public version of the SHINE responses to the NRC staffs request for additional information.

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.

3400 Innovation Ct.

• Janesville, WI 53546

• 877.512.6554

• info@shinemed.com

• www.SHINEtechnologies.com




      

Document Control Desk Page 2 I declare under the penalty of perjury that the foregoing is true and correct.

Executed on January 28, 2022.

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 1)