ML22178A033
| ML22178A033 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 06/27/2022 |
| From: | Jim Costedio SHINE Medical Technologies |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| Shared Package | |
| ML22178A032 | List: |
| References | |
| 2022-SMT-0073 | |
| Download: ML22178A033 (2) | |
Text
Enclosure 1 contains security-related information.
Withhold from public disclosure under 10 CFR 2.390.
Upon removal of Enclosure 1, this letter is uncontrolled.
3400 Innovation Ct
- Janesville, WI 53546
- 877.512.6554
- info@shinemed.com
- www.SHINEtechnologies.com June 27, 2022 2022-SMT-0073 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 Fire Protection (EPID No. L-2019-NEW-0004), dated June 23, 2021 (ML21162A318)
(3) SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Application for an Operating License Response to Request for Additional Information, dated December 30, 2021 (ML21364A055)
(4) SHINE Technologies, LLC letter to the NRC, SHINE Technologies, LLC Application for an Operating License Response to Request for Additional Information, dated February 28, 2022 (ML22059A017)
SHINE Technologies, LLC Application for an Operating License Revision 1 of the SHINE Response to Requests for Additional Information 9-8 and 9-9 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, Wisconsin via Reference 1. Via Reference 2, the NRC staff determined that additional information was required to enable the staffs continued review of the SHINE operating license application. SHINE responded to the NRC staffs request for additional information (RAI) via References 3 and 4.
SHINE has determined that the SHINE Response to RAI 9-8, provided via Reference 3, and the SHINE Response to RAI 9-9, provided via Reference 4, require revision.
This submittal contains security-related information which SHINE requests to be withheld from public disclosure in accordance with 10 CFR 2.390(d). Security-related information was identified utilizing the guidance contained in Regulatory Issue Summary (RIS) 2005-31, Revision 1.
provides the non-public version of Revision 1 of the SHINE Response to RAI 9-8 and the SHINE Response to RAI 9-9. Revision 1 of these responses supersede the previously provided SHINE Response to RAI 9-8 and SHINE Response to RAI 9-9. Enclosure 1 contains security-related information. SHINE requests the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.
Document Control Desk Page 2 provides the public version of Revision 1 of the SHINE Response to RAI 9-8 and the SHINE Response to RAI 9-9.
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 June 27, 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)