ML21232A620

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Shine Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 - Response to Request for Additional Information
ML21232A620
Person / Time
Site: SHINE Medical Technologies
Issue date: 08/20/2021
From: Jim Costedio
SHINE Medical Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML21242A028 List:
References
2021-SMT-0107
Download: ML21232A620 (2)


Text

THIS LETTER CONTAINS SECURITY-RELATED INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 contains security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 2 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 2021-SMT-0107 10 CFR 50.90 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555

References:

(1) NRC letter to SHINE Medical Technologies, Inc., "SHINE Medical Technologies, Inc. - Issuance of Construction Permit for Medical Isotope Facility," dated February 26, 2016 (ML16041A473)

(2)

SHINE Medical Technologies, LLC letter to the NRC, SHINE Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001, dated April 29, 2021 (ML21119A166)

(3)

NRC letter to SHINE Medical Technologies, LLC, SHINE Medical Technologies, LLC - Request for Additional Information Related to Construction Permit Amendment for the Receipt and Possession of Certain Radioactive Materials (EPID No. L-2021-LLA-0104), dated July 29, 2021 (ML21196A493)

SHINE Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information Pursuant to 10 CFR Part 50.90, SHINE Medical Technologies, LLC (SHINE) submitted a request to amend Construction Permit No. CPMIF-001 (Reference 1) to permit SHINE to receive and possess certain radioactive materials necessary for the continued construction of the SHINE medical isotope production facility (Reference 2). The NRC staff determined that additional information was required to enable the staffs continued review of the SHINE amendment request (Reference 3).

This submittal contains security-related information (SRI) which SHINE requests to be withheld from public disclosure 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 SHINE response to the NRC staffs request for additional information. provides a non-public version of the revised amendment request. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. provides a public version of the revised amendment request.

August 20, 2021

cc:

Project Manager, USNRC SHINE General Counsel Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 2)

Document Control Desk Page 2 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 20, 2021.

Very truly yours, James Costedio Vice President of Regulatory Affairs and Quality SHINE Medical Technologies, LLC Docket No. 50-608 Enclosures