ML23006A186
| ML23006A186 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 01/06/2023 |
| From: | Michael Balazik NRC/NRR/DANU |
| To: | Bartelme J SHINE Medical Technologies |
| References | |
| Download: ML23006A186 (3) | |
Text
From: Michael Balazik Sent: Friday, January 6, 2023 1:14 PM To: Jeffrey Bartelme Cc: Josh Borromeo; Holly Cruz
Subject:
Acceptance Review - SHINE Amendment Request to CPMIF-001 for SNM
Dear Dr. Piefer and Mr. Bartelme:
By letter dated October 6, 2022 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML22279A951), SHINE Technologies, LLC (SHINE) submitted an amendment to Construction Permit No. CPMIF-001 for its Medical Isotope Production Facility (the facility). The license amendment request (LAR) proposes to receive and possess U-235 contained in neutron detectors for installation within the neutron flux distribution system to support construction of the facility.
Consistent with Title 10 of the Code of Federal Regulations (10 CFR) Section 50.90, Application for amendment of license, construction permit, or early site permit, an application to amend a license (including the technical specifications) must be filed with the Commission, as specified in 10 CFR 50.4, Written communications. The application must fully describe the changes desired, and follow, as far as applicable, the form prescribed for the original application. Section 50.34, Contents of applications; technical information, of 10 CFR addresses the content of technical information required and stipulates that the submittal address the design and operating characteristics, unusual or novel design features, and principal safety considerations.
The U.S. Nuclear Regulatory Commission (NRC) staff performed an acceptance review of the LAR and concluded that it includes sufficient information for the NRC staff to begin its detailed technical review. Notwithstanding the acceptance review, the NRC staff may require additional information to complete the detailed technical review. If needed, the NRC staff will request this information by separate correspondence within approximately 30 days of the date of this letter.
Based on the acceptance review, the NRC staff has estimated that the review for this LRA will take approximately 120 hours0.00139 days <br />0.0333 hours <br />1.984127e-4 weeks <br />4.566e-5 months <br /> to complete. The NRC staff expects to complete its review and make a final determination on the LAR by April 14, 2023. This date could change due to several factors, including requests for additional information, unanticipated changes to the scope of the review, unsolicited supplements to the LAR, and others. If the forecasted completion date changes or significant changes in the forecasted hours, the NRC staff will notify you in writing the reasons for the changes along with the new estimates.
If you have any questions, please contact me at (301) 415-2856 or by electronic mail at Michael.Balazik@nrc.gov.
Best Regards, Michael Balazik Project Manager/Inspector Non-Power Production and Utilization Facility Licensing Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission Michael.Balazik@nrc.govl Tel: (301) 415-2856
Hearing Identifier: NRR_DRMA Email Number: 1893 Mail Envelope Properties (PH0PR09MB8795C21E3288B4265586B4F8EAFB9)
Subject:
Acceptance Review - SHINE Amendment Request to CPMIF-001 for SNM Sent Date: 1/6/2023 1:14:06 PM Received Date: 1/6/2023 1:14:00 PM From: Michael Balazik Created By: Michael.Balazik@nrc.gov Recipients:
"Josh Borromeo" <Joshua.Borromeo@nrc.gov>
Tracking Status: None "Holly Cruz" <Holly.Cruz@nrc.gov>
Tracking Status: None "Jeffrey Bartelme" <jeffbartelme@shinefusion.com>
Tracking Status: None Post Office: PH0PR09MB8795.namprd09.prod.outlook.com Files Size Date & Time MESSAGE 2824 1/6/2023 1:14:00 PM Options Priority: Normal Return Notification: No Reply Requested: No Sensitivity: Normal Expiration Date: