ML25258A232
| ML25258A232 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 09/12/2025 |
| From: | Michael Balazik NRC/NRR/DANU |
| To: | Bartelme J SHINE Technologies |
| References | |
| L-2025-LLA-0133 | |
| Download: ML25258A232 (3) | |
Text
From:
Michael Balazik Sent:
Friday, September 12, 2025 1:58 PM To:
ext_Jeff_Bartelme Cc:
Subject:
SHINE Amendment Request to CPMIF-001 (L-2025-LLA-0133)
Dear Mr. Bartelme:
By letter dated August 14, 2025 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML25226A150), 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 extend the latest date for the completion of construction of the SHINE medical isotope production facility to December 31, 2029.
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 LAR will take approximately 35 hours4.050926e-4 days <br />0.00972 hours <br />5.787037e-5 weeks <br />1.33175e-5 months <br /> to complete. The NRC staff expects to complete its review and make a final determination on the LAR by December 31, 2025. 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 F. Balazik Project Manager/Inspector Non-Power Production and Utilization Facility Licensing Office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission michael.balazik@nrc.gov l Tel: (301) 415-2856
Hearing Identifier:
NRR_DRMA Email Number:
2798 Mail Envelope Properties (PH0PR09MB8795BFDF8F52CFBB4ADF0741EA08A)
Subject:
SHINE Amendment Request to CPMIF-001 (L-2025-LLA-0133)
Sent Date:
9/12/2025 1:57:47 PM Received Date:
9/12/2025 1:57:00 PM From:
Michael Balazik Created By:
Michael.Balazik@nrc.gov Recipients:
"Jeff Rady" <Jeff.Rady@nrc.gov>
Tracking Status: None "Linh Tran" <Linh.Tran@nrc.gov>
Tracking Status: None "ext_Jeff_Bartelme" <>
Tracking Status: None Post Office:
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