ML22126A068
| ML22126A068 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 05/17/2022 |
| From: | Holly Cruz NRC/NRR/DANU/UNPL |
| To: | Piefer G SHINE Medical Technologies |
| Cruz H | |
| References | |
| Download: ML22126A068 (4) | |
Text
SHINE Medical Technologies, LLC May 17, 2022 Dr. Gregory Piefer Chief Executive Officer SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546
SUBJECT:
SHINE TECHNOLOGIES, LLC ACCEPTANCE OF REQUEST TO AMEND CONSTRUCTION PERMIT NO. CPMIF-001
Dear Dr. Piefer:
By letter dated April 1, 2022, SHINE Technologies, LLC (SHINE) submitted a license amendment request to change the licensees name from SHINE Medical Technologies, LLC to SHINE Technologies, LLC in the License Title, Section 1.A, Section 2, the Appendix A Title, and Appendix A Section 2.0, of Construction Permit No. CPMIF-001, and to extend the latest date for the completion of construction of the SHINE medical isotope production facility to December 31, 2025. The purpose of this letter is to provide the results of the U.S. Nuclear Regulatory Commission (NRC) staffs acceptance review of this amendment request. The acceptance review was performed to determine if there is sufficient information in scope and depth to allow the NRC staff to complete its detailed review. The acceptance review is also intended to identify whether the application has any readily apparent information insufficiencies in its characterization of the regulatory requirements or the licensing basis of the facility.
Consistent with Section 50.90 of Title 10 of the Code of Federal Regulations (10 CFR), an application for an amendment to a license (including the technical specifications) or construction permit must fully describe the changes requested, and following as far as applicable, the form prescribed for original applications. Section 50.34 of 10 CFR addresses the content of technical information required. This section stipulates that the submittal address the design and operating characteristics, unusual or novel design features, and principal safety considerations.
The NRC staff has reviewed your application and concluded that it does provide information in sufficient detail to enable the NRC staff to complete its detailed review and make an independent assessment regarding the acceptability of the proposed amendment in terms of regulatory requirements and the protection of public health and safety and the environment. Given the lesser scope and depth of the acceptance review as compared to the detailed technical review, there may be instances in which issues that impact the NRC staffs ability to complete the detailed technical review are identified despite completion of an adequate acceptance review.
You will be advised of any further information needed to support the NRC staffs detailed technical review by separate correspondence.
Based on the information provided in your submittal, the NRC staff has estimated that this licensing request will take approximately 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> to complete. The NRC staff expects to complete this review in approximately 6 months, which is December 31, 2022. If there are emergent complexities or challenges in our review that would cause changes to the initial forecasted completion date or significant changes in the forecasted hours, the reasons for the changes, along with the new estimates, will be communicated during the routine interactions with
G. Piefer the assigned project manager. These estimates are based on the NRC staffs initial review of the application, and they could change due to several factors including requests for additional information, unanticipated addition of scope to the review, and review by NRC advisory committees or hearing-related activities.
If SHINE has any questions, please contact me at (301) 415-1053, or via electronic mail at Holly.Cruz@nrc.gov.
Sincerely, Signed by Cruz, Holly on 05/17/22 Holly D. Cruz, Senior Project Manager Non-Power Production and Utilization Facility Licensing Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation Docket No. 50-608 Construction Permit No. CPMIF-001 cc: See next page
SHINE Medical Technologies, LLC Docket No. 50-608 cc:
Jeff Bartelme Licensing Manager SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 Nathan Schleifer General Counsel SHINE Technologies, LLC 3400 Innovation Court Janesville, WI 53546 Christopher Landers Director, Office of Conversion National Nuclear Security Administration, NA 23 U.S. Department of Energy 1000 Independence Ave SW Washington, DC 20585 Mark Paulson, Supervisor Radiation Protection Section Wisconsin Department of Health Services P.O. Box 2659 Madison, WI 53701-2659 Test, Research and Training Reactor Newsletter Attention: Amber Johnson Dept of Materials Science and Engineering University of Maryland 4418 Stadium Drive College Park, MD 20742-2115 Mark Freitag City Manager P.O. Box 5005 Janesville, WI 53547-5005 Bill McCoy 1326 Putnam Avenue Janesville, WI 53546 Alfred Lembrich 541 Miller Avenue Janesville, WI 53548
ML22126A068 NRR-106 OFFICE NRR/DANU/PM NRR/DANU/LA NRR/DANU/BC NRR/DANU/PM NAME HCruz NParker JBorromeo HCruz DATE 5/6/2022 5/10/2022 5/16/2022 5/17/2022