ML15286A053

Shine Medical Technologies, Inc. - Update to Review Schedule Regarding Application for Construction Permit

ML15286A053
Person / Time
Site:	SHINE Medical Technologies
Issue date:	10/16/2015
From:	Steven Lynch Research and Test Reactors Branch B
To:	Piefer G SHINE Medical Technologies
Balazik M, NRR/DPR, 301-415-2856
Shared Package
ML15288A498	List: ML15286A053
References
TAC MF2307
Download: ML15286A053 (5)

Text

October 16, 2015 Gregory Piefer, PhD Chief Executive Officer SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

SUBJECT:

SHINE MEDICAL TECHNOLOGIES, INC. - UPDATE TO REVIEW SCHEDULE AND NOTICE OF HEARING REGARDING APPLICATION FOR CONSTRUCTION PERMIT (TAC NO. MF2307)

Dear Dr. Piefer:

By letter dated March 26, 2013 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML13088A192), SHINE Medical Technologies, Inc. (SHINE) submitted part one, consisting primarily of its environmental report, of a two-part construction permit (CP) application for review by the U.S. Nuclear Regulatory Commission (NRC) under Title 10 of the Code of Federal Regulations (10 CFR), Part 50, Domestic Licensing of Production and Utilization Facilities. By letter dated May 31, 2013 (ADAMS Accession No. ML13172A361),

SHINE submitted the second and final part of its two-part application for a CP. By letter dated September 25, 2013 (ADAMS Accession No. ML13269A378), SHINE supplemented its application with a discussion of preliminary plans for coping with emergencies, as required by 10 CFR 50.34(a)(10), thereby completing its application for a construction permit. SHINEs construction permit, including its environmental report, may be viewed in its entirety in (ADAMS Accession No. ML13172A324).

On June 25, 2013, the NRC staff determined that part one of SHINEs application for a CP was complete and acceptable for docketing (ADAMS Accession No. ML13150A280), assigning the application Docket No. 50-608. By letter dated December 2, 2013 (ADAMS Accession No. ML13316B387), the NRC staff informed SHINE that part two of its CP application, as supplemented, contained the remainder of the preliminary safety analysis report (PSAR) required by 10 CFR 50.34(a), was submitted in accordance with the requirements of 10 CFR 2.101(a)(5), and was placed, in its entirety, under Docket No. 50-608.

By letter dated March 3, 2015 (ADAMS Accession No. ML15037A249), the NRC staff provided SHINE its safety and environmental review schedule for the SHINE CP application. Since that letter, all requests for additional information have been addressed, a draft safety evaluation report has been completed, the final environmental impact statement has been published, and a hearing has been scheduled. Accordingly, this letter updates the NRC staffs progress on the SHINE CP application review. The NRC staff will follow the enclosed schedule to complete the reviews of SHINEs PSAR and environmental report required by 10 CFR Parts 50 and 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions. As documented in SRM-SECY-15-0088, Selection of Presiding Officer for Mandatory Hearings Associated with Early Site Permit Applications and Construction Permit Applications for Medical Isotope Production and Utilization Facilities, (ADAMS Accession No.

ML15238B093), dated August 25, 2015, the Commission has agreed to conduct the mandatory hearings associated with construction permit applications for medical isotope production and utilization facilities.

A hearing on the SHINE construction permit application has been schedule for December 15, 2015. In accordance with the provisions of 10 CFR 2.104, a notice of the scheduling of this hearing will be forwarded to the Federal Register for publication. Enclosed is a copy of that notice.

If you have any questions, please contact me at 301-415-1524, or by electronic mail at Steven.Lynch@nrc.gov.

Sincerely,

/RA/

Steven T. Lynch, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-608

Enclosures:

1. Construction Permit Application Review Schedule

2. Notice of Hearing cc: See next page

cc:

Jim Costedio Licensing Manager SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713 Kirsten Cutler, Ph.D.

National Security and International Affairs Office of Science and Technology Policy Executive Office Building 1650 Pennsylvania Avenue Washington, DC 20503 Rilla Hamilton National Nuclear Security Administration, NA-212 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 Laura Bub Environmental Analysis and Review Specialist State of Wisconsin Department of Natural Resources 3911 Fish Hatchery Road Fitchburg, WI 53711 TRTR Newsletter University of Florida Department of Nuclear Engineering Sciences 202 Nuclear Sciences Center Gainesville, FL 32611 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 Gerald and Muriel Bumgarner 1735 S Osborne Ave Janesville, WI 53546

ML15286A053

• concurrence via e-mail NRR-106 OFFICE NRR/DPR/PRLB* NRR/DPR/LA NRR/DLR/RERB*

NRR/DPR/PRLB NRR/DPR/PRLB NAME MBalazik NParker MMoser AAdams SLynch DATE 10/13/15 10/13/15 10/16/15 10/ /15 10/ /15

SHINE Medical Technologies, Inc.

Construction Permit Application Review Schedule Milestone Scheduled Completion Date Status Receipt of Construction Permit Application (Part 1 of 2)

March 2013 Complete Receipt of Construction Permit Application (Part 2 of 2)

May 2013 Complete Docketing of Construction Permit Application (Part 1 of 2)

July 2013 Complete Environmental Scoping Meeting July 2013 Complete Environmental Site Audit August 2013 Complete Issuance of Request for Additional Information on Environmental Report August 2013 Complete Docketing of Construction Permit Application (Part 2 of 2)

December 2013 Complete Issuance of Request for Additional Information on Preliminary Safety Analysis Report and Environmental Report September 2014 Complete Issuance of Supplemental Requests for Additional Information on Preliminary Safety Analysis Report and Environmental Report January 2015 March 2015 April 2015 September 2015 Complete Complete Complete Complete Completion of Draft Environmental Impact Statement May 2015 Complete Advisory Committee on Reactor Safeguards Subcommittee Meeting June 2015 August 2015 September 2015 Complete Complete Complete Advisory Committee on Reactor Safeguards Full Committee Meeting October 2015 Complete Completion of Draft Safety Evaluation Report October 2015 Complete Publication of Final Environmental Impact Statement October 2015 Complete Publication of Safety Evaluation Report October 2015 Pending Mandatory Hearing on Construction Permit Application December 2015 Pending