ML15259A164

Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit

ML15259A164
Person / Time
Site:	SHINE Medical Technologies
Issue date:	09/24/2015
From:	Alexander Adams Research and Test Reactors Licensing Branch
To:	Piefer G SHINE Medical Technologies
Balazik M F, NRR/DPR, 415-2856
References
TAC MF2305, TAC MF2307
Download: ML15259A164 (9)

Text

September 24, 2015

Gregory Piefer, Ph.D. Chief Executive Officer SHINE Medical Technologies, Inc.

2555 Industrial Drive Monona, WI 53713

SUBJECT: SHINE MEDICAL TECHNOLOGIES, INC. - REQUEST FOR ADDITIONAL INFORMATION REGARDING APPLICATION FOR CONSTRUCTION PERMIT (TAC NOS. MF2305 AND MF2307)

Dear Dr. Piefer:

By letters dated July 23, 2015, and August 7, 2015 (Agencywide Documents Access and Management System (ADAMS) Accession Nos. ML15222A201 and ML15236A127, respectively), SHINE Medical Technologies, Inc. (SHINE) responded to the U.S. Nuclear Regulatory Commission (NRC) staff's March 25, 2015, request for additional information (RAI) (ADAMS Accession No. ML15055A116) to complete the review of SHINE's preliminary safety analysis report (PSAR) supporting a construction permit application.

In the course of reviewing SHINE's RAI responses submitted on July 23, 2015, and August 7, 2015, the NRC staff has determined that additional information is required to complete the review of SHINE's PSAR in order to prepare a safety evaluation report. This RAI supplements the NRC's previous RAI related to SHINE's construction permit application dated September 19, 2014, January 6, 2015, March 25, 2015, and April 15, 2015 (ADAMS Accession Nos. ML14195A159, ML15005A407, ML15055A116, and ML15099A607, respectively). The specific information requested is addressed in the enclosure to this letter.

A draft of this RAI was provided to SHINE via e-mail on August 26, 2015, and August 27, 2015 (ADAMS Accession Nos. ML15239A101 and ML15244A506, respectively), to ensure that the requests are understandable and the regulatory basis is clear. By letters dated September 2, 2015, and September 15, 2015 (ADAMS Accession Nos. ML15247A067 and ML15259A024),

SHINE submitted responses to the draft request for information. If information is needed to supplement the September 2, 2015, and September 15, 2015, responses and complete the NRC's review of SHINE's PSAR, additional RAIs will be issued. In accordance with Title 10 of the Code of Federal Regulations (10 CFR) Section 50.30(b), SHINE must execute its response in a signed original document under oath or affirmation. SHINE's response must be submitted in accordance with 10 CFR 50.4, "Written communications." Information included in this response that SHINE considers sensitive or proprietary must be marked in accordance with 10 CFR 2.390, "Public inspections, exemptions, requests for withholding." Any information related to security should be submitted in accordance with 10 CFR 73.21, "Protection of Safeguards Information: Performance Requirements." If you have any questions, please contact Steven Lynch at 301-415-1524, or by e-mail at Steven.Lynch@nrc.gov.

Sincerely,/RA/ Alexander Adams, Jr., Chief Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation

Docket No. 50-608

Enclosure:

Request for Additional Information

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

Cheryl Rogers 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