ML15147A203

Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information

ML15147A203
Person / Time
Site:	SHINE Medical Technologies
Issue date:	05/14/2015
From:	Bynum R SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML15147A211	List: ML15147A196 ML15147A197 ML15147A203
References
SMT-2015-018
Download: ML15147A203 (9)

Text

jSHINETh Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 May 14, 2015 SMT-2015-018 10 CFR 50.30 U.S. Nuclear Regulatory Commission 50- 606 ATTN: Document Control Desk Washington, DC 20555

References:

(1) SHINE Medical Technologies, Inc. letter to NRC, dated March 26, 2013, Part One of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML130880226)

(2) SHINE Medical Technologies, Inc. letter to NRC, dated May 31, 2013, Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit (ML13172A324)

(3) NRC letter to SHINE Medical Technologies, Inc., dated April 15, 2015, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML15099A607)

SHINE Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Pursuant to 10 CFR 50.30, SHINE Medical Technologies, Inc. (SHINE) submitted an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI (References 1 and 2). Via Reference (3), the NRC staff determined that additional information was required to enable the staff's continued review of the SHINE construction permit application. provides the non-public (proprietary) version of the SHINE response to the NRC staff's request for additional information. Enclosure 1 is being provided via optical storage media (OSM) as OSM#1. Enclosure 1 contains security-related information which was identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31.

SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. provides the public (non-proprietary) version of the SHINE response to the NRC staff's request for additional information. Enclosure 2 is being provided via OSM as OSM#2.

Enclosure 1 contains security-related information.

Enclosure 3 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

2555 Industrial Drive I Monona, WI 53713 1P (608) 210-1060 1F (608) 210-2504 1www.shinemed.com

Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 provides a non-public (proprietary) revision to the SHINE Preliminary Safety Analysis Report (PSAR), incorporating changes based on the SHINE responses to the NRC staff's request for additional information. Enclosure 3 is provided via OSM as OSM#3.

In addition to proprietary information, Enclosure 3 contains security-related information which was identified utilizing the guidance contained RIS 2005-31. SHINE requests that the NRC withhold Enclosure 3 from public disclosure under 10 CFR 2.390. provides a public (non-proprietary) revision to the SHINE PSAR, incorporating changes based on the SHINE responses to the NRC staff's request for additional information. is provided via OSM as OSM#4. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information pursuant to 10 CFR 2.390. Enclosure 3 contains information proprietary to SHINE.

Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on May 14, 2015.

Very truly yours, m, Ph.D.

Chief Operating Officer SHINE Medical Technologies, Inc.

Docket No. 50-608 Enclosures cc: Administrator, Region Ill, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosures 1 and 3)

Enclosure 1 contains security-related information.

Enclosure 3 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

ENCLOSURE1 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION NON-PUBLIC VERSION (OSM#1)

,%ISHINE Mdcal Technologies SMT-201 5-018 SHINE Medical Technologies, Inc.

Application for Construction Permit Response to Request for Additional Information N~. Non-Public Version (OSM#1)

Enclosure 1 contains security-related information.

Enclosure 3 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION PUBLIC VERSION (OSM#2)

HN SHINE Medical Technologies SMT-201 5-018 SHINE Medical Technologies, Inc.

Application for Construction Permit Response to Request for Additional Information

'K Public Version (OSM#2)

ENCLOSURE 3 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION PRELIMINARY SAFETY ANALYSIS REPORT NON-PUBLIC VERSION (OSM#3)

Enclosure 1 contains security-related information.

Enclosure 3 contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosures 1 and 3, this letter is uncontrolled.

ENCLOSURE 4 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION PRELIMINARY SAFETY ANALYSIS REPORT PUBLIC VERSION (OSM#4)

ENCLOSURE 5 SHINE MEDICAL TECHNOLOGIES, INC.

SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION AFFIDAVIT OF RICHARD VANN BYNUM 2 pages follow

• SHINE Medical Technologies AFFIDAVIT OF RICHARD VANN BYNUM STATE OF WISCONSIN )

)ss.

COUNTY OF DANE )

I, Richard Vann Bynum, Chief Operating Officer of SHINE Medical Technologies, Inc. (SHINE),

do hereby affirm and state:

1. I am authorized to execute this affidavit on behalf of SHINE. I am authorized to review information submitted to or discussed with the Nuclear Regulatory Commission (NRC) and apply for the withholding of information from public disclosure. The purpose of this affidavit is to provide the information required by 10 CFR 2.390(b) in support of SHINE's request for proprietary treatment of certain confidential commercial and financial information submitted in the SHINE response to the NRC staff's requests for additional information transmitted by letter SMT-2015-018 with enclosures. SHINE requests that the confidential information contained in Enclosure 3 be withheld from public disclosure in its entirety.

2. I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential.

3. Pursuant to the provisions of paragraph (a)(4) of 10 CFR 2.390, the following is furnished for consideration by the NRC in determining whether the information sought to be withheld from public disclosure should be withheld.

a. The information sought to be withheld from public disclosure contained in Enclosure 3 of SMT-2015-018 is owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality. This information is and has been held in confidence by SHINE.

b. The information sought to be protected in Enclosure 3 is not available to the public to the best of my knowledge and belief.

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c. The information contained in Enclosure 3 is of the type that is customarily held in confidence by SHINE, and there is a rational basis for doing so. The information that SHINE is requesting to be withheld from public disclosure includes trade secret, commercial financial information, commercial information, or information that is subject to export controls. SHINE limits access to these elements to those with a "need to know," and subject to maintaining confidentiality.

d. The proprietary information sought to be withheld from public disclosure in Enclosure 3 includes, but is not limited to: structural configuration, primary and supporting systems of the medical isotope facility, process and system locations, and process details. This would include information regarding the types, quantities, and locations of materials stored on site as would be referenced in facility configuration drawings. Public disclosure of the information in Enclosure 3 would create substantial harm to SHINE because it would reveal trade secrets owned by SHINE, its affiliates, or third parties to whom SHINE has an obligation to maintain its confidentiality.

e. Public disclosure of the information in Enclosure 3 would create substantial harm to SHINE because it would reveal valuable business information regarding SHINE's competitive expectations, assumptions, processes, and current position. Its use by a competitor could substantially improve their competitive position in the design, manufacture, shipment, installation, assurance of quality, or licensing of a similar product.

f. The information contained in Enclosure 3 of SMT-2015-018 is transmitted to the NRC in confidence and under the provisions of 10 CFR 2.390; it is to be received in confidence by the NRC. The information is properly marked.

I declare under the penalty of perjury that the foregoing is true and correct.

Executed on May 14, 2015.

f*ichard Va~n~nBynum, Ph.D.

COO - SHINE Medical Technologies, Inc.

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