ML14356A528

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Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information
ML14356A528
Person / Time
Site: SHINE Medical Technologies
Issue date: 12/03/2014
From: Bynum R
SHINE Medical Technologies
To:
Document Control Desk, Office of Nuclear Reactor Regulation
Shared Package
ML14356A527 List:
References
SMT-2014-040
Download: ML14356A528 (9)
v • d • e


Text

SSHINE TM Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 December 3, 2014 SMT-2014-040 10 CFR 50.30 U.S. Nuclear Regulatory Commission 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 September 19, 2014, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML14195A159)

(4) SHINE Medical Technologies, Inc. letter to NRC, dated October 15, 2014, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML14296A190)

SHINE Medical Technolooies, 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. SHINE responded to a portion of the NRC staff's requests via Reference (4). The SHINE responses to the remaining Reference (3) requests are provided in this submittal. 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. In addition to proprietary information, 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.

Enclosures 1 and 3 contain 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) 210-10601 F (608) 210-2504 1www.shinemed.com

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Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 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 provided via OSM as OSM#2. provides a non-public (proprietary) revision to the SHINE Preliminary Safety Analysis Report (PSAR), incorporating changes based on the SHINE response 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 in 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 response 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. Enclosures 1 and 3 contain 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 December 3, 2014.

Very truly yours,

-XIA. f017 R. Vann Bynum, 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)

Enclosures 1 and 3 contain 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 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.

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

,,NSHINET Meical Technologies SMT-201 4-040 SHINE Medical Technologies, Inc.

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

Enclosure 1 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.

ENCLOSURE2 SHINE MEDICAL TECHNOLOGIES, INC.

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

,ISHINE Meical Technologies SMT-201 4-040 SHINE Medical Technologies, Inc.

Application for Construction Permit Response to Request for Additional Information 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 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

)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-2014-040 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 and Enclosure 3 be withheld from public disclosure in their 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 1 and Enclosure 3 of SMT-2014-040 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 1 and Enclosure 3 is not available to the public to the best of my knowledge and belief.

1

c. The information contained in Enclosure 1 and 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 1 and 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 1 and 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. The information contained in Enclosure 1 and Enclosure 3 of SMT-2014-040 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 December 3, 2014.

Richard Vann .

COO - SHINE Medical Technologies, Inc.

2

SSHINE TM Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 December 3, 2014 SMT-2014-040 10 CFR 50.30 U.S. Nuclear Regulatory Commission 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 September 19, 2014, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML14195A159)

(4) SHINE Medical Technologies, Inc. letter to NRC, dated October 15, 2014, SHINE Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information (ML14296A190)

SHINE Medical Technolooies, 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. SHINE responded to a portion of the NRC staff's requests via Reference (4). The SHINE responses to the remaining Reference (3) requests are provided in this submittal. 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. In addition to proprietary information, 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.

Enclosures 1 and 3 contain 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) 210-10601 F (608) 210-2504 1www.shinemed.com

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Document Control Desk Page 2 THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 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 provided via OSM as OSM#2. provides a non-public (proprietary) revision to the SHINE Preliminary Safety Analysis Report (PSAR), incorporating changes based on the SHINE response 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 in 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 response 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. Enclosures 1 and 3 contain 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 December 3, 2014.

Very truly yours,

-XIA. f017 R. Vann Bynum, 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)

Enclosures 1 and 3 contain 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 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.

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

,,NSHINET Meical Technologies SMT-201 4-040 SHINE Medical Technologies, Inc.

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

Enclosure 1 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.

ENCLOSURE2 SHINE MEDICAL TECHNOLOGIES, INC.

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

,ISHINE Meical Technologies SMT-201 4-040 SHINE Medical Technologies, Inc.

Application for Construction Permit Response to Request for Additional Information 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 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

)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-2014-040 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 and Enclosure 3 be withheld from public disclosure in their 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 1 and Enclosure 3 of SMT-2014-040 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 1 and Enclosure 3 is not available to the public to the best of my knowledge and belief.

1

c. The information contained in Enclosure 1 and 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 1 and 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 1 and 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. The information contained in Enclosure 1 and Enclosure 3 of SMT-2014-040 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 December 3, 2014.

Richard Vann .

COO - SHINE Medical Technologies, Inc.

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