ML13172A361

Part Two of the Shine Medical Technologies, Inc. Application for Construction Permit

ML13172A361
Person / Time
Site:	SHINE Medical Technologies, PROJ0792
Issue date:	05/31/2013
From:	Bynum R SHINE Medical Technologies
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
Download: ML13172A361 (7)

Text

• SHINE" Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 May 31, 2013 SMT-2013-023 10 CFR 2.101 (a)(5) 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 February 18, 2013, Request for Exemption to Submit Application for Construction Permit in Two Parts (ML13051A007)

(3) NRC letter to SHINE Medical Technologies, Inc., dated March 20, 2013, SHINE Medical Technologies, Inc. - Exemption From Certain Requirements of 10 CFR 2.101 (a)(5), Regarding the Submission of a Construction Permit Application in Two Parts (TAC No. ME7820) (ML13072B1395)

Part Two of the SHINE Medical Technologies, Inc. Application for Construction Permit Pursuant to 10 CFR 50.30 and 10 CFR 2.101(a)(5), SHINE Medical Technologies, Inc. (SHINE) hereby submits part two of an application for a construction permit to construct a medical isotope facility to be located in Janesville, WI. SHINE previously provided part one via Reference (1). SHINE requested exemption from certain requirements of 10 CFR 2.101, which would allow the submittal of an application for construction permit in two parts, in accordance with 10 CFR 2.101 (a)(5) (Reference 2). The NRC granted SHINE the exemption via Reference (3).

Part two of SHINE's construction permit application provides the remaining Preliminary Safety Analysis Report (PSAR) chapters not provided in Reference (1). For clarity, Enclosures 1 and 2 provide the entire SHINE PSAR, including Chapter 2, Site Characteristics, and Chapter 19, Environmental Review, which were provided via Reference (1). SHINE has made no changes to Chapters 2 and 19 since the submittal of Reference (1).

The Integrated Safety Analysis (ISA) Summary will be provided with the Operating License Application. This is consistent with 10 CFR 70.65(b). provides the non-public (proprietary) version of the SHINE PSAR. 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) 2005-031. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.

Enclosure 1 of this letter contains proprietary information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 1, this letter is uncontrolled.

A00 ý 2555 Industrial Drive I Monona, WI 53713 1P (608) 210-1060 1F (608) 210-2504 1www.shinemed.com 0R-P-

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 PSAR. Enclosure 2 is being provided via OSM as OSM#2. provides an affidavit supporting the proprietary treatment of the SHINE proprietary information pursuant to 10 CFR 2.390. Enclosure 1 contains proprietary information. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390. Upon removal of Enclosure 1, this letter is uncontrolled.

Via Reference (1), in Section 2.6 of Enclosures 3 and 4, SHINE made an administrative error regarding the expected construction completion date of December 31, 2015. The correct expected construction completion date is December 31, 2016. Therefore, the wording is revised to read, "SHINE currently expects to complete construction of the facility by September 30, 2015 at the earliest, and December 31, 2016 at the latest."

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 31, 2013.

Very truly yours, R. Vann Bynum, PhD Chief Operating Officer SHINE Medical Technologies, Inc.

Project No.: PROJ0792 Enclosures cc: Administrator, Region Ill, USNRC Project Manager, USNRC (w/ Hard Copy)

Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1)

Enclosure 1 of this letter contains proprietary information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 1, this letter is uncontrolled.

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

PART TWO OF THE SHINE MEDICAL TECHNOLOGIES, INC.

APPLICATION FOR CONSTRUCTION PERMIT PRELIMINARY SAFETY ANALYSIS REPORT NON-PUBLIC VERSION (OSM#1) contains both proprietary and security-related information.

Withhold from public disclosure under 10 CFR 2.390.

Upon removal of Enclosure 1, this letter is uncontrolled.

ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC.

PART TWO OF THE SHINE MEDICAL TECHNOLOGIES, INC.

APPLICATION FOR CONSTRUCTION PERMIT PRELIMINARY SAFETY ANALYSIS REPORT PUBLIC VERSION (OSM#2)

ENCLOSURE 3 SHINE MEDICAL TECHNOLOGIES, INC.

PART TWO OF THE SHINE MEDICAL TECHNOLOGIES, INC.

APPLICATION FOR CONSTRUCTION PERMIT AFFIDAVIT OF RICHARD VANN BYNUM 2 pages follow

• SHINETM 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 Construction Permit (CP) application for the SHINE medical isotope facility transmitted by letter SMT-2013-023 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 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 of SMT-2013-023 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 is not available to the public to the best of my knowledge and belief.

c. The information contained in Enclosure 1 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, confidential financial information, commercial information or information that is subject to export controls. SHINE limits 1

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 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 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 1 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 1 of the CP application contained in letter SMT-2013-023 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.

Richard Vann Bynum, PhD COO - SHINE Medical Technologies, Inc.

Date: _______ / _3 Subscribed and sworn to before me, a Notary Public, in and for the county and state above named, this

• day of May 2013.

Notary Public in and for the State of Wisconsin My Commission expires I MCLAN 2W