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| issue date = 09/25/2013 | | issue date = 09/25/2013 | ||
| title = Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan | | title = Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan | ||
| author name = Bynum R | | author name = Bynum R | ||
| author affiliation = SHINE Medical Technologies, Inc | | author affiliation = SHINE Medical Technologies, Inc | ||
| addressee name = | | addressee name = | ||
| Line 18: | Line 18: | ||
=Text= | =Text= | ||
{{#Wiki_filter:* | {{#Wiki_filter:*SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 September 25, 2013 SMT-2013-033 10 CFR 50.30 U.S. Nuclear Regulatory Commission ATTN: Document Control Desk Washington, DC 20555 | ||
==References:== | ==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 (ML13172A361) | |||
(3) NRC letter to SHINE Medical Technologies, Inc., dated August 28, 2013, SHINE Medical Technologies, Inc. - Status of the Acceptance Review of Part Two of the Application for Construction Permit (TAC No. MF2307) | |||
(ML13233A356) | |||
Submittal of the SHINE Medical Technologies, Inc. Preliminary Emergency Plan 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 requested that SHINE provide a preliminary plan for coping with emergencies. provides the proprietary version of the SHINE Preliminary Emergency Plan. In addition to proprietary information, Enclosure 1 contains security-related information identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31, , Section 2.C, Emergency Planning/Fire Protection Information. SHINE requests that the NRC withhold Enclosure 1, in its entirety, from public disclosure in accordance with 10 CFR 2.390(d)(1). provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1, pursuant to 10 CFR 2.390. 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. | |||
If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730. | |||
Enclosure 1 contains both proprietary and security-related information. | |||
Withhold from public disclosure under 10 CFR 2.390. ýj %5 Upon removal of Enclosure 1, this letter is uncontrolled. , D 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 I declare under the penalty of perjury that the foregoing is true and correct. | |||
Executed on September 25, 2013. | |||
Very truly yours, 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 Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1) | |||
Enclosure 1 contains both proprietary and security-related information. | Enclosure 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. | 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. | |||
ENCLOSURE 1 | SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC. | ||
Withhold from public disclosure under 10 CFR 2.390.Upon removal of Enclosure 1, this letter is uncontrolled. | PRELIMINARY EMERGENCY PLAN PRELIMINARY EMERGENCY PLAN contains both proprietary and security-related information. | ||
48 pages follow ENCLOSURE | Withhold from public disclosure under 10 CFR 2.390. | ||
* | Upon removal of Enclosure 1, this letter is uncontrolled. | ||
) ss.COUNTY OF | 48 pages follow | ||
The purpose of this affidavit is to provide the information required | |||
SHINE requests that the confidential information contained in Enclosure 1 be withheld from public disclosure in | ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC. | ||
: 2. I have knowledge of the criteria used by SHINE in designating information | SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC. | ||
: 3. Pursuant to the provisions of paragraph (a)(4) of 10 CFR 2.390, the following | PRELIMINARY EMERGENCY PLAN AFFIDAVIT OF RICHARD VANN BYNUM 2 pages follow | ||
: a. The information sought to be withheld from public disclosure contained | * SHINE Medical Technologies AFFIDAVIT OF RICHARD VANN BYNUM STATE OF WISCONSIN | ||
) ss. | |||
: 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. | COUNTY OF DANE I, Richard Vann Bynum, Chief Operating Officer of SHINE Medical Technologies, Inc. (SHINE), | ||
SHINE limits access to these elements to those with a"need to know," and subject to maintaining confidentiality. | do hereby affirm and state: | ||
: d. The proprietary information sought to be withheld from public disclosure | : 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 information submitted in the preliminary emergency plan for the SHINE medical isotope facility transmitted by letter SMT-2013-033 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 be withheld from public disclosure in their entirety. | ||
This would | : 2. I have knowledge of the criteria used by SHINE in designating information as sensitive, proprietary, or confidential. | ||
: e. The information contained in Enclosure 1 of letter SMT-2013-033 | : 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-2013-033 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. | |||
1 | |||
: 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, 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 includes, but is not limited to: primary and supporting systems of the medical isotope facility and process details. This would include information regarding the types and quantities of materials stored on site. | |||
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. The information contained in Enclosure 1 of letter SMT-2013-033 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 September 25, 2013. | |||
Richard VanE Thn.D. | |||
COO - SHINE Medical Technologies, Inc. | |||
2}} | |||
Latest revision as of 14:08, 4 November 2019
| ML13269A378 | |
| Person / Time | |
|---|---|
| Site: | SHINE Medical Technologies |
| Issue date: | 09/25/2013 |
| From: | Bynum R SHINE Medical Technologies |
| To: | Document Control Desk, Office of Nuclear Reactor Regulation |
| References | |
| SMT-2013-033, TAC MF2307 | |
| Download: ML13269A378 (6) | |
Text
- SHINE Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 September 25, 2013 SMT-2013-033 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 (ML13172A361)
(3) NRC letter to SHINE Medical Technologies, Inc., dated August 28, 2013, SHINE Medical Technologies, Inc. - Status of the Acceptance Review of Part Two of the Application for Construction Permit (TAC No. MF2307)
Submittal of the SHINE Medical Technologies, Inc. Preliminary Emergency Plan 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 requested that SHINE provide a preliminary plan for coping with emergencies. provides the proprietary version of the SHINE Preliminary Emergency Plan. In addition to proprietary information, Enclosure 1 contains security-related information identified utilizing the guidance contained in Regulatory Information Summary (RIS) 2005-31, , Section 2.C, Emergency Planning/Fire Protection Information. SHINE requests that the NRC withhold Enclosure 1, in its entirety, from public disclosure in accordance with 10 CFR 2.390(d)(1). provides an affidavit supporting the proprietary treatment of the SHINE proprietary information contained in Enclosure 1, pursuant to 10 CFR 2.390. 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.
If you have any questions, please contact Mr. Jim Costedio, Licensing Manager, at 608/210-1730.
Enclosure 1 contains both proprietary and security-related information.
Withhold from public disclosure under 10 CFR 2.390. ýj %5 Upon removal of Enclosure 1, this letter is uncontrolled. , D 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 I declare under the penalty of perjury that the foregoing is true and correct.
Executed on September 25, 2013.
Very truly yours, 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 Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1)
Enclosure 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 1 CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 ENCLOSURE 1 SHINE MEDICAL TECHNOLOGIES, INC.
SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC.
PRELIMINARY EMERGENCY PLAN PRELIMINARY EMERGENCY PLAN 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.
48 pages follow
ENCLOSURE 2 SHINE MEDICAL TECHNOLOGIES, INC.
SUBMITTAL OF THE SHINE MEDICAL TECHNOLOGIES, INC.
PRELIMINARY EMERGENCY PLAN 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 information submitted in the preliminary emergency plan for the SHINE medical isotope facility transmitted by letter SMT-2013-033 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-2013-033 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.
1
- 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, 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 includes, but is not limited to: primary and supporting systems of the medical isotope facility and process details. This would include information regarding the types and quantities of materials stored on site.
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. The information contained in Enclosure 1 of letter SMT-2013-033 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 September 25, 2013.
Richard VanE Thn.D.
COO - SHINE Medical Technologies, Inc.
2