Letter Sequence Response to RAI |
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Administration
- Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance, Withholding Request Acceptance
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MONTHYEARML13172A3612013-05-31031 May 2013 Part Two of the Shine Medical Technologies, Inc. Application for Construction Permit Project stage: Request ML13269A3782013-09-25025 September 2013 Shine Medical Technologies, Inc., Submittal of Preliminary Emergency Plan Project stage: Other ML14119A0432014-03-17017 March 2014 Affidavit for Shine Medical Technologies, Inc. Discussion Notes Associated with March 20, 2014 Meeting Project stage: Request ML14121A5342014-05-0808 May 2014 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML14195A1592014-09-19019 September 2014 Shine Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML14356A5282014-12-0303 December 2014 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15005A4072015-01-0606 January 2015 Shine Medical Technologies, Inc., Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15043A3952015-02-0606 February 2015 Shine Medical Technologies, Inc. - Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15037A2492015-03-0303 March 2015 Shine Medical Technologies, Inc., - Proposed Review Schedule, Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures Project stage: Other ML15037A1082015-03-0404 March 2015 Federal Register Notice - Notice of Hearing, Opportunity to Petition for Leave to Intervene, and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information for Contention Preparation on a Construction Permit f Project stage: Request ML15092A4072015-03-23023 March 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information 11.1-9 Project stage: Response to RAI ML15055A1162015-03-25025 March 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15120A2412015-04-10010 April 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15099A6072015-04-15015 April 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit(Tac Nos. MF2305, MF2307, and MF2308) Project stage: RAI ML15131A4622015-05-0101 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15147A2032015-05-14014 May 2015 Shine Medical Technologies, Inc., Application for Construction Permit, Response to Request for Additional Information Project stage: Response to RAI ML15140A7342015-05-20020 May 2015 Shine Medical Technologies, Inc. Application for Construction Permit, Response to Request for Additional Information 13a2.2-5 Project stage: Response to RAI ML15140A7222015-05-21021 May 2015 Shine Medical Technologies, Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7232015-05-21021 May 2015 Shine Medical Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7242015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7252015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7262015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15140A7312015-05-21021 May 2015 Shine Technologies, Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15161A3432015-05-21021 May 2015 Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Revisions Resulting from Request for Additional Information Responses Project stage: Request ML15175A2132015-06-16016 June 2015 Shine Medical Technologies V. 0 - Chapter 06 - Engineered Safety Features Project stage: Request ML15175A1312015-06-16016 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit Revision to Sections 13b.3 and 19.4 of the Preliminary Safety Analysis Report Project stage: Request ML15183A2902015-06-19019 June 2015 Shine Medical Technologies, Inc. Application for Construction Permit - Response to Request for Additional Information Project stage: Response to RAI ML15222A2012015-07-23023 July 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information 6b.3-30 Project stage: Response to RAI ML15236A1272015-08-0707 August 2015 Shine Medical Technologies, Inc. Application for Construction Permit Submittal of Atkins-NS-TR-SHN-15-06, Revision 1 Project stage: Request ML15219A3032015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A2632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3352015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1822015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A3852015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A1632015-08-27027 August 2015 Shine Medical Technologies Inc., Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15219A4252015-08-27027 August 2015 Shine Medical Technologies Inc. - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15244A7712015-08-27027 August 2015 Draft Request for Additional Information Shine Medical Technologies, Inc. Preliminary Safety Analysis Report Supporting a Construction Permit Application Project stage: Draft RAI ML15244A5062015-08-27027 August 2015 E-mail from Steven Lynch to Jim Costedio Transmitting Draft Request for Additional Information Supporting Shine PSAR Project stage: Draft RAI ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information Project stage: Response to RAI ML15259A0242015-09-15015 September 2015 Shine Medical Technologies, Inc. - Application for Construction Permit, Revision 1 of Shine Response to Request for Additional Information 6b.3-34 Project stage: Response to RAI ML15259A1642015-09-24024 September 2015 Shine Medical Technologies, Inc., - Request for Additional Information Regarding Application for Construction Permit Project stage: RAI ML15267A2912016-01-0606 January 2016 June 19, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance ML15267A2672016-01-0606 January 2016 July 23, 2015 Shine Technologies, Inc., - Request for Withholding Information from Public Disclosure Project stage: Withholding Request Acceptance 2015-04-15
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Category:Letter
MONTHYEARML23229A0202023-08-17017 August 2023 Periodic Report Required by the License Conditions in Section 3.D.(1) of CPMIF-001 ML23087A2272023-05-0505 May 2023 Shine Technologies, LLC - Issuance of Amendment No. 4 to Construction Permit No. CPMIF-001 for the Receipt and Possession of Contained Special Nuclear Material ML23086C0502023-04-27027 April 2023 Shine Technologies, LLC - Letter, Environmental Assessment and Finding of No Significant Impact ML23088A3382023-04-0505 April 2023 Shine Technologies, LLC - Review of the Physical Security Plan in Support of an Operating License for a Medical Radioisotope Production Facility ML23010A1982023-02-24024 February 2023 Shine Technologies, LLC - Letter: Safety Evaluation Report for the Shine Medical Radioisotope Production Facility Operating License Application ML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML23034A1872023-02-0303 February 2023 Shine Medical Technologies, LLC Notice of Availability of Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility (Docket Number: 50-608) ML23010A2382023-02-0303 February 2023 Shine Technologies, LLC - Individual Notice of Consideration FRN Letter ML23023A0942023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0922023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23023A0862023-02-0202 February 2023 Notice of Availability of the Environmental Impact Statement Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML23024A1682023-02-0101 February 2023 Letter to Ken Westlake, EPA Region 5 - Issuance of Final EIS Supplement Related to the Operating License ML23024A1742023-02-0101 February 2023 Dr. Gregory Piefer, Chief Executive Officer - Issuance of Final EIS Supplement Related to the Operating License ML22287A1852023-02-0101 February 2023 Shine Technologies, LLC Regulatory Report on the Audit of Phased Startup Operations Application Supplement ML22308A2332023-01-0909 January 2023 Shine Technologies LLC - Regulatory Audit Report for Chapter 8 - Irradiation Facility and Radioisotope Production Facility Electrical Power Systems ML22347A2142023-01-0404 January 2023 Shine Technologies LLC - Regulatory Audit Report for I&C Combined Sessions ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22347A1772022-12-14014 December 2022 Shine Technologies LLC - Regulatory Audit Report for Programmable Logic Lifecycle ML22301A1492022-12-0707 December 2022 Shine Technologies, LLC - Regulatory Audit Report for Chapter 13 - Accident Analysis and Criticality Safety ML22322A2122022-12-0202 December 2022 Shine Medical Technologies - Cybersecurity Audit Summary Report ML22322A2232022-12-0202 December 2022 Shine Medical Technologies - Fire Protection Audit Summary Report ML22348A0672022-12-0101 December 2022 Shine Technologies, LLC - Request for Confirmatory Information Related to Instrumentation and Control Systems ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22292A3192022-11-30030 November 2022 Shine Medical Technologies, LLC Issuance of Order and Amendment No. 3 to Construction Permit No. CPMIF-001 ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22279A9512022-10-0606 October 2022 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 ML22271A9632022-09-28028 September 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 31 Revision to the Phased Startup Operations Application Supplement ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22220A2612022-09-12012 September 2022 Shine Technologies LLC - Regulatory Report on the Audit Chapter 14, Technical Specifications ML22251A3272022-09-0808 September 2022 Shine Technologies, LLC Application for an Operating License Revision 1 of Shine Response to Requests for Additional Information 7-38, 7-40, and 7-48 ML22249A1252022-08-31031 August 2022 Shine Technologies, LLC Final Safety Analysis Report - Application for an Operating License Supplement No. 30, Cover Letter ML22105A1102022-08-26026 August 2022 Shine Medical Technologies LLC - Request for Additional Information Related to the OGC Review of Phrase Approach ML22061A2122022-08-24024 August 2022 Shine Medical Technologies LLC - Regulatory Audit Plan for Phased Approach - Session 1 ML22213A0492022-08-0101 August 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22187A1342022-08-0101 August 2022 Shine Technologies, LLC - Update to Operating License Application Technical Review Schedule ML22206A2082022-07-27027 July 2022 Shine Medical Technologies, LLC - Request for Confirmatory Information Related to Radiation Protection Program and Waste Management ML22207A0062022-07-26026 July 2022 Shine Technologies, LLC Application for an Operating License Supplement No. 29 ML22202A4492022-07-21021 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 28 - Submittal of a Revision to the Shine Emergency Plan ML22188A2412022-07-14014 July 2022 Meeting with Shine Medical Technologies, LLC (EPID No. L-2019-NEW-0004), to Discuss Development of Shine'S Cybersecurity Program for It'S Medical Isotope Production Facility ML22175A0392022-07-11011 July 2022 Letter to Reid Nelson, Achp Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0542022-07-0808 July 2022 Letter to Gregory Piefer - Notice of Availability of the Draft EIS Supplement Related to the Operating License for the Shine Medical Isotope Production Facility ML22175A0912022-07-0808 July 2022 Notice of Availability and Request for Comments on the Draft Environmental Impact Statement Supplement Related to the Operating License for the Shine (Multiple Tribal Letters) ML22175A0772022-07-0808 July 2022 Letter to Daina Penkiunas - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22175A0632022-07-0808 July 2022 Letter to Ken Westlake, EPA Region 5 - Notice of Availability and Request for Comments on the Draft EIS Supplement Related to the Operating License for the Shine Facility ML22188A1942022-07-0707 July 2022 Shine Technologies, LLC, Application for an Operating License Supplement No. 27 ML22188A0562022-07-0707 July 2022 Shine Technologies, LLC Operating License Application Supplement No. 26 Submittal of a Revision to the Shine Material Control and Accounting Plan ML22223A0662022-07-0606 July 2022 Shine Technologies, LLC, Application for an Operating License, Revision 1 of the Response to Requests for Additional Information Related to Cyber Security ML22175A0742022-07-0101 July 2022 Letter to Mary Buelow Maintenance of Reference Materials at the Hedberg Public Library for the Environmental Review of Shine Medical Technologies, LLC Operating License Application 2023-08-17
[Table view] Category:Response to Request for Additional Information (RAI)
MONTHYEARML23048A2442023-02-17017 February 2023 Shine Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML22356A1932022-12-22022 December 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Confirmatory Information ML22335A5722022-12-0101 December 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22318A1782022-11-14014 November 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22304A1262022-10-31031 October 2022 Shine Technologies, LLC Application for an Operating License Response to Request for Confirmatory Information ML22263A3442022-09-20020 September 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22263A0272022-09-19019 September 2022 Shine Technologies, LLC - Application for an Operating License - Response to Request for Confirmatory Information ML22178A0352022-06-27027 June 2022 Enclosure 2 - Shine Technologies, LLC Application for an Operating License Revision 1 of the Shine Response to Requests for Additional Information 9-8 and 9-9 ML22143A8142022-05-23023 May 2022 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML22112A1952022-04-22022 April 2022 Shine Technologies, LLC Application for an Operating License - Response to Request for Additional Information ML22094A0452022-04-0404 April 2022 Shine Technologies, LLC - Application for an Operating License Revision 1 of Shine Response to Part (C) of Request for Additional Information 7-9 ML22077A0862022-03-18018 March 2022 Shine Technologies, LLC Application for an Operating License - Supplement No. 20 and Response to Request for Additional Information ML22059A0202022-02-28028 February 2022 Enclosure 2: Shine Technologies, LLC - Response to Request to Additional Information ML22032A3422022-02-0101 February 2022 Shine Technologies, LLC, Application for an Operating License Revision 1 of the Shine Response to Request for Additional Information 11-2 ML22028A2242022-01-28028 January 2022 Shine Technologies, LLC, Response to Request for Additional Information on Application for an Operating License ML21364A0552021-12-30030 December 2021 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML21350A1912021-12-16016 December 2021 Shine Technologies, LLC - Application for an Operating License Response to Request for Additional Information ML21326A2092021-11-22022 November 2021 Enclosure 3: Response to Request for Additional Information - Public Version ML21307A3062021-11-0303 November 2021 Shine Technologies, LLC, Application for an Operating License Response to Request for Additional Information ML21272A3442021-09-29029 September 2021 Shine Medical Technologies, LLC - Response to Request for Additional Information (Public Version) ML21271A0762021-09-28028 September 2021 Shine Medical Technologies, LLC, Application for an Operating License Revision 1 of Shine Response to Request for Additional Information 3.4-12 ML21243A2692021-08-31031 August 2021 Enclosure 2 - Response to Request for Additional Information Public Version ML21239A0492021-08-27027 August 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21232A5872021-08-20020 August 2021 Shine Medical Technologies, LLC - Application for an Operating License Response to Request for Additional Information ML21232A6202021-08-20020 August 2021 Shine Medical Technologies, LLC Request to Amend Construction Permit No. CPMIF-001 - Response to Request for Additional Information ML21232A6232021-08-20020 August 2021 Enclosure 3: Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML21232A6212021-08-20020 August 2021 Enclosure 1: Request to Amend Construction Permit No. CPMIF-001 Response to Request for Additional Information ML21208A1352021-07-27027 July 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21183A1282021-07-0202 July 2021 Enclosure 2: Shine Medical Technologies, LLC, Application for an Operating License, Response to Request for Additional Information Public Version ML21154A3032021-06-0303 June 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information 4a-15 ML21127A0512021-05-0707 May 2021 Shine Medical Technologies, LLC Application for an Operating License Response to Request for Additional Information ML21095A2352021-03-23023 March 2021 Shine Medical Technologies, LLC, Cover Letter for Response to Request Tor Additional Information and Supplement No. 7 ML21095A2292021-03-23023 March 2021 Shine Medical Technologies, LLC, Response to Request for Additional Information and Supplement No. 7 ML21075A0122021-03-16016 March 2021 Shine Medical Technologies, LLC - Application for an Operating License, Revision 1 of Shine Response to Request for Additional Information 2.4-1 ML21029A1032021-01-29029 January 2021 Enclosure 1 - Response to Final Safety Analysis Report Chapters 2, 3, and 8 Requests for Additional Information ML21029A1052021-01-29029 January 2021 Enclosure 3 - Response to Final Safety Analysis Report Chapters 6 and 13 Requests for Additional Information ML21022A0272021-01-22022 January 2021 Shine Medical Technologies, LLC Application for an Operating License, Response to Environmental Requests for Additional Information ML21011A2402020-12-15015 December 2020 Shine Medical Technologies, LLC - Operating License Application Supplement No. 6 and Response to Request for Additional Information ML20357A0872020-12-10010 December 2020 Enclosure 3 - Response to Request for Additional Information ML20255A0282020-08-28028 August 2020 Enclosure 1 - Response to Request for Additional Information ML20188A3022020-06-17017 June 2020 Shine Medical Technologies, LLC - Response to Request for Additional Information on Operating License Application ML20129J9202020-05-0808 May 2020 Shine Medical Technologies, LLC, Application for an Operating License Response to Supplemental Environmental Requests for Additional Information ML20073E8802020-03-13013 March 2020 Shine Medical Technologies, LLC Application for an Operating License Response to Environmental Requests for Additional Information ML19071A0562019-03-0808 March 2019 Shine Medical Technologies, Inc., Affidavit & Response to Request for Additional Information to Application for Order Approving Indirect Transfer of Control of Construction Permit Response to Request for Additional Information ML17040A1382017-02-0707 February 2017 Shine Medical Technologies, Inc. Safeguards Information (SGI) Protection Program Response to Request for Additional Information ML15259A0242015-09-15015 September 2015 Shine Medical Technologies, Inc. - Application for Construction Permit, Revision 1 of Shine Response to Request for Additional Information 6b.3-34 ML15247A0672015-09-0202 September 2015 Shine Medical Technologies, Inc. Application for Construction Permit Response to Request for Additional Information ML15258A5982015-08-27027 August 2015 Enclosure 2 - Revision 1 of the Shine Response to RAI 12.1-1 and RAI 12.2-1 ML15222A2422015-07-23023 July 2015 Enclosure 2 - Attachment 3 - Atkins-NS-DAC-SHN-15-02, Revision 0 ML15222A2442015-07-23023 July 2015 Enclosure 2 - Attachment 2 - Atkins-NS-DAC-SHN-15-04, Revision 0 2023-02-17
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Text
Medical Technologies THIS LETTER CONTAINS PROPRIETARY INFORMATION IN ACCORDANCE WITH 10 CFR 2.390 June 19, 2015 SMT-2015-033 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 (ML13172A324)
(3) NRC letter to SHINE Medical Technologies, Inc., dated March 25, 2015, SHINE Medical Technologies, Inc. - Request for Additional Information Regarding Application for Construction Permit (TAC Nos. MF2305, MF2307, and MF2308) (ML15055A116)
(4) SHINE Medical Technologies, Inc. letter to NRC, dated April 10, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit. Response to Request for Additional Information (ML15120A248)
(5) SHINE Medical Technologies, Inc. letter to NRC, dated May 1, 2015, SHINE Medical Technologies, Inc. Application for Construction Permit. Response to Request for Additional Information (ML15131A464)
SHINE Medical Technoloqies, 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 the NRC staff's requests via References (4) and (5). Via Reference (5), SHINE stated that a facility-specific validation report, supporting the SHINE Response to RAI 6b.3-23 and RAI 6b.3-26, would be provided at a later date. provides the non-public (proprietary) version of the SHINE Response to RAI 6b.3-23 and RAI 6b.3-26, including the facility-specific validation report. Enclosure 1 is being provided via optical storage media (OSM) as OSM#1. SHINE requests that the NRC withhold Enclosure 1 from public disclosure under 10 CFR 2.390.
Enclosure 1 contains proprietary information.
Withhold from public disclosure under 10 CFR 2.390.
Upon removal of Enclosure 1, this letter is uncontrolled.
2555 Industrial Drive I Monona, WI 537131 P (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 the public (non-proprietary) version of the SHINE Response to RAI 6b.3-23 and RAI 6b.3-26, including the facility-specific validation report. 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 information proprietary to SHINE.
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.
I declare under the penalty of perjury that the foregoing is true and correct.
Executed on June 19, 2015.
Very truly yours, R. Vann Bynum, Ph.D.
Chief Operating Officer SHINE Medical Technologies, Inc.
Docket No. 50-608 Enclosures cc: Administrator, Region III, USNRC Project Manager, USNRC Environmental Project Manager, USNRC Supervisor, Radioactive Materials Program, Wisconsin Division of Public Health (w/o Enclosure 1)
Enclosure 1 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.
SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION SHINE RESPONSE TO RAI 6B.3-23 AND RAI 6B.3-26 NON-PUBLIC VERSION (OSM#1)
Enclosure 1 contains proprietary 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.
SHINE MEDICAL TECHNOLOGIES, INC. APPLICATION FOR CONSTRUCTION PERMIT RESPONSE TO REQUEST FOR ADDITIONAL INFORMATION SHINE RESPONSE TO RAI 6B.3-23 AND RAI 6B.3-26 PUBLIC VERSION (OSM#2)
ENCLOSURE 3 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
Amedical Teclhnologies 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-2015-033 with enclosures. SHINE requests that the confidential information contained in Enclosure 1 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 1 of SMT-2015-033 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 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 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. The information contained in Enclosure 1 of SMT-2015-033 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 June 19, 2015.
Richard Vann lgnum, Ph.D.
COO - SHINE Medical Technologies, Inc.
2