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Category:Legal-Pre-Filed Exhibits
MONTHYEARML15363A1372015-12-29029 December 2015 NRC-002R - Shine Medical Technologies, Inc., Medical Isotope Production Facility Draft Construction Permit ML15363A1352015-12-29029 December 2015 NRC-014 - NRC Staff Responses to Post-Hearing Questions ML15356A8402015-12-22022 December 2015 SHN-030 - Shine Response to Commission Post Hearing Questions ML15342A2492015-12-15015 December 2015 SHN-028 - Shine Presentation Slides: Safety Panel 2 ML15342A2482015-12-15015 December 2015 SHN-027 - Shine Presentation Slides: Safety Panel 1 ML15342A2472015-12-15015 December 2015 SHN-026 - Shine Overview Panel Presentation ML15345A0712015-12-11011 December 2015 NRC-012-R - Staff Presentation Slides - Safety Panel 2 (December 8, 2015, Corrected Exhibit Filed December 11, 2015) ML15342A2292015-12-0808 December 2015 SHN-006 - Statement of Qualifications of Richard Vann Bynum ML15342A3872015-12-0808 December 2015 NRC-011 - Staff Presentation Slides - Safety Panel 1( December 8, 2015) ML15342A1752015-12-0808 December 2015 SHN-002 Shine Medical Technologies, Inc.'S Responses to Commission'S Public Pre-Hearing Questions ML15342A2382015-12-0808 December 2015 SHN-013 - Statement of Qualifications of C. Michael Launi ML15342A2372015-12-0808 December 2015 SHN-012 - Statement of Qualifications of Thomas Krzewinski ML15342A2362015-12-0808 December 2015 SHN-011 - Statement of Qualifications of Timothy P. Krause ML15342A2352015-12-0808 December 2015 SHN-010 - Statement of Qualifications of Catherine Kolb ML15342A2342015-12-0808 December 2015 SHN-009 - Statement of Qualifications of Alan Hull ML15342A2332015-12-0808 December 2015 SHN-008 - Statement of Qualifications of William Hennessy ML15342A2322015-12-0808 December 2015 SHN-007 - Statement of Qualifications of James Costedio ML15342A2312015-12-0808 December 2015 SHN-025 - Statement of Qualifications of Steven L. Zander ML15342A2302015-12-0808 December 2015 SHN-024 - Statement of Qualifications of Ernest Wright ML15342A2092015-12-0808 December 2015 SHN-004 - Statement of Qualifications of Joseph M. Aldieri ML15342A2282015-12-0808 December 2015 SHN-023 Statement of Qualifications of Tamela B. Wheeler ML15342A2272015-12-0808 December 2015 SHN-022 - Statement of Qualifications of George F. Vandergrift ML15342A2262015-12-0808 December 2015 SHN-021 - Statement of Qualifications of Eric N. Van Abel ML15342A2232015-12-0808 December 2015 SHN-020 - Statement of Qualifications of Louis Restrepo ML15342A2202015-12-0808 December 2015 SHN-019 Statement of Qualifications of Erwin T. Prater ML15342A2182015-12-0808 December 2015 SHN-018 Statement of Qualifications of Katrina M. Pitas ML15342A2142015-12-0808 December 2015 SHN-017 Statement of Qualifications of Greg Piefer ML15342A2132015-12-0808 December 2015 SHN-016 - Statement of Qualifications of William D. Newmyer ML15342A2122015-12-0808 December 2015 SHN-015 Statement of Qualifications of John B. Mclean ML15342A2112015-12-0808 December 2015 SHN-014 - Statement of Qualifications of James W. Mcintyre ML15342A2102015-12-0808 December 2015 SHN-005 - Statement of Qualifications of Jeffrey M. Bartelme ML15342A3862015-12-0808 December 2015 NRC-010 - Staff Presentation Slides - Overview (December 8, 2015) ML15342A4422015-12-0808 December 2015 NRC-006R - Shine Medical Technologies, Inc., Construction Permit Application - Environmental Report, (PSAR) Chapter 19, Figure 19.5.2-6 Through Figure 19.5.2-9 (August 27, 2015), ADAMS Accession No. ML15258A430 ML15342A4312015-12-0808 December 2015 NRC-006L - Shine Medical Technologies, Inc., Construction Permit Application - Environmental Report, (PSAR) Chapter 19, Figure 19.3.2-1 Through Figure 19.3.2-36 (August 27, 2015), ADAMS Accession No. ML15258A423 ML15342A3942015-12-0808 December 2015 NRC-002 - Draft Construction Permit for Shine Medical Technologies, Inc. (December 8, 2015) ML15342A3922015-12-0808 December 2015 NRC-004-R - NRC Staff Responses to Commission Pre-Hearing Questions, (Originally Filed on November 24, 2015), (Revised December 8, 2015) ML15342A3902015-12-0808 December 2015 NRC-013 - Staff Presentation Slides - Environmental Panel (December 8, 2015) ML15342A3892015-12-0808 December 2015 NRC-012 - Staff Presentation Slides - Safety Panel 2 (December 8, 2015) ML15342A2512015-12-0808 December 2015 SHN-029 - Shine Presentation Slides: Environmental Panel ML15342A3962015-12-0808 December 2015 NRC-008 - Safety Evaluation Report Related to Shine Medical Technologies, Inc. Construction Permit Application for a Medial Radioisotope Production Facility, (Revised December 8, 2015) ML15342A1742015-11-24024 November 2015 SHN-001 - Applicant'S Pre-Filed Testimony of James Costedio for the Mandatory Hearing on Uncontested Issues for the Shine Medical Technologies, Inc. Medical Radioisotope Production Facility ML15342A3952015-11-17017 November 2015 NRC-003 - Draft Record of Decision for Shine Medical Technologies, Inc. Construction Permit Application (November 17, 2015), ADAMS Accession No. ML15272A019 ML15342A3972015-10-31031 October 2015 NRC-009 - NUREG-2183, Final Environmental Impact Statement for the Construction Permit for the Shine Medical Radioisotope Production Facility (October 16, 2015), ADAMS Accession No. ML15288A046 ML15342A3932015-10-22022 October 2015 NRC-001 - SECY-15-0130, Staff Statement in Support of the Uncontested Hearing for Issuance of Construction Permit for the Shine Medical Technologies, Inc. Medical Radioisotope Production Facility (October 22, 2015), ADAMS Accession No. ML15 ML15342A4342015-09-16016 September 2015 NRC-006B - Shine Medical Technologies, Inc., Construction Permit Application - Updated General Information (September 16, 2015), ADAMS Accession No. ML15259A272 ML15342A4302015-08-27027 August 2015 NRC-006K - Shine Medical Technologies, Inc., Construction Permit Application - Environmental Report, (PSAR) Chapter 19 Figure 19.3.1-7 Through Figure 19.3.1-9 (August 27, 2015) ML15342A4262015-08-27027 August 2015 NRC-006J - Shine Medical Technologies, Inc., Construction Permit Application - Environmental Report, (PSAR) Chapter 19, Figure 19.3.1-1 Through Figure 19.3.1-6 (August 27, 2015). ML15258A421 ML15342A4322015-08-27027 August 2015 NRC-006M - Shine Medical Technologies, Inc., Construction Permit Application - Environmental Report, (PSAR) Chapter 19, Figure 19.3.3-1 Through Figure 19.3.3-7 (August 27, 2015) ML15342A4352015-08-27027 August 2015 NRC-006C - Shine Medical Technologies, Inc., Construction Permit Application - Preliminary Safety Analysis Report (Psar), Beginning Through Chapter 2, Figure 2.3-36 (August 27, 2015) ML15342A4362015-08-27027 August 2015 NRC-006D - Shine Medical Technologies, Inc., Construction Permit Application - (Psar), Chapter 2, Figure 2.4-1 Through Figure 2.4-11 (August 27, 2015), ADAMS Accession No. ML15258A395 2015-09-16
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Exhibit SHN-018 Katrina M. Pitas Experience Vice President of Business Development, SHINE Medical Technologies May 2014-present Responsible for the development and execution of all sales, marketing and public relations activities Monitors, understands and communicates market trends and their implications Develops and maintains high-profile external relationships with customers, professional and industry organizations, government agencies, and media Identifies potential strategic partners, alliances and relationships to expand core product lines or bring new product lines to the organization Partners with engineering to identify new product possibilities Serves as a member of the executive leadership team Environment, Safety & Health Manager, SHINE Medical Technologies Dec 2011-May 2014 Managed Facility and Laboratory Administrator Managed all non-NRC and non-FDA permitting and regulatory compliance needs for the future facility (OSHA, FAA, DNR, county, city, etc)
Wrote company Radiological Environmental Monitoring Plan Responsible for ensuring existing facility regulatory compliance Developed grant proposals for DOE/NNSA Developed budgets and project schedule input for ES&H work for the future facility Research Associate, SHINE Medical Technologies Feb 2011- Dec 2011 First employee of newly formed SHINE Medical Reported to CEO with duties focused on regulatory affairs, project controls, scheduling, market analysis, grant writing, fund raising support, waste issues and technical research Research Associate, Phoenix Nuclear Labs Feb 2009 - Feb 2011 Built, maintained, and repaired hardware associated with the fusion neutron source consisting of a deuterium ion source, 300 kV accelerator, and gas target Developed and edited technical portions of grant proposals Laboratory and shop work included machining and part fabrication, soldering and electronics troubleshooting, and work with sensitive vacuum equipment as well as high voltage Prepared progress reports on work done for Army Phase I SBIR award Designed and installed laboratory compressed air distribution system Helped troubleshoot 300 kV power supply Set up and maintained company telephone system
Education Carleton College, Northfield, MN 2007 Bachelor of Arts, magna cum laude GPA: 3.503 Physics, major Distinction on physics comprehensive exercise Japanese, concentration (minor)
Exhibit SHN-018 Katrina M. Pitas Experience Vice President of Business Development, SHINE Medical Technologies May 2014-present Responsible for the development and execution of all sales, marketing and public relations activities Monitors, understands and communicates market trends and their implications Develops and maintains high-profile external relationships with customers, professional and industry organizations, government agencies, and media Identifies potential strategic partners, alliances and relationships to expand core product lines or bring new product lines to the organization Partners with engineering to identify new product possibilities Serves as a member of the executive leadership team Environment, Safety & Health Manager, SHINE Medical Technologies Dec 2011-May 2014 Managed Facility and Laboratory Administrator Managed all non-NRC and non-FDA permitting and regulatory compliance needs for the future facility (OSHA, FAA, DNR, county, city, etc)
Wrote company Radiological Environmental Monitoring Plan Responsible for ensuring existing facility regulatory compliance Developed grant proposals for DOE/NNSA Developed budgets and project schedule input for ES&H work for the future facility Research Associate, SHINE Medical Technologies Feb 2011- Dec 2011 First employee of newly formed SHINE Medical Reported to CEO with duties focused on regulatory affairs, project controls, scheduling, market analysis, grant writing, fund raising support, waste issues and technical research Research Associate, Phoenix Nuclear Labs Feb 2009 - Feb 2011 Built, maintained, and repaired hardware associated with the fusion neutron source consisting of a deuterium ion source, 300 kV accelerator, and gas target Developed and edited technical portions of grant proposals Laboratory and shop work included machining and part fabrication, soldering and electronics troubleshooting, and work with sensitive vacuum equipment as well as high voltage Prepared progress reports on work done for Army Phase I SBIR award Designed and installed laboratory compressed air distribution system Helped troubleshoot 300 kV power supply Set up and maintained company telephone system
Education Carleton College, Northfield, MN 2007 Bachelor of Arts, magna cum laude GPA: 3.503 Physics, major Distinction on physics comprehensive exercise Japanese, concentration (minor)