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{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 16, 2018  
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 16, 2018 Memorandum to Applicant and Counsel for Staff:
 
Memorandum to Applicant and Counsel for Staff:  
 
Attached is a revised scheduling note for the U.S. Nuclear Regulatory Commission (NRC) evidentiary session to receive testimony and exhibits in the uncontested proceeding regarding the application from Northwest Medical Isotopes, LLC (NWMI), for a construction permit to construct a medical radioisotope production facility in Columbia, Missouri. The hearing will be held on January 23, 2018, beginning at 9:00 a.m. Eastern Time in the Commissioners' Conference Room on the first floor of the NRC's Headquarters building at One White Flint North, Rockville, Maryland.
Attached is a revised scheduling note for the U.S. Nuclear Regulatory Commission (NRC) evidentiary session to receive testimony and exhibits in the uncontested proceeding regarding the application from Northwest Medical Isotopes, LLC (NWMI), for a construction permit to construct a medical radioisotope production facility in Columbia, Missouri. The hearing will be held on January 23, 2018, beginning at 9:00 a.m. Eastern Time in the Commissioners' Conference Room on the first floor of the NRC's Headquarters building at One White Flint North, Rockville, Maryland.
The scheduling note will also be posted on our public website at http://www.nrc.gov/reading-rm/doc-collections/commission/tr/2018/.
The scheduling note will also be posted on our public website at http://www.nrc.gov/reading-rm/doc-collections/commission/tr/2018/.
If you have any questions, please contact Ms. Denise McGovern (denise.mcgovern@nrc.gov, 301-415-0681) of my staff.
If you have any questions, please contact Ms. Denise McGovern (denise.mcgovern@nrc.gov, 301-415-0681) of my staff.
Sincerely,  
Sincerely,
 
                                              /RA/
/RA/                 Annette L. Vietti-Cook    
Annette L. Vietti-Cook


==Enclosure:==
==Enclosure:==


As stated  
As stated


1  FINAL: 1/16/18   SCHEDULING NOTE Title:
FINAL: 1/16/18 SCHEDULING NOTE Title:             HEARING ON CONSTRUCTION PERMIT FOR NORTHWEST MEDICAL ISOTOPES PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)
HEARING ON CONSTRUCTION PERMIT FOR NORTHWEST MEDICAL ISOTOPES PRODUCTION FACILITY:
Purpose:           To receive testimony and exhibits regarding the application of Northwest Medical Isotopes, LLC, for a medical radioisotope production facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staffs review that are important for the Commission to make its final decision. The Commission will determine whether the staffs review has been adequate to support the findings in 10 C.F.R. §§ 50.35(a), 50.40, 50.50, and 51.105(a).
SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting) Purpose: To receive testimony and exhibits regarding the application of Northwest Medical Isotopes, LLC, for a medical radioisotope production facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staff's review that are important for the Commission to make its final decision. The Commission will determine whether the staff's review has been adequa te to support the findings in 10 C.F.R. §§ 50.35(a), 50.40, 50.50, and 51.105(a).
Scheduled:          January 23, 2018 9:00 am Duration:          1 day Location:          Commissioners Conference Room, 1st Floor OWFN NOTE: Chairman to provide opening remarks, admit exhibits, and swear              20 mins.
in witnesses.
Participants:                                                                Presentation (Note: Witnesses seated at the table are listed, other staff available to answer questions will be seated in the well and reserved rows.)
Overview (Northwest Medical Isotopes, LLC) (9:20 am)                            30 mins.*
At the table:
Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Roy Brown, Vice President, Curium Pharma Topic: Overview Commission Q & A (round of questions; 6 minutes each)                          18 mins.**
1


Schedule d:   January 23, 201 8  9:00 am Duration:
Overview (NRC Staff)                                                            30 mins.*
1 day Location:
At the table:
Commissioners' Conference Room, 1st Floor OWFN
Michele Evans, Deputy Director for Reactor Safety Programs and Mission Support, Office of Nuclear Reactor Regulation (NRR)
Mary Jane Ross-Lee, Deputy Director, Division of Licensing Projects, NRR Joseph Donoghue, Deputy Director, Division of Materials and License Renewal (DMLR), NRR Brian Smith, Deputy Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)
Topic: Overview of the staffs methodology for its review of the NWMI construction permit application and summary of key regulatory findings.
Commission Q & A (round of questions; 6 minutes each)                          18 mins.**
BREAK                                                                            5 mins.
NOTE: For the remaining panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and regulatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.
Safety Panel 1 (11:05 am)
Applicant                                                                        5 mins.*
At the table:
Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Gary Dunford, Process Engineering Manager, NWMI (AEM Consulting, Inc.)
Michael Corum, Senior Technical Advisor, NWMI Staff                                                                          12 mins.*
At the table:
Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Michael Balazik, Project Manager, Research and Test Reactors Licensing Branch, NRR David Tiktinsky, Senior Project Manager, Fuel Manufacturing Branch (FMB), NMSS Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Topic: Sections of the application and the following chapters from 2


NOTE: Chairman to provide open ing remarks, admit exhibits, and swear 20 mins.              in witnesses.
the Safety Evaluation Report:
Participants:                  Pre sentation  (Note: Witnesses seated at the table are listed, other staff available to answer questions will be seated in the well and reserved rows.)
Chapter 1, The Facility, and Chapter 4 Radioisotope Production Facility Description, including discussion of the unique licensing considerations; Colocation of Production Facility and Target Fabrication Area, and Quality Assurance Implementation.
Overview (Northwest Medical Isotopes, LLC)
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
(9:20 am)        30 mins.*  At the table:
o   Chapter 2, Site Characteristics o   Chapter 3, Design of Structures, Systems, and Components o   Chapter 5, Coolant Systems o   Chapter 6, Engineered Safety Features o   Chapter 12, Conduct of Operations***
Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Roy Brown, Vice President, Curium Pharma Topic:  Overview Commission Q & A (round of questions; 6 minutes each) 18 mins.**
Commission Q & A (round of questions; 6 minutes each)                         18 mins.**
2  Overview (NRC Staff)                                                                                        30 mins.*  At the table:
BREAK (Lunch Break-Approx. 11:45-1:15 pm)
Michele Evans , Deputy Director for Reactor Safety Programs and Mission Support, Office of Nuclear Reactor Regulation (NRR)
Safety Panel 2 (1:15 pm)
Mary Jane Ross-Lee , Deputy Director, Division of Licensing Projects, NRR Joseph Donoghue , Deputy Director, Division of Materials and License    Renewal (DMLR), NRR Brian Smith, Deputy Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)
Applicant                                                                       5 mins.*
Topic:  Overview of the staff's methodology for its review of the NWMI construction permit application and summary of key regulatory findings.
At the table:
Commission Q & A (round of questions; 6 minutes each) 18 mins.**  BREAK                  5 mins. NOTE:  For the remaining panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and regulatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.
Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Gary Dunford, Process Engineering Manager, NWMI (AEM Consulting, Inc.)
Safety Panel 1 (11:05 am)  Applicant                5 mins.* At the table:
Michael Corum, Senior Technical Advisor, NWMI Staff                                                                         12 mins.*
Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Gary Dunford
At the table:
, Process Engineering Manager, NWMI (AEM Consulting, Inc.)
Michael Balazik, Project Manager, Research and Test Reactors Licensing Branch, NRR April Smith, Reliability and Risk Analyst, Programmatic Oversight and Regional Support Branch, NMSS David Tiktinsky, Senior Project Manager, FMB, NMSS James Hammelman, Senior Chemical Engineer, FMB, NMSS Topic: Sections of the application and the following chapters from the Safety Evaluation Report:
Michael Corum
Chapter 13, Accident Analysis, including discussion of novel application of 10 CFR Part 70 accident analysis methodologies 3
, Senior Technical Advisor, NWMI  Staff 12 mi ns.* At the table:
Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Michael Balazik
, Project Manager, Research and Test Reactors Licensing Branch, NRR David Tiktinsky
, Senior Project Manager , Fuel Manufacturing Branch    (FMB), NMSS Steven Lynch , Project Manager, Research and Test Reactors Licensing Branch, NRR  Topic:  Sections of t he application and the following chapters from
 
3  the Safety Evaluation Report:
Chapter 1, "The Facility,"
and Chapter 4 "Radioisotope Production Facility Description,"
including discussion of the unique licensing considerations; Colocation of Production Facility and Target Fabrication Area, and Quality Assurance Implementation. Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
o Chapter 2, "Site Characteristics" o Chapter 3, "Design of Structures, Systems, and Components" o Chapter 5, "Cool ant Systems" o Chapter 6, "Engineered Safety Features" o Chapter 12, "Conduct of Operations"***
Commission Q & A (round of questions; 6 minutes each) 18 mins.**   BREAK (Lunch Break
-Approx. 11:45-1:15 pm)           Safety Panel 2 (1:15 pm) Applicant               5 mins.* At the table:
Carolyn Haass, Chief Operating Officer, NWMI Steven Reese , Irradiation Services Manager, NWMI Gary Dunford
, Process Engineering Manager, NWMI (AEM Consulting,     Inc.) Michael Corum
, Senior Technical Advisor, NWMI   Staff 12 mi ns.* At the table:
Michael Balazik, Project Manager, Research and Test Reactors Licensing Branch , NRR April Smith
, Reliability and Risk Analyst, Programmatic Oversight and Regional Support Branch, NMSS David Tiktinsky , Senior Project Manager, FMB, NMSS James Hammelman
, Senior Chemical Engineer, FMB, NMSS Topic: Sections of t he application and the following chapters from the Safety Evaluation Report:
Chapter 13, "Accident Analys is," including discussion of novel application of 10 CFR Part 70 accident analysis methodologies  


4  for radiological and chemical exposure accidents.
for radiological and chemical exposure accidents.
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.
o Chapter 7, "Instrumentation and Control Systems" o Chapter 8, "Electrical Power Systems" o Chapter 9, "Auxiliary Systems" o Chapter 11, "Radiation Protection Program and Waste Management" o Chapter 14, "Technical Specifications" o Chapter 15, "Financial Qualifications"  Commission Q & A (round of questions; 6 minutes each) 18 mins.** Environmental Panel (1:50 pm) Applicant             10 mins.* At the table:
o Chapter 7, Instrumentation and Control Systems o Chapter 8, Electrical Power Systems o Chapter 9, Auxiliary Systems o Chapter 11, Radiation Protection Program and Waste Management o Chapter 14, Technical Specifications o Chapter 15, Financial Qualifications Commission Q & A (round of questions; 6 minutes each)                       18 mins.**
Carolyn Haass, Chief Operating Officer, NWMI Steven Reese , Irradiation Services Manager, NWMI Staff 25 mi ns.* At the table:
Environmental Panel (1:50 pm)
Ben jamin Beasley
Applicant                                                                     10 mins.*
, Chief, Environmental Review and NEPA Branch, NRR Nancy Martinez, Physical Scientist, NRR Michelle Moser, Biologist, NRR David Drucker
At the table:
, Senior Project Manager, NRR Topic: Final Environmental Impact Statement Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:
Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Staff                                                                       25 mins.*
o The decision to prepare an EIS o Scope and connected actions o The scoping process o The staff's independent review and analysis o Issuance of the Draft EIS, public meeting on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts of the proposed action on the following resource areas: land use, visual resources, air  
At the table:
 
Benjamin Beasley, Chief, Environmental Review and NEPA Branch, NRR Nancy Martinez, Physical Scientist, NRR Michelle Moser, Biologist, NRR David Drucker, Senior Project Manager, NRR Topic: Final Environmental Impact Statement
quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice o Consultations with other Federal, State, and local agencies and Tribes
* Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:
 
o The decision to prepare an EIS o Scope and connected actions o The scoping process o The staffs independent review and analysis o Issuance of the Draft EIS, public meeting on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts of the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice o Consultations with other Federal, State, and local agencies and Tribes 4
5  Discuss the analysis of alternatives including; Range of reasonable alternatives , Alternative site , Alternative technologies, and the No-action alternative Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission Q & A (round of questions; 6 minutes each) 18 mins.**
* Discuss the analysis of alternatives including; Range of reasonable alternatives, Alternative site, Alternative technologies, and the No-action alternative
BREAK 5 mins.
* Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission Q & A (round of questions; 6 minutes each)                           18 mins.**
BREAK                                                                             5 mins.
Closing (2:50 pm)
Closing (2:50 pm)
Closing Statement by Applicant 10 mins.* Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass, Chief Operating Officer, NWMI Roy Brown, Vice President, Curium Pharma
Closing Statement by Applicant                                                   10 mins.*
 
Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass, Chief Operating Officer, NWMI Roy Brown, Vice President, Curium Pharma Closing Statement by Staff                                                     10 mins.*
Closing Statement by Staff                                                                             10 mins.* Michele Evans, Deputy Director for Reactor Safety Programs and Mission Support, NRR Commission Q & A a nd Closing State ments 18 mins.**
Michele Evans, Deputy Director for Reactor Safety Programs and Mission Support, NRR Commission Q & A and Closing Statements                                        18 mins.**
 
*For presentation only and does not include time for Commission Q & As.
*For presentation only and does not i nclude time for Commission Q & A's. **All Commissio ners will ha ve an opportunity to ask questions after each pan el. Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.
**All Commissioners will have an opportunity to ask questions after each panel. Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.
  *** Chapter 12, "Conduct of Operations," of the staff's S ER includes evaluations of NWMI's quality assurance program description and preliminary emergency plan.
*** Chapter 12, Conduct of Operations, of the staffs SER includes evaluations of NWMIs quality assurance program description and preliminary emergency plan.
 
5
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of )
  ) NORTHWEST MEDICAL ISOTOPES, LLC ) 
)  Docket No. 50-609-CP  )  (Medical Radioisotope Production Facility)  )    ) (Mandatory Hearing)    )
 
CERTIFICATE OF SERVICE
 
I hereby certify that copies of the foregoing MEMORANDUM FROM THE SECRETARY PROVIDING REVISED SCHEDULING NOTE have been served upon the following persons by Electronic Information Exchange.
 
U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication
 
Mail Stop: O-16B33 Washington, DC  20555-0001
 
ocaamail@nrc.gov
 
U.S. Nuclear Regulatory Commission Office of the General Counsel


Mail Stop: O-14A44 Washington, DC 20555-0001 Mitzi Young, Esq.
UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of                                  )
Jeremy Wachutka, Esq.
                                                  )
Catherine Scott, Esq.
NORTHWEST MEDICAL ISOTOPES, LLC                    )
                                                  )        Docket No. 50-609-CP
                                                  )
(Medical Radioisotope Production Facility)        )
                                                  )
(Mandatory Hearing)                                )
CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing MEMORANDUM FROM THE SECRETARY PROVIDING REVISED SCHEDULING NOTE have been served upon the following persons by Electronic Information Exchange.
U.S. Nuclear Regulatory Commission                U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication        Office of the Secretary of the Commission Mail Stop: O-16B33                                Mail Stop: O-16B33 Washington, DC 20555-0001                          Washington, DC 20555-0001 ocaamail@nrc.gov                                  hearing.docket@nrc.gov U.S. Nuclear Regulatory Commission                Carolyn Haass Office of the General Counsel                      Chief Operating Officer Mail Stop: O-14A44                                 Northwest Medical Isotopes, LLC Washington, DC 20555-0001                         22500 Hope Dale Avenue Mitzi Young, Esq.                                 Parker, CO 80138 Jeremy Wachutka, Esq.                             carolyn.haass@nwmedicalisotopes.com Catherine Scott, Esq.
Catherine Kanatas, Esq.
Catherine Kanatas, Esq.
John Tibbetts, Paralegal mitzi.young@nrc.gov jeremy.wachutka@nrc.gov catherine.scott@nrc.gov catherine.kanatas@nrc.gov john.tibbets@nrc.gov
John Tibbetts, Paralegal mitzi.young@nrc.gov jeremy.wachutka@nrc.gov catherine.scott@nrc.gov catherine.kanatas@nrc.gov john.tibbets@nrc.gov
 
[Original signed by Herald M. Speiser   ]
U.S. Nuclear Regulatory Commission Office of the Secretary of the Commission Mail Stop:  O-16B33 Washington, DC  20555-0001 hearing.docket@nrc.gov
Office of the Secretary of the Commission Dated at Rockville, Maryland, this 16th day of January, 2018}}
 
Carolyn Haass Chief Operating Officer Northwest Medical Isotopes, LLC 22500 Hope Dale Avenue Parker, CO 80138 carolyn.haass@nwmedicalisotopes.com
 
[Original signed by Herald M. Speiser     ]
Office of the Secretary of the Commission  
 
Dated at Rockville, Maryland, this 16 th day of January, 2018}}

Revision as of 05:40, 22 October 2019

Memorandum from the Secretary Providing Revised Scheduling Note
ML18016A763
Person / Time
Site: Northwest Medical Isotopes
Issue date: 01/16/2018
From: Annette Vietti-Cook
NRC/SECY
To:
NRC/OGC, Northwest Medical Isotopes
SECY RAS
References
50-609-CP, Construction Permit Mndtry Hrg, RAS 54169
Download: ML18016A763 (7)
v • d • e


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 January 16, 2018 Memorandum to Applicant and Counsel for Staff:

Attached is a revised scheduling note for the U.S. Nuclear Regulatory Commission (NRC) evidentiary session to receive testimony and exhibits in the uncontested proceeding regarding the application from Northwest Medical Isotopes, LLC (NWMI), for a construction permit to construct a medical radioisotope production facility in Columbia, Missouri. The hearing will be held on January 23, 2018, beginning at 9:00 a.m. Eastern Time in the Commissioners' Conference Room on the first floor of the NRC's Headquarters building at One White Flint North, Rockville, Maryland.

The scheduling note will also be posted on our public website at http://www.nrc.gov/reading-rm/doc-collections/commission/tr/2018/.

If you have any questions, please contact Ms. Denise McGovern (denise.mcgovern@nrc.gov, 301-415-0681) of my staff.

Sincerely,

/RA/

Annette L. Vietti-Cook

Enclosure:

As stated

FINAL: 1/16/18 SCHEDULING NOTE Title: HEARING ON CONSTRUCTION PERMIT FOR NORTHWEST MEDICAL ISOTOPES PRODUCTION FACILITY: SECTION 189A OF THE ATOMIC ENERGY ACT PROCEEDING (Public Meeting)

Purpose: To receive testimony and exhibits regarding the application of Northwest Medical Isotopes, LLC, for a medical radioisotope production facility construction permit. The testimony will focus on unique features of the facility or novel issues that arose as part of the review process and other significant technical or policy issues associated with aspects of the staffs review that are important for the Commission to make its final decision. The Commission will determine whether the staffs review has been adequate to support the findings in 10 C.F.R. §§ 50.35(a), 50.40, 50.50, and 51.105(a).

Scheduled: January 23, 2018 9:00 am Duration: 1 day Location: Commissioners Conference Room, 1st Floor OWFN NOTE: Chairman to provide opening remarks, admit exhibits, and swear 20 mins.

in witnesses.

Participants: Presentation (Note: Witnesses seated at the table are listed, other staff available to answer questions will be seated in the well and reserved rows.)

Overview (Northwest Medical Isotopes, LLC) (9:20 am) 30 mins.*

At the table:

Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Roy Brown, Vice President, Curium Pharma Topic: Overview Commission Q & A (round of questions; 6 minutes each) 18 mins.**

1

Overview (NRC Staff) 30 mins.*

At the table:

Michele Evans, Deputy Director for Reactor Safety Programs and Mission Support, Office of Nuclear Reactor Regulation (NRR)

Mary Jane Ross-Lee, Deputy Director, Division of Licensing Projects, NRR Joseph Donoghue, Deputy Director, Division of Materials and License Renewal (DMLR), NRR Brian Smith, Deputy Director, Division of Fuel Cycle Safety, Safeguards and Environmental Review, Office of Nuclear Material Safety and Safeguards (NMSS)

Topic: Overview of the staffs methodology for its review of the NWMI construction permit application and summary of key regulatory findings.

Commission Q & A (round of questions; 6 minutes each) 18 mins.**

BREAK 5 mins.

NOTE: For the remaining panels, the applicant is expected to discuss the contents of the construction permit application while the staff is expected to discuss its review process and regulatory conclusions. Each panel should include a discussion of any permit conditions associated with the subject matter of the panel.

Safety Panel 1 (11:05 am)

Applicant 5 mins.*

At the table:

Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Gary Dunford, Process Engineering Manager, NWMI (AEM Consulting, Inc.)

Michael Corum, Senior Technical Advisor, NWMI Staff 12 mins.*

At the table:

Alexander Adams, Jr., Chief, Research and Test Reactors Licensing Branch, NRR Michael Balazik, Project Manager, Research and Test Reactors Licensing Branch, NRR David Tiktinsky, Senior Project Manager, Fuel Manufacturing Branch (FMB), NMSS Steven Lynch, Project Manager, Research and Test Reactors Licensing Branch, NRR Topic: Sections of the application and the following chapters from 2

the Safety Evaluation Report:

Chapter 1, The Facility, and Chapter 4 Radioisotope Production Facility Description, including discussion of the unique licensing considerations; Colocation of Production Facility and Target Fabrication Area, and Quality Assurance Implementation.

Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.

o Chapter 2, Site Characteristics o Chapter 3, Design of Structures, Systems, and Components o Chapter 5, Coolant Systems o Chapter 6, Engineered Safety Features o Chapter 12, Conduct of Operations***

Commission Q & A (round of questions; 6 minutes each) 18 mins.**

BREAK (Lunch Break-Approx. 11:45-1:15 pm)

Safety Panel 2 (1:15 pm)

Applicant 5 mins.*

At the table:

Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Gary Dunford, Process Engineering Manager, NWMI (AEM Consulting, Inc.)

Michael Corum, Senior Technical Advisor, NWMI Staff 12 mins.*

At the table:

Michael Balazik, Project Manager, Research and Test Reactors Licensing Branch, NRR April Smith, Reliability and Risk Analyst, Programmatic Oversight and Regional Support Branch, NMSS David Tiktinsky, Senior Project Manager, FMB, NMSS James Hammelman, Senior Chemical Engineer, FMB, NMSS Topic: Sections of the application and the following chapters from the Safety Evaluation Report:

Chapter 13, Accident Analysis, including discussion of novel application of 10 CFR Part 70 accident analysis methodologies 3

for radiological and chemical exposure accidents.

Note that the panel will not have specific topics to discuss for the following chapters. If the Commission wishes to ask questions on these chapters, this panel would be the appropriate time.

o Chapter 7, Instrumentation and Control Systems o Chapter 8, Electrical Power Systems o Chapter 9, Auxiliary Systems o Chapter 11, Radiation Protection Program and Waste Management o Chapter 14, Technical Specifications o Chapter 15, Financial Qualifications Commission Q & A (round of questions; 6 minutes each) 18 mins.**

Environmental Panel (1:50 pm)

Applicant 10 mins.*

At the table:

Carolyn Haass, Chief Operating Officer, NWMI Steven Reese, Irradiation Services Manager, NWMI Staff 25 mins.*

At the table:

Benjamin Beasley, Chief, Environmental Review and NEPA Branch, NRR Nancy Martinez, Physical Scientist, NRR Michelle Moser, Biologist, NRR David Drucker, Senior Project Manager, NRR Topic: Final Environmental Impact Statement

  • Provide a summary of the process for developing the Final Environmental Impact Statement (EIS) including:

o The decision to prepare an EIS o Scope and connected actions o The scoping process o The staffs independent review and analysis o Issuance of the Draft EIS, public meeting on the Draft EIS, and solicitation of stakeholder comments on the Draft EIS o The environmental impacts of the proposed action on the following resource areas: land use, visual resources, air quality and noise, water resources, ecological resources, historic and cultural resources, socioeconomics, human health, transportation, waste management, and environmental justice o Consultations with other Federal, State, and local agencies and Tribes 4

  • Discuss the analysis of alternatives including; Range of reasonable alternatives, Alternative site, Alternative technologies, and the No-action alternative
  • Summarize conclusions and recommendation including a summary of the benefits and costs of the proposed action Commission Q & A (round of questions; 6 minutes each) 18 mins.**

BREAK 5 mins.

Closing (2:50 pm)

Closing Statement by Applicant 10 mins.*

Nicholas Fowler, Chief Executive Officer, NWMI Carolyn Haass, Chief Operating Officer, NWMI Roy Brown, Vice President, Curium Pharma Closing Statement by Staff 10 mins.*

Michele Evans, Deputy Director for Reactor Safety Programs and Mission Support, NRR Commission Q & A and Closing Statements 18 mins.**

  • For presentation only and does not include time for Commission Q & As.
    • All Commissioners will have an opportunity to ask questions after each panel. Commissioners will start the Q&A with their total time allotted to allocate as they see fit among the panels.
      • Chapter 12, Conduct of Operations, of the staffs SER includes evaluations of NWMIs quality assurance program description and preliminary emergency plan.

5

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of )

)

NORTHWEST MEDICAL ISOTOPES, LLC )

) Docket No. 50-609-CP

)

(Medical Radioisotope Production Facility) )

)

(Mandatory Hearing) )

CERTIFICATE OF SERVICE I hereby certify that copies of the foregoing MEMORANDUM FROM THE SECRETARY PROVIDING REVISED SCHEDULING NOTE have been served upon the following persons by Electronic Information Exchange.

U.S. Nuclear Regulatory Commission U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication Office of the Secretary of the Commission Mail Stop: O-16B33 Mail Stop: O-16B33 Washington, DC 20555-0001 Washington, DC 20555-0001 ocaamail@nrc.gov hearing.docket@nrc.gov U.S. Nuclear Regulatory Commission Carolyn Haass Office of the General Counsel Chief Operating Officer Mail Stop: O-14A44 Northwest Medical Isotopes, LLC Washington, DC 20555-0001 22500 Hope Dale Avenue Mitzi Young, Esq. Parker, CO 80138 Jeremy Wachutka, Esq. carolyn.haass@nwmedicalisotopes.com Catherine Scott, Esq.

Catherine Kanatas, Esq.

John Tibbetts, Paralegal mitzi.young@nrc.gov jeremy.wachutka@nrc.gov catherine.scott@nrc.gov catherine.kanatas@nrc.gov john.tibbets@nrc.gov

[Original signed by Herald M. Speiser ]

Office of the Secretary of the Commission Dated at Rockville, Maryland, this 16th day of January, 2018

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