ML18110A607

Acceptance for Review of Request for Exemption from Requirements of 10 CFR 70.21(F) for the Target Fabrication Portion of the Northwest Medical Isotopes Radioisotope Production Facility

ML18110A607
Person / Time
Site:	Northwest Medical Isotopes
Issue date:	04/26/2018
From:	David Tiktinsky Division of Fuel Cycle Safety, Safeguards, and Environmental Review
To:	Haass C Northwest Medical Isotopes
Tiktinsky D
References
Download: ML18110A607 (2)

Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 26, 2018 Ms. Carolyn C. Haass, Chief Operating Officer Northwest Medical Isotopes, LLC 815 NW 9th Ave, Suite 256 Corvallis, OR 97330

SUBJECT:

ACCEPTANCE FOR REVIEW OF REQUEST FOR EXEMPTION FROM REQUIREMENTS OF 10 CFR 70.21(F) FOR THE TARGET FABRICATION PORTION OF THE NORTHWEST MEDICAL ISOTOPES RADIOISOTOPE PRODUCTION FACILITY The U.S. Nuclear Regulatory Commission (NRC) has received your submittal dated December 18, 2017 (Agencywide Documents Access and Management System [ADAMS]

Accession Number ML17362A040, entered into ADAMS on December 28, 2017), Northwest Medical Isotopes (NWMI) submitted an exemption request from the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Paragraph 70.21(f), filing, for the 10 CFR Part 70 target fabrication portion of the Radioisotope Production Facility. NWMI previously submitted an application for a construction permit for a production facility under 10 CFR Part 50.

On February 6, 2018, the staff held a teleconference (ADAMS ML18052A056, dated February 15, 2018) with NWMI to discuss supplemental information that the NRC staff would need to initiate the review of the exemption request.

On March 12, 2018, (ADAMS ML18088A175, entered into ADAMS on March 29, 2018) NWMI submitted additional information to supplement its exemption request.

We have completed our acceptance review of your submittal and have identified no administrative omissions or deficiencies that would prevent us from proceeding with a detailed review. Please note that the complete review of this submittal may identify issues that require additional information. Based on our preliminary evaluation and projection of current schedules, we anticipate completing our review by June 30, 2018. This date could change depending on the findings of our technical review, urgent assignments, or other factors. We will promptly communicate any significant changes that may result in any schedule delays.

In accordance with 10 CFR Section 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records System component of the NRCs ADAMS. ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).

CHaass If you have any questions concerning this letter, please contact me at 301-415-8740, or via e-mail to David.Tiktinsky@nrc.gov.

Sincerely,

\RA\

David Tiktinsky, Senior Project Manager Fuel Manufacturing Branch Division of Fuel Cycle Safety, Safeguards, and Environmental Review Office of Nuclear Material Safety and Safeguards Docket No. 05000609

C. Haass

SUBJECT:

ACCEPTANCE FOR REVIEW OF REQUEST FOR EXEMPTION FROM REQUIREMENTS OF 10 CFR 70.21(F) FOR THE TARGET FABRICATION PORTION OF THE NORTHWEST MEDICAL ISOTOPES RADIOISOTOPE PRODUCTION FACILITY DATED: April 26, 2018 DISTRIBUTION:

FCSE, r/f NMSS, r/f ADAMS Accession Number: ML18110A607 *via email OFC FCSE/FMB FCSE/FMB NRR FSCE NAME DTiktinsky TBrockington MBalazik* RJohnson DATE 4/23/18 4/25/18 4/ 24/18 4/26/18 OFFICIAL RECORD COPY

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 26, 2018 Ms. Carolyn C. Haass, Chief Operating Officer Northwest Medical Isotopes, LLC 815 NW 9th Ave, Suite 256 Corvallis, OR 97330

SUBJECT:

ACCEPTANCE FOR REVIEW OF REQUEST FOR EXEMPTION FROM REQUIREMENTS OF 10 CFR 70.21(F) FOR THE TARGET FABRICATION PORTION OF THE NORTHWEST MEDICAL ISOTOPES RADIOISOTOPE PRODUCTION FACILITY The U.S. Nuclear Regulatory Commission (NRC) has received your submittal dated December 18, 2017 (Agencywide Documents Access and Management System [ADAMS]

Accession Number ML17362A040, entered into ADAMS on December 28, 2017), Northwest Medical Isotopes (NWMI) submitted an exemption request from the requirements of Title 10 of the Code of Federal Regulations (10 CFR) Paragraph 70.21(f), filing, for the 10 CFR Part 70 target fabrication portion of the Radioisotope Production Facility. NWMI previously submitted an application for a construction permit for a production facility under 10 CFR Part 50.

On February 6, 2018, the staff held a teleconference (ADAMS ML18052A056, dated February 15, 2018) with NWMI to discuss supplemental information that the NRC staff would need to initiate the review of the exemption request.

On March 12, 2018, (ADAMS ML18088A175, entered into ADAMS on March 29, 2018) NWMI submitted additional information to supplement its exemption request.

We have completed our acceptance review of your submittal and have identified no administrative omissions or deficiencies that would prevent us from proceeding with a detailed review. Please note that the complete review of this submittal may identify issues that require additional information. Based on our preliminary evaluation and projection of current schedules, we anticipate completing our review by June 30, 2018. This date could change depending on the findings of our technical review, urgent assignments, or other factors. We will promptly communicate any significant changes that may result in any schedule delays.

In accordance with 10 CFR Section 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records System component of the NRCs ADAMS. ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html (the Public Electronic Reading Room).

CHaass If you have any questions concerning this letter, please contact me at 301-415-8740, or via e-mail to David.Tiktinsky@nrc.gov.

Sincerely,

\RA\

David Tiktinsky, Senior Project Manager Fuel Manufacturing Branch Division of Fuel Cycle Safety, Safeguards, and Environmental Review Office of Nuclear Material Safety and Safeguards Docket No. 05000609

C. Haass

SUBJECT:

ACCEPTANCE FOR REVIEW OF REQUEST FOR EXEMPTION FROM REQUIREMENTS OF 10 CFR 70.21(F) FOR THE TARGET FABRICATION PORTION OF THE NORTHWEST MEDICAL ISOTOPES RADIOISOTOPE PRODUCTION FACILITY DATED: April 26, 2018 DISTRIBUTION:

FCSE, r/f NMSS, r/f ADAMS Accession Number: ML18110A607 *via email OFC FCSE/FMB FCSE/FMB NRR FSCE NAME DTiktinsky TBrockington MBalazik* RJohnson DATE 4/23/18 4/25/18 4/ 24/18 4/26/18 OFFICIAL RECORD COPY