ML15271A014

Northwest Medical Isotopes, LLC - Acknowledgement of Receipt and Availability, Application for Construction Permit Part Two - Letter

ML15271A014
Person / Time
Site:	Northwest Medical Isotopes, PROJ0803
Issue date:	11/05/2015
From:	Michael Balazik Research and Test Reactors Branch B
To:	Haass C Northwest Medical Isotopes
Balazik M, NRR/DPR, 301-415-2856
Shared Package
ML15271A002	List: ML15271A005 ML15271A014
References
TAC MF6138
Download: ML15271A014 (4)

Text

November 5, 2015 Carolyn C. Haass Vice President Northwest Medical Isotopes, LLC 8815 Northwest 9th Street, Suite 256 Corvallis, OR 97330

SUBJECT:

NORTHWEST MEDICAL ISOTOPES, LLC - ACKNOWLEDGMENT OF RECEIPT OF PART TWO OF THE APPLICATION FOR CONSTRUCTION PERMIT (TAC NO. MF6138)

Dear Ms. Haass:

By letter dated July 20, 2015, Northwest Medical Isotopes, LLC (NWMI), filed with the U.S.

Nuclear Regulatory Commission (NRC or the Commission) pursuant to Section 103 of the Atomic Energy Act, and Part 50 of Title 10 of the Code of Federal Regulations (10 CFR), the second and final part of its two-part application for a construction permit for a medical radioisotope production facility in Columbia, Missouri (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15086A262).

On November 7, 2014, NWMI submitted part one of its construction permit application to the NRC. By letter dated February 5, 2015 (ADAMS Accession No. ML15086A262, Package No.

ML15086A261), NWMI withdrew and resubmitted this portion of its construction permit application and included a discussion of connected actions in its environmental report in response to a January 23, 2015, letter from the NRC (ADAMS Accession No. ML14349A501).

The NRC staff acknowledged receipt of this partial application for a construction permit in the Federal Register (80 FR 22227) on April 21, 2015. An exemption from certain requirements of 10 CFR 2.101(a)(5) granted by the Commission on October 7, 2013 (ADAMS Accession No. ML13238A333 and 78 FR 63501), in response to a letter from NWMI dated August 9, 2013 (ADAMS Accession No. ML13227A295), allowed for NWMI to submit its construction permit application in two parts. Specifically, the exemption allowed NWMI to submit a portion of its application for a construction permit up to six months prior to the remainder of the application regardless of whether or not an environmental impact statement or a supplement to an environmental impact statement is prepared during the review of its application. In accordance with 10 CFR 2.101(a)(5), NWMI submitted the following in part one of the construction permit application:

the description and safety assessment of the site required by 10 CFR 50.34(a)(1),

the environmental report required by 10 CFR 50.30(f),

the filing fee information required by 10 CFR 50.30(e) and 10 CFR 170.21, the general information required by 10 CFR 50.33, and the agreement limiting access to classified information required by 10 CFR 50.37.

The NRC staff published in the Federal Register on June 8, 2015 (80 FR 32418), its determination that part one of NWMIs construction permit application is acceptable for docketing.

NWMI states that part two of its application for a construction permit contains the remainder of the preliminary safety analysis report required by 10 CFR 50.34(a).

The NRC staff will review part two of NWMIs application for a construction permit and make a determination on the completeness and acceptability for docketing of the application. Generally, this determination will be made within a period of thirty days. If the application is found acceptable, the NRC staff will docket the application. Should the NRC staff determine that the application is incomplete and not acceptable for processing, NWMI will be informed of the ways in which the application is deficient. Another completeness and acceptability review will be performed upon receipt of part two of NWMIs application for a construction permit.

Enclosed is the notice that will be forwarded to the Federal Register, informing the public of the receipt and availability of the subject application. To the extent possible, the NRC staff will communicate with NWMI any issues that arise during the acceptance review.

The NRC staff intends to publish a review schedule for part two of NWMIs construction permit application following the completion of the acceptance review.

If you have any questions, please contact me at Michael.Balazik@nrc.gov or 301-415-2856.

Sincerely,

/RA/

Michael F. Balazik, Project Manager Research and Test Reactors Licensing Branch Division of Policy and Rulemaking Office of Nuclear Reactor Regulation Docket No. 50-609

Enclosure:

Federal Register notice cc w/ encl.: See next page

Northwest Medical Isotopes Docket No. 50-609 cc:

Darrell Liles, CHP, PE Senior Health Physicist ARCADIS-SENES 8310 South Valley Highway Suite 135 Englewood, Colorado, 80112 Nicholas F. Fowler Chief Executive Officer Northwest Medical Isotopes, LLC 8815 Northwest 9th Street, Suite 256 Corvallis, OR 97330

Pkg: ML15271A002; Memo: ML15271A003; FRN: ML15271A005; Ltr: ML15271A014 OFFICE NRR/DPR/PRLB NRR/DPR/LA NRR/DPR/PRLB NRR/DPR/PRLB NAME MBalazik NParker AAdams MBalazik DATE 9/28/2015 9/30/2015 10/28/2015 11/5/2015