ML16081A210
| ML16081A210 | |
| Person / Time | |
|---|---|
| Site: | Northwest Medical Isotopes |
| Issue date: | 04/01/2016 |
| From: | James Danna Division of License Renewal |
| To: | Haass C Northwest Medical Isotopes |
| Martinez N, NRR/DLR, 415-2719 | |
| References | |
| Download: ML16081A210 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 1, 2016 Carolyn C. Haass Chief Operating Officer Northwest Medical Isotopes, LLC 815 Northwest 9th Street, Suite 256 Corvallis, OR 97330
SUBJECT:
REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE FOR NORTHWEST MEDICAL ISOTOPES, LLC RESPONSES TO ENVIRONMENTAL REQUEST FOR ADDITIONAL INFORMATION
Dear Ms. Haass:
By letter dated February 12, 2016 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML16053A204), you submitted an affidavit dated February 12, 2016 on behalf of Northwest Medical Isotopes, LLC (NWMI), requesting that the information contained in the following document be withheld from public disclosure pursuant to Title 10 of the Code of Federal Regulations (10 CFR), Section 2.390:
Attachment 2 - Non-Public Version of the Letter contains responses to the U.S. Nuclear Regulatory Commissions (NRCs) request for additional information dated January 19, 2016 (ADAMS Accession No. ML15364A376). A nonproprietary copy of this document has been placed in NRC's Public Document Room and added to the NRC Library in ADAMS (Accession No. ML16053A221).
The affidavit stated that the submitted information should be considered exempt from mandatory public disclosure for the following reasons:
In making this application for withholding of proprietary information of which it is the owner, NWMI believes that the information qualifies for withholding under the exemption from disclosure set forth in the Freedom of Information Act (FOIA), 5 U.S.C. Section 552(b)(4), the Trade Secrets Act, 18 U.S.C. Section 1905, and U.S. Nuclear Regulatory Commission (NRC) regulations 10 CFR 2.390(a)(4) for trade secrets and commercial information because:
- i. This information is and has been held in confidence by NWMI.
ii. This information is of a type that is customarily held in confidence by NWMI, and there is a rational basis for doing so because the information includes sensitive business information.
C. Haass iii. The information is being transmitted to the NRC voluntarily and in confidence.
iv. This information is not available in public sources and could not be gathered readily from other publicly available information.
- v. Public disclosure of this information would create substantial harm to the competitive position of NWMI by disclosing certain business decisions NWMI has made or is considering and the analysis that went behind those decisions.
Development and evaluation of this commercial information was achieved at, and disclosure could lead to additional, significant cost to NWMI.
vi. Public disclosure of the information sought to be withheld is likely to cause substantial harm to NWMI's competitive position and foreclose or reduce the availability of profit-making opportunities. The value of the information goes beyond the disclosure of actual information pertaining to NWMI's potential business, and includes substantial time and work towards developing the project, and represents significant efforts by NWMI and its associates. The research, development, engineering, and analytical costs comprise a substantial investment of time and money by NWMI. The precise value of the information is difficult to quantify, but clearly is substantial.
vii. NWMI's competitive advantage will be lost if its competitors are able to use the results of NWMI's activities to aid their own commercial activities. The value of this information to NWMI would be lost if the information were disclosed to the public. Making such information available to other entities without their having been required to undertake a similar expenditure of resources would unfairly provide competitors with a windfall, and deprive NWMI of the opportunity to exercise its competitive advantage to seek an adequate return on its large investment.
We have reviewed your application and the material in accordance with the requirements of 10 CFR 2.390 and, on the basis of the statements in the affidavit, have determined that the submitted information sought to be withheld contains proprietary commercial information and should be withheld from public disclosure.
Therefore, the Northwest Medical Isotopes, LLC Attachment 2 - Non-Public Version of the Letter, marked as proprietary will be withheld from public disclosure pursuant to 10 CFR 2.390(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended.
Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.
If the basis for withholding this information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a FOIA request includes your
C. Haass information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.
If you have any questions regarding this matter, please contact Ms. Nancy Martinez at 301-415-2719 or by e-mail at Nancy.Martinez@nrc.gov.
Sincerely,
/RA/
James G. Danna, Chief Environmental Review and Projects Branch Division of License Renewal Office of Nuclear Reactor Regulation Docket No. 50-609
ML16081A210 *concurrence via e-mail OFFICE LA:DLR PM:RERP:DLR PM:PRLB:DPR BC:RERP:DLR NAME IBetts NMartinez MBalazik JDanna DAT 3/22/16 3/24/16 3/28/16 4/1/16 UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 1, 2016 Carolyn C. Haass Chief Operating Officer Northwest Medical Isotopes, LLC 815 Northwest 9th Street, Suite 256 Corvallis, OR 97330
SUBJECT:
REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE FOR NORTHWEST MEDICAL ISOTOPES, LLC RESPONSES TO ENVIRONMENTAL REQUEST FOR ADDITIONAL INFORMATION
Dear Ms. Haass:
By letter dated February 12, 2016 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML16053A204), you submitted an affidavit dated February 12, 2016 on behalf of Northwest Medical Isotopes, LLC (NWMI), requesting that the information contained in the following document be withheld from public disclosure pursuant to Title 10 of the Code of Federal Regulations (10 CFR), Section 2.390:
Attachment 2 - Non-Public Version of the Letter contains responses to the U.S. Nuclear Regulatory Commissions (NRCs) request for additional information dated January 19, 2016 (ADAMS Accession No. ML15364A376). A nonproprietary copy of this document has been placed in NRC's Public Document Room and added to the NRC Library in ADAMS (Accession No. ML16053A221).
The affidavit stated that the submitted information should be considered exempt from mandatory public disclosure for the following reasons:
In making this application for withholding of proprietary information of which it is the owner, NWMI believes that the information qualifies for withholding under the exemption from disclosure set forth in the Freedom of Information Act (FOIA), 5 U.S.C. Section 552(b)(4), the Trade Secrets Act, 18 U.S.C. Section 1905, and U.S. Nuclear Regulatory Commission (NRC) regulations 10 CFR 2.390(a)(4) for trade secrets and commercial information because:
- i. This information is and has been held in confidence by NWMI.
ii. This information is of a type that is customarily held in confidence by NWMI, and there is a rational basis for doing so because the information includes sensitive business information.
C. Haass iii. The information is being transmitted to the NRC voluntarily and in confidence.
iv. This information is not available in public sources and could not be gathered readily from other publicly available information.
- v. Public disclosure of this information would create substantial harm to the competitive position of NWMI by disclosing certain business decisions NWMI has made or is considering and the analysis that went behind those decisions.
Development and evaluation of this commercial information was achieved at, and disclosure could lead to additional, significant cost to NWMI.
vi. Public disclosure of the information sought to be withheld is likely to cause substantial harm to NWMI's competitive position and foreclose or reduce the availability of profit-making opportunities. The value of the information goes beyond the disclosure of actual information pertaining to NWMI's potential business, and includes substantial time and work towards developing the project, and represents significant efforts by NWMI and its associates. The research, development, engineering, and analytical costs comprise a substantial investment of time and money by NWMI. The precise value of the information is difficult to quantify, but clearly is substantial.
vii. NWMI's competitive advantage will be lost if its competitors are able to use the results of NWMI's activities to aid their own commercial activities. The value of this information to NWMI would be lost if the information were disclosed to the public. Making such information available to other entities without their having been required to undertake a similar expenditure of resources would unfairly provide competitors with a windfall, and deprive NWMI of the opportunity to exercise its competitive advantage to seek an adequate return on its large investment.
We have reviewed your application and the material in accordance with the requirements of 10 CFR 2.390 and, on the basis of the statements in the affidavit, have determined that the submitted information sought to be withheld contains proprietary commercial information and should be withheld from public disclosure.
Therefore, the Northwest Medical Isotopes, LLC Attachment 2 - Non-Public Version of the Letter, marked as proprietary will be withheld from public disclosure pursuant to 10 CFR 2.390(b)(5) and Section 103(b) of the Atomic Energy Act of 1954, as amended.
Withholding from public inspection shall not affect the right, if any, of persons properly and directly concerned to inspect the documents. If the need arises, we may send copies of this information to our consultants working in this area. We will, of course, ensure that the consultants have signed the appropriate agreements for handling proprietary information.
If the basis for withholding this information from public inspection should change in the future such that the information could then be made available for public inspection, you should promptly notify the NRC. You also should understand that the NRC may have cause to review this determination in the future, for example, if the scope of a FOIA request includes your
C. Haass information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified in advance of any public disclosure.
If you have any questions regarding this matter, please contact Ms. Nancy Martinez at 301-415-2719 or by e-mail at Nancy.Martinez@nrc.gov.
Sincerely,
/RA/
James G. Danna, Chief Environmental Review and Projects Branch Division of License Renewal Office of Nuclear Reactor Regulation Docket No. 50-609
ML16081A210 *concurrence via e-mail OFFICE LA:DLR PM:RERP:DLR PM:PRLB:DPR BC:RERP:DLR NAME IBetts NMartinez MBalazik JDanna DAT 3/22/16 3/24/16 3/28/16 4/1/16