ML19063C203
| ML19063C203 | |
| Person / Time | |
|---|---|
| Issue date: | 03/07/2019 |
| From: | Lymari Sepulveda NRC/NMSS/DMSST/MSLB |
| To: | Arzate K Varian Medical Systems |
| Sepulveda L | |
| Shared Package | |
| NKL18278A007 | List: |
| References | |
| SSD 19-02 | |
| Download: ML19063C203 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 7, 2019 Varian Medical Systems, Inc.
ATTN: Mrs. Katherine Arzate Brachytherapy Radiation Safety Officer 3100 Hansen Way Palo Alto, CA 94304
SUBJECT:
U.S. NUCLEAR REGULATORY COMMISSION APPROVAL OF VARIAN MEDICAL SERVICES, INC. REQUEST FOR WITHHOLDING INFORMATION FROM PUBLIC DISCLOSURE
Dear Mrs. Arzate:
Varian Medical Services, Inc. submitted an affidavit dated September 18, 2018, executed by Steven Joseph Nguyen, requesting that the marked documents and drawings included in your application submitted in connection to your request to your sealed safety and device registration certificate and exempt distribution license be withheld from public disclosure pursuant to Title 10 of the Code of Federal Regulations (10 CFR) 2.390.
The affidavit stated that the submitted information should be considered exempt from mandatory public disclosure because the documents provide details on the design and the information is unavailable in other public documents and is of the type that if disclosed publicly, would cause substantial harm to Varian Medical Services, Inc.
We have reviewed your application and the material in accordance with the requirements of 10 CFR 9.17 and 2.390 and, on the basis of your statements, have determined that the submitted information sought to be withheld contains trade secrets or confidential or privileged commercial or financial information and should be withheld from public disclosure.
Therefore, Varian Medical Services, Inc. information in the letters dated September 18, 2018 and December 12, 2018, will be withheld from public disclosure pursuant to 10 CFR 9.17 and 10 CFR 2.390(b)(4) 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 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 U.S. Nuclear Regulatory Commission (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 Freedom of Information Act request includes your information. In all review situations, if the NRC makes a determination adverse to the above, you will be notified of the date of public disclosure, in advance which will be a reasonable time thereafter.
K. Arzate 2 If you have any questions, please contact me at (301) 415-5619, or by e-mail at Lymari.Sepulveda@nrc.gov.
Sincerely,
/RA/
Lymari Sepulveda, Mechanical Engineer Materials Safety Licensing Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
ML19063C203 OFC NMSS/MSST NMSS/MSST NMSS/MSST NAME LSepulveda THerrera LSepulveda DATE 3/5/2019 3/7/2019 3/7/2019