ML20030A152
| ML20030A152 | |
| Person / Time | |
|---|---|
| Issue date: | 02/03/2020 |
| From: | Thi Herrera NRC/NMSS/DMSST/MSLB |
| To: | Schilthelm S BWXT ITG Canada |
| Herrera T | |
| Shared Package | |
| ML20015A008 | List: |
| References | |
| 20-09 | |
| Download: ML20030A152 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 February 3, 2020 BWXT ITG Canada, Inc.
ATTN: Steven Schilthelm Director, Regulatory Affairs 109 Ramsey Place Lynchburg, VA 24501
SUBJECT:
BWXT ITG CANADA, INCORPORATED AMENDED SEALED SOURCE AND DEVICE REGISTRATION CERTIFICATE NR-1490-D-101-S
Dear Mr. Schilthelm:
This is in response to the BWXT ITG Canada, Inc. (BWXT ITG) letter dated January 9, 2020, requesting an amendment to Sealed Source and Device Registration Certificate NR-1490-D-101-S to provide a copy of BWXT ITGs ISO quality management certificate. In addition, staff identified that a Food and Drug Administration Approval Summary section that should have been included in the registration was not included, the section has been added as part of your amendment request. We have completed our review of your request, and a copy of the amended registration NR-1490-D-101-S is enclosed.
Please be advised that you must manufacture and distribute any registered product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificates. A registration certificate is meant to indicate that your product is acceptable for licensing purposes but does not authorized distribution or possession of radioactive material. As a general rule, you must request and obtain an amendment to the certificate before you make changes or modifications to the information submitted to obtain the certificate.
Please read over the registration certificate in its entirety and notify us immediately of any errors or omissions.
You are obligated to notify us promptly in writing if you decide to no longer manufacture, distribute, or offer service support for the product.
S. Schilthelm 2
If you have any questions, please contact me at Tomas.Herrera@nrc.gov or at (301) 415-7138.
Sincerely,
/RA/
Tomas Herrera, Team Leader Materials Safety and Tribal Liaison Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Amended Registration NR-1490-D-101-S
ML20030A152 OFC NMSS/MSTB NMSS/MSTB NMSS/MSTB NAME THerrera LSepulveda THerrera DATE 2/3/2020 2/3/2020 2/3/2020