ML010510164
| ML010510164 | |
| Person / Time | |
|---|---|
| Issue date: | 02/27/2001 |
| From: | Samson Lee NRC/NMSS/IMNS/MSIB |
| To: | Charette M MDS Nordion |
| References | |
| SSD 00-50 | |
| Download: ML010510164 (3) | |
Text
February 27, 2001 Marc-André Charette Regulatory Affairs Senior Associate MDS Nordion 447 March Road Kanata, Ontario Canada, K2K 1X8
SUBJECT:
ISSUANCE OF NR-0220-S-120-S FOR MODEL C-198 SOURCE
Dear Mr. Charette:
Based on the information submitted in your application dated December 14, 2000, and subsequent communication, we conclude that the Model C-198 is acceptable for licensing purposes in accordance with the conditions of the enclosed amended registration certificate (NR-0220-S-120-S).
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. 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.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRCs licensing and inspection fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-7544.
Please send us a request to amend the registration certificate number NR-0220-D-107-S because the Model C-198 source is listed in the certificate as to be used in the Model Gammacell 220 irradiator only. As we understand you wanted to remove this restriction and use the source in other irradiators.
If you have any questions, please contact me at (301) 415-5787 or Dr. John Jankovich at (301) 415-7904.
Sincerely,
/RA/
Seung J. Lee, Mechanical Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated cc w/encl:
SKimberley, LFDCB
Marc-André Charette Regulatory Affairs Senior Associate MDS Nordion 447 March Road Kanata, Ontario Canada, K2K 1X8
SUBJECT:
ISSUANCE OF NR-0220-S-120-S FOR MODEL C-198 SOURCE
Dear Mr. Charette:
Based on the information submitted in your application dated December 14, 2000, and subsequent communication, we conclude that the Model C-198 is acceptable for licensing purposes in accordance with the conditions of the enclosed amended registration certificate (NR-0220-S-120-S).
Please be advised that you must manufacture and distribute the product in accordance with the statements and representations contained in your application, with enclosures thereto, and the information set out in your registration certificate. 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.
Please be aware that, as a holder of an NRC registration, you may be subject to the NRCs licensing and inspection fees in accordance with 10 CFR Part 170, and annual fees in accordance with 10 CFR Part 171. If you have any questions concerning the fee requirements, please contact the License Fee and Debt Collection Branch at (301) 415-7544.
Please send us a request to amend the registration certificate number NR-0220-D-107-S because the Model C-198 source is listed in the certificate as to be used in the Model Gammacell 220 irradiator only. As we understand you wanted to remove this restriction and use the source in other irradiators.
If you have any questions, please contact me at (301) 415-5787 or Ms. Michele Burgess at (301) 415-7868.
Sincerely,
/RA/
Seung J. Lee, Mechanical Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated Distribution:
NMSS r/f IMNS r/f SSD-00-50 ML010510164 DOCUMENT NAME: K:\\Document Processing Center_Ascent\\ADAMSP8-2039\\downloads\\001 -
100\\038\\ML010510164.wpd To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy OFFICE MSIB E MSIB NAME SLee JJankovich DATE 02/20/01 02/ /01 OFFICIAL RECORD COPY