ML19352E902
| ML19352E902 | |
| Person / Time | |
|---|---|
| Issue date: | 12/19/2019 |
| From: | Thi Herrera NRC/NMSS/DMSST/MSLB |
| To: | John Miller International Isotopes |
| Herrera T | |
| Shared Package | |
| ML19269B721 | List: |
| References | |
| SSD 19-40 | |
| Download: ML19352E902 (3) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 December 19, 2019 International Isotopes, Inc.
ATTN: John J. Miller Radiation Safety Officer 4137 Commerce Circle Idaho Falls, ID 83401
SUBJECT:
REQUEST FOR ADDITIONAL INFORMATION FOR INTERNATIONAL ISOTOPES, INCORPORATED AMENDMENT REQUEST DATED SEPTEMBER 24, 2019
Dear Mr. Miller:
This letter is in response to your letter requesting to amend NR-1235-S-107-S, dated September 24, 2019, for the safety evaluation of the new Source Model BM83-12. In reviewing your request, we find that additional information is required to complete our evaluation. In the enclosure to this letter, we have summarized the issues not addressed in your request.
Please be aware that you may request that certain portions of your submittal to the U.S. Nuclear Regulatory Commission (NRC) be withheld from public disclosure as proprietary information.
To do this, you must execute an affidavit as specified in Title 10 of the Code of Federal Regulations (10 CFR) Section 2.390. You must list all portions that you wish to be withheld as proprietary, along with your reasoning as to why that is appropriate.
Please submit the requested information within 30 calendar days of the date of this letter. If we have not received complete information within 30 days, we will consider your request as having been abandoned by you. This is without prejudice to the submission of a complete new request.
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:
Request for Additional Information
J. Miller 2
SUBJECT:
REQUEST FOR ADDITIONAL INFORMATION FOR INTERNATIONAL ISOTOPES, INCORPORATED AMENDMENT REQUEST DATED SEPTEMBER 24, 2019 DATED: December 19, 2019 DISTRIBUTION:
SSD 19-40 ADAMS ACCESSION No.: ML19352E902 OFFICE MSST/MSTB MSST/MSTB MSST/MSTB NAME THerrera CValentin- THerrera Rodriguez DATE 12/18/2019 12/18/2019 12/19/2019 OFFICIAL RECORD COPY
INTERNATIONAL ISOTOPES, INC.
AMENDMENT REQUEST DATED SEPTEMBER 24, 2019 REQUEST FOR ADDITIONAL INFORMATION The U.S. Nuclear Regulatory Commission (NRC) staff has reviewed the International Isotopes, Inc. (International Isotopes) amendment request dated September 24, 2019 and determined that additional information is needed. In order to continue with our review, please address the issues listed below. This information is required by Title 10 of the Code of Federal Regulations (10 CFR) Section 32.210 and described in the relevant guidance document NUREG-1556, Volume 3, Revision 2, titled Applications for Sealed Source and Device Evaluation and Registration.
Description/Construction
- 1. We note that Source Model BM83-12 most closely resembles Source Model BM83-40, currently registered in NR-1235-S-107-S. Please describe the similarities and differences between the two source models.
- 2. Please identify the type of stainless used in the construction of Source Model BM83-12.
- 3. On Page 2 of 5 of your amendment request, International Isotopes listed the Active Length of Source Model BM83-12 as 27.67 cm. However, the active length is listed as 260 mm in Drawing No. B008312. Please explain the difference in the dimensions.
In addition, please confirm the overall length of the source assembly.
Labeling
- 4. We note that the label provided on Page 3 of 5 of your request is different from the labeling included in your current registration certificate in that it does not identify International Isotopes, Inc. as the manufacturer of the source. Please indicate if this is an updated label to be used in all products in NR-1235-S-107-S or confirm that the submitted label will only be used for Source Model BM83-12.
Quality Assurance
- 5. Please confirm that there have been no changes in the International Isotopes quality assurance program since the last amendment to NR-1235-S-107-S.
Enclosure