ML20153F786
| ML20153F786 | |
| Person / Time | |
|---|---|
| Issue date: | 09/25/1998 |
| From: | Michele Burgess NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Vondera V ARMY, DEPT. OF |
| References | |
| SSD, NUDOCS 9809290250 | |
| Download: ML20153F786 (5) | |
Text
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g i UNITED STATES
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NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20066 4 001
- September 25, 1998
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L Vemon E.Vondera Chief, Safety Office Department of the Army U.S. Army Tank, Automotive, and Armaments Command ~
Rock Island, IL 61299-7630
Dear Mr. Vondera:
1 i
This letter is in response to the information submitted in your application dated December 8, 1997, and subsequent letters thereto, requesting registration of the Model ACADA cell module for use by persons exempt from licensing in accordance with 10 CFR 30.20. We have reviewed the additionalinformation submitted, and have identified the following issues that remain to be addressed:
l 1. Please provide the following:
- a. engineering drawings (including dimensions, tolerances, and materials) for the drift tube and manifold blocks that the cells are contained in. Please mark the locations of the tamper-resistant screws.
- b. assembly drawing of the DTM.
- 2. Please provide dose rates before and after the drop tests performed as described in item number 4b and Enclosure 1 of your response that demonstrate that the change in dose rate does not exceed 20%.
- 3. . Your response to item number 5 indicated that the users will not be required to perform leak tests. Please verify your understanding that no requirements may be placed on the /g users of exempt use products, and that this includes all aspects of use and maintenance, as well as, leak testing. Please verify that you will ensure that the
- instructions that you will provide to the user do not state, or imply, that any of the
~ instructions are NRC requirements.
- 4. ' The information provided to date regarding the quality assurance / quality control (QA/QC) procedures does not clearly demonstrate that it satisfies the requirements in Appendix C to Reg'ulatory Guide (RG) 6.9. . Please provide information regarding the following remaining issues:
- a. Please verify that the design conformity checks under the QA/QC program will ensure that the following are in accordance with commitments, as submitted oursuant to reoistration of this oroduct:'(1) dimensions, (2) materials, (3) any manufacturing and assembly notes (4) label content and placement, and (5) that the devices contain the proper tamper-resistant screws in the proper locations.
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- b. Please verify that the sampling rate for the design conformity checks will satisfy the minimum requirements in Appendix C of RG 6.9.
- c. Please verify that if you will do less then 100% inspection, then for lots that fail inspection, they will be either (1) 100% rejected, or (2) 100% retested for the inspection criteria that the sample unit tailed.
.d. Please note that Department of the Army /U.S. Army Tank, Automotive, and Armaments Command will be considered ultimately responsible for ensuring that ,
the commitments, as submitted oursuant to ranintration of this oroduct. are met.
Please verify that the Department of the Army /U.S. Army Tank, Automotive, and '
l_ Armaments Command will have sufficient control over the " Defense Contract Management Command-Northem Europe" in order to ensure this. ,
- 5. Regarding your plan, in item number 13, to recall specifically licensed units currently in the field, please provide: (1) whether all will be recalled or if some will remain in use as specifically licensed units, (2) if al1 units are to be recalled, how you will ensure that no specifically licensed remain in the field, and (3) estimated timeframes for initiation / completion of the recall.
Please provide the requested information within thirty (30) days of the date of this letter. If we do not receive complete information, that fully aduresses all issues, within thirty (30) days of the date of this letter, we will consider your application as having been abandoned by you. This is without prejudice to the resubmission of a complete application. If you have any questions, please contact me at (301) 415-5868, Steve Baggett at (301) 415-7273.
Sincerely, 3
Michele L. urgess,' Mechanical Engineer Materials Safety Branch.
Division of Industrial and Medical Nuclear Safety
- Office of Nuclear Material Safety 4
~ and Safeguards Distnbution:
IMNS r/f SSD-97 NE02-SSD-1
' DOCUMENT NAME: H:\SJL%CADA.'DE4
- . 71 resehe o ear of this document indsete in the hes: "C" = Copy without ettschment/ enclosure "E' = Copy with attachment /e'wlosure "N" = No copv OFFICE -
NAME.
MSB MBurgess/mbW/M lC -l l l ' N~
DATE 09/.,25 /98 '
OFFICIAL RECORD COPY
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