ML20154C517
| ML20154C517 | |
| Person / Time | |
|---|---|
| Issue date: | 09/30/1998 |
| From: | Kirkwood A NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Lau F HONG KONG |
| References | |
| NUDOCS 9810060296 | |
| Download: ML20154C517 (2) | |
Text
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k UNITED STATES g
j NUCLEAR REGULATORY COMMISSION g
WASHINGTON, D.C. 30666 4001 September 30,1998 Garvan Enterprises, Ltd.
ATTN: ' Freddie Lau Marketing Executive Rm 16-17,21/F., Wing Hing ind. Bldg.,
83-93 Chai Wan Kok St., Tsuen Wan, Hong Kong
Dear Mr. Lau:
This refers to your request of September 29,1998, concerning the application process for obtaining a license pursuant to Section 32.26,10 CFR Part 32, authorizing the distribution of smoke detectors, in order to possess aru use byproduct material, you must first satisfy the general requirements of 10 CFR 30.33. Therefore, you must apply for and obtain a specific license authorizing the possession and use of byproduct material. As a foreign entity you would have to establish an office in the United States for licensing and inspection purposes. Based on the state (s) from which a device will be manufactured and/or distributed, either submit the enclosed NRC Form 313 to the appropriate U.S. Nuclear Regulatory Commission (NRC) regional office or, since the NRC has no regulatoryjurisdiction in an Agreement State. contact the appropriate Agreement State office (s) for application information.
An applicant wishing to distribute or initially transfer products containing byproduct material, such as smoke detectors, to persons exempt from licensing, must also obtain an exempt distribution license. Prior to licensing smoke detectors for distribution, it will be necessary for our Sealed Source Safety Staff (or an Agreement State) to perform a device review pursuant to the issuance of a device registration sheet. The product information to be submitted for a distribution license and a device registration is outlined in 10 CFR Part 32, specifically in Sections 32.26,32.27, and 32.29(c), and in Regulatory Guide 6.9 and NUREG's 1562 and 1556, Vol 3. While it is not necessary that you provide a sample of the smoke detectors, you should submit detailed drawings of the device and an example of the point-of-sale package.
An application for a distribution license should not contain information concerning the
- possession and use of radioactive material as covered in a possession license. Therefore, you should only answer questions 1 through 6,12 and 13 on the enclosed NRC Form 313,
" Application for Material License."
Regarding the fees required for NRC, you should contact Ms. Sandra Kimberley, of the License 0
Fee and Debt Collection Branch, at (301) 415-6096, for fee information. Payment of the fee
- (oh should be mailed, along with the application package, to the U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Division of Industrial and Medical Nuclear Safety, Washington, DC 20555, Please note that this fee is only for an NRC exempt distribution license and/or a device review, L l ~ k n l ~) v f
i 9810060296 900930 PDR ORG NorlA PDR
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F.Lau l For your use'in understanding and applying for a distribution license and device review, I have enclosed reference copies of:
Regu!atory Gu'de 6.9; 1
i
.10 CFR Parts 30,32,170, and 171; and NUREG's-1562 and 1556, Vol.' 3.
If I can be of further assistance, please contact me at (301) 415-6140 or e-mail ask@nrc. gov.
1 Sincerely, Original Signed By:
Anthony S. Kl* wood Anthony S. Kirkwood Materials Safety Branch Division of industrial and Medical Nuclear Safety
' Office of Nuclear Material Safety l
and Safeguards Enclosurest
- 1. NRC Form 313
. 2. Reg Guide 6.9 l
3.10 CFR Parts 30,32,170, and 171
- 4. NUREG's-1562 and 1556, Vol. 3.
i DISTRIBUTION.
NRC File Room i
IMNS Central Fiie SLBaggett
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'DATE 09/30/98 l
- OFFICIAL RECORD COPY
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