ML20212B714
| ML20212B714 | |
| Person / Time | |
|---|---|
| Issue date: | 09/15/1999 |
| From: | Kirkwood A NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Sia P AFFILIATION NOT ASSIGNED |
| References | |
| NUDOCS 9909200219 | |
| Download: ML20212B714 (2) | |
Text
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4 September 15,1999 Homewatch, Limited
~ ATTN: P.K.B. Sia 1906 Chung Tat Centre 18 Chung Lee Street Chal Wan, Hong Kong
Dear Mr. Sia:
This refers to your request of September 15,1999, 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 and 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 regulatory jurisdiction 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 l
Sections 32.26,32.27, and 32.29(c), and in Regulatory Guide 6.9 (RG 6.9) " Establishing lD Quality Assurance Programs For The Manufacturing And Distribution Of Sealed Sources And Devices Containing Byproduct Material" and NUREG-1556, Vol. 8, " Consolidated Guidance About Materials Licenses, Program-specific Guidance About Exempt Distribution Licenses," and n
NUREG-1556, Vol. 3, " Consolidated Guidance About Material Licenses, Applications for Q^
Sealed Source and Device Evaluation and Registration." While it is not necessary that you y
provide a sample of the smoke detectors, you should submit detailed drawings of the device y
and an example of the point-of-sale package. You may submit previous information if the device has already been registered in the United States.
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." NRC allows 90 days for the processing of a new exempt
- distribution license. You may contact Frederick Sturz, email: fes@nrc.aov. for registration information.
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P. Sk Regarding the fees required for NRC, you should contact Ms. Sandra Kimberley, of the License Fee and Debt Collection Branch, at (301) 415-6096, for fee information. Payment of the fee should be mailed, along with the application package, to the U.S. Nuclear Regulatory
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Commission, Office of Nuclear Material Safety and Safeguards, Division of Industrial and Medical Nuclear Safety, Washington, DC 20555. Please note that this fee F3 only for an NRC exempt distribution license and/or a device review.
For your use in understanding and applying for a distribution license and device review, I have enclosed reference copies of:
Regulatory Guide 6.9; 10 CFR Parts 30,32,170, and 171; and NUREG's-1556, Vol. 8 and 1556, Vol. 3.
If I can be of further assistance, please contact me at (301) 415-6140 or e-mail ask@nrc. gov.
Sincerely, Original S!gned By:
Anthony S. KMmood i
' Anthony S. Kirkwood Materials Safety and Inspection Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. NRC Form 313
' 2. Reg Guide 6.9 3.' 10 CFR Parts 30,32,170, and 171 4.- NUREG's-1556, Vol. 8 and 1556, Vol. 3 i
DISTRIBUTION:
NRC File Room -
lMNS Central File SLKimberley/LFARB j
PDR-YES TSKime LDOCUMENT NAME: HAEXEMPM2.26\\APPLTRS\\HOMEWATCH.WPD l
- C = COVER E = COVER & ENCLOSURE N = NO COPY OFc MSIB K(
NAME
' ASKirkwood:ask DATE 9/tg /99 OFFICIAL RECORD COPY