ML20237C132

Refers to Request Re Application Process for Obtaining License Per Section 32.22,10CFR32,authorizing Distribution of Products Containing Tritium Vials

ML20237C132
Person / Time
Issue date:	08/17/1998
From:	Kirkwood A NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Jacqwan Walker AFFILIATION NOT ASSIGNED
References
NUDOCS 9808200236
Download: ML20237C132 (2)

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August 17,1998 Nanoptics, Inc..

ATTN:. James Walker, Ph.D 3014 NE 21st Way Gainesville, Florida 32609

Dear Dr. Walker:

This refers to your request concerning the application process for obtaining a license pursuant to Section 32.22,10 CFR Part 32, authorizing the distribution of products containing tritium vials. The address for SRB Technologies, Inc. is 2597 Landmark Dr., P.O. Box 5536, Winston-l Salem, NC - 27103 and 21st Century Technologies is 2513 E Loop 820 N, Fort Worth, Tx i

76118-6919. I am unable to find the address for Lumitec.

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1 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 possession and use of byproduct material from the U.S. Nuclear Regulatory Commission.

(NRC) whose address can be found on the enclosed NRC Form 313, or an Agreement State, whoever has jurisdiction.

As an applicant wishing to distribute or initially transfer products containing byproduct material,

such as tritium vials, to persons exempt from licensing, you must also obtain an exempt distribution license from the NRC. Prior to licensing your tritium vials for distribution, it will be

' necessary for our Sealed Source Safety Engineers to perform a device review pursuant to the issuance of a device registration sheet.' The product information to be submitted for your

. distribution license and device registration is outlined in 10 CFR Part 32, specifically in Sections 32.22,32.23, and 32.25, and in Regulatory Guidet 6.9 and NUREG's 1556, Vol. 3 and 1562.

While it is not necessary that you provide a sample of the tritium viais, you should submit detailed drawings of the device indicating the location and content of the required label.

Your application for a distribution license should not contain information conceming the possession and use of radioactive material as covered in your possession license. Therefore, I

while you should address all the questions on the _NRC Form 313 for your possession license, you should only answer questions 1 through 6, and 12 and 13 for your distribution license Application.. Submit your distribution application to the U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Division of Industrial and Medical Nuclear Safety, Washington, DC. 20555.

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! For information regarding the fees required, you should contact Ms. Sandra Kimberley of the i

~ License Fee and Accounts Receivable Branch, at (301) 415-6096. Payment of the fee should i

' be mailed with the appropriate application package.

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4 Walker.

For your use in applying for a distribution license and device registration, I have enclosed reference copies of Regulatory Guide 6.9, NUREG's 1556, Vol. 3 and 1562, and 10 CFR Pads 2,19,20,30,32,170, and 171.

If I can be of further assistance, please contact me at (301) 415-6140.

Sincerely, Original Signed By:

Anthcny S. Kirkw'00d Anthony S. Kirkwood Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards

Enclosures:

1. NRC Form 313

2. Reg Guide 6.9

3. 10 CFR Pads 2,19, 20, 30, 32, 170, and 171 l

4. NUREG's 1556, Vol. 3 and 1562 DISTRIBUTION:

NRC File Room IMNS r/f SLBaggett PDR - ask 1

DOCUMENT NAME: H:\\ EXEMPT \\32.22\\APPLTRS\\NANOPTICS C = COVER E = COVER & ENCLOSURE N = NO COPY oFC MSB NMSs M

NAME ASKirkwood ask DATE 08/17/98 OFFiclAL RECORD COPY 1

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