ML20217Q808

Responds to Request Re Application Process for Obtaining License Per Section 32.21,10CFR32,authorizing Distribution of Capsules Containing C-14 Urea as Exempt Quantities

ML20217Q808
Person / Time
Issue date:	05/05/1998
From:	Kirkwood A NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Doyle T External (Affiliation Not Assigned)
References
NUDOCS 9805110116
Download: ML20217Q808 (2)

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J May 5,' 1998 1

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. Ballard Medical Products

' ATTN: Tom Doyle 12050 Lone Peak Parkway 1

Draper, Utah 84020 i

Dear Mr. Doyle:

I am responding to your recent request concerning the application process for obtaining a license pursuant to Section 32.21,10 CFR Part 32, authorizing the distribution'of I

capsules containing carbon-14 urea as exempt quantities.

I

' 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 State of Utah:

William J. Sinclair, Director Division of Radiation Control

- Department of Environmental Quality.

168 North 1950 West

' P. O. Box 144850

. Salt Lake City, Utah 84114-4850 PH (801) 536-4250 FX (801) 533-4097 - INET:

eqrad.bsinclai@email. state.ut.us ~

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As an applicant wishing to distribute or initially transfer products containing byproduct material, such as capsules containing carbon-14 urea, to persons exempt from.

f)h3 licensing, you must also obtain an exempt distribution license from the U.S. Nuclear qgfj i

p Regulatory Commission. The product inforrnation to be submitted for your distribution f license is outlined in 10 CFR Part 32, specifically in Sections 32.21, 32.21(a), and i

' 32 72(a)(2)_and-in NUREG-1562.-

Your application for a distribution license should not contain information concerning the i

1 possession and use of radioactive material as covered in your possession license.

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. Therefore, you should answer only questions 1 through 6, and 12 and 13 on the enclosed NRC Form 313," Application for M 4

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l T. Doyle Regarding the fees required,'you should contact Ms. Sandra Kimberley of the License

' Fee and Accounts Receivable Eranch, at (301) 415-6096, for fee information. ' Payment of fees 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 a distribution license.

For your use in applying for a distribution license, I have enclosed reference copies of 10 CFR Parts 30, 32,170, and.171, Federal Register No.(FR) 63640 and NUREG-1562.-

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

Sincerely,.

Original Signed By:-

Anthony S. Kirkwood Anthony S. Kirkwood Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards

Enclosures:

1. NRC Form 313

2. NUREG-1562 3.10 CFR Parts 30,32, 170, and 171

4. FR 63640 DISTRIBUTION:

NRC File Room-IMNS r/f SLBaggett PDR - Yes

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l DOCUMENT NAME: H:\\ EXEMPT \\32.21\\APPLTRS\\BALLARD C = COVER E = COVER & ENCLOSURE N = NO COPY l

OFC NMSS:MSB W

NAME ASKirkwood:ask DATE 05/05/98 OFFICIAL RECORD COPY I

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