ML20199B238

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Refers to 971211 Fax Requesting Confirmation of Understanding of Distribution of Exempt Quantities of Licensed Matl.Also Refers to 971210 & 11 Telcons Re Transfer of Exempt Quantities of Licensed Matl
ML20199B238
Person / Time
Issue date: 12/30/1997
From: Kinneman J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To: Raig W
AFFILIATION NOT ASSIGNED
Shared Package
ML20199B240 List:
References
NUDOCS 9801280211
Download: ML20199B238 (3)


Text

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DEC 30 }gg7 Wendi D. Raig, Radiation Safety Officer Triangle Pharmaceuticals 4 University Place 4611 University Drive Durham, North Carolina 27707

Dear Ms. Raig:

This refers to your letter 'eceived by facsimile on December 11,1997 requesting confirmation of your understanding of distribution of exempt quantitles of licensed material. It also refers to the telephone conversations un December 10 and 11,1997, between you and Betsy Ullrich and Richard Gibson of this office regarding transfer of exempt quantities of licensed material. We understand that you are a licensee of the State of North Carolina, and wish to send samples labelled wi,th carbon-14 to collaborators in an NRC reguland state in Region 1. As a state licensee, you should contact the State of North Carolina to be sure that you are in compliance with the state regulations.

Your understanding of the NRC regulations concerning distribution of exempt quantitles, as documented in your letter, are correct. As discussed with you during the telephone conversations, in accordance with the NRC regulations found in Title 10, Code of Federal Regulations, Part 30.18 (10 CFR 30.18) " Exempt Quantitles", any person is exempt from the requirements for a license to the extent tha'. the person receives, possess, uses, transfers, owns, or acquires byproduct materials in individual quantities which do not exceed the applicable quantity listed in 10 CFR 30.71, Schedule B. The applicable quantity for carbon-14 is 100 microcuries.10 CFR 30.18(c) and (d) prohibits commercial distribution of such exempt quantities, unless the distributor is authorized pursuant to 10 CFR 32.18 for commercial distribution of e exempt quantities. Therefore, you may send labelled samples to a collaborator, and they may receive the samples, if the indi/idual quantities are less than 100 microcuries and if this is not a commercial distribution.

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Triangle Pharmaceuticals 2 If you have any additional questions, we will be pleased to discuss them with you. ,

~ Sincerely, f'

ORIGINAL SIGNED BY:  ;

John D. Kinneman, Chief Nuclear Materials Safety Branch 2 Division of Nuclear Materials Safety '

Enclosures:

10 CFR Parts 30 and 32 cc:

State of North Carolina e

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. OFFICIAL RECORD COPY -

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W. Held 3 Triangle Pharrnaceuticals Distribution: (w/o encl)

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