ML20196B248

Responds to Recent Request Re Application Process for Obtaining General License,Authorizing Use of Byproduct Matl for Certain in Vitro Clinical Testing

ML20196B248
Person / Time
Issue date:	11/24/1998
From:	Raddatz C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Sepulveda M AFFILIATION NOT ASSIGNED
References
NUDOCS 9812010025
Download: ML20196B248 (2)

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Al U.NITED STATES (p ~l.

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WASHINGTON, D.C. 20555 4001

<*yE****J November 24, 1998 i

' -Soratorio Clinico Heg-Marr i

A t TN.: Mary Sepulveda, Lab Director P.O. Box 4571 Vega Baja, PR 00694

Dear Ms. Sepulveda:

' The purpose of this letter is to respond to your recent request concerning the appiication process for obtaining a generallicense pursuant to Section 31.11 of Title 10 of the Code of Federal Regulations (10 CFR 31.11), authorizing the use of byproduct material for certain in vitro clinical testing.

In 10 CFR 31.11,"Generallicense for use of byproduct material", NRC establishes a general license authorizing clinical laboratories to receive, acquire, possess, or use certain small l

quantities of byproduct material for in vitro tests not involving " medical use" (i.e., not involving administration to humans). Section 31.11 fucher explains the requirements for using the materials listed. If the generallicense alone meets your needs, only the enclosed NRC Form 483, " Registration Certificate - In Vitro Testing With Byproduct Material Under General License," need be filed with the NRC. The completed form 483 should be mailed to the Director

. of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,-

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. D.C. 20555-0001.

in 10 CFR 31.11, the NRC limits possession to a total eJ 200 microcuries, at any time, of photon emitting materials listed in 10 CFR 30.11. If you need more than 200 microcuries of these rnaterials, you must apply for a specific license from the NRC Region ll office. You may request the increased inventory limit on the enclosed NRC Form 313 application. If you request an L

increased inventory limit, you will be subject to the requirements of 10 CFR Parts 19,20,21, and j

35, including the requirements for waste disposal. If needed, the completed form 313 should be mailed to Atlanta Federal Center, U.S. Nuclear Regulatory Commission, Region 11,61 Forsyth Street, S.W., Suite 23T85, Atlanta, GA 30303-3415.

For your use in applying for a license, I have enclosed a copy of forms 483 and 313, as well as

,10 CFR Parts 19,20,21,31,35,170 and 171, l

i If you need a specific license, please contact Ms. Sandra Kimberley, of the License Fee and Accounts Receivable Branch, at (301) 415-6096, for further information. Payment of fees should be mailed with the appropriate application package. There is no fee for a general

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I trust this has been. responsive to your request, however if you have any additional questions, please contact Raeann Shane of my staff at (301) 415-7832.

Sincerely, 6

Charleen T Raddatz Deputy Chief, Materiais Safety Branch -

Division of industrial and Medical Nuclear Safety Office of Nuclear Materials Safety and Safeguards

Enclosures:

- 1. NRC Forms 483 and 313 2.210 CFR Parts 19, 20, 21, 30, 31, 35,' 170, and 171

~ D.STRIBUTION: Closed IMNS 7213 W

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