ML20140G307

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Responds to Re Labeling of in Vitro Diagnostic Test Kits.Circumstances May Preclude Labeling of Final Source Container W/Info Required by 10CFR32.71
ML20140G307
Person / Time
Issue date: 06/11/1997
From: Jeffery Lynch
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
To: Collins S
ILLINOIS, STATE OF
Shared Package
ML20140G311 List:
References
NUDOCS 9706160136
Download: ML20140G307 (1)


Text

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  1. 5"%q UNITED STATES h,

NUCLEAR REGULATORY COMMISSION 8

REGION HI I

Ea fE 801 WARRENVILLE ROAD

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usLE. ILUNOIS 60532-4351

...o June 11, 1997 i

Steven C. Collins, Chief Division of Radioactive Materials Illinois Department of. Nuclear Safety 1035 Outer Park Drive Springfield, IL 62704

Dear Mr. Collins:

This is in response to your May 28., 1997, letter to me regarding labeling of

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in vitro diagnostic test kits. The 1987 NRC memorandum that you referenced i

reflects the current policy for addressing labeling exemption requests for 10 CFR 32.71.

Circumstances may preclude labeling of a final source container with all of the information required by 10 CFR 32.71.

It is'important, however, that the i

required information be provided to the user of the test kits.

If the final source container cannot be effectively labeled with all of the required information in 10 CFR 32.71, we would suggest that the deleted information be placed on the next larger container or packaging.

If the final l

source container is packaged in bubble pack, then the information may be attached there.

If a larger box contains several units, the box may be an appropriate place for the-full required text.

j Please call me at-(630) 829-9661, if you would like to discuss this matter in greater detail.

Sincerely, l

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(;n ( L ik l

J m Lynch State Agreements Officer

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cc w/ltr dtd 05/28/97:

R. L. Bangart, OSP A. B. Beach, RIII

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