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2005N-0507:
Agency Emergency Processing Under OMB Review; Guidance on Informed
Consent for In Vitro Diagnostic Device Studies Using Leftover Human
Specimens that are Not Individually Identifiable
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| N1
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| 01/06/2006
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| FDA
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| FDA
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| 01/09/2006
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| 1429-1430
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| txt
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| Signature:
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| SHUREN, JEFFREY
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| NAL1
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| 03/27/2006
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| FDA
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| FDA
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| 03/28/2006
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| 15418-15419
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| txt
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| Expires 9/30/2006
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| Signature:
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| Jeffrey Shuren
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| SS1
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| 03/28/2006
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| 03/28/2006
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| Federal Government
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| Supporting Statement
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| pdf
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| Signature:
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| Supporting Statement
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Page last updated
May 25, 2006
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