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Rulemaking History for OTC Time and Extent Applications
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Final Monograph (21 CFR 330.14):  
Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded
 


Date Federal Register
Citation
Description
10/3/1996 61FR51625 PDF document
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Advance Notice of Proposed Rulemaking
12/20/1999 64FR71062 PDF document
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Proposed Rule
1/23/2002 67FR3060 PDF document
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Final Rule
7/11/2003 68FR41386 PDF document
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Request for Data: Amiloxate, enzacamene, and octyl triazone (sunscreen)
2/10/2004 69FR6309 PDF document
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Notice: Availability of guidance
2/18/2004 69FR7652 PDF document
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Request for Data: Piroctone olamine (dandruff)
5/19/2004 69FR28932 PDF document
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Extension of Comment Period: 2/18/2004 Request for Data
7/6/2004 69FR40640 PDF document
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Request for Data: Triclosan (antiplaque/antigingivitis)
8/23/2004 69FR51852 PDF document
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Request for Data: Saccharomyces boulardii (antidiarrheal)
12/5/2005 70FR72447 PDF document
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Request for Data: Triclosan (acne)
12/5/2005 70FR72448 PDF document
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Request for Data: Climbazole (dandruff)
12/5/2005 70FR72449 PDF document
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Request for Data: Bisoctrizole and bemotrizinol (sunscreen)
6/22/2006 71FR35917 PDF document
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Request for Data: Sodium picosulfate (laxative)
7/26/2006 71FR42405 PDF document
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Request for Data: Diethylhexyl butamido triazone (sunscreen)
9/12/2008 73FR53029 PDF document
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Request for Data: Time and Extent Applications
(Terephthalylidene dicamphor sulfonic acid [ecamsule])

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Date updated: September 16, 2008

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