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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Time and Extent Applications

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

OTC Time and Extent Applications found on this page:


Time and Extent Applications: Acne
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Triclosan [PDF] 12/5/2005 70FR72447

Time and Extent Applications: Antidiarrheal
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Saccharomyces boulardii [PDF] 8/23/2004 69FR51852
Notice of Withdrawal:Saccharomyces boulardii 10/27/2009 74FR55245

Time and Extent Applications: Antiplaque/Antigingivitis
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Triclosan [PDF]   7/6/2004 69FR40640

Time and Extent Applications: Dandruff
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Piroctone olamine [PDF] 2/18/2004 69FR7652
    Extension of Comment Period [PDF] 5/19/2004 69FR28932
Request for Data: Climbazole [PDF] 12/5/2005 70FR72448
Request for Data: Sodium shale oil sulfonate [PDF] 4/7/2009 74FR15741

Time and Extent Applications: Laxative
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Sodium picosulfate [PDF] 6/22/2006 71FR35917

Time and Extent Applications: Sunscreen
Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Amiloxate, enzacamene, and octyl triazone [PDF] 7/11/2003 68FR41386
Request for Data: Bisoctrizole and bemotrizinol [PDF] 12/5/2005 70FR72449
Request for Data: Diethylhexyl butamido triazone [PDF] 7/26/2006 71FR42405
Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule) [PDF] 9/12/2008 73FR53029
Request for Data: Drometrizole Trisiloxane [PDF] 6/2/2010 75FR30838

 

Time and Extent Applications: Establishing Regulations

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 10/3/1996 61FR51625
Proposed Rule Date FR Citation
Proposed Rule [PDF] 12/20/1999 64FR71062
Final Rule Date FR Citation
Final Rule [PDF] 1/23/2002 67FR3060
Notice: Draft Guidance on Time and Extent Applications [PDF] 2/10/2004 69FR6309

Notice: Guidance on Time and Extent Applications for Nonprescription Products [PDF]

Guidance [PDF]

9/29/2011 76FR60504
Request for Data: Potential Environmental Impact [PDF] 2/22/2010 75FR7606
PRA 60-day Notice: Proposed Collection of Information [PDF] 10/8/2010 75FR62404
PRA 30-day Notice: Proposed Collection of Information 2/8/2011 76FR6801