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  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Time and Extent Applications
  1. Historical Status of OTC Rulemakings

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

For current status of OTC Time and Extent applications (both sunscreen and nonsunscreen) as well as new requests under the 2014 Sunscreen Innovation Act, please visit the regulatory policy grid for SIA.

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 12/5/2005 70FR72447

Time and Extent Applications: Antidiarrheal

Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Saccharomyces boulardii 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 7/6/2004 69FR40640

Time and Extent Applications: Dandruff

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

Time and Extent Applications: Laxative

Advance Notice Of Proposed Rulemaking Date FR Citation
Request for Data: Sodium picosulfate  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 7/11/2003 68FR41386
Request for Data: Bisoctrizole and bemotrizinol 12/5/2005 70FR72449
Request for Data: Diethylhexyl butamido triazone 7/26/2006 71FR42405
Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule) 9/12/2008 73FR53029
Request for Data: Drometrizole Trisiloxane 6/2/2010 75FR30838

Time and Extent Applications: Establishing Regulations

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Notice: Draft Guidance on Time and Extent Applications 2/10/2004 69FR6309

Notice: Guidance on Time and Extent Applications for Nonprescription Products

Guidance

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

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