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 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History for OTC Time and Extent ApplicationsHistorical Status of OTC Rulemakings Rulemaking History for OTC Time and Extent Applications
  
  	
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    Print**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:

Acne
	Antidiarrheal
	Antiplaque/Antigingivitis
	Dandruff
	Laxative
	Sunscreen
	Establishing Regulations**Time and Extent Applications: Acne**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: Triclosan
			12/5/2005
			70FR72447

**Time and Extent Applications: Antidiarrheal**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: *Saccharomyces boulardii*
			8/23/2004
			69FR51852Notice of Withdrawal:*Saccharomyces boulardii*
			10/27/2009
			74FR55245

**Time and Extent Applications: Antiplaque/Antigingivitis**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: Triclosan
			7/6/2004
			69FR40640

**Time and Extent Applications: Dandruff**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: Piroctone olamine
			2/18/2004
			69FR7652Extension of Comment Period
			5/19/2004
			69FR28932Request for Data: Climbazole
			12/5/2005
			70FR72448Request for Data: Sodium shale oil sulfonate
			4/7/2009
			74FR15741

**Time and Extent Applications: Laxative**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: Sodium picosulfate
			6/22/2006
			71FR35917

**Time and Extent Applications: Sunscreen**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationRequest for Data: Amiloxate, enzacamene, and octyl triazone
			7/11/2003
			68FR41386Request for Data: Bisoctrizole and bemotrizinol
			12/5/2005
			70FR72449Request for Data: Diethylhexyl butamido triazone
			7/26/2006
			71FR42405Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule)
			9/12/2008
			73FR53029Request for Data: Drometrizole Trisiloxane
			6/2/2010
			75FR30838

**Time and Extent Applications: Establishing Regulations**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			10/3/1996
			61FR51625Proposed Rule
			Date
			*FR* CitationProposed Rule
			12/20/1999
			64FR71062Final Rule
			Date
			*FR* CitationFinal Rule
			1/23/2002
			67FR3060Notice: 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
			76FR60504Request for Data: Potential Environmental Impact
			2/22/2010
			75FR7606PRA 60-day Notice: Proposed Collection of Information
			10/8/2010
			75FR62404PRA 30-day Notice: Proposed Collection of Information
			2/8/2011
			76FR6801

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                                                                                  Content current as of:
      03/01/2022Historical Status of OTC Rulemakings
 
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