Rulemaking History for OTC Time and Extent Applications Drug Products

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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

OTC Time and Extent Applications found on this page:

Establishing Regulations
Acne
Antidiarrheal
Antiplaque/Antigingivitis
Dandruff
Laxative
Sunscreen

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**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
Availability of guidance	2/10/2004	69FR6309

**Time and Extent Applications: Acne**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data: Triclosan	12/5/2005	70FR72448

**Time and Extent Applications: Antidiarrheal**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data: Saccharomyces boulardii	8/23/2004	69FR51852

**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

**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

Date created: December 28, 2006; Last updated: September 16, 2008