Drugs

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 RulemakingDateFR Citation
Request for Data: Triclosan12/5/200570FR72447

Time and Extent Applications: Antidiarrheal

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Saccharomyces boulardii 8/23/200469FR51852
Notice of Withdrawal:Saccharomyces boulardii10/27/200974FR55245

Time and Extent Applications: Antiplaque/Antigingivitis

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Triclosan7/6/200469FR40640

Time and Extent Applications: Dandruff

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Piroctone olamine2/18/200469FR7652
    Extension of Comment Period5/19/200469FR28932
Request for Data: Climbazole12/5/200570FR72448
Request for Data: Sodium shale oil sulfonate4/7/200974FR15741

Time and Extent Applications: Laxative

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Sodium picosulfate 6/22/200671FR35917

Time and Extent Applications: Sunscreen
 

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Amiloxate, enzacamene, and octyl triazone7/11/200368FR41386
Request for Data: Bisoctrizole and bemotrizinol12/5/200570FR72449
Request for Data: Diethylhexyl butamido triazone7/26/200671FR42405
Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule)9/12/200873FR53029
Request for Data: Drometrizole Trisiloxane6/2/201075FR30838

Time and Extent Applications: Establishing Regulations

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking10/3/199661FR51625
Proposed RuleDateFR Citation
Proposed Rule12/20/199964FR71062
Final RuleDateFR Citation
Final Rule1/23/200267FR3060
Notice: Draft Guidance on Time and Extent Applications2/10/200469FR6309

Notice: Guidance on Time and Extent Applications for Nonprescription Products

Guidance

9/29/201176FR60504
Request for Data: Potential Environmental Impact2/22/201075FR7606
PRA 60-day Notice: Proposed Collection of Information10/8/201075FR62404
PRA 30-day Notice: Proposed Collection of Information2/8/201176FR6801

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Page Last Updated: 02/16/2017
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