• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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 RulemakingDateFR Citation
Request for Data: Triclosan [PDF]12/5/200570FR72447

Time and Extent Applications: Antidiarrheal
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Saccharomyces boulardii [PDF]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: Triclosan [PDF]  7/6/200469FR40640

Time and Extent Applications: Dandruff
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Piroctone olamine [PDF]2/18/200469FR7652
    Extension of Comment Period [PDF]5/19/200469FR28932
Request for Data: Climbazole [PDF]12/5/200570FR72447
Request for Data: Sodium shale oil sulfonate [PDF]4/7/200974FR15741

 

Time and Extent Applications: Establishing Regulations

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]10/3/199661FR51625
Proposed RuleDateFR Citation
Proposed Rule [PDF]    12/20/199964FR71062
Final RuleDateFR Citation
Final Rule [PDF]1/23/200267FR3060
Notice: Draft Guidance on Time and Extent Applications [PDF] 2/10/200469FR6309

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

Guidance [PDF]

9/29/201176FR60504
Request for Data: Potential Environmental Impact [PDF]2/22/201075FR7606
60-day Notice: Proposed Collection of Information [PDF]10/8/201075FR62404
30-day Notice: Proposed Collection of Information2/8/201176FR6801

Time and Extent Applications: Laxative
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Sodium picosulfate [PDF]6/22/200671FR35917

Time and Extent Applications: Sunscreen
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data: Amiloxate, enzacamene, and octyl triazone [PDF]7/11/200368FR41386
Request for Data: Bisoctrizole and bemotrizinol [PDF]12/5/200570FR72449
Request for Data: Diethylhexyl butamido triazone [PDF]7/26/200671FR42405
Request for Data:Terephthalylidene dicamphor sulfonic acid (ecamsule) [PDF]9/12/200873FR53029
Request for Data: Drometrizole Trisiloxane [PDF]6/2/201075FR30838