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 |
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 |