Over-the-Counter Drug Products; Safety and Efficacy Review; Additional Dandruff Control Ingredient; Extension of Comment Period

摘要

The Food and Drug Administration (FDA) is extending to August 16, 2004, the comment period for the safety and effectiveness review of piroctone olamine, 0.05 percent to 0.5 percent and 0.1 percent to 1.0 percent, for use as a dandruff control single active ingredient in leave-on and rinse-off dosage forms, respectively. FDA published a notice of eligibility and call-for-data for safety and effectiveness data and information on piroctone olamine in the Federal Register of February 18, 2004. FDA is taking this action in response to a request for extension of the comment period to allow interested persons additional time to submit data and information on the safety and effectiveness of piroctone olamine as a dandruff control single active ingredient.