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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2005-12-05/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Sun, Nov 23 2008 11:00:00 GMT</pubDate>
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  <title><![CDATA[  Over-the-Counter Drug Products; Safety and Efficacy Review;  Additional Acne Ingredient]]></title>
  <link>http://thefederalregister.com/d.p/2005-12-05-05-23570</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing a call-
fordata for safety and effectiveness information on the following 
conditions as part of FDA's ongoing review of overthecounter (OTC) 
drug products: Triclosan, 0.2 to 0.5 percent and 0.3 to 1.0 percent, as 
a topical acne active ingredient in leaveon and rinseoff dosage 
forms, respectively. FDA has reviewed a time and extent application 
(TEA) for these conditions and determined that they are eligible for 
consideration in its OTC drug monograph system. FDA will evaluate the 
submitted data and information to determine whether these conditions 
can be generally recognized as safe and effective (GRAS/E) for their 
proposed OTC use.
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  <guid>http://thefederalregister.com/d.p/2005-12-05-05-23570</guid>
  <pubDate>Mon, Dec 5 2005 11:00:00 GMT</pubDate>
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  <title><![CDATA[  Over-the-Counter Drug Products; Safety and Efficacy Review;  Additional Dandruff Control Ingredient]]></title>
  <link>http://thefederalregister.com/d.p/2005-12-05-05-23569</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing a call-
fordata for safety and effectiveness information on the following 
conditions as part of FDA's ongoing review of overthecounter (OTC) 
drug products: Climbazole, 0.1 to 0.5 percent and 0.5 to 2.0 percent, 
as a dandruff control active ingredient in leaveon and rinseoff 
dosage forms, respectively. FDA has reviewed a time and extent 
application (TEA) for these conditions and determined that they are 
eligible for consideration in its OTC drug monograph system. FDA will 
evaluate the submitted data and information to determine whether these 
conditions can be generally recognized as safe and effective (GRASE) 
for their proposed OTC use.
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  <guid>http://thefederalregister.com/d.p/2005-12-05-05-23569</guid>
  <pubDate>Mon, Dec 5 2005 11:00:00 GMT</pubDate>
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  <title><![CDATA[  Over-the-Counter Drug Products; Safety and Efficacy Review;  Additional Sunscreen Ingredients]]></title>
  <link>http://thefederalregister.com/d.p/2005-12-05-05-23576</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing a call-
fordata for safety and effectiveness information on the following 
conditions as part of FDA's ongoing review of overthecounter (OTC) 
drug products: Bisoctrizole, up to 10 percent, as a sunscreen single 
active ingredient and in combination with other sunscreen active 
ingredients; and bemotrizinol, up to 10 percent, as a sunscreen single 
active ingredient and in combination with other sunscreen active 
ingredients. FDA reviewed time and extent applications (TEAs) for these 
conditions and determined that they are eligible for consideration in 
our OTC drug monograph system. FDA will evaluate the submitted data and 
information to determine whether these conditions can be generally 
recognized as safe and effective (GRAS/E) for their proposed OTC use.
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  <guid>http://thefederalregister.com/d.p/2005-12-05-05-23576</guid>
  <pubDate>Mon, Dec 5 2005 11:00:00 GMT</pubDate>
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