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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2008-06-11/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Mon, Dec 1 2008 11:00:00 GMT</pubDate>
    <lastBuildDate>Mon, Dec 1 2008 11:00:00 GMT</lastBuildDate>
    <webMaster>info@thefederalregister.com</webMaster>
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  <title><![CDATA[2005P-0450) ]]></title>
  <link>http://thefederalregister.com/d.p/2008-06-11-E8-13122</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is reopening until 
August 11, 2008, the comment period for the notice of public hearing, 
published in the Federal Register of October 23, 2007 (72 FR 59973), 
requesting comments regarding FDA's current framework of policies 
regarding salt and sodium and potential future approaches, including 
approaches described in a citizen petition. The agency is taking this 
action in response to a request for an extension to allow interested 
persons additional time to submit comments. FDA is also reopening the 
comment period to update comments and to receive any new information.
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  <guid>http://thefederalregister.com/d.p/2008-06-11-E8-13122</guid>
  <pubDate>Wed, Jun 11 2008 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Determination of Regulatory Review Period for Purposes of Patent  Extension; ROTATEQ]]></title>
  <link>http://thefederalregister.com/d.p/2008-06-11-E8-13109</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) has determined the 
regulatory review period for ROTATEQ and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an application to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human biological product.
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  <guid>http://thefederalregister.com/d.p/2008-06-11-E8-13109</guid>
  <pubDate>Wed, Jun 11 2008 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Summaries of Medical and Clinical Pharmacology Reviews of  Pediatric Studies; Availability]]></title>
  <link>http://thefederalregister.com/d.p/2008-06-11-E8-13099</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) is announcing the 
availability of summaries of medical and clinical pharmacology reviews  of pediatric studies submitted in supplements for ABILIFY <br/>
(aripiprazole), ANDROGEL (testosterone), and DIOVAN (valsartan). These 
summaries are being made available consistent with the Best 
Pharmaceuticals for Children Act, enacted in 2002, (the 2002 BPCA). For 
all pediatric supplements submitted under the 2002 BPCA, the 2002 BPCA 
required FDA to make available to the public, including by publication 
in the Federal Register, a summary of the medical and clinical 
pharmacology reviews of the pediatric studies conducted for the 
supplement.
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  <guid>http://thefederalregister.com/d.p/2008-06-11-E8-13099</guid>
  <pubDate>Wed, Jun 11 2008 11:00:00 GMT</pubDate>
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