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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/department/DEPARTMENT_OF_HEALTH_AND_HUMAN_SERVICES/2005-12-01/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Fri, Dec 5 2008 11:00:00 GMT</pubDate>
    <lastBuildDate>Fri, Dec 5 2008 11:00:00 GMT</lastBuildDate>
    <webMaster>info@thefederalregister.com</webMaster>
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  <title><![CDATA[  Change of Address; Technical Amendment ]]></title>
  <link>http://thefederalregister.com/d.p/2005-12-01-05-23521</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is amending its 
regulations to reflect a change in the address for the American Society 
for Testing Materials (ASTM). This action is editorial in nature and is 
intended to improve the accuracy of the agency's regulations.
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  <guid>http://thefederalregister.com/d.p/2005-12-01-05-23521</guid>
  <pubDate>Thu, Dec 1 2005 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Agency Information Collection Activities; Submission for Office  of Management and Budget Review; Comment Request;]]></title>
  <link>http://thefederalregister.com/d.p/2005-12-01-05-23519</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.
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  <guid>http://thefederalregister.com/d.p/2005-12-01-05-23519</guid>
  <pubDate>Thu, Dec 1 2005 11:00:00 GMT</pubDate>
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  <title><![CDATA[  Draft Guidance for Industry on Safety, Efficacy, and  Pharmacokinetic Studies to Support Marketing of Immune Globulin ]]></title>
  <link>http://thefederalregister.com/d.p/2005-12-01-05-23520</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of 
Immune Globulin Intravenous (Human) as Replacement Therapy for Primary 
Humoral Immunodeficiency,'' dated November 2005. The draft guidance 
document provides recommendations for testing the safety, efficacy, and 
pharmacokinetics of immune globulin intravenous (human) (IGIV) products 
as replacement therapy in primary humoral immunodeficiency. The draft 
guidance document is intended to assist sponsors with the design of 
clinical trials to assess IGIV as replacement therapy in primary 
humoral immunodeficiency.
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  <guid>http://thefederalregister.com/d.p/2005-12-01-05-23520</guid>
  <pubDate>Thu, Dec 1 2005 11:00:00 GMT</pubDate>
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