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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2003-12-16/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Sun, Nov 23 2008 11:00:00 GMT</pubDate>
    <lastBuildDate>Sun, Nov 23 2008 11:00:00 GMT</lastBuildDate>
    <webMaster>info@thefederalregister.com</webMaster>
    <item>
  <title><![CDATA[  Guidance for Industry: Questions and Answers on the Interim Final  Rule on Prior Notice of Imported Food; Availability]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-16-03-31038</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Prior Notice of Imported Food, 
Questions and Answers.'' The guidance responds to various questions 
raised about the section 307 of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism 
Act) and the agency's implementing regulations that require, beginning 
on December 12, 2003, prior notice to FDA before food is imported or 
offered for import into the United States.
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  <guid>http://thefederalregister.com/d.p/2003-12-16-03-31038</guid>
  <pubDate>Tue, Dec 16 2003 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Agency Information Collection Activities; Announcement of Office  of Management and Budget Approval; Requirements for]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-16-03-30962</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Requirements for Submission of 
Labeling for Human Prescription Drugs and Biologics in Electronic 
Format'' has been approved by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995.
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  <guid>http://thefederalregister.com/d.p/2003-12-16-03-30962</guid>
  <pubDate>Tue, Dec 16 2003 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Agency Information Collection Activities; Announcement of Office  of Management and Budget Approval; Guidance for]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-16-03-30963</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry: Submitting 
and Reviewing Complete Responses to Clinical Holds'' has been approved 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995.
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  <guid>http://thefederalregister.com/d.p/2003-12-16-03-30963</guid>
  <pubDate>Tue, Dec 16 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Agency Information Collection Activities; Proposed Collection;  Comment Request; Premarket Notification Submissions]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-16-03-30964</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for premarket notification (510(k)) submissions.
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  <guid>http://thefederalregister.com/d.p/2003-12-16-03-30964</guid>
  <pubDate>Tue, Dec 16 2003 11:00:00 GMT</pubDate>
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