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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2008-07-10/</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>
    <item>
  <title><![CDATA[  Applications for Approval to Market a New Drug; Complete Response  Letter; Amendments to Unapproved Applications]]></title>
  <link>http://thefederalregister.com/d.p/2008-07-10-E8-15608</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) is amending its 
regulations on new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs) for approval to market new drugs and generic drugs 
(drugs for which approval is sought in an ANDA). The final rule 
discontinues FDA's use of approvable letters and not approvable letters 
when taking action on marketing applications. Instead, we will send 
applicants a complete response letter to indicate that the review cycle 
for an application is complete and that the application is not ready 
for approval. We are also revising the regulations on extending the 
review cycle due to the submission of an amendment to an unapproved 
application and starting a new review cycle after the resubmission of 
an application following receipt of a complete response letter. In 
addition, we are adding to the regulations on biologics license 
applications (BLAs) provisions on the issuance of complete response 
letters to BLA applicants. We are taking these actions to impl<script type="text/javascript">
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  <guid>http://thefederalregister.com/d.p/2008-07-10-E8-15608</guid>
  <pubDate>Thu, Jul 10 2008 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Draft Guidance for Industry on Voluntary Third-Party  Certification Programs for Foods and Feeds; Availability]]></title>
  <link>http://thefederalregister.com/d.p/2008-07-10-E8-15715</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Voluntary 
ThirdParty Certification Programs for Foods and Feeds.'' This draft 
guidance describes the general attributes FDA believes a voluntary 
thirdparty certification program should have in order to help ensure 
its certification is a reliable reflection that the foods and feeds 
from certified establishments are safe and meet applicable FDA 
requirements.
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  <guid>http://thefederalregister.com/d.p/2008-07-10-E8-15715</guid>
  <pubDate>Thu, Jul 10 2008 11:00:00 GMT</pubDate>
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  <title><![CDATA[  Voluntary Third-Party Certification Programs for Imported  Aquacultured Shrimp; Notice of Pilot Program]]></title>
  <link>http://thefederalregister.com/d.p/2008-07-10-E8-15713</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) is seeking third-party 
certification bodies that certify foreign processors of aquacultured 
shrimp for compliance with FDA's Seafood Hazard Analysis and Critical 
Control Point (HACCP) regulations to volunteer to participate in a 
pilot program to be conducted by FDA's Center for Food Safety and 
Applied Nutrition (CFSAN) and Office of Regulatory Affairs (ORA). The 
goal of the pilot program is to gather technical and operational 
information that will assist FDA in determining its infrastructure 
needs, as well as the process for evaluating thirdparty certification 
programs, in order to assist FDA in moving towards broader recognition 
of voluntary thirdparty certification programs, including thirdparty 
certification programs for aquacultured shrimp, at a later time.
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  <guid>http://thefederalregister.com/d.p/2008-07-10-E8-15713</guid>
  <pubDate>Thu, Jul 10 2008 11:00:00 GMT</pubDate>
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