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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2007-11-30/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Thu, Oct 16 2008 11:00:00 GMT</pubDate>
    <lastBuildDate>Thu, Oct 16 2008 11:00:00 GMT</lastBuildDate>
    <webMaster>info@thefederalregister.com</webMaster>
    <item>
  <title><![CDATA[  Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug  Products for Over-the-Counter Human Use; Final Rule for]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-30-E7-23207</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is amending its 
regulations (exemption for certain drugs limited by newdrug 
applications to prescription sale, and warning and caution statements 
required by regulations for drugs) by removing the entries for 
carbetapentane citrate. This action is associated with FDA's 
determination that carbetapentane citrate has not been shown to be 
effective at the overthecounter (OTC) doses stated in the exempting 
regulation. FDA made this determination in 1987 as part of its ongoing 
review of OTC drug products.
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  <guid>http://thefederalregister.com/d.p/2007-11-30-E7-23207</guid>
  <pubDate>Fri, Nov 30 2007 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Medical Devices; Hematology and Pathology Devices:  Reclassification of Automated Blood Cell Separator Device]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-30-E7-23285</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is reclassifying from 
class III to class II the automated blood cell separator device 
operating by centrifugal separation principle and intended for the 
routine collection of blood and blood components. FDA is taking this 
action on its own initiative based on new information. Elsewhere in 
this issue of the Federal Register, FDA is announcing the availability 
of a guidance document that will serve as the special controls for this 
device, as well as the special controls for the device with the same 
intended use but operating on a filtration separation principle.
[[Page 67641]]
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  <guid>http://thefederalregister.com/d.p/2007-11-30-E7-23285</guid>
  <pubDate>Fri, Nov 30 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Agency Information Collection Activities; Submission for Office  of Management and Budget Review; Comment Request;]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-30-E7-23275</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/2007-11-30-E7-23275</guid>
  <pubDate>Fri, Nov 30 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Food Labeling: Use of Symbols to Communicate Nutrition  Information, Consideration of Consumer Studies and Nutritional]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-30-E7-23211</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is reopening to January 
15, 2008, the comment period for the notice of public hearing that 
published in the Federal Register of July 20, 2007. In the notice of 
public hearing, FDA requested comments on the use of symbols to 
communicate nutrition information on food labels. The agency is taking 
this action in response to a request for an extension to allow 
interested persons additional time to submit comments.
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  <guid>http://thefederalregister.com/d.p/2007-11-30-E7-23211</guid>
  <pubDate>Fri, Nov 30 2007 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Guidance for Industry and Food and Drug Administration Staff:  Class II Special Controls Guidance Document: Automated]]></title>
  <link>http://thefederalregister.com/d.p/2007-11-30-E7-23281</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Guidance for Industry and FDA 
Staff: Class II Special Controls Guidance Document: Automated Blood 
Cell Separator Device Operating by Centrifugal or Filtration Separation 
Principle'' dated November 2007. The guidance document serves as the 
special control for the automated blood cell separator device operating 
on a centrifugal or filtration separation principle intended for the 
routine collection of blood and blood components, and describes a means 
by which the device may comply with the requirement of special controls 
for class II devices. Elsewhere in this issue of the Federal Register, 
FDA is publishing a final rule to reclassify the automated blood cell 
separator device operating by centrifugal separation principle into 
class II (special controls).
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  <guid>http://thefederalregister.com/d.p/2007-11-30-E7-23281</guid>
  <pubDate>Fri, Nov 30 2007 11:00:00 GMT</pubDate>
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