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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2003-12-01/</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[  Civil Money Penalties Hearings; Maximum Penalty Amounts and  Compliance With the Federal Civil Penalties Inflation]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-01-03-29741</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) is proposing a new 
regulation to adjust for inflation the maximum civil money penalty 
amounts for the various civil money penalty authorities within our 
jurisdiction. We are taking this action to comply with the Federal 
Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), as amended.
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  <guid>http://thefederalregister.com/d.p/2003-12-01-03-29741</guid>
  <pubDate>Mon, Dec 1 2003 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Dental Devices; Gold Based Alloys, Precious Metal Alloys, and  Base Metal Alloys; Designation of Special Controls]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-01-03-29739</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is proposing to amend 
the classification regulations of goldbased alloys and precious metal 
alloys for clinical use and base metal alloy devices. FDA is also 
proposing to exempt these devices from premarket notification and 
designate a special control for these devices. The agency is taking 
this action on its own initiative. This action is being taken under the 
Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe  Medical Devices Act of 1990 (SMDA), and the Food and Drug <br/>
Administration Modernization Act of 1997 (FDAMA). Elsewhere in this 
issue of the Federal Register, FDA is announcing the availability of 
guidance documents that would serve as special controls for these  devices.<br/>
[[Page 67098]]
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  <guid>http://thefederalregister.com/d.p/2003-12-01-03-29739</guid>
  <pubDate>Mon, Dec 1 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Agency Information Collection Activities; Announcement of OMB  Approval; Export of Medical Devices--Foreign Letters of]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-01-03-29743</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Export of Medical DevicesForeign 
Letters of Approval'' 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/2003-12-01-03-29743</guid>
  <pubDate>Mon, Dec 1 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Agency Information Collection Activities; Announcement of OMB  Approval; Agreement for Shipment of Devices for]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-01-03-29745</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Agreement for Shipment of Devices 
for Sterilization'' 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/2003-12-01-03-29745</guid>
  <pubDate>Mon, Dec 1 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Determination of Regulatory Review Period for Purposes of Patent  Extension; DERAMAXX]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-01-03-29742</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) has determined the 
regulatory review period for DERAMAXX 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 animal drug product.
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  <guid>http://thefederalregister.com/d.p/2003-12-01-03-29742</guid>
  <pubDate>Mon, Dec 1 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Vulcan Chemicals; Filing of Food Additive Petition ]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-01-03-29744</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing that 
Vulcan Chemicals has filed a petition proposing that the food additive 
regulation for chlorine dioxide be amended to provide for an additional 
method for producing the additive.
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  <guid>http://thefederalregister.com/d.p/2003-12-01-03-29744</guid>
  <pubDate>Mon, Dec 1 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Draft Guidance for Industry and FDA Staff; Class II Special  Controls Guidance Document: Dental Precious Metal Alloys]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-01-03-29740</link>
  <description><![CDATA[  The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance documents entitled ``Class II 
Special Controls Guidance Document: Dental Precious Metal Alloys'' and 
``Class II Special Controls Guidance Document: Dental Base Metal 
Alloys.'' These guidance documents describe means by which goldbased 
alloys and precious metal alloys for clinical use and base metal alloy 
devices may comply with the requirement of special controls for class 
II devices. Elsewhere in this issue of the Federal Register, FDA is 
publishing a proposed rule to amend the classification regulations of 
goldbased alloys and precious metal alloys for clinical use and base 
metal alloy devices presently classified in class II. In the proposed 
rule, FDA is also proposing to exempt these devices from premarket 
notification.
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  <guid>http://thefederalregister.com/d.p/2003-12-01-03-29740</guid>
  <pubDate>Mon, Dec 1 2003 11:00:00 GMT</pubDate>
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