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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2003-12-02/</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[  Medical Devices: Classification of the Dental Sonography Device  and Jaw Tracking Device]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-29863</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is classifying the 
dental sonography device into class I, when it is used to monitor 
temporomandibular joint sounds, and into class II, when it is used to 
interpret temporomandibular joint sounds for the diagnosis of 
temporomandibular joint disorders and associated orofacial pain. FDA is 
classifying the jaw tracking device into class I, when it is used to 
monitor mandibular jaw positions relative to the maxilla, and into 
class II, when it is used to interpret mandibular jaw positions 
relative to the maxilla, for the diagnosis of temporomandibular joint 
disorders and associated orofacial pain. Elsewhere in this issue of the 
Federal Register, FDA is announcing the availability of a guidance 
document that will serve as the special control for this device. FDA is 
taking this action under the Federal Food, Drug, and Cosmetic Act (the 
act) as amended by the Medical Device Amendments of 1976 (the 1976 
amendments), the Safe Medical Devices Act of 1990 (the SMDA), <script type="text/javascript">
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-29863</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Determination of Regulatory Review Period for Purposes of Patent  Extension; ELOXATIN]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-29928</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) has determined the 
regulatory review period for ELOXATIN 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 
that claims that human drug product.
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-29928</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Determination of Regulatory Review Period for Purposes of Patent  Extension; INVANZ]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-29929</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) has determined the 
regulatory review period for INVANZ 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 
that claims that human drug product.
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-29929</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Determination of Regulatory Review Period for Purposes of Patent  Extension; LEXAPRO]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-29927</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) has determined [[Page 67456]]<br/>
the regulatory review period for LEXAPRO 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 that claims that human drug product.
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-29927</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Relative Risk to Public Health From Foodborne Listeria  Monocytogenes Among Selected Categories of Ready-to-Eat Foods;]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-30076</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is correcting a 
document that announced a public meeting to be held on December 4, 
2003, in the Federal Register of November 7, 2003 (68 FR 63108). The 
location of the meeting at the FDA Center for Food Safety and Applied 
Nutrition Harvey W. Wiley Building in College Park, MD was incorrect. 
This document corrects that error.
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-30076</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Guidance for Industry and FDA Staff; Class II Special Controls  Guidance Document: Dental Sonography and Jaw Tracking]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-29864</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Dental Sonography and Jaw Tracking Devices.'' This 
guidance document describes a means by which certain dental sonography 
and jaw tracking 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 final rule to classify certain types of 
these devices into class II (special controls).
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-29864</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Draft Guidance for Industry and Food and Drug Administration  Staff; Premarket Submissions and Labeling]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-29855</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Draft Guidance for  Industry and FDA Staff; Premarket Submission and Labeling <br/>
Recommendations for Drugs of Abuse Screening Tests.'' This draft 
guidance is intended to assist industry in preparing premarket 
notification submissions for drugs of abuse screening tests. The draft 
guidance also provides recommendations regarding the labeling of these 
tests. This draft guidance is neither final nor is it in effect at this 
time.
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-29855</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Listeria Monocytogenes Risk Management Action Plan; Availability]]></title>
  <link>http://thefederalregister.com/d.p/2003-12-02-03-30025</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) of the Department of 
Health and Human Services (HHS) is announcing the availability of a 
Listeria monocytogenes risk management action plan. The action plan 
identifies activities planned by FDA and the Centers for Disease 
Control and Prevention (CDC) that are targeted to reduce L. 
monocytogenes associated with illnesses; these activities are intended 
to help achieve the Healthy People 2010 goal of reducing listeriosis by 
50 percent by the year 2005.
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  <guid>http://thefederalregister.com/d.p/2003-12-02-03-30025</guid>
  <pubDate>Tue, Dec 2 2003 11:00:00 GMT</pubDate>
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