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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2008-06-13/</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>
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  <title><![CDATA[  Medical Devices; Medical Device Reporting; Baseline Reports]]></title>
  <link>http://thefederalregister.com/d.p/2008-06-13-E8-13350</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is amending its medical 
device reporting regulations to remove a requirement for baseline 
reports that the agency deems no longer necessary. Currently, 
manufacturers provide baseline reports to FDA that include the FDA 
product code and the premarket approval or premarket notification 
number. Because most of the information in these baseline reports is 
also submitted to FDA in individual adverse event reports, FDA is 
removing the requirement for baseline reports. The removal of this 
requirement will eliminate unnecessary duplication and reduce the 
manufacturer's reporting burden. FDA is amending the regulation in 
accordance with its direct final rule procedures. Elsewhere in this 
issue of the Federal Register, we are publishing a companion proposed 
rule under FDA's usual procedures for notice and comment to provide a 
procedural framework to finalize the rule in the event we receive a 
significant adverse comment and withdraw this direct final rule.
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  <guid>http://thefederalregister.com/d.p/2008-06-13-E8-13350</guid>
  <pubDate>Fri, Jun 13 2008 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Oral Dosage Form New Animal Drugs; Deracoxib ]]></title>
  <link>http://thefederalregister.com/d.p/2008-06-13-E8-13353</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Novartis Animal Health US, Inc. The 
supplemental NADA provides for the addition of a 50milligram size 
deracoxib tablet which is used for the control of pain and inflammation 
in dogs.
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  <guid>http://thefederalregister.com/d.p/2008-06-13-E8-13353</guid>
  <pubDate>Fri, Jun 13 2008 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Oral Dosage Form New Animal Drugs; Ivermectin, Fenbendazole, and  Praziquantel Tablets]]></title>
  <link>http://thefederalregister.com/d.p/2008-06-13-E8-13354</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of an original new animal drug 
application (NADA) filed by Intervet, Inc. The NADA provides for the 
veterinary prescription use of chewable tablets containing ivermectin, 
fenbendazole, and praziquantel for the treatment and control of various 
internal parasites and for the prevention of canine heartworm disease 
in adult dogs.
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  <guid>http://thefederalregister.com/d.p/2008-06-13-E8-13354</guid>
  <pubDate>Fri, Jun 13 2008 11:00:00 GMT</pubDate>
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<item>
  <title><![CDATA[  Medical Devices; Medical Device Reporting; Baseline Reports;  Companion to Direct Final Rule]]></title>
  <link>http://thefederalregister.com/d.p/2008-06-13-E8-13349</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is proposing to amend 
its medical device reporting regulations to remove a requirement for 
baseline reports that the agency deems no longer necessary. Currently, 
manufacturers provide baseline reports to FDA that include the FDA 
product code and the premarket approval or premarket notification 
number. Because most of the information in these baseline reports is 
also submitted to FDA in individual adverse event reports, FDA is 
proposing to remove the requirement for baseline reports. The removal 
of this requirement would eliminate unnecessary duplication and reduce 
the manufacturer's reporting burden. This proposed rule is a companion 
document to the direct final rule published elsewhere in this issue of 
the Federal Register.
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  <guid>http://thefederalregister.com/d.p/2008-06-13-E8-13349</guid>
  <pubDate>Fri, Jun 13 2008 11:00:00 GMT</pubDate>
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