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    <title>The Federal Register</title>
    <link>http://thefederalregister.com/b.p/agency/Food_and_Drug_Administration/2001-04-23/</link>
    <description>Daily Publications of Meetings and Rules Changes for the Federal Government</description>
    <pubDate>Thu, May 23 2013 11:00:00 GMT</pubDate>
    <lastBuildDate>Thu, May 23 2013 11:00:00 GMT</lastBuildDate>
    <webMaster>info@thefederalregister.com</webMaster>
    <item>
  <title><![CDATA[  Public Hearing Before a Public Advisory Committee; Examination of  Administrative Record and Other Advisory Committee]]></title>
  <link>http://thefederalregister.com/d.p/2001-04-23-01-9950</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) published in the 
Federal Register of January 8, 2001, a proposed rule (66 FR 1276) and a 
direct final rule (66 FR 1257) to amend FDA regulations governing the 
public disclosure of written information for consideration by an 
advisory committee at an advisory committee meeting. The comment period 
closed March 26, 2001. FDA is withdrawing the direct final rule because 
the agency received significant adverse comment.
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  <guid>http://thefederalregister.com/d.p/2001-04-23-01-9950</guid>
  <pubDate>Mon, Apr 23 2001 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  New Animal Drugs for Use in Animal Feeds; Amprolium, Bacitracin  Methylene Disalicylate, and Roxarsone]]></title>
  <link>http://thefederalregister.com/d.p/2001-04-23-01-9872</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(NADA) <strong>filed</strong> by Alpharma, Inc. The NADA provides for use of approved, 
singleingredient amprolium, bacitracin methylene disalicylate, and 
roxarsone Type A medicated articles to make threeway combination drug 
Type C medicated feeds for replacement chickens.
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  <guid>http://thefederalregister.com/d.p/2001-04-23-01-9872</guid>
  <pubDate>Mon, Apr 23 2001 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Revision to Requirements for Licensed Anti-Human Globulin and  Blood Grouping Reagents; Confirmation of Effective Date]]></title>
  <link>http://thefederalregister.com/d.p/2001-04-23-01-9873</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is confirming the 
effective date of June 11, 2001, for the direct final rule that 
appeared in the Federal Register of December 12, 2000 (65 FR 77497). 
The direct final rule rule amends the biologics regulations applicable 
to microbiological controls for licensed AntiHuman Globulin and Blood 
Grouping Reagents by removing the requirement that these products be 
sterile. This document confirms the effective date of the direct final 
rule.
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  <guid>http://thefederalregister.com/d.p/2001-04-23-01-9873</guid>
  <pubDate>Mon, Apr 23 2001 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Studies of Adverse Effects of Marketed Drugs; Availability of  Grants (Cooperative Agreements); Request for]]></title>
  <link>http://thefederalregister.com/d.p/2001-04-23-01-9949</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of April 4, 2001 (66 FR 17907). 
The document announced the anticipated availability of funds for 
cooperative agreements to study adverse affects of drugs marketed in 
the United States and its territories. The document was published with 
some inadvertent errors. This document corrects those errors.
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  <guid>http://thefederalregister.com/d.p/2001-04-23-01-9949</guid>
  <pubDate>Mon, Apr 23 2001 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Draft Guidance for Industry on Using FDA-Approved Patient  Labeling in Consumer-Directed Print Advertisements;]]></title>
  <link>http://thefederalregister.com/d.p/2001-04-23-01-9948</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Using FDA
Approved Patient Labeling in ConsumerDirected Print Advertisements.'' 
This draft guidance describes how sponsors can use certain FDAapproved 
patient labeling to fulfill the requirement that prescription drug and 
biological product advertisements directed toward consumers (DTC) in 
print media contain adequate risk disclosure. FDA does not intend to 
object to the use of certain FDAapproved patient labeling, reprinted 
exactly as approved, to fulfill the requirement that DTC print 
advertisements contain a brief summary of the product's risks.
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  <guid>http://thefederalregister.com/d.p/2001-04-23-01-9948</guid>
  <pubDate>Mon, Apr 23 2001 11:00:00 GMT</pubDate>
</item>
<item>
  <title><![CDATA[  Extra-Label Use of Medicated Feeds for Minor Species; Compliance  Policy Guide; Availability]]></title>
  <link>http://thefederalregister.com/d.p/2001-04-23-01-10164</link>
  <description><![CDATA[ The Food and Drug Administration (FDA) is announcing the 
availability of a new compliance policy guide (CPG) section 615.115 
entitled ``ExtraLabel Use of Medicated Feeds for Minor Species.'' The 
purpose of this CPG is to provide guidance to FDA personnel concerning 
the agency's exercise of regulatory discretion with regard to the 
extralabel use of medicated feeds for minor species. This CPG has been 
revised in response to comments received on the draft.
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  <guid>http://thefederalregister.com/d.p/2001-04-23-01-10164</guid>
  <pubDate>Mon, Apr 23 2001 11:00:00 GMT</pubDate>
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