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  <version>3.0.0</version>
  <bill>
    <number>828</number>
    <updateDate>2023-01-15T22:03:58Z</updateDate>
    <updateDateIncludingText>2023-01-15T22:03:58Z</updateDateIncludingText>
    <originChamber>House</originChamber>
    <originChamberCode>H</originChamberCode>
    <type>HR</type>
    <introducedDate>2003-02-13</introducedDate>
    <congress>108</congress>
    <committees>
      <item>
        <systemCode>hsif00</systemCode>
        <name>Energy and Commerce Committee</name>
        <chamber>House</chamber>
        <type>Standing</type>
        <subcommittees>
          <item>
            <systemCode>hsif14</systemCode>
            <name>Health Subcommittee</name>
            <activities>
              <item>
                <name>Referred to</name>
                <date>2003-02-26T20:54:44Z</date>
              </item>
            </activities>
          </item>
        </subcommittees>
        <activities>
          <item>
            <name>Referred to</name>
            <date>2003-02-13T15:07:00Z</date>
          </item>
        </activities>
      </item>
    </committees>
    <actions>
      <item>
        <actionDate>2003-02-26</actionDate>
        <committees>
          <item>
            <systemCode>hsif14</systemCode>
            <name>Health Subcommittee</name>
          </item>
        </committees>
        <sourceSystem>
          <code>1</code>
          <name>House committee actions</name>
        </sourceSystem>
        <text>Referred to the Subcommittee on Health.</text>
        <type>Committee</type>
      </item>
      <item>
        <actionDate>2003-02-13</actionDate>
        <text>Referred to the House Committee on Energy and Commerce.</text>
        <type>IntroReferral</type>
        <actionCode>H11100</actionCode>
        <sourceSystem>
          <code>2</code>
          <name>House floor actions</name>
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        <committees>
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            <systemCode>hsif00</systemCode>
            <name>Energy and Commerce Committee</name>
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        </committees>
      </item>
      <item>
        <actionDate>2003-02-13</actionDate>
        <text>Introduced in House</text>
        <type>IntroReferral</type>
        <actionCode>Intro-H</actionCode>
        <sourceSystem>
          <code>9</code>
          <name>Library of Congress</name>
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      <item>
        <actionDate>2003-02-13</actionDate>
        <text>Introduced in House</text>
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        <actionCode>1000</actionCode>
        <sourceSystem>
          <code>9</code>
          <name>Library of Congress</name>
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    </actions>
    <sponsors>
      <item>
        <bioguideId>M000309</bioguideId>
        <fullName>Rep. McCarthy, Carolyn [D-NY-4]</fullName>
        <firstName>CAROLYN</firstName>
        <lastName>MCCARTHY</lastName>
        <party>D</party>
        <state>NY</state>
        <district>4</district>
        <isByRequest>N</isByRequest>
      </item>
    </sponsors>
    <cosponsors>
      <item>
        <bioguideId>E000287</bioguideId>
        <fullName>Rep. Emanuel, Rahm [D-IL-5]</fullName>
        <firstName>Rahm</firstName>
        <lastName>Emanuel</lastName>
        <party>D</party>
        <state>IL</state>
        <district>5</district>
        <sponsorshipDate>2003-02-13</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>N000147</bioguideId>
        <fullName>Del. Norton, Eleanor Holmes [D-DC-At Large]</fullName>
        <firstName>ELEANOR</firstName>
        <lastName>NORTON</lastName>
        <party>D</party>
        <state>DC</state>
        <middleName>HOLMES</middleName>
        <district>0</district>
        <sponsorshipDate>2003-02-13</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>O000159</bioguideId>
        <fullName>Rep. Owens, Major R. [D-NY-11]</fullName>
        <firstName>MAJOR</firstName>
        <lastName>OWENS</lastName>
        <party>D</party>
        <state>NY</state>
        <middleName>R.</middleName>
        <district>11</district>
        <sponsorshipDate>2003-02-13</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>I000057</bioguideId>
        <fullName>Rep. Israel, Steve [D-NY-2]</fullName>
        <firstName>STEVE</firstName>
        <lastName>ISRAEL</lastName>
        <party>D</party>
        <state>NY</state>
        <district>2</district>
        <sponsorshipDate>2003-02-13</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>R000011</bioguideId>
        <fullName>Rep. Rahall, Nick J., II [D-WV-3]</fullName>
        <firstName>NICK</firstName>
        <lastName>RAHALL</lastName>
        <party>D</party>
        <state>WV</state>
        <middleName>J.</middleName>
        <district>3</district>
        <sponsorshipDate>2003-02-25</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>B001241</bioguideId>
        <fullName>Rep. Bell, Chris [D-TX-25]</fullName>
        <firstName>Chris</firstName>
        <lastName>Bell</lastName>
        <party>D</party>
        <state>TX</state>
        <district>25</district>
        <sponsorshipDate>2003-06-12</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>P000149</bioguideId>
        <fullName>Rep. Payne, Donald M. [D-NJ-10]</fullName>
        <firstName>DONALD</firstName>
        <lastName>PAYNE</lastName>
        <party>D</party>
        <state>NJ</state>
        <middleName>M.</middleName>
        <district>10</district>
        <sponsorshipDate>2003-06-16</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>R000053</bioguideId>
        <fullName>Rep. Rangel, Charles B. [D-NY-15]</fullName>
        <firstName>CHARLES</firstName>
        <lastName>RANGEL</lastName>
        <party>D</party>
        <state>NY</state>
        <middleName>B.</middleName>
        <district>15</district>
        <sponsorshipDate>2003-07-08</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
    </cosponsors>
    <policyArea>
      <name>Health</name>
    </policyArea>
    <subjects>
      <legislativeSubjects>
        <item>
          <name>Clinical trials</name>
        </item>
        <item>
          <name>Commerce</name>
        </item>
        <item>
          <name>Congress</name>
        </item>
        <item>
          <name>Congressional investigations</name>
        </item>
        <item>
          <name>Congressional reporting requirements</name>
        </item>
        <item>
          <name>Drug approvals</name>
        </item>
        <item>
          <name>Drug industry</name>
        </item>
        <item>
          <name>Drugs</name>
        </item>
        <item>
          <name>Economics and Public Finance</name>
        </item>
        <item>
          <name>Federal aid to research</name>
        </item>
        <item>
          <name>Generic drugs</name>
        </item>
        <item>
          <name>Government Operations and Politics</name>
        </item>
        <item>
          <name>Intellectual property</name>
        </item>
        <item>
          <name>Medical research</name>
        </item>
        <item>
          <name>Patents</name>
        </item>
        <item>
          <name>Pharmaceutical research</name>
        </item>
        <item>
          <name>Prescription pricing</name>
        </item>
        <item>
          <name>Profit</name>
        </item>
        <item>
          <name>Research and development</name>
        </item>
        <item>
          <name>Research grants</name>
        </item>
        <item>
          <name>Restrictive trade practices</name>
        </item>
        <item>
          <name>Science, Technology, Communications</name>
        </item>
        <item>
          <name>Small business</name>
        </item>
      </legislativeSubjects>
      <policyArea>
        <name>Health</name>
      </policyArea>
    </subjects>
    <summaries>
      <summary>
        <versionCode>00</versionCode>
        <actionDate>2003-02-13</actionDate>
        <actionDesc>Introduced in House</actionDesc>
        <updateDate>2006-11-28T17:35:40Z</updateDate>
        <text><![CDATA[Pharmaceutical Fiscal Accountability Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act to treat certain subsequent certified abbreviated new drug applications as if they were the first such application and therefore entitled to a period of 180 day generic drug exclusivity. (Abbreviated new drug applications are filed where the new drugs uses or active ingredient(s) are the same as those for a previously approved drug, also known as a "listed drug.")<p>Amends the Public Health Service Act to require the Director of the National Institutes of Health to support qualifying clinical research on the development of new drugs at designated small public or private entities. Emphasizes drug research which has the potential to make a significant contribution for the prevention, diagnosis, or treatment of a disease which has not received significant Federal funding. Entitles the Director to five percent of the profits from sales during the patent period.<p>Requires the Comptroller General to study and report to Congress on the effects of: (1) Federal funding on the costs of research and the pricing of prescription drugs; and (2) pharmaceutical patent extensions and market exclusivity periods on delays in introducing generic versions.]]></text>
      </summary>
    </summaries>
    <title>Pharmaceutical Fiscal Accountability Act of 2003</title>
    <titles>
      <item>
        <titleType>Display Title</titleType>
        <title>Pharmaceutical Fiscal Accountability Act of 2003</title>
      </item>
      <item>
        <titleType>Official Title as Introduced</titleType>
        <title>To amend the Federal Food, Drug, and Cosmetic Act to allow certain applicants for approval of a generic drug to be eligible for a 180-day period of protection from competition, and for other purposes.</title>
        <billTextVersionName>Introduced in House</billTextVersionName>
        <billTextVersionCode>IH</billTextVersionCode>
      </item>
      <item>
        <titleType>Short Titles as Introduced</titleType>
        <title>Pharmaceutical Fiscal Accountability Act of 2003</title>
      </item>
    </titles>
    <textVersions>
      <item>
        <type>Introduced in House</type>
        <date>2003-02-13T05:00:00Z</date>
        <formats/>
      </item>
    </textVersions>
    <latestAction>
      <actionDate>2003-02-26</actionDate>
      <text>Referred to the Subcommittee on Health.</text>
    </latestAction>
  </bill>
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    <dc:language>EN</dc:language>
    <dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
    <dc:contributor>Congressional Research Service, Library of Congress</dc:contributor>
    <dc:description>This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.</dc:description>
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