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  <bill>
    <number>3203</number>
    <updateDate>2023-01-11T13:22:05Z</updateDate>
    <updateDateIncludingText>2023-01-11T13:22:05Z</updateDateIncludingText>
    <originChamber>House</originChamber>
    <originChamberCode>H</originChamberCode>
    <type>HR</type>
    <introducedDate>2011-10-14</introducedDate>
    <congress>112</congress>
    <constitutionalAuthorityStatementText><![CDATA[<pre>From the Congressional Record Online through the Government Publishing Office [<a href='http://www.gpo.gov'>www.gpo.gov</a>]By Mr. BILBRAY:H.R. 3203.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8 of the United States Constitutionwhich states that Congress has the power to make all lawswhich shall be necessary and proper for carrying intoexecution the foregoing powers, and all other powers vestedby this Constitution in the government of the United States,or in any department or officer thereof.[Page H6977]</pre>]]></constitutionalAuthorityStatementText>
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        <name>Energy and Commerce Committee</name>
        <chamber>House</chamber>
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            <name>Health Subcommittee</name>
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            <date>2011-10-14T13:00:17Z</date>
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        <actionDate>2011-10-18</actionDate>
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        <text>Referred to the Subcommittee on Health.</text>
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        <actionDate>2011-10-14</actionDate>
        <text>Referred to the House Committee on Energy and Commerce.</text>
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    <sponsors>
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        <bioguideId>B000461</bioguideId>
        <fullName>Rep. Bilbray, Brian P. [R-CA-50]</fullName>
        <firstName>BRIAN</firstName>
        <lastName>BILBRAY</lastName>
        <party>R</party>
        <state>CA</state>
        <middleName>P.</middleName>
        <district>50</district>
        <isByRequest>N</isByRequest>
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    </sponsors>
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        <bioguideId>B001243</bioguideId>
        <fullName>Rep. Blackburn, Marsha [R-TN-7]</fullName>
        <firstName>Marsha</firstName>
        <lastName>Blackburn</lastName>
        <party>R</party>
        <state>TN</state>
        <district>7</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>L000567</bioguideId>
        <fullName>Rep. Lance, Leonard [R-NJ-7]</fullName>
        <firstName>Leonard</firstName>
        <lastName>Lance</lastName>
        <party>R</party>
        <state>NJ</state>
        <district>7</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>B001248</bioguideId>
        <fullName>Rep. Burgess, Michael C. [R-TX-26]</fullName>
        <firstName>Michael</firstName>
        <lastName>Burgess</lastName>
        <party>R</party>
        <state>TX</state>
        <middleName>C.</middleName>
        <district>26</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>P000594</bioguideId>
        <fullName>Rep. Paulsen, Erik [R-MN-3]</fullName>
        <firstName>Erik</firstName>
        <lastName>Paulsen</lastName>
        <party>R</party>
        <state>MN</state>
        <district>3</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>C001036</bioguideId>
        <fullName>Rep. Capps, Lois [D-CA-23]</fullName>
        <firstName>LOIS</firstName>
        <lastName>CAPPS</lastName>
        <party>D</party>
        <state>CA</state>
        <district>23</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>G000558</bioguideId>
        <fullName>Rep. Guthrie, Brett [R-KY-2]</fullName>
        <firstName>Brett</firstName>
        <lastName>Guthrie</lastName>
        <party>R</party>
        <state>KY</state>
        <district>2</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>H001048</bioguideId>
        <fullName>Rep. Hunter, Duncan D. [R-CA-52]</fullName>
        <firstName>Duncan</firstName>
        <lastName>Hunter</lastName>
        <party>R</party>
        <state>CA</state>
        <middleName>D.</middleName>
        <district>52</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>D000604</bioguideId>
        <fullName>Rep. Dent, Charles W. [R-PA-15]</fullName>
        <firstName>Charles</firstName>
        <lastName>Dent</lastName>
        <party>R</party>
        <state>PA</state>
        <middleName>W.</middleName>
        <district>15</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>S000822</bioguideId>
        <fullName>Rep. Stearns, Cliff [R-FL-6]</fullName>
        <firstName>CLIFF</firstName>
        <lastName>STEARNS</lastName>
        <party>R</party>
        <state>FL</state>
        <district>6</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>L000566</bioguideId>
        <fullName>Rep. Latta, Robert E. [R-OH-5]</fullName>
        <firstName>Robert</firstName>
        <lastName>Latta</lastName>
        <party>R</party>
        <state>OH</state>
        <middleName>E.</middleName>
        <district>5</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>S000364</bioguideId>
        <fullName>Rep. Shimkus, John [R-IL-19]</fullName>
        <firstName>JOHN</firstName>
        <lastName>SHIMKUS</lastName>
        <party>R</party>
        <state>IL</state>
        <middleName>M.</middleName>
        <district>19</district>
        <sponsorshipDate>2011-10-14</sponsorshipDate>
        <isOriginalCosponsor>True</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>C001048</bioguideId>
        <fullName>Rep. Culberson, John Abney [R-TX-7]</fullName>
        <firstName>JOHN</firstName>
        <lastName>CULBERSON</lastName>
        <party>R</party>
        <state>TX</state>
        <middleName>ABNEY</middleName>
        <district>7</district>
        <sponsorshipDate>2011-10-24</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>W000791</bioguideId>
        <fullName>Rep. Walden, Greg [R-OR-2]</fullName>
        <firstName>GREG</firstName>
        <lastName>WALDEN</lastName>
        <party>R</party>
        <state>OR</state>
        <district>2</district>
        <sponsorshipDate>2011-11-01</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>C000059</bioguideId>
        <fullName>Rep. Calvert, Ken [R-CA-44]</fullName>
        <firstName>KEN</firstName>
        <lastName>CALVERT</lastName>
        <party>R</party>
        <state>CA</state>
        <district>44</district>
        <sponsorshipDate>2011-11-01</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>M001182</bioguideId>
        <fullName>Rep. Mulvaney, Mick [R-SC-5]</fullName>
        <firstName>Mick</firstName>
        <lastName>Mulvaney</lastName>
        <party>R</party>
        <state>SC</state>
        <district>5</district>
        <sponsorshipDate>2012-01-18</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>R000592</bioguideId>
        <fullName>Rep. Rokita, Todd [R-IN-4]</fullName>
        <firstName>Todd</firstName>
        <lastName>Rokita</lastName>
        <party>R</party>
        <state>IN</state>
        <district>4</district>
        <sponsorshipDate>2012-01-23</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>M001142</bioguideId>
        <fullName>Rep. Matheson, Jim [D-UT-2]</fullName>
        <firstName>JIM</firstName>
        <lastName>MATHESON</lastName>
        <party>D</party>
        <state>UT</state>
        <district>2</district>
        <sponsorshipDate>2012-02-01</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
      <item>
        <bioguideId>G000565</bioguideId>
        <fullName>Rep. Gosar, Paul A. [R-AZ-1]</fullName>
        <firstName>Paul</firstName>
        <lastName>Gosar</lastName>
        <party>R</party>
        <state>AZ</state>
        <middleName>A.</middleName>
        <district>1</district>
        <sponsorshipDate>2012-04-24</sponsorshipDate>
        <isOriginalCosponsor>False</isOriginalCosponsor>
      </item>
    </cosponsors>
    <policyArea>
      <name>Health</name>
    </policyArea>
    <subjects>
      <legislativeSubjects>
        <item>
          <name>Administrative remedies</name>
        </item>
        <item>
          <name>Department of Health and Human Services</name>
        </item>
        <item>
          <name>Drug safety, medical device, and laboratory regulation</name>
        </item>
        <item>
          <name>Food and Drug Administration (FDA)</name>
        </item>
        <item>
          <name>Health technology, devices, supplies</name>
        </item>
      </legislativeSubjects>
      <policyArea>
        <name>Health</name>
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    </subjects>
    <summaries>
      <summary>
        <versionCode>00</versionCode>
        <actionDate>2011-10-14</actionDate>
        <actionDesc>Introduced in House</actionDesc>
        <updateDate>2012-01-27T20:32:40Z</updateDate>
        <text><![CDATA[ <p>Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services (HHS) classifies the device as a class III device in response to the person filing a notice of intent to market the device.</p>]]></text>
      </summary>
    </summaries>
    <title>Novel Device Regulatory Relief Act of 2011</title>
    <titles>
      <item>
        <titleType>Display Title</titleType>
        <title>Novel Device Regulatory Relief Act of 2011</title>
      </item>
      <item>
        <titleType>Official Title as Introduced</titleType>
        <title>To amend section 513 of the Federal Food, Drug, and Cosmetic Act to expedite the process for requesting de novo classification of a device.</title>
        <billTextVersionName>Introduced in House</billTextVersionName>
        <billTextVersionCode>IH</billTextVersionCode>
      </item>
      <item>
        <titleType>Short Titles as Introduced</titleType>
        <title>Novel Device Regulatory Relief Act of 2011</title>
      </item>
    </titles>
    <textVersions>
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        <type>Introduced in House</type>
        <date>2011-10-14T04:00:00Z</date>
        <formats>
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            <url>https://www.govinfo.gov/content/pkg/BILLS-112hr3203ih/xml/BILLS-112hr3203ih.xml</url>
          </item>
        </formats>
      </item>
    </textVersions>
    <latestAction>
      <actionDate>2011-10-18</actionDate>
      <text>Referred to the Subcommittee on Health.</text>
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    <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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