<billStatus>
 <version>
  3.0.0
 </version>
 <bill>
  <number>
   2853
  </number>
  <updateDate>
   2023-03-08T20:11:59Z
  </updateDate>
  <updateDateIncludingText>
   2023-03-08T20:11:59Z
  </updateDateIncludingText>
  <originChamber>
   House
  </originChamber>
  <type>
   HR
  </type>
  <introducedDate>
   2021-04-26
  </introducedDate>
  <congress>
   117
  </congress>
  <constitutionalAuthorityStatementText>
   &lt;pre&gt;[Congressional Record Volume 167, Number 71 (Monday, April 26, 2021)][House]From the Congressional Record Online through the Government Publishing Office [&lt;a href="https://www.gpo.gov"&gt;www.gpo.gov&lt;/a&gt;]By Mr. SCHRADER:H.R. 2853.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, clause 3.[Page H2115]&lt;/pre&gt;
  </constitutionalAuthorityStatementText>
  <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>
         2021-04-27T13:20:41Z
        </date>
       </item>
      </activities>
     </item>
    </subcommittees>
    <activities>
     <item>
      <name>
       Referred to
      </name>
      <date>
       2021-04-26T16:04:15Z
      </date>
     </item>
    </activities>
   </item>
  </committees>
  <actions>
   <item>
    <actionDate>
     2021-04-27
    </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>
     2021-04-26
    </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>
    </sourceSystem>
    <committees>
     <item>
      <systemCode>
       hsif00
      </systemCode>
      <name>
       Energy and Commerce Committee
      </name>
     </item>
    </committees>
   </item>
   <item>
    <actionDate>
     2021-04-26
    </actionDate>
    <text>
     Introduced in House
    </text>
    <type>
     IntroReferral
    </type>
    <actionCode>
     Intro-H
    </actionCode>
    <sourceSystem>
     <code>
      9
     </code>
     <name>
      Library of Congress
     </name>
    </sourceSystem>
   </item>
   <item>
    <actionDate>
     2021-04-26
    </actionDate>
    <text>
     Introduced in House
    </text>
    <type>
     IntroReferral
    </type>
    <actionCode>
     1000
    </actionCode>
    <sourceSystem>
     <code>
      9
     </code>
     <name>
      Library of Congress
     </name>
    </sourceSystem>
   </item>
  </actions>
  <sponsors>
   <item>
    <bioguideId>
     S001180
    </bioguideId>
    <fullName>
     Rep. Schrader, Kurt [D-OR-5]
    </fullName>
    <firstName>
     Kurt
    </firstName>
    <lastName>
     Schrader
    </lastName>
    <party>
     D
    </party>
    <state>
     OR
    </state>
    <district>
     5
    </district>
    <isByRequest>
     N
    </isByRequest>
   </item>
  </sponsors>
  <policyArea>
   <name>
    Health
   </name>
  </policyArea>
  <subjects>
   <legislativeSubjects>
    <item>
     <name>
      Competition and antitrust
     </name>
    </item>
    <item>
     <name>
      Drug safety, medical device, and laboratory regulation
     </name>
    </item>
    <item>
     <name>
      Health care costs and insurance
     </name>
    </item>
    <item>
     <name>
      Health care coverage and access
     </name>
    </item>
    <item>
     <name>
      Licensing and registrations
     </name>
    </item>
    <item>
     <name>
      Marketing and advertising
     </name>
    </item>
    <item>
     <name>
      Prescription drugs
     </name>
    </item>
   </legislativeSubjects>
   <policyArea>
    <name>
     Health
    </name>
   </policyArea>
  </subjects>
  <summaries>
   <summary>
    <versionCode>
     00
    </versionCode>
    <actionDate>
     2021-04-26
    </actionDate>
    <actionDesc>
     Introduced in House
    </actionDesc>
    <updateDate>
     2021-09-01T17:26:04Z
    </updateDate>
    <text>
     &lt;p&gt;&lt;b&gt;Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the&lt;/b&gt; &lt;b&gt;BLOCKING Act of 2021&lt;/b&gt;&lt;/p&gt; &lt;p&gt;This bill modifies provisions related to market exclusivity for a generic drug.&lt;/p&gt; &lt;p&gt;Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.&lt;/p&gt; &lt;p&gt;The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.&lt;/p&gt;
    </text>
   </summary>
  </summaries>
  <title>
   Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
  </title>
  <titles>
   <item>
    <titleType>
     Display Title
    </titleType>
    <title>
     Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
    </title>
   </item>
   <item>
    <titleType>
     Official Title as Introduced
    </titleType>
    <title>
     To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.
    </title>
    <billTextVersionName>
     Introduced in House
    </billTextVersionName>
    <billTextVersionCode>
     IH
    </billTextVersionCode>
   </item>
   <item>
    <titleType>
     Short Title(s) as Introduced
    </titleType>
    <title>
     Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
    </title>
    <billTextVersionName>
     Introduced in House
    </billTextVersionName>
    <billTextVersionCode>
     IH
    </billTextVersionCode>
   </item>
   <item>
    <titleType>
     Short Title(s) as Introduced
    </titleType>
    <title>
     BLOCKING Act of 2021
    </title>
    <billTextVersionName>
     Introduced in House
    </billTextVersionName>
    <billTextVersionCode>
     IH
    </billTextVersionCode>
   </item>
  </titles>
  <textVersions>
   <item>
    <type>
     Introduced in House
    </type>
    <date>
     2021-04-26T04:00:00Z
    </date>
    <formats>
     <item>
      <url>
       https://www.govinfo.gov/content/pkg/BILLS-117hr2853ih/xml/BILLS-117hr2853ih.xml
      </url>
     </item>
    </formats>
   </item>
  </textVersions>
  <latestAction>
   <actionDate>
    2021-04-27
   </actionDate>
   <text>
    Referred to the Subcommittee on Health.
   </text>
  </latestAction>
 </bill>
 <dublinCore xmlns:dc="http://purl.org/dc/elements/1.1/">
  <dc:format>
   text/xml
  </dc:format>
  <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>
 </dublinCore>
</billStatus>

2021-04-27
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-04-26
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
2021-04-26T16:04:15Z
Referred to
House
Energy and Commerce Committee
2021-04-27T13:20:41Z
Referred to
Health Subcommittee
hsif14
hsif00
Standing
Congressional Research Service, Library of Congress
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.
text/xml
EN
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.
2021-04-26
2021-04-27
Referred to the Subcommittee on Health.
House
Health
S001180
5
Kurt
Rep. Schrader, Kurt [D-OR-5]
N
Schrader
D
OR
Competition and antitrust Drug safety, medical device, and laboratory regulation Health care costs and insurance Health care coverage and access Licensing and registrations Marketing and advertising Prescription drugs
2021-04-26
Introduced in House
 <p><b>Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the</b> <b>BLOCKING Act of 2021</b></p> <p>This bill modifies provisions related to market exclusivity for a generic drug.</p> <p>Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.</p> <p>The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.</p>
2021-09-01T17:26:04Z
00
2021-04-26T04:00:00Z
Introduced in House
https://www.govinfo.gov/content/pkg/BILLS-117hr2853ih/xml/BILLS-117hr2853ih.xml
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Short Title(s) as Introduced
IH
Introduced in House
BLOCKING Act of 2021
Short Title(s) as Introduced
HR
2023-03-08T20:11:59Z
2023-03-08T20:11:59Z
3.0.0
2021-04-27
Health Subcommittee
hsif14
1
House committee actions
Referred to the Subcommittee on Health.
Committee
H11100
2021-04-26
Energy and Commerce Committee
hsif00
2
House floor actions
Referred to the House Committee on Energy and Commerce.
IntroReferral
Intro-H
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
1000
2021-04-26
9
Library of Congress
Introduced in House
IntroReferral
S001180
5
Kurt
Rep. Schrader, Kurt [D-OR-5]
N
Schrader
D
OR
Competition and antitrust Drug safety, medical device, and laboratory regulation Health care costs and insurance Health care coverage and access Licensing and registrations Marketing and advertising Prescription drugs
2021-04-26
Introduced in House
 <p><b>Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the</b> <b>BLOCKING Act of 2021</b></p> <p>This bill modifies provisions related to market exclusivity for a generic drug.</p> <p>Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.</p> <p>The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.</p>
2021-09-01T17:26:04Z
00
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Display Title
IH
Introduced in House
To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes.
Official Title as Introduced
IH
Introduced in House
Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021
Short Title(s) as Introduced
IH
Introduced in House
BLOCKING Act of 2021
Short Title(s) as Introduced
2021-04-27
Referred to the Subcommittee on Health.