<?xml version="1.0" encoding="UTF-8"?><BillSummaries>
<item congress="115" measure-type="hr" measure-number="1587" measure-id="id115hr1587" originChamber="HOUSE" orig-publish-date="2017-03-16" update-date="2017-07-13">
<title>Preservation of Antibiotics for Medical Treatment Act of 2017</title>
<summary summary-id="id115hr1587v00" currentChamber="HOUSE" update-date="2017-07-13">
<action-date>2017-03-16</action-date>
<action-desc>Introduced in House</action-desc>
<summary-text><![CDATA[<p><b>Preservation of Antibiotics for Medical Treatment Act of 2017</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to the nontherapeutic use of the drug.</p> <p>Medically important antimicrobials are drugs intended for use in food-producing animals that contain: (1) specified antibiotics, or (2) certain drugs on the World Health Organization&rsquo;s list of critically important antimicrobials.</p> <p> Two years after enactment of this bill, the Food and Drug Administration (FDA) must withdraw approval of a drug's nontherapeutic use in food-producing animals unless the FDA makes a determination that, based on the application holder's demonstration or an FDA risk analysis, there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.</p> <p> The FDA must rescind an exemption for investigational use of, or approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in food-producing animals two years after the exemption is granted or the application for approval is submitted unless there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.</p> <p>A medically important antimicrobial cannot be administered (including through animal feed) to a food-producing animal for disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the animal.</p>]]></summary-text>
</summary>
</item>
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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 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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