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<BillSummaries>
<item congress="113" measure-type="hr" measure-number="3742" measure-id="id113hr3742" originChamber="HOUSE" orig-publish-date="2013-12-12" update-date="2014-04-09">
<title>Antibiotic Development to Advance Patient Treatment Act of 2013</title>
<summary summary-id="id113hr3742v00" currentChamber="HOUSE" update-date="2014-04-09">
<action-date>2013-12-12</action-date>
<action-desc>Introduced in House</action-desc>
<summary-text><![CDATA[<p>Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.</p> <p>Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.</p> <p>Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.</p> <p>Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.</p> <p>Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.</p> <UL> <UL> </UL> </UL> <UL> </UL>]]></summary-text>
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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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