3.0.0 1150 2023-01-11T13:23:14Z 2023-01-11T13:23:14Z House H HR 2013-03-14 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. SLAUGHTER:H.R. 1150.Congress has the power to enact this legislation pursuantto the following:Clauses 1, 3, and 18 of Section 8 of Article I of theConstitution[Page H1428]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-03-15T18:55:18Z Referred to 2013-03-14T14:02:10Z Preventing Antibiotic Resistance Act of 2013 113 1256 S 2013-06-27 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2013-03-15 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-03-14 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-03-14 Sponsor introductory remarks on measure. (CR E299) IntroReferral B00100 9 Library of Congress 2013-03-14 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-03-14 Introduced in House IntroReferral 1000 9 Library of Congress S000480 Rep. Slaughter, Louise McIntosh [D-NY-25] LOUISE SLAUGHTER D NY M. 25 N D000216 Rep. DeLauro, Rosa L. [D-CT-3] ROSA DELAURO D CT 3 2013-04-10 False L000559 Rep. Langevin, James R. [D-RI-2] JAMES LANGEVIN D RI R. 2 2013-04-10 False D000197 Rep. DeGette, Diana [D-CO-1] DIANA DEGETTE D CO 1 2013-04-10 False L000551 Rep. Lee, Barbara [D-CA-13] BARBARA LEE D CA 13 2013-04-10 False R000053 Rep. Rangel, Charles B. [D-NY-13] CHARLES RANGEL D NY B. 13 2013-04-10 False N000179 Rep. Napolitano, Grace F. [D-CA-32] GRACE NAPOLITANO D CA F. 32 2013-04-10 False C001078 Rep. Connolly, Gerald E. [D-VA-11] Gerald Connolly D VA E. 11 2013-04-10 False M000087 Rep. Maloney, Carolyn B. [D-NY-12] CAROLYN MALONEY D NY B. 12 2013-04-10 False H001032 Rep. Holt, Rush [D-NJ-12] RUSH HOLT D NJ D. 12 2013-04-10 False M001160 Rep. Moore, Gwen [D-WI-4] Gwen Moore D WI 4 2013-04-10 False K000009 Rep. Kaptur, Marcy [D-OH-9] MARCY KAPTUR D OH 9 2013-04-10 False C001067 Rep. Clarke, Yvette D. [D-NY-9] Yvette Clarke D NY D. 9 2013-04-10 False L000397 Rep. Lofgren, Zoe [D-CA-19] ZOE LOFGREN D CA 19 2013-04-10 False H001047 Rep. Himes, James A. [D-CT-4] James Himes D CT A. 4 2013-04-10 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2013-04-10 False W000215 Rep. Waxman, Henry A. [D-CA-33] HENRY WAXMAN D CA A. 33 2013-04-10 False L000560 Rep. Larsen, Rick [D-WA-2] RICK LARSEN D WA 2 2013-04-10 False P000523 Rep. Price, David E. [D-NC-4] DAVID PRICE D NC E. 4 2013-04-10 False M001143 Rep. McCollum, Betty [D-MN-4] BETTY MCCOLLUM D MN 4 2013-04-10 False P000597 Rep. Pingree, Chellie [D-ME-1] Chellie Pingree D ME 1 2013-04-19 False M001149 Rep. Michaud, Michael H. [D-ME-2] Michael Michaud D ME H. 2 2013-04-19 False M000725 Rep. Miller, George [D-CA-11] GEORGE MILLER D CA 11 2013-04-19 False D000191 Rep. DeFazio, Peter A. [D-OR-4] PETER DEFAZIO D OR A. 4 2013-04-25 False L000563 Rep. Lipinski, Daniel [D-IL-3] Daniel Lipinski D IL William 3 2013-04-26 False G000551 Rep. Grijalva, Raúl M. [D-AZ-3] Raúl Grijalva D AZ M. 3 2013-04-26 False W000800 Rep. Welch, Peter [D-VT-At Large] Peter Welch D VT 0 2013-05-09 False S001175 Rep. Speier, Jackie [D-CA-14] Jackie Speier D CA 14 2013-05-09 False H000324 Rep. Hastings, Alcee L. [D-FL-20] ALCEE HASTINGS D FL L. 20 2013-05-09 False S001170 Rep. Shea-Porter, Carol [D-NH-1] Carol Shea-Porter D NH 1 2013-05-09 False B001245 Del. Bordallo, Madeleine Z. [D-GU-At Large] Madeleine Bordallo D GU Z. 0 2013-05-09 False F000030 Rep. Farr, Sam [D-CA-20] SAM FARR D CA 20 2013-05-09 False T000266 Rep. Tierney, John F. [D-MA-6] JOHN TIERNEY D MA F. 6 2013-05-09 False P000604 Rep. Payne, Donald M., Jr. [D-NJ-10] Donald Payne D NJ M. 10 2013-05-09 False C001080 Rep. Chu, Judy [D-CA-27] Judy Chu D CA 27 2013-05-09 False E000215 Rep. Eshoo, Anna G. [D-CA-18] ANNA ESHOO D CA G. 18 2013-05-09 False H001063 Rep. Hahn, Janice [D-CA-44] Janice Hahn D CA 44 2013-05-09 False C001090 Rep. Cartwright, Matt [D-PA-17] Matt Cartwright D PA 17 2013-05-09 False B000574 Rep. Blumenauer, Earl [D-OR-3] EARL BLUMENAUER D OR 3 2013-05-20 False L000263 Rep. Levin, Sander M. [D-MI-9] SANDER LEVIN D MI M. 9 2013-05-20 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2013-05-20 False C001084 Rep. Cicilline, David N. [D-RI-1] David Cicilline D RI N. 1 2013-05-20 False L000557 Rep. Larson, John B. [D-CT-1] JOHN LARSON D CT B. 1 2013-06-06 False M000133 Rep. Markey, Edward J. [D-MA-5] Edward Markey D MA J. 5 2013-06-17 False H001068 Rep. Huffman, Jared [D-CA-2] Jared Huffman D CA 2 2013-06-17 False R000515 Rep. Rush, Bobby L. [D-IL-1] BOBBY RUSH D IL L. 1 2013-06-17 False M000312 Rep. McGovern, James P. [D-MA-2] JAMES MCGOVERN D MA P. 2 2013-06-17 False E000288 Rep. Ellison, Keith [D-MN-5] Keith Ellison D MN 5 2013-06-28 False W000187 Rep. Waters, Maxine [D-CA-43] MAXINE WATERS D CA 43 2013-07-24 False C001068 Rep. Cohen, Steve [D-TN-9] Steve Cohen D TN 9 2013-07-24 False H001034 Rep. Honda, Michael M. [D-CA-17] MICHAEL HONDA D CA M. 17 2013-09-27 False B001270 Rep. Bass, Karen [D-CA-37] Karen Bass D CA 37 2013-09-30 False J000126 Rep. Johnson, Eddie Bernice [D-TX-30] EDDIE JOHNSON D TX BERNICE 30 2013-09-30 False P000598 Rep. Polis, Jared [D-CO-2] Jared Polis D CO 2 2013-10-09 False C000714 Rep. Conyers, John, Jr. [D-MI-13] JOHN CONYERS D MI 13 2013-10-11 False D000598 Rep. Davis, Susan A. [D-CA-53] SUSAN DAVIS D CA A. 53 2013-10-11 False F000010 Del. Faleomavaega, Eni F. H. [D-AS-At Large] Eni Faleomavaega D AS F. H. 0 2013-10-23 False N000147 Del. Norton, Eleanor Holmes [D-DC-At Large] ELEANOR NORTON D DC HOLMES 0 2013-11-15 False D000399 Rep. Doggett, Lloyd [D-TX-35] LLOYD DOGGETT D TX 35 2013-11-15 False R000486 Rep. Roybal-Allard, Lucille [D-CA-40] LUCILLE ROYBAL-ALLARD D CA 40 2013-11-15 False T000469 Rep. Tonko, Paul [D-NY-20] Paul Tonko D NY 20 2013-12-02 False M000404 Rep. McDermott, Jim [D-WA-7] JIM MCDERMOTT D WA 7 2013-12-03 False T000465 Rep. Tsongas, Niki [D-MA-3] Niki Tsongas D MA 3 2013-12-04 False L000579 Rep. Lowenthal, Alan S. [D-CA-47] Alan Lowenthal D CA S. 47 2013-12-09 False I000057 Rep. Israel, Steve [D-NY-3] STEVE ISRAEL D NY 3 2013-12-09 False G000571 Rep. Gabbard, Tulsi [D-HI-2] Tulsi Gabbard D HI 2 2013-12-12 False S000344 Rep. Sherman, Brad [D-CA-30] BRAD SHERMAN D CA 30 2013-12-12 False B001278 Rep. Bonamici, Suzanne [D-OR-1] Suzanne Bonamici D OR 1 2013-12-19 False Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2014-03-11 False R000577 Rep. Ryan, Tim [D-OH-13] TIM RYAN D OH 13 2014-03-13 False S001150 Rep. Schiff, Adam B. [D-CA-28] ADAM SCHIFF D CA B. 28 2014-05-22 False P000595 Rep. Peters, Gary C. [D-MI-14] Gary Peters D MI 14 2014-06-12 False M001163 Rep. Matsui, Doris O. [D-CA-6] Doris Matsui D CA O. 6 2014-06-24 False S001156 Rep. Sánchez, Linda T. [D-CA-38] Linda Sánchez D CA T. 38 2014-07-25 False E000290 Rep. Edwards, Donna F. [D-MD-4] Donna Edwards D MD F. 4 2014-07-31 False N000187 Rep. Negrete McLeod, Gloria [D-CA-35] Gloria Negrete McLeod D CA 35 2014-09-15 False D000610 Rep. Deutch, Theodore E. [D-FL-21] Theodore Deutch D FL E. 21 2014-11-13 False K000382 Rep. Kuster, Ann M. [D-NH-2] Ann Kuster D NH M. 2 2014-11-13 False R000599 Rep. Ruiz, Raul [D-CA-36] Raul Ruiz D CA 36 2014-12-02 False Health Administrative law and regulatory procedures Administrative remedies Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Livestock Veterinary medicine and animal diseases Health 00 2013-03-14 Introduced in House 2015-05-11T17:21:19Z Preservation of Antibiotics for Medical Treatment Act of 2013 - 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 due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration.

Defines “medically important antimicrobial” as a drug intended for use in food-producing animals and composed wholly or partly of: (1) any kind of specified antibiotics, including penicillin and tetracycline; or (2) a drug from an antimicrobial class that is listed on the World Health Organization’s list of critically important antimicrobials.

Requires the Secretary to withdraw approval for the nontherapeutic use in food-producing animals of a medically important antimicrobial marketed for human use unless the Secretary makes a final written determination that, based on either the application holder's demonstration or an HHS risk analysis, there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the drug's nontherapeutic use.

Requires the Secretary to rescind approval of an exemption for investigational use of, or of approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in a food-producing animal two years after the exemption is granted or the application for approval is submitted. Exempts from this requirement any drugs for which there has been found a reasonable certainty of no harm to human health.

Prohibits the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. Requires the administration of the antimicrobial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission.

]]> Preservation of Antibiotics for Medical Treatment Act of 2013 Display Title Preservation of Antibiotics for Medical Treatment Act of 2013 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases. Introduced in House IH Short Titles as Introduced Preservation of Antibiotics for Medical Treatment Act of 2013 Introduced in House 2013-03-14T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr1150ih/xml/BILLS-113hr1150ih.xml 2013-03-15 Referred to the Subcommittee on Health. 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. 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.