3.0.0 820 2022-11-15T16:34:36Z 2022-11-15T16:34:36Z House H HR 2013-02-26 113 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. WAXMAN:H.R. 820.Congress has the power to enact this legislation pursuantto the following:This bill is enacted pursuant to the power granted toCongress under Article I of the United States Constitutionand its subsequent amendments, and further clarified andinterpreted by the Supreme Court of the United States.[Page H659]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2013-03-01T21:30:25Z Referred to 2013-02-26T15:01:50Z 2013-03-01 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2013-02-26 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2013-02-26 Introduced in House IntroReferral Intro-H 9 Library of Congress 2013-02-26 Introduced in House IntroReferral 1000 9 Library of Congress W000215 Rep. Waxman, Henry A. [D-CA-33] HENRY WAXMAN D CA A. 33 N S000480 Rep. Slaughter, Louise McIntosh [D-NY-25] LOUISE SLAUGHTER D NY M. 25 2013-02-26 True R000053 Rep. Rangel, Charles B. [D-NY-13] CHARLES RANGEL D NY B. 13 2013-04-17 False C000380 Del. Christensen, Donna M. [D-VI-At Large] DONNA CHRISTENSEN D VI M. 0 2013-04-17 False T000266 Rep. Tierney, John F. [D-MA-6] JOHN TIERNEY D MA F. 6 2013-05-17 False S001145 Rep. Schakowsky, Janice D. [D-IL-9] JANICE SCHAKOWSKY D IL D. 9 2013-06-25 False L000397 Rep. Lofgren, Zoe [D-CA-19] ZOE LOFGREN D CA 19 2013-09-10 False M000933 Rep. Moran, James P. [D-VA-8] JAMES MORAN D VA P. 8 2013-11-18 False Q000023 Rep. Quigley, Mike [D-IL-5] Mike Quigley D IL 5 2014-03-12 False R000577 Rep. Ryan, Tim [D-OH-13] TIM RYAN D OH 13 2014-03-25 False B001270 Rep. Bass, Karen [D-CA-37] Karen Bass D CA 37 2014-06-17 False Health Administrative law and regulatory procedures Business records Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Food supply, safety, and labeling Government information and archives Government studies and investigations Infectious and parasitic diseases Livestock Medical research Retail and wholesale trades Veterinary medicine and animal diseases Health 00 2013-02-26 Introduced in House 2013-05-15T19:53:15Z Delivering Antimicrobial Transparency in Animals Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to revise reporting requirements for the sponsor of a new animal drug containing an antimicrobial active ingredient. Requires a sponsor's annual report to the Secretary of Health and Human Services (HHS) to specify for each dosage form the known or estimated amounts of the antimicrobial active ingredient sold or distributed for use in each food-producing animal for which the new animal drug is approved.

Repeals the requirement that such report list, for each dosage form, the target animals, indications, and production classes specified on the approved label of the product.

Requires live poultry dealers, swine contractors, or feed lot operators who purchase, contract, or manufacture animal feed in final formulation bearing or containing a new animal drug with an antimicrobial active ingredient to report annually to the Secretary information about such ingredient by food-producing animal for which the new animal drug is approved and, if applicable, by production class of the animal. Exempts dealers, contractors, or operators from this reporting requirement if the value of their live animals does not exceed $10 million or such other sum as the Secretary may specify. Authorizes the Secretary to specify alternative reporting requirements.

Establishes requirements for: (1) publicly available summaries of the information in the annual reports, including data by antimicrobial class; and (2) how to report data with fewer than three sponsors of such approved new animal drugs.

Requires the Secretary, acting through the Commissioner of Food and Drugs (FDA), to increase collaboration and coordination with the Secretary of Agriculture (USDA) to expand and coordinate the collection of data on the use of antimicrobial drugs in or on food-producing animals, as well as provide information to the Secretary of Agriculture for use by: (1) the Animal and Plant Health Inspection Service to help inform its collection of data through the National Animal Health Monitoring System, and (2) the Economic Research Service to help inform its collection of data through the Agricultural Resource Management Survey.

Requires the Secretary to publish a final version of draft guidance #213 entitled “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209.” Requires the Comptroller General (GAO), within three years after such publication, to evaluate: (1) the voluntary approach used by the FDA to eliminate injudicious use of antimicrobial drugs in food-producing animals, and (2) the effectiveness of FDA data collection activities regarding antimicrobial resistance.

]]> Delivering Antimicrobial Transparency in Animals Act of 2013 Display Title Delivering Antimicrobial Transparency in Animals Act of 2013 Short Titles as Introduced Delivering Antimicrobial Transparency in Animals Act of 2013 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to enhance the reporting requirements pertaining to use of antimicrobial drugs in food animals. Introduced in House 2013-02-26T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-113hr820ih/xml/BILLS-113hr820ih.xml 2013-03-01 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.