Bill113th Congress

H.R. 820

Delivering Antimicrobial Transparency in Animals Act of 2013

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Introduced
Feb 26, 2013
Origin Chamber
House
Policy Area
Health
Latest Action
Mar 1, 2013

Sponsor

Rep. Waxman, Henry A. [D-CA-33]

Democrat·CA-33
Bioguide ID: W000215
First Name: HENRY
Middle Name: A.
Last Name: WAXMAN
By Request: N
10
Cosponsors
1
Committees
4
Actions
0
Amendments
0
Related Bills
14
Subjects
1
Summaries
3
Titles
1
Text Versions

Bill Details

Update Date
Nov 15, 2022
Origin Chamber
House
Bill Type
HR
Bill Number
820
Congress
113
Introduced Date
Feb 26, 2013
Policy Area
Health
Is Law
No
Mar 1, 2013Committee

Referred to the Subcommittee on Health.

Source: House committee actions

Feb 26, 2013IntroReferralH11100

Referred to the House Committee on Energy and Commerce.

Source: House floor actions

Feb 26, 2013IntroReferralIntro-H

Introduced in House

Source: Library of Congress

Feb 26, 2013IntroReferral1000

Introduced in House

Source: Library of Congress

Introduced in House· Feb 26, 20130

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.

Energy and Commerce Committee

House· Standing
Administrative law and regulatory proceduresBusiness recordsCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Food supply, safety, and labelingGovernment information and archivesGovernment studies and investigationsInfectious and parasitic diseasesLivestockMedical researchRetail and wholesale tradesVeterinary medicine and animal diseases

Introduced in House

Feb 26, 2013

Delivering Antimicrobial Transparency in Animals Act of 2013 — Informed