Delivering Antimicrobial Transparency in Animals Act of 2013

Bill: 113-hr-820
Sponsor: Rep. Waxman, Henry A. [D-CA-33]
Introduced: 2013-02-26 in the House
Policy area: Health
Subjects: 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

Summary:
action_date: 2013-02-26
text: 
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 &ldquo;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.&rdquo; 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.


Legislative actions:
action_date: 2013-03-01
text: Referred to the Subcommittee on Health.
action_date: 2013-02-26
text: Referred to the House Committee on Energy and Commerce.
action_date: 2013-02-26
text: Introduced in House
action_date: 2013-02-26
text: Introduced in House