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FDA seeks comment on antimicrobial drug use data collection

The U.S. Food and Drug Administration is seeking public comment on how the agency can collect more detailed information on antimicrobial drug use in food-producing animals and how best distribute the information, as part of an effort to better correlate antimicrobial drug use to antimicrobial resistance.

The Government Accountability Office said information currently collected by FDA does not provide sufficient data to analyze trends in antimicrobial resistance, so the agency is requesting that manufacturers provide an estimate on how much of each drug is being used on each species.

Under current law, manufacturers are required to report how much of each antimicrobial product they sell and distribute and for which species the product is indicated. However, some classes of antimicrobials are indicated for more than one species, making it difficult for FDA to determine how much of each product is being used in each species.

FDA also publishes antimicrobial sales and distribution reports for public consumption, but under current law the agency is allowed only to report those antimicrobial drug classes with three or more distinct sponsors to protect confidential sales information. FDA is seeking comment on how best to compile and present summary information on antimicrobial use without disclosing the confidential sales data.

Additionally, FDA is seeking input on other methods for assessing antimicrobial use in food-producing animals that would aid in comparing antimicrobial use to antimicrobial resistance.

Comments should be submitted by September 25, and should include Docket No. FDA-2012-N-0447. Submit comments electronically at, via fax to +1.301.827.6879, or sent via mail to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

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