The U.S. Food & Drug Administration announced Aug. 14 that it is publishing a paper proposing the use of a biomass denominator to adjust annual data on the amount of antimicrobials sold or distributed for use in food-producing animals in the U.S.

This adjusted estimate will provide insight into broad shifts in the amount of antimicrobials sold for use in food-producing animals and will give the agency a more nuanced view of why sales increase or decrease over time in a manner that is specific to U.S. animal production.

FDA said such an analysis will also support its ongoing efforts to encourage the judicious use of antimicrobials in food-producing animals to help ensure the continued availability of safe and effective antimicrobials for animals and humans.

A biomass denominator is defined as the population of a given livestock species in the U.S. multiplied by the average weight of that species. The proposed method will help calculate estimates of annual antimicrobial drug sales adjusted for the size of the animal population (also known as the animal biomass) potentially being treated with those drugs. FDA is currently considering the best way to make biomass-adjusted antimicrobial sales data publicly available.

FDA said it is publishing the paper to engage stakeholders on the proposed biomass method and to seek comment on the methodology and the utility of this type of data analysis. The agency will seek public comment on this proposal for 90 days beginning Aug. 15, 2017.

To submit comments to the docket electronically, visit www.regulations.gov, and type FDA-2017-N-1197 into the search box.

To submit comments to the docket by mail, be sure to include docket number FDA-2017-N-1197 on each page of the written comments, and send them to the following address:

Dockets Management Staff
HFA-305
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852