Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01) Clinical Trials Optional

The purpose of this Funding Opportunity is to solicit applications to generate evidence that could support the approval of label changes to establish more targeted durations of use for certain approved medically important antimicrobial new animal drugs in food animals. These cooperative agreements are intended to provide publicly available evidence to be used by sponsor(s) of affected approved new animal drugs to fulfill a portion of or all of the requirements for the effectiveness technical section for the approval of future supplemental new animal drug applications. Such supplemental new animal drug applications are intended to: 1) Revise approved dosage regimens to provide for use durations that are more targeted (i.e., are more specifically defined) and, 2) That the revised dosage regimens continue to provide effectiveness that is comparable to the currently approved regimen while reducing the risk of antimicrobial resistance development