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

The purpose of this Funding Opportunity is to solicit applicationsto conduct studies that could support the approval of label changes toestablish more targeted durations of use for certain approved medicallyimportant antimicrobial new animal drugs in food animals. These cooperative agreements are intended to providepublicly available data to be used by sponsor(s) of affected approved newanimal drugs to support approval of future supplemental new animal drugapplications. Such supplemental new animal drug applications are intended to: 1) Revise approved dosage regimens to provide for usedurations that are more targeted (i.e., are more specifically defined) and, 2) That the revised dosage regimens continue to provide effectivenessthat is comparable to the currently approved regimen while reducing the risk ofantimicrobial resistance development.