(FOA)-Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required); June 3, 2019

 

Agency

U.S. Food and Drug Administration (FDA)

 

Description

The purpose of this Funding Opportunity is to solicit applications to conduct studies 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 data to be used by sponsor(s) of affected approved new animal drugs to support 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.

 

Announcement Number

RFA-FD-19-024

 

Closing Date

June 3, 2019 

 

Link to Full Announcement

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-19-024.html

 

Contact Information

John M. Mussman, DVM
240-402-0589 
John.Mussman@fda.hhs.gov