(FOA)-Conduct
Studies to Establish More Targeted Durations of Use for Certain Approved
Antimicrobial New Animal Drugs in Food Animals (U01) Clinical Trials Optional;
May 1, 2020
Agency
U.S.
Food and Drug Administration
Description
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.
See
list of affected new animal drug applications at [List of Approved Medically
Important Antimicrobial Drugs Administered in the Feed of Food-Producing
Animals that Lack a Defined Duration of Use.].
Announcement
Number:
RFA-FD-20-025
Closing
Date:
May
1, 2020
Link
to Full Announcement
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-20-025.html
Contact
Information
Rita
Viskup
240-402-1568