Food and Drug Administration

Description

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.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses

Contact

Rene A Vasquez <br/>Grants Management Specialist <br/>Email: rene.vasquez@fda.hhs.gov
rene.vasquez@fda.hhs.gov