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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.
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.
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Estimated Funding: $1,500,000
Office: Food and Drug Administration
Estimated Funding: $1,500,000
Who's Eligible
Obtain Full Opportunity Text:
Full Announcement of RFA-FD-19-024
Additional Information of Eligibility:
Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutionso Historically Black Colleges and Universities (HBCUs)o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutionso Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)Nonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit OrganizationsSponsors of impacted applications Small Businesses For-Profit Organizations (Other than Small Businesses) GovernmentsState Governments County Governments City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized) U. S. Territory or Possession OtherIndependent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Foreign InstitutionsNon-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U. S. Organizations are not eligible to apply.Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.
Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-19-024.html
Contact:
Agency Email Description:
work
Agency Email:
Date Posted:
2019-04-01
Application Due Date:
Archive Date:
2019-07-04
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