OpportunityTitle: Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01) Clinical Trials Optional
AdditionalInformationOnEligibility: 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 OrganizationsSmall 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.
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
GrantorContactEmailDescription: Work Email
GrantorContactText: Rene A Vasquez &lt;br/&gt;Grants Management Specialist &lt;br/&gt;Phone 301-796-3546