FDA: Establishing Targeted Durations of Use for Antimicrobial New Animal Drugs Grant

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.

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.

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.

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.

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.

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.

Public/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 Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

Nonprofits 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 Organizations

Sponsors of impacted applications
Small Businesses
For-Profit Organizations (Other than Small Businesses)
Governments

State 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
Other

Independent 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 Institutions
Non-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.