Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01) Clinical Trials Optional

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
Related Programs

Food and Drug Administration_Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: Food and Drug Administration

Estimated Funding: $2,000,000


Relevant Nonprofit Program Categories





Obtain Full Opportunity Text:
FULL ANNOUNCEMENT

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 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.

Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-20-025.html

Contact:


Agency Email Description:
Work Email

Agency Email:


Date Posted:
2020-01-24

Application Due Date:


Archive Date:
2020-06-01



Social Entrepreneurship
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Social Enterprise Crafts Sweet Design


Social Enterprise Crafts Sweet Design

Florence Norman founded Sweet Cavanagh, an award-winning peer-led aftercare social enterprise based in Notting Hill. The company hires women and trains them how to make and design jewelry. However, these women are in the process of recovering from eating disorders and addictions.




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