Opportunity Information: Apply for RFA FD 19 024

This FDA funding opportunity (RFA-FD-19-024) supports cooperative agreement projects designed to generate the kind of rigorous, publicly available study data that can be used to update the labels of certain already-approved, medically important antimicrobial new animal drugs used in food-producing animals. The central idea is to move away from broad or loosely defined treatment lengths and toward more targeted, clearly specified durations of use. By refining how long these antimicrobials are used, the program aims to preserve treatment effectiveness for animal health while also lowering the chance that antimicrobial resistance develops or spreads due to unnecessary exposure.

The work funded under this opportunity is meant to directly support future supplemental New Animal Drug Applications (sNADAs) submitted by the drug sponsors whose products are affected. In practical terms, the studies should be designed so their results can help sponsors request label changes that (1) revise the approved dosage regimens to include durations that are more targeted and specifically defined, and (2) demonstrate that these revised regimens remain comparably effective to the currently approved regimen. The public health motivation is explicit: maintaining therapeutic benefit while reducing selective pressure that can drive resistance. Because this is a U01 cooperative agreement and labeled "Clinical Trial Required," the expectation is that applicants will be conducting controlled, well-planned studies in relevant food-animal settings that meet FDA-quality standards and can credibly inform regulatory decisions.

Administratively, the opportunity is run by the U.S. Food and Drug Administration under CFDA 93.103, with an activity category that spans agriculture, consumer protection, and food and nutrition. The funding instrument is a cooperative agreement, which typically means FDA will have substantial programmatic involvement compared with a standard grant, such as input on study design expectations, milestones, and data quality needs, reflecting the regulatory purpose of the work. The posted award ceiling is $2,500,000. The original closing date listed for applications was 2019-06-03, and the opportunity record shows a creation date of 2019-04-01.

Eligibility is broad across U.S.-based organizations that can credibly conduct the necessary studies and manage the reporting and data-sharing requirements. Eligible applicants include public and private institutions of higher education (including public/state-controlled and private universities), nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education in those categories), and for-profit organizations (including small businesses and other for-profits). Government entities at multiple levels are also eligible, including state, county, city or township, and special district governments, as well as independent school districts. Tribal eligibility includes federally recognized Native American tribal governments and other Native American tribal organizations. The announcement also notes that faith-based and community-based organizations, public housing authorities/Indian housing authorities, U.S. territories or possessions, and regional organizations appear among the eligible organization types described in the narrative eligibility section.

Foreign participation is explicitly restricted. Non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by the HHS Grants Policy Statement) are not allowed. In other words, the work is intended to be planned, performed, and managed entirely within eligible U.S. organizational structures.

A notable emphasis is placed on encouraging applications from certain types of higher education institutions that are often underrepresented in federal research funding, including Hispanic-serving institutions, historically Black colleges and universities (HBCUs), tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American, Native American, and Pacific Islander-serving institutions (AANAPISIs). The intent is to broaden participation while still focusing on studies that produce regulatory-grade evidence capable of supporting label refinements that align animal health needs with antimicrobial stewardship goals.

  • The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01 Clinical Trial Required)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
  • This funding opportunity was created on 2019-04-01.
  • Applicants must submit their applications by 2019-06-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $2,500,000.00 in funding.
  • Eligible applicants include: 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 tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses.
Apply for RFA FD 19 024

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