Opportunity Information: Apply for RFA FD 20 025
This funding opportunity (RFA FD 20 025) is a U.S. Food and Drug Administration (FDA) cooperative agreement program under the Department of Health and Human Services that aims to improve how certain medically important antimicrobial drugs are used in food-producing animals. The central goal is to support studies that generate solid, publicly available evidence to justify updating (through label changes) the approved duration-of-use instructions for specific antimicrobial new animal drugs. In practical terms, the FDA is looking for research that can help move from broader or less precise treatment durations toward more targeted, clearly defined durations that still treat disease effectively while also helping to reduce the chance that antimicrobial resistance develops or spreads.
A key feature of the program is that it is designed to produce data that can be used in future supplemental New Animal Drug Applications (sNADAs). Rather than creating brand-new drug approvals, these future submissions would amend existing approvals by revising dosage regimens, specifically the length of time the drug is used. The studies supported under this opportunity are intended to generate evidence that drug sponsors can rely on to meet some or all of the requirements for the "effectiveness" technical section of those supplemental applications. In other words, the FDA is encouraging independent or collaborative research that can be leveraged by companies with already-approved products to support a formal change in labeling, so that duration recommendations are both scientifically defensible and better aligned with stewardship goals.
The results expected from funded projects are twofold. First, applicants should produce evidence that supports more targeted treatment durations (meaning the duration is more specifically defined rather than open-ended or overly long by default). Second, the evidence should demonstrate that the revised, more targeted regimen remains comparably effective to the currently approved regimen. The public health rationale is explicit: maintaining clinical effectiveness while reducing unnecessary antimicrobial exposure, which is one of the core strategies for lowering selection pressure that can contribute to antimicrobial resistance.
Mechanistically, this is a cooperative agreement (U01), which typically means the FDA expects to have substantial involvement during the project compared with a standard grant. The opportunity is listed as "Clinical Trials Optional," indicating that proposed work may include clinical trials but does not have to; applicants can propose the most suitable study designs to answer duration and effectiveness questions in relevant food animal settings. The activity category is aligned with agriculture and consumer protection/food and nutrition, consistent with FDA responsibilities related to animal drug oversight and the safety of the food supply.
From an administrative standpoint, the opportunity was created January 24, 2020, with an original closing date of May 2, 2020. The award ceiling is $500,000, and the FDA anticipated making around 10 awards. Eligibility is described broadly as "Others (see text field entitled Additional Information on Eligibility for clarification)," signaling that a range of applicant types may be considered depending on the specific eligibility language in the full announcement.
Overall, the program is best understood as a targeted evidence-generation effort meant to support antimicrobial stewardship in food animals through more precise labeling. By funding studies that can confirm shorter or otherwise better-defined durations without sacrificing treatment success, the FDA is trying to enable regulatory changes that preserve animal health outcomes while also addressing antimicrobial resistance risks in a way that is grounded in data and usable for formal regulatory submissions.Apply for RFA FD 20 025
- The Department of Health and Human Services, 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 Trials Optional" 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 Jan 24, 2020.
- Applicants must submit their applications by May 02, 2020. (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 $500,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: FDA Cooperative Agreement RFA FD 20 025 (U01)
What is RFA FD 20 025?
RFA FD 20 025 is a U.S. Food and Drug Administration (FDA) funding opportunity offered as a cooperative agreement program under the Department of Health and Human Services. It supports research focused on improving how certain medically important antimicrobial drugs are used in food-producing animals, particularly by generating evidence to justify updates to approved duration-of-use instructions through label changes.
What is the main goal of this funding opportunity?
The central goal is to fund studies that produce solid, publicly available evidence that can support changing the approved treatment duration on existing antimicrobial new animal drug labels. The aim is to move toward more targeted, clearly defined treatment durations that still effectively treat disease while reducing unnecessary antimicrobial exposure and helping limit antimicrobial resistance risks.
What kinds of drug labeling changes is the FDA trying to support?
This opportunity is focused specifically on revising dosage regimens by changing the length of time (duration) an already-approved antimicrobial new animal drug is used. The intent is to replace broader, less precise, or potentially overly long default durations with more targeted and clearly defined durations that are supported by evidence.
Does this program support entirely new animal drug approvals?
No. The program is intended to generate data that can be used for future supplemental New Animal Drug Applications (sNADAs), which amend existing approvals. The emphasis is on updating labeling for already-approved products rather than creating brand-new drug approvals.
How will the study results be used in the regulatory process?
The studies are designed to produce evidence that drug sponsors can use in future sNADAs. Specifically, the data may help meet some or all of the requirements for the "effectiveness" technical section of those supplemental applications when proposing a change to duration-of-use labeling.
What evidence is the FDA expecting funded projects to produce?
Funded projects are expected to generate two key outcomes: (1) evidence supporting more targeted treatment durations (more specifically defined durations, rather than open-ended or overly long instructions), and (2) evidence showing that the revised, more targeted duration remains comparably effective to the currently approved regimen.
Why is the FDA focusing on treatment duration for antimicrobials in food animals?
The public health rationale is to maintain clinical effectiveness while reducing unnecessary antimicrobial exposure. Reducing avoidable exposure is a core antimicrobial stewardship strategy intended to lower selection pressure that can contribute to the development or spread of antimicrobial resistance.
What does "more targeted duration" mean in this context?
In this program, "more targeted duration" means treatment duration instructions that are more precisely defined rather than broad, vague, open-ended, or longer by default than necessary. The goal is a clearer duration recommendation that remains effective for treating disease.
Do proposed studies have to show the new duration is better than the current label duration?
Based on the opportunity description, the expectation is that the revised, more targeted regimen is comparably effective to the currently approved regimen. The emphasis is on preserving effectiveness while improving precision and stewardship, rather than demonstrating superiority.
What funding mechanism is used for this opportunity?
The mechanism is a cooperative agreement (U01). A cooperative agreement typically means the FDA expects to have substantial involvement in the project compared with a standard grant.
What does "substantial involvement" mean for applicants and awardees?
The announcement indicates this is a cooperative agreement (U01), which generally implies the FDA will be more actively engaged during the project than it would be under a typical grant. The specific form of involvement is not detailed in the summary provided, but applicants should expect an elevated level of FDA participation consistent with a U01 mechanism.
Are clinical trials required under this opportunity?
No. The opportunity is listed as "Clinical Trials Optional," meaning proposed work may include clinical trials but does not have to. Applicants can propose the study designs they believe are most suitable for answering duration and effectiveness questions in relevant food animal settings.
What topic area or activity category does this opportunity fall under?
The activity category is aligned with agriculture and consumer protection/food and nutrition. This aligns with the FDA's responsibilities for animal drug oversight and the safety of the food supply.
Who is the sponsoring agency?
The sponsoring agency is the U.S. Food and Drug Administration (FDA), under the Department of Health and Human Services.
What is the maximum award amount (award ceiling)?
The award ceiling listed for this opportunity is $500,000.
How many awards did the FDA anticipate making?
The FDA anticipated making around 10 awards.
When was this funding opportunity created?
The opportunity was created on January 24, 2020.
What was the original closing date?
The original closing date listed for this opportunity was May 2, 2020.
What types of applicants are eligible to apply?
Eligibility is described broadly as "Others (see text field entitled Additional Information on Eligibility for clarification)." This suggests that multiple applicant types may be eligible, depending on the specific eligibility language contained in the full announcement.
Is the program intended for independent research, collaborations, or industry-sponsored work?
The opportunity encourages independent or collaborative research that can be leveraged by companies with already-approved antimicrobial products. The data are intended to be usable for formal regulatory submissions (sNADAs) supporting label changes.
Are funded study results expected to be publicly available?
Yes. The program description emphasizes generating solid, publicly available evidence to justify updating approved duration-of-use instructions through label changes.
What is the practical impact the FDA is aiming for?
Practically, the FDA is looking for research that supports moving from broader or less precise treatment durations to more targeted, clearly defined durations that still treat disease effectively, while reducing the chance that antimicrobial resistance develops or spreads.
What is the connection between this opportunity and antimicrobial stewardship?
The opportunity is best understood as a targeted evidence-generation effort to support antimicrobial stewardship in food animals through more precise labeling. By confirming shorter or otherwise better-defined durations without sacrificing treatment success, the program aims to enable regulatory label updates that reduce unnecessary antimicrobial exposure.
Does the opportunity specify which antimicrobials or animal species must be studied?
The summary describes the focus as "certain medically important antimicrobial drugs" used in food-producing animals, but it does not list specific drugs or species within the information provided here.
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|---|
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18) Clinical Trials Not Allowed Apply for RFA FD 20 012 Funding Number: RFA FD 20 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $70,000 |
| Cooperative Agreement for Data Collection on Antimicrobial Use in Dogs and Cats (UO1) Clinical Trials Not Allowed Apply for RFA FD 20 026 Funding Number: RFA FD 20 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed Apply for PAR 20 105 Funding Number: PAR 20 105 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed Apply for RFA FD 20 027 Funding Number: RFA FD 20 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $8,000,000 |
| FDA's National Curriculum Standard Development and Training Delivery and Development (U18) Clinical Trial Not Allowed Apply for RFA FD 20 024 Funding Number: RFA FD 20 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens (U01) Clinical Trials Not Allowed Apply for PAR 20 124 Funding Number: PAR 20 124 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 031 Funding Number: RFA FD 20 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed Apply for PAR 20 132 Funding Number: PAR 20 132 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 030 Funding Number: RFA FD 20 030 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed Apply for RFA FD 20 028 Funding Number: RFA FD 20 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Cooperative Agreement to Support FDA Land and Water Initiative (U01) Clinical Trial Not Allowed Apply for RFA FD 20 034 Funding Number: RFA FD 20 034 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain (U01) Clinical Trials Not Allowed Apply for RFA FD 20 029 Funding Number: RFA FD 20 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Drug Development Science Support (U01) Clinical Trials Optional Apply for RFA FD 20 033 Funding Number: RFA FD 20 033 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| CBER FY20 FOA for AAV vector manufacturing for diseases affecting very small populations (R01) Clinical Trial Not Allowed Apply for RFA FD 20 032 Funding Number: RFA FD 20 032 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| Renewal - Federal and University Partnership to Improve the Safety of Seafood from the Gulf of Mexico (U19) Clinical Trials Not Allowed Apply for RFA FD 21 009 Funding Number: RFA FD 21 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $125,000 |
| Renewal - Cooperative Agreement to Support Shellfish Assistance Project (U01) Clinical Trial Not Allowed Apply for RFA FD 21 006 Funding Number: RFA FD 21 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal - Research, Education, and Outreach on Botanical Natural Products (U01) Clinical Trial Not Allowed Apply for RFA FD 21 010 Funding Number: RFA FD 21 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
| Renewal - Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U50 Clinical Trial Not Allowed Apply for RFA FD 21 011 Funding Number: RFA FD 21 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| National Food and Nutrient Analysis Program (U01) Clinical Trial Not Applicable Apply for RFA FD 21 023 Funding Number: RFA FD 21 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U2F) Clinical Trials Not Allowed Apply for RFA FD 21 028 Funding Number: RFA FD 21 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
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