Opportunity Information: Apply for RFA FD 24 042

This funding opportunity is a single-source cooperative agreement from the U.S. Food and Drug Administration (FDA), specifically through the Center for Food Safety and Applied Nutrition (CFSAN). FDA is signaling that it intends to receive and consider one application, and eligibility is limited to Cornell University. The award mechanism is a U18 cooperative agreement, which typically means FDA expects to be substantially involved in guiding or coordinating the work rather than simply providing funds with minimal federal interaction. Clinical trials are explicitly not allowed, indicating the work is intended to focus on laboratory, applied food safety, and process-focused research rather than human or animal clinical intervention studies.

The overall goal is to strengthen FDAs research effort around Highly Pathogenic Avian Influenza A (HPAI) H5N1 in dairy-related contexts, with an emphasis on understanding how the virus is inactivated or persists under real-world processing and handling conditions. Cornell University is positioned to support this through its Center for Veterinary Medicine and the College of Agricultural and Life Sciences, bringing together expertise across virology, dairy science, food processing, and public health-oriented risk reduction. The work is described as multidisciplinary and applied, meaning the expected outputs are practical findings that can inform industry practices, disposal or treatment methods, and risk management decisions.

A major focus area is raw milk cheese aging. The research is intended to examine the conditions during cheese production and aging that influence inactivation of HPAI H5N1, with specific mention of pH and water activity as key variables. In practice, pH and water activity are central levers in food safety because they affect microbial survival and viral stability. By studying how these parameters change over the course of aging, and how they correlate with virus inactivation, the project aims to generate data that can help clarify what processing or aging conditions reduce risk, and under what circumstances additional controls might be warranted.

A second focus area targets waste milk management, particularly milk that might be fed to calves or disposed of. The opportunity calls for research on commonly used acidification methods for treating waste milk, with the goal of understanding how these approaches affect HPAI H5N1. Acidification is frequently used on farms as a practical treatment step to manage microbial growth and stabilize milk prior to feeding or disposal. FDA is looking for applied evidence on whether typical acidification practices meaningfully inactivate the virus, what parameters matter most (for example, target pH, contact time, temperature, or the specific acidification approach), and how robust those effects are under conditions that reflect real farm use.

A third major research thrust is characterizing thermal inactivation kinetics of HPAI H5N1 across a wide variety of dairy products. Thermal inactivation kinetics refers to the quantitative relationship between heat exposure and the reduction of viable virus over time, often expressed in terms that help compare processes and validate control steps. This is especially relevant for dairy because products vary widely in composition (fat content, solids, sugars, proteins), processing steps, and heating profiles. By generating kinetics data across different product types, the project can help FDA and stakeholders understand how reliably heat treatments reduce viral loads, where uncertainties remain, and whether certain matrices protect the virus more than others.

Beyond specific experiments, the cooperative agreement also aims to expand capacity for HPAI H5N1 testing to meet FDAs research agenda. This suggests Cornell would provide added laboratory throughput, validated methods, or surge capability to process samples and generate results when FDA needs additional analytical support. In an emerging or rapidly changing situation, having dependable testing capacity can be as important as the research itself, because it enables quicker answers, better coordination across projects, and more timely data for decision-making.

Another explicit expectation is active engagement with academic and industry stakeholders. The purpose is twofold: first, to ensure the work complements other ongoing research rather than duplicating it, and second, to facilitate practical use of the results. This points to an emphasis on coordination, data sharing where appropriate, and translating findings into actionable knowledge for dairy producers, processors, regulators, and related partners. Stakeholder engagement in this context often includes regular communication, workshops or briefings, alignment with parallel studies, and producing outputs that are usable for guidance, best practices, or risk assessments.

In terms of administrative details, the opportunity is listed as discretionary funding with an activity category spanning agriculture, consumer protection, and food and nutrition. The program is associated with CFDA number 93.103. The funding opportunity number is RFA FD 24 042. FDA anticipates making one award, consistent with the single-source nature of the announcement. The award ceiling is $1,150,000, and the original closing date is 2024-08-30, with the opportunity created on 2024-07-30. Overall, this is a targeted investment intended to produce applied, decision-relevant data on how HPAI H5N1 behaves in dairy processing and handling scenarios, while also building testing capacity and improving coordination across the broader research landscape.

  • The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Single Source Cooperative Agreement to Support HPAI H5N1 Research at Cornell University (U18) - Clinical Trails Not Allowed" 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 2024-07-30.
  • Applicants must submit their applications by 2024-08-30. (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 $1,150,000.00 in funding.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: Others.
Apply for RFA FD 24 042

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Frequently Asked Questions (FAQs)

What is this funding opportunity?

This is a single-source cooperative agreement funding opportunity from the U.S. Food and Drug Administration (FDA), through the Center for Food Safety and Applied Nutrition (CFSAN), focused on Highly Pathogenic Avian Influenza A (HPAI) H5N1 in dairy-related contexts.

Which agency and FDA center are offering the award?

The award is offered by the U.S. Food and Drug Administration (FDA), specifically through the Center for Food Safety and Applied Nutrition (CFSAN).

What is the funding opportunity number?

The funding opportunity number is RFA FD 24 042.

What is the CFDA number associated with this program?

The program is associated with CFDA number 93.103.

What type of award mechanism is being used?

The mechanism is a U18 cooperative agreement, which generally indicates that FDA expects to be substantially involved in guiding or coordinating the work rather than providing funds with minimal federal interaction.

Is this a competitive opportunity?

No. FDA is signaling its intent to receive and consider a single application, and the opportunity is single-source in nature.

Who is eligible to apply?

Eligibility is limited to Cornell University.

How many awards does FDA expect to make?

FDA anticipates making one award.

What is the maximum award amount (ceiling)?

The award ceiling is $1,150,000.

What are the key dates listed for this opportunity?

The opportunity was created on 2024-07-30, and the original closing date is 2024-08-30.

What is the overall purpose of the project?

The overall goal is to strengthen FDA research on HPAI H5N1 in dairy-related contexts, especially how the virus is inactivated or persists under real-world processing and handling conditions, and to generate applied, decision-relevant data for risk management.

Are clinical trials allowed under this award?

No. Clinical trials are explicitly not allowed, indicating the work is intended to focus on laboratory, applied food safety, and process-focused research rather than human or animal clinical intervention studies.

What kinds of research approaches are emphasized?

The work is described as multidisciplinary and applied, aiming to produce practical findings that can inform industry practices, disposal or treatment methods, and risk management decisions.

Why is Cornell University specifically mentioned in the opportunity description?

Cornell University is positioned to support the work through its Center for Veterinary Medicine and the College of Agricultural and Life Sciences, bringing together expertise across virology, dairy science, food processing, and public health-oriented risk reduction.

What are the main research focus areas described?

The opportunity describes three major research thrusts: (1) raw milk cheese aging and how conditions influence virus inactivation, (2) waste milk management using common acidification methods, and (3) thermal inactivation kinetics of HPAI H5N1 across a variety of dairy products.

What is the focus of the raw milk cheese aging research?

The research is intended to examine conditions during cheese production and aging that influence inactivation of HPAI H5N1, with specific emphasis on pH and water activity as key variables and how these change over the course of aging.

Which variables are specifically called out for the cheese aging work?

pH and water activity are specifically mentioned as key variables because they affect microbial survival and viral stability and are central levers in food safety.

What is the purpose of studying pH and water activity in raw milk cheese aging?

The purpose is to generate data linking aging-related changes in pH and water activity to virus inactivation, helping clarify which processing or aging conditions reduce risk and when additional controls might be warranted.

What does the opportunity mean by "waste milk management"?

It refers to managing milk that might be fed to calves or disposed of, particularly in contexts where treatment steps may be used to reduce risks or stabilize the milk prior to feeding or disposal.

What treatment approach is highlighted for waste milk management?

The opportunity calls for research on commonly used acidification methods for treating waste milk and how those approaches affect HPAI H5N1.

What is FDA seeking to learn about acidification of waste milk?

FDA is looking for applied evidence on whether typical acidification practices meaningfully inactivate HPAI H5N1 and which parameters matter most under conditions that reflect real farm use.

What parameters are mentioned as potentially important for acidification effectiveness?

Examples mentioned include target pH, contact time, temperature, and the specific acidification approach.

What is meant by "thermal inactivation kinetics" in this opportunity?

Thermal inactivation kinetics refers to the quantitative relationship between heat exposure and the reduction of viable virus over time, often expressed in ways that help compare processes and validate control steps.

Why is thermal inactivation work important for dairy products?

It is important because dairy products vary widely in composition and processing conditions, and the project aims to generate kinetics data across product types to understand how reliably heat treatments reduce viral loads and whether certain product matrices protect the virus more than others.

Does the opportunity address differences among dairy product types?

Yes. It notes that dairy products vary in fat content, solids, sugars, proteins, processing steps, and heating profiles, and the research is intended to cover a wide variety of dairy products.

What does the opportunity say about expanding testing capacity?

It aims to expand capacity for HPAI H5N1 testing to meet FDA's research agenda, suggesting added laboratory throughput, validated methods, or surge capability to process samples and generate results when FDA needs additional analytical support.

Why is increased testing capacity considered important in this project?

The description indicates that dependable testing capacity can be as important as the research itself in an emerging or rapidly changing situation because it supports quicker answers, better coordination, and more timely data for decision-making.

What does FDA expect regarding engagement with stakeholders?

The cooperative agreement explicitly expects active engagement with academic and industry stakeholders to ensure the work complements other ongoing research rather than duplicating it and to help facilitate practical use of the results.

What is the stated purpose of stakeholder engagement?

The stated purpose is twofold: (1) coordination and alignment so the work complements other research, and (2) translation of results into actionable knowledge for dairy producers, processors, regulators, and related partners.

How is this opportunity categorized in terms of funding type and activity area?

It is listed as discretionary funding with an activity category spanning agriculture, consumer protection, and food and nutrition.

What kinds of outcomes are implied by the opportunity description?

The description emphasizes practical findings and applied, decision-relevant data that can inform industry practices, disposal or treatment methods, and risk management decisions related to HPAI H5N1 in dairy processing and handling scenarios.

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