Opportunity Information: Apply for RFA FD 24 014
The grant opportunity "Strengthening Regulatory Systems to Improve Global Food and Medical Product Quality and Safety (U01) Clinical Trials Not Allowed" is a discretionary cooperative agreement issued by the U.S. Food and Drug Administration (FDA) under Funding Opportunity Number RFA-FD-24-014 (CFDA 93.103). It is designed to continue and expand an established collaboration between the FDA and the World Health Organization (WHO). The central purpose is to support data-driven, science-based public health strategies that align with both FDA domestic priorities and its broader global health goals, with a clear emphasis on improving the quality and safety of food and medical products worldwide.
The program focuses on strengthening regulatory systems internationally by building the evidence base and practical capacity needed to prevent, detect, and respond to quality and safety problems in global supply chains. The FDA describes the cooperative agreement as a way to address specific challenges that hinder global efforts to ensure that foods and medical products are safe and of high quality. Rather than funding clinical research, the opportunity explicitly states that clinical trials are not allowed, which signals that supported work should center on public health policy, regulatory science, standards development, surveillance approaches, systems assessment, and capacity-building activities that help regulators perform effectively.
The core strategies highlighted in the announcement fall into three broad areas. First, the work is expected to support the development of global norms and standards, meaning internationally relevant guidance, benchmarks, and harmonized approaches that countries can adopt or adapt to improve oversight of products that move across borders. Second, the program seeks the articulation of evidence-based policy options, including policy options related to regulatory systems performance. In practice, this implies analyzing what works, measuring and comparing regulatory performance, and translating findings into realistic policy pathways that governments and national regulatory authorities can use to strengthen their systems. Third, the award supports the provision of technical support to national regulatory authorities and governments through systems-strengthening efforts, which can include targeted assistance, tools, training approaches, and implementation support that help regulators improve core functions such as standard setting, inspection and compliance, post-market surveillance, laboratory capacity, and rapid response to emerging risks.
The funding instrument is a cooperative agreement (U01), which typically indicates substantial programmatic involvement by the funding agency compared to a standard grant. In other words, the FDA is likely to remain actively engaged with the recipient during planning and execution, coordinating activities and ensuring alignment with shared objectives. The opportunity anticipates a single award, with an award ceiling of $750,000. The original closing date listed is March 31, 2024, and the opportunity was created on December 11, 2023.
Eligibility is highly restricted. Only the World Health Organization (WHO) is identified as eligible to apply. The notice also states that foreign institutions and non-U.S. entities are eligible, that non-U.S. components of U.S. organizations may apply, and that foreign components as defined in the HHS Grants Policy Statement are allowed. However, the explicit restriction to WHO indicates that, in practical terms, this opportunity is intended for WHO as the applicant organization, consistent with the stated goal of continuing and expanding an existing FDA-WHO collaboration.
Overall, this opportunity is best understood as an FDA-supported, WHO-led effort to advance global regulatory strengthening for food and medical products through standard-setting, evidence-based policy development, and hands-on technical assistance to national regulators. The intended impact is improved global capacity to safeguard consumers and patients by reducing the risks associated with substandard, unsafe, or poor-quality products, and by reinforcing regulatory systems that can adapt to evolving public health threats and increasingly complex globalized supply chains.Apply for RFA FD 24 014
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Strengthening Regulatory Systems to Improve Global Food and Medical Product Quality and Safety (U01) Clinical Trials 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 2023-12-11.
- Applicants must submit their applications by 2024-03-31. (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 $750,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others.
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| Funding Opportunity |
|---|
| Natural History, Clinical Outcome Assessment, and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 24 024 Funding Number: RFA FD 24 024 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Public Health Regulatory Systems Strengthening - U01 Clinical Trials Not Allowed Apply for RFA FD 24 015 Funding Number: RFA FD 24 015 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| National Project to Support and Promote Consistent Implementation of the Regulatory Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption and Produce Regulatory Standards (PRPS) (U2F) -Cooperative Agreements Apply for RFA FD 24 012 Funding Number: RFA FD 24 012 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Produce Safety Alliance-U01 Clinical Trials Not Allowed Apply for RFA FD 24 018 Funding Number: RFA FD 24 018 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| FDA OMHHE Health Equity Innovation Award: Enhance Equity Funding Opportunity (U01) Clinical Trials Not Allowed Apply for RFA FD 24 022 Funding Number: RFA FD 24 022 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - Clinical Trials Not Allowed Apply for RFA FD 24 020 Funding Number: RFA FD 24 020 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 026 Funding Number: RFA FD 24 026 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 023 Funding Number: RFA FD 24 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) Apply for RFA FD 24 025 Funding Number: RFA FD 24 025 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional Apply for RFA FD 24 029 Funding Number: RFA FD 24 029 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Critical Path Public Private Partnerships Clinical Trials Optional Apply for RFA FD 24 027 Funding Number: RFA FD 24 027 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $20,000,000 |
| Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed Apply for RFA FD 24 007 Funding Number: RFA FD 24 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional Apply for RFA FD 24 006 Funding Number: RFA FD 24 006 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) Apply for RFA FD 24 008 Funding Number: RFA FD 24 008 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 005 Funding Number: RFA FD 24 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 24 011 Funding Number: RFA FD 24 011 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed Apply for RFA FD 24 010 Funding Number: RFA FD 24 010 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional Apply for RFA FD 24 038 Funding Number: RFA FD 24 038 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033 Funding Number: RFA FD 24 033 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $15,000,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032 Funding Number: RFA FD 24 032 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
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