Opportunity Information: Apply for RFA FD 18 022
The Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01) opportunity (RFA-FD-18-022) is a discretionary cooperative agreement offered by the U.S. Department of Health and Human Services through the Food and Drug Administration (FDA). It is designed to support and expand ongoing collaboration between the World Health Organization (WHO) and the FDA, coordinated through FDA's Office of International Programs (OIP). The central purpose is to advance data-driven and science-based public health work that aligns with FDA priorities in the United States while also strengthening global approaches to regulating food and medical products.
At its core, this award focuses on improving how regulatory systems around the world protect the public from unsafe, ineffective, or poor-quality products. The program emphasizes building the evidence base for what works in regulation, identifying persistent gaps and challenges in global oversight, and then applying research and practical support to improve regulatory performance. Rather than being limited to a single technical project, the scope is broad and oriented toward systems-level improvements that can be used by national regulatory authorities and governments to better ensure the safety and quality of both foods and medical products across international supply chains.
The FOA highlights three main strategy areas. First, it supports the development of global norms and standards, meaning common benchmarks, guidance, and best practices that regulators can use to harmonize expectations and reduce inconsistency across countries. Second, it promotes the creation and communication of evidence-based, science-based policy options, including approaches that help evaluate and improve regulatory system performance. This implies work that can measure how well regulatory systems function, identify where they fall short, and propose policy solutions backed by data rather than opinion. Third, it prioritizes technical support for national regulatory authorities and governments, delivered through regulatory systems strengthening, research activities, and broader public health and scientific efforts. In practice, this can include targeted capacity building, applied research to address regulatory questions, and technical collaboration that helps countries adopt or strengthen effective oversight mechanisms.
Because this is a cooperative agreement (U01), it typically indicates substantial involvement by the funding agency compared with a standard grant. The intent is not just to fund an independent project, but to carry out coordinated work in partnership with FDA, reflecting shared priorities and active collaboration. The opportunity sits within the funding activity category of Agriculture, Consumer Protection, Food and Nutrition, and is listed under CFDA number 93.103.
In terms of scale and competitiveness, the FOA anticipated a single award (ExpectedAwards: 1), with an award ceiling of $4,500,000. The opportunity was originally posted on April 25, 2018, and had an original application closing date of July 2, 2018. Eligibility is described broadly as "Others," with clarification referenced in the FOA's additional eligibility information, suggesting it was aimed at a specific type of applicant or a limited set of organizations suited to carry out global regulatory systems work at scale.
Overall, the opportunity is best understood as an investment in strengthening the global infrastructure of regulation for foods and medical products, using science-based methods, shared standards, and hands-on technical support to improve how countries prevent, detect, and respond to safety and quality risks. The intended impact is improved regulatory performance worldwide, contributing to safer supply chains and stronger public health protections across borders.Apply for RFA FD 18 022
- 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 "Strengthen Regulatory Systems to Ensure the Safety and Quality of Food and Medical Products (U01)" 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 Apr 25, 2018.
- Applicants must submit their applications by Jul 02, 2018. (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 $4,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Applicants who have applied for this opportunity (RFA FD 18 022) also looked into and applied for these:
| Funding Opportunity |
|---|
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19) Apply for RFA FD 18 025 Funding Number: RFA FD 18 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,000,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFA FD 18 018 Funding Number: RFA FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Strengthening Global Competency and Capacity in Inspectional Approaches and Good Manufacturing Practices (GMP) (U01) Apply for RFA FD 18 024 Funding Number: RFA FD 18 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Minor Use Minor Species Development of Drugs (R01) Apply for PAR 18 827 Funding Number: PAR 18 827 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| Request for Information (RFI): FDA Standard Core Clinical Outcome Assessments and Endpoints Apply for RFI NOT FD 18 014 Funding Number: RFI NOT FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Validating Human Stem Cell Cardiomyocyte Technology for Better Predictive Assessment of Drug-Induced Cardiac Toxicity (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 002 Funding Number: RFA FD 19 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01) Clinical Trial Optional Apply for RFA FD 19 005 Funding Number: RFA FD 19 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Patient Reported Outcomes Tool Development for Use in Non-Cystic Fibrosis Bronchiectasis Clinical Trials (U01- Clinical Trial Required) Activity Code Apply for RFA FD 19 014 Funding Number: RFA FD 19 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Bioequivalence of Topical Products: Bioequivalence Considerations for Ungual, Scalp, Vaginal, Anal or Rectal Dosage Forms (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 008 Funding Number: RFA FD 19 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Bioequivalence of Topical Products: Elucidating the Sensorial and Functional Characteristics of Compositionally Different Topical Formulations (U01 Clinical Trial Required) Apply for RFA FD 19 009 Funding Number: RFA FD 19 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 010 Funding Number: RFA FD 19 010 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 the Illinois Institute of Technology's Institute for Food Safety and Health (U19 Clinical Trial Optional) Apply for RFA FD 19 003 Funding Number: RFA FD 19 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $10,000,000 |
| Enhancing Regulatory Science for the Risk Based Quality Assessment of Complex Products (U01) - Clinical Trials Optional Apply for RFA FD 19 011 Funding Number: RFA FD 19 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Advancing Post-Market Surveillance of High-Risk Facilities and Products through Signal detection, Data analysis, and the Review of the State of Quality (U01) Clinical Trial Optional Apply for PAR 19 190 Funding Number: PAR 19 190 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Advancing Manufacturing Processing and Control Strategies for Drug Substances and Drug Products (U01)- Clinical Trial Optional Apply for PAR 19 216 Funding Number: PAR 19 216 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Implementation of the Animal Feed Regulatory Program Standards (U18 Clinical Trial Not Allowed) Apply for RFA FD 19 021 Funding Number: RFA FD 19 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial Optional) Apply for RFA FD 19 020 Funding Number: RFA FD 19 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 019 Funding Number: RFA FD 19 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trial Required Apply for RFA FD 19 015 Funding Number: RFA FD 19 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $37,500,000 |
| Convener and organizer of activities and engagements focused on the development of medical products and related processes, surveillance, and policies relevant to ongoing public health activities. (U01) Clinical Trial Not Allowed Apply for RFA FD 19 013 Funding Number: RFA FD 19 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,500,000 |
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