Opportunity Information: Apply for RFA FD 19 019
This funding opportunity is a cooperative agreement from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), intended to support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF). The STDF is a long-running global partnership created by the Food and Agriculture Organization (FAO), the World Organisation for Animal Health (OIE), the World Bank, the World Health Organization (WHO), and the WTO. Its core mission is to help developing countries strengthen their ability to implement international sanitary and phytosanitary (SPS) standards, guidelines, and recommendations. In practical terms, that means improving food safety and public health protections, animal and plant health safeguards, and the capacity to meet export and import requirements so countries can gain or maintain access to regional and global markets.
The STDF operates in two complementary ways. First, it serves as a coordinating mechanism by bringing together governments, technical agencies, and stakeholders to align SPS-focused technical assistance, avoid duplication, and promote approaches that have proven effective. Second, it acts as a financing mechanism by funding SPS capacity-building work, including full projects and smaller project preparation grants that help countries design stronger, evidence-based proposals. Since 2004, the STDF has supported more than 60 projects and issued 52 project preparation grants, with a large share of that support benefiting least developed and other low-income countries. The emphasis is on overcoming SPS-related constraints that can block trade or create health risks, such as weak inspection systems, inadequate laboratory capacity, limited risk-based oversight, or gaps in regulatory and institutional frameworks.
A major theme in this opportunity is the STDF's role as a knowledge and learning platform. Beyond simply funding activities, the STDF is positioned as a hub for information exchange, sharing country experiences, and identifying and disseminating good practices in SPS-related technical cooperation. It supports global research and analysis aimed at improving the effectiveness of food safety systems in low- and middle-income countries, including work that examines what interventions work best, under what conditions they succeed, and how to measure whether a proposed program is actually delivering results. Effectiveness is monitored using performance metrics built into each grant proposal and through post-grant evaluations carried out by independent third-party groups. The intent is that lessons learned do not stay isolated within single projects, but are incorporated into future food safety decision-making and published through STDF open resource materials so that other countries and partners can adopt and adapt the findings.
The opportunity also highlights a specific decision-support approach the STDF uses called Multi-Criteria Decision Analysis (MCDA). MCDA is described as a key tool to help countries and stakeholders establish SPS priorities and allocate limited resources more efficiently. Its value is in structuring complex decisions transparently, using multiple factors rather than a single criterion, and enabling open discussion among public and private stakeholders about needs, trade-offs, and capacity-building investments. The FDA views this approach as a distinctive strength of the STDF model, particularly for aligning priorities in environments where resources are limited and SPS needs can be extensive.
From the FDA's perspective, the rationale for funding this cooperative agreement is tied to the reality of an increasingly diverse and complex global food supply. FDA's interest is to strengthen food safety systems internationally so that problems can be prevented earlier, rather than addressed only after contaminated or unsafe products enter commerce. The notice makes the point that FDA cannot achieve that goal alone and that partnering with other WTO member countries through the STDF allows FDA to broaden the reach and scale of food safety capacity-building efforts. In other words, the cooperative agreement is meant to deepen FDA's international partnerships, increase the overall impact of capacity-building investments, and leverage resources contributed by other countries and institutions.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism, which generally means substantial involvement or partnership between the funder (FDA) and the award recipient in carrying out the work. The funding opportunity number is RFA-FD-19-019, and it is listed under CFDA 93.103 in the Agriculture, Consumer Protection, Food and Nutrition activity area. The award ceiling is $750,000, with one expected award. The original posting date is March 27, 2019, with an original closing date of May 28, 2019. The eligibility category is listed broadly as "Others," with additional eligibility details referenced in the full announcement. Finally, the title specifies "U01 Clinical Trial Not Allowed," indicating that the supported activities are not intended to include clinical trials, and are focused instead on international food safety and SPS capacity building, research, prioritization, evaluation, and knowledge-sharing functions aligned with the STDF mission.Apply for RFA FD 19 019
- 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 "Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01 Clinical Trial 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 Mar 27, 2019.
- Applicants must submit their applications by May 28, 2019. (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 (see text field entitled Additional Information on Eligibility for clarification).
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Applicants who have applied for this opportunity (RFA FD 19 019) also looked into and applied for these:
| Funding Opportunity |
|---|
| 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 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 19 016 Funding Number: RFA FD 19 016 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 Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U01) Clinical Trials Not Allowed Apply for RFA FD 19 026 Funding Number: RFA FD 19 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Information Sharing System for State-Regulated Drug Compounding Activities (U01) Clinical Trial Not Allowed Apply for RFA FD 19 025 Funding Number: RFA FD 19 025 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,600,000 |
| Renewal Application: Critical Path Public Private Partnerships (U18) Clinical Trials Optional Apply for RFA FD 19 027 Funding Number: RFA FD 19 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $100,000,000 |
| Implementation of U.S. Food Safety Modernization Act - Identifying, Researching, and Implementing Alternative Methods to Expand the Reach across the Global Supply Chain (U01) - Clinical Trials Not Allowed Apply for RFA FD 19 022 Funding Number: RFA FD 19 022 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,750,000 |
| Cigar Tobacco Reference Products Program (UC2) Clinical Trials Not Allowed Apply for RFA FD 20 002 Funding Number: RFA FD 20 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,400,000 |
| Rare Disease Clinical Outcome Assessment Consortium (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 029 Funding Number: RFA FD 19 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Drug Development Tools Research Grants (U01 Clinical Trial Not Allowed) Apply for RFA FD 19 028 Funding Number: RFA FD 19 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Heart Failure Collaboratory (R18) Clinical Trials Optional Apply for RFA FD 20 005 Funding Number: RFA FD 20 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,150,000 |
| Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 006 Funding Number: RFA FD 20 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01) Clinical Trial Not Allowed Apply for RFA FD 20 004 Funding Number: RFA FD 20 004 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: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed Apply for RFA FD 20 019 Funding Number: RFA FD 20 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Physiologically-based pharmacokinetic/pharmacodynamic model extrapolation to human from rabbit for ophthalmic drug products (U01) Clinical Trials Not Allowed Apply for RFA FD 20 018 Funding Number: RFA FD 20 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (U01) Clinical Trials Not Allowed Apply for RFA FD 20 017 Funding Number: RFA FD 20 017 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $800,000 |
| Center for Collaborative Research on Complex Generics (U18) Clinical Trials Optional Apply for RFA FD 20 007 Funding Number: RFA FD 20 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Enhancing Regulatory Science for Advancing Pharmaceutical Quality and Manufacturing (U01) Clinical Trials Optional Apply for PAR 20 083 Funding Number: PAR 20 083 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Renewal - Investigation of impact of manufacturing difference and formulation variation on drug release for Levonorgestrel Intrauterine System (U01) Clinical Trials Not Allowed Apply for RFA FD 20 020 Funding Number: RFA FD 20 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional) Apply for RFA FD 20 021 Funding Number: RFA FD 20 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $3,000,000 |
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