Opportunity Information: Apply for RFA FD 19 020
This funding opportunity from the U.S. Food and Drug Administration (HHS/FDA) supports projects that strengthen how the nation generates real-world evidence about medical devices after they reach the market. The premise is that, even when a device is approved or cleared based on the evidence available at the time, some residual uncertainty about performance in everyday care often remains. Because of that, FDA and its partners need practical, reliable ways to collect and analyze postmarket data that reflects real patients, real clinicians, and real health systems. The opportunity is designed to build a stronger national capacity for studying device safety, effectiveness, and longer-term outcomes using routinely collected electronic health information, aligning with the National Evaluation System for health Technology (NEST).
A central focus is advancing Coordinated Registry Networks (CRNs). Traditional clinical registries already hold detailed, curated clinical information across millions of patients, and they can serve as a backbone for real-world studies. However, registries can also be fragmented, inconsistent, or limited in scope. CRNs were proposed and refined through efforts like the National Medical Device Registry Task Force and MDEpiNet to address those limitations by coordinating across registries and stakeholders, standardizing data elements, improving interoperability, and enabling analyses that are broader, faster, and more generalizable. The FOA also highlights the CRN Community of Practice (COP), which brings together registry leaders and a wide range of partners such as patients and advocacy groups, clinicians and hospitals, payors, regulators, health services researchers, manufacturers, software and health information exchange organizations, and government agencies. The larger intent is to evolve registries into mature CRNs that consistently produce high-value data that can answer patient-centered and regulatory questions and can also connect to related initiatives such as social determinants of health efforts.
The announcement lays out four main scientific and infrastructure aims. First, it seeks to facilitate coordination and continued maturation of the CRN Community of Practice, essentially strengthening the collaborative ecosystem and shared standards that allow CRNs to function at scale. Second, it calls for the development and real-world testing of novel CRN methods for surveillance and evidence generation, specifically leveraging big data analytics rather than relying only on traditional, slower study approaches. Third, it emphasizes augmenting CRNs by linking registry data with other data sources, including administrative claims, electronic health records, patient-generated data, and other relevant datasets, so that analyses can capture broader care trajectories and longer follow-up. Fourth, it requires collaboration with NEST partners and others to enhance FDA capacity to address complex questions across the total product life cycle, from early adoption through longer-term monitoring and signal evaluation.
A major expected outcome is a more harmonized and interoperable evidence-generation infrastructure that supports more sophisticated study designs and analytics across devices, therapies, patient populations, and episodes of care. Standardization is treated as a practical enabler: if CRNs collect comparable core data elements, it becomes easier to exchange information, combine datasets, and run repeatable analyses that different stakeholders can trust. The opportunity specifically highlights the value of including Unique Device Identifiers (UDIs) in the CRN minimum core dataset, since UDIs make device-specific tracking feasible and improve the ability to investigate and validate postmarket safety signals. It also underscores the importance of patient-generated data to connect lived experiences and patient-centered outcomes to clinical and administrative records, and the importance of claims linkages to better capture longitudinal outcomes and adverse events that may appear outside a single health system or registry.
The FOA is also explicit about expectations for transparency, access, privacy, and scalability. Applicants are expected to support transparency so that analyses can be understood and replicated by stakeholders such as patients, clinicians, hospitals, insurers, industry, and regulators. Applications should clearly explain data access and availability for partners, including FDA access for research and for total product life cycle evaluation. Strong plans for patient privacy and data security are required, especially given the emphasis on linking multiple disparate data sources. The methods and systems developed are expected to be broadly applicable across the medical device landscape, not narrowly tailored to a single use case, and they should be designed to work with existing data assets held by both public and private organizations. Finally, beyond the technical and scientific plan, applicants must include a sustainability framework: a partnership and business infrastructure plan that supports continued operation and expansion toward substantial national or even international coverage over time.
From an administrative standpoint, this is a discretionary cooperative agreement (U01) with clinical trials listed as optional. Eligible applicants are broad and include many types of governments, public and private higher-education institutions, tribal entities, nonprofits (with or without 501(c)(3) status), for-profit organizations (including small businesses), and certain public authorities. The opportunity was issued by HHS/FDA under CFDA 93.103, with an award ceiling of $3,000,000 and an expectation of about four awards (creation date March 22, 2019; original closing date May 28, 2019). Overall, the program is aimed at making postmarket device evaluation faster, more reliable, more patient-centered, and more usable for both regulatory decision-making and broader health system learning by turning registries into coordinated, data-linked, analytics-ready networks.Apply for RFA FD 19 020
- 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 "Novel Approaches to Translational Evidence Generation to Advance Coordinated Registry Networks (CRNs) via Big Data Analytics Using Disparate Data Sources (U01 Clinical Trial 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 Mar 22, 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 $3,000,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses.
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| Funding Opportunity |
|---|
| 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 |
| 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 |
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