Opportunity Information: Apply for RFA FD 20 021
The FDA funding opportunity titled "Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional)" (RFA-FD-20-021) is a cooperative agreement designed to strengthen the United States' ability to evaluate medical devices using real-world data. It sits within FDA's broader effort to build the National Evaluation System for health Technology (NEST), which aims to generate timely, reliable, and cost-effective Real-World Evidence (RWE) by drawing not only from clinical registries, but also from electronic health records (EHRs), pharmacy data, public and private insurance claims, and patient-generated data. The core premise is that registries already hold high-value, curated clinical information on millions of patients who receive diagnostics and treatments involving medical devices, and with the right coordination and modernization, those registries can become a national infrastructure for continuous device evaluation across the total product life cycle.
A key motivation for the program is that traditional registries, while rich in detail, often have limitations that reduce their usefulness for broad regulatory-grade and stakeholder-ready analyses, such as inconsistent data standards, limited interoperability, incomplete device identification, and uneven access for different user groups. To address these limitations, the Coordinated Registry Network (CRN) model was recommended by the National Medical Device Registry Task Force and further advanced by the Medical Device Epidemiology Network (MDEpiNet). CRNs are intended to move beyond siloed registries by harmonizing data elements, aligning governance and analytic practices, and creating the capacity to answer device-related questions more quickly and credibly. In parallel, MDEpiNet established a CRN Community of Practice (COP), a learning and partnership community of national registries working toward CRN maturity. The COP is explicitly multi-stakeholder, bringing together patient organizations, clinicians and hospitals, payors, regulators, researchers, manufacturers, software vendors, health information exchanges, and government entities, with an emphasis on incorporating patient perspectives and supporting initiatives that may include social determinants of health and other public programs.
The main goal of this FOA is to fund infrastructure and methodology research that helps registries evolve into mature CRNs capable of producing relevant, reliable, and timely evidence about health technologies, especially medical devices. The FOA lays out four major aims. First, it seeks to facilitate coordination and maturation of the CRN Community of Practice, meaning applicants are expected to strengthen the collaborative operating model that allows registries to align their approaches rather than working independently. Second, it calls for the development and "test driving" of novel CRN science and surveillance methods, particularly those that use big data analytics to improve signal detection, surveillance, and evidence generation. Third, it emphasizes augmenting CRNs through linkage of registry data to other sources such as administrative claims, EHRs, and patient-generated data, recognizing that long-term outcomes, utilization patterns, and adverse event signals often live outside any single dataset. Fourth, it requires active collaboration with NEST partners and others to expand FDA's capacity to address complex questions about medical device performance, safety, and effectiveness in real-world use.
The intended outcome is a more strategic, patient-centered approach to evidence generation for the medical device ecosystem, enabled by harmonized and interoperable data infrastructure that supports more sophisticated study designs and analyses. Standardizing data elements is framed as a practical way to reduce duplicative data collection, improve comparability across sites and settings, and enable data exchange across therapies, patient groups, and episodes of care. The FOA highlights several concrete examples of what modernization should enable. Incorporating Unique Device Identification (UDI) into a CRN minimum core dataset is presented as essential for routinely answering device-specific questions and investigating postmarket safety signals with adequate precision. Including patient-generated data is positioned as a way to connect lived patient experience and patient-centered endpoints to clinical outcomes and device performance, which can improve both regulatory insight and future study design. Linking registries to claims data and other longitudinal sources is emphasized as a way to understand longer-term outcomes and adverse events that matter for informed decisions by patients, providers, and regulators.
The FOA also sets clear expectations for how applicants should approach governance, access, privacy, and sustainability. Projects are expected to support transparency so that analyses are accessible to relevant stakeholders and replicable, which implies attention to analytic documentation, shared definitions, and consistent methodological practices. Applicants are expected to leverage existing partnerships to increase data access and availability across stakeholders, explicitly including FDA access for research and total product life cycle evaluation. At the same time, proposals must spell out how patient privacy and data security will be established and maintained, reflecting the sensitivity of multi-source data linkage and large-scale networked analytics. The program strongly encourages building methods and infrastructure that are not bespoke to a single device or registry, but broadly applicable across the medical device landscape and useful to multiple CRNs spanning different clinical areas. Finally, beyond the scientific and technical plan, applicants are expected to propose a framework for a sustainable partnership and business infrastructure that can support substantial national or even international coverage over time, signaling that FDA is looking for durable capacity rather than one-off research products.
Administratively, this opportunity is offered by the U.S. Department of Health and Human Services, Food and Drug Administration, using the cooperative agreement mechanism (U01), with clinical trials listed as optional. The CFDA number is 93.103. Eligibility is broad and includes various levels of government, public and private institutions of higher education, tribal governments and organizations, nonprofits (with and without 501(c)(3) status), for-profit organizations (including small businesses), and individuals. The posting indicates an award ceiling of $3,000,000 and an expectation of four awards, with the original opportunity timeline showing a creation date of January 13, 2020 and an original closing date of March 16, 2020. Overall, the grant is aimed at accelerating the practical maturation of coordinated registry networks into interoperable, analytically robust, and stakeholder-responsive systems that can continuously generate real-world evidence about medical devices in ways that are useful for patients, clinicians, payors, researchers, manufacturers, and FDA.Apply for RFA FD 20 021
- 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 Advance Coordinated Registry Networks (CRNs) (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 Jan 13, 2020.
- Applicants must submit their applications by Mar 16, 2020. (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, Individuals, For profit organizations other than small businesses, Small businesses.
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| Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) Clinical Trial Not Allowed Apply for RFA FD 20 013 Funding Number: RFA FD 20 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Conduct Studies to Establish More Targeted Durations of Use for Certain Approved Antimicrobial New Animal Drugs in Food Animals (U01) Clinical Trials Optional Apply for RFA FD 20 025 Funding Number: RFA FD 20 025 Agency: Department of Health and Human Services, 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) (U18) Clinical Trials Not Allowed Apply for RFA FD 20 012 Funding Number: RFA FD 20 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $70,000 |
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| Laboratory Flexible Funding Model (LFFM) (U19) Clinical Trials Not Allowed Apply for PAR 20 105 Funding Number: PAR 20 105 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Integrated Pathogen Reduction Technologies for whole blood and blood components for transfusion (R01) Clinical Trial Not Allowed Apply for RFA FD 20 027 Funding Number: RFA FD 20 027 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $8,000,000 |
| FDA's National Curriculum Standard Development and Training Delivery and Development (U18) Clinical Trial Not Allowed Apply for RFA FD 20 024 Funding Number: RFA FD 20 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 031 Funding Number: RFA FD 20 031 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed Apply for PAR 20 132 Funding Number: PAR 20 132 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $600,000 |
| Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional Apply for RFA FD 20 030 Funding Number: RFA FD 20 030 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $12,000,000 |
| Retail Food Safety Association Collaboration (U18) Clinical Trial Not Allowed Apply for RFA FD 20 028 Funding Number: RFA FD 20 028 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 FDA Land and Water Initiative (U01) Clinical Trial Not Allowed Apply for RFA FD 20 034 Funding Number: RFA FD 20 034 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support an Evidence-based Clinical Practice Guideline for the Treatment of Acute Dental Pain (U01) Clinical Trials Not Allowed Apply for RFA FD 20 029 Funding Number: RFA FD 20 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
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| Renewal - Federal and University Partnership to Improve the Safety of Seafood from the Gulf of Mexico (U19) Clinical Trials Not Allowed Apply for RFA FD 21 009 Funding Number: RFA FD 21 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $125,000 |
| Renewal - Cooperative Agreement to Support Shellfish Assistance Project (U01) Clinical Trial Not Allowed Apply for RFA FD 21 006 Funding Number: RFA FD 21 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Renewal - Research, Education, and Outreach on Botanical Natural Products (U01) Clinical Trial Not Allowed Apply for RFA FD 21 010 Funding Number: RFA FD 21 010 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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