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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Frequently Asked Questions (FAQs)
What is the title and number of this FDA funding opportunity?
The opportunity is titled "Novel Approaches to Advance Coordinated Registry Networks (CRNs) (U01 Clinical Trial Optional)" and the FOA number is RFA-FD-20-021.
What is the main purpose of this grant?
The purpose is to strengthen the United States' ability to evaluate medical devices using real-world data by funding infrastructure and methodology work that helps clinical registries evolve into mature Coordinated Registry Networks (CRNs) capable of producing timely, reliable real-world evidence (RWE) across the medical device total product life cycle.
How does this opportunity relate to NEST?
This FOA sits within FDA's broader effort to build the National Evaluation System for health Technology (NEST). NEST aims to generate timely, reliable, and cost-effective real-world evidence by drawing from multiple data sources, including registries, electronic health records (EHRs), pharmacy data, insurance claims, and patient-generated data.
What is a Coordinated Registry Network (CRN) in the context of this FOA?
A CRN is a model designed to move beyond siloed registries by harmonizing data elements, aligning governance and analytic practices, and building capacity to answer medical device questions more quickly and credibly, using coordinated and interoperable registry-based infrastructure.
Why is FDA emphasizing CRNs instead of traditional standalone registries?
The FOA highlights that while traditional registries can be rich in clinical detail, they may have limitations that reduce their usefulness for broader regulatory-grade or stakeholder-ready analyses, including inconsistent data standards, limited interoperability, incomplete device identification, and uneven access for different user groups. CRNs are intended to address these barriers through coordination, standardization, and modernization.
What is the CRN Community of Practice (COP)?
The CRN Community of Practice is described as a learning and partnership community of national registries working toward CRN maturity. It is explicitly multi-stakeholder and is intended to support collaboration across many groups involved in medical device evidence generation.
Who are the stakeholders involved in the CRN Community of Practice?
The FOA describes a multi-stakeholder community that can include patient organizations, clinicians and hospitals, payors, regulators, researchers, manufacturers, software vendors, health information exchanges, and government entities, with an emphasis on incorporating patient perspectives.
What are the major aims of this FOA?
The FOA lays out four major aims: (1) facilitate coordination and maturation of the CRN Community of Practice; (2) develop and "test drive" novel CRN science and surveillance methods, including big data analytics for signal detection and evidence generation; (3) augment CRNs by linking registry data to other sources such as claims, EHRs, and patient-generated data; and (4) actively collaborate with NEST partners and others to expand FDA's capacity to address complex real-world questions about device performance, safety, and effectiveness.
What kinds of methods or research does FDA want applicants to develop and test?
The FOA emphasizes novel CRN science and surveillance methods, particularly approaches that use big data analytics to improve signal detection, surveillance, and evidence generation relevant to medical devices in real-world use.
What data sources does FDA expect CRNs to connect or link with?
The FOA highlights linking registry data to additional real-world data sources such as administrative claims, electronic health records (EHRs), pharmacy data, public and private insurance claims, and patient-generated data.
Why is linking registry data to claims or other longitudinal data important?
The FOA notes that longer-term outcomes, utilization patterns, and adverse event signals often exist outside any single dataset. Linkage is presented as a way to capture outcomes over time and better understand real-world device performance and safety.
What does the FOA say about Unique Device Identification (UDI)?
The FOA frames incorporating UDI into a CRN minimum core dataset as essential for routinely answering device-specific questions and investigating postmarket safety signals with adequate precision.
How does the FOA address patient-generated data and patient perspectives?
The FOA emphasizes incorporating patient perspectives through the multi-stakeholder Community of Practice and highlights patient-generated data as a way to connect lived patient experience and patient-centered endpoints to clinical outcomes and device performance.
Does the FOA mention social determinants of health?
Yes. The FOA notes an emphasis on incorporating patient perspectives and supporting initiatives that may include social determinants of health and other public programs within the multi-stakeholder collaboration approach.
What expectations are included around standards and interoperability?
The FOA stresses harmonizing and standardizing data elements to reduce duplicative data collection, improve comparability across sites and settings, and enable data exchange across therapies, patient groups, and episodes of care. Interoperability is presented as a key requirement for registries to function as a coordinated network.
What does the FOA require regarding governance and access?
The FOA sets expectations that applicants address governance and access in ways that support transparency, replicability, and broader stakeholder use. It also explicitly expects applicants to leverage existing partnerships to increase data access and availability across stakeholders, including FDA access for research and total product life cycle evaluation.
What does the FOA say about transparency and replicability of analyses?
Projects are expected to support transparency so analyses are accessible to relevant stakeholders and replicable. The FOA implies attention to analytic documentation, shared definitions, and consistent methodological practices.
What privacy and security expectations are described in the FOA?
The FOA states that proposals must explain how patient privacy and data security will be established and maintained, reflecting the sensitivity of linking multiple data sources and conducting large-scale networked analytics.
Is FDA looking for solutions tailored to one registry or one device?
No. The FOA strongly encourages 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.
What does the FOA say about sustainability after the award period?
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, indicating FDA is looking for durable capacity rather than one-off research outputs.
Which agency is offering this funding opportunity?
The opportunity is offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What is the funding mechanism for this program?
The mechanism is a cooperative agreement (U01). The FOA notes that clinical trials are optional.
What does "clinical trial optional" mean in this FOA?
The FOA indicates that clinical trials are optional under this cooperative agreement. The focus described is on infrastructure and methodology to enable real-world evidence generation through CRNs and linked data sources.
What is the CFDA number listed for this opportunity?
The CFDA number listed is 93.103.
Who is eligible to apply?
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.
What is the maximum award amount (award ceiling) mentioned?
The posting indicates an award ceiling of $3,000,000.
How many awards does FDA expect to make?
The opportunity indicates an expectation of four awards.
What were the original posting dates for this opportunity?
The original timeline shows a creation date of January 13, 2020 and an original closing date of March 16, 2020.
What types of outcomes is FDA trying to enable through this program?
The intended outcome is a more strategic, patient-centered approach to evidence generation for medical devices, enabled by harmonized and interoperable data infrastructure that supports more sophisticated study designs and analyses and can continuously evaluate device performance, safety, and effectiveness in real-world settings.
How is this funding expected to help FDA and other decision-makers?
The FOA emphasizes expanding FDA's capacity (through collaboration with NEST partners and others) to address complex questions about medical device performance, safety, and effectiveness in real-world use, producing evidence that can be useful for patients, clinicians, payors, researchers, manufacturers, and regulators.
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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 |
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