Opportunity Information: Apply for RFA FD 20 017
The grant opportunity "Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (U01) Clinical Trials Not Allowed" (Funding Opportunity Number RFA-FD-20-017) is a cooperative agreement offered by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), specifically through the Center for Drug Evaluation and Research (CDER). Its central purpose is to support projects that investigate and demonstrate how the HL7 Fast Healthcare Interoperability Resources (FHIR) standard can be used to automate the transfer of standardized laboratory test data from healthcare institutions into clinical registries. In practical terms, the FDA is interested in improving the pipeline from routine clinical lab systems to registry databases in a way that reduces manual work, improves data quality and consistency, and strengthens the utility of real-world data for regulatory and public health uses. Clinical trials are explicitly not allowed under this opportunity, signaling that the FDA is looking for informatics, standards-based implementation work and real-world operational demonstrations rather than interventional research.
A key technical emphasis of the opportunity is the movement of "LOINC-coded" laboratory data. LOINC (Logical Observation Identifiers Names and Codes) is widely used to standardize the identification of lab tests and clinical observations, making results comparable across different laboratories and electronic health record (EHR) systems. The challenge the FDA is pushing applicants to address is how to reliably extract these LOINC-coded results from a healthcare institution's systems and transmit them into registries using FHIR, a modern interoperability protocol designed for consistent, API-driven healthcare data exchange. By focusing on "harmonized" laboratory data, the program is pointing toward solutions that not only move data but also preserve consistent meanings, units, reference ranges where applicable, and other contextual elements that registries need to interpret lab values correctly across sites.
The funding mechanism is a U01 cooperative agreement, which typically means the FDA expects substantial involvement in the project, such as providing input on technical direction, milestones, and deliverables, rather than acting as a hands-off funder. The program falls under a discretionary funding category and is associated with CFDA number 93.103. The opportunity anticipated making about two awards, with an award ceiling of $800,000, suggesting projects of meaningful scope that can produce concrete, reusable outputs such as implementation approaches, profiles, mappings, workflows, and documentation that other institutions and registries could potentially adopt or adapt.
Eligibility is broad and includes many types of organizations that could realistically participate in interoperability and registry infrastructure work. Eligible applicants include state and local governmental entities (county governments, city or township governments, and special district governments), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments and certain tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses, and small businesses. This wide eligibility list is consistent with the interdisciplinary nature of the work, which could involve health systems, universities, standards and interoperability groups, registry operators, health IT vendors, and research or nonprofit organizations with experience in data standards and exchange.
Timing-wise, the opportunity was created on December 25, 2019, with an original application closing date of March 4, 2020. While those dates indicate this specific solicitation was time-bounded, the themes remain relevant to ongoing national priorities around interoperability, real-world evidence, and reducing the burden of data capture for quality improvement and regulatory-grade data collection.
Overall, the opportunity is best understood as an FDA-sponsored effort to move the healthcare ecosystem closer to scalable, standards-based automation for lab-to-registry reporting. Applicants would be expected to explore and demonstrate practical ways to use HL7 FHIR to transmit LOINC-coded lab results from clinical environments into registries with minimal manual intervention, while maintaining data integrity and consistency. The intended outcome is not a clinical study, but rather the development and validation of an interoperable data-transfer approach that can support registries and, by extension, improve the reliability and efficiency of real-world data used for monitoring therapies, understanding outcomes, and supporting FDA-related evidence needs.Apply for RFA FD 20 017
- 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 "Transferring Harmonized Laboratory Data from Healthcare Institutions to Registries Using FHIR Protocol (U01) Clinical Trials 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 Dec 25, 2019.
- Applicants must submit their applications by Mar 04, 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 $800,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: 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, Others (see text field entitled Additional Information on Eligibility for clarification).
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| 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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