Opportunity Information: Apply for RFA FD 22 022
The grant opportunity "Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions" (RFA-FD-22-022) is a cooperative agreement (U01; clinical trial not allowed) funded by the U.S. Department of Health and Human Services through the Food and Drug Administration. It supports research and development work focused on real-world data (RWD) and how it can be made more consistently usable for clinical research and, especially, for regulatory submissions. The core problem it targets is that data concepts across common RWD sources such as electronic health records (EHRs), insurance claims, and digital health technologies often look similar on the surface but differ in their underlying meaning. Those subtle differences force teams to rely on manual interpretation when mapping and transforming data, which makes results harder to reproduce, slows analysis, and limits the possibility of reliable, automated, computer-driven data pipelines.
The main objective of the funding is to push beyond simply labeling or listing data elements and instead break RWD down into its most elemental components in a way that makes the meaning explicit and computable. In practical terms, the opportunity is aimed at clarifying what a data element truly represents, how it is defined, and what assumptions or business practices are embedded in it. Many real-world datasets carry implied definitions based on how a health system documents care, how billing rules shape claims, or how devices generate measurements. These implied meanings can lead two datasets to use the "same" concept (for example, a diagnosis, medication exposure, laboratory result, or clinical outcome) in ways that are not actually equivalent. FDA is looking for work that can make these meanings clear enough that future harmonization can rely less on human judgment and more on standardized, computable definitions that travel with the data.
The broader intent is to improve harmonization and interoperability between RWD and the data frameworks used in clinical research and regulatory submissions. By defining the elemental components of RWD concepts, the project is expected to help create a foundation for standardization that reduces ambiguity during conversion or mapping into research and submission-oriented formats. This is meant to enable more consistent use of RWD across different sources and contexts, and to reduce the risk that transformations introduce errors or subjective choices that could undermine regulatory-grade evidence. Although the award is not for running a clinical trial, it is meant to strengthen the upstream data standards and conceptual alignment needed for RWD to be used more confidently in regulatory decision-making.
Administratively, this is a single expected award with a funding ceiling of $350,000. Eligible applicants are broad and include federal-recognized tribal governments and tribal organizations, state and local governments, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), public housing authorities/Indian housing authorities, and for-profit organizations including small businesses. The opportunity was created on January 12, 2022, with an original closing date of March 31, 2022, under CFDA 93.103, and falls within FDA-related research and development areas tied to consumer protection and science and technology. The cooperative agreement structure also implies substantial federal involvement during the project, meaning the FDA is likely to collaborate on direction, milestones, and alignment with regulatory priorities rather than functioning only as a pass-through funder.Apply for RFA FD 22 022
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions. (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 Jan 12, 2022.
- Applicants must submit their applications by Mar 31, 2022. (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 $350,000.00 in funding.
- The number of recipients for this funding is limited to 1 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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Frequently Asked Questions (FAQs)
What is the name and identifier of this grant opportunity?
The opportunity is titled "Deconstruction of data and standards to support harmonization and interoperability with real world data for clinical research and regulatory submissions" and its identifier is RFA-FD-22-022.
Which federal agency is funding this opportunity?
It is funded by the U.S. Department of Health and Human Services (HHS) through the Food and Drug Administration (FDA).
What funding mechanism is used for this award?
This is a cooperative agreement under the U01 activity code. Clinical trials are not allowed under this opportunity.
What does "cooperative agreement" mean in this context?
A cooperative agreement indicates substantial federal involvement during the project. Based on the opportunity description, FDA is expected to collaborate on direction, milestones, and alignment with regulatory priorities, rather than acting only as a pass-through funder.
What problem is this grant trying to solve?
The grant targets a key issue in real-world data (RWD): data concepts across common sources (such as electronic health records, insurance claims, and digital health technologies) can look similar but differ in underlying meaning. Those differences often require manual interpretation during mapping and transformation, which can reduce reproducibility, slow analysis, and limit reliable automation.
What types of data sources are specifically mentioned as examples of real-world data?
The opportunity explicitly references electronic health records (EHRs), insurance claims, and digital health technologies as common RWD sources.
What is the main objective of the funded work?
The main objective is to go beyond simply labeling or listing data elements and instead break real-world data down into the most elemental components so that meaning is explicit and computable. This includes clarifying what a data element truly represents, how it is defined, and what assumptions or business practices are embedded in it.
What does "deconstruction" of data mean here?
In this opportunity, deconstruction refers to analyzing RWD concepts to identify their most basic components and making their meaning explicit and computable. The goal is to capture definitions and implied assumptions that might otherwise remain hidden in documentation practices, billing rules, or device-generated measurements.
Why is manual interpretation during data mapping considered a problem?
Manual interpretation can introduce subjective choices, make analyses harder to reproduce, slow down workflows, and limit the ability to build reliable computer-driven data pipelines. The opportunity is focused on reducing reliance on human judgment by making data meanings more standardized and computable.
What kinds of "concepts" in healthcare data are mentioned as examples where meanings can differ?
The description cites examples such as diagnoses, medication exposure, laboratory results, and clinical outcomes as concepts that may appear equivalent across datasets but can differ in meaning due to underlying assumptions or source-specific practices.
How do implied definitions arise in real-world datasets?
Implied definitions can come from how health systems document care, how billing rules shape claims data, or how devices generate measurements. These embedded practices can change the practical meaning of a data element even when the label appears the same across sources.
What does the opportunity mean by making data meaning "computable"?
"Computable" meaning refers to definitions that are explicit enough to be consistently interpreted by computer-driven processes, reducing ambiguity and reliance on manual interpretation when harmonizing or transforming data.
How does this work relate to harmonization and interoperability?
By defining the elemental components of RWD concepts, the project is expected to create a stronger foundation for standardization. This reduces ambiguity when converting or mapping RWD into clinical research and regulatory submission-oriented formats, improving harmonization and interoperability across sources and contexts.
How is this expected to support clinical research and regulatory submissions?
The effort is intended to strengthen upstream data standards and conceptual alignment so RWD can be used more consistently for clinical research and more confidently for regulatory decision-making. It aims to reduce the risk that transformations introduce errors or subjective interpretations that could undermine regulatory-grade evidence.
Is the funding intended to run a clinical trial?
No. The opportunity is explicitly listed as "clinical trial not allowed." The focus is on research and development related to data standards, meaning, and interoperability rather than conducting a clinical trial.
How many awards are expected?
The opportunity indicates a single expected award.
What is the maximum funding amount available?
The funding ceiling for this opportunity is $350,000.
Who is eligible to apply?
Eligibility is broad and includes: federally recognized tribal governments and tribal organizations; state and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); public housing authorities/Indian housing authorities; and for-profit organizations, including small businesses.
When was this opportunity created and when did it close?
The opportunity was created on January 12, 2022, and the original closing date was March 31, 2022.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.103.
What general area does this opportunity fall under?
It falls within FDA-related research and development areas tied to consumer protection and science and technology, with a specific emphasis on real-world data standards and interoperability for clinical research and regulatory submissions.
What is the intended long-term impact of this project?
The intended impact is to reduce ambiguity in RWD meaning, enable more consistent harmonization across datasets, improve reproducibility, and support more reliable automated data pipelines. This, in turn, is meant to strengthen the foundation for using RWD in regulatory-grade evidence and decision-making.
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