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) | RFA FD 22 022

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.

• 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.

Apply for RFA FD 22 022

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