Standardization of C-peptide and HbA1c Measurements Program (UC4) | Apply Online

Opportunity Summary:

The "Standardization of C-peptide and HbA1c Measurements Program (UC4)" grant opportunity (RFA DK 16 011) is a National Institutes of Health (NIH) funding announcement under HHS (listed as HHS-NIH11) focused on improving the consistency and comparability of two key laboratory measurements used in type 1 diabetes clinical research: C-peptide and HbA1c. The core purpose is to support harmonization and standardization efforts so that results generated across different clinical laboratories, studies, and testing platforms can be compared more reliably. This matters because even small differences in lab methods, reagents, or calibration approaches can lead to measurement variability that complicates clinical trial interpretation, cross-study comparisons, and longitudinal tracking of biomarkers.

The funding is structured as a cooperative agreement (UC4), meaning the project is expected to involve substantial interaction and coordination with the NIH rather than operating purely as an investigator-directed research grant. The FOA seeks applications to establish a Central Primary Reference Laboratory (CPRL). In practical terms, the CPRL functions as the central hub that anchors measurement standardization: it is expected to coordinate laboratories and stakeholders, manage the operational and administrative pieces of harmonization, and provide reference-level measurement services that others can align to.

A major part of the CPRL role described in the announcement is administrative and coordinating work. The laboratory is expected to bring together clinical laboratories involved in type 1 diabetes research and also engage commercial suppliers whose reagents and measurement methods influence how C-peptide and HbA1c are quantified. This coordination piece is important because standardization is not only a technical laboratory task; it often requires agreement on protocols, calibration materials, traceability chains, quality assurance practices, data reporting conventions, and processes for handling method changes over time. The FOA indicates the CPRL will help organize and support these harmonization activities across the relevant ecosystem.

Alongside coordination, the CPRL is also expected to perform measurements of reference values specifically for C-peptide and HbA1c. In a standardization framework, reference values serve as the benchmark needed to align results from multiple sites and methods. By producing high-quality reference measurements, the CPRL helps ensure that participating labs and studies can calibrate or validate their own assays against a consistent standard, reducing systematic differences and improving the overall interpretability of clinical research data in type 1 diabetes.

From an administrative standpoint, the opportunity falls under the "Discretionary" category and the activity category of "Food and Nutrition, Health," with CFDA numbers 93.847 and related listings. The FOA is open to a broad range of applicant organizations, including federal recognized tribal governments and tribal organizations, state and local governments, public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including small businesses), and other entities as permitted in the announcement's eligibility clarification. This wide eligibility signals that NIH is primarily looking for the best-qualified organization to serve as the central reference laboratory, regardless of whether it sits in academia, government, nonprofit, or industry, as long as it can meet the technical and coordination demands.

In terms of funding and scale, the award ceiling is listed as $350,000, with an expectation of one award. That points to a single centralized awardee model, where one CPRL is selected to lead and deliver the reference laboratory and harmonization support functions for the program. Key dates provided show the FOA was created and posted on May 23, 2016, with an application closing date of November 22, 2016 (original and current closing dates are the same), indicating it was a time-limited solicitation with a defined submission window.

Overall, this opportunity is essentially about building the measurement backbone for type 1 diabetes research by selecting one central laboratory to coordinate stakeholders and produce reference measurements for C-peptide and HbA1c. The intended outcome is better standardization across studies and sites, improving confidence that biomarker results mean the same thing regardless of where or how they were measured, which in turn strengthens clinical trial quality and the ability to compare findings across research efforts.

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