Standardization of C-Peptide and HbA1C Measurements Program (U01 Clinical Trial Not Allowed) | RFA DK 21 007

Opportunity Information: Apply for RFA DK 21 007

The Standardization of C-Peptide and HbA1C Measurements Program is a National Institutes of Health (NIH) funding opportunity from the U.S. Department of Health and Human Services focused on improving the consistency and comparability of two laboratory measurements that are central to type 1 diabetes research: C-peptide and HbA1c. The program is offered through a cooperative agreement mechanism (U01), which generally means the NIH expects to be substantially involved in the project’s direction and coordination rather than acting only as a pass-through funder. Clinical trials are not allowed under this announcement, so the work is centered on laboratory and coordination activities that enable better research, not testing interventions in participants.

The core purpose of the award is to establish and support a Central Primary Reference Laboratory (CPRL). In practical terms, this CPRL serves as the central hub for harmonization and standardization efforts across multiple clinical laboratories and commercial entities that provide reagents, assays, and measurement methods. A major problem in multi-site clinical research is that the same biomarker can be measured differently depending on the assay platform, the lab’s procedures, calibration materials, or even reagent lots. Those differences can introduce noise, bias, and site-to-site variability that make it harder to compare results across studies, merge datasets, interpret trial outcomes, or set consistent eligibility and endpoint thresholds. This program targets that issue directly by funding a single reference laboratory to coordinate and technically support alignment across the broader measurement ecosystem.

The CPRL’s responsibilities include both administrative coordination and technical measurement functions. On the coordination side, the laboratory is expected to organize and manage the harmonization process among participating clinical laboratories and commercial suppliers, which can involve communication, documentation, planning, and ongoing oversight to keep methods aligned over time. On the technical side, the CPRL is expected to provide measurements of reference values for C-peptide and HbA1c. These reference measurements act as anchors for standardization, helping other labs verify accuracy, validate methods, and calibrate or adjust their procedures so that results are comparable regardless of where they were generated. In the context of type 1 diabetes research, this is especially important because C-peptide is widely used as a marker of endogenous insulin secretion and beta-cell function, while HbA1c is a key indicator of longer-term glycemic exposure and is often used for outcomes, risk stratification, and study eligibility.

The opportunity is listed as a discretionary grant in the health-related activity category (CFDA 93.847). It anticipated a single award, reflecting the centralized nature of the CPRL concept. The stated award ceiling was $350,000, and the expected number of awards was 1. The funding opportunity number is RFA-DK-21-007, and it was created on May 7, 2021, with an original closing date of October 20, 2021.

Eligibility is broad and includes many types of organizations that could plausibly operate or host a high-quality reference laboratory and coordinate national or multi-site standardization work. Eligible applicants include various government entities (state, county, city/township, special districts), federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, independent school districts, public and private institutions of higher education, nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories), for-profit organizations (other than small businesses), and small businesses, as well as other entities as described in the announcement’s additional eligibility language. This broad eligibility reflects the fact that reference laboratory capacity and standardization expertise can exist in academic medical centers, specialized nonprofit research organizations, government labs, or qualified commercial laboratories.

Overall, the program is designed to strengthen the reliability of type 1 diabetes clinical research by ensuring that two foundational biomarkers, C-peptide and HbA1c, are measured in a harmonized and standardized way across laboratories and over time. By funding a single Central Primary Reference Laboratory to coordinate stakeholders and generate reference values, NIH aims to reduce measurement variability, improve cross-study comparability, and support more consistent interpretation of results in the wider type 1 diabetes research community.

• The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Standardization of C-Peptide and HbA1C Measurements Program (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): 93.847.
• This funding opportunity was created on May 07, 2021.
• Applicants must submit their applications by Oct 20, 2021. (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, Others (see text field entitled Additional Information on Eligibility for clarification).

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