Standardization of C Peptide and HbA1C (UC4) | Apply Online

Opportunity Summary:

The grant opportunity "Standardization of C Peptide and HbA1C (UC4)" (Funding Opportunity Number RFA-DK-11-020) is a National Institutes of Health (NIH) discretionary funding announcement that supports a cooperative agreement to establish and operate a Central Primary Reference Laboratory (CPRL). The main purpose is to improve the accuracy, comparability, and overall standardization of two key diabetes-related laboratory measurements: HbA1c (hemoglobin A1c) and C peptide. By funding a central reference laboratory, NIH is aiming to strengthen the measurement foundation that clinicians, researchers, and public health efforts rely on when diagnosing diabetes, monitoring glucose control, and evaluating therapies or disease progression.

A major driver for this program is the recognized clinical and public health importance of HbA1c testing. HbA1c reflects average blood glucose levels over the prior several weeks to months and is widely used to monitor diabetes management. At the time of this announcement, an international expert committee had emphasized the need for improved HbA1c measurement specifically because HbA1c was increasingly being used not just for monitoring, but also for diagnosing diabetes. Diagnosis places a higher burden on measurement reliability, since small differences in assay performance or calibration between laboratories and testing platforms can shift clinical decisions. The CPRL is therefore intended to help ensure HbA1c results are consistent and trustworthy across sites, methods, and settings, reducing variability that could affect diagnosis, treatment adjustments, clinical trial outcomes, and longitudinal patient follow-up.

The opportunity also highlights the growing importance of standardized C peptide measurement. C peptide is produced when the body makes endogenous insulin, so it is used as a marker of remaining beta-cell function. In Type 1 diabetes, particularly near the time of diagnosis, C peptide levels can provide insight into how much insulin the pancreas is still producing. The announcement points to increasing evidence that preserving endogenous insulin production in people with recent-onset Type 1 diabetes can yield meaningful long-term clinical benefits. That makes accurate and comparable C peptide testing especially valuable for clinical research studies, intervention trials aimed at beta-cell preservation, and potentially for stratifying patients or interpreting outcomes. A reference laboratory that can anchor and harmonize C peptide assays helps ensure that results across studies and clinical sites can be interpreted on the same scale and with known performance characteristics.

Administratively, this is a cooperative agreement (UC4), meaning NIH expects substantial involvement with the awardee beyond what is typical for a standard research grant. While the announcement text provided here does not list all operational requirements, the cooperative mechanism generally signals an active partnership where NIH program staff may coordinate, guide, or collaborate on milestones, data and method harmonization, dissemination of standards, and integration with broader measurement standardization efforts. The funded CPRL would be positioned as a central technical authority to support improvement and standardization activities rather than serving as a typical single-site research lab focused only on internal experiments.

The opportunity falls under the NIH program area of Diabetes, Digestive, and Kidney Diseases (CFDA 93.847). The award ceiling listed is $350,000, and there is no cost sharing or matching requirement. The original posting date is August 9, 2011, with an original and current closing date of November 17, 2011, and an archive date of December 18, 2011. The announcement is therefore historical/archived, but it reflects an important NIH priority: ensuring the measurement science behind major diabetes biomarkers is rigorous enough for both everyday clinical care and high-stakes research applications.

Eligibility is broad and includes many types of domestic organizations and government entities. Eligible applicants include public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, state and local governments (including counties, cities/townships, special districts, and independent school districts), public housing authorities/Indian housing authorities, Native American tribal governments and tribal organizations (including those other than federally recognized), and additional institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Federal agencies are also listed as eligible. This wide eligibility suggests NIH was prioritizing technical capacity and infrastructure for reference laboratory functions, not limiting participation to a narrow set of academic applicants.

For applicants and stakeholders who needed the complete requirements, deliverables, and cooperative agreement terms, NIH provided the full announcement through an Additional Information link (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-11-020.html). The contact point included is the NIH Office of Extramural Research (OER) webmaster for access or linking issues (FBOWebmaster@OD.NIH.GOV).

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