Mass Spectrometric Assays for the Reliable and Reproducible Detection of Proteins/Peptides of Importance in Type 1 Diabetes (T1D) Research (U01 Clinical Trial Not Allowed) | RFA DK 21 031

Opportunity Information: Apply for RFA DK 21 031

The NIH funding opportunity "Mass Spectrometric Assays for the Reliable and Reproducible Detection of Proteins/Peptides of Importance in Type 1 Diabetes (T1D) Research" (RFA-DK-21-031) is a cooperative agreement (U01) aimed at strengthening the measurement tools available to the type 1 diabetes research community. The main goal is to support projects that develop and/or validate targeted mass spectrometry assays, such as Multiple Reaction Monitoring (MRM), to reliably detect and quantify specific proteins and peptides that are especially important for T1D research and related biology. A key theme throughout the announcement is practicality for the broader field: the assays are expected to be robust, reproducible, and designed so they can be transferred and adopted by other laboratories rather than remaining as one-off methods that only work in a single setting.

The FOA focuses on targeted assays for high-priority T1D-relevant analytes, explicitly highlighting examples like glucagon and other proglucagon-derived peptides, C-peptide, insulin, proinsulin, glycated CD59, islet amyloid polypeptide (IAPP), and chromogranins A and B (CgA, CgB). These molecules are central to studying beta cell function, glucose regulation, endocrine pancreas biology, and potential biomarkers of disease activity or therapeutic response. Because many of these targets can be difficult to measure accurately with traditional immunoassays due to cross-reactivity, interference, or lack of standardization across platforms, the FOA emphasizes mass spectrometric approaches that can provide higher analytical specificity and better comparability when properly standardized.

A major requirement is that the proposed assays be validated in human plasma or serum, reflecting the intent to create tools that are directly applicable to clinical and translational research settings. In practice, this means applicants are expected to demonstrate performance characteristics that make an assay credible and reusable across sites, such as sensitivity, specificity, precision, reproducibility, and stability in the relevant human matrices. The announcement also signals that, in some cases, success may depend on creating shared resources for the community, including standards and reference materials when they do not already exist. This point matters because even a technically excellent mass spectrometry method can be hard to compare across labs without harmonized calibrators, reference peptides/proteins, and agreed-upon protocols for sample handling and quantification.

The award mechanism is a cooperative agreement (U01), which typically implies more substantial scientific and/or programmatic involvement by NIH staff than a standard research project grant. While the FOA text provided does not spell out the operational details of that interaction, the cooperative structure generally aligns with the overall aim here: to produce assays and resources that the larger T1D research ecosystem can rely on, rather than isolated proof-of-concept work. The FOA is explicitly "Clinical Trial Not Allowed," meaning the supported work should focus on assay development and validation rather than testing clinical interventions in trial formats.

In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations: state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and certain tribal organizations; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses, and small businesses are also listed as eligible); independent school districts; special district governments; and public housing authorities/Indian housing authorities. The FOA also calls out additional eligible applicant categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, AANAPISISs, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. On the international side, non-U.S. institutions themselves are not eligible to apply as the applicant organization, but non-domestic components of U.S. organizations are allowed, and foreign components (as defined by NIH policy) are allowed, which can enable certain types of cross-border collaboration when justified.

Administratively, this opportunity is listed under CFDA 93.847, with an award ceiling of $700,000, and it was created on 2022-07-14 with an original closing date of 2022-10-26. Overall, the FOA is best understood as an NIH effort to improve the reliability and cross-lab consistency of protein/peptide measurements that are foundational for T1D research, by funding targeted mass spectrometry assays that are not only technically strong but also standardized, validated in real human sample types, and set up for broader adoption by the research community.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Mass Spectrometric Assays for the Reliable and Reproducible Detection of Proteins/Peptides of Importance in Type 1 Diabetes (T1D) Research (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 2022-07-14.
• Applicants must submit their applications by 2022-10-26. (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 $700,000.00 in funding.
• 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.

Apply for RFA DK 21 031

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