Biomarkers for Diabetes, Digestive, Kidney and Urologic Diseases Using Biosamples from the NIDDK Repository (R01) | PAR 17 123

Opportunity Information: Apply for PAR 17 123

The National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), offered the grant opportunity titled "Biomarkers for Diabetes, Digestive, Kidney and Urologic Diseases Using Biosamples from the NIDDK Repository (R01)" under funding opportunity number PAR-17-123. It uses the NIH R01 research project grant mechanism and sits within the broad health and food and nutrition research category (CFDA 93.847). The central purpose of the opportunity is to fund investigators to run laboratory assays on biospecimens that are already stored in the NIDDK Repository, and to support the related data analysis needed to interpret those assay results. In other words, the award is designed to help researchers turn existing, curated samples and their linked clinical data into new biomarker findings without requiring the time and cost of collecting new cohorts.

The program is aimed at studies focused on diseases and conditions within NIDDKs mission areas, especially diabetes, digestive diseases, kidney disease, and urologic disorders. Applicants are expected to propose biomarker-focused projects that can produce meaningful scientific advances, such as clarifying disease mechanisms, identifying or explaining pathogenic processes, improving understanding of disease progression, or predicting and characterizing clinical responses to interventions. A key emphasis is that proposals should leverage not only the samples themselves but also the accompanying data generated in the original NIDDK-supported clinical trials and observational studies. Reviewers are instructed to consider both whether the proposed project can appropriately access the requested repository-held samples and whether the requested funding for assays is justified and well matched to the amount, type, and rarity of the samples.

A notable feature of the opportunity is that it encourages strong alignment with the original intent of the parent clinical study or trial that produced the specimens. That means applicants should demonstrate that the planned biomarker work respects the context in which the samples were collected, including the study design, participant characteristics, timing of specimen collection, endpoints, and any relevant clinical protocols. Projects that make smart, integrated use of the existing clinical and phenotypic datasets associated with the repository samples are viewed favorably, because they are positioned to generate more interpretable and clinically relevant conclusions rather than isolated lab measurements.

The FOA explicitly welcomes exploratory and discovery-oriented biomarker research, particularly when sample availability is not severely constrained and when the exploratory approach is well justified. The expectation is not simply to run assays, but to design studies that can reasonably lead to new biological or clinical insight, including hypotheses about pathways, stratification of disease subtypes, or markers that correlate with outcomes or treatment effects. At the same time, because repository samples can be finite, applicants generally need to make a case that the chosen assays are efficient, appropriately powered (given sample numbers), and likely to yield interpretable results in light of available covariates and clinical endpoints.

In terms of who can apply, eligibility is broad and includes many common domestic applicant types such as state, county, and local governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; special district governments; federally recognized Native American tribal governments; public housing authorities and Indian housing authorities; tribal organizations that are not federally recognized as governments; nonprofits (with or without 501(c)(3) status) that are not institutions of higher education; for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible groups, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible federal agencies; regional organizations; U.S. territories or possessions; and non-U.S. (foreign) entities. This broad eligibility is consistent with a repository-based research model where specialized assay capabilities and analytic expertise may exist across many sectors and locations.

Administrative details in the source indicate the opportunity was categorized as discretionary, with an award ceiling listed at $250,000. The FOA record shows a creation date of January 17, 2017, and an original closing date of May 7, 2020. Overall, the opportunity is best understood as a mechanism to unlock additional scientific value from existing NIDDK-funded clinical research by enabling researchers to apply modern biomarker assays and robust analysis to well-characterized stored biospecimens, with the goal of producing insights that can move the field forward on pathogenesis, prognosis, and treatment response across diabetes, digestive, kidney, and urologic diseases.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Biomarkers for Diabetes, Digestive, Kidney and Urologic Diseases Using Biosamples from the NIDDK Repository (R01)" 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 2017-01-17.
• Applicants must submit their applications by 2020-05-07. (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 $250,000.00 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.

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