Opportunity Information: Apply for PAR 13 228

  • 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 Diabetes, Digestive, and Kidney Diseases Extramural Research.
  • This funding opportunity was created on May 15, 2013 and posted on May 15, 2013.
  • Applicants must submit their applications by Sep 7, 2016. (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: Special district governments State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities County governments For profit organizations other than small businesses Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Public and State controlled institutions of higher education Independent school districts Native American tribal governments (Federally recognized).
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Apply for PAR 13 228

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Opportunity Summary:

The grant opportunity titled "Biomarkers for Diabetes, Digestive, Kidney and Urologic Diseases Using Biosamples from the NIDDK Repository (R01)" (Funding Opportunity Number PAR-13-228) is a National Institutes of Health (NIH) discretionary research grant designed to help investigators run biomarker assays and perform the related data analysis using biospecimens that are already stored in the NIDDK Repository. In practical terms, the program is meant to lower the barrier to doing high-value biomarker work by pairing two things that usually have to be pursued separately: (1) access to existing, well-characterized repository samples from completed or ongoing NIDDK-supported clinical studies and trials, and (2) research funding to conduct the laboratory testing and analytic work needed to extract new knowledge from those samples.

The scientific focus is on diseases and conditions within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which includes diabetes, digestive diseases, kidney disease, and urologic conditions. The central expectation is that proposed studies will use repository-held biosamples to produce meaningful discoveries about disease mechanisms and biology, including how diseases start and evolve (pathogenic processes), how they progress over time, and how patients respond clinically to interventions or other exposures. The FOA is structured to encourage biomarker research that can connect molecular or biochemical signals in stored specimens to real clinical outcomes and phenotypes, using the strengths of NIDDK’s existing clinical datasets.

A key review emphasis is that applications are evaluated not only on the scientific plan and assay approach, but also on how well the project aligns with, and takes advantage of, the repository resource itself. Reviewers consider the appropriateness and feasibility of using the available repository samples, as well as the justification for the requested assays and analyses. Projects are strongly encouraged to make robust use of the associated clinical data that accompany repository specimens, such as data derived from the parent clinical trial or observational study. The announcement also signals that reviewers will value proposals that respect and build on the original intent of the parent study or trial that generated the samples, rather than attempting to stretch the samples into a direction that is inconsistent with how and why they were collected.

The FOA explicitly welcomes exploratory and discovery-oriented studies, especially in situations where biosamples are not extremely scarce and the proposed work is well-justified. This is an important detail because biomarker discovery can be high-impact but also iterative: early-stage work often aims to identify promising signals, patterns, or candidate markers that can later be validated. At the same time, the FOA makes it clear that exploratory work still needs to be responsible and scientifically grounded, particularly when dealing with limited or precious specimens, and it should remain consistent with the purpose and design context of the original clinical research effort.

From an administrative standpoint, the mechanism is an R01 research project grant, and it falls under the NIH’s health-related funding activity category (CFDA 93.847: Diabetes, Digestive, and Kidney Diseases Extramural Research). The listed award ceiling is $250,000, and there is no cost sharing or matching requirement. The opportunity was posted on May 15, 2013, with an original and final closing date of September 7, 2016, and it was archived on October 8, 2016, indicating it is no longer active as a current competition, but it remains useful as a reference point for how NIDDK structured repository-based biomarker funding.

Eligibility is broad and includes many types of domestic and international applicants. Eligible organizations span federal, state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; public housing authorities; independent school districts; and a wide range of mission-specific institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, and regional organizations. Importantly, foreign organizations and foreign institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined under the NIH Grants Policy Statement, making the program accessible to qualified teams outside the United States when appropriate.

Overall, this FOA is best understood as a targeted support mechanism for biomarker assay work that leverages existing NIDDK repository biosamples and their linked clinical data to generate new insights into NIDDK-relevant diseases. The strongest projects under this model are typically those that are tightly matched to the available specimens, use the accompanying clinical datasets intelligently, and produce interpretable findings that advance understanding of disease biology, progression, or treatment response while honoring the scientific context in which the samples were originally collected.

Frequently Asked Questions

What is the title and funding opportunity number for this grant?

The opportunity is titled "Biomarkers for Diabetes, Digestive, Kidney and Urologic Diseases Using Biosamples from the NIDDK Repository (R01)" and the Funding Opportunity Number is PAR-13-228.

What type of grant mechanism is this?

This is an NIH R01 research project grant.

What is the main purpose of this funding opportunity?

The goal is to support investigators in running biomarker assays and performing related data analysis using biospecimens that are already stored in the NIDDK Repository. In practice, it is designed to reduce the usual barriers by combining (1) access to well-characterized repository samples from completed or ongoing NIDDK-supported clinical studies and trials and (2) funding to do the laboratory testing and analytic work that can generate new findings from those samples.

What kinds of research are expected to be supported?

Projects are expected to use repository-held biosamples to produce meaningful discoveries about disease mechanisms and biology. This includes work on how diseases start and evolve (pathogenic processes), how they progress over time, and how patients respond clinically to interventions or other exposures, using the strengths of the linked clinical datasets associated with the specimens.

Which disease areas are within scope for this FOA?

The scientific focus is on diseases and conditions within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), including diabetes, digestive diseases, kidney disease, and urologic conditions.

Do applicants need to use samples from the NIDDK Repository?

Yes. The central expectation is that proposed studies will use biosamples stored in the NIDDK Repository, rather than newly collected specimens.

Does the FOA emphasize using clinical data linked to the biosamples?

Yes. Applications are strongly encouraged to make robust use of the associated clinical data that accompany repository specimens, such as data derived from the parent clinical trial or observational study.

What do reviewers specifically look for besides the scientific plan?

Reviewers evaluate not only the assay approach and overall scientific plan, but also how well the project aligns with and takes advantage of the repository resource itself. This includes the appropriateness and feasibility of using the available repository samples, and the justification for the requested assays and analyses.

How important is alignment with the original parent study or trial?

Very important. The FOA indicates that reviewers will value proposals that respect and build on the original intent of the parent study or trial that generated the samples, rather than pushing the specimens into a direction that is inconsistent with how and why they were collected.

Are exploratory or discovery-oriented biomarker studies allowed?

Yes. The FOA explicitly welcomes exploratory and discovery-oriented studies, especially when biosamples are not extremely scarce and the proposed work is well-justified.

Are there cautions around exploratory work?

Yes. Even exploratory work is expected to be responsible and scientifically grounded, particularly when dealing with limited or precious specimens, and it should remain consistent with the purpose and design context of the original clinical research effort that generated the samples.

What is the maximum award amount listed for this opportunity?

The listed award ceiling is $250,000.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement listed.

What is the CFDA number and program category?

The opportunity falls under NIH health-related funding and is listed under CFDA 93.847: Diabetes, Digestive, and Kidney Diseases Extramural Research.

When was this opportunity posted and when did it close?

It was posted on May 15, 2013. The original and final closing date listed is September 7, 2016.

Is this funding opportunity still active?

No. It was archived on October 8, 2016, meaning it is no longer active as a current competition. It may still be useful as a reference for how NIDDK structured repository-based biomarker funding.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic and international applicants. Eligible organizations include (among others) federal, state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (other than small businesses) as well as small businesses; public housing authorities; independent school districts; and a range of mission-specific institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, and regional organizations.

Are foreign (non-U.S.) organizations allowed to apply?

Yes. Foreign organizations and foreign institutions are eligible to apply.

Are non-U.S. components of U.S. organizations allowed?

Yes. Non-U.S. components of U.S. organizations are eligible.

Are foreign components allowed under this FOA?

Yes. Foreign components are allowed as defined under the NIH Grants Policy Statement.

What is the practical advantage of this FOA for biomarker research?

It effectively pairs two elements that often require separate efforts: access to existing, well-characterized repository samples from NIDDK-supported clinical studies and trials, and research funding to perform the biomarker assays and data analysis needed to generate new insights from those samples.

What kinds of outcomes should projects try to connect biomarkers to?

The FOA emphasizes connecting molecular or biochemical signals in stored specimens to real clinical outcomes and phenotypes, using the linked clinical datasets from the parent studies.

What kinds of projects tend to fit this FOA best (based on the description provided)?

The strongest-fit projects are typically those that are tightly matched to the available specimens, use the accompanying clinical datasets intelligently, and produce interpretable findings that advance understanding of disease biology, progression, or treatment response while honoring the scientific context in which the samples were originally collected.

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