Opportunity Information: Apply for PAR 14 258
Apply for PAR 14 258
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)" 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 Jun 11, 2014 and posted on Jun 10, 2014.
- Applicants must submit their applications by Nov 20, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $7,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $7,000,000.00 in funding.
- Eligible applicants include: Native American tribal organizations (other than Federally recognized tribal governments) Public and State controlled institutions of higher education Private institutions of higher education County governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Special district governments Small businesses City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Others (see text field entitled Additional Information on Eligibility for clarification) 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.
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Opportunity Summary:
The NIH funding opportunity titled "Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)" (Funding Opportunity Number PAR-14-258) was designed to support ancillary research that leverages already identified, well characterized human participants from major type 1 diabetes clinical research cohorts. The core idea is to treat these existing cohorts as a kind of "living biobank," meaning investigators can propose add-on studies that draw on the people, clinical histories, and in many cases previously collected samples and data from those studies, rather than building an entirely new recruitment pipeline from scratch. The overarching scientific goal is to accelerate discovery in type 1 diabetes by taking advantage of unique populations that have been followed carefully, often for long periods, and that include deep clinical phenotyping relevant to disease risk, onset, progression, and complications.
The FOA specifically invites applications that use subjects who were enrolled in, or even just screened for participation in, the Type 1 Diabetes TrialNet clinical trials network, as well as subjects enrolled in the landmark Diabetes Control and Complications Trial (DCCT) and its long-running follow-up study, Epidemiology of Diabetes Interventions and Complications (EDIC). By focusing on TrialNet and DCCT/EDIC, NIH is pointing applicants toward cohorts that are unusually valuable for mechanistic and biomarker research: TrialNet is closely tied to immune mediated disease progression and prevention studies, while DCCT/EDIC provides decades of data on glycemic exposure and the development of microvascular and other complications. Ancillary studies can therefore ask questions that are hard to answer in typical short-term, single-site studies, including how biological signatures evolve over time, what predicts progression, and what differentiates responders from non-responders to particular interventions or clinical trajectories.
The research emphasis is on generating scientific discoveries about disease mechanisms, pathogenic processes, and biomarkers related to type 1 diabetes and its complications. In practice, that means proposals are expected to go beyond simply describing clinical outcomes and instead aim at understanding why the disease behaves the way it does, how immune and metabolic pathways contribute to progression, and what measurable indicators (biomarkers) can track disease activity, forecast complications, or reflect clinical responses. Biomarkers in this context could include immunologic, metabolic, genetic, proteomic, cellular, or other molecular measures, as long as the work is strongly tied to type 1 diabetes biology and progression and makes use of the unique advantages of these cohorts.
A key boundary in the announcement is that it is not intended to fund clinical trials aimed at demonstrating clinical efficacy endpoints. NIH explicitly notes that studies should not be designed as clinical efficacy trials, including endpoints such as C-peptide preservation. That distinction matters because TrialNet and DCCT/EDIC participants may be attractive populations for testing therapies, but this FOA is structured to fund ancillary, discovery oriented research that can be embedded alongside existing studies or conducted using these participants and their linked data, rather than launching new efficacy trials. In other words, the emphasis is on mechanism and measurement rather than proving that an intervention works in the clinical trial sense.
From an administrative and eligibility standpoint, this was a discretionary grant opportunity under NIH, with activity aligned to the diabetes, digestive, and kidney diseases extramural research area (CFDA 93.847). The posting dates were in June 2014, with an original and current closing date of November 20, 2014, and an archive date of December 21, 2014, indicating the specific solicitation is no longer active. The opportunity listed an estimated total funding amount of $7,000,000, with an award ceiling also stated as $7,000,000, and it indicated there was no cost sharing or matching requirement. The eligible applicant pool was broad and included public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses and for-profits other than small businesses), state, local, and tribal governments, public housing authorities, school districts, and special district governments. It also explicitly included a range of institution types and organizations 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, certain federal government agencies, U.S. territories or possessions, and non-U.S. entities (foreign organizations) and regional organizations, reflecting NIH's broad eligibility approach depending on the scientific fit and ability to carry out the proposed ancillary work.
Overall, the opportunity can be summarized as an NIH mechanism to help researchers extract additional high-value scientific insights from existing, deeply characterized type 1 diabetes clinical study populations. It encourages investigators to design add-on projects that capitalize on TrialNet and DCCT/EDIC participant access and associated longitudinal data to uncover mechanisms and validate or discover biomarkers tied to disease progression and complications, while clearly steering applicants away from proposing new clinical efficacy trials as the primary goal. For further details, NIH provided the full announcement link (http://grants.nih.gov/grants/guide/pa-files/PAR-14-258.html) and referenced NIH Office of Extramural Research contacts for technical access issues.
Frequently Asked Questions (FAQs)
What is the title and funding opportunity number for this NIH grant?
The opportunity is titled "Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)" and the Funding Opportunity Number (FOA) is PAR-14-258.
What is the main purpose of this funding opportunity?
The purpose is to support ancillary, discovery-oriented research that leverages already identified and well characterized human participants from major type 1 diabetes clinical research cohorts. The intent is to accelerate type 1 diabetes discovery by using existing participants, their clinical histories, and in many cases previously collected samples and data, rather than creating a brand-new recruitment effort.
What does "living biobank" mean in this FOA?
In this context, "living biobank" refers to using existing clinical study cohorts as an ongoing resource of participants with deep clinical characterization and longitudinal follow-up. Investigators can propose add-on studies that draw on these participants, their linked clinical data, and potentially existing samples and measurements.
Which cohorts does NIH want applicants to use for this research?
The FOA specifically invites applications using subjects who were enrolled in, or even screened for participation in, the Type 1 Diabetes TrialNet clinical trials network, and subjects enrolled in the Diabetes Control and Complications Trial (DCCT) and its follow-up study, Epidemiology of Diabetes Interventions and Complications (EDIC).
Can a project use people who were screened but not enrolled in TrialNet trials?
Yes. The FOA invites applications that use subjects who were enrolled in, or screened for participation in, the Type 1 Diabetes TrialNet clinical trials network.
Why are TrialNet and DCCT/EDIC considered valuable for ancillary research?
The FOA highlights these cohorts because they are unusually valuable for mechanistic and biomarker research. TrialNet is closely tied to immune-mediated disease progression and prevention studies, while DCCT/EDIC provides decades of data related to glycemic exposure and the development of microvascular and other complications. Together, they support questions that benefit from long-term follow-up and deep phenotyping.
What kinds of scientific questions is this FOA trying to support?
The emphasis is on generating discoveries about disease mechanisms, pathogenic processes, and biomarkers related to type 1 diabetes and its complications. Examples of the kinds of questions implied by the FOA include how biological signatures change over time, what predicts disease progression, and what differentiates responders from non-responders to interventions or clinical trajectories within these established cohorts.
Is the FOA focused on clinical outcomes research or mechanistic discovery?
It is focused on mechanistic discovery and biomarker-related research. The FOA indicates proposals are expected to go beyond simply describing clinical outcomes and instead aim to understand underlying biology, including immune and metabolic pathways that contribute to disease progression and complications.
What does NIH mean by "biomarkers" in this opportunity?
Biomarkers can include immunologic, metabolic, genetic, proteomic, cellular, or other molecular measures, as long as the work is strongly tied to type 1 diabetes biology and progression and makes use of the unique advantages of the TrialNet and/or DCCT/EDIC cohorts.
Are clinical trials allowed under this FOA?
The FOA explicitly states it is not intended to fund clinical trials aimed at demonstrating clinical efficacy endpoints. The focus is on ancillary, discovery-oriented research that can be embedded alongside existing studies or conducted using these participants and their linked data, rather than launching new efficacy trials.
Are clinical efficacy endpoints like C-peptide preservation allowed?
No. NIH explicitly notes that studies should not be designed as clinical efficacy trials, including endpoints such as C-peptide preservation.
What is meant by an "ancillary" study in this announcement?
An ancillary study is an add-on research project that leverages participants, data, and (in many cases) prior samples from existing cohorts. The key idea is to extract additional scientific value from already established studies rather than initiating a new stand-alone recruitment pipeline.
What NIH area or CFDA listing is associated with this opportunity?
The opportunity is aligned with the diabetes, digestive, and kidney diseases extramural research area and is associated with CFDA 93.847.
What were the key dates for this funding opportunity?
The FOA was posted in June 2014. The original and current closing date was November 20, 2014. The archive date was December 21, 2014.
Is this funding opportunity currently active?
No. The archive date of December 21, 2014 indicates the specific solicitation is no longer active.
How much total funding was estimated for this FOA?
The estimated total funding amount listed was $7,000,000.
What was the maximum award amount (award ceiling) listed?
The award ceiling was stated as $7,000,000.
Was cost sharing or matching required?
No. The opportunity indicated there was no cost sharing or matching requirement.
Who was eligible to apply?
The eligible applicant pool was broad and included public and private institutions of higher education; nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities); for-profit organizations (including small businesses and for-profits other than small businesses); and government entities such as state, local, and tribal governments, public housing authorities, school districts, and special district governments.
Did eligibility include specific institution types like HBCUs and Hispanic-serving institutions?
Yes. The FOA explicitly included a range of institution types and organizations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISI institutions, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations.
Could non-U.S. (foreign) organizations apply?
Yes. The eligibility description explicitly included non-U.S. entities (foreign organizations) and regional organizations.
Where can applicants find the full announcement?
NIH provided the full announcement link at http://grants.nih.gov/grants/guide/pa-files/PAR-14-258.html.
Who was referenced for technical access issues?
NIH referenced NIH Office of Extramural Research contacts for technical access issues.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 14 258) also looked into and applied for these:
| Funding Opportunity |
|---|
| Chronic Kidney Disease Biomarkers Consortium (CKD BioCon) (U01) Apply for RFA DK 14 011 Funding Number: RFA DK 14 011 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $450,000 |
| Improving Diabetes Management in Young Children with Type 1 Diabetes (DP3) Apply for RFA DK 14 022 Funding Number: RFA DK 14 022 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Critical Path Public Private Partnerships Apply for RFA FD 14 089 Funding Number: RFA FD 14 089 Agency: Food Drug Administration Category: Food and Nutrition Health Funding Amount: $10,500,000 |
| NIDDK Mentored Research Scientist Development Award (K01) Apply for PAR 14 266 Funding Number: PAR 14 266 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition Data Coordinating Center for The Environmental Determinants of Diabetes in the Young (TEDDY) Study (UC4) Apply for RFA DK 14 505 Funding Number: RFA DK 14 505 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $20,000,000 |
| NIAID SBIR Technology Transfer Direct Phase II (SBIR TT) (R44) Apply for RFA AI 14 049 Funding Number: RFA AI 14 049 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,000,000 |
| NIDDK Cooperative Hematology Specialized Core Centers (U54) Apply for RFA DK 14 001 Funding Number: RFA DK 14 001 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $1,000,000 |
| Limited Competition for the Continuation of the Adult Acute Liver Failure Study Group (U01) Apply for RFA DK 14 504 Funding Number: RFA DK 14 504 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $3,500,000 |
| NIDDK Physician Scientist Diversity Mentoring Award (K05) Apply for RFA DK 14 005 Funding Number: RFA DK 14 005 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| NIDDK Central Repositories Non renewable Sample Access (X01) Apply for PAR 14 301 Funding Number: PAR 14 301 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Type 1 Diabetes TrialNet Clinical Centers (U01) Apply for RFA DK 14 016 Funding Number: RFA DK 14 016 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $450,000 |
| Prevention of Lower Urinary Tract Symptoms in Women Bladder Health Scientific and Data Coordinating Center (PLUS SDCC) (U01) Apply for RFA DK 14 018 Funding Number: RFA DK 14 018 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Prevention of Lower Urinary Tract Symptoms in Women Bladder Health Clinical Centers (PLUS CCs) (U01) Apply for RFA DK 14 004 Funding Number: RFA DK 14 004 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $500,000 |
| Limited Competition Data Coordinating Center for Type 1 Diabetes TrialNet (UC4) Apply for RFA DK 14 507 Funding Number: RFA DK 14 507 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $45,000,000 |
| Identification of Novel Targets and Pathways Mediating Weight Loss, Diabetes Resolution and Related Metabolic Disease after Bariatric Surgery in Humans (R01) Apply for RFA DK 14 025 Funding Number: RFA DK 14 025 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $500,000 |
| Limited Competition for the Continuation of the Hepatitis B Research Network Clinical Centers (U01) Apply for RFA DK 14 506 Funding Number: RFA DK 14 506 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Hepatitis B Research Network Immunology Center (U01) Apply for RFA DK 14 509 Funding Number: RFA DK 14 509 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Hepatitis B Research Network Data Coordination Center (U01) Apply for RFA DK 14 510 Funding Number: RFA DK 14 510 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Type 1 Diabetes Complications IMPACT Award (DP3) Apply for RFA DK 14 017 Funding Number: RFA DK 14 017 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $2,000,000 |
| Consortium on Beta cell Death and Survival (HIRN CBDS) (UC4) Apply for RFA DK 14 021 Funding Number: RFA DK 14 021 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $900,000 |
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