Opportunity Information: Apply for PAR 14 064
Apply for PAR 14 064
- 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 I 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 Jan 7, 2014 and posted on Jan 7, 2014.
- Applicants must submit their applications by Apr 10, 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 $4,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Private institutions of higher education Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities County governments City or township governments Native American tribal governments (Federally recognized) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts For profit organizations other than small businesses State governments Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education.
- 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.
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Opportunity Summary:
The National Institutes of Health (NIH) funding opportunity PAR-14-064, titled "Research Using Subjects From Selected Type I Diabetes Clinical Studies (Living Biobank) (DP3)," supported ancillary research projects that leverage participants from two major, already-established type 1 diabetes clinical research resources: the Type 1 Diabetes TrialNet clinical trials network and the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort. The central idea behind the announcement was to treat these well-characterized participant groups as a kind of "living biobank," meaning investigators could propose new, add-on studies that use these existing human subjects (including people who were screened for TrialNet studies, not only those ultimately enrolled) to answer additional scientific questions without building a new cohort from scratch.
The scientific emphasis was on advancing understanding of type 1 diabetes biology rather than testing whether a treatment works in the traditional clinical efficacy sense. NIH was looking for projects that could produce discoveries about disease mechanisms and pathogenic processes, identify or validate biomarkers that track disease progression or predict clinical responses, and deepen knowledge about complications of type 1 diabetes. In practical terms, this could include mechanistic studies, immunologic or metabolic profiling, genetic or omics analyses, and work aimed at developing markers that help interpret risk, progression, or downstream outcomes, as long as the work was anchored in the TrialNet or DCCT/EDIC participant populations. A key boundary condition was that the FOA was not meant to fund clinical trials designed to demonstrate clinical efficacy endpoints; the announcement explicitly noted that efficacy trials, including those focused on C-peptide preservation, were out of scope. In other words, the program was designed to add scientific value to existing major studies by enabling additional analyses and ancillary protocols, not to launch new efficacy-driven intervention trials.
Administratively, this was a discretionary NIH grant opportunity using the grant funding instrument, and it was categorized under the activity area aligned with diabetes research (CFDA 93.847, Diabetes, Digestive, and Kidney Diseases Extramural Research). The FOA was posted on January 7, 2014, with an original and current closing date of April 10, 2014, and it was archived on May 11, 2014. The estimated total funding amount listed for the opportunity was $4,000,000, indicating NIH expected to support a set of meritorious ancillary projects within that overall funding level.
Eligibility was broad and intentionally inclusive, spanning most common applicant types that participate in NIH research funding. Eligible applicants included public and private institutions of higher education, nonprofit organizations (including both 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations (including small businesses and other for-profits), and a wide range of government entities (state, county, city/township, special district governments, and independent school districts). Tribal organizations and tribal governments were eligible, including federally recognized tribal governments as well as other tribal entities, along with tribally controlled colleges and universities. The announcement also allowed participation from U.S. territories or possessions and specifically permitted foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) could apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were allowed. The FOA also explicitly recognized and welcomed applications from mission-serving institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, and other community- or faith-based organizations where appropriate.
For applicants, the practical takeaway is that proposals needed to be clearly positioned as ancillary to TrialNet or DCCT/EDIC, demonstrate strong scientific rationale for using those particular participant populations, and articulate how the study would generate new knowledge about type 1 diabetes mechanisms, progression, biomarkers, clinical responses, or complications. At the same time, applicants needed to avoid framing the project as an efficacy clinical trial and instead focus on discovery, mechanism, and/or biomarker-driven aims that make use of the depth, longitudinal character, and clinical characterization already embedded in these hallmark cohorts.
The sponsoring agency was NIH, and the public listing provided a link to the full announcement on the NIH Grants Guide (http://grants.nih.gov/grants/guide/pa-files/PAR-14-064.html). For technical issues accessing the announcement, the contact listed was the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV).
FAQs - NIH PAR-14-064: Research Using Subjects From Selected Type I Diabetes Clinical Studies (Living Biobank) (DP3)
What is PAR-14-064?
PAR-14-064 was a National Institutes of Health (NIH) funding opportunity announcement titled "Research Using Subjects From Selected Type I Diabetes Clinical Studies (Living Biobank) (DP3)." It supported ancillary (add-on) research projects that used participants from two major, already-established type 1 diabetes clinical research resources: the Type 1 Diabetes TrialNet clinical trials network and the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) cohort.
What does "living biobank" mean in this funding opportunity?
In this context, "living biobank" referred to leveraging existing, well-characterized human participant groups as a resource for new research questions. Instead of creating a new cohort from scratch, investigators could propose new studies anchored in TrialNet or DCCT/EDIC participants to generate additional scientific insights.
Which participant populations could be used for proposed research?
Projects needed to leverage human subjects from either the TrialNet clinical trials network or the DCCT/EDIC cohort. The opportunity also allowed the use of individuals who were screened for TrialNet studies, not only those who were ultimately enrolled.
What kinds of research were encouraged?
The scientific emphasis was on advancing understanding of type 1 diabetes biology rather than testing whether a treatment works in a traditional clinical efficacy framework. Examples of encouraged work included mechanistic studies, immunologic or metabolic profiling, genetic or omics analyses, studies of pathogenic processes, biomarker identification or validation, and research aimed at better understanding type 1 diabetes complications, as long as the work was anchored in TrialNet or DCCT/EDIC participants.
What were the main scientific goals NIH was looking for?
NIH was looking for projects that could produce discoveries about disease mechanisms and pathogenic processes, identify or validate biomarkers that track disease progression or predict clinical responses, and deepen knowledge about complications of type 1 diabetes.
Were clinical trials allowed under this FOA?
The announcement was not intended to fund clinical trials designed to demonstrate clinical efficacy endpoints. It explicitly noted that efficacy trials, including those focused on C-peptide preservation, were out of scope.
If efficacy trials were out of scope, what was the intended role of this program?
The program was designed to add scientific value to existing major studies by enabling additional analyses and ancillary protocols. The focus was on discovery, mechanism, and biomarker-driven aims that take advantage of the depth and longitudinal characterization already present in TrialNet and DCCT/EDIC.
What is the funding agency and mechanism?
The sponsoring agency was the National Institutes of Health (NIH). The opportunity used the grant funding instrument and was described as a discretionary NIH grant opportunity.
What activity area or program classification was associated with this opportunity?
The opportunity was categorized under an activity area aligned with diabetes research and listed under CFDA 93.847, "Diabetes, Digestive, and Kidney Diseases Extramural Research."
How much total funding was estimated for this opportunity?
The estimated total funding amount listed for the opportunity was $4,000,000, indicating NIH expected to support a set of meritorious ancillary projects within that overall funding level.
When was PAR-14-064 posted, and what were the key dates?
The FOA was posted on January 7, 2014. The original closing date and the current closing date were both April 10, 2014. The opportunity was archived on May 11, 2014.
Is this funding opportunity still open?
No. Based on the listed dates, the closing date was April 10, 2014, and the FOA was archived on May 11, 2014.
Who was eligible to apply?
Eligibility was broad and included public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit organizations (including small businesses), and many types of government entities (including state, county, city/township, special district governments, and independent school districts). Tribal organizations and tribal governments were eligible, including federally recognized tribal governments and other tribal entities, along with tribally controlled colleges and universities.
Were U.S. territories or possessions eligible?
Yes. The announcement allowed participation from U.S. territories or possessions.
Could foreign organizations apply?
Yes. The FOA specifically permitted foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) could apply, non-U.S. components of U.S. organizations were eligible, and foreign components as defined by NIH policy were allowed.
Did NIH encourage applications from mission-serving institutions?
Yes. The FOA explicitly recognized and welcomed applications from institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, and other community- or faith-based organizations where appropriate.
What did applicants need to emphasize in their proposals?
Proposals needed to be clearly positioned as ancillary to TrialNet or DCCT/EDIC, demonstrate a strong scientific rationale for using those specific participant populations, and explain how the work would generate new knowledge about type 1 diabetes mechanisms, progression, biomarkers, clinical responses, or complications.
What was a key pitfall applicants needed to avoid?
Applicants needed to avoid framing the project as an efficacy clinical trial. The FOA was intended for discovery and ancillary research rather than trials aimed at clinical efficacy endpoints (including C-peptide preservation efficacy studies).
Where could applicants find the full announcement?
The public listing provided a link to the full announcement on the NIH Grants Guide: http://grants.nih.gov/grants/guide/pa-files/PAR-14-064.html.
Who was the contact for technical issues accessing the announcement?
For technical issues accessing the announcement, the listed contact was the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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| Diabetes Impact Award Closed Loop Technologies Clinical, Physiological and Behavioral Approaches to Improve Type 1 Diabetes Outcomes (DP3) Apply for RFA DK 14 014 Funding Number: RFA DK 14 014 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Diabetes Impact Award Closed Loop Technologies Development and Integration of Novel Components for an Automated Artificial Pancreas System (DP3) Apply for RFA DK 14 015 Funding Number: RFA DK 14 015 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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| Increasing the Quality and Efficiency of Clinical Trials (R18) Apply for RFA FD 14 017 Funding Number: RFA FD 14 017 Agency: Food Drug Administration Category: Food and Nutrition Health Funding Amount: $7,500,000 |
| U.S. India Bilateral Collaborative Research Partnerships (CRP) on Diabetes Research (R21) Apply for RFA DK 14 006 Funding Number: RFA DK 14 006 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $275,000 |
| Polycystic Kidney Disease (PKD) Research and Translation Core Centers (P30) Apply for RFA DK 14 013 Funding Number: RFA DK 14 013 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3) Apply for PAR 14 257 Funding Number: PAR 14 257 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $4,000,000 |
| Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3) Apply for PAR 14 258 Funding Number: PAR 14 258 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $7,000,000 |
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| 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 |
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