Opportunity Information: Apply for PAR 13 028
Apply for PAR 13 028
- 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 Nov 27, 2012 and posted on Nov 27, 2012.
- Applicants must submit their applications by Apr 2, 2013. (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.
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities County governments Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Independent school districts Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education For profit organizations other than small businesses Special district governments.
- 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 NIH funding opportunity PAR 13-028, titled "Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)," supports ancillary research projects that leverage existing, well-characterized participant groups from major type 1 diabetes clinical research efforts. The central idea is to treat these cohorts as a kind of "living biobank," meaning investigators can build new, add-on studies around people who have already been enrolled in (or, in some cases, screened for participation in) the Type 1 Diabetes TrialNet clinical trials network, or who are part of the long-running Diabetes Control and Complications Trial and its follow-up study, Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC). Rather than starting from scratch with recruitment and baseline characterization, applicants are expected to take advantage of the deep clinical histories, established follow-up, and infrastructure already in place within these cohorts.
The purpose of the program is to generate new scientific insights into type 1 diabetes by conducting focused, hypothesis-driven ancillary studies that can illuminate disease mechanisms, pathogenic processes, and biomarkers. This includes work aimed at understanding how and why type 1 diabetes develops and progresses, identifying measurable indicators that track disease progression or predict clinical responses, and improving understanding of type 1 diabetes complications. In practice, this could mean studies that analyze immune signatures, genetic or environmental contributors, metabolic trajectories, or markers associated with microvascular or macrovascular complications, so long as the work is grounded in the participants and data resources connected to TrialNet or DCCT/EDIC.
A key boundary of this FOA is that it is not meant to fund new clinical efficacy trials. Projects that are essentially intervention studies designed to prove clinical benefit using traditional efficacy endpoints are outside the intent of the announcement. The FOA explicitly notes that it is not intended to support clinical trials with endpoints for clinical efficacy, including but not limited to C-peptide preservation. In other words, the emphasis is on discovery science and biomarker or mechanistic research conducted as ancillary work within these existing cohorts, not on launching a new therapeutic trial to demonstrate that an intervention works.
From an administrative standpoint, this is a discretionary NIH grant opportunity using the DP3 activity mechanism, with an estimated total funding level of about $7,000,000 for the announcement. There is no cost sharing or matching requirement stated. The opportunity was posted on November 27, 2012, with an original closing date of April 3, 2013 and a current closing date listed as April 2, 2013, and it was archived May 3, 2013. The program is associated with the NIH and is listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), reflecting its connection to NIH-supported diabetes research infrastructure.
Eligibility is broad and includes many types of domestic U.S. organizations, such as public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), small businesses, for-profit organizations (other than small businesses), and various governmental entities (state, county, city/township, special district, and certain housing authorities). The FOA also allows applications from tribal governments and tribal organizations, as well as a range of mission-specific institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities. Importantly, foreign organizations and foreign institutions are eligible to apply, non-U.S. components of U.S. organizations may apply, and foreign components are allowed as defined by NIH policy, which signals that NIH anticipated international scientific participation where appropriate and justified.
Overall, this grant opportunity is designed for investigators who have strong scientific questions that can be answered efficiently and convincingly by working with participants already embedded in TrialNet or DCCT/EDIC. The value proposition is access to richly phenotyped individuals, established follow-up frameworks, and a research setting where ancillary measurements and analyses can meaningfully advance understanding of type 1 diabetes biology, progression, response patterns, and complications, without turning the project into a stand-alone clinical efficacy trial.
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity PAR-13-028?
PAR-13-028 is an NIH funding opportunity titled "Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3)." It supports ancillary, hypothesis-driven research projects that use existing participants from major type 1 diabetes clinical research cohorts rather than recruiting and characterizing a brand-new study population.
What does "living biobank" mean in this program?
In this FOA, "living biobank" refers to well-characterized groups of people who are already enrolled in, or in some cases screened for participation in, specific type 1 diabetes clinical studies. Investigators can build add-on (ancillary) studies around these participants, leveraging their deep clinical histories, established follow-up, and existing research infrastructure.
Which participant cohorts are specifically referenced as eligible sources for ancillary studies?
The FOA is centered on participants and resources connected to (1) the Type 1 Diabetes TrialNet clinical trials network and (2) the Diabetes Control and Complications Trial and its follow-up study, Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC).
What is the main purpose of this funding opportunity?
The program aims to generate new scientific insights into type 1 diabetes by supporting focused, hypothesis-driven ancillary studies. The emphasis is on illuminating disease mechanisms, pathogenic processes, and biomarkers, including better understanding of disease development, progression, and complications.
What types of scientific questions or topics fit the intent of the FOA?
Projects should be anchored in the TrialNet or DCCT/EDIC participants and data resources and may include mechanistic or biomarker-oriented work such as immune signatures, genetic or environmental contributors, metabolic trajectories, or markers associated with microvascular or macrovascular complications, provided the study is hypothesis-driven and aligned with the program's discovery focus.
Is this FOA intended to fund new clinical efficacy trials?
No. A key boundary is that the FOA is not meant to fund new clinical trials designed to demonstrate clinical efficacy using traditional efficacy endpoints.
Are intervention studies allowed under this FOA?
The FOA states it is not intended to support clinical trials with endpoints for clinical efficacy. Projects that are essentially intervention studies to prove clinical benefit using traditional efficacy endpoints are considered outside the intent of the announcement.
Does the FOA specifically mention any endpoints that are out of scope?
Yes. The FOA explicitly notes it is not intended to support clinical trials with endpoints for clinical efficacy, including but not limited to C-peptide preservation.
What makes these cohorts valuable for ancillary research?
The value proposition is that these participant groups are already richly phenotyped, have deep clinical histories, and often have established follow-up and infrastructure. This allows applicants to avoid starting from scratch with recruitment and baseline characterization and instead conduct efficient ancillary studies that can add new measurements or analyses.
What NIH activity mechanism is used for this opportunity?
This opportunity uses the DP3 activity mechanism.
What is the estimated total funding level for the announcement?
The estimated total funding level is about $7,000,000 for the announcement.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated in the information provided.
What is the CFDA number associated with this program?
The program is listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
When was the opportunity posted and what are the relevant dates mentioned?
The opportunity was posted on November 27, 2012. It lists an original closing date of April 3, 2013 and a current closing date of April 2, 2013. It was archived on May 3, 2013.
Who is eligible to apply (in general terms)?
Eligibility is broad and includes many types of domestic U.S. organizations (e.g., institutions of higher education, nonprofits, small businesses, for-profit organizations, and governmental entities). The FOA also includes a range of mission-specific institution types and includes tribal governments and tribal organizations.
Are foreign organizations or foreign institutions eligible to apply?
Yes. Foreign organizations and foreign institutions are eligible to apply. The FOA also allows non-U.S. components of U.S. organizations to apply, and foreign components are allowed as defined by NIH policy.
What kinds of U.S. governmental entities are mentioned as eligible?
The information provided lists various governmental entities, including state, county, city/township, special district, and certain housing authorities.
Are specific types of minority-serving or mission-specific institutions included in eligibility?
Yes. The FOA allows applications from a range of mission-specific institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian serving institutions, and tribally controlled colleges and universities.
What kind of project is this FOA designed for?
It is designed for investigators with strong scientific questions that can be answered by working with participants already embedded in TrialNet or DCCT/EDIC, using those existing cohorts and infrastructure to conduct ancillary research that advances understanding of type 1 diabetes biology, progression, response patterns, and complications.
What is the core expectation about how applicants will use the cohorts?
Applicants are expected to leverage the existing depth of clinical history, baseline characterization, ongoing follow-up, and infrastructure already in place within TrialNet or DCCT/EDIC, rather than building a de novo cohort.
How does this FOA distinguish discovery-oriented research from efficacy-focused clinical trials?
Discovery-oriented research under this FOA is framed as focused, hypothesis-driven ancillary work aimed at mechanisms and biomarkers. In contrast, clinical efficacy trials (including those using endpoints like C-peptide preservation) are explicitly described as outside the program's intent.
What NIH institute area does the CFDA listing suggest this opportunity aligns with?
Based on CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), the opportunity aligns with NIH-supported extramural research infrastructure in diabetes and related areas.
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| Technological Improvements to Data Collection in NIDDK Kidney and Urology Clinical Studies (SBIR) (R43/R44) Apply for PA 13 052 Funding Number: PA 13 052 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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| Continuation of the Clinical Centers for the Drug Induced Liver Injury Network DILIN (U01) Apply for RFA DK 13 003 Funding Number: RFA DK 13 003 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
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