Opportunity Information: Apply for PAR 11 349
Apply for PAR 11 349
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Research Using Subjects From The Type 1 Diabetes TrialNet Natural History Study (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 Sep 27, 2011 and posted on Sep 27, 2011.
- Applicants must submit their applications by Jun 7, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Public and State controlled institutions of higher education Small businesses Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Independent school districts City or township governments County governments Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) 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-11-349, titled "Research Using Subjects From The Type 1 Diabetes TrialNet Natural History Study (Living Biobank) (DP3)," supports ancillary research projects that leverage the existing participant base and infrastructure of the Type 1 Diabetes TrialNet clinical trials network. The central idea is to make it easier for investigators to pursue focused, discovery-oriented studies by working with people who are already enrolled in, or have been screened for participation in, TrialNet studies. Because TrialNet follows individuals at risk for type 1 diabetes and those at early stages of disease, the network functions as a kind of "living biobank" where participants, clinical characterization, and in many cases longitudinal follow-up can be used to answer important biological and translational questions.
The scientific scope is geared toward generating new insights into how type 1 diabetes starts and progresses, including underlying disease mechanisms, pathogenic processes, and the identification or refinement of biomarkers. Projects are expected to contribute to understanding disease progression or to reveal markers that predict progression, stratify risk, or reflect clinical responses. In practical terms, this can include studies that analyze immunologic, metabolic, genetic, or other biological signals in TrialNet participants, especially when tied to well-defined clinical phenotypes and timelines that TrialNet is designed to capture. The emphasis is on research that adds value to the TrialNet resource and produces discoveries that can inform future prevention strategies, staging, or therapeutic development, rather than simply collecting data without a clear mechanistic or biomarker-driven question.
A key boundary in this announcement is that it is not meant to fund clinical trials aimed at demonstrating clinical efficacy. Applications proposing efficacy endpoints are considered out of scope, including endpoints such as preservation of C-peptide (a common measure of beta cell function). In other words, the mechanism is intended for ancillary studies that complement or capitalize on the TrialNet platform, not for launching new interventional efficacy trials. The supported work is better understood as hypothesis-driven, mechanistic, and biomarker-focused research that uses TrialNet-accessible participants and associated data/resources, rather than as a pathway to fund full-scale clinical outcome studies.
From a funding and administrative standpoint, this is a discretionary grant opportunity under the NIH, with an activity category listed as Food and Nutrition/Health and a CFDA number of 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). NIH anticipated making about 5 awards, with an estimated total funding amount of $5,000,000. The award ceiling is $300,000, and there is no cost sharing or matching requirement. The announcement was posted on September 27, 2011, with an original and current closing date of June 7, 2012, and an archive date of July 8, 2012.
Eligibility is broad and includes many organization types: public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3) entities), small businesses and other for-profit organizations (other than small businesses), independent school districts, and a wide range of local, county, state, and special district governments. The eligibility language also explicitly includes several institution categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, among others. Importantly, non-U.S. entities are eligible to apply, non-U.S. components of U.S. organizations may apply, and foreign components are allowed consistent with NIH policy.
Overall, PAR-11-349 is best summarized as an NIH effort to accelerate discovery in type 1 diabetes by encouraging researchers to conduct well-justified ancillary studies using TrialNet’s unique cohort of screened and followed individuals. The program’s purpose is to extract additional scientific value from this established network by supporting studies that clarify disease biology and yield biomarkers relevant to progression and response, while drawing a clear line against funding clinical efficacy trials under this specific FOA.
FAQs: NIH PAR-11-349 (DP3) - Research Using Subjects From The Type 1 Diabetes TrialNet Natural History Study (Living Biobank)
What is NIH PAR-11-349 (DP3) in plain terms?
PAR-11-349 is an NIH funding opportunity that supports ancillary, discovery-oriented research that uses participants and infrastructure from the Type 1 Diabetes TrialNet Natural History Study and the broader TrialNet clinical trials network. It is designed to help investigators answer focused biological and translational questions by leveraging people who are already enrolled in, or have been screened for, TrialNet studies.
What does TrialNet mean by a "living biobank"?
In this context, "living biobank" refers to TrialNet's ongoing cohort of individuals who are at risk for type 1 diabetes or at early stages of disease, along with their clinical characterization and, in many cases, longitudinal follow-up. Rather than being only stored specimens, the resource includes real participants with well-defined phenotypes and timelines that can support mechanistic and biomarker discovery studies.
What types of research questions is this FOA meant to support?
The FOA emphasizes hypothesis-driven research that generates new insights into how type 1 diabetes starts and progresses. It is particularly geared toward studies of disease mechanisms, pathogenic processes, and the identification, refinement, or validation of biomarkers tied to disease progression, risk stratification, or clinical response signals.
What kinds of data or signals might be studied under this opportunity?
Based on the description, projects may analyze immunologic, metabolic, genetic, or other biological signals in TrialNet participants, especially when those signals can be interpreted in relation to well-characterized clinical phenotypes and TrialNet-defined timelines.
What is the main value proposition of using TrialNet participants for this work?
The main advantage is that investigators can build studies around an existing, screened, and clinically characterized population (often with follow-up) rather than starting from scratch. The FOA is intended to extract additional scientific value from this established network by accelerating discovery and biomarker development relevant to type 1 diabetes progression and prevention.
Is this funding meant for clinical trials that test whether an intervention works?
No. The FOA draws a clear boundary against funding clinical efficacy trials. Applications proposing efficacy endpoints are considered out of scope.
Are there specific endpoints that are explicitly out of scope?
Yes. The FOA notes that efficacy endpoints such as preservation of C-peptide (commonly used as a measure of beta cell function) are out of scope for this funding opportunity.
If efficacy trials are out of scope, what is in scope instead?
Studies are expected to be ancillary to, and to capitalize on, the TrialNet platform. The intended work is mechanistic and biomarker-focused, aimed at understanding disease biology, identifying markers that predict progression, stratify risk, or reflect clinical responses, and generating discoveries that can inform future prevention strategies, staging, or therapeutic development.
Does the FOA expect projects to be tied to TrialNet clinical phenotypes and timelines?
Yes. The description emphasizes linking biological measurements to well-defined clinical phenotypes and the timelines that TrialNet is designed to capture, which is part of why the TrialNet resource is valuable for progression and biomarker-focused studies.
How many awards did NIH anticipate making under this FOA?
NIH anticipated making about 5 awards.
What was the estimated total funding amount?
The estimated total funding amount was $5,000,000.
What is the award ceiling for individual awards?
The award ceiling is $300,000.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
Which NIH program area or classification is associated with this opportunity?
The activity category is listed as Food and Nutrition/Health, and the CFDA number is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
Who is eligible to apply?
Eligibility is broad. It includes public and private institutions of higher education; nonprofits (both 501(c)(3) and non-501(c)(3)); small businesses; other for-profit organizations (other than small businesses); independent school districts; and many government entities including local, county, state, and special district governments.
Are minority-serving institutions and community-based organizations included in the eligibility language?
Yes. The eligibility language explicitly includes institution categories such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations, among others.
Can non-U.S. organizations apply?
Yes. Non-U.S. entities are eligible to apply, non-U.S. components of U.S. organizations may apply, and foreign components are allowed consistent with NIH policy.
What were the key dates for this FOA?
The announcement was posted on September 27, 2011. The original and current closing date was June 7, 2012. The archive date was July 8, 2012.
Is this opportunity still open?
No. Based on the provided dates, the closing date was June 7, 2012 and the opportunity was archived on July 8, 2012.
What does "ancillary research" mean in the context of this FOA?
Here, ancillary research means studies that complement, extend, or take advantage of the existing TrialNet participant base and infrastructure to answer additional mechanistic or biomarker questions, rather than initiating a new clinical efficacy trial intended to demonstrate clinical benefit.
What kind of outcomes are projects expected to deliver?
Projects are expected to contribute to understanding type 1 diabetes initiation and progression and/or to identify or refine biomarkers that predict progression, stratify risk, or reflect clinical response signals. The FOA emphasizes adding value to the TrialNet resource and producing discoveries that can inform future prevention strategies, staging approaches, or therapeutic development.
How should applicants think about "adding value" to TrialNet?
The FOA frames value as generating clear mechanistic insights or biomarker advances using TrialNet-accessible participants and associated data/resources. It discourages proposals that primarily collect data without a clear mechanistic or biomarker-driven research question.
What is the overall goal of PAR-11-349?
The overall goal is to accelerate discovery in type 1 diabetes by encouraging well-justified ancillary studies that use TrialNet's unique cohort of screened and followed individuals, while explicitly excluding clinical efficacy trials from this specific funding mechanism.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 11 349) also looked into and applied for these:
| Funding Opportunity |
|---|
| Research Using Biosamples From Selected Type 1 Diabetes Clinical Studies (DP3) Apply for PAR 11 350 Funding Number: PAR 11 350 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21) Apply for PAR 11 352 Funding Number: PAR 11 352 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Function of Type 1 Diabetes Genes (DP3) Apply for RFA DK 11 019 Funding Number: RFA DK 11 019 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Causes and Consequences of Cystic Fibrosis Related Diabetes (R01) Apply for RFA DK 11 025 Funding Number: RFA DK 11 025 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Professional Society Programs to Promote Diversity (R25) Apply for RFA DK 11 014 Funding Number: RFA DK 11 014 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $140,000 |
| NIDDK Interconnectivity Network Coordinating Unit (U24) Apply for RFA DK 11 030 Funding Number: RFA DK 11 030 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $400,000 |
| Type 1 Diabetes Mouse Resource (UC4) Apply for RFA DK 11 031 Funding Number: RFA DK 11 031 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $300,000 |
| Career Development Programs in Diabetes Research for Behavioral Scientists (K12) Apply for RFA DK 11 028 Funding Number: RFA DK 11 028 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Improving Adherence in Pre teens, Adolescents and Young Adults with Type 1 Diabetes (DP3) Apply for RFA DK 11 029 Funding Number: RFA DK 11 029 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $400,000 |
| Targeted Analyses of Jackson Heart Study Data (R01) Apply for RFA HL 13 007 Funding Number: RFA HL 13 007 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Bioengineering Interdisciplinary Training and Education for Type I Diabetes Research (T90/R90) Apply for RFA DK 11 023 Funding Number: RFA DK 11 023 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| NIDDK Mentored Research Scientist Development Award (K01) Apply for PAR 12 020 Funding Number: PAR 12 020 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| NIDDK Education Program Grants (R25) Apply for PAR 12 047 Funding Number: PAR 12 047 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $100,000 |
| Prevention and Treatment of Obesity, Diabetes, and Chronic Kidney Disease in Military Populations (R01) Apply for PAR 12 048 Funding Number: PAR 12 048 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01) Apply for RFA DK 11 026 Funding Number: RFA DK 11 026 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| Planning Centers for Interdisciplinary Research in Benign Urology (IR BU) (P20) Apply for RFA DK 12 003 Funding Number: RFA DK 12 003 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Limited Competition for the Data Coordinating Center for Type 1 Diabetes TrialNet (UC4) Apply for RFA DK 12 503 Funding Number: RFA DK 12 503 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition Continuation of the Clinical Islet Transplantation (CIT) Consortium Data Coordinating Center (U01) Apply for RFA DK 12 501 Funding Number: RFA DK 12 501 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Nutrition Obesity Research Centers (P30) Apply for RFA DK 12 004 Funding Number: RFA DK 12 004 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| NIDDK Inflammatory Bowel Disease Genetics Consortium (IBDGC) Genetic Research Centers (GRCs) (U01) Apply for RFA DK 11 032 Funding Number: RFA DK 11 032 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
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