Opportunity Information: Apply for RFA DK 14 028
Apply for RFA DK 14 028
- The National Institutes of Health in the education food and nutrition health sector is offering a public funding opportunity titled "Consortium for the Study of Chronic Pancreatitis, Diabetes and Pancreatic Cancer Coordination and Data Management Center (CSCPDPC CDMC) (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.399 Cancer Control 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Oct 17, 2014 and posted on Oct 17, 2014.
- Applicants must submit their applications by Apr 2, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $6,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education County governments Special district governments Public and State controlled institutions of higher education Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses City or township governments Small businesses State governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal 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 not 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:
This NIH funding opportunity (RFA-DK-14-028) supports the creation of a national clinical research consortium focused on chronic pancreatitis and its links to pancreatogenic (type 3c) diabetes and pancreatic cancer. The award mechanism is a U01 cooperative agreement, which means the NIH expects an active partnership with the awardees rather than a hands-off grant. The consortium structure is intentionally centralized: it will include one Coordination and Data Management Center (CDMC) working together with up to nine separately funded Clinical Centers (which are competed under a companion FOA, RFA-DK-14-027). The overall goal is to make large, coordinated human studies possible by standardizing how patients are characterized, how data are captured and analyzed, and how biospecimens are collected and shared across sites.
Scientifically, the consortium is designed to study chronic pancreatitis (CP) across its course and complications, including patients with acute recurrent pancreatitis (ARP) as part of the CP spectrum. The research emphasis is broad and integrative: clinical, epidemiological, and biological characterization of children and adults with CP, and targeted investigation of factors that increase pancreatic cancer risk in several key patient groups. Those groups include patients with CP, patients with pancreatogenic/type 3c diabetes (T3cDM, diabetes resulting from pancreatic disease), and patients with newly diagnosed diabetes, since new-onset diabetes can sometimes be an early sign or risk state for pancreatic cancer. By looking across these overlapping conditions, the consortium aims to clarify disease mechanisms (pathophysiology) and clinically important outcomes such as chronic pain, exocrine pancreatic insufficiency, development of T3cDM, and the broader diabetes-pancreatic cancer association. In parallel, the consortium will also conduct studies specifically aimed at understanding pancreatic cancer development in people with newly diagnosed diabetes, supporting the longer-term objective of improving risk stratification and early detection.
The CDMC is the operational backbone of the consortium and is central to what this FOA is buying. Its role goes beyond basic coordination: it is expected to provide the administrative leadership, build and manage the consortium data systems, develop and enforce common data elements and quality control procedures, coordinate study operations across sites, and perform or oversee data management and statistical analyses. In practice, the CDMC is responsible for enabling the conduct of ongoing and future multi-center studies from the Clinical Centers, which implies maintaining adaptable infrastructure that can support multiple protocols over time, not just a single fixed study. Because this is a cooperative agreement, the CDMC is also expected to function as a true coordinating hub for multidisciplinary teams that span the Clinical Centers, keeping recruitment, phenotyping, follow-up, and data harmonization aligned across the network.
A major consortium-wide deliverable is the creation of an annotated biospecimen repository designed for biomarker discovery and validation. The FOA highlights collection and banking of blood, pancreatic juice and duodenal juice, stool samples, and when feasible pancreatic tissue. The emphasis on annotation matters: specimens are intended to be linked to high-quality clinical and epidemiologic data so they can be used for rigorous biomarker work, including identifying markers that predict pancreatic cancer risk, distinguish subtypes of pancreatitis and diabetes, or enable earlier detection of malignancy. By organizing biospecimen collection across multiple sites with consistent protocols, the consortium is meant to generate sufficiently large and well-characterized sample sets to support validation, not just exploratory findings.
From an applicant and administrative standpoint, the opportunity is categorized as discretionary funding through NIH, with no cost sharing or matching requirement. The total estimated funding amount listed is $6,000,000, with an award ceiling of $1,000,000. The FOA was posted on October 17, 2014, with an application due date of April 2, 2015 (archived May 3, 2015). Eligibility is broad and includes many types of domestic organizations such as public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses, with some limitations), and various government entities (state, county, city/township, special districts), as well as tribal governments and tribally controlled colleges and universities. While non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply as the primary applicant, foreign components as defined by NIH policy are allowed, and non-domestic components of U.S. organizations may participate.
In plain terms, this FOA is about building the centralized infrastructure that makes a multi-site pancreatitis-diabetes-pancreatic cancer research network function: the CDMC runs the operations, data backbone, and analytics, and it helps create a shared biospecimen resource. The expectation is that, by combining standardized clinical characterization with linked biospecimens across many sites, the consortium will be positioned to answer higher-confidence questions about disease progression and cancer risk than any single center could manage on its own.
Frequently Asked Questions (FAQs)
What is the NIH funding opportunity RFA-DK-14-028 about?
RFA-DK-14-028 supports the creation of a national clinical research consortium focused on chronic pancreatitis and its links to pancreatogenic (type 3c) diabetes and pancreatic cancer. The specific award funded under this FOA is the Coordination and Data Management Center (CDMC), which serves as the centralized operational and data backbone for the consortium.
What type of award mechanism is used?
This opportunity uses a U01 cooperative agreement. Under a cooperative agreement, NIH expects an active partnership with awardees rather than a hands-off relationship.
What is being funded under this FOA versus the companion FOA?
RFA-DK-14-028 funds one Coordination and Data Management Center (CDMC). Up to nine separately funded Clinical Centers are competed under a companion funding opportunity announcement (RFA-DK-14-027).
How is the consortium structured?
The consortium is intentionally centralized. It includes one CDMC working together with up to nine Clinical Centers. The CDMC coordinates and supports multi-center clinical research by standardizing patient characterization, data capture and analysis, and biospecimen collection and sharing across sites.
What is the overall goal of creating this consortium?
The goal is to make large, coordinated human studies possible by creating shared infrastructure and standardization across multiple sites. This includes harmonized clinical and epidemiological characterization, consistent data systems and quality control, and coordinated biospecimen collection linked to high-quality annotation.
What diseases and patient populations are within the scientific scope?
The consortium is designed to study chronic pancreatitis (CP) across its course and complications, including patients with acute recurrent pancreatitis (ARP) as part of the CP spectrum. It also targets investigation of factors that increase pancreatic cancer risk in key patient groups, including patients with CP, patients with pancreatogenic/type 3c diabetes (T3cDM), and patients with newly diagnosed diabetes.
Why are patients with newly diagnosed diabetes included?
The FOA notes that new-onset (newly diagnosed) diabetes can sometimes be an early sign or risk state for pancreatic cancer. The consortium includes studies aimed at understanding pancreatic cancer development in people with newly diagnosed diabetes to support longer-term goals in risk stratification and early detection.
What kinds of research approaches does the consortium emphasize?
The research emphasis is broad and integrative, including clinical, epidemiological, and biological characterization of children and adults with chronic pancreatitis, along with targeted investigations of pancreatic cancer risk across overlapping conditions such as CP and diabetes related to pancreatic disease.
What outcomes and complications are highlighted as important to study?
The FOA highlights clinically important outcomes such as chronic pain, exocrine pancreatic insufficiency, development of pancreatogenic/type 3c diabetes (T3cDM), and the broader diabetes-pancreatic cancer association.
What is the CDMC, and why is it central to this opportunity?
The Coordination and Data Management Center (CDMC) is the operational backbone of the consortium and is the primary focus of this FOA. Its role extends beyond basic coordination to include administrative leadership, building and managing consortium data systems, developing and enforcing common data elements and quality control procedures, coordinating study operations across sites, and performing or overseeing data management and statistical analyses.
What does it mean that the CDMC must support "ongoing and future" multi-center studies?
It means the CDMC is expected to maintain adaptable infrastructure capable of supporting multiple protocols over time, not just one fixed study. The CDMC enables the conduct of ongoing and future multi-center studies originating from the Clinical Centers.
What standardization activities are expected across sites?
The consortium aims to standardize how patients are characterized (phenotyping), how data are captured and analyzed, and how biospecimens are collected and shared. The CDMC is expected to develop and enforce common data elements and quality control procedures to keep data harmonized across the network.
What types of biospecimens are planned for the repository?
The FOA highlights collection and banking of blood, pancreatic juice and duodenal juice, stool samples, and, when feasible, pancreatic tissue.
What is meant by an "annotated" biospecimen repository?
Annotation means biospecimens are intended to be linked to high-quality clinical and epidemiologic data. This linkage is emphasized so specimens can be used for rigorous biomarker discovery and validation, including markers related to pancreatic cancer risk, pancreatitis and diabetes subtypes, or earlier detection of malignancy.
How does the multi-site structure help biomarker discovery and validation?
By organizing biospecimen collection across multiple sites with consistent protocols and linking specimens to standardized, high-quality data, the consortium is intended to produce sufficiently large and well-characterized sample sets to support validation, not only exploratory biomarker findings.
Is cost sharing or matching required?
No. The opportunity is described as discretionary NIH funding with no cost sharing or matching requirement.
What is the total estimated funding and the award ceiling?
The total estimated funding amount listed is $6,000,000, with an award ceiling of $1,000,000.
When was the FOA posted, and what were the key dates?
The FOA was posted on October 17, 2014. The application due date was April 2, 2015, and the opportunity was archived on May 3, 2015.
What types of organizations are eligible to apply?
Eligibility is broad and includes many types of domestic organizations, including public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses, with some limitations), and various U.S. government entities (state, county, city/township, special districts), as well as tribal governments and tribally controlled colleges and universities.
Are foreign organizations eligible to apply as the primary applicant?
No. Non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply as the primary applicant under this FOA.
Are any foreign activities allowed at all?
Yes. Foreign components, as defined by NIH policy, are allowed. In addition, non-domestic components of U.S. organizations may participate.
What does "cooperative agreement" imply for how NIH will interact with the awardee?
Because this is a U01 cooperative agreement, NIH expects an active partnership with the awardees. For the CDMC, this aligns with functioning as a true coordinating hub for multidisciplinary teams spanning the Clinical Centers and keeping recruitment, phenotyping, follow-up, and data harmonization aligned across the network.
In plain terms, what is this FOA really funding?
This FOA funds the centralized infrastructure needed to make a multi-site pancreatitis-diabetes-pancreatic cancer research network function. The CDMC runs the operations, builds and manages the data backbone and analytics, coordinates work across Clinical Centers, and helps create a shared, annotated biospecimen resource.
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