Opportunity Information: Apply for RFA DK 14 027

  • 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 Clinical Centers (CSCPDPC CCs) (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 $270,000.00 in funding.
  • Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments County governments Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) State governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Public and State controlled institutions of higher education City or township 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:

The National Institutes of Health (NIH) funding opportunity RFA-DK-14-027 supports the creation of a multi-site clinical research consortium focused on chronic pancreatitis (CP), pancreatogenic (type 3c) diabetes (T3cDM), and pancreatic cancer risk, using a U01 cooperative agreement mechanism. The overall aim is to build a coordinated network that can systematically study how chronic pancreatitis develops over time, why some patients progress to major complications like chronic pain and pancreatic insufficiency, how CP relates to T3cDM, and how diabetes and pancreatic cancer are connected, especially in people with newly diagnosed diabetes. The consortium structure is designed to bring together clinical care, epidemiology, and biological sample analysis at a scale that single institutions typically cannot achieve on their own.

This FOA specifically solicits applications for up to nine Clinical Centers (CCs). In parallel, NIH also solicits a separate but linked application for a single Coordination and Data Management Center (CDMC) under a different announcement (RFA-DK-14-028). The expectation is that the CCs will recruit and deeply characterize patients across key groups, including children and adults with chronic pancreatitis and those with acute recurrent pancreatitis (ARP), along with patients who have T3cDM or are newly diagnosed with diabetes. The clinical centers are meant to serve as the patient-facing engines of the consortium, enrolling participants, collecting standardized clinical and epidemiologic data, and contributing biospecimens and follow-up information needed to understand disease progression and cancer risk.

A central scientific emphasis is comprehensive characterization, meaning the consortium is expected to collect harmonized, high-quality information spanning clinical history, imaging and diagnostic findings, risk factors, outcomes, and biological measurements. By combining these data across multiple sites, the consortium can identify patterns and subtypes of disease, explore mechanisms that drive CP and its sequelae, and evaluate factors that may signal elevated risk for pancreatic cancer. In addition to studying CP-related cancer risk, the consortium is also tasked with investigating pancreatic cancer development among people with newly diagnosed diabetes, reflecting growing interest in diabetes as a potential early indicator or risk state for pancreatic cancer in certain patients.

Collaboration is built into the program design rather than treated as optional. Clinical centers are expected to form multidisciplinary teams and to work across the consortium, sharing results and developing trans-consortium projects that leverage the combined expertise, patient populations, and technical capabilities distributed across sites. Because the awards are cooperative agreements (U01), the program is intended to involve substantial NIH scientific and programmatic involvement, with coordinated decision-making and shared infrastructure rather than fully independent, investigator-initiated projects.

A major shared deliverable is the creation of an annotated biospecimen repository to support biomarker discovery and validation. The FOA highlights collection of blood, pancreatic and duodenal juice, stool samples, and, when feasible, pancreatic tissue. The intent is to link these biospecimens to well-annotated clinical data so researchers can identify and validate biomarkers useful for risk stratification and/or early detection, particularly for pancreatic cancer in high-risk settings such as chronic pancreatitis, T3cDM, and new-onset diabetes. This repository approach supports both near-term studies within the consortium and longer-term research value, since carefully collected and curated samples can be used to test emerging hypotheses and technologies over time.

From an administrative standpoint, the opportunity falls under NIH discretionary funding and uses the cooperative agreement funding instrument. The program was posted October 17, 2014, with an original and current closing date of April 2, 2015, and an archive date of May 3, 2015. The estimated total funding amount listed is $6,000,000, and the award ceiling is $270,000 (as provided in the source data). No cost sharing or matching is required.

Eligibility is broad and includes many common NIH applicant types, such as nonprofit organizations (including 501(c)(3) entities), public and private institutions of higher education, small businesses, for-profit organizations other than small businesses, and a range of government entities (state, county, city/township, special district). The announcement also notes eligibility considerations for certain institution types such as HBCUs, Hispanic-serving institutions, tribal colleges and universities, and Alaska Native and Native Hawaiian-serving institutions, among others. Non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply directly, but non-domestic components of U.S. organizations may participate, and foreign components (as defined by NIH policy) are allowable.

In practical terms, an applicant Clinical Center would be proposing to serve as one node in a national network: recruiting and following well-defined patient groups, collecting standardized clinical data and biospecimens, contributing to shared protocols and governance, and participating in cross-site analyses aimed at clarifying disease mechanisms and improving early detection and risk prediction for pancreatic cancer in the settings of chronic pancreatitis and diabetes. The full announcement is linked in the provided record at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-14-027.html.

Frequently Asked Questions (FAQs) - NIH RFA-DK-14-027 (Clinical Centers)

What is RFA-DK-14-027?

RFA-DK-14-027 is a National Institutes of Health (NIH) funding opportunity announcement that supports the creation of a multi-site clinical research consortium focused on chronic pancreatitis (CP), pancreatogenic (type 3c) diabetes (T3cDM), and pancreatic cancer risk. The awards are made using a U01 cooperative agreement mechanism.

What is the overall goal of the consortium supported by this FOA?

The goal is to build a coordinated, multi-site network that can systematically study how chronic pancreatitis develops and progresses over time, why some patients develop major complications (such as chronic pain and pancreatic insufficiency), how CP relates to T3cDM, and how diabetes and pancreatic cancer are connected. A specific emphasis includes understanding pancreatic cancer development among people with newly diagnosed diabetes.

What type of award mechanism is used (and what does that imply)?

This FOA uses the U01 cooperative agreement mechanism. Based on the provided description, that implies substantial NIH scientific and programmatic involvement, coordinated decision-making, and shared infrastructure across the consortium rather than fully independent, investigator-initiated projects.

Is this FOA for Clinical Centers or for a data coordinating center?

This FOA specifically solicits applications for up to nine Clinical Centers (CCs). A separate, linked announcement solicits a single Coordination and Data Management Center (CDMC) under RFA-DK-14-028.

How many Clinical Centers are expected to be funded?

The FOA solicits applications for up to nine Clinical Centers.

What is the Coordination and Data Management Center (CDMC), and where is it announced?

The consortium includes a single Coordination and Data Management Center that is solicited under a separate but linked NIH announcement: RFA-DK-14-028.

What patient groups are Clinical Centers expected to recruit and study?

Clinical Centers are expected to recruit and deeply characterize key groups, including children and adults with chronic pancreatitis (CP), individuals with acute recurrent pancreatitis (ARP), patients with pancreatogenic (type 3c) diabetes (T3cDM), and patients who are newly diagnosed with diabetes.

What are the primary responsibilities of a funded Clinical Center?

Based on the information provided, Clinical Centers serve as the patient-facing engines of the consortium. Core responsibilities include enrolling participants, collecting standardized clinical and epidemiologic data, contributing biospecimens, providing follow-up information to understand disease progression and cancer risk, and participating in shared protocols, governance, and cross-site analyses.

What does "comprehensive characterization" mean in this FOA?

The FOA emphasizes collecting harmonized, high-quality information spanning clinical history, imaging and diagnostic findings, risk factors, outcomes, and biological measurements. The intent is to combine data across multiple sites to identify patterns and subtypes, explore mechanisms of disease and complications, and evaluate factors related to pancreatic cancer risk.

How does pancreatic cancer risk fit into the research scope?

The consortium is designed to study pancreatic cancer risk in the context of chronic pancreatitis and related conditions, and it is also tasked with investigating pancreatic cancer development among people with newly diagnosed diabetes. This reflects interest in diabetes as a potential early indicator or risk state for pancreatic cancer in certain patients.

What kinds of biospecimens are expected to be collected?

The FOA highlights collection of blood, pancreatic and duodenal juice, stool samples, and, when feasible, pancreatic tissue. These samples are intended to be linked to well-annotated clinical data.

What is the purpose of the biospecimen repository?

A major shared deliverable is an annotated biospecimen repository to support biomarker discovery and validation, including biomarkers for risk stratification and/or early detection of pancreatic cancer in settings such as chronic pancreatitis, T3cDM, and new-onset diabetes. The repository is also intended to have longer-term research value through careful collection and curation.

Is collaboration optional, or is it required?

Collaboration is built into the program design. Clinical Centers are expected to work across the consortium, share results, and develop trans-consortium projects that leverage combined expertise, patient populations, and technical capabilities across sites.

What kinds of disciplines or expertise are expected at a Clinical Center?

The FOA expects Clinical Centers to form multidisciplinary teams and integrate clinical care, epidemiology, and biological sample analysis as part of a coordinated consortium approach.

What is the total estimated funding amount for this opportunity?

The estimated total funding amount listed for the opportunity is $6,000,000.

What is the award ceiling listed in the source data?

The award ceiling is listed as $270,000 in the provided source data.

Is cost sharing or matching required?

No cost sharing or matching is required.

What are the key dates for this FOA?

The opportunity was posted on October 17, 2014. The original and current closing date is April 2, 2015. The archive date is May 3, 2015.

What types of organizations are eligible to apply?

Eligibility is broad and includes nonprofit organizations (including 501(c)(3) entities), public and private institutions of higher education, small businesses, for-profit organizations other than small businesses, and government entities such as state, county, city/township, and special district governments. The announcement also notes eligibility considerations for institution types including HBCUs, Hispanic-serving institutions, tribal colleges and universities, and Alaska Native and Native Hawaiian-serving institutions, among others.

Are non-U.S. (foreign) organizations eligible to apply directly?

Non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply directly based on the provided information.

Can foreign components participate in a project under this FOA?

Yes. Non-domestic components of U.S. organizations may participate, and foreign components (as defined by NIH policy) are allowable, according to the provided information.

Where can applicants find the full FOA text?

The full announcement is linked at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-14-027.html.

In practical terms, what would a funded Clinical Center be proposing to do?

A funded Clinical Center would propose to function as one node in a national network by recruiting and following well-defined patient groups, collecting standardized clinical data and biospecimens, contributing to shared protocols and consortium governance, and participating in cross-site analyses aimed at clarifying disease mechanisms and improving early detection and risk prediction for pancreatic cancer in the settings of chronic pancreatitis and diabetes.

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