Opportunity Information: Apply for PAR 21 334

This opportunity, titled "Pancreatic Cancer Detection Consortium: Research Units (U01 Clinical Trial Optional)" (PAR-21-334), is a National Institutes of Health funding announcement that uses a cooperative agreement mechanism (U01). Its core goal is to fund Research Units (RUs) within the Pancreatic Cancer Detection Consortium (PCDC) to advance the early detection of pancreatic ductal adenocarcinoma (PDAC) and to better understand and characterize PDAC precursor lesions. A major emphasis is identifying which individuals are most likely to progress to cancer, especially people already considered high risk due to inherited genetic factors or the presence of precursor conditions such as pancreatic cystic lesions. The work aligns with research priorities laid out in the National Cancer Institute's 2014 Scientific Framework for PDAC and is geared toward enabling earlier intervention, when treatment has a better chance of improving outcomes.

The funded Research Units are expected to be multidisciplinary teams that can tackle biomarker and screening problems from multiple angles. The FOA highlights several example activities: discovering and testing biomarkers that can be measured in bodily fluids (for example, blood-based, urine-based, or other minimally invasive sample types) for early PDAC detection and/or detection of precursor lesions; determining which pancreatic cysts are most likely to progress to malignancy; developing molecular and/or imaging approaches to screen populations at elevated PDAC risk; applying machine learning and other computational approaches to help discover, refine, or validate biomarkers; and conducting biomarker validation studies. A key practical deliverable is the collection of longitudinal biospecimens, meaning repeated samples over time from participants, to help build a biorepository that can support both current consortium projects and future discovery and validation efforts.

Collaboration is built into the structure of the program. Each Research Unit is expected to participate actively in consortium-wide activities, share ideas, and contribute biospecimens and data so that findings can be compared, harmonized, and validated across sites rather than remaining isolated within one institution. The PCDC is organized around two scientific components: these Research Units, and a separate Management and Data Coordination Unit (MDCU). While applicants to this FOA are for the Research Units, the announcement clarifies that the MDCU will provide cross-consortium infrastructure support such as study design input, protocol development support, statistical analysis, coordination across projects, harmonization of methods, and data management and stewardship for collaborative efforts, including the biorepository-building work.

From an administrative standpoint, this is a discretionary federal funding opportunity in the health and education activity area (CFDA 93.394). The agency is the National Institutes of Health. The listed award ceiling is $600,000. The original closing date shown in the source information is 2024-06-11, and the FOA creation date is 2021-09-16. The funding instrument is explicitly cooperative, which typically means NIH staff will have substantial programmatic involvement compared with a standard research project grant, reflecting the consortium and coordination-heavy nature of the work.

Eligibility is broad across many U.S.-based organization types. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also calls out other eligible applicant categories such as Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, though foreign components (as defined by NIH policy) are allowed, which can matter for collaborations, specialized assays, or access to particular cohorts or expertise.

Overall, the opportunity is designed to push the field toward practical, validated ways to detect PDAC earlier and to sort high-risk precursor states from lower-risk ones, using integrated biomarker science, imaging, advanced computation, and coordinated multi-site validation. The consortium model, with required sharing of specimens and data and centralized coordination through the MDCU, is intended to speed progress and improve reproducibility by ensuring that promising signals can be tested and confirmed across multiple settings rather than relying on single-site results.

  • The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Pancreatic Cancer Detection Consortium: Research Units (U01 Clinical Trial Optional)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
  • This funding opportunity was created on 2021-09-16.
  • Applicants must submit their applications by 2024-06-11. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Each selected applicant is eligible to receive up to $600,000.00 in funding.
  • Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
Apply for PAR 21 334

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Frequently Asked Questions (FAQs)

What is the name of this funding opportunity?

The opportunity is titled "Pancreatic Cancer Detection Consortium: Research Units (U01 Clinical Trial Optional)" and is identified as PAR-21-334.

Which federal agency is offering this opportunity?

The funding announcement is offered by the National Institutes of Health (NIH).

What funding mechanism does this announcement use?

This opportunity uses a cooperative agreement mechanism (U01). In cooperative agreements, NIH staff typically have substantial programmatic involvement compared with standard research project grants, reflecting the coordination and consortium-driven nature of the work.

What is being funded through this FOA?

The FOA funds Research Units (RUs) within the Pancreatic Cancer Detection Consortium (PCDC). These Research Units are expected to conduct multidisciplinary research aimed at improving early detection of pancreatic ductal adenocarcinoma (PDAC) and better characterizing PDAC precursor lesions.

What is the overarching goal of the Pancreatic Cancer Detection Consortium (PCDC) Research Units?

The core goal is to advance the early detection of PDAC and to better understand and characterize PDAC precursor lesions, with a major emphasis on identifying which individuals are most likely to progress to cancer.

Which populations are emphasized in the research goals?

A major emphasis is on people considered high risk for PDAC, including individuals with inherited genetic risk factors and people with precursor conditions such as pancreatic cystic lesions.

How does this opportunity connect to NCI scientific priorities?

The work aligns with research priorities described in the National Cancer Institute's 2014 Scientific Framework for PDAC and is geared toward enabling earlier intervention when treatment may have a better chance of improving outcomes.

What kinds of research activities are examples under this FOA?

The FOA highlights several example activities, including:

  • Discovering and testing biomarkers measurable in bodily fluids (for example, blood-based, urine-based, or other minimally invasive sample types) for early PDAC detection and/or detection of precursor lesions
  • Determining which pancreatic cysts are most likely to progress to malignancy
  • Developing molecular and/or imaging approaches to screen populations at elevated PDAC risk
  • Applying machine learning and other computational methods to discover, refine, or validate biomarkers
  • Conducting biomarker validation studies

Are clinical trials allowed under this funding opportunity?

Yes. The FOA is labeled "Clinical Trial Optional," meaning clinical trials may be proposed but are not required.

What is meant by "longitudinal biospecimens," and why are they important here?

Longitudinal biospecimens are repeated samples collected over time from participants. A key practical deliverable of the Research Units is collecting longitudinal biospecimens to build a biorepository that supports both current consortium projects and future discovery and validation efforts.

Is collaboration required, or can projects be done independently?

Collaboration is built into the program structure. Each Research Unit is expected to participate actively in consortium-wide activities, share ideas, and contribute biospecimens and data so results can be compared, harmonized, and validated across sites rather than staying isolated at a single institution.

How is the PCDC organized?

The PCDC includes two scientific components: (1) the Research Units funded under this FOA, and (2) a separate Management and Data Coordination Unit (MDCU) that provides cross-consortium infrastructure support.

What does the Management and Data Coordination Unit (MDCU) do?

Although applicants under this FOA apply for Research Units (not the MDCU), the MDCU is described as providing consortium-wide support such as study design input, protocol development support, statistical analysis, project coordination, harmonization of methods, and data management and stewardship, including for biorepository-building efforts.

What does "cooperative agreement" imply for how the project will be run?

Because the instrument is explicitly cooperative, NIH staff typically have substantial programmatic involvement. This fits the consortium model where coordination, harmonization, and multi-site comparability are central expectations.

What is the activity area and assistance listing for this opportunity?

The opportunity is described as a discretionary federal funding opportunity in the health and education activity area. The CFDA listing provided is 93.394.

What is the award ceiling listed for this opportunity?

The listed award ceiling is $600,000.

What are the key dates provided in the opportunity information?

The FOA creation date shown is 2021-09-16. The original closing date shown in the source information is 2024-06-11.

Who is eligible to apply?

Eligibility is broad across many U.S.-based organization types, including:

  • State, county, and city or township governments
  • Special district governments
  • Independent school districts
  • Public and state-controlled institutions of higher education
  • Private institutions of higher education
  • Federally recognized Native American tribal governments
  • Native American tribal organizations other than federally recognized tribal governments
  • Public housing authorities/Indian housing authorities
  • Nonprofits with or without 501(c)(3) status (other than institutions of higher education)
  • For-profit organizations other than small businesses
  • Small businesses

Are there specific types of institutions called out as eligible?

Yes. The FOA also calls out categories such as Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Are non-U.S. organizations eligible to apply?

No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply.

Can foreign collaborators be involved in any way?

Yes. While non-U.S. entities cannot apply, foreign components (as defined by NIH policy) are allowed. This may matter for collaborations, specialized assays, or access to particular cohorts or expertise.

What kinds of scientific approaches does the FOA encourage?

The FOA emphasizes integrated approaches spanning biomarker science (including minimally invasive biomarkers), imaging and molecular screening strategies for high-risk populations, computational approaches such as machine learning, and validation studies designed to confirm promising results across multiple settings.

Why is multi-site validation and harmonization emphasized?

The consortium model is intended to speed progress and improve reproducibility by ensuring that promising signals can be tested, compared, harmonized, and confirmed across multiple sites instead of relying on results from a single institution.

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