Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title
Pancreatic Cancer Detection Consortium: Management and Data Coordination Unit (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-21-335
Companion Funding Opportunity
PAR-21-334 , U01 Research Project (Cooperative Agreements)
Assistance Listing Number(s)
93.394
Funding Opportunity Purpose

Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) is soliciting applications for the establishment of the Management and Data Coordination Unit (MDCU), one of the two scientific components of the Pancreatic Cancer Detection Consortium (PCDC). The PCDC will continue to address one of the four research priorities identified in the National Cancer Institute's 2014 Scientific Framework for Pancreatic Ductal Adenocarcinoma and conduct research on early detection of pancreatic ductal adenocarcinoma (PDAC) and characterization of its precursor lesions to identify those patients who are at high risk of progression to cancer. The PCDC-MDCU will provide support toward collaborative efforts such as: study design, protocol development, statistical analysis, coordination and data management. Other PCDC-MDCU activities include: coordination and support toward biorepository building; and organizational and logistics support for PCDC activities.

The other scientific component of the PCDC will be the Research Units (PCDC-Rus; see companion PAR-21-334). The PCDC-RUs will conduct research for the development and testing of new molecular and imaging biomarkers for early detection of PDAC and/or for identifying those patients at high risk of PDAC (because of genetic factors and/or family history or presence of precursor lesions) who could be candidates for early intervention.

Key Dates

Posted Date
September 16, 2021
Open Date (Earliest Submission Date)
October 15, 2021
Letter of Intent Due Date(s)

October 15, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 15, 2021 November 15, 2021 Not Applicable March 2022 May 2022 July 2022
June 10, 2022 June 10, 2022 Not Applicable November 2022 January 2023 April 2023
October 11, 2022 October 11, 2022 Not Applicable March 2023 May 2023 July 2023
February 10, 2023 February 10, 2023 Not Applicable July 2023 October 2023 December 2023
June 13, 2023 June 13, 2023 Not Applicable November 2023 January 2024 April 2024
October 11, 2023 October 11, 2023 Not Applicable March 2024 May 2024 July 2024
June 11, 2024 June 11, 2024 Not Applicable November 2024 January 2025 April 2025

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
June 12, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Through this Funding Opportunity Announcement (FOA) the National Cancer Institute (NCI) is soliciting applications for the establishment of the Management and Data Coordination Unit (MDCU), one of the two scientific components of the Pancreatic Cancer Detection Consortium (PCDC). The PCDC will support research for the development and testing of new molecular and imaging biomarkers for early detection of pancreatic ductal adenocarcinoma (PDAC) and/or for identifying those patients at high risk of PDAC (because of genetic factors and/or family history or presence of precursor lesions) who could be candidates for early intervention. The other scientific component of the PCDC will be the Research Units (PCDC-RUs; see companion PAR-21-334).

Clinically useful screening markers should be present in those patients with high-grade precursor lesions (intraductal papillary mucinous neoplasm [IPMN], mucinous cystic neoplasm [MCN] and pancreatic intraepithelial neoplasia-grade 3 [PanIN-3]) and early-stage PDAC, while absent in those without neoplasia, such as pancreatitis. These biomarkers should be readily detectable in easily obtainable biofluids, ideally collected using non-invasive or minimally-invasive techniques (e.g., blood, saliva, urine, stool, cyst fluid, pancreatic juice).

Key Definitions for this FOA

PCDC-MDCU (This FOA): The PCDC-MDCU will be expected to work with all PCDC-RUs for coordinating Consortium collaborative projects and providing support toward collaborative efforts such as: study design, protocol development, statistical analysis, coordination and data management. Other PCDC-MDCU activities include: coordination and support toward biorepository building; and organizational and logistics support for PCDC activities. The PCDC-MDCU will be supported by one U24 cooperative agreement award.

PCDC-RU (companion PAR-21-334): The PCDC-RUs will consist of multi-disciplinary teams and will undertake studies to: develop and test biomarkers measurable in bodily fluids and imaging methods for improved detection of early-stage PDAC, and high-grade lethal precursors (IPMNs, MCNs, PanIN-3s); develop and test biomarkers and imaging methods to determine which mucinous neoplasms (IPMNs and MCNs) are likely to progress to cancer; study cancerization of pancreatic ducts to identify biomarkers that can help detect cancer early; develop molecular- and/or imaging-based approaches for screening populations at high risk of PDAC to detect cancer early; use machine learning and computational approaches for biomarker discovery and/or validation; conduct biomarker validation studies; and collect prospective, longitudinal biospecimens for contribution to a biorepository. The PCDC-RUs will be supported by the companion U01 cooperative agreement award.

Biomarker Definition. In the context of this FOA, biomarkers are defined as cellular, morphological, biochemical, molecular, histological and imaging (molecular or radiographic) characteristics by which normal and/or abnormal biological processes can be recognized and/or monitored. Biomarkers are measurable in biological materials, such as, in tissues, cells, and/or bodily fluids.

Background

Pancreatic Cancer: Pancreatic cancer is the third leading cause of cancer-related mortality in the United States and is projected to move up to the second position by 2030. The poor prognosis of pancreatic cancer is primarily due to diagnosis of the disease at advanced stages as patients often present with locally advanced or metastatic disease where resection is not feasible. The lack of symptoms or presence of non-specific symptoms at early stages makes it challenging to detect this cancer early. The earlier the pancreatic cancer is caught, the better the chance a person has of surviving longer. Surgical resection is currently the only potentially curative treatment, but only 15-20% of patients are candidates for surgery and recurrence rate is still high among resected cases. The Recalcitrant Cancer Research Act of 2012 called upon the National Cancer Institute (NCI) to identify and make progress on recalcitrant and deadly malignancies with 5-year relative survival rate of less than 20% and estimated to cause at least 30,000 deaths per year. Pancreatic cancer is a recalcitrant cancer with a 5-year relative survival rate of 10.8%, and an estimated 60,430 new cases and 48,220 deaths in 2021, according to the Surveillance, Epidemiology, and End Results (SEER) Program’s Cancer Statistics Facts (Pancreatic Cancer — Cancer Stat Facts). The most prevalent type of pancreatic cancer is PDAC, representing >90% of all pancreatic malignancies. The NCI 2014 Scientific Framework for Pancreatic Ductal Adenocarcinoma identified four research priorities based on the recommendations of an expert panel of extramural scientists convened by the NCI. One of the specific initiatives recommended by this panel was “Evaluation of longitudinal screening protocols concomitant with development of new molecular and imaging biomarkers for patients at high risk for PDAC (because of genetic factors or the presence of mucinous pancreatic cysts) who could be candidates for early surgical intervention.” The NCI PCDC was established in 2016 to address this recommendation.

The majority of PDAC is sporadic, i.e., occurring without a family history or a genetic predisposition of the disease. It is estimated that it takes more than 10 years before an initiating mutation in a normal pancreas cell progresses to the non-metastatic parental founder cell of PDAC, and at least five more years are required for the acquisition of metastatic ability. This window of time offers an opportunity for curative interventions if the disease could be diagnosed at an earlier stage. It is noteworthy that recent evidence also supports the hypothesis that once PDAC becomes detectable, the clinical progression from early-stage to advanced-stage disease is rapid; therefore, the best outcomes will be tied with detection at the earliest stages of the disease. Despite substantial advancement in technologies and progress towards identifying biomarkers for early detection of the disease, there remains a need for the development of better molecular, imaging and/or integrated molecular and imaging approaches that are highly discriminating for pancreatic cancer and clinically useful. For patients with a strong clinical and radiological suspicion of PDAC, having a highly discriminating, non-invasive tool may expedite patients’ diagnostic workups so that they could proceed to receive treatment. Alternatively, for patients with a low suspicion of PDAC based on clinical information and radiologic imaging, having a highly discriminating, non-invasive tool should obviate additional costly workups. Another area of impact involves those patients with a high risk for developing PDAC, who do not need immediate clinical intervention but can be surveilled instead.

Current PCDC Overview: Currently available modalities for screening those at high risk of pancreatic cancer are mostly anatomical imaging methods, including traditional cross-sectional imaging such as abdominal ultrasound or computed tomography (CT), or imaging used in surveillance protocols such as magnetic resonance imaging (MRI)/magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasound (EUS), or CT when MRI and EUS are not possible. Traditional cross-sectional imaging has little role in screening for sporadic pancreatic cancer. The question then arises, whom to screen? Given the low prevalence of PDAC, it is advantageous to first focus on developing better tests for screening those at high risk of the disease, as outlined in the Scientific Framework recommendation mentioned earlier. The PCDC focuses on two main types of high-risk populations that are outlined below:

(1) Individuals at high risk of developing PDAC because of genetic factors, i.e., presence of germline variants in cancer susceptibility genes that includes high-penetrance genes such as BRCA2, STK11/LKB1, CDKN2A, PALB2, hereditary pancreatitis (PRSS1 mutation carriers), and some other known variants. Individuals could also be a high risk of PDAC due to a family history of pancreatic cancer. Approximately 10% of PDAC occurs in families with a history of PDAC. Studies have shown that when at least one pair of first degree relatives were affected with pancreatic cancer, the risk of developing pancreatic cancer was 18 times that for relatives of an individual with only one sporadic pancreatic cancer; in pancreatic cancer kindreds with three or more affected family members, there is reportedly a 57-fold increased risk of pancreatic cancer.

(2) Individuals at high risk of developing PDAC because of the presence of mucinous cysts (e.g., IPMN and MCN), and other suspected precursors such as PanIN-3. IPMNs and MCNs are being increasingly detected because of increased abdominal imaging such as CT done for diagnostic workup of non-specific symptoms. An estimated 15% of PDAC originate from these lesions, but their natural history is not well defined. Resection of IPMNs or MCNs prior to the development of invasive cancer is considered curative, but there are substantial risks of morbidity and mortality associated with surgery. Currently, it is also difficult to distinguish precancerous mucinous cysts from benign non-mucinous cysts, the timing and frequency of malignant progression within the mucinous cysts is unknown, and there is a need for biomarkers of high-grade dysplasia and risk of progression. While PanINs are not detectable using current imaging modalities, and there are also no biomarkers that can detect PanIN-3 lesions or distinguish progressor PanINs vs. non-progressors, advancement in metabolic and other molecular imaging technologies have started to show promise and potential for future clinical use.

PCDC Research Focus: The PCDC objectives include the development of biomarkers measurable in bodily fluids that can accurately and reliably detect early-stage PDAC or its lethal precursor lesions, and also distinguish progressor vs. non-progressor precursors. Although genome-wide association studies (GWAS) have reported useful findings, their utility in measuring PDAC risk is limited due to the lack of functional tests. The development of biomarker tests with high clinical sensitivity and specificity that can accurately detect progressive precursors and early-stage PDAC in non-invasively or minimally-invasively obtained biospecimens is a challenging task. High specificity is particularly important, since a positive test may trigger invasive procedures, which add their own risk of morbidity and mortality. In addition, to encourage compliance and use, the tests also need to be rapid, require a small volume of biofluids for assays, be relatively inexpensive, be widely distributable to maximize test access, and overall, have a practical approach while keeping the real world setting in mind. Since blood or other biological fluid-based biomarkers alone may not provide sufficient tissue specificity and imaging is important for precise anatomic location and for delineating disease characteristics, the PCDC research focus includes the development of biomarkers in conjunction with imaging (radiographic, metabolic and other molecular imaging).

The PCDC follows the same biomarker development principles established by the Early Detection Research Network (EDRN), where the five phases for biomarker discovery and validation were defined as:

  • Phase 1: The preclinical exploratory phase;
  • Phase 2: The clinical assay validation phase (case-control);
  • Phase 3: The retrospective longitudinal validation phase;
  • Phase 4: The prospective screening phase; and
  • Phase 5: The cancer control phase.

The PCDC also follows the EDRN-established comprehensive set of guidelines for biomarker discovery and validation studies for early cancer detection, diagnosis and prognosis, known as the prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) study design.

The articles on five-phase approach and PRoBE study design are available on the EDRN website (https://edrn.nci.nih.gov/about/bookshelf).

PCDC Resource Building Efforts: A major impediment to pancreatic cancer research is the limited access to well-characterized and well-annotated specimens from early stages and lethal precursors that can be used to discover and validate biomarkers. The development of extensive and efficient registries to explore novel approaches to early detection of pancreatic cancer is a necessary resource in the field. Pancreatic cancer is often diagnosed at late stages and the rapid demise of patients with PDAC contributes to the difficulty of obtaining well-annotated biospecimens. A minority of pancreatic resections are performed in a setting where tissue is routinely banked for research purposes. Even clinical centers with well-established collection protocols have very few specimens from patients with PanIN-3 and early-stage PDAC. Another shortcoming in the field is the inability of investigators to fully utilize the existing resources of individual facilities across institutions/universities. Even when registries and cohorts of patients at high risk of PDAC have been developed, they seldom have pre-diagnostic specimens and very few have serial/longitudinal samples, which hinders the much-needed progress in biomarker discovery and development for early detection. PCDC is addressing these challenges by building two longitudinal biorepositories. Samples that have already been collected under ongoing PCDC activities are in the process of being shipped to the NCI at Frederick Central Repository for long-term storage, per NCI requirement. The use of these precious samples for EDRN-defined Phase 3 biomarker validation studies will be determined following NCI-established processes. The NCI expects full commitment from the PCDC investigators towards meeting the Consortium goals and building the necessary valuable resources for the scientific community.

PCDC Signature Cohorts: This is a unique, ongoing collection of prospective, longitudinal biospecimens (blood [serum, plasma], cyst fluid, pancreatic juice) for the two types of high-risk cohorts mentioned earlier in the PCDC Research Overview section. These cohorts are called "PCDC Signature Cohorts", and collections are being accomplished through strong multi-institutional collaborations across all PCDC awardees. The collection of sufficient biospecimens that will enable the design of adequately powered, EDRN-defined Phase 3 validation studies will require continued commitment and strong collaborations among multiple institutions and participating Cancer Centers.

PCDC Reference Sets: The PCDC teams are also prospectively collecting blood samples from consented participants who have the following conditions:

  • PDAC;
  • Pancreatic cyst;
  • Pancreatitis;
  • Other pancreatic cancer;
  • Familial/genetic risk;
  • Non-PDAC control.

These biospecimens can be designated as reference sets (EDRN-defined Phase 2, case-control) for various larger validation projects, within PCDC or with other NCI-funded consortia (e.g., EDRN).

Specific Research Scope and Responsibilities for this FOA

Scope. The objective of this FOA is to establish a PCDC-MDCU. The PCDC-MDCU will serve as the organizational hub for the entire PCDC program and provide support for overall program coordination, administration, facilitating steering committee and working group calls and meetings, data management, biostatistical support, and biorepository building. The PCDC-MDCU will integrate efforts across the program, facilitate research collaborations, and coordinate trans-PCDC projects. The MDCU must have expertise and capabilities in biostatistics, data management, protocol development, biorepository building, and in coordinating and providing logistical support for Consortium-wide call, meetings and workshops. It is essential that the MDCU applicants familiarize themselves with the companion FOA for the PCDC-RUs (PAR-21-334), with which the MDCU must work.

Responsibilities. MDCU responsibilities include, but are not limited to, the following:

  • Support the development, coordination, implementation, and conduct of Steering Committee-approved, collaborative research studies;
  • Support the ongoing development of the high-risk PCDC Signature Cohorts (as mentioned earlier) that are estimated to enroll thousands of patients; responsibility includes, but is not limited to, the following: obtain data from the PCDC-RUs and track/monitor/document enrollment; build and maintain virtual databases (i.e., virtual management of patient registry with clinical and demographic information and biospecimen record keeping); and coordinate the transfer of biospecimens to the NCI at Frederick Central Repository;
  • For collaborative studies, coordinate the harmonization, collection and sharing of all data and metadata;
  • Support NIH Single-Institutional Review Board (sIRB) policy to enhance and streamline the IRB process for multi-site research studies;
  • Work closely with PCDC-RU investigators to support data analysis for collaborative projects; additional consultations and statistical support will be made available through the NCI Division of Cancer Prevention's Biometry Research Group as directed by the Steering Committee and the NCI staff;
  • Lead blinding and unblinding procedures for trans-PCDC validation projects;
  • Provide overall PCDC coordination and integration functions, and also logistical and administrative support toward organizing PCDC-wide calls, meetings and workshops;
  • Update, maintain, and populate the PCDC portal (both public and secure sites);
  • Coordinate PCDC-wide effort to make resources broadly available to the scientific community, and as directed by the PCDC Steering Committee.

PCDC Administrative and Governance Structure

The PCDC will include multiple U01 recipients (RUs) and a U24 recipient (MDCU) and will be governed by a Steering Committee. The Steering Committee will comprise of representatives from the RUs, MDCU, and the NCI. The Steering Committee will provide input towards and oversight of PCDC collaborative activities, as well as overall integration of efforts among all PCDC awardees. The Chair and the co-Chair of the Steering Committee will be PDs/PIs of PCDC cooperative agreement awards and will be elected by the Steering Committee. Any member of the Steering Committee can offer nominations for the Chair and co-Chair, including self-nominations.

Further details of Steering Committee composition and responsibilities are provided in Section VI. Award Administration Information - Cooperative Agreement Terms and Conditions of Award.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
New
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NCI intends to commit an estimated total of $825K total cost per year to fund one award. If an award is made after a submission round, the subsequent receipt dates/submission rounds will be canceled, i.e., this FOA will be terminated.

Award Budget

The maximum amount per award may not exceed $500K direct cost per year. Application budgets need to reflect the actual needs of the proposed project.

Award Project Period

The project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

An investigator designated as a Contact PD/PI of an application under this FOA must not be the designated Contact PD/PI on any application for the companion PCDC FOA.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Sharmistha Ghosh-Janjigian, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7122
Email: ghoshjanjigias@mail.nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

In addition, it is preferred that the PCDC-MDCU includes expertise in data analytics and artificial intelligence/deep learning/machine learning language, but it is not required.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

  • PD(s)/PI(s) Effort: The Contact PD/PI must commit a minimum of 1.8 person-month of his/her time per year and all other PDs/PIs (if multiple) must commit a minimum of 1.2 person-month of their time per year to the U24 award. This commitment cannot be reduced in later years of the award.
  • Set-Aside Funds for Trans-PCDC Projects: Applicants must set aside $75,000 (direct cost) of their annual budget for PCDC collaborative studies developed post-award. The set-aside amount should be presented in the "Other Direct Costs" category under the heading “Consortium Collaborative Funds". The collaborative studies will be subject to review and recommendation for approval by the Steering Committee. The NCI authorization of use of these restricted funds will be contingent upon the recommendation of the Steering Committee.
  • Travel Funds: Applicants must budget for travel and per diem expenses for Steering Committee meetings. The Contact PD/PI together with at least one MPI or a senior investigator will attend two Steering Committee meetings each year of the award; one in-person meeting and one virtual meeting. The virtual meetings will allow participation of the larger team members.
  • Other Budget-Related Information: Applicants should budget for coordination of sIRB-related activities. Budget for personnel services directly involved in the activities of the MDCU should be clearly identified.
  • Prior Approval of Pilot Projects: Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation. The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval. The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.
R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Specific Aims: The PCDC-MDCU applicant should describe how the specific aims will help PCDC achieve its overall goals. The applicant must state their willingness and describe the strategies to work collaboratively with the PCDC-RUs, the PCDC Steering Committee, the NCI, and the NCI at Frederick Central Repository.

Research Strategy: Applicants must organize the Research Strategy to include the sub-section elements identified below. Applicants may include other sub-sections as needed but must include the information requested below.

Sub-section A: Coordination and Data Management Support

(i) Team Organization, Administrative, and Logistics Support

  • Without repeating the information provided in the Senior/Key Person section earlier or in the biosketches, describe the team leadership structure, project management skills, and how the team members bring complementary expertise for consortium coordination and data management activities to achieve the overall goals of the MDCU;
  • Describe MDCU's plans for communication, management and integration of the PCDC-MDCU activities, and who will oversee the day-to-day activities for the different types of activities, and oversight mechanisms for ensuring effective PCDC-MDCU operations;
  • Describe plans for communication with the PCDC-RUs and the NCI and support overall PCDC integration;
  • Describe how to provide logistical and administrative assistance in arranging monthly Steering Committee calls, bi-annual meetings and PCDC working group calls and workshops;
  • Describe plans to support NIH sIRB policy to enhance and streamline the IRB process for multi-site research studies, if/when necessary;
  • Describe strategies for preparing/maintaining listserv; preparing, distributing and maintaining meeting minutes; working with NCI for developing, populating, updating and maintaining the NCI-hosted PCDC portal, both public facing and secure sites; and updating the PCDC Manual of Operations document.

(ii) Coordination of the Development of the PCDC Biorepository

  • Describe plans to support the development of high-risk PCDC cohorts (e.g., PCDC Signature Cohorts, mentioned earlier), including plans to work with the PCDC-RUs to track/monitor/document enrollment;
  • Describe plans to build and maintain virtual databases (e.g., virtual management of patient registry with clinical and demographic information and biospecimen record keeping);
  • Describe plans to work with the PCDC-RUs for building case-control PCDC Reference Sets (described earlier) and assist in data collection and entry, sample tracking, calculation of populations and power analysis;
  • Describe plans to coordinate the transfer of biospecimens to the NCI at Frederick Central Repository.

(iii) Coordination of PCDC Collaborative Studies

  • Describe how the MDCU will support the study design, data standardization and harmonization, management, coordination, implementation, and conduct of Steering Committee-approved collaborative studies;
  • Describe statistical support for collaborative studies; additional consultations and statistical support will be made available through the NCI Division of Cancer Prevention's Biometry Research Group as directed by the Steering Committee and the NCI staff);
  • Describe the process for blinding and unblinding that may be necessary for trans-PCDC validation projects;
  • Restricted/set-aside funds (see R&R Budget section) will be used towards any additional collaborative activity and needs to be developed post-award and approved by the Steering Committee.

Sub-section B: Relevant Accomplishments

Describe accomplishments relevant to data coordination and management for programs focused on early detection of cancers and/or pancreatic cancer. The description should address, but is not limited to, the following:

  • Organization and coordination of consortium or multi-institutional activities (e.g., meetings);
  • Biorepository building and management;
  • Statistical support.

Sub-section C: Annual Milestones

The following major benchmarks of progress must be addressed. Any application lacking milestones will be considered incomplete.

Applicants should provide a clear set of annual, quantitative benchmarks for each specific aim of the PCDC-MDCU associated with timelines. These milestones must be well described and quantitative. Discuss the milestones as a means for judging the success of the MDCU functions. Specific aims may not be regarded as milestones (unless they include quantitative endpoints).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Unit address the needs of the research consortium that it will coordinate? Is the scope of activities proposed for the Unit appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research consortium?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Unit? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing cancer research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Unit? Does the applicant have experience overseeing selection and management of subawards, if needed?

Specific to this FOA: How adequately trained and qualified are the PD(s)/PI(s) and support personnel for managing multi-institutional collaborations and biorepositories, including expertise in biostatistics?

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research consortium the Unit will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium the Unit will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the consortium, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the consortium is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the consortium? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this FOA: Are the milestones adequately described and help achieve the overall goal of the MDCU?

Environment

Will the institutional environment in which the Unit will operate contribute to the probability of success in facilitating the research consortium it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Unit proposed? Will the Unit benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?

Specific to this FOA: How adequate is the infrastructure for data storage, data security and data analysis appropriate to support the PCDC collaborative activities (e.g., for the PCDC Signature Cohorts)?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility for the project as a whole resides with the recipients, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PDs/PIs will have primary responsibility for:

  • Overseeing the PCDC-MDCU activities to ensure that its areas of responsibility are fulfilled.
  • Assuming responsibility and accountability to the applicant organization and to the NCI for the performance and proper conduct of the research in accordance with the terms and conditions of the award.
  • Committing and maintaining throughout the life of the PCDC-MDCU a minimum of 1.8 person-months of effort per year for the contact PD/PI and a minimum of 1.2 person-months of effort per year for any investigator designated as an MPI.
  • Agreeing to be an active participant in the PCDC, including collaborative activities and attending and organizing meetings/scientific workshops. In accordance with this cooperative agreement, the contact PD/PI together with at least one MPI (if it is a multi-PD/PI application) or a senior investigator will be required to attend two Steering Committee meetings each year of the award; one in-person meeting and one virtual meeting.
  • Serving on the PCDC Steering Committee and participating as a voting member of the Steering Committee.
  • Accepting and implementing the goals, priorities, procedures, and policies agreed upon by the Steering Committee to the extent consistent with applicable grant regulations.
  • Overseeing the implementation of the approved resource and data sharing plan; the PDs/PIs and their recipient institutions will be accountable for implementing the approved plan.
  • Sharing of knowledge, data, research materials, and any other resources necessary and relevant to the PCDC.
  • Disseminating research resources (e.g., approaches, methods, models, software, tools, biospecimens) to the scientific community and posting these resources on the PCDC website, when appropriate.
  • Abiding by the governance of the PCDC and all program policies agreed upon by the PCDC Steering Committee and approved by NCI Program Officials to the extent consistent with the applicable rules and regulations.
  • Reporting progress to the NCI Program Officials on all PCDC research and outreach activities annually. The PDs/PIs may be expected to provide additional information, outside the scope of the standard reporting requirement, as needed and requested by program staff members.
  • Participating in the NCI-coordinated evaluation of the PCDC-MDCU and the overall PCDC program, including timely submission of required progress reports and one site visit (in person or virtual) by the NCI during the five-year grant period.

PD(s)/PI(s) responsibilities for PCDC collaborative studies are:

  • Collaborating with PCDC-RUs to advance promising early detection assays/tests towards validation studies.
  • Accepting and implementing the goals, priorities, common protocols, procedures, and policies agreed upon by the Steering Committee for PCDC collaborative studies.
  • Ensuring review and approval of protocols, concepts, final protocol documents, informed consents, and study amendments by the PCDC Steering Committee and the NCI, and advise NCI of changes in protocol status, when applicable.
  • Collaborating on common research designs or protocols, including methods and requirements for joint participation and collaboration as recommended by the Steering Committee, and handling of data, including appropriate sharing of methods and data among collaborating organizations.
  • Reviewing and coordinating information on specimen collections (e.g., for PCDC Signature Cohorts).
  • Defining objectives and approaches, including the logistic support for the Steering Committee calls and meetings, organization of workshops (if any), and providing assistance for other activities of the PCDC.
  • Coordinating sIRB for approved PCDC collaborative studies, if applicable.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NCI Program Officials have substantial programmatic involvement that is above and beyond the normal stewardship role in cooperative agreement awards. The substantially involved NCI Program Official, acting as Project Coordinator, will coordinate in a centralized fashion the various activities of the recipients. Additionally, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Additional Program Officials who are not responsible for the normal scientific and programmatic stewardship of the award may be designated as Project Scientists and assist in Consortium activities. Specific responsibilities of the NCI Program Officials will include, but will not be limited to, the following aspects:

  • Coordinating and facilitating various activities of the PCDC program.
  • Participating in the activities of the PCDC Steering Committee as a voting and/or non-voting member.
  • Serving as a liaison between the Steering Committee, the PCDC recipients, and the NIH;
  • Ensuring that there is effective communication among the PCDC units, and between the PCDC and the NCI.
  • Assisting the Steering Committee in developing and drafting PCDC operating policies and policies for dealing with recurring situations that require coordinated action.
  • Facilitating collaborative research efforts that involve multiple PCDC recipients.
  • Assisting the Steering Committee, the PCDC-MDCU, and individual PCDC recipients in avoiding unwarranted duplications of effort across the PCDC.
  • Assisting the recipients as a resource in facilitating their broader interactions with other NCI and NIH programs to disseminate results, tools, and models from the PCDC and take advantage of existing NIH/NCI resources and infrastructures.
  • Co-organizing and participating in the PCDC-sponsored meetings.
  • Monitoring the scientific progress of individual U01/U24 awards and the entire PCDC program.
  • Reviewing the compliance of PCDC recipients with the recommendations developed by the Steering Committee.
  • Developing working groups and trans-PCDC projects as needed.
  • Authorizing the use of individual set-aside funds for activities reviewed and recommended by the Steering Committee.

The NCI reserves the right to adjust funding, withhold, suspend, or terminate the support to those Consortium recipient institutions that are unable to meet the performance requirements set forth in these Terms and Conditions of Award, or significantly change the level of performance.

Areas of joint responsibility include:

Steering Committee: The Steering Committee will be the main governing body for the PCDC. The Steering Committee will be composed of the following voting members:

  • Two PDs/PIs representing each PCDC U01/U24 award; in case of a single PD/PI award, an additional key personnel may also vote to keep the number of voters uniform across all awards.
  • The NCI-designated Project Coordinator.

Each voting member will have one vote.

Additional NIH staff may participate in Steering Committee meetings as non-voting members as needed (for example to provide additional expertise). The non-voting members may include representatives from NCI extramural divisions and a representative from the NCI CBIIT.

Additional non-voting members may participate on the Steering Committee in an advisory capacity on an as needed basis and decided by the existing voting committee members.

The Chair of the Steering Committee (who cannot be an NIH staff) will be selected by the Steering Committee.

The Steering Committee will meet twice every year, at locations selected by the Steering Committee in consultation with the NCI; one in-person meeting and one virtual meeting.

The Steering Committee may establish working groups for specific purposes. The NCI Project Coordinator/Scientists and Program Officials will serve on such working groups, as appropriate.

Primary responsibilities of the Steering Committee include, but are not limited to, the following activities:

  • Identifying scientific and policy issues that need to be, or can benefit by being, addressed at the Consortium level and develop recommendations to NIH/NCI Program Officials for addressing such issues.
  • Updating and refining established policies and procedures, including those for collaborative projects, protocols, and PCDC-defined projects.
  • Updating and refining established policies and procedures at the request of specific PCDC units for reviewing changes in projects not showing translational significance, and making recommendations to the NCI for replacing the project with more promising ones with the revised scope and adjusted budget (increase in the budget will not be permitted).
  • Reviewing patient accrual, follow-up, study protocol compliance, results of audits, and regulatory requirements at the participating PCDC units and formally report the results of its reviews to the NCI.
  • Overseeing the refinement/modification of the PCDC Manual of Operations.
  • Developing and/or refining guidelines for the collection and distribution of specimen reference sets for collaborative research.
  • Developing and/or refining guidelines for PCDC Signature Cohorts, and overseeing the biorepository building effort.
  • Setting the overall research priorities for the PCDC and identifying emerging research opportunities, which can be best explored through trans-PCDC efforts.
  • Promoting and fostering the inclusion of women and racial/ethnic minorities in accrual and assure the completeness of informed consent.
  • Tracking PCDC research progress and assuring that the study results are published in peer-reviewed journals in a timely manner and in accordance with the publication policies of the Network.
  • Participating in planning Steering Committee meetings and any additional workshops; PCDC-MDCU will provide logistical support for these meetings.
  • Examining validation data for early detection tests/assays developed by the PCDC, and deciding when these are sufficiently validated, or recommending when to stop non-productive experiments relating to the test/assay validation.
  • Reviewing (with the assistance of external reviewers, as needed) and discussing collaborative projects/study protocols to be pursued with the support of the individual set-aside funds; overseeing data submission to the PCDC-MDCU; defining the rules regarding access to data and publications consistent with NCI policies.
  • Advising NCI on activating funds for the recommended collaborative projects.
  • Reviewing the progress of the PCDC toward meeting the collective goals of the Consortium.
  • Ensuring that all PCDC members are utilizing/leveraging existing NCI and NIH resources and programs.
  • Implementing the policy that the resource sharing and intellectual property requirements set forth for PCDC recipients are also adhered to by collaborating non-PCDC investigators and their institutions (e.g., participation of non-PCDC investigators in set-aside projects).
  • Serving as a nucleus for a broader outreach to the entire extramural research community.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Sudhir Srivastava, Ph.D., M.P.H.
National Cancer Institute (NCI)
Telephone: 240-276-7028
Email: srivasts@mail.nih.gov

Sharmistha Ghosh-Janjigian, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-7122
Email: ghoshjanjigias@mail.nih.gov

Matthew Young, Ph.D.
National Cancer Institute (NCI)
Telephone:240-276-5846
Email: youngma@mail.nih.gov

Peer Review Contact(s)

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: ncirefof@dea.nci.nih.gov

Financial/Grants Management Contact(s)

Amy R. Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6375
Email: amy.bartosch@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 2 CFR Part 200, 42 CFR Part 52 and 45 CFR Part 75.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
NIH Office of Extramural Research Logo
Department of Health and Human Services (HHS) - Home Page
Department of Health
and Human Services (HHS)
USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.