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

Imaging and Biomarkers for Early Detection of Aggressive Cancer (U01)

Activity Code

U01 Research Project Cooperative Agreements

Announcement Type

Reissue of PAR-13-189

Related Notices
  • May 1, 2019 - This PAR has been reissued as PAR-19-264.
  • November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
  • NOT-OD-18-009 - Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018.
  • September 20, 2017 - Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018. See NOT-OD-17-114.
  • May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.
  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
Funding Opportunity Announcement (FOA) Number


Companion Funding Opportunity


Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.393; 93.394

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to: (i) invite researchers to submit collaborative research project (U01) applications to improve cancer screening, early detection of aggressive cancer, assessment of cancer risk and cancer diagnosis aimed at integrating multi-modality imaging strategies and multiplexed biomarker methodologies into a singular complementary approach, and (ii) establish a Consortium for Imaging and Biomarkers (CIB) to perform collaborative studies, exchange information, share knowledge and leverage common resources. The research will be conducted by individual multi-disciplinary research teams, hereafter called Units. All Units are expected to participate in collaborative activities with other Units within the Consortium.

Key Dates
Posted Date

January 25, 2016

Open Date (Earliest Submission Date)

June 11, 2016

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

July 11, 2016; December 14, 2016; July 10, 2017; December 11, 2017; July 10, 2018; December 11, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

September/October 2016; March/April 2017; September/October 2017; March/April 2018

Advisory Council Review

January 2017; August 2017; January 2018; August 2018; January 2019; August 2019

Earliest Start Date

February 2017; October 2017; February 2018; October 2018; February 2019; October 2019

Expiration Date

December 12, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description


The purpose of this Funding Opportunity Announcement (FOA) is to: (i) invite researchers to submit collaborative research project (U01) applications to improve cancer screening, early detection of aggressive cancer, assessment of cancer risk and cancer diagnosis aimed at integrating multi-modality imaging strategies and multiplexed biomarker methodologies into a singular complementary approach, and (ii) establish a Consortium for Imaging and Biomarkers (CIB) to perform collaborative studies, exchange information, share knowledge and leverage common resources. The research will be conducted by individual multi-disciplinary research teams, hereafter called Units. All Units are expected to participate in collaborative activities with other Units within the Consortium.

Overdiagnosis and false positives present significant clinical problems in the prevention, detection and treatment of cancer. Therefore, there is an unmet clinical need to more accurately identify early-stage aggressive cancers and distinguish lesions that are life threatening from those that are not. The specific objective of this FOA is to stimulate and support cancer imaging and biomarker research to develop, optimize, and clinically validate novel methods to:

  • Detect aggressive cancers at the earliest stages possible;
  • Reduce overdiagnosis;
  • Reduce false positive tests; and
  • Identify lethal cancers from non-lethal disease.

These goals can be met by a research strategy involving preclinical and clinical investigations to improve early cancer detection and diagnosis where validated cancer biomarkers can be combined with experimental imaging methods, or conversely, where established clinical imaging methods can be combined with experimental biomarkers. It is also possible that experimental imaging and biomarker integration strategies may be combined in such a manner that a clear path to clinical application is maintained. For example, clinically established imaging approaches or validated multiplexed biomarker(s) tests may not be currently available, well defined and suitable for direct incorporation into multi-site validation studies, i.e., experimental imaging combined with experimental biomarker(s) or the development of novel imageable biomarkers. For grant applications involving such a strategy, an established reference standard or gold standard (e.g., histology or immunohistochemistry) is required and should be clearly defined within the grant application in order to perform ongoing or future verification, pre validation and clinical validation studies.

This FOA will utilize the Research Project Cooperative Agreement (U01) mechanism to increase collaborative imaging and biomarker research. Applicants may take advantage of the option to designate multiple Program Directors/Principal Investigators (PDs/PIs), each of whom would contribute unique expertise and scientific insights toward the successful completion of the proposed research.

Background and Rationale

Clinical Needs: While early stage cancers that were heretofore undetectable can now be detected by screening, many lesions detected by imaging or biomarkers are not cancer and many of the detected cancers are not life threatening. Simply stated, although it is possible to detect early stage cancers with greater frequency, one does not always know which lesions are cancer and cannot always distinguish cancers that are life threatening from those that are not.

Overdiagnosis is the term used when the diagnosis of a disease is correctly made, but the disease does not give rise to symptoms during the patient's lifetime or have lethal potential for the patient. False positive is the term used when the test for disease in a patient is "positive" when the disease is not present. Our inability to differentiate lethal from indolent cancer (frequently over diagnosed), particularly at an early stage, and to differentiate benign disease from cancer (false positives) is a significant clinical problem.

The goal of this FOA is to develop improved methods for the early detection of aggressive cancer by managing overdiagnosis, reducing false positives and identifying lethal cancers from non-lethal disease using strategies aimed at effective integration and validation of imaging and biomarkers. It is acknowledged that a biomarker is conceptually defined as a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or a biological response that could be used for early cancer detection.

While imaging and biomarkers can both be derived from tissue, cancer cells, serum, plasma, urine or other bodily fluids, for the purpose of this FOA, a biomarker will specifically refer to results obtained from the analysis of biofluids and tissues that are not spatially or temporally resolved. Likewise, imaging is referred to as a tool used to graphically depict spatially or temporally resolved cancer cells, tissues and their surroundings. In the context of this FOA, imaging can employ any of a variety of radiographic, sonographic, and other diagnostic technologies. Imaging and biomarker tests used in this fashion are obtained separately and serially as a function of time. An imageable biomarker, for the purpose of this FOA, combines structural and/or functional information from one or more biomarker(s) and imaging obtained simultaneously (rather than serially) resulting in a visual representation of cancer cells, cellular features, molecular analytes, or image derived features (genomic, proteomics, metabolomics, or other omics data including radiomic approaches) that may or may not be directly mapped for visualization, but are nonetheless associated with and derived from image-based acquisitions. Data obtained in this manner can include morphologic/physiologic relationships and connectivities related to individual pixel/voxel characteristics, meta data, features and numerical associations that correlate to disease processes and aberrant metabolic pathways, or other information that could be applied clinically in the context of precision medicine.

Three clinical examples are provided below to illustrate possible approaches responsive to this FOA:

EXAMPLE #1: Validated Biomarker(s) + Investigational Imaging Approach

Prostate Cancer: Aberrant biomarker results trigger subsequent imaging: Currently, prostate specific antigen (PSA) is used to screen men for prostate cancer, but the rates of both overdiagnosis and false positives are unacceptably high. The biomarker prostate cancer antigen-3 (PCA3) has recently been approved by the FDA as a urine test for predicting prostate cancer on second biopsy. The FDA has also recently approved pro prostate specific antigen (proPSA) as a serum biomarker for prostate cancer. While these biomarkers are superior to PSA alone, the number of false positive and extent of overdiagnosis are still too high.

The successful integration and validation of imaging and biomarker approaches might be used to help guide and better define criteria used for clinical decisions. The need for better pathologic, molecular, genetic, and imaging predictive markers as well as the evaluation of their validity and reliability is critical for advancing of our understanding the natural history of prostate cancer and for establishing guidelines to be used for active surveillance in the management of men with localized prostate cancer and for managing overdiagnosis.

A specific example for combining a known biomarker with an investigational imaging method is when screening results from a validated biomarker are abnormal and consistent with prostate cancer. Subsequent biopsy of the prostate suggests a moderate grade cancer (Gleason grade 5-7). A decision regarding treatment or active surveillance needs to be made. In such cases, the application of a functional imaging test might be used to determine cancer extent and assess cancer aggressiveness.

EXAMPLE #2: Established Imaging + Investigational Biomarker(s) Approach

Lung Cancer: Indeterminate lesion on imaging triggers subsequent biomarker(s) study: The results from the National Lung Screening Trial (NLST) of high-risk current and former smokers found that low-dose helical computed tomography (CT) decreased lung cancer mortality by 20%. Data from the NLST suggest that a reduction in mortality of more than 23,000 per year could be achieved by population screening for lung cancer in people who currently use tobacco. However, 25% of the subjects in the CT arm of NLST demonstrated abnormalities and 95% of those lesions were determined to be false-positives. Lesions thought to be malignant on imaging often require additional diagnostic procedures resulting in increased radiation exposure, needle biopsy or other invasive procedures such as thoracotomy. Potentially serious complications can result from these procedures and delay treatment of aggressive cancer.

While diagnostic imaging based strategies to address this problem are ongoing, many questions remain given the high false positive rate of CT. The ability to better stratify patients at risk and to determine which CT or X-ray detected lung nodules truly represent aggressive lung cancer in a safe, cost effective manner could facilitate early treatment and thereby improve lung cancer outcomes while minimizing complications from diagnostic procedures performed on patients without lung cancer.

A specific example for combining a known imaging method with an investigational biomarker is that after a positive CT for lung cancer, a biomarker or panel biomarkers with very high sensitivity for cancer and even modest specificity (high negative predictive value) could be subsequently used to eliminate a large fraction of false positive nodules and unnecessary follow up procedures.

EXAMPLE #3: Investigational Imageable Biomarker(s) + Clinical Standard-of-Care + Established Calibration or Gold Standard for Multi-Site Clinical Validation Studies

Pancreatic Cancer: Investigational imageable biomarker(s) combined with standard-of-care diagnostic tests and an established reference standard or calibration standard triggers active surveillance of high-risk cohorts or additional studies: The poor prognosis of Pancreatic Ductal Adenocarcinoma (PDAC) is primarily due to its advanced stage at diagnosis. Pancreatic cancer does not exhibit early symptoms, and symptoms, when they do occur, are often nonspecific. Consequently, patients often present with locally advanced or metastatic disease. Surgical resection is currently the only potentially curative treatment, but it is only possible for 15-20% of patients, and most patients who undergo surgical resection will have disease recurrence. Studies suggest an average of approximately 17 years between the occurrence of the initiating mutation and the acquisition of metastatic potential in PDAC. This window of time may offer an opportunity for curative interventions if the disease could be diagnosed at an earlier stage.

Most imaging strategies for pancreatic cancer include invasive studies such as endoscopic retrograde cholangiopancreatography or endoscopic ultrasound (EUS). Having a safe, highly discriminatory, noninvasive tool to detect PDAC would provide a mechanism for these patients to be screened safely and effectively, with the hope of decreasing mortality from PDAC through early detection. Currently available modalities for screening for pancreatic cancer are mostly anatomical, including traditional cross-sectional imaging such as abdominal ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), and invasive imaging such as EUS. Traditional cross-sectional imaging has little role in screening for sporadic pancreatic cancer. There have been significant advances in biomedical imaging and related physical technologies that may allow for the detection of PaniN-3s and early stage PDAC. For example, quantitative EUS elastography and microbubble contrast-enhanced EUS, which allow better visualization and delineation of focal pancreatic lesions.

Patients with IPMN and MCN are at high risk of developing PDAC. IPMNs and MCNs can be detected by abdominal imaging because they produce radiographically identifiable ductal dilatations and have been increasingly identified using abdominal imaging such as CT done for workup of nonspecific symptoms. However, the natural history of these lesions is not well defined. An estimated 15% of PDAC originate from these lesions. One-third of IPMNs are associated with an invasive carcinoma, and at the time of diagnosis, there is a 40% to 50% chance of the IPMN already being cancerous. MCNs are large mucin-producing pre-cancerous lesions that are less common than IPMNs. MCNs can progress to PDAC, and one-third of patients with resected MCNs have cancer. 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 difficult to distinguish pre-cancerous 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 accurate biomarkers, imaging protocols and the development of imageable biomarkers to identify high-grade dysplasia and risk of progression.

Specific Research Objectives

This FOA will support collaborative research focused on the integration of imaging and biomarker(s) applied specifically toward improving current clinical methods used for cancer screening, early detection of aggressive cancer, assessment of cancer risk and diagnosis.

Scientific areas appropriate for Applications under this FOA

Applicable clinical research directions could include, but not be limited to, the following:

  • Use of molecular diagnostic tests to evaluate lesions observed by imaging and biomarker(s) to distinguish aggressive from indolent cancer or benign lesion from cancer.
  • Use of imaging to evaluate biomarker results to improve sensitivity and specificity of early detection and diagnostic tests.
  • Correlation of imaging with genomic results (radiogenomics) or other omics' results, such as the rich TCGA database.
  • Combine and develop multiplexed panels of both multimodality molecular imaging and multiplexed biomarker panels that could improve current standards-of-care for screening, early detection of aggressive cancer, assessment of risk or diagnosis.

Appropriate strategies used to optimize the performance of imaging and biomarker approaches for ultimate clinical validation include:

  • Leveraging advances in novel imaging methods that can perform across wide resolution scales from the molecular, cellular and organ level either by external tomography, localized detectors or implanted devices in vivo or as applied to laboratory methods;
  • Leveraging advances in novel multi-parametric biomarker detection technologies and approaches including genomics, proteomics, epigenomics, metabolomics, radiogenomics, and histologic approaches; and/or
  • The development of informatics resources to help optimize the above strategies and support sharing of data and validation methods to promote more standardized approaches for data integration and clinical decision support for combining laboratory, imaging and/or imageable biomarkers.

The optimization, application and validation of emerging imaging or biomarker approaches targeted specifically for clinical application are appropriate and can include:

  • Novel imaging probes or contrast (enhancing) agents applied to established, commercially available imaging instrumentation would be considered if used to answer a well-defined clinically significant question, and, quantitative reference standards are used for verification and validation.
  • Customized imaging probes or approaches incorporated into commercially available imaging instrumentation that might be acceptable include, but not limited to: positron emission tomography (PET), single photon-emission computed tomography (SPECT), magnetic resonance (MR) imaging, computed tomography (CT), ultrasound (US), photo acoustic imaging (PAI), nuclear polarization (NP) and photonic based approaches.

NCI has a rich history of support for collaborative networks, resources, archives and biorepositories including, but not limited to:

  • Early Detection Research Network (EDRN);
  • Alliance of Glycobiologists (AG);
  • Molecular Characterization of Screen Detected Lesions (MCL) Consortium;
  • American College of Radiology Imaging Network (ACRIN);
  • Network for Translational Research (NTR);
  • Oncology Co-Clinical Imaging Research Resources to Encourage Consensus on Quantitative Imaging Methods and Precision Medicine (OCIRR);
  • Informatics Technology for Cancer Research (ITCR);
  • Quantitative Imaging Network (QIN); and/or
  • Related public resources such as:
  • The Cancer Genome Atlas (TCGA);
  • Cancer Imaging Archive (TCIA); and
  • EDRN data archives and biorepositories.

While there is no requirement that investigators submitting applications to this FOA incorporate existing NCI collaborative networks, resources, archives or biorepositories into their experimental design, it is expected that the research funded through this FOA will take advantage of, whenever possible and appropriate, currently available NCI resources, expertise and collaborations.

Consortium Goals

The CIB will be structured around individual scientific Units, funded through this FOA. Although the Units will be funded by individual U01 awards and will operate independently, they will be required to interact closely with other Consortium awardees, engage in collaborative activities, and share resources, ideas and expertise beyond the scope of a single research team. Teams will collaboratively develop Standard Operating Procedures (SOPs) and Common Data Elements (CDEs) for future pre-clinical and clinical validation studies.

Consortium Administrative Structure

Steering Committee: All scientific Units of the Consortium will be linked through a governing body, the Steering Committee. The Steering Committee will include representatives of the Consortium awardees and the NCI Project Coordinator. In addition, Chairs of other NIH programs may serve on the Steering Committee as ex officio members. The responsibilities of the Steering Committee include managing, overseeing and coordinating the integration of efforts among the awardees and all collaborative activities, including uniform standards of specimen and data collections and analysis. The Chair and co Chair of the Steering Committee will be PDs/PIs of the Cooperative Agreement awards and will be selected by the Steering Committee in consultation with NCI. Further details of Steering Committee composition and responsibilities are provided in Section VI. Award Administration Information. Cooperative Agreement Terms and Conditions of Award.

Consortium Coordinating Unit: Application for the Consortium Coordination responsibilities is optional. The NCI will select one of the funded Units to serve as the Consortium Coordinating Unit, from the applicants who also apply for this responsibility. Additional funds will be provided for performing this role. Applications should include appropriate budgetary information and justification in their application as well as describe their available resources, and, what services they plan to provide to the Consortium. These activities may include, but are not limited to:

  • Providing logistical and administrative assistance in arranging meetings to allow for efficient interactions, consultations, and oversight functions of the Steering Committee (e.g., preparing, distributing and maintaining minutes);
  • Working with NCI Program Staff to develop and maintain an interactive webpage to publicize the activities of the Consortium, to announce the availability of Consortium-supported resources and receive input from investigators;
  • Developing and maintaining a "listserv", Consortium documents including SOPs, standard procedures/protocols for data analysis and specimen collection;
  • Supporting the development, coordination, implementation, and conduct of Consortium collaborative research protocols;
  • Supporting the formation and distribution of Consortium materials relevant to Consortium members.

Research projects that are not appropriate for this FOA

This FOA will NOT support the development of new imaging technology or approaches aimed at biomarker discovery. This FOA specifically focuses on facilitating multidisciplinary collaboration of experts from the imaging and biomarker research communities for the sole purpose of developing integrative imaging and biomarker(s) approaches for the cancer screening, early detection of aggressive cancer, assessment of cancer risk and cancer diagnosis.

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



The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Clinical Trials Not Allowed for due dates on or after January 25, 2018: 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

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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)


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


  • 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
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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) (formerly CCR) 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.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or registration. 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.
  • Applicants must have an active DUNS number and SAM registration in order to complete the 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.

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

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Richard Mazurchuk, Ph.D.
National Cancer Institute (NCI)
Division of Cancer Prevention
Telephone: 240-276-7126

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.

R&R or Modular Budget

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

a) PD(s)/PI(s) Effort: The PD/PI must include a minimum of 3.0 person months of his/her time per year. For multiple PD/PI applications, the contact PD/PI must include a minimum of 3.0 person months of his/her time per year and all other PDs/PIs must include a minimum of 1.5 person months of their time per year to the award. This commitment cannot be reduced in later years of the award.

b) Restricted Travel Expenses Budget: Applicants must budget for travel and per diem expenses for Steering Committee meetings. In the first year, applicants should plan for the PD/PI and an additional senior investigator to attend a Planning Meeting and one Steering Committee meeting. In the second and subsequent years, applicants should plan for the PD/PI and another investigator to attend one Steering Committee meeting per year.

c) Budget Information Related to Consortium Coordination Activities: Application for the Consortium Coordination responsibilities is optional. For this purpose, applicants interested in coordination responsibilities should provide a separate section for this role in the Budget Justification, under the heading "Coordinating Unit Responsibilities".

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: In addition to the specific aims and approach(es), applicants should include the relevance of the research to the objectives of this FOA.

Research Strategy:


Outline the overall theme of the proposed research and the unmet clinical need that the proposed research addresses as well as the Significance of the proposed studies. It is essential that each Unit identify and concentrate resources on the most promising scientific opportunities, studies be completed as planned, and methodologies employed are sound, and where appropriate, innovative. For each of the proposed research approaches, the following strategies should be used, wherever relevant.

  • Define the nature and scope of the investigative and established research approach(es) proposed;
  • Determine the specificity and sensitivity of a combined imaging, biomarker(s), or imageable biomarker to detect early stage aggressive cancer;
  • Determine the accuracy of imaging, biomarker(s) or imageable biomarkers to predict the extent or severity of disease;
  • Perform comprehensive studies, whenever appropriate, in targeted, high-risk populations for validation and potential integration of novel detection strategies;

Study Design

A study may involve the use of retrospectively and/or prospectively collected clinical specimens or pre-clinical animal models of disease. A clear statement on how the research proposed addresses an unmet clinical need is required and as well as how statistical power is defined when using multiple biomarkers and multi-modality imaging platforms and what sample size is required to achieve the power used for statistical analysis. Examples of power definition: (a) the probability to detect at least one of possible true non-zero effects; (b) the probability to detect all non-zero effects; and (c) true discovery rate, etc. The Cooperative Agreement support mechanism includes substantial federal scientific or programmatic involvement to assist, guide, coordinate, or participate in project activities. This includes complex statistical methods performed for power determinations when multiple platforms and panels of biomarkers need to be analyzed.

Collaborative Responsibilities

Each Unit should provide plans for working collaboratively with the other Consortium Units to facilitate the discovery, verification, pre-clinical and clinical validation as well as clinical application of biomarkers through participation in multi-institutional studies whenever appropriate. The Units will provide expertise on cohorts, protocol development, and pathological assessment, and will participate in data quality control, analysis, and interpretation of pre validation and validation studies whenever appropriate.

Letters of Support: In addition to the standard items, please provide letters from collaborators documenting access to appropriate samples, animal models and/or high-risk patient populations.

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, with the following modification:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

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 (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 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 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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research 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.


Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?


Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?


Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?


Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in 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 children, justified in terms of the scientific goals and research strategy proposed?


Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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 six 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 six 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 Children

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 children 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.


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.


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.


Not Applicable


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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Center for Scientific Review 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:

  • 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.
  • Will receive a written critique.

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 grantee’s business official.

Awardees 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.

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, Grantees, 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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see; and Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at

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, 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 awardees 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 resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

Primary responsibilities of the PD(s)/PI(s):

The PD(s)/PI(s) will have primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of studies conducted under this program. The PD(s)/PI(s) assume responsibility and accountability to the applicant organization officials and to the NCI for the performance and proper conduct of the research supported by the U01 award.

Specific PD/PI responsibilities and rights include:

  • Coordinating efforts and cooperating with the other U01 components of the CIB and with NCI Program staff. These actions include (but will not be limited to) participation in appropriate CIB designated meetings and/or working groups, and/or teleconferences as needed;
  • Overseeing the implementation of the approved data sharing plan and resource sharing plan; Institutions/organizations participating in the CIB will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the CIB;
  • Annotation of samples, SOPs and protocols used for data acquisition and analysis through the use of Consortium-defined guidelines and Common Data Elements (CDEs).

Awardees 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 DHHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

A designated NCI Program Staff member, acting as a Project Scientist, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.

Specifically, the NCI Project Scientist(s) will:

  • Coordinate and facilitate the interactions among all the U01 awardees under this initiative;
  • Work closely with investigators on Collaborative Research projects to coordinate and facilitate interactions/collaborations among the U01 awardees across the CIB;
  • Serve as liaison between the Collaborative Research awardees and NCI staff members and investigators from other NIH or NCI programs, such as the NCI Center for Bioinformatics and Information Technology (CBIIT), the Quantitative Imaging Network (QIN), or the Early Detection Research Network (EDRN), if appropriate, facilitating interactions and scientific integration among the U01 awardees and these programs;
  • Review of all major collaborations that the awardee might propose with research groups outside the CIB and advise on their appropriateness before implementation to assure consistency with the goals of this FOA;
  • Provide technical assistance and advice to the awardees as appropriate;
  • Assist in avoiding unwarranted duplication of effort with other NCI efforts;
  • Monitor institutional commitments and resources to the awardees;
  • Suggest reprogramming efforts, including options to modify projects/programs when certain objectives of this FOA are not met - specifically, the NCI Project Scientist may recommend withholding of support, suspension, or termination of a U01 award for lack of adherence to required policies and/or procedures;
  • Develop working groups and trans-project efforts as needed;
  • Monitor progress and direction of awardees and working groups as needed; and
  • Organize and conduct regular meetings to share progress either by teleconference, videoconference, or face-to-face, as needed between the U01 awardees of the CIB.

In addition, an NCI Program Official will be responsible for the normal scientific and programmatic stewardship of the awards and will be named in the award notice. The Program Official may also have substantial programmatic involvement (as a Project Scientist) and may be the same person as Project Scientist. In that case, the individual involved will not attend peer review meetings, or will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Areas of Joint Responsibility include:

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

  • Two representatives from each Consortium award (the PD(s)/PI(s) or a PD/PI and a designated senior investigator) who will have one vote each; and
  • NCI Project Coordinator (who will have one vote).

The NCI Program Official and Project Scientist(s) will participate in Steering Committee meetings as non-voting members. Additional NIH staff members, serving in an advisory capacity, may also participate in these meetings as non-voting members. This decision will be made by the existing voting members of the Steering Committee. These members may include representatives from NCI extramural divisions and a representative from the NCI CBIIT.

The Chair of the Steering Committee will be selected from the representatives of all awardees.

In addition, Chairs of other NIH programs may serve on the Consortium Steering Committee as ex officio members.

The Steering Committee will meet once every year, at locations selected by the Steering Committee in consultation with the NCI.

The Steering Committee may decide to establish sub-committees for specific purposes. The NCI Project Coordinator will serve on such sub-committees, as they deem appropriate.

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

  • Establishing Consortium policies and procedures;
  • Establishing policies and procedures for collaborative projects, protocols, and Consortium-defined projects;
  • Setting the overall research priorities for the Consortium and identifying emerging research opportunities which can be best explored through a joint collaborative effort via the Consortium;
  • Serving as a nucleus for a broader outreach to the entire extramural research community investigating indolent versus aggressive cancers or cancers detected via existing screening programs or based on the appearance of clinical symptoms.

Joint Consortium Activities: A significant part of the Consortium will be Joint Consortium activities. While each funded Unit will be largely self-sufficient, investigators will be expected to devote a portion of their effort to participating in collaborative activities with other Consortium members. The individual Unit will have access to resources, information, technologies, ideas, and expertise that are beyond the scope of any single research Unit. Awardees will be charged with developing collaborative projects, resources for the community, and where possible, Consortium-sponsored outreach activities. These efforts will require interaction and collaboration among Consortium-funded investigators and/or with other investigators. Support for these collaborative activities will be provided by the restricted funds of each U01 award. The plans to use these restricted funds will be subject of review and approval by the Consortium Steering Committee and final approval by the NCI to release specific funds from the individual U01 awards.

The Consortium will:

  • provide an appropriate venue for close interactions among investigators;
  • facilitate exchange of data and comparison of results obtained across a variety of tumors; and,
  • disseminate expertise that may be initially concentrated within a single Unit.

The NCI will ensure common access to Consortium-generated resources for the broader cancer research community. The NCI will also encourage the Consortium members to interact with existing NCI-supported multidisciplinary Units.

To facilitate communications among the participants in the Consortium and between the Consortium and the NCI, the NCI will establish and maintain an internet-based information technology solution for rapid data and document transmission and electronic communications for the Consortium.

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 awardee. This special dispute resolution procedure does not alter the awardee'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, awardees 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 progress report, 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 awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free) Customer Support (Questions regarding registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Richard Mazurchuk, Ph.D
National Cancer Institute (NCI)
Telephone: 240-276-7126

Keyvan Farahani, Ph.D.
National Cancer Institute (NCI)

Peer Review Contact(s)

Solita Chiayeng Wang, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-2397

Financial/Grants Management Contact(s)

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291

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 42 CFR Part 52 and 45 CFR Part 75.

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