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
Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Data and Resource Coordination Center (CAP-IT DRCC) (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
New
Related Notices

  • July 20, 2021 - Notice of Pre-application Webinar for Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) - RFA-CA-21-038 and RFA-CA-21-039. See Notice NOT-CA-21-097.
  • Funding Opportunity Announcement (FOA) Number
    RFA-CA-21-039
    Companion Funding Opportunity
    RFA-CA-21-038 , U54 Specialized Center (Cooperative Agreements)
    Assistance Listing Number(s)
    93.396
    Funding Opportunity Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to solicit Applications for the Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Data and Resource Coordination Center (CAP-IT DRCC) (U24). The overall goal of this FOA and the companion FOA (U54 CAP-IT Specialized Centers, RFA-CA-21-038) is to establish an agile and effective network infrastructure to undertake collaborative research focusing on precision cancer prevention and interception, with the overarching goal of discovering molecularly or immunologically targeted agents designed to prevent or intercept the oncogenic process in higher-risk populations. The CAP-IT network will be formed by up to three U54 Specialized Centers (RFA-CA-21-038) and one U24 CAP-IT DRCC (this FOA). The CAP-IT DRCC will function as the Program’s centralized data management and network activity coordination center.

    Key Dates

    Posted Date
    July 15, 2021
    Open Date (Earliest Submission Date)
    September 07, 2021
    Letter of Intent Due Date(s)

    September 07, 2021

    Application Due Dates Review and Award Cycles
    New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
    October 07, 2021 Not Applicable Not Applicable March 2022 May 2022 July 2022

    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.

    No late applications will be accepted for this Funding Opportunity Announcement

    Expiration Date
    October 08, 2021
    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

    This Funding Opportunity Announcement (FOA) solicits Applications for the Cancer Prevention-Interception Targeted Agent Discovery Program (CAP-IT) Data and Resource Coordination Center (CAP-IT DRCC) (U24). The overall goal of this FOA and the companion FOA (U54 CAP-IT Specialized Centers, RFA-CA-21-038) is to establish an agile and effective network infrastructure to undertake collaborative research focusing on precision cancer prevention and interception, with the overarching goal of discovering molecularly or immunologically targeted agents designed to prevent or intercept the oncogenic process in specific higher-risk populations. In this FOA, cancer prevention means primary prevention of cancer before the oncogenic process begins, while cancer interception is defined as disruption of the oncogenic process during the precursor or precancer state or stage. Precision cancer prevention-interception refers to an approach employing cancer preventive-interceptive interventions individually tailored for different higher-risk populations such as those with hereditary cancer syndromes (HCS) and individuals diagnosed with high-grade precursor abnormalities that place individuals at higher risk of cancer e.g., precancer. To achieve the Program's overarching goal, CAP-IT research objectives are:

    • To identify targets that can be potentially exploited for cancer preventive or interceptive interventions specifically in higher-risk populations, by collaborating with the NCI and other programs with a research focus on molecular profiling of precancer, early cancer, and/or oncogenic signaling pathways. High-value tumor-driving molecular targets/pathways, immune targets, and tumor-specific/tumor-associated antigens, collectively referred to as "oncotargets" in this FOA, will be prioritized for the discovery of targeted interventions;
    • To functionally validate the critical roles of the high-value oncotargets in tumor initiation and/or progression to invasive cancer and select oncotargets suitable for targeted intervention strategies; and
    • To discover innovative targeted agents through in vitro and in vivo efficacy evaluation and advance promising efficacious agents to the NCI's existing R&D pipeline for further development.

    The CAP-IT network will be formed by up to three U54 Specialized Centers (the companion FOA [RFA-CA-21-038] and one U24 Data and Resource Coordination Center (this FOA).

    The CAP-IT DRCC will function as the Program’s centralized data management and network activity coordination center with the following responsibilities:

    1. CAP-IT research database: Establishing and managing a centralized CAP-IT research database for the entire network in coordination with each CAP-IT Center’s Informatics group in accordance with the policies established by the CAP-IT Steering Committee (CAP-IT SC).
    2. Network research tools and resources information: Facilitating in-network sharing of research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens, and agents) by establishing a centralized information hub for shareable tools and resources in accordance with the policies established by the CAP-IT SC.
    3. Program operational support: Providing program management support, including logistical and administrative assistance on in-network communications and cross-network collaborative activities, and coordinating and facilitating network-wide meetings (e.g., CAP-IT SC meetings, Annual CAP-IT Investigators’ meetings, workshops, and seminars).

    Key Definitions for the Context of this FOA

    • Cancer prevention: Cancer prevention is defined as primary prevention of cancer before the oncogenic process begins.
    • Cancer interception: Cancer interception is defined as disruption of the oncogenic process during the precancer stage before the development of invasive cancer.
    • Higher-risk populations, higher-risk cohorts: These are individuals with an increased risk of cancer such as those with hereditary cancer syndromes (HCS) and precursor abnormalities that place individuals at higher risk of cancer e.g., precancer.
    • Precision cancer prevention and interception: Precision cancer prevention-interception refers to an approach employing cancer preventive-interceptive interventions individually tailored for different higher-risk populations.
    • Oncotargets: Tumor-driving molecular targets/pathways, immune targets, and tumor-specific/tumor-associated antigens are collectively referred to as oncotargets in this FOA.
    • Actionable oncotargets: These represent previously identified and well-characterized targets as drivers or enhancers of oncogenesis, against which efficacious agents are already available for clinical studies but have not been explored for cancer prevention and interception.
    • Potentially exploitable oncotargets: These represent targets that are considered as potential drivers or enhancers of oncogenesis, detected in tumor precursor cells or in tumor stroma, which consists of immune cells, fibroblasts and other stromal components, and are prioritized based on the extent of expression, cell-type specificity (e.g. precancerous cells, tumor stromal components, and normal cells), types (i.e. mutated vs. wild type proteins), cellular expression patterns, timing (e.g. expressed early in oncogenesis), and prevalence of target expression among a defined higher-risk cohort.

    Background

    While much progress has been made in the development of new or improved methods of determining cancer risk and detecting and monitoring emerging precancer, current approaches for cancer risk reduction are still centered on surgical procedures. With the increasing knowledge of early drivers of the oncogenic process, reduction in cancer mortality can be significantly improved if oncogenic pathway-targeted interventions are successfully deployed to further mitigate cancer risk and better manage precancer especially in higher-risk populations. Because higher-risk populations represent a diverse group of individuals with different genetic susceptibilities, varying histories of exposure to carcinogens, different lifestyles, age, gender, and the presence of other comorbidities, it is nearly impossible to find and deliver universally efficacious cancer preventive interventions in this heterogenous population. A more rational approach to cancer prevention and interception in higher-risk cohorts is to employ preventive measures specifically tailored for individual risk factors, an approach referred to as precision cancer prevention-interception. Success of precision cancer prevention-interception depends on two complementary steps. First, higher-risk individuals need to be identified, e.g., through screening and early detection of precursor/precancers, some of which may progress to cancer, and testing for genetic susceptibility. Second, innovative, safe, and efficacious measures designed to reduce cancer risk or molecularly/immunologically intercept, arrest, and possibly eliminate precancer in these higher-risk individuals are needed to complement or replace surgical resection or ablation. However, because very few target-specific agents are available for these higher-risk individuals, current cancer interception strategies predominantly rely on surgical interventions. It is this gap in discovering and bringing risk-tailored targeted agents to the higher-risk populations for cancer prevention and interception that CAP-IT will address.

    Beginning with the earliest stage of tumor formation through the establishment of fully invasive cancers, oncogenesis is a continuum of dynamic interplay between emerging aberrant cell clones and the host tumor surveillance machineries. Better understanding of the early oncogenic processes and surveillance machineries can shed light on molecular physiological changes that are responsible for driving progressive tumor growth and weakening the host defense mechanisms. Recent advances in cancer immunotherapy with immune checkpoint inhibitors have indicated that the host’s own defense system can indeed mount effective antitumor immune responses if the tumor-associated immunosuppressive microenvironment is overcome by immune checkpoint blockade. Importantly, growth and progression trajectories of screen-detected and incidentally identified precancers are not uniform or linear. Biological and molecular events and changes in tumor precursor cells as well as in the tissue microenvironment can potentially tilt the balance for or against tumor growth. Some of these events may serve as oncotargets that can be exploited.

    The Human Tumor Atlas Network (HTAN) includes the Pre-Cancer Atlas (PCA), which specifically aims to: 1) construct comprehensive, dynamic, high-resolution, multidimensional, multiparametric, temporal and scalable atlases of precancer and their surrounding microenvironment and 2) more deeply understand the transition from pre-malignant to malignant state as a function of time, so better risk stratification and effective early intervention strategies can be developed. In addition to PCA, there are existing NCI programs with accessible genomic and molecular profiles and biomarker databases, including NCI Consortium of Molecular and Cellular Characterization of Screen-detected Lesions (MCL), the Cancer Genome Atlas (TCGA; through NCI Genomic Data Commons, GDC), NCI Clinical Proteomic Tumor Analysis Consortium (CPTAC), and Cancer Target Discovery and Development (CTD2). Furthermore, Early Detection Research Network (EDRN) and other biomarker discovery and translational research initiatives continually uncover oncogenic driver pathways and networks, some of which can be targeted to prevent or intercept the oncogenic process. CAP-IT is intended to take advantage of these existing program databases that can reveal potentially exploitable oncotargets and critical oncogenic modules for new agent discovery research.

    In targeted agent discovery, it is a prerequisite that viable and high-value targets be first functionally validated for their critical roles in the disease process, such as oncotargets for oncogenesis. Oncotargets validated and prioritized for agent discovery research may include actionable targets and those that are new but deemed potentially exploitable for interventions. Actionable targets represent previously identified and well-characterized targets as drivers or enhancers of oncogenesis, against which efficacious agents are already available for clinical studies but have not been tested for cancer prevention and interception. These agents include FDA approved or clinically investigated agents. Potentially exploitable targets represent those that are considered as potential drivers or enhancers of oncogenesis; detected in tumor precursor cells or in tumor stroma, which consists of immune cells, fibroblasts and other stromal components; and can be prioritized based on the extent of expression, cell-type specificity (e.g. precancerous cells, tumor stromal components, and normal cells), types (i.e. mutated vs. wild type proteins), cellular expression patterns, timing (e.g. expressed early in oncogenesis), and prevalence of target expression among a defined higher-risk cohort.

    One example of a successful outcome of molecularly targeted cancer preventive-interceptive intervention is the inhibition of hedgehog (HH) pathway in individuals with Gorlin syndrome. This autosomal-dominant cancer predisposition syndrome is caused by germline mutations in the tumor suppressor gene Patched-1 (PTCH1), which result in the aberrantly activated HH signaling and drive the growth of basal cell carcinomas (BCCs) of the skin. Use of a topical HH inhibitor has been shown to reduce BCC burden as well as to prevent new BCC growth in the affected individuals (J Clin Oncol 2018, 36: e21626). Other examples of potentially exploitable oncotargets that have been reported in the literature include DCLK1 for pancreatic precancer (Cell Stem Cell 2016, 18:441), OXPHOS pathway for lung precancer (Clin Cancer Res 2017, 23: 5091), frameshift mutation-derived neoepitopes in Lynch syndrome (Nat Comm 2020, 11:4740), progression-associated mutation-derived neoepitopes in lung adenomatous precancer (Cancer Res 2019, 79:5022), and WNT/CTNNB1 signaling pathway in familial adenomatous polyposis (JAMA Oncol 2018, 4:1085).

    CAP-IT establishes a new discovery research paradigm in cancer prevention that leverages the potential oncotarget leads identified from precancer biology research and related databases and exploits their oncogenic characteristics and vulnerabilities to discover innovative cancer prevention-interception agents especially focusing on higher-risk populations. The ultimate goals of CAP-IT are to advance newly discovered efficacious cancer preventive or interceptive agents to the existing NCI, Division of Cancer Prevention preclinical and clinical development pipelines, PREVENT Program for further development towards IND and Cancer Prevention Clinical Trials Network (CP-CTNet) for early phase clinical trials, and thereby to establish a scientific roadmap and a more streamlined foundational infrastructure for fast-tracking agent discovery and development for cancer prevention and interception from bench to bedside.

    CAP-IT Goals and Functions of the CAP-IT DRCC

    The CAP-IT program's overarching goal is to discover molecularly or immunologically targeted agents designed to prevent or intercept the oncogenic process for precision cancer prevention and interception. To achieve the goal, CAP-IT research objectives are as follows:

    • To identify targets that can be potentially exploited for cancer preventive or interceptive interventions specifically in higher-risk populations, by collaborating with the NCI and other programs with a research focus on molecular profiling of precancer, early cancer, and/or oncogenic signaling pathways. High-value tumor-driving molecular targets/pathways, immune targets, and tumor-specific/tumor-associated antigens, collectively referred to as "oncotargets" in this FOA, will be prioritized for the discovery of targeted interventions;
    • To functionally validate the critical roles of the high-value oncotargets in tumor initiation and/or progression to invasive cancer and select oncotargets suitable for targeted intervention strategies; and
    • To discover innovative targeted agents through in vitro and in vivo efficacy evaluation and advance promising efficacious agents to the NCI's existing R&D pipeline for further development.

    The CAP-IT network will be formed by up to three U54 Specialized Centers (the companion FOA, RFA-CA-21-038) and one CAP-IT DRCC (this FOA).

    The CAP-IT DRCC will function as the Program’s centralized data management and network activity coordination center with the following responsibilities:

    1. CAP-IT research database: Establishing and managing a centralized CAP-IT research database for the entire network in coordination with each CAP-IT Center’s Informatics group in accordance with the policies established by the CAP-IT SC.
    2. Network research tools and resources information: Facilitating in-network sharing of research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens, and agents) by establishing a centralized information hub for shareable tools and resources in accordance with the policies established by the CAP-IT SC.
    3. Program operational support: Providing program management support, including logistical and administrative assistance on in-network communications and cross-network collaborative activities, and coordinating and facilitating network-wide meetings (e.g., CAP-IT SC meetings, Annual CAP-IT Investigators’ meetings, workshops, and seminars).

    The CAP-IT DRCC must have appropriate expertise, background, skills, managerial capacity, and established infrastructure required to carry out the Center responsibilities and must have the following key attributes:

    1. Leadership and Management Vision: The CAP-IT DRCC must be able to provide centralized data management for the CAP-IT in coordination with each CAP-IT Center Informatics group. Accordingly, the CAP-IT DRCC must demonstrate strong leadership, innovative thinking, expertise, and managerial capacity to bring individual Center Informatics groups together and build the database team to implement data management and sharing policies established by the CAP-IT SC.
    2. Data Coordination and Centralized Data Management: The CAP-IT DRCC must be able to work closely and coordinate with each CAP-IT Center Informatics group, formulate and deploy management techniques for quality data collection and integration, develop and maintain a centralized database, and devise and implement secure procedures for data management and in-network sharing. The CAP-IT DRCC will leverage, where feasible, technology from related NCI-sponsored informatics initiatives, for example the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of algorithms, tools, and resources across the continuum of cancer research.
    3. Resource Coordination: In addition to in-network sharing of the Program research data, the CAP-IT DRCC is expected to facilitate in-network sharing of shareable research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens and agents) generated through the conduct of CAP-IT research in accordance with the policies established by the CAP-IT SC. The CAP-IT DRCC should plan to work with each CAP-IT Center Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) or their designated representative(s) on creating a centralized information hub concerning network-shareable digitally identifiable research tools and resources in accordance with the policies established by the CAP-IT SC. The CAP-IT DRCC should also establish access protocols for these data to facilitate efficient sharing of shareable resources and technologies among CAP-IT investigators.
    4. Administrative and Logistical Support: The CAP-IT DRCC is expected to provide program management support, including administrative and logistical assistance on in-network communications and cross-network collaborative activities, and coordinate and facilitate network-wide meetings. The CAP-IT DRCC must establish and maintain unified and coordinated procedures for network-wide communications with the CAP-IT Centers and NCI and be able to function as an information and implementation hub for CAP-IT trans-network activities.

    CAP-IT Network, Governance and Trans-Network Activities

    Because of the complexity and highly specialized nature of research activities required to achieve the Program's research objectives, the CAP-IT network will be formed by up to three U54 CAP-IT Centers (the companion FOA, RFA-CA-21-038) and one U24 CAP-IT DRCC (this FOA). The ultimate goals of the Program are to advance newly discovered efficacious cancer preventive or interceptive agents to the existing NCI, Division of Cancer Prevention preclinical and clinical development pipelines, PREVENT Program for further development towards IND and Cancer Prevention Clinical Trials Network (CP-CTNet) for early phase clinical trials, and thereby to establish a scientific roadmap and a more streamlined foundational infrastructure for fast-tracking agent discovery and development for cancer prevention and interception from bench to bedside.

    Upon the inception of the Program, the CAP-IT SC will be formed, consisting of CAP-IT Centers’ PIs, CAP-IT DRCC PI, and NCI staff members. For details on the composition and responsibilities of the CAP-IT SC, see Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.

    Once the network is established, each CAP-IT Center (U54) is expected to develop new additional projects under the direction of the CAP-IT Center PDs/PIs and other designated leadership members. All new CAP-IT projects will be subject to NCI approval in accordance with the Cooperative Agreement Terms and Conditions of Awards. The CAP-IT DRCC may be tasked to aid new project development processes by facilitating in-network communications and sharing of data, resources and/or tools.

    CAP-IT Trans-Network Activities applicable to the CAP-IT DRCC will include but are not limited to:

    • Interacting with the CAP-IT Centers’ informatics groups to establish a centralized CAP-IT research database for in-network data archiving and sharing in accordance with the policies established by the CAP-IT SC;
    • Facilitating in-network sharing of new research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens and agents) developed through the conduct of CAP-IT research by establishing a centralized information hub for shareable tools and resources in accordance with the policies established by the CAP-IT SC;
    • Coordinating, facilitating, and participating in network-wide meetings, such as an Annual CAP-IT Investigators’ Meeting, workshops, seminars and CAP-IT SC meetings.

    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

    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 $400,000 in fiscal year 2022 to fund one award. It is expected that $400,000 per year will be available in FY 2023 - 2026, but future year amounts will depend on annual appropriations.

    Award Budget

    The award budget should not exceed $240,000 per year in direct costs, including subawards.

    Award Project Period

    The maximum 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 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.

    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:

    Shizuko Sei, M.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-5005
    Email: seis@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.

    R&R Budget

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

    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:

    For this FOA, the Research Strategy must consist of the following sub-sections A - E.

    Sub-section A. The Overview of the Proposed CAP-IT DRCC Capabilities

    This section must address the following key elements:

    1. The overall vision of the proposed CAP-IT DRCC to achieve the Center’s key responsibilities and support CAP-IT research objectives. Describe any unique approaches that reflect innovative and strategic thinking.
    2. The proposed organization and staffing of the CAP-IT DRCC. Without repeating information in individual biosketches and Facilities and Other Resources, highlight major strengths and critical experience of the proposed leadership and key personnel team, particularly in experiences in database construction and management, program communications and coordination in support of multi-institutional projects and/or trans-disciplinary research program, and logistical support to promote scientific collaborations.
    3. Institutional infrastructures and resources available to the proposed CAP-IT DRCC. Describe the institutional resources that can contribute to the successful operation and activities of the CAP-IT DRCC, including but not limited to collecting and integrating individual CAP-IT Center’s research data; managing the Program centralized database; facilitating in-network data and resource sharing and trans-Center collaborations and interactions; facilitating the planning of the Annual Investigators’ meeting and addressing logistics; and providing program management support.

    Sub-section B. Leadership and Administration Unit

    This section must address the following key aspects:

    1. The structure and organization of the Leadership and Administration Unit of the proposed CAP-IT DRCC.
    2. Mechanism(s) of general oversight on the proposed CAP-IT DRCC operation and its contributions to the CAP-IT and plans to ensure the CAP-IT DRCC will meet the Center responsibilities.
    3. Plans and capacity for providing administrative and logistical support for trans-network activities for the CAP-IT (e.g., the Annual CAP-IT Investigators’ Meetings and CAP-IT SC Meetings) and facilitating in-network communications and cross-network collaborative activities.

    Sub-section C. CAP-IT Centralized Database Management

    This section must address the following key aspects:

    1. Plans for collaborating and coordinating with each CAP-IT Center Informatics group to identify and catalogue the Center’s CAP-IT research data in preparation for data transfer.
    2. Plans and capacity for formulating and deploying management techniques for quality data collection and integration into a centralized database, implementing secure procedures for data management and providing access to CAP-IT investigators for in-network sharing in accordance with the policies established by the CAP-IT SC.
    3. Plans and capacity for functioning as the Program centralized data management center in close collaboration and coordination with each CAP-IT Center Informatics group throughout the award period.

    Sub-section D. CAP-IT Shareable Resource Coordination

    This section must address the following key aspects:

    1. Plans for identifying and collecting information on shareable research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens and agents) generated through the conduct of CAP-IT research in close communication and coordination with each CAP-IT Center PD(s)/PI(s) or their designated representative(s) in accordance with the policies established by the CAP-IT SC.
    2. Plans and capacity for establishing a centralized information hub for the Program’s shareable tools and resources in accordance with the policies established by the CAP-IT SC.
    3. Plans and capacity for establishing access protocols for these data to facilitate efficient sharing of unique resources and technologies among CAP-IT investigators and providing detailed instructions to the Program investigators on how to access the Program shareable resources information hub.

    Sub-section E. Milestones and Adaptability

    This section must describe specific milestones and measurable goals/benchmarks for the entire award period. Milestones are intermediate steps towards the completion of concrete goals. The milestones must be well-defined to serve as appropriate objective performance targets. The CAP-IT DRCC is also expected to evolve, adapt, and improve during the award period in response to the needs of the CAP-IT research community. Specifically, this section must address the following key aspects:

    1. Measurable milestones as goals/benchmarks that will identify progress (or signal emergent difficulties).
    2. For each milestone, appropriately detailed (quantitative) criteria by which milestone achievement can be assessed.
    3. A detailed timeline for the anticipated attainment of each milestone and the overall goal (use of a Gantt chart is recommended).
    4. Evidence that the proposed CAP-IT DRCC team will have the expertise and flexibility to accommodate increasing data volume and evolving data types.
    5. Plans to improve the usability of the centralized research database and resources information hub by soliciting user feedback and/or analysis of usage. This plan should describe the frequency of these evaluations and how this information will be used to best serve the needs of the CAP-IT community.

    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.

    The following modifications also apply:

    • 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive 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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?

    Specific for this FOA: How well will the proposed CAP-IT DRCC contribute to the Program’s research objectives by serving as the network data and resources information hub and facilitating trans-network activities and cross-network collaborations? Do the Center’s vision and goals provide unique benefits and capacities to the Program?

    Investigator(s)

    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?

    Specific for this FOA: Do the PD(s)/PI(s) have experience and accomplishments in overseeing data management for multi-institutional research programs focused on molecularly or immunologically targeted agent discovery and development? How appropriate is the leadership structure of the proposed CAP-IT DRCC in terms of achieving the overall goals of the Center? Do the PD(s)/PI(s) have appropriate experience in program management and are their managerial and collaborative capabilities adequately supported? Do the proposed Center members have necessary qualifications and prior experience to successfully execute and implement the proposed CAP-IT DRCC activities?

    Innovation

    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?

    Specific for this FOA: How likely do the proposed approaches contribute to achieving the Program’s research objectives by functioning as the network information hub for research data and resources, providing program management support, enhancing in-network communications, and creating a synergistic research community?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed 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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    Specific for this FOA: Are the overall strategy and organization of the proposed CAP-IT DRCC and methods for data collection and integration and coordination with individual CAP-IT Center Informatics groups adequately developed, feasible, and appropriate to accomplish the specific goals of the CAP-IT DRCC? Are detailed plans to develop a centralized database for CAP-IT-generated research data and an access portal to the CAP-IT research community provided? Are the proposed plans for creating and maintaining a virtual information hub for shareable resources (e.g., novel assay technologies, protocols, preclinical biospecimens, and agents) adequately described? Can the Center's concepts and strategies ensure robust and unbiased scientific collaborations across the program? Does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Is the plan for workflow and proposed timelines appropriate? How adequate are the plans to achieve compatibility with the CAP-IT research projects to facilitate and support data and resource sharing across the CAP-IT research community?

    Environment

    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?

    Specific for this FOA: Are the institutional infrastructure, facilities, equipment, and resource deployment strategies appropriate for the proposed CAP-IT DRCC to facilitate its mission and potential success? To what extent will these environment(s) help respond to the needs of the Program?

    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

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    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 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.

    Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

    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 appropriate national Advisory Council or 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.

    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.

    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 awardee 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, 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 awardee 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 awardee for the project as a whole, although specific tasks and activities may be shared between the awardee and the NIH as defined below.

    The PD(s)/PI(s) will have the following primary responsibilities:

    • Planning and conducting the operations defined by the terms and conditions of the cooperative agreement award. This includes establishing the CAP-IT DRCC’s goals, objectives, and approaches, setting milestones, and ensuring scientific and operational rigor to successfully achieve the stated goals.
    • Overseeing and ensuring the Center’s operational progress, and reporting progress on milestones or objectives to the CAP-IT community and NCI staff.
    • Assuming responsibility and accountability to the applicant organization officials and to the NIH for the performance and proper conduct of the research and administrative functions supported under this FOA in accordance with the terms and conditions of award, as well as all pertinent laws, regulations and policies.
    • Participating in a cooperative, interactive, and collaborative manner with NCI staff, other CAP-IT network investigators, and one another to maximize impact of the CAP-IT network and meet the Program’s goals and objectives.
    • Serving as voting members of the CAP-IT SC that is responsible for the governance of CAP-IT activities (as described below).
    • Accepting and implementing the goals, priorities, procedures, protocols, and policies agreed upon by the CAP-IT SC.
    • Maintaining the confidentiality of the information developed or handled by the CAP-IT, including, without limitation, unpublished data, protocols, data analysis, confidential exchanges between members of the CAP-IT, and any confidential information received by third party collaborators.
    • Facilitating the public release and dissemination of results, data, reagents, models, technologies and other products generated through this award in a timely manner. The PD/PI shall ensure a centralized research database and shareable resources information hub will be accessible to the CAP-IT members in accordance with the approved plan for making quality-assured data and materials available to the scientific community and the NIH as written in the final version of the grant application, and consistent with sharing policies and recommendations developed and approved by the CAP-IT SC, NIH sharing policies, and the goals of the FOA.
    • Ensuring that any industry collaborations should be governed by a research collaboration agreement with terms that ensure the collaboration is conducted in accordance with the applicable NIH policies and procedures and any policies and procedures developed by the CAP-IT SC.
    • Operating in accordance with processes and goals as delineated in the FOA, and in accordance with processes, goals, and procedures established by the SC to the extent of applicable grant regulations.
    • Accepting and implementing the goals, priorities, procedures, protocols, and network policies agreed upon by the CAP-IT SC, to the extent consistent with grants regulations. This includes compliance with program policies and procedures including, as applicable, the use of common protocols, publication of study results, collaborative procedures, confidentiality, and sharing plans to be developed by the SC in collaboration with NCI.
    • Attending an Annual Investigators' Meeting of the CAP-IT PDs/PIs.
    • Adhering to a Network Communication Plan: A consensus Communication Plan will be drafted by the CAP-IT SC during the kickoff meeting of the CAP-IT. This plan will clearly spell out interactive requirements that all CAP-IT investigators are expected to follow, including:
      • Participation in regular conference calls with fellow CAP-IT colleagues through contribution to various sub-committees and working groups;
      • Participation and presentation of findings at the CAP-IT Annual Investigators' Meeting;
      • Coordination of efforts with other members of the CAP-IT;
      • Jointly publishing on CAP-IT collaborations in a timely manner.
    • The awardee 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.
    • Providing information to the NCI concerning progress by submitting the annual progress report.

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

    An NCI Program Director acting as Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. Additionally, an NCI Program staff member(s) will act as a Project Lead Scientist(s) to assist the project team leadership and will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Additional NCI staff members may be designated to have substantial involvement (as Project Scientists).

    The specific functions of the substantially involved NCI staff include, but not limited to the following activities:

    • Advising the awardee on specific scientific issues as well as programmatic priorities.
    • Serving as NCI lead Project Scientists and a voting member of the CAP-IT SC.
    • Co-organizing and participating in CAP-IT SC meetings, CAP-IT Annual Investigators' meetings, specialized workshops, seminars, and webinars.
    • Assisting in the management of the CAP-IT SC including the development of draft sharing and operating policies that are in accordance with NIH guidelines.
    • Serving as a resource for the CAP-IT Centers and the network as a whole in promoting interactions with other ongoing NCI activities that may be relevant to the goals of the CAP-IT and facilitating access to databases, technical capabilities, and other resources available through NCI to which the teams may have access.
    • Facilitating collaborative research efforts that involve multiple CAP-IT Research Centers.
    • Monitoring the performance of the Program, making recommendations on overall directions and efficient utilization of resources, and minimizing unwarranted duplication of effort across the Program.
    • Reviewing the progress of individual research projects and collaborative activities between the program participants and making recommendations on overall project directions.
    • Reviewing the compliance of CAP-IT awardees with the recommendations developed by the SC; and coordinating external evaluation of the CAP-IT.
    • Recommending topics and initiatives for the use of CAP-IT supplemental funds that may be available for CAP-IT members to collaborate with researchers external to the Program.
    • The NCI reserves the right to adjust funding or withhold future support on the CAP-IT DRCC award in the event of: (1) a substantial shortfall in accomplishing the CAP-IT DRCC center management goals and responsibilities as stated in the reviewed application; (2) a failure to meet the CAP-IT policies and procedures; (3) substantive changes in the management structures of the CAP-IT DRCC that are not in keeping with the objectives of the FOA; and/or (4) failure to make substantial progress towards milestones with the go/no-go decision points established by the CAP-IT DRCC leadership.
    • The NCI will have pre-publication access to the data generated and will periodically review the data, with the intent of facilitating optimal integration and dissemination of the results. Awardees will engage in data sharing in accordance with the CAP-IT network policies as established by the SC and within NIH guidelines. However, the awardees will retain custody and primary rights to their data developed under these awards. NIH and NCI will encourage timely publication of findings and public access to publications.

    Areas of Joint Responsibilities include:

    Serving on the CAP-IT Steering Committee. CAP-IT will have a Steering Committee (SC) as the main governing body. The CAP-IT SC will consist of the following voting members:

    • The PD(s)/PI(s) of each awarded CAP-IT Center (or senior investigator as proxy when applicable) will collectively have one vote;
    • The PD(s)/PI(s) of an awarded CAP-IT DRCC Center (or senior investigator as proxy when applicable) will collectively have one vote; and
    • The NCI Project Scientists collectively have one vote for the NCI.

    Additional NIH/NCI program staff and other government staff may participate in CAP-IT Steering Committee meetings as non-voting members. The structure is designed to allow awarded investigators and NCI staff to work together to facilitate trans-CAP-IT activities based on synergistic expertise and projects.

    Additional non-voting members to serve in an advisory capacity may be added to the Steering Committee as needed by a decision of the existing voting committee members.

    The CAP-IT SC may decide to establish subcommittees for specific purposes. The NCI Project Scientists and Program Officers will serve on such sub-committees, as they deem appropriate.

    A PD/PI representing one of the CAP-IT Centers or the CAP-IT DRCC will be selected to serve as a chairperson of the Steering Committee on a rotating basis following the formation of the CAP-IT SC. All CAP-IT SC decisions and recommendations that require voting will be based on a majority vote.

    The CAP-IT SC will meet virtually quarterly (and on an ad hoc basis as needed) and in-person once a year at the CAP-IT Annual Investigators' Meeting. TheCAP-IT Steering Committee responsibilities include:

    • Developing collaborative protocols and CAP-IT network policies, including but not limited to centralized data management and in-network data and resource sharing policies;
    • Identifying scientific and policy issues that need to be, or can benefit by being, addressed at the Network level and developing recommendations to NIH/NCI Program Officials as appropriate;
    • Reviewing the potential of shared support infrastructure(s) at individual CAP-IT Centers and the CAP-IT DRCC to serve the needs of the entire CAP-IT program;
    • Facilitating communication and fostering collaboration across the CAP-IT research community;
    • Identifying opportunities for sharing techniques, materials, information and tools developed within each individual CAP-IT member center;
    • Evaluating collaborative activities, and providing feedback to the NCI Program Staff;
    • Ensuring that CAP-IT Centers and CAP-IT DRCC leverage, where feasible, resources and technology from NIH and NCI-sponsored initiatives and tools, for example the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of algorithms, tools, and resources across the continuum of cancer research;
    • Co-leading the planning of major events such as the CAP-IT Annual Investigators’ Meeting;
    • Discussing important issues relevant to targeted agent discovery for precision cancer prevention-interception;
    • Reviewing progress of the CAP-IT research towards meeting the overall Program goals and determining future directions for the network;
    • Developing publication policies to facilitate collaborations and co-publications by CAP-IT members;
    • Making recommendations on the possible use of any supplemental funds that may be available for collaborations with members of the scientific community external to the CAP-IT;
    • Discussing implementation of recommendations or suggestions from the NCI and any external consultants and planning a timely implementation strategy; and

    Coordinating dissemination of Network output to the broader cancer 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 CAP-IT SC 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 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 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 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)

    Shizuko Sei, M.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-5005
    Email: seis@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 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 42 CFR Part 52 and 45 CFR Part 75.


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