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

Novel Technology Tools to Facilitate Research Using Next Generation Patient-derived Cancer Models (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
  • July 17, 2019 - Pre-Application Webinar for RFA-CA-19-055. See Notice NOT-CA-19-060.
Funding Opportunity Announcement (FOA) Number

RFA-CA-19-055

Companion Funding Opportunity

None

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

 93.353, 93.394, 93.395, 93.396  

Funding Opportunity Purpose

 Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) will support the development of technology tools that will facilitate, accelerate, and/or enhance research using advanced human-derived next generation cancer models (NGCMs), such as organoids, conditionally reprogrammed cells, and others. 

The studies proposed under this FOA must focus entirely on the next generation cancer models developed under the auspices of an international consortium with NCI participation, Human Cancer Models Initiative.

"Technology tools" to be developed under this FOA may include new and/or optimized laboratory methods, reagents/reference materials, agents for NGCMs perturbation or screening read-outs, and/or software/bioinformatics tools for data processing and/or facilitated/enhanced interpretations. (The development of new hardware/equipment will not be supported).

The proposed technology tools are expected to a) facilitate the utilization of the cancer models, e.g., in terms of increasing robustness, rigor, and/or reproducibility of results, b) enable advanced interpretations of experiments in which these model are used, c) design and test genomic editing/manipulating reagents for all cancer and NGCM types, and d) develop robust approaches to method standardization, quality assurance/control, etc., that could serve as routine workflows/best practices for use in a wide range of laboratories.

The collective outcomes of projects under this FOA should facilitate the adoption of NGCMs by the research community and expedite sharing and validating of NGCMs-derived results. The new tools and broader use of NCGMs are expected to contribute to the progress in such areas as the identification of novel therapeutic targets, mechanisms of resistance, development of diagnostic and/or predictive biomarkers, and other aspects relevant to precision oncology.   

This FOA is associated with the Beau Biden Cancer Moonshot SM Initiative that is intended to accelerate cancer research. Specifically, this FOA falls under a scientific priority designated by the Blue Ribbon Panel (BRP) Recommendation J "Develop New Cancer Technologies" (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel#ui-id-3).     

Key Dates

 

Posted Date

June 28, 2019

Open Date (Earliest Submission Date)

July 30, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

August 30, 2019 

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

No late applications will be accepted for this Funding Opportunity Announcement.

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

October-November 2019

Advisory Council Review

January 2020

Earliest Start Date

April 2020

Expiration Date

August 31, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow 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 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.


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 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

    Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) will support the development of technology tools (see definition below) that will facilitate, accelerate, and/or enhance research using advanced human-derived next generation cancer models, such as organoids, conditionally reprogrammed cells, and others. 

    The studies proposed under this FOA must focus entirely on the next generation cancer models developed under the auspices of an international consortium with NCI participation, Human Cancer Models Initiative.

    "Technology tools" to be developed under this FOA may include new and/or optimized laboratory methods, reagents/reference materials, and/or appropriate software/bioinformatics tools. (The development of new hardware/equipment will not be supported).

    The proposed technology tools are expected to a) facilitate the utilization of the cancer models, e.g., in terms of increasing robustness, rigor, and/or reproducibility of results, b) enable advanced interpretations of experiments in which these model are used, c) design and test NGCM genomic editing/manipulating reagents for all cancer and NGCM types, and d) develop robust approaches to method standardization, quality assurance/control, etc., that could serve as routine workflows/best practices for use in a wide range of laboratories.

    The collective outcomes of projects under this FOA should facilitate the adoption of NGCMs by the research community and expedite sharing and validating of NGCMs-derived results. The new tools and broader use of NCGMs are expected to contribute to the progress in such areas as the identification of novel therapeutic targets, mechanisms of resistance, development of diagnostic and/or predictive biomarkers, and other aspects relevant to precision oncology.    

    This FOA is associated with the Beau Biden Cancer Moonshot SM Initiative that is intended to accelerate cancer research. Specifically, this FOA falls under a scientific priority designated by the Blue Ribbon Panel (BRP) Recommendation J "Develop New Cancer Technologies" (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel#ui-id-3).

    Key Definitions for This FOA

    Next Generation Cancer Models (NCGMs): Human, patient-derived models for cancer research, which include organoids, conditionally reprogrammed cells, and other recently developed novel models, collectively referred to also as NCGMs. For this FOA, NCGMs denote specifically cancer models developed under the auspices of the Human Cancer Models Initiative (see below);

    Human Cancer Models Initiative (HCMI) and Annotated NGCMs: HCMI is an international consortium (of which the NCI is a participant), formed to develop a large number of human patient derived, next generation cancer models. The HCMI models (in the periodically updated HCMI Searchable catalog) must be used for all research projects under this FOA.

    The HCMI models are annotated with two types of data that are available through the NCI’s Genomic Data Commons (GDC) or European Nucleotide Archive:

    • The clinical data of the patient who donated the specimen from which the model derived; and
    • The genome and transcriptome sequencing data for the parent tumor and the model (together with case-matched normal/non-tumor tissue).

    Technology tools for NGCMs: This term refers to diverse types of tools that may include methods/ protocols/reagents/standards as well as algorithms/software/bioinformatics tools (but not hardware devices or equipment).  Preferably, technology tools proposed should be broadly applicable to many (or most) of NGCMs and suitable for high/medium throughput studies (see below). They should also enhance the applicable models and facilitate their adoption, e.g., in terms of increasing reproducibility of results, facilitating advanced interpretations, and/or developing standards/reference materials and robust methods that could serve many laboratories.

    High/medium throughput studies: Experiments exploring the function in cancer of all known genes, or genes/proteins that are part of the Hallmarks of Cancer (defined by Hanahan and Weinberg, 2012).

    Perturbagen: A perturbagen is an agent (small molecule, genetic reagent, genome-editing/manipulation tool, etc.) designed to disrupt intracellular processes (such as gene expression) and thereby provide information about the operation of pathways and networks within a cell.

    Background

    Beau Biden Cancer Moonshot Initiative.  NCI convened the Blue Ribbon Panel (BRP) in 2016 to provide recommendations for achieving the Cancer Moonshot's goal of accelerating progress in cancer research, now called the Beau Biden Cancer MoonshotSM Initiative.  The BRP was charged with assessing the state of the science in specific areas and identifying major research opportunities that could uniquely benefit from the support of the Cancer Moonshot and could lead to significant advances in our understanding of cancer and how to intervene in its initiation and progression. The recommendations focused on areas in which a coordinated effort could profoundly accelerate the pace of progress in the fight against cancer and were not intended to replace existing cancer programs, initiatives, and policies already underway. The BRP final report was approved by the National Cancer Advisory Board and included a recommendation to “Establish a Network for Direct Patient Engagement”. The 21st Century Cures Act was signed into law in December 2016 dedicating new funds to support efforts associated with the Beau Biden Cancer MoonshotSM Initiative, including support for this FOA.

    This FOA falls under a scientific priority designated by the Blue Ribbon Panel (BRP) Recommendation J "Develop New Cancer Technologies" (https://www.cancer.gov/research/key-initiatives/moonshot-cancer-initiative/blue-ribbon-panel#ui-id-3)

    As appropriate for research proposed in response to this FOA, applicants are encouraged to engage a pool of scientists from diverse backgrounds, including those from underrepresented groups. In line with NIH-wide policies (NOT-OD-18-210), fostering diversity and addressing underrepresentation in the scientific research workforce is one of the key components of the NCI strategy to facilitate scientific discovery and enhance innovation.

    Cancer Models in Perspective. For the past 60 years, cancer research relied heavily on established cancer cell lines. These in vitro models were used to study various aspects of cancer biochemistry and biology as well as to understand the perturbations of candidate therapeutic targets and develop small molecules which would be subsequently tested in in vivo models or the clinic. The traditional established cell lines, however, have limitations as models of clinical tumors. Because their genomes are known to have evolved over many passages in vitro, established cell lines may not reflect well the various salient features of clinical tumors (e.g., sensitivity/resistance to cancer therapeutics). In addition, for most part, there are no molecular/sequencing data on the original tumor and the clinical information about the patient is generally very limited. The advances in cell biology and other areas make it possible to create new patient-derived cancer models that are well characterized at the molecular and clinical levels and offer the potential to better recapitulate in vitro the characteristics of the original tumor than the traditional models. 

    Efforts to Develop Next Generation Cancer Models. Advanced cancer models have a great promise to facilitate and enhance studies in various areas of cancer research. Recognizing the needs of the research community, the NCI, along with several international partners have formed a consortium, the Human Cancer Models Initiative (HCMI, https://ocg.cancer.gov/programs/HCMI). The HCMI intends to collectively develop ~1000 models within the next couple of years. The HCMI expects that these models will offer benefits when used in wide-range of cancer-relevant discoveries, from genomic research, cell biology or bio/chemistry studies, to improvements in pre-clinical and clinical applications. 

    The NCI and other HCMI partners are working to ensure that the models developed appropriately represent cancer types such as: a) common cancers, b) poor-outcome cancers, c) pediatric cancers, d) cancers in under-represented minorities, and e) metastatic or relapsed cancers.  As gaps in model subtypes are identified, e.g., if models for certain molecular subtypes are lacking, efforts will be made to make them. 

    The clinical data for the original tumor along with molecular characterization data are available through the NCI’s Genomic Data Commons (GDC) or European Nucleotide Archive. The latter datasets include the sequences of the genomes and transcriptomes not only of the models generated but also of the tumor from which a given model was derived, and matched “normal” (non-tumor) tissue. Some models will also be characterized for epigenetic changes. The development protocols and other pertinent information are also provided (at https://ocg.cancer.gov/programs/hcmi/resources) when they become available.  The HCMI models, materials and data generated by the project are a “Community Resource”. 

    Research Objectives and Main Requirements
     

    Areas of Cancer Research to be Targeted by New Tools for NGCMs

    The overarching goal of this FOA is to enhance the NGCMs for facilitated use in basic cancer research and accelerated transitions to clinical applications.

    The U01 projects proposed in response to this FOA should be centered on the development of technology tools that would enable, facilitate and/or accelerate the use of NGCMs for at least one of the three areas of cancer research defined below:

    Area 1: Understanding of cancer biology (initiation, progression, metastasis, etc.);

    Area 2: Exploration of new targets for therapeutic exploitation or target combinations (e.g. overcoming pathway redundancies or synthetic lethality approaches); and

    Area 3: Screening drug candidates, prediction of responses to cancer therapeutics and understanding of resistance.

    Required NGCMs

    All U01 projects proposed must be focused on and use the HCMI models listed in the HCMI Searchable catalog. The use of cancer models not from HCMI catalog may be proposed only for comparative or auxiliary purposes.

    Applicants may propose to study any models in the HCMI Searchable catalog; they should expect that additional models will be released by the time the U01 awards are made.  The selected models will be available to the awardees from the NCI. The NCI will provide up to approximately 50 models to each U01 awardee upon award activation, with the possibility of additional models to be provided later. 

    Characteristics of Responsive Technology Tools

    Technology tools proposed in U01 Projects must meet all of the following requirements:

    • The new technology tools to be proposed may include various types, such as methods/reagents/algorithms-software/bioinformatics tools;
    • Regardless of their nature, all tools must be designed for NGCMs and should be applicable to many models rather than be specific for a single or a few models; and
    • The proposed U01 projects must include testing of these tools in NGCMs as well as a rigorous validation that is appropriate for the nature of a given tool. 

    Examples of technology tools for use with the NGCMs that would be responsive include (but are not limited to) the following:

    • Biological, biochemical, genetic and high-throughput screening approaches aimed to understand the cancer-relevant alterations of initiation, progression, metastasis;
    • New gene editing/manipulating-based approaches (e.g. optimal Cas9/gRNA combinations) for loss-of-function and/or gain-of-function screens;
    • Open-reading frame (ORF) expression screens addressing any adaptation needed for delivery to and expression in NGCMs;
    • Validated and effective reagents for high/medium-throughput perturbagen screens;
    • Development of perturbagens and experimental and analytical methods of their use to interrogate specific genomic or other features of NGCMs;
    • New small molecule screening techniques and platforms, such as high/medium throughput approaches (for single agents and/or agent combinations);
    • New or markedly enhanced analytical approaches and/or software tools for analyses and/or enhanced interpretation of data generated in screens, functional assays, etc. using NGCMs;
    • Technologies that will reduce models' experimental variabilities, yet maintain the models’ characteristics as close as possible to the primary tumor;
    • Technologies (other than sequencing) to efficiently and effectively detect genetic and phenotypic changes in the models in response to culture conditions and/or passage number; and/or
    • New methods for culturing NGCMs, especially relevant to such aspects as:

    o   growth conditions optimized for functional screens (like the ones listed above), e.g., approaches to enable substantial culture scale-up suitable for high throughput screens;

    o   media/growth conditions applicable to multiple models and model types (e.g., 2D versus 3D growth) while ensuring the preservation of the original tumor characteristics; and

    o   culture manipulations to address in vitro specific changes in tumor microenvironments in vivo.

    Number and Types of Tools to Be Proposed

    It is expected that each U01 project will address the development of at least 2 types of tools (that represent different technologies and do not serve a similar purpose) and 3 different tools (like the examples given above or equivalent). Within the selected types, the number of individual tools proposed may depend on various factors, such as tool complexity, feasibility, the breadth of applicability.

    Team Expertise

    It is expected that to conduct the research required by this FOA, the U01 teams will include experts in cancer biology as well as technology tools development.

    Trans-network Activities

    The awardees will be expected to form a Network, with a Steering Committee as the governing body (for details see Section VI.2. Terms and Conditions of Cooperative Agreements).  The programmatic goals and funding priority of the initiative are to ensure that as many areas listed above are covered.  Still, it is possible that more than one awardee's aims may partially overlap with another.

    To facilitate and enhance interactions across the Network, the awardees will be expected to share their data through timely publications and contribution to the HCMI web site.   Moreover, it is also expected that final validated technology tools will be made publicly available (through the HCMI resources web pages maintained by the NCI, (for details see Data Sharing Plan in Section IV).

    Non-Responsive Applications

    The following types of research activities are outside the scope of this FOA and will be considered non-responsive. (Non-responsive applications will not be reviewed.)

    • Development of new cancer models;
    • Research focused on addressing biological aspects rather than technology tools;
    • Technology development applicable for a single or small number of models
    • Studies focused primarily on the mechanism of genomic editing/manipulating tools, e.g. Cas9 enzymes, or other perturbagens, e.g. RNAi; and
    • Development of hardware tools/equipment.

    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

    The NCI intends to commit $3.3 million (total costs) in Fiscal Year 2020 to fund up to three awards.

    Award Budget

    Application budgets are limited to $700,000 in direct cost per year and must reflect the actual needs of the proposed project.

    Award Project Period

     The project period of up to three years may be proposed.       

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)

    Governments

    • State Governments
    • County Governments
    • U.S. Territory or Possession
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

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

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • o   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 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 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:

    Daniela S. Gerhard, Ph.D.

    Director, Office of Cancer Genomics
    Telephone: 240-781-3280
    email: gerhardd@mail.nih.gov

    Page Limitations

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

    Instructions for Application Submission

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

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    Facilities & Other Resources: In addition to the information required in the standard instructions, list available facilities and/or shared resources etc., that will be available to the proposed project (e.g. laboratories, informatics/computational platforms, data storage resources, communication platforms).

    Other Attachments: Applicants must provide the following additional materials in support of their application. Attachment should be uploaded as a separate PDF using the indicated filename (which will serve as application bookmark). These additional materials must not exceed 3 pages.

    Attachment 1: Prior Studies and Accomplishments [use filename "Accomplishments"].

    Without repeating information in individual biosketches, provide summary tables related to the team efforts over the last 5 years in areas relevant to the proposed aims.  

    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.

    Leadership Effort Commitment: The contact PD/PI must commit and maintain through the life of the award a minimum of 1.2 person-months of effort. Other PDs/PIs (if designated) must commit and maintain a minimum effort of 1.2 person-months.

    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: Outline specific aims for the project. Include main benchmarks to be used to assess the progress in development and validation of the proposed technology tools.

    Research Strategy: Use standard subsections and in addition, include main benchmarks to be used to assess the progress in development and validation of the proposed technology tools.

    Significance:

    In addition to standard content, address the following specific aspects:

    • Explain how the technology tools proposed are expected to accelerate the use of the NGCM;
    • Discuss the tools applicability to such areas as medium/high throughput screening, studies of cancer mechanisms, identification of novel potential targets, determination of mechanisms of resistance, etc. 
    • Include a cogent summary of the tools and describe the improvements over tools currently in use and validation information. 

    Innovation:

    Highlight any innovative aspects of the tool(s) proposed, especially, if applicable, in the context of accelerating the application of NGCMs to research aimed to facilitate "Precision Oncology".

    Approach:

    In addition to standard items, all applications must address all the generally applicable aspects listed below.

    • Identify models that are proposed for tool development, assuming the use of approximately 50 NGCMs*;
    • Identify the number/types of additional models that would be desirable for your project;
    • Address the requirement that there are at least 3 tools proposed that correspond to at least 2 areas (technology types); identify the types of technology
    • Describe each tool proposed separately under descriptive tool name as a heading;
    • For each tool proposed, use a sub-heading "Validation" to describe specific steps and approaches to assess the tool performance (provide appropriate benchmarks, which should be quantitative, if possible);

    As applicable to your project, address also aspects specific to types of tools proposed:

    For tools related to cell growth conditions, stability of phenotype/genotype, describe such items as:

    o  How to measure phenotypic drift without the need of sequencing

    o  How to expand models from many tumor types under more uniform conditions without changing phenotype

    o  Impact of 2D vs. 3D propagation on the preservation of model characteristics

    o  Impact of organ origin on the physical structure (hollow or filled spheres, etc.) of the NGCM

    o  Impact of co-culturing NGCMs with tumor infiltrating lymphocytes on the model's longevity and/or phenotype and the ability to predict effectiveness of "immunotherapy"

    For tools related to screening drug candidates, prediction of responses to cancer therapeutics and understanding of resistance, describe such items as:

    o  Impact on biology of growth factors used to establish the models

    o  Impact of the size and geometry (i.e. a solid vs. hollow sphere, cell polarity, shape of cells, etc.) of the 3D NGCM on perturbagen efficiency of penetration, effectiveness etc.

    o  Approaches to scaling up the propagation NGCMs that will allow for high-throughput screens;

    For tools related to the development and testing of genetic editing/manipulating perturbagens, describe items as:

    o   The vector components that are necessary for effective activity of Cas9 enzymes with already understood activity (cutting or activating) in NGCMs 

    o   The feasibility of a single Cas9/gRNA lentiviral or transfection construct in which the enzyme and the target guide would be highly functional and efficient in NGCMs

    o   The parameters that influence Cas9 off-target effects in NGCM

    o   The “read-outs” of genome of induced phenotypes for use in pooled genome editing/manipulating screens 

    o   The experimental protocols and/or the reagents required for whole genome screens.

    For tools related to the development and testing of other perturbagens, describe items as:

    o   The “read-outs” of genome of induced phenotypes for use in pooled genome editing/manipulating screens 

    o   The experimental protocols and/or the reagents required for whole genome screens of e.g. small molecules and ORFs.

    *Note: Supplemental documentation is requested under Other Attachments

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, all materials developed need to be shared expeditiously and all information through the web site https://ocg.cancer.gov/programs/hcmi/resources.

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan including sharing of unpublished data on the Network Steering Committee meetings and depositing data to the HCMI web site. 
    • Any sharing of genomic data should be consistent w/ NCI policy https://datascience.cancer.gov/data-sharing/genomic-data-sharing.
    • Addressing the Cancer Moonshot Open Access Pilot Program: Utilizing the provision outlined in the 21st Century Cures Act, NCI has established a data sharing policy for projects that are funded as part of the Beau Biden Cancer MoonshotSM Initiative that requires applicants to submit a Public Access and Data Sharing Plan that: (1) describes their proposed process for making resulting publications and to the extent possible, the underlying primary data immediately and broadly available to the public upon publication; and (2) if applicable, provides a justification to NCI if such sharing is not possible. NCI will give competitive preference and funding priority to applications that comply with the strategy described here. The data sharing plan will become a term and condition of award.
    • Guiding Principles for Cancer Moonshot Biobanking Activities: The goal in developing these guiding principles is to accelerate research by a) increasing the availability of biospecimens for Cancer Moonshot-related and other biomedical research through facilitation of investigator to investigator sharing of biospecimens, and b) increasing the reproducibility of Cancer Moonshot research through improved biospecimen practices and corresponding annotation. These guiding principles also seek to facilitate, where possible, increased engagement of research participants through researchers' communication of aggregate research results and, in some cases, individual genomic findings that may be medically actionable for research participants. NCI will give competitive preference and funding priority to applications that conform to the "Guiding Principles for Cancer Moonshot Biobanking Activities" (http://biospecimens.cancer.gov/programs/cancermoonshot/principles) and are consistent with the "2016 NCI Best Practices for Biospecimen Resources" (https://biospecimens.cancer.gov/bestpractices/).

    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 the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Use of Common Data Elements in NIH-funded Research

    Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies.  CDEs are data elements that have been identified and defined for use in multiple data sets across different studies.  Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.  NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository).  NIH has established a “Common Data Element (CDE) Resource Portal" (http://cde.nih.gov/) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection.  The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research.  Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.  

    For NCI-relevant CDEs, please visit  CDE (Common Data Element) Browser.  In addition, for  sharing of data, the Network will develop CDEs which pertain to their results or adopt ones which were developed for other NCI programs, e.g. Cancer Target Discovery and Development program.

    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.

    For this particular announcement, note the following:

    The emphasis of the FOA is on the potential of the proposed technology tools to facilitate clinically-relevant cancer research in such areas as identification of novel therapeutic targets, screening for new anticancer agents (especially in medium/high throughput assays), mechanisms of resistance, etc.  Moreover, it is essential that the proposed work ensures rigorous validation of the tools to be developed.

    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:  What is the likelihood that the technology tools proposed will accelerate the use of the next generation cancer models for clinically-relevant cancer research? 

    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:  How appropriate are the depth and balance of needed expertise (cancer biology, technology) across the members of the team?

    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 compelling are the proposed approaches in terms of breadth of coverage, throughput, efficiency etc.?  How adequate are the applicants' efforts to maximize the applicability of the proposed tools across multiple cancer types and models? Does the application contain acceptable plans for addressing the NCI Cancer Moonshot? Public Access and Data Sharing Policy?

    Benchmarks: Are the benchmarks for each tool proposed appropriate, sufficiently rigorous, and realistic?

    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? 

    Specific for this FOA:  How compelling are the proposed approaches in terms of breadth of coverage, throughput, efficiency etc.?  How comprehensive are the applicants' efforts to maximize the applicability of the proposed tools across multiple cancer types and models?   

    Benchmarks: Are the benchmarks for each tool proposed appropriate, sufficiently rigorous, and realistic?

    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?  

    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?   

    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 the NCI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

    As part of the scientific peer review, all applications:

    • Will receive a written critique.

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

    Applications will be assigned  to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the NCI 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. Programmatic priority will be to ensure that all awards collectively provide optimal, broad coverage across types of technology tools as well as a broad applicability broad applicability across multiple cancer model.
    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 https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. 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 http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 Parts 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.


    The PD(s)/PI(s) will have the primary responsibility for:

    • Defining the research plan and goals;
    • Overseeing the execution of the project and coordinating/overseeing research design;
    • Ensuring compliance with the mandatory regulations (including protection of human subjects);
    • Overseeing establishment and maintenance of appropriate quality control procedures;
    • Overseeing final data analysis and interpretation and preparation of publications;
    • Serving as a voting member of the Steering Committee;
    • Implementing the recommendations of the Steering Committee to the extent consistent with the applicable grant regulations;
    • Ensuring and overseeing sharing results, resources, methods, etc. within the Network and with the scientific community upon validation;
    • Complying with the recommendations of the Steering Committee regarding common policies, standardized data reporting solutions, the usage of Common Data Elements, etc.; and
    • Any PD/PI on an award must maintain effort commitment of at least 1.2 person-month in each year of the award.

    Awardees will be expected to share their experiences and work together with other awardees and the NCI on the overall goals of this FOA. 

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

    A designated NCI Program Director(s) acting as a Project Scientist(s) will have the following responsibilities:

    • Participating in the activities of the Steering Committee;
    • Providing technical assistance and advice to the awardees as appropriate;
    • Discussing scientific aspects of individual projects with awardee research teams (e.g., during site visits);
    • Stimulating interactions among awardees;
    • Facilitating interactions/collaborations between the awardees and other NCI-sponsored programs, investigators, or organizations that may contribute to the Network's goals;
    • Serving as a liaison between the awardees and NCI staff members and investigators that may provide additional expertise and/or resources to the program;
    • Monitoring the adherence of the awardees to the approved data sharing plans; and
    • Coordinating the additional resources that NCI will establish for this program, including electronic communication support (see details below).

    The NCI will also assist the awardees by establishing and maintaining communication resources for intra-Network document sharing and hosting Network webpages for data, information and resource sharing with the scientific community at large.

    In carrying out its stewardship of Beau Biden Cancer Moonshot initiatives, the National Cancer Institute (NCI) will monitor and evaluate progress to meet the expectations set forth by Congress in the 21st Century Cures Act.

    In addition, an NCI Program Director acting as the Program Official will be responsible for the normal scientific and programmatic stewardship of the award, and will be named in the award notice.

    Areas of Joint Responsibility include:

    The Steering Committee will serve as the main governing board for this Network. The Steering Committee will consist of the following voting members:

    • One representative of each awardee (a PD/PI or a designated senior investigator); and
    • One NCI representative (Project Scientist).

    Each voting member will have one vote.  The Steering Committee will be chaired by one of the awarded teams' PDs/PIs on rotating basis to be determined upon start of the Program.  Additional NIH/NCI representatives may participate in the Steering Committee meetings as non-voting members as needed.

    The Steering Committee may form subcommittees as needed. NCI Project Scientist may participate in such sub-committees as he/she deems relevant. Other NIH/NCI staff members or non-NIH scientists may be invited as members of such sub-committees as needed.

    The main functions of the Steering Committee will include the following:

    • Coordination of the development and implementation of common, uniform standard operating procedures (SOP) and technical formats for depositing data into public databases by all awardees; and
    • Reviewing on a regular basis the overall performance of the teams as a Network. 

    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 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)

    Daniela S. Gerhard, Ph.D.
    Director, Office of Cancer Genomics
    Telephone: 240-781-3280
    email: gerhardd@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Crystal Wolfrey
    National Cancer Institute (NCI)
    Telephone: 301-276-6277 
    Email: wolfreyc@mail.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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