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

Research Centers for Cancer Systems Biology (U54 Clinical Trial Not Allowed)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-CA-15-014

Related Notices

  • August 18, 2021 - Notice of Correction to RFA-CA-21-048. See Notice NOT-CA-21-109.
  • August 4, 2021 - Pre-application Webinar for RFA-CA-21-048. See Notice NOT-CA-21-104.

Funding Opportunity Announcement (FOA) Number

RFA-CA-21-048

Companion Funding Opportunity

None

Assistance Listing Number(s)

93.396

Funding Opportunity Purpose

The National Cancer Institute (NCI) supports the application of systems biology approaches to cancer research through the Cancer Systems Biology Consortium (CSBC). The CSBC includes U01 Research Projects and, through this FOA, U54 Research Centers. These multi-project Research Centers should address challenges in basic cancer biology that require a coordinated systems biology approach. Research Centers should address a well-defined overarching scientific theme that will be pursued through two or three research projects. The research projects should be driven by a specific hypothesis and incorporate iterative cycles of quantitative experimentation, analysis, modeling, and validation in a disease-relevant context. Each Research Center will be led by an interdisciplinary team of researchers with expertise in quantitative and cancer biology. An Administrative Core, optional Shared Resource Core(s), and an Outreach Core will support the overall Research Center scientific theme. Each Research Center will prioritize sharing interoperable datasets and accessible tools, with the support of a multi-consortium U24 Coordinating Center (being solicited under RFA-CA-21-049). Research Center personnel will actively collaborate within and outside the consortium and will support a welcoming and diverse community at the Research Center and consortium.

Key Dates
Posted Date

July 28, 2021

Open Date (Earliest Submission Date)

October 12, 2021

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 12, 2021; October 19, 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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2022; March 2023

Advisory Council Review

May 2022; May 2023

Earliest Start Date

July 2022; July 2023

Expiration Date

October 20, 2022

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Multi-Project (M) 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. 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

    Purpose/Background

    Purpose

    The purpose of this Funding Opportunity Announcement (FOA) is to solicit multi-project U54 Research Centers to address challenges in basic cancer biology that require a coordinated systems biology approach. These Research Centers will join the existing NCI-supported Cancer Systems Biology Consortium (CSBC). The goals of the CSBC are to (1) advance understanding of mechanisms that underlie fundamental processes in cancer; (2) support the broad application of systems biology approaches in cancer research; and (3) support the growth of a strong, stable, and diverse research community in cancer systems biology. Information about the scientific goals of the currently funded CSBC U54 Research Centers and U01 Research Projects can be found at https://csbconsortium.org/. The CSBC will be supported by the Division of Cancer Biology (DCB) Multi-Consortia Coordinating Center (the MC2 Center, solicited under RFA-CA-21-049), a common coordinating body tasked to facilitate collaborations, resource sharing, and outreach activities across multiple basic cancer biology research programs (https://www.cancer.gov/about-nci/organization/dcb/research-programs).

    CSBC U54 Research Centers proposed in response to this FOA should address a well-defined overarching scientific theme that will be pursued through two or three research projects. The projects should integrate experimentation with analysis and predictive modeling and should include validation in a disease-relevant context. These projects should be interrelated and synergistic. Each Research Center will be led by an interdisciplinary research team whose members have expertise in quantitative and cancer biology. An Administrative Core, optional Shared Resource Core(s), and an Outreach Core will support the overall Research Center scientific theme. Each U54 Research Center will make sharing interoperable datasets and community accessible tools a priority with the support of the MC2 Center, actively collaborate within and outside the consortium, and support a welcoming and diverse research community at the Research Center and consortium level.

    Background

    Cancer occurs through the orchestration of dynamic processes at the molecular, cellular, and multicellular scales. These interactive processes adapt and evolve due to internal and external events, making it challenging to predict, prevent, and treat disease. Cancer systems biology approaches provide an iterative experimental and analytical toolkit necessary to interrogate the complexities of cancer and to predict the biological mechanisms underlying disease progression, treatment response, and, ultimately, patient outcome. Through targeted deployment of experimental technologies, generation of hypothesis-driven datasets, and integration of computational, mathematical, and algorithmic tools, cancer systems biologists are uniquely poised to address questions in cancer research that would be difficult, if not impossible, to explore fully using less comprehensive approaches. See the Research Objectives section of this RFA for examples of challenges in cancer research amenable to a coordinated systems biology approach.   

    The NCI launched the CSBC in 2016 to support the application of systems biology approaches to basic cancer biological research. The CSBC defines “cancer systems biology” as a holistic approach to the study of the complexities of cancer through the explicit integration of experimental biology and computational and mathematical methods to build predictive models of cancer that are tested or validated in a disease-relevant context. This definition requires an iterative framework, encourages interdisciplinary research, and leverages resources developed in other NCI programs. Because the range of specific cancer questions addressed by applicants to the CSBC is not prescribed, the unifying theme of the CSBC is the common pursuit of a mechanistic understanding of disease through the marriage of experimentation and computation. Current consortium topics along with publications can be found on the CSBC website (https://csbconsortium.org/research-portfolio/publications/).

    Research Objectives

    To be responsive to this FOA, each CSBC U54 Research Center must address an overarching scientific theme in basic cancer biology that requires a coordinated systems biology approach. This approach should include strong integration of experimental biology and computational or mathematical modeling to build hypotheses or ideas that are tested and/or validated in a disease-relevant context. This theme should serve to integrate the individual Research Projects.

    The scope of the scientific theme addressed in CSBC U54 Research Center applications should not be readily addressable through other research mechanisms or initiatives. Possible Research Center themes include, but are not limited to, the following:

    • Prediction and exploitation of generalizable molecular or cellular mechanisms across tumor types;
    • Delineation of cellular interactions that lead to local or systemic, collective or emergent cellular behaviors that underlie cancer processes such as cancer initiation, progression, metastasis, and/or response to treatment;
    • Elucidation of the interactions between tumor and non-tumor components in mediating the response, or lack of response, to therapy including standard, targeted, or immunotherapeutic approaches;
    • Integration of the biology underlying normal physiological processes, such as development, aging, metabolism and/or immunity, to further understanding of cancer development, progression, metastasis, or treatment response;
    • Discovery and testing of biologically informed combination therapies through systems biology approaches that uncover and prioritize specific targetable molecular or cellular mechanisms, account for potential patient toxicities, and consider variables such as dose and timing;
    • Optimization of treatment choices through an increased knowledge of tumor behaviors in the context of patient comorbidities, real world polypharmacy, and/or known health disparities;
    • Understanding the dynamic relationships between immune cell subsets, immune repertoires, microbiomes, and other host factors or mechanisms that regulate the balance between immune responses to tumor versus immune responses to self (e.g., immune-related adverse events) in response to single agent or combination immunotherapy; and
    • Integration of molecular and cellular oncogenic processes with population-level risk factors and systemic stresses, such as obesity or chronic inflammation, including molecular or environmental factors that may differentially impact patient populations.

    Each Research Project within the center should address a discrete biological question related to the Center theme. Each individual Project should reflect a self-standing scientifically meritorious research effort. In addition, the individual Projects should be interrelated and synergistic so that the research ideas, efforts, and outcomes of the Center as a whole will offer a distinct advantage over pursuing the individual projects separately. Individual Projects might address the Center theme at distinct length or time scales (e.g., local, mid-, or long-range signaling), stages of disease progression (e.g., initiation, subtype transformation, metastasis), cancer types (e.g., astrocytoma, ependymoma, medulloblastoma), by focusing on distinct components in the system (e.g., glycobiome, extracellular matrix, microbiome), or using different approaches (e.g., mechanobiology, population science, clinical oncology). 

    Potential applicants are encouraged to visit the CSBC website or NIH Reporter to learn more about the current CSBC U54 Research Centers. A diversity of systems biology approaches and cancer questions are of programmatic interest. Potential applicants are encouraged to contact NCI Program Staff prior to submission with questions regarding Research Center goals and scope.

    The emphasis of each proposed U54 Research Center project must be on a specific cancer-relevant question or hypothesis. Nonetheless, projects or shared resource cores may include appropriate efforts to develop new experimental and/or computational and/or mathematical systems biology approaches.

    Organization of Individual CSBC Research Centers

    CSBC Research Center Expertise: This FOA requires that applicants assemble collaborating teams of researchers with expertise in quantitative and cancer biology research. Each Research Center should consist of a research team of investigators with complementary expertise organized around an overall research theme, such as those described in the Research Objectives section above. Relevant expertise could involve cell biology, computational biology, development biology, ecology, engineering, evolutionary biology, mathematics, physics, physiology, synthetic biology, the development or application of novel technologies and data integration. Consequently, each CSBC Research Center will require a leadership team whose members have the ability to manage and understand the various approaches needed.

    Each Research Center will consist of the following components:

    • Research Projects – At the foundation of each CSBC Research Center will be high impact research projects that support the overall research theme. CSBC Research Centers will consist of a minimum of two and a maximum of three Research Projects that should interact and integrate into the overall research theme.
    • Administrative Core – Each CSBC Research Center will have their own Administrative Core that will guide the organizing framework and connect the individual Research Center to the broader CSBC community and the NCI. Expectations for the Administrative Core include:
    • ·    Serving as the primary contact for all internal logistical and organizational aspects of the Research Center;
    • ·    Serving as the primary contact for external interactions with the CSBC, the NCI, and the cancer research community;
    • ·    Implementing strategies to enhance diversity and inclusion in cancer systems biology;
    • ·    Managing solicitation, review, and funding of Research Center pilot projects; and
    • ·    Ensuring timely sharing of data and resources produced by all Research Center Projects and Cores through the U24 Coordinating Center and NIH/NCI resources.
    • Shared Resource Core(s) – Although not required, up to two Shared Resource Cores may be established to provide expertise and resources (e.g., imaging, technology, experimental models, biological specimens, computational modeling and analysis). Shared Resource Cores are not research projects and should play a supporting role.
    • Outreach Core – The required Outreach Core will coordinate scientific outreach activities that contribute to the overall research theme, increase the accessibility of the computational and modeling approaches developed within their Research Center, and recruit involvement of diverse investigators, cancer biologists, and clinicians.

    External Advisory Board (EAB): Each awarded CSBC Research Center must recruit external experts (from outside the Center) who will serve as scientific advisors to the Research Center leadership. This EAB will advise the Research Center on ongoing research and strategic planning for future research directions. The EAB should include one member from within the CSBC and the remainder from outside of the consortium. Do not name EAB members within the application.

    Organization of the CSBC

    CSBC overall organization currently consists of:

    • Several U54 Research Centers (currently supported under RFA-CA-15-014; the U54 Research Centers to be supported under this FOA will be added to this pool);
    • One U24 Coordinating Center (currently supported under RFA-CA-15-015; a multi-consortium U24 Coordinating Center to be supported under RFA-CA-21-049 will replace this Center); and
    • Several U01 Research Projects (supported under PAR-16-131).

    The CSBC functions as a collaborative network and individual U54 Research Centers and U01 Research Projects are encouraged to share resources and model systems, cross validate ideas and observations, and integrate data. Members of the CSBC interact through monthly teleconferences, annual in-person meetings, and working groups (https://csbconsortium.org/resources-outreach/working-groups/) that focus on scientific topics, resource and data sharing, and education and outreach.

    Governance of the CSBC: The CSBC program, which includes CSBC U54 Research Centers, is governed by the CSBC Steering Committee. Details on the composition and functions of the CSBC Steering Committee are provided in Section VI: Terms and Conditions of Cooperative Agreement.

    Evaluation of the Program: As the efficiency of the funded research is an important priority for NCI, CSBC Research Centers will be required to participate in an external evaluation process of the CSBC program coordinated by NCI Program Staff. During the course of award, NCI program staff will also recruit outside experts (non-awardees) as External Program Consultants (EPCs) to provide advice directly to NCI program staff (see Section VI: Terms and Conditions of Cooperative Agreement).

    Non-Responsive Projects

    The following types of projects are non-responsive for this FOA, and applications meeting these criteria will not be reviewed:

    • Applications in which experimental validation or testing of systems biology predictions within a relevant cancer context is not proposed; 
    • Applications that do not propose both experimentation and computation;
    • Applications proposing correlative studies with no underlying mechanistic interrogation, or those cataloging changes due to tumorigenesis or drug treatment without a cancer systems biology model; and
    • Applications focused on validation of clinical correlative statistical models in the absence of the study of disease mechanism.

    IMPORTANT NOTE: Applicants uncertain as to whether their intended project meets the requirements of this FOA are encouraged to contact the Scientific/Research Contact listed below in Section VII.

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New
    Resubmission

    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 up to $12.376M in each fiscal year in FY 2022 and 2023 for new U54 awards. Collectively, a total of approximately 10 U54 awards is anticipated.

    Award Budget

    Budget requests may not exceed $1.5M per year in direct costs.

    Award Project Period

    A project period of 5 years is required.

    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
    • City or Township Governments
    • Special District Governments
    • Indian/Native American Tribal Governments (Federally Recognized)
    • Indian/Native American Tribal Governments (Other than Federally Recognized)
    • Eligible Agencies of the Federal Government
    • U.S. Territory or Possession

    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.
    • 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.

    Due to the multi-disciplinary nature of the Research Centers and the focus on collaboration and expertise sharing, this FOA encourages the use of the multi-PD/PI mechanism.

    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 or an institutional system-to-system solution. A button to apply using ASSIST is 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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 announcement

    The letter of intent should be sent to:

    Hannah Dueck, Ph.D.
    Division of Cancer Biology
    National Cancer Institute (NCI)
    Telephone: 240-276-5751
    Email: hannah.dueck@mail.nih.gov

    Page Limitations

    Component Name

    Research Strategy/Program Plan Page Limits

    Required/ Optional

    Minimum Instances

    Maximum Instances

    Overall

    12

    Required

    1

    1

    Admin Core (use for Administrative Core)

    6

    Required

    1

    1

    Project (use for each Research Project)

    12

    Required

    2

    3

    Core (use for each Shared Resource Core)

    6

    Optional

    1

    2

    Core (Outreach Core)

    6

    Required

    1

    1

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

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    The application should consist of the following components:

    • Overall: required
    • Administrative Core: 1 required
    • Research Projects: 2 required with a maximum of 3
    • Shared Research Core(s): 1 or 2 optionalOutreach Core: 1 required
    Overall Component

    When preparing your application, use Component Type ‘Overall’.

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

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

    Research & Related Other Project Information (Overall)

    Follow standard instructions. These additional instructions apply:

    Project Summary /Abstract: Succinctly summarize the overarching scientific theme for the CSBC Research Center and why a coordinated systems biology approach is required.

    Project Narrative: State how the outcomes of the CSBC Research Center will further knowledge in basic cancer research, and the potential impact on public health.

    Facilities & Other Resources: In addition to standard items, describe existing facilities and/or other resources (such as existing institutional shared resource cores) available to the proposed CSBC Research Center. As applicable and pertinent to the proposed research, describe partnerships that will provide relevant capabilities (technology development, tissue engineering, reagents, cancer biology models, computational expertise, etc.). Indicate on what basis these resources will be available to other CSBC investigators (e.g., in-lab, freely available, fee-for-service, etc.).

    Project/Performance Site Location(s) (Overall)

    Enter primary site only.

    A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

    Research & Related Senior/Key Person Profile (Overall)

    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

    A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

    Budget (Overall)

    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

    A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

    PHS 398 Research Plan (Overall)

    Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.

    Specific Aims: State the overall vision, goals, and specific aims for the CSBC Research Center as a whole. Describe the expected impact of the overall Research Center on basic cancer biology research and why a coordinated systems biology approach is required.

    Research Strategy: Present a concise overall vision and plan for the proposed CSBC Research Center. The vision should focus on the plans for the funding period of the Research Center and how the work will contribute to a more comprehensive understanding of mechanisms that underlie fundamental processes in cancer. This section should describe the primary questions in basic cancer biology that will be addressed by the Research Center and how they integrate to form an overall research theme. Items to be addressed include:

    • Research Theme: Define the overall central scientific theme of the CSBC Research Center. Provide a brief background and rationale for this selection and outline the significance of research in the selected area.
    • Research Center Organization: Provide a concise description of the structure of the Research Center and explain the following aspects: (1) how the skills of individual team members will translate into the collective ability of the Research Center to accomplish the stated goals for research and other activities; (2) how the integration of the components into a coordinated Research Center will increase the impact of proposed research beyond what could be achieved by stand-alone research projects; and (3) how the components of the Research Center, including key personnel, will interact to realize center goals.
    • Research Projects: In a brief overview, outline the rationale for each project and the expected gains in terms of new knowledge advancing the research theme of the Research Center.
    • Shared Resource Core(s) (If applicable): Briefly explain the need for any Shared Resource Core(s), indicating the specific Research Projects that will be supported by each Core. It is generally expected that a Shared Resources Core will support at least two research projects.  
    • Leadership in the Cancer Systems Biology Research Community: Briefly explain how the combined efforts of the proposed Research Center will contribute towards the broad application of systems biology approaches in cancer research, and the growth of a strong, stable and diverse research community. State how the Outreach Core and the intra-center pilot projects will advance these goals while integrating with the Research Center’s overall theme and goals.

    Letters of Support: In addition to standard items, applicants must provide letters from the respective leadership official(s) in the institution(s) of the proposed Research Center documenting specific institutional commitments to the proposed center.

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

    All applications, regardless of the amount of direct costs requested for any one year, should include a Data Management and Sharing Plan. The plan should describe strategies for data management, preservation, and sharing of scientific data and accompanying metadata. Applicants should address the following topics within the Data Management and Sharing Plan:

    • Estimated Data Volume: Applicants should estimate the volume and type of scientific data and metadata that will be generated and shared. 
    • Data Repository Selection: Applicants should name the data repositories that will be utilized to share scientific data and metadata. NIH strongly encourages the use of established repositories to the extent possible for preserving and sharing scientific data.
    • Data Sharing Timelines: Plans should explicitly state when scientific data and metadata sharing is expected. Shared scientific data and metadata should be made accessible in accordance with current NIH policies, including the NIH’s 2014 Genomic Data Sharing (GDS) Policy. Applicants are encouraged to share scientific data as soon as possible, and no later than the time of an associated publication. 
    • Considerations for Scientific Data Derived from Human Participants: Researchers proposing to generate scientific data derived from human participants should outline in their plans how privacy, rights, and confidentiality of human research participants will be protected (i.e., through de-identification, Certificates of Confidentiality, and other protective measures). NIH strongly encourages researchers to plan for how data management and sharing will be addressed in the informed consent process, including communicating with prospective participants how their scientific data are expected to be used and shared. Researchers should consider whether access to scientific data derived from humans, even if de-identified and lacking explicit limitations on subsequent use, should be controlled.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    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 (Overall)

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

    Administrative Core

    When preparing your application, use Component Type ‘Admin Core.’

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

    SF424 (R&R) Cover (Administrative Core)

    Complete only the following fields:

    • ·      Applicant Information
    • ·      Type of Applicant (optional)
    • ·      Descriptive Title of Applicant’s Project
    • ·      Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Administrative Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Administrative Core)
    • ·     In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • ·     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • ·     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • ·     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • ·     The CSBC Research Center PD/PI (contact PD/PI for applications with multiple PDs/PIs) must serve as the Administrative Core leader.
    • ·     The Administrative Core must have a qualified Research Center Administrator to manage the day-to-day operations with responsibility for the administrative, budgetary, and operational aspects of the center. For the Center Administrator, in the additional Senior/Key Profiles section, use Project Role of 'Other (Specify)' and provide the role under 'Other Project Role Category' as 'Research Center Administrator'.
    • ·     The Administrative Core must designate a qualified Data Manager who will interact with the consortium in order to facilitate timely sharing of interoperable datasets and community accessible resources. The Data Manager will participate in the Resource and Data Sharing Working Group of the CSBC. This working group is open to all members of the CSBC and is responsible for discussions regarding best practices for sharing interoperable datasets and community accessible tools within and outside of the consortium. The Data Manager will also be the Research Center’s point-of-contact for the MC2 Center Resource Coordinating Hub.
    Budget (Administrative Core)

    Budget forms appropriate for the specific component will be included in the application package.

    Leadership Effort Commitment: The CSBC Research Center contact PD/PI must dedicate a minimum of 2.4 person months of effort for the life of the award. If the Core has multiple leads, then each lead who is not the contact PI must dedicate a minimum of 1.2 person months effort to the Core for the life of the award. The required levels of effort may reflect an aggregate of the effort for the entire CSBC (listed here under Administrative Core) and the efforts for other CSBC components, as applicable.

    Research Center Administrator: Applicants must propose and budget for a Research Center Administrator to manage day-to-day operations.

    Data Manager: Applicants must propose and budget for a Data Manager to facilitate data and resource sharing.

    Funds for Intra-Center Pilot Projects: A minimum of $50,000 per year (direct costs) must be allocated to a fund for support of post-award pilot projects hosted within the Research Center.

    Funds for Cross-Consortium Projects: $75,000 (direct costs) per year in years 2-5 must be allocated to a fund to facilitate joint cross-consortium projects on areas of high value and common interest.

    Travel Funds: The budget should include funds to support travel for Research Center and consortium activities, including but not limited to supporting the travel and participation of PD(s)/PI(s) and other CSBC Research Center members in the annual CSBC Investigators Meeting and annual site visits.

    Other: Funds (including travel if appropriate) may be allocated for expenses related to the formation of an EAB. It is expected that funds will be allocated for the implementation of plans to enhance diverse perspectives in cancer biology, and for open-access publishing. Budget for data and resource sharing should be included in individual Research Projects.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Administrative Core)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: Succinctly describe the list of specific objectives and goals of the Administrative Core.   

    Research Strategy: The Administrative Core is expected to have appropriate and effective administrative and organizational capabilities to support a collaborative and integrated multi-project Research Center. This section will present a concise overall vision for the organization and administration of the proposed CSBC Research Center.

    In lieu of the standard Research Strategy subsections (Significance, Innovation, Approach) use the sub-sections defined below:

    Sub-section A: Organizational Structure and Staff Responsibilities

    • ·    Outline the organization of the leadership structure and overall Research Center structure (provide respective organizational diagrams).
    • ·    Describe the structures and procedures governed by the Administrative Core leadership that will foster synergy and integration of the Research Projects and Cores.
    • ·    Describe how progress will be evaluated across the center and how these evaluations will be used to ensure that the main goals of the Research Center will be achieved.
    • ·    Describe how the Administrative Core will ensure timely sharing of data and resources produced by all Research Center projects and Cores, considering interactions with data-generators at the Research Center and the MC2 Center.  
    • ·    Describe how the Administrative Core will implement and oversee activities described in the Plan to Enhance Diverse Perspectives, monitor progress towards milestones and ensure that goals are achieved.

    Sub-section B: Enhancing diverse perspectives in cancer systems biology

    Include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. Strategies should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the Research Center, and can address elements related to significance, investigators, innovation, approach and environment, as appropriate. Plans will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the Research Center is structured. Applicants should include a timeline and milestones for implementation of specific strategies. Examples of items that advance inclusivity in research include, but are not limited to:

    • ·    Opportunities for engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
    • ·    Description of any planned partnerships that may enhance geographic and regional diversity.
    • ·    Plan to enhance participation of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
    • ·    Proposed monitoring activities to identify and measure diversity and inclusivity progress benchmarks. Plans should state specific goals, including metrics that can be quantified at the beginning of the program and monitored over time.
    • ·    Plan to utilize the Research Center infrastructure to support career-enhancing research opportunities for diverse trainee, early- and mid-career researchers.
    • ·    Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers, and co-investigators from diverse backgrounds.
    • ·    Plan to develop collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
    • ·    Publication plan that enumerates planned manuscripts and proposed lead authorship.
    • ·    Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

    NIH NOT-OD-21-053 provides additional guidance on enhancing diversity and creating safe and inclusive environments.

    Sub-section C: Intra-Center Pilot Projects

    Briefly describe plans to implement one-year intra-center pilot projects to support non-U54 funded investigators. Include details about application solicitation, review, selection and oversight. Briefly describe how non-performing projects will be handled. Note: Do NOT propose any pilot projects in the application. Support of projects that increase the diversity of the CSBC community and/or move Research Center findings towards the clinic are especially encouraged.

    Sub-section D: Stewardship plan

    Briefly explain how infrastructure, collaborations, data and resources developed under this Research Center will be sustained beyond this award period. Describe how Research Center-developed concepts and technology would be transitioned into future projects and programs; plans to facilitate access and broad adoption of data and resources generated by the Research Center under the period of funding; and plans to facilitate the transfer of center-developed concepts to the cancer pre-clinical and clinical research community.

    Sub-section E: External Advisory Board: Describe the size of the EAB, the scientific disciplines and expertise of anticipated board members, and how the board will be expected to contribute to the Research Center's activities. Potential EAB members MUST NOT be contacted or appointed prior to completion of the application submission and review and should not be named in the application.  

    Letters of Support: Include letters of support as appropriate.

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

    • ·     All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • ·     Resource Sharing Plans should only be included in the Overall component.

    Appendix:

    Only limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.    

    PHS Human Subjects and Clinical Trials Information (Administrative Core)

    When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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

    Research Projects

    When preparing your application, use Component Type ‘Project.’

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

    SF424 (R&R) Cover (Research Projects)

    Complete only the following fields:

    • ·     Applicant Information
    • ·     Type of Applicant (optional)
    • ·     Descriptive Title of Applicant’s Project starting with "Project 1:", "Project 2:", etc.
    • ·     Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Research Projects)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Research Projects)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Summary/Abstract: Provide an abstract/summary for the proposed Research Project, including how it fits within the research theme of the CSBC Research Center.

    Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Research Projects)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Research Projects)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • For projects with multiple leads, in the Project Director/Principal Investigator section of the form, use Project Role of ‘Other (Specify)’ and designate the role under 'Other Project Role Category' as ‘Project Co-Lead’ and provide a valid eRA Commons ID in the Credential field. For other co-leaders, in the additional Senior/Key Profiles section, use Project Role of ‘Other (Specify)’ and provide the role under 'Other Project Role Category' as ‘Project Co-Lead’ and provide a valid eRA Commons ID in the Credential field.
    Budget (Research Projects)

    Budget forms appropriate for the specific component will be included in the application package. The Project Lead must dedicate 1.8 person months effort to the project for the life of the award. If the project has multiple leads, then each lead must dedicate at least 1.2 person months effort to the project for the life of the award. It is expected that funds will be allocated for data and resource sharing.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Research Projects)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: State the specific aims of the Research Project and provide a rationale and description of how they fit into the research theme of the Research Center.

    Research Strategy: The Research Projects constitute the most important activities of the Research Center and should address fundamental question(s) in cancer research through the explicit integration of experimental biology and computational and mathematical modeling. The research projects should be driven by a specific hypothesis and incorporate iterative cycles of quantitative experimentation, analysis, predictive modeling, and validation in a disease-relevant context.

    Applicants should use the standard structure of the Research Strategy section (i.e., sub-sections Significance, Innovation, and Approach).

    Within these sub-sections, address the following additional aspects of each project:

    • Provide a concise description of how the Project is integrated within the Research Center and contributes to the Research Center's overall research theme.
    • State the multidisciplinary aspects of the Research Project and how it benefits from the unique scientific expertise of Research Center personnel.
    • Indicate how the project team will take advantage of the Research Center infrastructure to allow for new approaches or perspectives to be quickly implemented or tested.
    • Highlight any innovative experimental and/or computational systems biology approaches used or developed within the project.

    If the Research Project will utilize the Shared Resource Core(s), describe how the Core(s) capabilities impact the proposed project.  

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • Resource Sharing Plans should only be included in the Overall component.

    Appendix:

    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. 

    PHS Human Subjects and Clinical Trials Information (Research Projects)

    When involving human subjects research and/or NIH-defined clinical research 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 a 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.

    Shared Resource Core

    When preparing your application, use Component Type ‘Core.’

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

    SF424 (R&R) Cover (Shared Resource Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project starting with "Core 1:", "Core 2:"
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Shared Resource Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Shared Resource Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Shared Resource Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Shared Resource Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    • For Cores with multiple leads, in the Project Director/Principal Investigator section of the form, use Project Role of ‘Other (Specify)’ and designate the role under 'Other Project Role Category' as ‘Core Director’ and provide a valid eRA Commons ID in the Credential field. For other co-leaders, in the additional Senior/Key Profiles section, use Project Role of ‘Other (Specify)’ and provide the role under 'Other Project Role Category' as ‘Core Director’ and provide a valid eRA Commons ID in the Credential field.
    Budget (Shared Resource Core)

    Budget forms appropriate for the specific component will be included in the application package.

    The Core Director(s) must each commit and maintain through the life of the award a minimum of 0.6 person months per year of effort. If there are multiple Core Directors, it is not necessary that each commit equal effort to the Core.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Shared Resource Core)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.

    Specific Aims: In addition to outlining the specific aims of the Shared Resource Core, state the Core’s relationship to the proposed Center goals and how it relates to the individual Research Projects and other Cores in the application.

    Research Strategy: The Shared Resource Cores may be physical or virtual infrastructures (e.g., cloud-based computing or storage) providing a biological, computational, or engineering resource that supports other Research Center components in their activities. Each Shared Resource Core is expected to support at least two Research Projects and the services and resources provided to other Research Center components should be clearly defined. Shared Resource Cores are not research projects and should play a supporting role. Issues to be addressed include, but are not limited to:

    • Value of the Core services to the Research Center and Research Projects;
    • Integration between the Core and Research Projects;
    • Procedures for selecting Research Projects to use the Core, including allocating resources, cost effectiveness, and increased efficiency; and
    • Quality control measures.

    Any proposed new shared resources must not duplicate analogous resources already established in the applicant institutions. If existing cores and resources are to be used, then funding to augment such existing resources may be requested. Description of how work related to the Research Center will be prioritized within such a core must be provided.

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

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • Resource Sharing Plans should only be included in the Overall component.

    Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information (Shared Resource Core)

    When involving human subjects research and/or NIH-defined clinical research 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 a 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.

    Outreach Core

    When preparing your application, use Component Type ‘Core.’

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

    SF424 (R&R) Cover (Outreach Core)

    Complete only the following fields:

    • Applicant Information
    • Type of Applicant (optional)
    • Descriptive Title of Applicant’s Project: "Outreach Core"
    • Proposed Project Start/Ending Dates
    PHS 398 Cover Page Supplement (Outreach Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Outreach Core)

    Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

    Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

    Project Narrative:  Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

    Project /Performance Site Location(s) (Outreach Core)

    List all performance sites that apply to the specific component.

    Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

    Research & Related Senior/Key Person Profile (Outreach Core)
    • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
    • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
    • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
    • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
    Budget (Outreach Core)

    Budget forms appropriate for the specific component will be included in the application package.

    A minimum of $100,000 direct costs per year must be allocated to the Outreach Core.

    Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

    PHS 398 Research Plan (Outreach Core)

    Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each core.

    Specific Aims: Outline Specific Aims for Outreach Core.

    Research Strategy: The Outreach Core will serve to promote the broad use of systems biology in cancer research, broadly disseminate and increase accessibility of computational and experimental approaches developed within the Research Center, and recruit the involvement of diverse investigators, cancer biologists and clinicians. Identify and describe the outreach activities that will be undertaken by the Research Center. Include a plan to evaluate the effectiveness of the proposed outreach activities. The proposed activities should relate to the research theme of the Research Center. Potential activities include but are not limited to:

    • Short courses. Engaging non-experts and individuals outside of the CSBC in use of the data and tools developed by the Research Center.
    • Seminar series. Hosting clinicians and clinical researchers to facilitate bi-directional flow of information and build relationships.
    • Think Tanks. Holding small meetings of investigators with diverse perspectives, including all stages of career development, to identify ways to support the clinical translation of basic research performed at the Research Center.
    • Workshops. Hosting small, focused meetings that bring together critical cancer researchers outside of systems biology and the CSBC.
    • Personnel Exchanges. Facilitating exchanges involving Research Center undergraduates, graduate students, postdoctoral fellows, or investigators with trainees at different types of institutions and organizations (e.g., research-intensive and research active, undergraduate-focused, minority-serving, community-based).
    • Educational Website. Establishing a Research Center website to increase usability of data and tools developed by the center for non-experts and individuals outside of the CSBC.
    • Research Center Annual Meeting. Disseminating CSBC Research Center advances through an open meeting, with a focus on increasing uptake of systems biology approaches across the wider cancer research 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, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
    • Resource Sharing Plans should only be included in the Overall component.

    Appendix: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.  

    PHS Human Subjects and Clinical Trials Information (Outreach Core)

    When involving human subjects research and/or NIH-defined clinical research 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 a 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.

     
    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) using ASSIST or other electronic submission systems. 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.

    For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

    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) and component Project Leads 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.

    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 (SAM). 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 NCI, 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.

    For this FOA, note the following:

    Reviewers will provide an overall Impact Score for the entire CSBC Research Center and numerical score for individual components (Research Projects, Administrative Core, Shared Research Core(s), and Outreach Core). Reviewers will be assigned to evaluate the entire application.  

    For the evaluation of the CSBC Research Center application, the Research Projects will be assessed as the scientific basis of each Research Center and its most important components, with additional components enhancing and integrating the overall research/outreach program. The overall Impact Score will reflect the synergy and integration provided by inclusion of each CSBC Research Center component.

    Overall Impact - Overall

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CSBC Research Center 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 CSBC Research Center proposed).

    Scored Review Criteria - Overall

    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 CSBC Research Center 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 CSBC Research Center 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 to this FOA: How much will the use of a coordinated multi-project systems biology approach increase the impact of proposed research beyond what could be achieved by stand-alone research projects? What is the potential for the proposed Research Center to contribute towards: (1) the broad application of systems biology approaches in cancer research; and (2) the growth of a strong, stable and diverse research community?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CSBC Research Center? 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 to this FOA: How strong are the team members' records in disseminating research, tools and techniques to a broad audience? How strong is the team's track record in fostering collaborative and inclusive interactions that engage a diverse set of scientists?

    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?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CSBC Research Center? Have 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 CSBC Research Center involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks, and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?   

    Specific to this FOA: How well does the overall research theme of the Research Center integrate experimental and mathematical or computational perspectives? How amenable is the overall research theme to predictive modeling of cancer biological processes?  

    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 to this FOA: How well does the Research Center environment and proposed organizational structure facilitate interaction and collaboration between researchers, both within and across components? To what extent will features of the environment described in the Plan for Enhancing Diverse Perspectives (e.g., collaborative arrangements, geographic diversity, institutional support) contribute to the success of the project?

    Additional Review Criteria - Overall

    As applicable for the CSBC Research Center 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.

    Integration

    How important is a center-based research structure for successfully pursuing the overall research theme and other proposed activities (Cores, Research Projects)? How scientifically and technically complementary and integrated are the proposed projects and optional shared resource core(s)? How well does the proposed Research Center organizational structure promote the scientific, technical and administrative interactions required for a cohesive center? How well do the proposed interactions and collaborations between the PD(s)/PI(s) and other key personnel advance the science of the Research Center?

    Scored Review Criteria - Research Projects

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

    Significance

    Does the Research 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 Research 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?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Research 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? Is the leadership approach, governance and organizational structure appropriate for the project?

    Specific to this FOA: How well does the Project draw on the unique multidisciplinary scientific expertise of the Research Center?

    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 to this FOA: How are the proposed cancer systems biology approaches being applied in an innovative fashion (i.e., if the methods themselves are not innovative, how are they being applied in an innovative manner)? How well does the project use Research Center infrastructure to quickly implement new approaches or perspectives?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Research Project? Have 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 CSBC Research Center involves human subjects and/or NIH-defined clinical research, are the plans to address:

     1) the protection of human subjects from research risks; and

     2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    Specific to this FOA: How well integrated is experimentation with analysis and predictive modeling in this project? How well thought out and informative are the iterative cycles of modeling and experimentation? How frequently are disease-relevant contexts used for testing and validation?

    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?

    Review Criteria - Administrative Core

    Reviewers will provide only one numerical score for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following criteria to determine an impact score:

    • Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the Research Center?
    • How well will the structure of the Administrative Core promote communication between the various Research Center components?
    • How likely is the proposed plan to enhance diverse perspectives in cancer biology improve the impact and significance of the Research Center through expanded inclusivity? Are the implementation strategy, timeline and milestones associated with the plan well-developed and feasible?
    • How fair and sensible is the plan for intra-center pilot project solicitation, review, and funding?
    • How comprehensive and concrete is the stewardship plan?  
    • How appropriate are the anticipated scope of expertise and processes for oversight and strategic planning of the EAB? How well will they address the needs of the proposed Research Center?
    Review Criteria - Outreach Core

    Reviewers will provide only one numerical score for the Administrative Core (criterion scoring is not used for this component). Reviewers will consider the following criteria to determine an impact score:

    • Are there sufficient and appropriate technical and scientific expertise, mentoring experience, and available faculty and staff to conduct the proposed outreach activities?
    • How effectively will the proposed outreach activities engage diverse investigators, cancer biologists, clinicians, non-experts, and individuals outside of the consortium?
    • How well will the proposed outreach activities increase accessibility of computational and experimental approaches developed within the Research Center?
    • How well do the proposed outreach activities relate to and integrate with the research theme of the Research Center?
    • Are the plans for evaluating the proposed outreach activities suitable?
    Review Criteria - Shared Resource Cores (if applicable)

    Reviewers will provide only one numerical score for the Shared Resource Cores (criterion scoring is not used for this component). Reviewers will consider the following criteria to determine an impact score:

    • How well matched is the proposed Shared Resource Core(s) to the needs of the overall Research Center? Are the services of the Shared Resource Core(s) essential to the goals of more than one Research Project?
    • Are the qualifications, experience, and effort commitment of the Shared Resource Core Director(s) and other key personnel adequate and appropriate for providing the proposed facilities or services?
    • Will the proposed Shared Resource Core(s) provide cost effective services to the Research Center, prevent duplication, and/or increase efficiency?
    • What is the overall quality level of the proposed Core(s) services and technologies and the rigor of processes for quality control/quality assurance?
    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 CSBC Research Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

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

    Biohazards

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

    Resubmissions

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

    Renewals

    Not Applicable.

    Revisions

    Not Applicable.

    Additional Review Considerations - Overall

    As applicable for the Research Center 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 .


    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:

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

    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 National Cancer Advisory Board. The following will be considered in making funding decisions:

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

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

    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 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:

    • Overseeing the scientific research in the Research Center, analyzing and interpreting research data, reporting results to the scientific community, and disseminating approaches, methods, models, software, and tools broadly.
    • Agreeing to be an active participant in the CSBC, including attending the Annual Investigators Meeting, participating in other consortium sponsored meetings and workshops, and participating in collaborative activities.
    • Committing to treat all individuals encountered through CSBC activities with respect and dignity, and to refrain from bullying, discrimination, and harassment.
    • Promoting trans-CSBC and external collaborations to advance cancer systems biology research.
    • Serving on the CSBC Steering Committee. The CSCB Research Center PD(s)/PI(s) (contact PD/PI for applications with multiple PD(s)/PI(s)) are required to serve as members of the Steering Committee.
    • Abiding by the governance of the CSBC and all consortium policies agreed upon by the CSBC Steering Committee and approved by NCI Program Officials to the extent consistent with the applicable rules and regulations.
    • Reporting progress to the NCI Program Officials on all CSBC Research Center research and outreach activities annually. The PD(s)/PI(s) may be expected to provide additional information, outside the scope of the standard reporting requirement, as needed and requested by program staff members on a semi-annual basis.
    • Ensuring active participation by the designated Data manager on the Resource and Data Sharing working group.
    • Ensuring timely coordination with the MC2 Center (solicited under RFA-CA-21-049) to facilitate public sharing of data, models, software, and other tools and resources developed as part of this Research Center.  
    • Ensuring that results of the Research Projects are published in a timely manner.
    • Being prepared for the annual site visits of NCI Program staff members and participation in the NCI-coordinated evaluation of the CSBC program.
    • Ensuring that restricted set-aside funds are used expeditiously.
    • Notifying NCI Program staff members about intra-center pilot projects (those funded through restricted funds in the Administrative Core) selected for implementation (with information on the scope of these projects and how they can contribute to the overall research theme of the Research Center).

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

    One or more designated NCI Program staff members will have substantial involvement as Project Scientists in the awards under this FOA. The specific roles of the substantially involved NCI staff members include the following activities:

    • Serving as voting members of the CSBC Steering Committee.
    • Serving as a resource for the CSBC in making them aware of other ongoing NCI activities that may be relevant to the study or goals of the CSBC.
    • Serving as a member of the Resource and Data sharing working group. 
    • Assisting the Steering Committee, and individual U54 and U01 awardees in avoiding unwarranted duplications of effort across the CSBC.
    • Assisting the awardees as a resource in facilitating their broader interactions with other NCI and NIH programs to disseminate results, tools, and models from the CSBC and take advantage of existing NIH/NCI resources and infrastructures.
    • Ensuring that the services of the Resource Coordinating Hub of the MC2 Center are provided to CSBC members in a reasonable and expeditious way.
    • Monitoring the operations of the CSBC awardees and making recommendations on overall project directions.
    • Participating in periodic site visits.
    • Participating in organizing annual CSBC meetings, specialized workshops, and webinars of the consortium.

    Additionally, an agency Program Official or IC Program Director will be responsible for the standard scientific and programmatic stewardship of the award and will be named in the award notice.

    Areas of Joint Responsibility include:

    The CSBC is governed by a Steering Committee. The CSBC Steering Committee consists of:

    • The contact PD/PI (for CSBC Research Centers or Research Projects with multiple PD(s)/PI(s)) from each awarded U54 CSBC Research Center (this FOA) and U01 Research Project (PAR-16-131 or PAR-19-287)
    • NCI Project Scientist

    All members of the Steering Committee will have one vote. Additional NIH/NCI Program staff and other government staff may participate in CSBC Steering Committee meetings as non-voting members. The structure is designed to allow awarded investigators and NCI staff to work together to facilitate trans-CSBC activities based on synergistic expertise and projects.

    Two PD(s)/PI(s), representing two different CSBC awards, serve as chairs of the Steering Committee. All CSBC Steering Committee decisions and recommendations that require voting will be based on a majority vote. The Steering Committee may have additional non-voting members. The contact PD/PI of the awarded MC2 Center is a permanent non-voting member.

    The CSBC Steering Committee will meet annually at the CSBC Annual Investigator Meeting and as needed.

    The CSBC Steering Committee will:

    • Identify scientific and policy issues that need to be, or can benefit by being, addressed at the consortium level and develop recommendations to NIH/NCI Program Officials for addressing such issues.
    • Review progress of the CSBC toward meeting the overall consortium goals.
    • Coordinate dissemination of consortium output to the broader cancer research community.
    • Review the potential for sharing of consortium resources (e.g. Shared Resource Cores) to serve the needs of other Research Centers or Research Projects and develop appropriate policies for such activities.
    • Ensure that the consortium takes advantage of existing NCI and NIH resources and programs.
    • Establish, as necessary, subcommittees to ensure progress of the CSBC Network and its current (as well as any successor) components.

    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: 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.

    In addition to standard information, the annual report must include (under Administrative Core component, Section B "Accomplishments") the following information:

    • Details pertaining to the outcomes of each intra-center pilot project;
    • A summary of the outcomes associated with each collaborative project administered using the restricted funds for Cross-Consortium Projects;
    • A summary of the outcomes of administrative supplement funding;
    • A list of trainees and positions obtained after CSBC funding; and
    • A list of collaborations facilitated by CSBC activities.

    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)

    Hannah Dueck, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-5751
    Email: hannah.dueck@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Amy Bartosch
    National Cancer Institute (NCI)
    Telephone: 240-276-6912
    Email: bartoschar@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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