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
Division of Cancer Biology Multi-Consortia Coordinating Center (U24 Clinical Trial Not Allowed)
Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type
Reissue of RFA-CA-15-015
Related Notices

  • August 4, 2021 - Pre-application Webinar for RFA-CA-21-049. See Notice NOT-CA-21-105.

Funding Opportunity Announcement (FOA) Number
RFA-CA-21-049
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.396
Funding Opportunity Purpose

The mission of the National Cancer Institute (NCI) Division of Cancer Biology (DCB) is to ensure continuity and stability in basic cancer research while encouraging and facilitating the emergence of new concepts, technologies, and possibilities. Towards its mission, the DCB supports multiple collaborative research programs focused on addressing important questions in basic cancer biology. To maximize the combined impact of DCB programs, this FOA aims to create a common coordinating body to facilitate collaborations, resource sharing, and outreach activities across DCB programs. DCB research programs to be coordinated by the DCB Multi-Consortia Coordinating Center (MC2 Center) include the Cancer Cell Biology Imaging Resource (CCBIR), the Cancer Systems Biology Consortium (CSBC), the Cancer Tissue Engineering Collaborative (TEC), the Metastasis Research Network (MetNet), the Patient-Derived Models of Cancer Initiative (PDMC), and the Physical Sciences-Oncology Network (PS-ON). In carrying out its roles, the MC2 Center is expected to work collaboratively with DCB research program investigators, other investigators collaborating with DCB research programs, and NCI program staff.

Key Dates

Posted Date
July 29, 2021
Open Date (Earliest Submission Date)
October 12, 2021
Letter of Intent Due Date(s)

October 15, 2021

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
November 12, 2021 Not Applicable Not Applicable March 2022 May 2022 July 2022

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

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

Expiration Date
November 13, 2021
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

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

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

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

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


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Through its Division of Cancer Biology (DCB), the NCI supports research in the field of basic cancer biology, focusing on the mechanisms that underlie fundamental processes such as cell growth, transformation of normal cells to cancer cells, response of tumors and tissues to cancer therapies, and the spread, or metastasis, of cancer cells. This research provides building blocks for new insights into interventions and treatments, clinical trials, and improved understanding of the progression of disease. To facilitate focused efforts in research areas of particular interest, DCB manages multiple collaborative research programs, representing emphasis areas such as cancer systems biology, physical oncology, bioengineered tissue systems and patient-derived experimental models, the development of new cellular and molecular imaging technologies, and the metastatic process. In addition to generating new scientific knowledge, DCB research programs produce data, tools, and resources that may be of high value to the research community. A dedicated effort in program and resource coordination will promote discoverability of data and tools and facilitate secondary use of DCB research program resources. Therefore, this funding announcement solicits applications for the Multi-Consortia Coordinating Center (MC2 Center), a Center intended to coordinate DCB research programs, including the Cancer Cell Biology Imaging Research Program (CCBIR, https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-21-002.html), the Cancer Systems Biology Consortium (CSBC, www.csbconsortium.org), the Cancer Tissue Engineering Collaborative (TEC, www.cancer.gov/tec), the Metastasis Research Network (MetNet, https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-20-029.html), the Patient-Derived Models of Cancer initiative (PDMC, www.cancer.gov/pdmc), and the Physical Sciences-Oncology Network (PS-ON, https://physics.cancer.gov).

Scope and Objectives

Relevant definitions:

For the purposes of this FOA, the following definitions apply:

Resources: In the context of this FOA the term "resources" relates to scientific data, experimental models, computational tools or models, mathematical models, software, experimental protocols, etc., generated by investigators within DCB programs and, potentially, by other related NCI-supported programs.

Scientific Data: Consistent with the NIH Policy for Data Management and Sharing (NOT-OD-21-013), scientific data is defined as the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications. Scientific data do not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects, such as laboratory specimens. The MC2 Center will be expected to coordinate annotation and deposition of scientific data generated by DCB research programs to NIH/NCI data commons resources.

Experimental model: Any in vitro, in vivo, ex vivo, or in situ biospecimen or reagent utilized to generate data for the purpose of generating, testing, or validating biological hypotheses. The MC2 Center is not expected to create biobanking infrastructure for the collection, storage, and/or distribution of experimental models generated by DCB research programs.

Computational or mathematical model: A formalism executed in silico to understand relationships between variables or systems components in a quantitative or qualitative manner. Key personnel of the MC2 Center are expected to work with DCB research programs to make curated computational or mathematical models available to the scientific research community.

Curation: The verification of functionality of a resource and in the context of this FOA refers specifically to the application of computational or mathematical models, computational tools and/or software given a specific data set (most likely the data utilized in publication with the resource). Key personnel of the MC2 Center are expected to propose and execute methods of curation in collaboration with DCB research programs.

MC2 Center Structure

The MC2 Center will provide leadership, infrastructure, and administration for three activities that are expected to enhance the integration of DCB research programs: (1) facilitate intra- and cross-consortium research collaborations via the Collaboration Hub; (2) promote discoverability of data and tools and facilitate secondary use of DCB research program resources via the Resource Coordinating Hub; and (3) coordinate dissemination of research advances, concepts, and capabilities of the DCB research programs via the Outreach Hub.

The Collaboration Hub

The primary goal of the Collaboration Hub is to facilitate intra- and cross-consortium research collaborations through the initiation and organization of scientific interactions among investigators within DCB research programs. This goal covers leading the organization and execution of the annual investigator and early-career investigator meetings for each program, as well as a broad range of activities to promote scientific interactions between investigators at all levels (e.g., periodic workshops, focus or working groups, in-person and internet-mediated interactions, codeathons, think tanks, or other non-traditional collaboration building efforts) both within individual DCB research programs (i.e., within CCBIR) or between DCB programs (i.e., between the CSBC and PS-ON, TEC, MetNet, CCBIR, or PDMC or with outside investigators when appropriate). Concerted efforts of the key personnel at the MC2 Center should design activities that increase the diversity, equity, and inclusion of these research communities. Investigators within the MC2 Center will be in a unique position to recognize and act upon scientific synergies through in-depth knowledge of the research programs that it coordinates.

The Resource Coordinating Hub

Although the initiatives supported by DCB are dominated by hypothesis-driven research questions, most are generating scientific data and resources that are broadly useful for the cancer research community. Employment of community standard data formats and annotations will decrease barriers to secondary data use and increase the overall impact of any one DCB program. Therefore, the Resource Coordinating Hub will provide data labeling tools and wrangling services to investigators within DCB research programs with the goal of depositing well-annotated clinical and experimental data to the relevant nodes of the NCI Cancer Research Data Commons (CRDC, https://datacommons.cancer.gov) or other NIH-supported resource.

The MC2 Center is expected to implement data standards, metadata dictionaries, and ingress resources developed by existing NCI programs whenever possible (for example, the NCI Human Tumor Atlas Network (https://data.humantumoratlas.org/standards), the NCI Genomic Data Commons (https://datacommons.cancer.gov/repository/genomic-data-commons), the NCI Proteomic Data Commons (https://datacommons.cancer.gov/repository/proteomic-data-commons), the NCI thesaurus (https://ncithesaurus.nci.nih.gov/ncitbrowser/), etc.), and especially in the case of mature data types (for example, bulk whole exome sequencing, bulk RNA sequencing, 3' single-cell sequencing, mass spectrometry-based proteomics, etc.).

It is expected that staff within the MC2 Center Resource Coordinating Hub will work with PD/PIs who are supported by DCB research programs to deposit well-annotated scientific data to the appropriate NCI CRDC resource or NIH resource. To facilitate secondary use of the data generated by DCB research programs, the Resource Coordinating Hub is also expected to stand up a virtual portal for external researchers to locate and access digitally identifiable resources, including protocols, scientific data, computational or mathematical models, and computational tools and/or software created by the DCB research programs. This portal will be open access, though will interface with controlled-access repositories. Because of the overlapping timing of the funding of various DCB research program parts (including the CSBC U54 Research Centers (RFA-CA-21-048) and ongoing funding announcements supporting other DCB research programs), the detailed scope of scientific data and resources that the MC2 Center will handle remains to be fully determined. Therefore, the MC2 Center needs to have staff members with broad expertise and swift, responsive, and flexible capabilities in a wide range of scientific data and computational and mathematical modeling approaches relevant to cancer research. For information about scientific data, computational and mathematical models, and computational tools and software generated during the current phase of the CSBC, PS-ON, and TEC, please visit the Cancer Complexity Knowledge Portal (https://www.cancercomplexity.synapse.org/).

The Outreach Hub

The goal of the Outreach Hub is to coordinate dissemination of research advances, concepts, and capabilities of the DCB research programs to cancer researchers and patient advocates as well as broader scientific communities, such as clinicians and clinical investigators. In particular, the MC2 Center Outreach Hub should have a specific focus on curation (as defined above) and broad distribution of computational tools, software, and computational and mathematical models developed within DCB research programs. These efforts should include providing a qualitative and/or quantitative measure of confidence in resources hosted by the MC2 Center portal and providing an environment that facilitates instructional use of tools and computational or mathematical models, including creating educational materials and facilitating virtual or in-person training. Importantly, it is expected that the MC2 Center will have the capability to curate computational and mathematical models and computational tools and/or software ensuring that resources promoted by the Outreach Hub are functional for the community. Staff members of the Outreach Hub will work with DCB research program investigators and NCI program staff to identify and prioritize resources primed for outreach efforts.

Additional required efforts of the MC2 Center Outreach Hub include the coordination of education and outreach activities proposed by the CSBC U54 Research Center Outreach Cores and support of DCB research program investigator activities related to the CSBC/PS-ON Summer Undergraduate Research Program (https://frederick.cancer.gov/Careers/InternshipsAndFellowships/SummerProgram/).

Applicants for the MC2 Center need to have sufficiently broad scientific expertise in the fields of basic and translational cancer research, including relevant aspects of bioinformatics and computational biology, that would allow them to play a key role in fulfilling the scientific objectives of the various DCB programs assigned for coordination.

Relevant DCB Research Program Goals

The goal of the Cellular Cancer Biology Imaging Research (CCBIR) program is to develop and test enabling imaging technologies at the cellular, tissue, and/or organ scales driven by specific fundamental basic and pre-clinical research problems in cancer biology. The CCBIR Centers will produce an interoperable suite of state-of-the-art imaging technologies with transformative potential to study the cancer biology process(es) that defines the Center. The cadre of CCBIR Centers (anticipated to be awarded in December 2021) will form a consortium that will be expected to engage with the broader cancer research community. More information about the CCBIR can be found at RFA-CA-21-002.

The goal of the Cancer Systems Biology Consortium (CSBC) is to advance the mechanistic understanding of cancerusingsystems biology approaches. For the purposes of this FOA, 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. Information about current CSBC funding opportunities, including RFA-CA-21-048 and current CSBC awards, can be found at www.csbconsortium.org.

The goal of the Cancer Tissue Engineering Collaborative (TEC) research program is to support the development and characterization of state-of-the-art biomimetic tissue-engineered technologies for cancer research. Collaborative, multidisciplinary projects that engage the fields of regenerative medicine, tissue engineering, biomaterials, and bioengineering with cancer biology are essential for generating novel experimental models that mimic cancer pathophysiology in the context of a testable cancer research hypothesis.More information about the TEC, including current awards, can be found at https://cancer.gov/tec and PAR-19-113.

The goal of the Metastasis Research Network (MetNet) is to facilitate a comprehensive and cohesive view of metastasis that accounts for the dynamic, non-linear, multi-scale interactions and processes required for a cancer cell to disseminate and colonize a secondary site. Through the application of integrated systems-level approaches, the MetNet seeks to advance mechanistic understanding of metastasis as a complex, whole-body, physiological process. Each MetNet research center will address fundamental themes of metastasis, that together will yield a higher-level understanding of the metastatic process and its integration with the patient. More information about the MetNet can be found at RFA-CA-20-029.

The goal of the Patient-Derived Models of Cancer (PDMC) program is to test and compare distinct patient-derived models developed from common patient samples with the objective of improving the understanding of the strengths and limitations of different patient-derived models as representatives of human tumors. Additionally, the program is undertaking systematic studies of patient-derived model’s evolution related to intrinsic tumor factors and microenvironmental pressures. Improved patient-derived models for cancer may inform the development of novel cancer therapies. More information about the PDMC including current PDMC awards, can be found at https://www.cancer.gov/about-nci/organization/dcb/research-programs/pdmc.

The goal of the Physical Sciences-Oncology Network (PS-ON) is to foster the convergence of physical sciences approaches and perspectives with cancer research to advance our understanding of cancer biology and oncology. PS-ON research broadly covers the areas of: (1) physical dynamics of cancer; and (2) spatio-temporal organization and information transfer in cancer. More information about the PS-ON, including current PS-ON awards, can be found at https://physics.cancer.gov/ and PAR-19-101.

Evaluation of the MC2 Center

As the efficiency of the funded center is an important priority for NCI, the MC2 Center investigators are required to participate in program evaluation processes 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. EPCs will attend MC2 Center site visits and DCB research program annual meetings to inform NCI program staff regarding challenges and opportunities for enriching MC2 Center activities.

Non-responsive Applications

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

  • Projects that do not address the specifications and requirements of all sub-sections described in the Research Strategy instructions (see Section IV.2: Content and Form of Application Submission - PHS 398 Research Plan).

Projects that propose basic cancer biology research instead of the activities outlined in the Coordination, Research Coordinating, and Outreach Hubs.

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

Renewal of applications for RFA-CA-15-015

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 fund 1 award, corresponding to $1,200,000 (direct costs), for fiscal year 2022. Future year amounts will depend on annual appropriations.

Award Budget

The award budget should not exceed $1,200,000 (direct costs) but needs to reflect the actual needs of the proposed center.

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:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

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

Other

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

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

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed. 

Required Registrations

Applicant organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

Applicants for the MC2 Center need to have sufficiently broad scientific expertise in the field of cancer research, including relevant aspects of bioinformatics and computational biology, that would allow them to play a leadership role in fulfilling the scientific objectives of the various DCB research programs assigned for coordination.

If so desired, PD(s)/PI(s) on applications or awards within DCB programs (CSBC, PS-ON, TEC, MetNet, CCBIR, or PDMC) may also serve as PDs/PIs on applications for the MC2 Center award under this FOA.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent (via email) to:

Shannon Hughes, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6224
Email: Shannon.Hughes@mail.nih.gov

Page Limitations

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

R&R Budget

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

Under Budget Justification, provide the budget break down to indicate the direct costs expected for the Collaboration Hub, Resource Coordinating Hub, and Outreach Hub.

In planning the costs, the applicants are expected to account for the following required budget items within the hub structure:

  • Annual investigator meetings for the CCBIR, TEC, CSBC, MetNet, PDMC, and PS-ON programs. Include the estimated cost of facilities and audio/visual support for one 2-3 day meeting per year per program.
  • Travel for MC2 Center investigators and staff to attend annual investigator meetings.
  • Dedicated, full-time MC2 Center Program Manager(s) to serve as points of contact between MC2 Center, DCB research program investigators, and NCI program staff.
  • Dedicated staff within the Resource Coordinating Hub to support data labeling and wrangling services for DCB research program investigators. It is expected that the budget for these staff will increase over the course of the award as data labeling and deposition demands increase.

If the Outreach Hub proposes activities to engage patients and/or patient advocates, a budget must be included to support the efforts of the involved patients or patient advocates.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Research Strategy: In lieu of the Standard sub-sections listed in the SF424 (R&R) Application Guide, the Research Strategy must consist of the following modified sub-sections.

Sub-section A: Overview and Significance

Provide an overview of the MC2 Center vision by stating how the structure will enhance and facilitate the research of DCB-supported research programs. Specific aspects of the MC2 Center that will lead to potential synergy among program members with respect to advancing knowledge of mechanisms underlying basic cancer biology should be especially highlighted. Additionally, applicants should:

  • Describe how their organizational structure and concepts will utilize the experience of individual team members, especially with regards to breadth of knowledge of basic cancer biology, metastasis, cellular imaging technologies, bioengineering, patient-derived experimental model generation, cancer systems biology and/or physical oncology;
  • State how, if applicable, existing or novel support from organizations outside the scope of this FOA (i.e., industry, foundations) might contribute to building each of the three required hubs.

Sub-section B: Collaboration Hub

Facilitating collaboration across DCB research programs

Describe plans for coordination of the Annual Investigator Meeting for each DCB research program (CCBIR, CSBC, TEC, MetNet, PDMC, PS-ON).

Describe activities that may lead to and/or facilitate collaborations within DCB research programs (for example, between CSBC U54 Research Center and U01 Research Project investigators), among investigators supported by DCB research programs (for example, between those within the PDMC and those within the PS-ON, MetNet, TEC, CCBIR or CSBC), or between investigators supported by supported by DCB programs and those within the wider research community.

A range of collaboration-related activities might be appropriate. Examples of potential appropriate activities include, but are not limited to:

  • Specialized meetings (outside of the Annual Investigator Meeting) that focus on a particular research area of interest across DCB programs and the wider cancer research community.
  • Monthly video conferences that highlight newly published research from DCB research program investigators at all levels.
  • Workshops, special interest groups, or working groups that focus on trans-consortium model building or tool sharing with the goal of developing inter- or intra-consortia pilot projects.
  • Specialized meetings that highlight collaboration opportunities within or across DCB programs and/or within or across NIH Institutes and Centers and/or other sponsored programs.
  • Think tanks that assess the evolving needs of cancer biologists, technologists, physical scientists, cancer systems biologists, mathematicians, computer scientists and computational biologists, with the goal of developing trans-consortium collaborations or pilot projects to address recommendations.
  • Specialized scientific retreats to facilitate interactions between specific investigator groups and/or to build new or broaden emerging communities.
  • Working groups to engage appropriate patient advocates.
  • Mechanisms to enrich research experiences of graduate students and/or post-doctoral fellows, e.g., through research-based exchanges across DCB-supported programs and to increase diversity, equity, and inclusion.

For each collaboration-building activity proposed:

  • State any innovative aspects and how they go beyond normal team-building activities.
  • State which DCB research program(s) and/or investigator community (or communities) are most appropriate for the activity.

Enhancing diverse perspectives in cancer biology

Include a summary of strategies to advance the scientific and technical merit of the proposed MC2 Center through expanded inclusivity. Strategies should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the MC2 Center, and can address elements related to significance, investigators, innovation, approach and environment, as appropriate. Plans will vary depending on the goals, expertise required, environment and performance site(s), as well as how the MC2 Center is structured. Applicants should include a timeline and milestones for implementation of specific strategies. Examples of actions 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 in collaborative activities.
  • Proposed monitoring of DCB research program 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 MC2 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).

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

Benchmarks of Collaboration Hub Performance

State what data and evidence will be collected to evaluate collaboration promoting activities on an ongoing basis to determine their effectiveness. Include information on how often activities will be evaluated and how information gained from the evaluation process will be utilized to increase, improve, redirect, or end current efforts.

Sub-section C: Resource Coordinating Hub

Describe a plan for creation and maintenance of the Resource Coordinating Hub that addresses, at a minimum, all the aspects, attributes, and functions of the hub:

Interactions with DCB Research Program Scientific Data Producers

Successful sharing of DCB research program scientific data and resources will require the MC2 Center team members to work closely with DCB research program investigators and NCI program staff. Applicants should describe plans and strategies for facilitating interactions that allow the efficient development of policies, tools, and procedures to facilitate deposition of well-annotated data to the NCI CRDC.

MC2 Center tasks that will require significant interaction between MC2 Center investigators, investigators supported by DCB research programs, and NCI program staff include, but are not limited to:

  • Recommendation of standardized machine-readable data formats and common data elements using well-defined formats and associated controlled vocabularies. The MC2 Center should reuse existing resources developed by past or ongoing NCI- or NIH-supported programs or data commons to the greatest extent possible to increase the interoperability of DCB research program data with existing NCI and NIH data resources.
  • Definition of standard experimental metadata, epidemiological data, and clinical data required to be submitted with each dataset, as appropriate for data generated by individual DCB programs. Note that an approach where common, high-value data types, as defined in collaboration with DCB research program investigators and NCI program staff, are identified and prioritized is acceptable.
  • Facilitation of the timely and efficient transfer of scientific data and metadata to the NCI CRDC. Note that different DCB programs may have variable timelines for data deposition, but at a minimum all programs must abide by current NIH policies. It is encouraged that the MC2 Center provide a plan for implementing program-specific data sharing policies and timelines.

Data Wrangling

The MC2 Center must provide mechanisms and staff to interact with the data production groups across DCB programs to facilitate the timely and efficient transfer of data and metadata to the NCI CRDC (or other NIH resource). Applicants should describe plans for working closely with DCB research program investigators and NCI program staff to facilitate labeling and sharing of scientific data, accompanying metadata (including information on biospecimens and samples), protocols, computational or algorithmic models, tools and resources, and/or visualization tools. The breadth of data to be handled by MC2 Center is large and applicants should describe previous experience with wrangling of relevant data types. A snapshot of scientific data types produced by a subset of DCB research programs (CSBC, PS-ON, TEC) can be found on the Cancer Complexity Knowledge Portal (https://www.cancercomplexity.synapse.org/).

MC2 Center Portal

It is envisioned that the MC2 Center will rapidly facilitate sharing of well-labeled scientific data and resources from DCB research program investigators. Secondary use of scientific data will be aided through consistent data formats, standardized data annotation, and report of quality control metrics, but discovery of DCB research program data, tools, and resources may remain a challenge. The MC2 Center Portal should address this challenge by providing access to scientific data and resources generated by investigators within DCB programs. Applicants should describe plans for developing a portal accessible to both DCB research program investigators and the wider scientific public for the purpose of discovering and using DCB research program resources within the NCI CRDC (or other NIH resources, as possible). Note that while it will interface with controlled-access data repositories, this portal will be open access.

Minimally, the portal should allow a user to:

  • Search for DCB research program awards, investigators, scientific data, tools, and resources;
  • Return search results in an intuitive user interface; and
  • Provide information on how to access, download, use, and/or analyze the resulting data, tools, or resources.

In addition to details regarding portal functionality, applicants should:

  • Describe how existing resources will be leveraged, especially those being supported through the NCI CRDC (i.e., the Cancer Data Aggregator, Bento) or those supported by the current CSBC/PS-ON Coordinating Center (i.e., the Cancer Complexity Knowledge Portal);
  • Describe how use cases and user personas will be utilized in the design, and during the construction and optimization, of the MC2 Center portal. Include details of specific UI/UX approaches that will be employed and how user testing will inform portal versions and releases;
  • Describe how unique aspects or products of the individual DCB research programs will be highlighted on the MC2 Center portal;
  • Describe how end users will be supported upon launch of the portal; and
  • Highlight any additional innovative aspects of the MC2 Center portal, especially in the areas of analysis and/or visualization tools.

Scientific Data and Resource Provenance

The MC2 Center should assign a unique identifier that enables subsequent tracking for submitted scientific data of all types. Applicants should describe how scientific data submitted to the NCI CRDC (or other NIH resource) will be attributed to specific DCB research programs and subsequently searchable via the MC2 Center portal. The plan should include details regarding how updates to data and resources will be versioned and tracked within the MC2 Center portal and/or propagated to the NCI CRDC (or other NIH resource).

Example Workflow

Applicants should provide an example workflow that illustrates the role of the MC2 Center in identification, annotation, procurement, and deposition of scientific data and resources from DCB research program investigators to the NCI CRDC or other NIH resource, with subsequent discovery, search, and presentation of data via the MC2 Center portal.

Benchmarks of Resource Coordinating Hub Performance

Applicants should provide a framework for evaluating performance of the Resource Coordinating Hub, including benchmarks and a timeline for achieving full functionality. Describe how ideas and concerns of DCB research program investigators regarding activities of the Resource Coordinating Hub will be addressed, including how those ideas and concerns might be integrated into the current application.

Sub-section D: Outreach Hub

Applicants should address how the Outreach Hub will satisfy two main requirements:

Dissemination of Curated Computational and Mathematical Models, Tools, and Software

Applicants should provide a plan for sharing curated computational and mathematical models and computational tools and/or software developed within DCB research programs, potentially through the MC2 Center portal. Applicants should present plans to curate resources produced by DCB research program investigators and subsequent delineation of these resources as such.

Describe strategies for promotion of computational and mathematical models and computational tools and/or software, including, but not limited to creation of educational materials, hosting and/or facilitating virtual or in-person training, providing incentives for download, use, and citation of resources. A plan to prioritize resources for curation, dissemination, promotion, and training is required due to the potential breadth of resources generated. Applicants should discuss how priorities will be set in collaboration with DCB research program investigators and NCI program staff.

Coordination of Education and Outreach Activities

Explain how the Outreach Hub will support the activities of the CSBC U54 Research Center Outreach Cores. (Note that only the CSBC U54 Research Centers are required to include an Outreach Core. For examples of activities that may require coordination, please see https://pubmed.ncbi.nlm.nih.gov/33168416/ and RFA-CA-21-048). Applicants should also propose other activities that might be appropriate for the Outreach Hub, including past examples of success in outreach activities. Examples include, but are not limited to:

  • Development of a short course, workshop series, or fellowship to expose scientists, engineers, mathematicians, and physical scientists at all levels to research within DCB-supported programs.
  • Dissemination of DCB research program activities and accomplishments through social media outlets, including production of training videos or massive open online classes, with concerted efforts to increase diversity, equity, and inclusion in cancer research.
  • Engagement of patient advocates to promote research performed by DCB research program investigators and/or outreach to patient populations to facilitate collaborative activities between patients and investigators supported by DCB research programs.
  • Facilitation of cross-DCB consortium collaborative and outreach activities for early-career researchers.

Benchmarks of Outreach Hub Performance

Provide information on how Outreach Hub activities will be tracked and evaluated, including how information gained from the evaluation process will be communicated to DCB research program investigators and utilized to increase, improve, redirect, or end current efforts.

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

The following modifications also apply:

  • Applicants should consider pre-existing intellectual property rights associated with the use of existing technologies. If proprietary tools/devices are used in building the coordinating center, applicants should clearly state the licensing agreement and are advised to contact NCI and seek assistance as needed from the NCI Technology Transfer Center (https://techtransfer.cancer.gov/) in determining whether such arrangements are appropriate and/or adequate.
  • Computational software and tools, and computational and mathematical models from this FOA are expected to be shared in an easily accessible format with the scientific community to increase the value of the significant public investment. Note that the NCI Program staff may negotiate modifications to these plans prior to funding (see Section VI: Terms and Conditions of Cooperative Agreement).
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by 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.

Overall Impact

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

Scored Review Criteria

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

Significance

How does the proposed Coordinating Center address the needs of the research supported by the DCB research programs that it will coordinate? How appropriate is the scope of activities proposed for the MC2 Center to meet those needs? How will the successful completion of the aims bring unique advantages or capabilities to the research supported by the CCBIR, TEC, CSBC, MetNet, PDMC, and PS-ON programs?

Specific to this FOA: How will the proposed MC2 Center be able to meaningfully contribute to the DCB research programs, e.g., by resolving major challenges in data management, consortium coordination, and outreach? How likely are the proposed activities of the MC2 Center to enhance enhance the diversity of perspectives across DCB research programs?

Investigator(s)

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

Specific to this FOA: How well do the PD(s)/PI(s) demonstrate evidence of experience working productively in collaborative environments and in large, distributed scientific projects?

Innovation

Does the application propose novel network coordination, data wrangling, and outreach strategies in coordinating the research programs the Coordinating Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of data coordination, network collaboration, and outreach strategies proposed?

Approach

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

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research programs the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the DCB research programs, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? Are an appropriate plan for work-flow and a well-established timeline proposed?

Specific to this FOA: How well does the research plan address the MC2 Center's three hubs: (1) Data Coordination Hub; (2) Resource Coordination Hub; and (3) Outreach Hub? How will the diversity and inclusivity activities proposed by the MC2 Center contribute to the scientific goals of the DCB Programs that it serves?

Environment

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

Specific to this FOA: How well does the environment promote the collaborations, research approaches, and flexibility required to solve the technical and scientific problems of the proposed MC2 Center?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the 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 MC2 Center and ensuring that the activities of the Collaboration Hub, the Resource Coordinating Hub, and Outreach Hub act to serve the goals of the DCB research programs as described in the full FOA.
  • Agreeing to be an active participant in DCB research programs, including ensuring that MC2 Center staff attend each Annual Investigators Meeting and participate in other consortium sponsored meetings and workshops.
  • Committing to treat all individuals encountered through MC2 Center activities with respect and dignity, and to refrain from bullying, discrimination, and harassment.
  • Attending the Steering Committee meetings for all DCB research programs included in the full FOA.
  • Abiding by all program policies agreed upon by the DCB research program Steering Committees and approved by NCI Program Officials to the extent reasonable and consistent with the applicable rules and regulations.
  • Reporting progress to the NCI Program Officials on all MC2 Center 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 timely coordination with the various DCB research program awardees to facilitate public sharing of data, models, software, and other tools and resources developed as part of their research activities.
  • Being prepared for the annual site visits of NCI Program staff members and participation in the NCI-coordinated evaluation of DCB research programs.

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 award under this FOA. The specific roles of the substantially involved NCI staff members include the following activities:

  • Serving as resource for the MC2 Center in making them aware of other ongoing NCI activities that may be relevant to the study or goals of the MC2 Center and DCB research programs.
  • Assisting the awardees as a resource in facilitating their broader interactions with other NCI and NIH programs to disseminate results, tools, and scientific data from the MC2 Center and DCB research programs 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 DCB research program members in a reasonable and expeditious way.
  • Evaluating the effectiveness and facilitating consortium-wide adoption of the MC2 Center Resource Coordinating Hub practices.
  • Monitoring the operations of the MC2 Center awardees and making recommendations on overall project directions.
  • Participating in annual site visits.

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 CCBIR, CSBC, MetNet, PDMC, and PS-ON are each governed by an independent Steering Committee. In each case, the Steering Committee consists of the contact PD/PI for each award and one NCI Project Scientist. The contact PD/PI of the awarded MC2 Center will act as a permanent non-voting member of each Steering Committee.

The TEC program is not governed by a Steering Committee, but instead meets quarterly as a Special Interest Group. The contact PD/PI of the awarded MC2 Center will be expected to join the TEC quarterly meeting.

Descriptions of the specifications and requirements for each of the CCBIR, CSBC, MetNet, PDMC, and PS-ON Steering Committees can be found in the relevant FOAs. Steering Committees meet annually at the program Annual Investigator Meeting and as needed.

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.

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: 301-276-5751
Email: hannah.dueck@nih.gov

Shannon Hughes, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6224
Email: shannon.hughes@nih.gov

Peer Review Contact(s)

NCI 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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