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

Participant Engagement and Cancer Genome Sequencing (PE-CGS): Coordinating Center (U24 Clinical Trial Not Allowed)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices
  • August 23, 2019 - Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-137.
  • July 26, 2019 - Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research. See Notice NOT-OD-19-128.
  • July 31, 2019 - Pre-Application Webinars for Participant Engagement and Cancer Genome Sequencing (PE-CGS): Funding Opportunities (RFA-CA-19-045, RFA-CA-19-046). See Notice NOT-CA-19-065.
Funding Opportunity Announcement (FOA) Number

RFA-CA-19-046

Companion Funding Opportunity

RFA-CA-19-045, U2C Resource-Related Research Multi-Component Projects and Centers Cooperative Agreements

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

  93.353, 93.396, 93.393  

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSMInitiative that is intended to accelerate cancer research. Specifically, this FOA falls under a scientific priority designated by the Blue Ribbon Panel (BRP) as Recommendation A "Establish a Network for Direct Patient Engagement".

The National Cancer Institute (NCI) intends to support the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network, which will include:

Several U2C Research Centers (to be supported under companion RFA-CA-19-045); and

One U24 Coordinating Center (to be supported under this FOA).

The overall purpose of the PE-CGS Network is twofold:

To promote and support research on direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research; and

To use such approaches for rigorous cancer genome sequencing projects addressing important knowledge gaps in the genomic characterizations of tumors in areas such as, but not limited to:

  • Rare cancers or rare cancer subsets;
  • Highly lethal cancers;
  • Cancers with an early age of onset;
  • Cancers with high disparities in incidence and/or mortality; or
  • Cancers in understudied populations.

PE-CGS U2C Research Centers, together with the PE-CGS U24 Coordinating Center, will form a collaborative Network.

The PE-CGS U24 Coordinating Center will have three major areas of responsibility: (1) Network Coordination; (2) Network Outreach and Promotion; and (3) Network Best Practices. 

Key Dates

 

Posted Date

July 30, 2019

Open Date (Earliest Submission Date)

September 30, 2019

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

October 30, 2019; July 30, 2020 

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)

No late applications will be accepted for this Funding Opportunity Announcement

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

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

January 2020; September 2020

Advisory Council Review

May 2020; January 2021

Earliest Start Date

July 2020; April 2021

Expiration Date

July 31, 2020   

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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

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

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

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

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


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

    This Funding Opportunity Announcement (FOA) is associated with the Beau Biden Cancer MoonshotSMInitiative that is intended to accelerate cancer research. Specifically, this FOA falls under a scientific priority designated by the Blue Ribbon Panel (BRP) as Recommendation A "Establish a Network for Direct Patient Engagement".

    The National Cancer Institute (NCI) intends to support the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network, which will include:

    • Several U2C Research Centers (to be supported under companion RFA-CA-19-045); and
    • One U24 Coordinating Center (to be supported under this FOA).

    The overall purpose of the PE-CGS Network is twofold:

    • To promote and support research on direct engagement of cancer patients and post-treatment cancer survivors as participants in cancer research; and
    • To use such approaches for rigorous cancer genome sequencing projects addressing important knowledge gaps in the genomic characterizations of tumors in areas such as, but not limited to:
    • Rare cancers or rare cancer subsets;
    • Highly lethal cancers;
    • Cancers with an early age of onset;
    • Cancers with high disparities in incidence and/or mortality; or
    • Cancers in understudied populations.

    PE-CGS U2C Research Centers, together with the PE-CGS U24 Coordinating Center, will form a collaborative Network.

    The PE-CGS U24 Coordinating Center will have three major areas of responsibility: (1) Network Coordination; (2) Network Outreach and Promotion; and (3) Network Best Practices. 

    Key Definitions for this FOA:

    • Cancer and/or population subset:  A subset/sub-type of a specific cancer (e.g., triple negative breast cancer), or cancer in a specific population (e.g., breast cancer in Hispanic women).
    • Clinical Trials: The NIH definition of a clinical trial stated in NOT-OD-15-015 applies to this FOA. A clinical trial is defined as 'research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
    • Direct participant engagement: Participant engagement is defined as an ongoing, mutually beneficial interaction between participants and researchers, where participants are included as an integral part throughout the research process: including the identification of research priorities and the design, conduct and uptake of research.  In direct participant engagement, research teams interact directly with participants or caregivers (via the web, social media, collaborations with patient groups or organizations, or using other forms of outreach), not necessarily through providers or the clinical setting. In some situations, contacts/outreach may include proxies (e.g., caregivers or family members of deceased participants).
    • Genomic characterization: characterizations of the genomic abnormalities in a given tumor by sequencing DNA along with characterizing the alterations at the transcriptome level by sequencing RNA.
    • Highly lethal cancers: or recalcitrant cancers, defined in the Recalcitrant Cancer Research Act of 2012 as having a 5-year survival rate for affected patients of less than 20% and estimated to cause deaths of 30,000 individuals in the United States per year.
    • Knowledge gap refers to a lack of (or substantial insufficiency) of genomic characterization data for a specific tumor type, or subtype, or for a specific subset of patient populations with a given tumor type/sub-type.
    • PE-CGS Network: Refers to the combined effort of the PE-CGS U2C Research Centers, the PE-CGS U24 Coordinating Center and the NCI to advance the science of participant engagement and cancer genome sequencing.
    • Rare cancers: are defined as those cancers for which the age-adjusted incidence rate is less than 15 cases per 100,000 individuals in the population.
    • Study Participant: Individuals with a history of a cancer diagnosis who may be interested and eligible for voluntarily offering their tumor sample for molecular characterizations such as genome sequencing. The participants may be cancer patients actively receiving treatment or post-treatment survivors.
    • Understudied populations:  Understudied populations as a specific group, who may or may not be medically underserved or socially disadvantaged but whose data on cancer health risks and outcomes are currently limited. There is a lack of sufficient data on this diverse group to inform evidence-based cancer control, prevention, and intervention. The dearth of research and information for these groups underscores the urgency to improve our available data and knowledge regarding cancer risks and outcomes within these understudied populations.
    Background

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

    In the recommendation to “Establish a Network for Direct Patient Engagement”, the BRP called for NCI to “enlist direct patient engagement through a federated Network where patients will be offered comprehensive tumor profiling”. The panel further noted the importance of directly engaging with patients to facilitate participation in research and ensure patients are respected and have access to the research enterprise. Moreover, the panel stated that efforts to reach minority and underserved populations should be a high priority.  This FOA is a step towards accomplishing the recommendation goals.

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

    The Advances and Challenges in Cancer Genome Sequencing. Recent technological advances, in particular next-generation sequencing (NGS) technologies, have revolutionized our ability to conduct cancer sequencing. For example, The Cancer Genome Atlas (TCGA) program generated a comprehensive molecular characterization of 33 tumor types, using biospecimens from over 11,000 patients. Notably, this comprehensive “atlas” of cancer genomic profiles allowed for the discovery of major cancer-associated genomic alterations, helping to generate novel insights into cancer biology that could be applied to develop new cancer therapies, diagnostic methods, and preventive strategies.

    Currently, there are opportunities to address knowledge gaps which remain. For example, many of the hundreds of different forms of cancer have not been sufficiently characterized. Furthermore, for those cancers that have been well characterized molecularly, questions remain about the generalizability of those data due to underrepresentation of samples from specific cancer subsets and understudied populations such as racial or ethnic minorities. Finally, most current cancer genomics studies lack adequate clinical or epidemiologic data.

    Addressing these gaps can be facilitated by innovative ways to directly engage participants in cancer sequencing studies.  Various strategies are possible for direct participant engagement (e.g., via the web, social media, collaborations with patient groups or organizations, or using other forms of outreach). Optimal approaches are likely to depend on the context of cancer/population subsets to be studied.

    Research Objectives and Main Requirements

    Role of the Coordinating Center in the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network

    The PE-CGS U24 Coordinating Center will operate as supporting infrastructure for the PE-CGS Network. In this capacity, the PE-CGS U24 Coordinating Center will collaborate with PE-CGS U2C Research Center investigators and interact with involved NCI staff members and with other stakeholders, as needed.

    Major responsibilities of the Coordinating Center will include:

    • Administrative and scientific coordination of Network activities (Network Coordination);
    • Development and coordination of outreach and promotion materials and communication channels (Outreach and Promotion); and
    • Development and implementation of standardized approaches to data collection and processing as well as other "best practices" for the Network (Network Best Practices).

    Specific functions of the Coordinating Center for these three areas will include (but will not be limited to) the following activities:

    Network Coordination:

    • Providing the administrative infrastructure necessary to facilitate and coordinate common activities of the PE-CGS Network;
    • Managing the PE-CGS Network governing and advisory bodies including the PE-CGS Network Steering Committee, Working Groups, and External Advisory Panel, by for example organizing web-based teleconferences, preparing agendas, taking meeting minutes, and drafting reports for the various committees, working groups, and panels.
    • Organizing PE-CGS Network meetings including for example an PE-CGS Network Kickoff Meeting and annual in-person meetings of the PE-CGS Network Steering Committee, the PE-CGS Network External Advisory Panel and PE-CGS participants;
    • Facilitating other PE-CGS Network activities, such as organizing small topical workshops; collaborations with outside groups; implementation of PE-CGS Network developed policies; and facilitating consortium opinion and perspective pieces;
    • Coordinating communication across the PE-CGS Network and NCI to identify common issues and needs for establishment of Scientific Working Groups or collaborative projects to address common issues in the consortium. 

    Network Outreach and Promotion:

    • Developing unified PE-CGS Network branding materials for use across the PE-CGS Network;
    • Coordinating PE-CGS Network branding and public relations outreach to increase awareness of PE-CGS among relevant stakeholders;
    • Developing PE-CGS Network participant engagement and communication materials such as Network websites;
    • Facilitating interactions with other Cancer Moonshot-supported research efforts, other NCI and NIH supported efforts, and/or non-NIH partners involved in activities relevant to the mission of the PE-CGS Network.
    • Managing other outreach activities, such as organizing sessions and tutorials at scientific meetings and managing the PE-CGS Network social media presence.

    Network Best Practices:

    • Identifying participant engagement and cancer genome sequencing issues that have broad applicability, within and external to the PE-CGS Network; accelerate the resolution of these issues; and disseminate methods, tools and best practices for participant engagement and cancer genome sequencing;
    • Establishing common data elements, data standards, metadata requirements, clinical and epidemiological data requirements, and controlled vocabularies for all PE-CGS data to ensure that the data are findable accessible, interoperable, and reusable (FAIR) to make the data and results maximally useful to the public;
    • Developing common data submission processes to appropriate unrestricted or controlled-access databases, ensuring that all PE-CGS data, participant engagement and cancer genome sequencing protocols, biospecimen and reagent information, analysis and visualization tools, are deposited in a timely manner and made accessible consistent with the sharing policies of the Cancer Moonshot Initiative;
    • Assisting the PE-CGS Network and the PE-CGS Steering Committee in planning efforts and exploration of possible routes to Network sustainability beyond the project period of NCI support.

    PE-CGS U24 Coordinating Center Team Expertise and Composition:

    The composition of the research team for the proposed PE-CGS U24 Coordinating Center must ensure the requisite expertise in participant engagement and cancer genome characterization. In addition, the team should be capable of effective communications and productive collaborations with various stakeholder groups. Therefore, the team is expected to include senior members who have considerable leadership skills and experience in productive collaborations with large research teams and/or multi-stakeholder groups (e.g., clinics, health departments, community-based organizations, hospitals) in diverse settings (e.g., rural, urban).

    It is expected that in order to adequately fulfill scientific and administrative coordination responsibilities, the PE-CGS Coordinating Center team will need multidisciplinary expertise such as:

    • Experience in coordination of multi-center networks related to stakeholder engagement or cancer genome characterization;
    • Knowledge of evidence base for optimal approaches for participant engagement, including but not limited to culturally-sensitive, targeted recruitment and enrollment strategies for underserved populations;
    • Expertise in cancer genome characterizations, including direct experience with current technologies and best practices;
    • Creativity and demonstrated success in anticipating and solving research challenges and facilitating consensus approaches to resolve these issues;
    • Demonstrated successful partnerships with multiple study teams across diverse settings and regions in the design, implementation, and completion of large-scale research studies;
    • Knowledge of social and behavioral science, including capacity in conducting health communication and health literacy research;
    • Expertise in expanding and sustaining network outreach and promotion;
    • Experience developing and implementing best practices;
    • Collaborative engagement with relevant stakeholder groups, including but not limited to patients, providers, clinics, health departments, hospitals, integrated delivery systems, federally qualified health centers, and community-based organizations;
    • Experience in the development of accessible, user-friendly communications materials (e.g., training manuals, brochures, flyers, newsletters), and ability to leverage various communication channels to share information to target end-users;

    Structure and Coordination of the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network

    Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network overall organization:

    The PE-CGS Network will consist of multiple PE-CGS U2C Research Centers and the PE-CGS U24 Coordinating Center.  The PE-CGS Network will function as a collaborative network allowing PE-CGS U2C Research Centers to address common issues, share best practices and lessons learned, and utilize common methods where appropriate. 

    The PE-CGS U24 Coordinating Center will be required to interact closely with the PE-CGS U2C Research Centers (to be supported under companion RFA-CA-19-045).  Therefore, the prospective Coordinating Center applicants are expected to read RFA-CA-19-045 and familiarize themselves with the scope and responsibilities of the PE-CGS U2C Research Centers.

    PE-CGS Network Steering Committee: The Network will be governed by the PE-CGS Network Steering Committee. Details on the composition and responsibilities of the Steering Committee are provided in Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.

    PE-CGS Network External Advisory Panel:  This panel will be formed as a sub-committee to the Steering Committee. The external members will include individuals with a history of cancer diagnosis, cancer advocates, oncologists, established scientific leaders, communication experts, and other relevant stakeholders. Details on the composition and responsibilities of the External Advisory Panel are provided in Section VI.2 under Cooperative Agreement Terms and Conditions of the Award.

    Non-Responsive Applications

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

    • Applications that fail to address the three required areas of responsibility for the Coordinating Center.

    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 of application submitted to the earlier round of this FOA

    Important Note: If an appropriate awardee is selected from the first round of applications, the FOA will be expired   before the second application receipt date (i.e., resubmission of applications unfunded in the first round may not be possible).

    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 $500,000 (total costs) in FY 2020 to fund one award.

    Award Budget

    Application budgets are limited to no more than $350,000 direct costs and need to reflect the actual needs of the proposed project.

    Award Project Period

      The project period of up to 5 years may be requested.   

    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)
    • U.S. Territory or Possession
    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

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

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

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

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

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

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

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

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

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

    2. Content and Form of Application Submission

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

    Letter of Intent

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

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

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

    The letter of intent should be sent to:

    Elizabeth M. Gillanders, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-6764
    Fax: 240-276-7920
    Email: NCI_PE-CGS@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, with the following additional instructions:

    • In the biosketches of specific senior/key persons explain how their individual expertise will contribute to the expected breadth of expertise outlined in Section I.
    • If applicable for a given individual, the biosketches should also describe any experiences in coordination of participant engagement and/or coordination of cancer genome characterization networks, and/or expanding network outreach and promotion, and/or developing/implementing network best practices, data standardization, etc.
    R&R Budget

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

    Leadership Effort Commitment: The PE-CGS U24 Coordinating Center contact PD/PI must commit and maintain through the life of the award a minimum of 1.8 person-months of effort. For applications with multiple PDs/PIs, a minimum effort of 1.8 person-months is required for the Contact PD/PI and 1.2 person-months of effort per additional PD/PI is required.

    Meeting Organization and Conference calls: The cost of organizing two PE-CGS Network meetings per year (to be held in NIH space), should be included in the proposed research budget. The costs associated with monthly conference calls (for example for the PE-CGS Steering Committee or working groups) should also be included in the proposed research budget. 

    Travel Funds: Budgets should include the costs of necessary staff members from the PE-CGS U24 Coordinating Center to attend the meetings described above, as well as including travel for an average of ten additional participants or advisors per meeting (External Advisory Panel members or Network Participants).

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Specific Aims: Outline the general objectives of the proposed PE-CGS U24 Coordinating Center, the overall approach for achieving these goals, and how the approach will support the PE-CGS U2C Research Centers. The proposed specific aims should address all the main areas of responsibility identified under Research Objectives and Main Requirements in Section I.

    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: Vision and Organization

    • Explain the collective capabilities of the study team in terms of their qualifications and experiences in coordinating large, multi-site research initiatives, and their qualifications in conducting research in patient engagement and cancer genome characterization. Emphasize how the combined, interdisciplinary expertise of the team will meet the needs of the PE-CGS Coordinating Center activities. Do not repeat information provided in biosketches;
    • Describe the organizational and governing structure for the PE-CGS U24 Coordinating Center, including responsibilities and reporting structure.
    • Describe their contingency plans as program needs evolve or shift, and the expertise that makes them uniquely qualified to meet changing needs and unforeseen challenges.

    Sub-Section B: Network Coordination

    • Describe an approach to provide the administrative infrastructure necessary to facilitate and coordinate all common activities of the PE-CGS Network, including supporting various PE-CGS Network governing and advisory bodies including the PE-CGS Network Steering Committee, Working Groups, and External Advisory Panel.
    • Provide a plan for coordinating communication across the PE-CGS Network in order to facilitate collaboration. Include a discussion of working in collaboration with NCI and PE-CGS U2C Research Centers to communicate directly with PE-CGS participants, in particular providing updates about network activities.

    Sub-Section C: Network Outreach and Promotion

    • Provide a plan for developing and maintaining unified branding materials for use across the PE-CGS Network. The plan should describe approaches for coordinating PE-CGS Network branding and public relations outreach to increase awareness of the PE-CGS Network among relevant stakeholders. Applicants should also describe their strategies for promoting and sustaining PE-CGS Network visibility and outreach to the stakeholder community, including other relevant participant engagement and cancer genome characterization efforts.
    • Describe approaches to be used for initiating outreach activities that will help raise public awareness of the research program and disseminate research results. Applicants should discuss plans for development of the PE-CGS Network website, the main entry point for the sharing of information related to PE-CGS Network activities.

    Sub-Section D: Network Best Practices

    • Provide details for a process for interacting with the PE-CGS U2C Research Centers and the NCI to address key participant engagement and cancer genome characterization issues.
    • Outline plans for formalizing and implementing best practices across Research Centers.
    • Describe the approaches to dissemination of relevant methods, tools and best practices for participant engagement and cancer genome characterization.
    • Describe the approaches to assisting PE-CGS U2C Research Centers in establishing common data elements, data standards, metadata requirements, clinical and epidemiological data requirements, and controlled vocabularies for all PE-CGS data [the approaches used should ensure that the data are findable, accessible, interoperable, and reusable (FAIR) to make the data and results maximally beneficial/useful to the public.]

    Sub-Section E: Health Disparities

    If applicable to the type of research being proposed, address how minority or health disparity populations or data will be integrated into the proposed studies. Highlight, as relevant, any opportunities that, if implemented, can reduce the burden of cancer in the health disparities that currently exist. In this context, efforts are encouraged to address the needs of minority populations and other health disparity populations, including those from urban and rural areas who are poor and medically underserved, who continue to suffer disproportionately from certain cancers and have higher morbidity and mortality rates.

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

    Appendix:

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

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    7. Other Submission Requirements and Information

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

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

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

    Important reminders:

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

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

    See more tips for avoiding common errors.

    Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by the NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

    Overall Impact

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

    Scored Review Criteria

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

    Significance

    Does the proposed Coordinating Center address the needs of the research Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network that it will coordinate? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research Network?  

    Specific to this FOA: What is the likelihood that the PE-CGS U24 Coordinating Center, as proposed, will meet all the network coordination, outreach and data standardization needs and help develop shared best practices for the PE-CGS Network? Will the proposed PE-CGS U24 Coordinating Center be able to contribute to the PE-CGS Network, e.g., by resolving major challenges in network coordination, outreach and best practices? How well will the coordination and facilitation activities of the PE-CGS U24 Coordinating Center, as proposed, contribute to the success of the PE-CGS Network in generating comprehensive genomic landscapes of cancers (or cancer and/or population subsets) that are currently poorly characterized and the optimization of direct participant engagement approaches for cancer sequencing projects?

    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 multidisciplinary research? Do the investigators demonstrate significant experience with coordinating collaborative large-scale cancer genome sequencing and direct participant engagement-based 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, cross-disciplinary collaboration, conflict resolution plans and skills, 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?  Have the PD(s)/PI(s) participated in any collaborative, multi-center networks? Have the PD(s)/PI(s) contributed substantially to efforts involving direct participant engagement?  Is the management plan well-described and commensurate with the level of complexity required for this FOA?

    Innovation

    Does the application propose novel organizational concepts or management strategies in coordinating the research Network 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 network coordination, outreach and best practices/data standardization strategies proposed?

    Specific to this FOA: Is the proposed approach or methodology dynamic and responsive to evolving changes in cancer sequencing or direct participant engagement?  Does the applicant demonstrate the ability to be facile and responsive to external input or other external factors (e.g. changes in policies or technologies, changes in Network needs) in this rapidly moving field?

    Approach

    Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research Network the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the Network, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the Network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the Network? Are an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?

    Specific to this FOA: Are the plans for assisting with PE-CGS Network activities, providing logistical support and fulfilling Coordinating Center functions likely to increase the synergy and productivity of the Network? How strong are the research plans for each of the three major areas of responsibilities: (1) Network Coordination; (2) Network Outreach and Promotion; and (3) Network Best Practices and Data Standardization and Usage? Does the application contain acceptable plans for facilitating the NCI Cancer Moonshot Public Access and Data Sharing Policy?

    Environment

    Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the research Network 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: Is the infrastructure adequate to meet the needs of the project? How well does the environment promote the collaborations, transdisciplinary approaches, and flexibility required to solve the technical and scientific problems of the proposed PE-CGS U24 Coordinating 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

    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

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

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources:

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

    Budget and Period of Support

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

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute, 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  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.
    • Compliance with Beau Biden Cancer Moonshot Open Access and Data Sharing Policy
    3. Anticipated Announcement and Award Dates

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

    Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

    Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

    Institutional Review Board or Independent Ethics Committee Approval: Grantee 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    Cooperative Agreement Terms and Conditions of Award

    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75. 

    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:

    • Disseminating Network results to the scientific community, and disseminating approaches, methods, software, and tools broadly.
    • Committing and maintaining throughout the life of the PE-CGS U24 Coordinating Center a minimum of 1.8 person-months of effort per year for the investigator designated as the contact PD/PI.
    • Committing and maintaining throughout the life of the PE-CGS U24 Coordinating Center a minimum of 1.2 person-months of effort per year for any investigator designated as a non-contact PD/PI of the PE-CGS Network Coordinating Center.
    • Agreeing to be an active participant in the PE-CGS Network, including attending the annual network meetings and participant centered meetings, participating in other network sponsored meetings, webinars and workshops, and participating in collaborative activities.
    • Serving on the PE-CGS Network Steering Committee. The PE-CGS U24 Coordinating Center PD/PI (contact PD/PI for applications with multiple PD(s)/PI(s)) is required to serve as a member of the PE-CGS Network Steering Committee.
    • Abiding by the governance of the PE-CGS Network and all program policies agreed upon by the PE-CGS Network 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 PE-CGS U24 Coordinating Center research and outreach activities annually. In addition to standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.
    • Being prepared for ad hoc site visits of NCI Program staff members and participation in the NCI-coordinated evaluation of the PE-CGS Network.
    • Leveraging, where feasible, technology from related NCI-sponsored informatics initiatives, for example the NCI Informatics Technology for Cancer Research (ITCR) program, which supports the development of informatics algorithms, tools, and resources across the continuum of cancer research.
    • Coordinating with and leveraging, where feasible, the technology of the NCI Cancer Research Data Commons, a program that will provide infrastructure to make diverse cancer research data broadly available and to maximize their reuse and impact.
    • Ensuring that data are deposited in a timely manner to the NCI GDC, and software and other tools and resources developed as part of this Research Center are made publicly available according to PE-CGS policies and in accordance with the Beau Biden Cancer Moonshot Public Access and Data Sharing Policy.
    • Ensuring that participants are engaged in the research and feel respected, empowered, and motivated to participate in the PE-CGS research study.

    Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

    PE-CGS U24 Coordinating Center investigators will also be encouraged to participate, as appropriate, in other PE-CGS meetings and workshops, collaborative activities, and/or scientific and programmatic working groups.

    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 Scientist(s) for the PE-CGS Network Coordinating Center.

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

    The specific roles of the substantially involved NCI staff members include the following activities:

    • Serving as voting and non-voting members of the PE-CGS Network Steering Committee.
    • Assisting the PE-CGS Network Steering Committee, the PE-CGS Coordinating Center, and individual PE-CGS Center awardees in avoiding unwarranted duplications of effort across the PE-CGS Network.
    • Facilitating collaborative research efforts that involve multiple PE-CGS centers and would be suitable for consideration as a trans- PE-CGS Network collaborative project to be funded by restricted Research Center collaborative funds.
    • Supporting the awardees as a resource in facilitating their broader interactions with other NCI and NIH programs to disseminate results, tools, and best practices from the PE-CGS Network and take advantage of existing NIH/NCI resources and infrastructures.
    • Monitoring the operations of the PE-CGS Network awardees and making recommendations on overall project directions and allocations of PE-CGS funds.
    • Participating in organizing annual PE-CGS investigator meetings, participant centered meetings, specialized workshops, and webinars of the network.

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

    Areas of Joint Responsibility include:

    PE-CGS Network Steering Committee. The PE-CGS Network Steering Committee will be the main governing body for the PE-CGS Network. The PE-CGS Network Steering Committee will be composed of one representative (contact PD/PI or other senior level investigator) from each PE-CGS awardee, i.e., from the PE-CGS U2C Research Centers and the PE-CGS Coordinating Center who will have one vote each.

    If needed, other NIH staff members may also participate in PE-CGS Network Steering Committee meetings as non-voting members.

    Two PD(s)/PI(s), representing two different PE-CGS U2C Research Centers, will be selected to serve as chairpersons of the PE-CGS Network Steering Committee starting at the first meeting of the PE-CGS Network Steering Committee following award issuance. All PE-CGS Network Steering Committee decisions and recommendations that require voting will be based on a majority vote.

    The PE-CGS Network Steering Committee will meet quarterly by videoconference and in-person at the PE-CGS annual network meeting, annual participant meeting, and as needed.

    The PE-CGS Network Steering Committee will:

    • Identify scientific and policy issues that can benefit by being addressed at the Network level and develop recommendations to NIH/NCI Program Officials for addressing such issues.
    • Review progress of the PE-CGS Network toward meeting the overall Network goals.
    • Receive input and guidance from the PE-CGS Network External Advisory Panel.
    • Serve as a venue for consideration of ethical and psychosocial implications of returning genomic data results to participants.
    • Ensure that all PE-CGS members utilize the resources developed by the PE-CGS Coordinating Center.
    • Discuss and prioritize the collaborative projects to be supported by the restricted "PE-CGS Collaborative Project" funds within each Research Center.
    • Ensure that the Network takes advantage of existing NCI and NIH resources and programs.
    • Establish, as necessary, subcommittees or working groups to ensure progress by tackling common issues for the individual Research Centers and the Network.

    The Steering Committee may form sub-committees as needed, including the External Advisory Panel (see below).

    PE-CGS Network External Advisory Panel. An External Advisory Panel (EAP) will be convened as a sub-committee to the PE-CGS Steering Committee. EAP will evaluate the progress of the PE-CGS Network and advise the Steering Committee and PE-CGC awardees regarding the scientific directions of the program.  The panel will be logistically supported by the PE-CGS Coordinating Center.

    The PE-CGS Network EAP will be composed of nine individuals (selected by the PE-CGS Steering Committee), including established scientific leaders in oncological sciences, individuals with a history of cancer diagnosis, cancer advocates, and other stakeholders with relevant expertise. If needed, EAP membership may be enlarged permanently or on an ad hoc basis. The EAP will meet at least once a year, either in person with the Steering Committee meeting or by telephone conference.

    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)

    Elizabeth M. Gillanders, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-6764
    Email: NCI_PE-CGS@mail.nih.gov

    Leah E. Mechanic, Ph.D., M.P.H.
    National Cancer Institute (NCI))
    Telephone: 240-276-6847
    Email: NCI_PE-CGS@mail.nih.gov

    Wen-Ying Sylvia Chou, Ph.D., M.P.H.
    National Cancer Institute (NCI)
    Telephone: 240-276-6954
    Email: NCI_PE-CGS@mail.nih.gov

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Crystal Wolfrey
    National Cancer Institute (NCI)
    Telephone: 240-276-6277
    Email: wolfreyc@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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