Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Purpose

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to establish a Cancer Immunoprevention Network (CIP-Net) Data and Resource Coordinating Center (DRCC). The overall goal of this NOFO and the companion NOFO (RFA-CA-23-029, Cancer Immunoprevention Network (CIP-Net) Research Projects (UG3/UH3 Clinical Trials Not Allowed)) is to establish an agile and effective network to undertake collaborative research focusing on cancer immunoprevention research, with the overarching goal to support a deeper understanding of basic mechanisms of immunoprevention, discover novel immunoprevention strategies, preclinical development and testing of interventions (agents/vaccines), and foster a community of cancer immunoprevention researchers.

The overall Cancer Immunoprevention Network (CIP-Net) will comprise UG3/UH3 cooperative agreement research grants awards (the companion NOFO RFA-CA-23-029) and this one U24 Data and Resource Coordination Center (DRCC; this NOFO RFA-CA-24-036).

To achieve the Program's overarching goal, CIP-Net research objectives will be accomplished in two phases: 

• The initial UG3 phase will enable de novo discovery of immune pathways, targets, immunoprevention mechanisms, investigation of new vaccines or immunomodulatory agents, or preclinical development and testing of interventions.
• Successful completion of UG3 phase milestones will lead to the UH3 phase for validation of actionable targets, further evaluation of immune mechanisms of action, investigating mechanisms of efficacy and potential side effects of precision cancer prevention-interception strategies, and/or further preclinical development. 
• The UG3/UH3 research projects will be complemented by the U24 DRCC that will foster collaborations, facilitate data, and resource sharing across CIP-Net, and enhance scientific communication and outreach to cancer prevention research communities.

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

1. CIP-Net research support: The CIP-Net DRCC will provide overall data and resource coordination, support, and facilitate collaboration across CIP-Net. The CIP-Net DRCC will provide bioinformatic and analytical support with the policies established by the CIP-Net Steering Committee (CIP-Net SC).
2. Network research tools and resources information: The CIP-Net DRCC will facilitate in-network sharing of research tools and resources (e.g., novel assay technologies, protocols, preclinical biospecimens, animal models, and agents) by establishing a centralized information infrastructure for shareable tools.
3. Program operational support: The CIP-Net DRCC will provide program management support, including logistical and administrative assistance on in-network communications and collaborative activities, and coordinating and facilitating network-wide meetings (e.g., CIP-Net SC meetings, Annual CIP-Net Investigators meetings, workshops (in-person with hybrid option), and seminars), support immunoprevention community building, conduct scientific outreach to build immunoprevention bridges across complementary cancer research communities, and foster early career scientist career development.

Key Definitions for the Context of this NOFO

• Cancer immunoprevention: Cancer immunoprevention is the prevention of invasive cancer onset (not recurrence) with immunological means such as vaccines or immunomodulatory agents.
• Cancer interception: Cancer interception is defined as the disruption of the oncogenic process during the precancer stage before the development of invasive cancer (not recurrence).
• Higher-risk populations, higher-risk cohorts: These are individuals with an increased risk of cancer such as those with hereditary cancer syndromes (HCS), precursor abnormalities, or exposure to agents that can induce cancer (e.g., smoking, asbestos).
• Precision cancer prevention and interception: Precision cancer prevention-interception refers to an approach employing cancer preventive-interceptive interventions individually tailored for different higher-risk populations as defined above.
• Resources: In the context of this NOFO the term "resources" relates to scientific data, experimental models, computational tools or models, mathematical models, software, experimental protocols, etc., generated by CIP-Net investigators 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.

Background

The national trends in cancer death rates suggest a notable and continued decline for several organ site cancers. These trends demonstrate that scientific advances in treatment strategies and public health efforts to minimize risk factors through lifestyle changes (dietary, metabolic, smoking cessation, etc.), timely cancer screening (early detection and prevention), and primary cancer immunoprevention (in healthy humans that is currently restricted to tumors related to infectious agents, such as hepatitis B virus (HBV) and human papillomavirus (HPV)) are making a real difference in health outcomes at the population level. While primary cancer immunoprevention has been successfully applied to infectious agents, about 85% of human tumors are unrelated to infectious agents. Immunoprevention of cancers not driven by infectious agents remains an outstanding challenge in the general human population, mainly because it would require vaccines completely devoid of significant toxicities and should confer long-term protection against the risk of developing tumors. Recent proof-of-principle preclinical studies have demonstrated that vaccines and other immunological interventions induce host immune responses, indicating that immunoprevention can be effectively implemented in human cohorts affected by specific cancer risks. Importantly, preclinical studies have demonstrated that vaccines and immunomodulatory agents clearly provide significant immunoprevention efficacy by controlling tumor onset and progression in animal models of various organ site cancers.

Preventive vaccines have clear and important advantages. For example, vaccination may trigger a more effective immune response in healthy individuals with normal immune systems compared to cancer patients with compromised immune systems and immunosuppressed tumor microenvironments. Tumorigenesis is a continuum of a dynamic interplay between emerging aberrant cell clones and host tumor immune surveillance from the earliest stage of tumor formation to the establishment of fully invasive cancers. Importantly, growth and progression trajectories of screen-detected and incidentally identified precancers are not uniform or linear. A better understanding of early oncogenic processes and immune surveillance machinery can shed light on immune pathways and basic mechanisms that are responsible for driving progressive tumor growth and weakening the host defense mechanisms. Further, chronic inflammation and tissue injury can lead to persistent exposure to antigens, resulting in progressive loss of immune effector cell functions, e.g., immune exhaustion. What events and immunological changes in tumor precursor cells as well as in the tissue microenvironment tilt the balance for or against tumor growth and progression have yet to be fully elucidated. Features of the microenvironment are also likely to be distinctly different and more favorable in newly emerging pre-malignant lesions. Little is currently known about the time course for the appearance of immune targets during the carcinogenic process or the best way to stimulate immunity. The potential for controlling the induced immune response is increasing with the advent of novel targets and adjuvants that is likely to continue. Genomic analyses have been useful in defining patterns of mutations occurring in established tumors, and while The Human Tumor Atlas Network (HTAN), Pre-Cancer Atlas (PCA), Translational and Basic Science Research in Early Lesions (TBEL), and other recent research initiatives are getting underway, genomic, and molecular profiling data of early-stage cancers are already available from programs like NCI Consortium of Molecular and Cellular Characterization of Screen-detected Lesions (MCL). The data from these programs could be harnessed to illuminate novel immune pathways, targets, vaccine designs, and immune responses in genetically-engineered or carcinogen-induced mouse models that represent high-risk cohorts.

Scientific Scope

The scientific scope of the Cancer Immunoprevention Network Data and Resource Coordinating Center (CIP-Net DRCC) is to provide scientific leadership and coordination toward the overall CIP-Net goals of establishing a community of cancer immunoprevention researchers collectively and collaboratively researching basic mechanisms of immunoprevention, discovering novel immunoprevention strategies, and conducting preclinical development and testing of immunoprevention interventions.

The overall Cancer Immunoprevention Network (CIP-Net) will comprise UG3/UH3 cooperative agreement research awards (the companion NOFO RFA-CA-23-029 and one U24 Data and Resource Coordination Center (DRCC; this NOFO RFA-CA-24-036)).

The CIP-Net DRCC must have appropriate expertise, background, skills, managerial capacity, and established infrastructure required to carry out the responsibilities. The CIP-Net DRCC will provide scientific leadership, data and resource sharing, and outreach for CIP-Net through three integrated and coordinated elements:

Element A: CIP-Net Administration and Coordination. The CIP-Net DRCC will serve as the administrative and organizational center and will work closely with CIP-Net investigators to facilitate collaboration among all CIP-Net components and coordination between CIP-Net and other National Cancer Institute (NCI) supported initiatives or networks (TBEL, PREVENT, DDNP-CIP, CAP-IT and other relevant programs). Accordingly, the CIP-Net DRCC must demonstrate strong leadership, innovative thinking, expertise, and managerial capacity to bring grantee groups together and build the team to implement data management and sharing policies established by the CIP-Net SC. The CIP-Net DRCC will provide program management support, including administrative and logistical assistance on in-network communications and collaborative activities, and coordinate and facilitate network-wide meetings.  The DRCC will organize and coordinate CIP-Net monthly and annual (in-person with hybrid option) Steering Committee meetings and Working Group meetings. The DRCC will organize and coordinate activities to support early career scientist career development across the immunoprevention research community. The CIP-Net DRCC must establish and maintain unified and coordinated procedures for network-wide communications with the investigators and NCI and be able to function as an information and implementation hub for CIP-Net network activities.

Element B: CIP-Net Data and Resource Sharing. The DRCC will develop a central CIP-Net website that will constitute the main entry point for the sharing of data and resources and information related to CIP-Net activities and a virtual biorepository to enable findable and accessible sharing of immunoprevention specific biospecimens, animal models, tools and technologies, and other data and resources. The CIP-Net DRCC will coordinate the sharing and distribution of CIP-Net generated data and resources among CIP-Net investigators and the wider scientific community. For data sharing and analysis, the DRCC will provide essential bioinformatics, computational, and analytical support for the design, collection, management, and analysis of data (including genomic data, tumor targets, cellular analyses, and others) for CIP-Net investigators. It is anticipated that CIP-Net will generate broad, varied and complex data including neoantigens, circulating and tumor-infiltrating immune cell parameters; cell subset analyses; immunohistochemistry; immunofluorescence; and various types of genomic, epigenomic, transcriptomic, proteomic, and spatial datasets. The DRCC will support coordination and transport of animal model sharing within the network, development of standard operating procedures for the functioning of DRCC and data management. The DRCC is required to work closely with CIP-Net investigators to share data, protocols, tools and technologies, and information on biospecimens and other immunoprevention resources and make the scientific community aware that this information is publicly accessible.

Element C: CIP-Net Community Building. The CIP-Net DRCC will support immunoprevention outreach and community building both within CIP-Net and with the wider scientific community. The DRCC will conduct scientific outreach to build immunoprevention bridges across complementary cancer research communities. Outreach and community building activities will enhance and increase immunoprevention research awareness through scientific communications and meetings. CIP-Net community building will require direct patient engagement by integrating immunoprevention research advocates into CIP-Net. Immunoprevention research community building through the CIP-Net DRCC will require engagement of early career scientists. CIP-Net outreach and community building must include a Plan for Enhancing Diverse Perspectives (PEDP).  

Other CIP-Net DRCC application considerations: As immunoprevention data and resource generation, storage, analysis, and dissemination needs of CIP-Net evolve over time, the DRCC may be asked to implement modifications to its workflows as agreed upon by the CIP-Net investigators and NCI staff. In addition, increasing efficiencies in generating data along with potential changes in technology platforms may dramatically alter the types and volume of data to be deposited, curated, and analyzed by the DRCC. Further, the data will likely be generated across many organ sites and cancer-relevant transitions, adding another layer of complexity to the curation and mining of the data. The DRCC should remain flexible in their implementation of data coordination, analysis, and outreach workflows.

CIP-Net Governance: Upon inception of the program, the CIP-Net SC will be formed, consisting of CIP-Net UG3 PIs, CIP-Net DRCC PIs, and NCI staff members. For details on the composition and responsibilities of the CIP-Net SC, see Section VI under Cooperative Agreement Terms and Conditions of the Award.

Non-responsive Applications  

Applications which do not include a description of all three CIP-Net DRCC elements (A: Administration and Coordination, B: Data and Resource Sharing, and C: Community Building) will be viewed as non-responsive and will not be reviewed.
 

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

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex (including gender identify, sexual orientation, or transgender status) of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 Government

• 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

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. 

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

• 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.
  • 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.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; 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 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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:

Altaf Mohammed, Ph.D. and Lillian Kuo, Ph.D.
National Cancer Institute (NCI)
Email: [email protected]
 

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status).
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status).

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP guidance materials.

All instructions in the How to Apply - Application Guide must be followed.

R&R Budget

All instructions in the How to Apply - Application Guide must be followed.

Under Budget Justification, provide the budget break down to indicate the direct costs expected for the Cancer Immunoprevention Network Data and Resource Coordinating Center (CIP-Net DRCC) Element A: CIP-Net Administration and Coordination, Element B: CIP-Net Data and Resource Sharing, and Element C: CIP-Net Community Building.  In planning the costs, the applicants are expected to account for the following required budget items within each Element.  

Element A: Annual CIP-Net investigator meetings (in-person with hybrid option). Include the estimated cost of travel, facilities, and audio/visual support for a two-day meeting per year per award. Travel for DRCC investigators and staff to attend annual CIP-Net investigator meetings. Dedicated, full-time CIP-Net DRCC Program Manager(s) to serve as points of contact between the CIP-Net DRCC, CIP-Net investigators, and NCI program staff.

Element B: Dedicated bioinformatic and computational staff within the DRCC to support design, collection, management, and analysis of data and resource for CIP-Net investigators. It is anticipated that the budget for these staff may increase over the course of the award as data and resource demands may increase.

Element C: Dedicated staff to support immunoprevention outreach and community building both within CIP-Net and with the wider scientific community.
 

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: The applicant is to provide the overall objective for the Cancer Immunoprevention Network Data and Resource Coordinating Center (CIP-Net DRCC) and the plans to achieve these goals listed in well-defined specific aims. The specific aims must include all three Elements, Element A: CIP-Net Administration and Coordination, Element B: CIP-Net Data and Resource Sharing, and Element C: CIP-Net Community Building.

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

Overview and Significance. Provide an overview of the Cancer Immunoprevention Network Data and Resource Coordinating Center (CIP-Net DRCC). Describe how the DRCC will provide overall data and resource coordination, support, and facilitate collaboration across CIP-Net. Describe the anticipated overall DRCC impact and significance toward establishing a community of cancer immunoprevention researchers collectively and collaboratively researching basic mechanisms of immunoprevention, discovering novel immunoprevention strategies, and conducting preclinical development and testing of immunoprevention interventions. Describe the overall vision and impact toward building immunoprevention bridges across complementary cancer research communities and foster early career scientist career development.

Sub-section A: Element A: CIP-Net Administration and Coordination. The CIP-Net DRCC will serve as the administrative and organizational center and will work closely with CIP-Net investigators to facilitate collaboration among all CIP-Net components and coordination between CIP-Net and other National Cancer Institute (NCI) supported initiatives or networks (TBEL, PREVENT, DDNP-CIP, CAP-IT and other relevant programs). The CIP-Net DRCC must demonstrate strong leadership, innovative thinking, expertise, and managerial capacity to bring awardee groups together and build the team to implement data management and sharing policies established by the CIP-Net SC. The CIP-Net DRCC will provide program management support, including administrative and logistical assistance on in-network communications and collaborative activities, and coordinate and facilitate network-wide meetings. The DRCC will organize and coordinate CIP-Net monthly and annual Steering Committee meetings and Working Group meetings. The DRCC will organize and coordinate activities to support early career scientist career development across the immunoprevention research community. The CIP-Net DRCC must establish and maintain unified and coordinated procedures for network-wide communications with the investigators and NCI and be able to function as an information and implementation hub for CIP-Net network activities.

A range of organizational activities may be appropriate for CIP-Net DRCC Administration and Coordination.  Address the anticipated activities of Element A: CIP-Net DRCC Administration and Coordination that include (but are not limited to):

• Provision of the administrative infrastructure necessary to facilitate and coordinate all common activities of the CIP-Net;
• Organization and coordination of all CIP-Net governing and advisory bodies including the CIP-Net Steering Committee and subcommittees, CIP-Net working groups, and external scientific panels;
• Manage these activities by organizing web-based conferences, taking minutes, and drafting reports for various committees, working groups, and panels. Develop, maintain, and make accessible all significant CIP-Net-related documents, including policies, reports, and standard operating procedures generated by the various CIP-Net committees, working groups, and panels;
• Develop and maintain a centralized CIP-Net website that will constitute the main entry point for the sharing of resources and information related to CIP-Net activities;
• Develop and implement user-friendly approaches to navigate and access resources generated by CIP-Net, including protocols, data standards, tools and technologies, animal models, biospecimens and reagent information;
• The centralized CIP-Net website should be accessible to a broad audience including patients, advocacy groups, the general public, and the larger scientific community;
• The centralized CIP-Net website should include basic information on cancer immunoprevention, the goals of CIP-Net, CIP-Net members contact information, and the scope of the funded projects. This part of the website will prospectively house future achievements of the Consortium (e.g., publications, discoveries, hand-offs for clinical testing, etc.);
• The centralized CIP-Net website should also feature a controlled access site that will serve the members of CIP-Net for sharing privileged and sensitive information including patient data, preliminary data, pre-publication manuscripts, and other information not ready for public release;
• Provide restricted access, internet-based resources such as mailing lists, wiki site, file sharing, or social media tools to share data and enable discussions within CIP-Net;
• Organize an annual CIP-Net investigators meeting (in-person with hybrid option). This meeting will have 50 to 200 attendees and take place in the Bethesda/Rockville, MD, area. All attendees will support their own travel and lodging through their funded awards;
• Manage or facilitate other CIP-Net activities, including but not limited to: organizing small topical workshops (All attendees will support their own travel and lodging through their funded grants); collaborations with outside groups; implementation of CIP-Net developed policies; and facilitating consortium opinion and perspective pieces; and
• Facilitate, as needed, interactions with NCI and NIH supported efforts, and/or non-NIH partners. These may include consortia, biorepositories, databases, or non-profit organizations involved in activities relevant to the mission of the CIP-Net. The focus should be on developing interactions that can benefit both investigators and partners of the CIP-Net through the sharing of information, expertise, and reagents, or through leveraging the coordination of research and technology development in areas of common interest.

Sub-section B: Element B: CIP-Net Data and Resource Sharing. The DRCC will develop a central CIP-Net website that will constitute the main entry point for the sharing of data and resources and information related to CIP-Net activities and a virtual biorepository to enable findable and accessible sharing of immunoprevention specific biospecimens, animal models, tools and technologies, and other data and resources. The CIP-Net DRCC will coordinate the sharing and distribution of CIP-Net generated data and resources among CIP-Net investigators and the wider scientific community. For data sharing and analysis, the DRCC will provide essential bioinformatics, computational, and analytical support for the design, collection, management, and analysis of data (including genomic data, tumor targets, cellular analyses, and others) for CIP-Net investigators. It is anticipated that CIP-Net will generate broad, varied and complex data including neoantigens, circulating and tumor-infiltrating immune cell parameters; cell subset analyses; immunohistochemistry; immunofluorescence; and various types of genomic, epigenomic, transcriptomic, proteomic, and spatial datasets. The DRCC will support coordination and transport of animal model sharing within the network, development of standard operating procedures for the functioning of DRCC and data management. The DRCC is required to work closely with CIP-Net investigators to share data, protocols, tools and technologies, and information on biospecimens and other immunoprevention resources and make the scientific community aware that this information is publicly accessible.

A range of organizational activities may be appropriate for CIP-Net DRCC Data and Resource Sharing. Address the anticipated activities of Element B: CIP-Net DRCC Data and Resource Sharing that include (but are not limited to):

• Provide essential bioinformatics and computational support for the design, collection, management, and analysis of varied and complex data (including genomic data, tumor targets, cellular analyses, tissue pathological analyses, cell subset analyses; immunohistochemistry; immunofluorescence and others) for all CIP-Net research; 
• Deploy computational tools and support for CIP-Net studies relevant to neoantigen identification, circulating and tumor-infiltrating immune cell analyses, T cell receptor profiling, and other immunogenomic analyses;
• Enhance data management and sharing through optimization of data collection methodologies suitable for immune-related studies;
• Work closely with CIP-Net Investigators and NIH staff to establish common data elements, data standards, metadata requirements, controlled vocabularies, and quality control metrics for all CIP-Net data to ensure that the data are findable accessible, interoperable, and reusable (FAIR) to ensure the data and results are maximally useful to the public;
• Facilitate data use by the broader scientific community by depositing all CIP-Net -generated datasets in appropriate unrestricted or controlled-access databases and develop a Data Portal (accessible through the centralized CIP-Net website) for user-friendly access to these databases that will constitute the main entry point for access to CIP-Net -generated data and linked databases;
• Develop an Application Programming Interface (API) to facilitate interactions with other NCI Data Coordinating Centers, NCI Cancer Research Data Commons (CRDC), the Cancer Data Ecosystem, and/or other NCI or NIH programs as specified;
• Provide NCI staff with quantitative updates on data deposition, data quality, and data usage statistics upon request and full access.
• Develop or obtain and implement a Virtual Biorepository to oversee tracking and distribution of organ site-specific biospecimens, animal models, tools and technologies, and other resources;
• The Virtual Biorepository will need to be structured in a way that allows for multiple levels of access, based on the level of confidentiality of the data, resource, or information being requested.
• Develop training and outreach strategies to disseminate CIP-Net data, resources, and tools to the broader scientific community and;
• Develop strategic plans to promote CIP-Net activities and resources to the larger scientific community that could include sponsoring sessions at scientific meetings, establishing discussion forums, or utilizing appropriate social media outlets; and
• Work closely with NIH staff and relevant public data/resource repositories to ensure the long-term archiving and distribution of CIP-Net datasets and resources beyond its funding period.

Sub-section C: Element C: CIP-Net Community Building. The CIP-Net DRCC will support immunoprevention outreach and community building both within CIP-Net and with the wider scientific community. The DRCC will conduct scientific outreach to build immunoprevention bridges across complementary cancer research communities. Outreach and community building activities will enhance and increase immunoprevention research awareness through scientific communications and meetings.  CIP-Net community building will require direct patient engagement by integrating immunoprevention research advocates into CIP-Net.  Immunoprevention research community building through the CIP-Net DRCC will require engagement of early career scientists. CIP-Net outreach and community building must include a Plan for Enhancing Diverse Perspectives (PEDP).  The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout CIP-Net.

A range of organizational activities may be appropriate for CIP-Net Outreach and Community Building. Address the anticipated activities of Element C: CIP-Net Community Building that include (but are not limited to):

• Direct patient engagement by integrating immunoprevention research advocates into CIP-Net;
• Direct communications, engagement, and outreach with relevant immunoprevention research communities (e.g., SITC, AAI, AACR, ASCO, Cancer Prevention Research Conference, ASPO, ESMO, et al.) and NCI and NIH programs (e.g., HTAN, TBEL, PCA, PREVENT, DDNP-CIP, CAP-IT and other relevant programs);
• Facilitating joint meetings, workshops and other collaborative activities with relevant immunoprevention research stakeholders; and
• Providing opportunities to early career scientist career development, including (but not limited to): training, leadership development opportunities and platforms for early career scientists in emerging and diverse areas of cancer immunoprevention, specialized workshops or working groups focused on early career scientist immunoprevention research development.

Enhancing diverse perspectives in cancer immunoprevention.  Plan for Enhancing Diverse Perspectives (PEDP): The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.
To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.
This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation. Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex (including gender identity, sexual orientation or transgender status) of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.
The PEDP will be submitted as Other Project Information as an attachment (see Section IV). Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance materials (https://grants.nih.gov/policy/plan-for-enhancing-diverse-perspectives.htm). 

The CIP-Net DRCC is also expected to evolve, adapt, and improve during the project in response to the needs of the immunoprevention research community. CIP-Net DRCC applicants must demonstrate that their team will have the expertise and flexibility to accommodate increasing data volume and evolving data types.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide. 

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan (DMSP).
• DMSP should briefly describe the types of data and computational resources that are expected to be generated by the funding under this award and shared, consistent with achieving the goals of the CIP-Net.
• DMSP should describe plans for anonymization, annotation, multimodal data integration, transfer learning, development of robust statistical, artificial intelligence, and/or machine learning-ready datasets (as applicable) to facilitate formats that are findable, accessible, interoperable, and reusable (FAIR) to increase the value of these data and unique resources for sharing with the scientific community.
• Formats, analytical algorithms, computational modeling and visualizations, and other bioinformatics tools resulting from this NOFO are expected to be compatible with the NIH-approved bioinformatics platforms, such as those designed and implemented by the NCI Center for Bioinformatics platforms (https://cbiit.cancer.gov/data-sharing).
• To facilitate the establishment of a CIP-Net database, Network members will be expected to adhere to data collection and coordination policies set forth by the CIP-Net Data Coordinating Center (DRCC) in collaboration with NCI and the CIP-Net members.
• Applicants should provide a plan for essential bioinformatics, computational, and analytical support for the design, collection, management, and analysis of data (including genomic data, tumor targets, cellular analyses, and others) for the CIP-Net UG3/UH3 projects.
• As applicable to collaborations with the CIP-Net UG3/UH3 projects, scientific data generated by the DRCC U24 under funding of this award in collaboration with CIP-Net investigators should also be covered under the DRCC U24 DMSP.

Note that NCI Program staff may negotiate modifications to these plans prior to funding.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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

Part I. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - Application Guide.

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected]. 

Applicants are required to follow the instructions for post-submission materials, as described 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).

As part of the overall impact score, reviewers should consider and indicate how the Plan to Enhance Diverse Perspectives affects the scientific merit of the project.

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 DRCC address the needs of the research projects that it will coordinate? Is the scope of activities proposed for the DRCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research projects?

.

Investigator(s)

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

.

Innovation

Does the application propose novel organizational concepts and management strategies in coordinating the research projects the DRCC will serve? Are the concepts and strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and management strategies proposed?

.

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research projects the DRCC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the projects? 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?

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

.

Environment

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

.

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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

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 Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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 NOFO.

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 NOFO. 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, including the PEDP, as determined by scientific peer review
• Availability of funds.
• Relevance of the proposed project to program priorities.

Please note that reviewers will not consider race, ethnicity, age, or gender (including gender identity, sexual orientation or transgender status) of the researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its funding decisions.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov.  NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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 recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

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 (HHS) grant administration regulations at 2 CFR Part 200, 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 recipients 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 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.

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

• Recipients 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 HHS, PHS, and NIH policies.
• Defining objectives and approaches, and to ensure scientific rigor in the planning, conducting, analyzing, and publishing of results, interpretations, and conclusions of studies conducted under this program;
• Setting project milestones in consultation with NIH staff, and reporting progress and objectives to NIH staff;
• Coordinating efforts and cooperating with the other components of the Cancer Immunoprevention Network (CIP-Net) with NCI Project Scientists. These actions may involve (but will not be limited to) participation in appropriate coordinating meetings and/or working groups, and/or teleconferences/videoconferences as needed;
• Overseeing the implementation of an approved data-sharing plan and resource-sharing plan. Institutions/organizations participating in CIP-Net will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to CIP-Net;
• Submitting materials and updates to NCI extramural staff on research progress, accomplishments, and challenges as requested;
• Leveraging, where feasible, technologies from related NCI-sponsored informatics initiatives, for example, The NCI Informatics Technology for Cancer Research (ITCR, https://itcr.cancer.gov/ 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 (https://cbiit.cancer.gov/ncip/cancer-research-data-commons);
• Maintaining the confidentiality of the information shared by CIP-Net, including, without limitation, unpublished data, protocols, data analysis, confidential exchanges between members of CIP-Net, as well as any confidential information received by third-party collaborators;
• Annotating samples through the use of Consortium-defined Common Data Elements (CDEs).
•  Adhering to the CIP-Net Communication Plan: A consensus Communication Plan will be drafted by the CIP-Net Steering Committee. This plan will clearly spell out interactive requirements that all CIP-Net PI(s) and DRCC PI(s) are expected to follow, including: Participating in regular conference calls and contributing to various sub-committees and working groups; Serving as a voting member on the CIP-Net Steering Committee; Participating and presenting findings at CIP-Net annual investigator meetings; and Coordinating efforts with other members of CIP-Net.
• Provide updates at least annually on progress in PEDP implementation. 
  1. Meeting yearly milestones as defined by PI(s) and NCI Project Scientists at the time of award;
  2. Participating in NCI-coordinated evaluation of CIP-Net. Recipients 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 HHS, PHS, and NIH policies.
      

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

• Serving as a voting member on the CIP-Net Steering Committee;
• Provide scientific input and advice on the research projects;
• Coordinating and facilitating interactions among investigators across CIP-Net;
• Working closely with investigators on research projects to coordinate and facilitate interactions/collaborations between recipients across the consortium;
• Assisting the recipients as a resource in facilitating their broader interactions with other NCI and NIH programs for the purpose of leveraging and coordinating existing NIH/NCI resources and infrastructures, such as the NCI Cancer Research Data Commons;
• Assisting in avoiding unwarranted duplication of effort with other NIH efforts;
• Suggesting reprogramming efforts, including options to modify projects/programs when certain objectives of this NOFO are not met;
• Developing working groups and trans-project efforts as needed;
• Monitoring progress and direction of recipients and working groups as needed; and
• Organizing and conducting regular meetings, as needed, to share progress between the recipients of CIP-Net either by teleconference, videoconference, or face-to-face interaction.
• Contributing to scientific manuscripts and other scientific and scholarly activities (e.g., conference presentations) resulting from the project; and
• NIH reserves the right to withhold support, suspension, or termination of an award for lack of adherence to required CIP-Net policies and/or procedures.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The CIP-Net Steering Committee (SC) will serve as the main governing board for CIP-Net and recipients will join the CIP-Net SC. Voting members for the CIP-Net SC include: 
  1. The NCI Project Scientists will collectively have one vote for NCI; and
  2. One representative from each new UG3/UH3 (a PI or their designee) will have one vote.
  3. One representative from DRCC will have one vote.
• Other PD(s)/PI(s) can participate in SC meetings as non-voting members according to established CIP-Net Steering Committee bylaws
• Primary responsibilities of the CIP-Net SC include, but are not limited to, the following activities:
  1. Conducting monthly teleconferences or virtual meetings;
  2. Establishing the CIP-Net policies, procedures, and guidelines;
  3. Establishing CIP-Net policies and procedures for collaborative projects and protocols;
  4. Developing guidelines for the collection and distribution of specimen reference sets for collaborative research;
  5. Identifying impediments to success and developing strategies to overcome them;
  6. Serving as a nucleus for a broader outreach to the entire extramural immunoprevention research community;
  7. Organizing agendas for annual Steering Committee meetings;
  8. CIP-Net’s all major scientific and policy decisions will be determined by voting policies as established by the SC;
  9. Developing shared tools for disseminating information about the CIP-Net; and
  10. The SC may decide to establish subcommittees for specific purposes and NCI Project Scientists will serve on such subcommittees, as they deem appropriate.
       

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting.  To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

• Awardees will provide updates at least annually on implementation of the PEDP.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Altaf Mohammed, Ph.D.
Division of Cancer Prevention
National Cancer Institute (NCI)
Telephone: 240-276-6082
Email: [email protected]

Lillian Kuo, Ph.D.
Division of Cancer Biology
National Cancer Institute (NCI)
Telephone: 240-276-7687
Email: [email protected] 
 

Referral Officer
National Cancer Institute (NCI) 
Telephone: 240-276-6390
Email: [email protected]
 

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]
 

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.

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 2 CFR Part 200.