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 Funding Opportunity Announcement.

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

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) to support a deeper understanding of basic mechanisms of immunoprevention, discover novel immunoprevention strategies, preclinical development and testing of interventions, and foster a community of cancer immunoprevention researchers. The UG3/UH3 research projects will enable de novo discovery of immune pathways, targets, immunoprevention mechanisms, or investigate the efficacy and potential side effects of new vaccines or immunomodulatory agents. Applicants responding to this NOFO must apply for both the UG3 and UH3 phases together in a single application. Achievement of the UG3 milestones will be necessary for the transition to the UH3 phase.

KEY DEFINITIONS FOR THE CONTEXT OF THIS NOFO

• Cancer immunoprevention: Cancer immunoprevention is the prevention of invasive cancer onset 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.
• Higher-risk populations, higher-risk cohorts: These are individuals with an increased risk of cancer such as those with hereditary cancer syndromes (HCS) and precursor abnormalities that place individuals at higher risk of cancer, e.g., precancer.
• 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.

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.

RESEARCH OBJECTIVES

The overarching objective of the Cancer Immunoprevention Network (CIP-Net) is to support a deeper understanding of the basic mechanisms of immunoprevention and the discovery and development of novel translational immunoprevention strategies. Emerging research is providing a solid premise to further investigate prevention-specific exploitable immune pathways and identify novel targets for immunoprevention. Research on novel immunoprevention approaches will interrogate mechanisms of action, evaluate vaccine/agent efficacy, and investigate neoantigens and/or targets in the highest risk populations (e.g., inherited cancer predisposition, individuals with precancers or exposed to occupational/environmental carcinogens, cancer survivorship cohorts, etc.) for the development of interventions in cancer interception and risk-reduction. Currently, the CIP-Net will be comprised of exploratory UG3/UH3 research projects. 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 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 resource coordinating center that will foster collaborations, facilitate data and resource sharing across CIP-Net, and enhance scientific communication and outreach to cancer prevention research communities. Taken together, CIP-Net will support basic and preclinical translational immunoprevention research toward addressing unmet scientific needs and filling research gaps in exploring novel immunoprevention pathways and targets and development of immunopreventive interventions and studying the immune mechanisms of precision cancer prevention-interception.

The scientific scope of the CIP-Net will span the entire immunoprevention research continuum from early basic discovery and mechanistic research through pre-clinical/ translational research. The CIP-Net UG3/UH3 research will address unique unexplored immune pathways and targets for immunoprevention targeting high-risk populations (i.e., high-penetrance germline mutations, heritable cancer syndromes (HCS)), individuals diagnosed with precancer and/or exposed to environmental carcinogens, special populations (e.g., Monoclonal gammopathy of undetermined significance (MGUS), and/or cancer survivorship cohorts). Specific areas of immunoprevention research may include but are not limited to:

• Basic research on novel immune pathways in early tumorigenesis, precancerous microenvironment, or early immunologic changes in precancerous tumor immune microenvironment;
• Preclinical development and testing of novel immunopreventive interventions (agents/vaccines);
• Immunomodulation to promote antitumor immune surveillance, block tumor formation, and progression;
• Identifying novel immune targets in early tumorigenesis;
• Immune mechanisms of preventive cancer vaccines and immunomodulatory agents;
• Immune mechanism-based prevention strategies by investigating epigenetic changes, modulating precancerous inflammatory pathways, innate immune signaling, enhancing immunoediting, etc.;
• Characterizing immune consequences of checkpoint inhibitors in the precancerous and early-stage tumor immune microenvironment;
• Immunoprevention mechanisms for oncoviruses (e.g., KSHV, EBV, etc.) and carcinogenic bacteria (e.g., H. pylori);
• Multi-modal immune profiling of premalignant lesions for precancer immune interception;
• Developing and optimizing model systems (including animal, computational, and/or mathematical models) specific for immunoprevention research;
• Identification of exploitable retired antigens and development of preventive vaccines;
• Neoantigen discovery and vaccine development (profiling mutational and neoantigen burden during precancerous stages and tumor progression);
• Novel preventive vaccine platforms;
• Vaccine formulation and effective adjuvant development for prevention vaccines;
• Vaccines development for high-risk cohorts such as hereditary cancer syndromes (e.g., Lynch syndrome, FAP, etc.), individuals with precancer lesions or those exposed to carcinogens;
• Mechanisms of vaccine efficacies and toxicities/autoimmunity in preclinical models representing the high-risk cohorts;
• Immunoprevention optimization (i.e., at what precancerous stages, the timing of initiation, dosing, scheduling, and treatment duration, as well as possible combination regimens with other prevention agents);
• Proof-of-principle preclinical studies in appropriate genetically modified or in carcinogen-exposed mice to demonstrate that vaccines and other immunological treatments induce host immune responses that effectively control tumor onset and progression; and
• Second malignancy prevention in the pediatric and adult population by immunoprevention.

UG3/UH3 PHASED AWARDS

An initial cooperative agreement award for up to 2 years will be made for the UG3 phase. The UG3 phase will enable de novo discovery of immune pathways, immunoprevention mechanisms, or preclinical investigation of new vaccines or immunomodulatory targets or agents with the potential for the development of immunopreventive interventions. Successful completion of UG3 milestones will lead to the UH3 phase for further evaluation of efficacy, immune mechanisms of action, validation of actionable targets, and/or further preclinical development. Prior to the end of the UG3 phase, NIH program staff will review the progress toward the UH3 phase for the UG3 to UH3 transition. 

UG3 Phase to UH3 Phase Transition

Utilization of milestones is a key characteristic of this NOFO. A milestone is defined as a scheduled event in the project timeline signifying the completion of a major project stage or activity. Applications must include well-defined milestones for the UG3 phase and annual milestones for the UH3 phase. Milestones for the UG3 phase must be objectively defined and quantifiable with clear go/no-go criteria to ensure clear demonstration that the proposed milestones were met at the time of the transition request. Criteria to determine whether the award will transition from the UG3 phase to the UH3 phase will include:

• successful completion of established milestones during the UG3 phase of the project;
• demonstration of the feasibility for the proposed UH3 research; and
• extent to which UG3 phase activities support the aims of the UH3 phase.  

Only projects that meet their UG3 milestones will have an opportunity to move to the UH3 phase. UH3 milestones will be the basis for judging progress towards and completion of the UH3 phase.

Note: A Notice of Funding Opportunity (NOFO) using the U24 mechanism will be announced later to create a coordinating center with the aim to coordinate activities of the CIP-Net.

NON-RESPONSIVE APPLICATIONS

The following types of studies are beyond the scope of this NOFO and applications proposing them will be considered non-responsive to this NOFO and will not be reviewed:

• Research proposed exclusively focused on therapy (immunotherapy), without novelty and application toward cancer prevention;
• Projects proposing studies that meet the current NIH definition of clinical trials; and
• Projects proposing studies on HPV vaccines. 

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

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

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 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. 

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.

• 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 SF424 (R&R) Application Guide.

2. Cost Sharing

This NOFO 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, per 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 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 SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity 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:

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

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

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

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

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

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

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

R&R Budget

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

R&R Subaward Budget

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

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

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

nSpecific Aims: Describe the overall goals for the entire application and indicate separately Specific Aims to be accomplished in the UG3 Phase and in the UH3 Phase.  The UG3 phase research may include discovering and investigating novel immune pathways, mechanisms, innovative targets for immunopreventative intervention, and preclinical investigation of new vaccines or immunomodulatory agents. The UH3 phase research may include validation and deeper mechanistic interrogation of pathways, candidate or target development, or preclinical testing to evaluate immunopreventive efficacy, mechanisms, and potential side effects.

Research Strategy: Applicants should describe both the UG3 phase and the UH3 phase and organize the Research Strategy into the subsections identified below.

Sub-section A. Background and Significance:

• The high-risk cohort or population that will be the subject of this research and the rationale for selection must be defined. High-risk populations may include penetrance germline mutations, heritable cancer syndromes (HCS), individuals diagnosed with precancer and/or exposed to environmental carcinogens, special populations (e.g., MGUS), and/or cancer survivorship cohorts. Explain the significance of the selected organ site cancer and justify why the proposed target, pathway, mechanism, immunopreventive agent, or vaccine is likely to have an impact on cancer interception and prevention. Explain why the specific immunoprevention intervention addresses an unmet medical need, the global burden of disease; which patients will benefit; how patients will benefit; the potential public health impact if the proposed research successfully translates to the clinic. The clinical relevance of the target class for the proposed indication, or how the mechanism of action of the proposed target and the agents has been understudied for the indication; and if the same target/mechanism of action has been studied in the proposed patient population, discuss the value added to the proposed studies. Which patients benefit if the lead immunopreventive intervention is successfully translated to the clinic.
• Preliminary data are not required for this application. However, if preliminary data are available, they may be included in this sub-section.

Sub-section B. Investigator: The research team's multidisciplinary scientific expertise necessary to carry out the proposed research must be demonstrated. It is required to demonstrate that the research team has expertise in the cancer prevention, immunoprevention and cancer immunology. It is required to demonstrate that the appropriate collaborators are involved in the proposed study and provide evidence of successful collaboration between the research team and the proposed key partners.

Subsection C. Innovation:  Discuss how the proposed project fills a gap in cancer immunoprevention research and the high need for target and agent discovery and development efforts to identify new modalities to change the current trajectory of cancer interception and prevention research. Provide compelling information (and include data, where applicable) that demonstrates that the proposed immunoprevention research for cancer interception and prevention is missing, largely absent, or underrepresented. How this project shifts translational science paradigms: Address any ways that the project will generally improve the success or efficiency of translational science. Discuss the ways in which any learnings from the current immunopreventive agent discovery and development campaign could be applied to other translational science efforts.

Sub-section D. Approach:  The research approach must be divided into the UG3 Phase and the UH3 Phase.

• Overall Strategy and Analyses: Projects should have clear, testable hypotheses and the research plan should use quantifiable measures. A statistician should be consulted to make sure all experiments have adequate power and statistical rigor. Justification and statistical calculation for the proposed number of animals for applicable in vivo models should be included. An experimental setting that enables the definition of changes in potential immune targets or pathways as a function of time during carcinogenesis must be defined. Approaches may be based on classical models of cancer initiation and progression or de novo models. Models should reflect biology inherent to high-risk clinical cohorts who could be the population targeted for interception and prevention (translational studies).
• UG3 Phase: Description of the proposed experimental setting for the conduct of the research. Provide a rationale for how this setting can support the identification of targets, mechanisms for immune interventions, or preclinical investigation of new vaccines or immunomodulatory agents with the potential for the development of immunopreventive interventions. Describe the plan for establishing the validity of targets, agent efficacy, or mechanisms.
• Plans for transition to the UH3 Phase: Establish scientific and quantitative milestones for the UG3 research.  The transition to UH3 will be evaluated on a) successful completion of established milestones during the UG3 phase of the project, and b) demonstration of the feasibility of the proposed UH3 research.
• UH3 Phase: Plans for the development of interventions based on immunoprevention targets or immune mechanisms investigated in the UG3 Phase must be described.  Research plans for validation and deeper mechanistic interrogation of immunopreventative pathways.  Plans for production or acquisition of reagents, as necessary for the development of interventions. Demonstration of preclinical cancer preventive efficacy, mechanisms of action (MOA), potential side effects, or further preclinical development of novel translational immunoprevention strategies.
• Health Disparities: If applicable to the type of research being proposed, address how 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 racially/ethnically diverse populations and 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.

Sub-section E. Milestones and Timelines:

• Using separate sub-headings, provide detailed timelines and milestones that are aligned with the objectives of each phase:
• Milestones for the UG3 Phase: Include specific scientific and quantitative milestones that will serve as criteria for progressing to the UH3 Phase
• Milestones for UH3 Phase: The description of milestones for each phase must include objective criteria for determining whether a milestone has been achieved.
• In addition, outline the anticipated steps/activities for the future expansion of the project beyond the UH3 phase.

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. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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.

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

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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.

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

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.

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.

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 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 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.

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.

For this particular announcement, note the following: Applications in response to this NOFO will include two phases: the UG3 phase and the UH3 phase. Milestones to be accomplished in the UG3 phase for transition to the UH3 phase must be proposed by the Principal Investigator in the application and will require NCI administrative review and approval before the UH3 phase is awarded. Annual milestones for the UH3 phase must also be proposed by the Principal Investigator in the application.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this NOFO:

How well are the high-risk cohorts defined by this grant application? How well does the proposed research address a research issue that could not be addressed previously? What is the likelihood that the proposed research will substantially advance the understanding of cancer immunoprevention targets in higher-risk populations and the discovery and development of novel immunoprevention agents and strategies for cancer interception and prevention? 
 

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance, and organizational structure appropriate for the project?

Specific for this NOFO:How well does the application provide evidence that the investigative team has scientific expertise in cancer prevention, immunology, proposed pathway/target area, and/or develop immunoprevention interventions and their ability to organize, manage and implement the proposed studies and meet milestones and timelines? 

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific for this NOFO:
How well do the proposed studies explore innovative immunopreventive biological concepts to improve the understanding and knowledge of cancer preventive and interceptive targets/pathways and to develop immunopreventive agents and vaccines for cancer interception and prevention?  How novel is the research methods proposed to validate potential targets and discover efficacious immunologically targeted interventions for higher-risk populations? How well does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, the potential for information, or potential to advance scientific knowledge?
 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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?

Specific to this NOFO: How well does the proposed research describe the plan for immune target or mechanism identification? How well does the grant application describe the potential for mechanism-based cancer immunoprevention research development in the UH3 Phase? 

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

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

Milestones: How clearly are the steps and milestones defined? How feasible and quantifiable are the milestones with respect to the proposed objectives? How adequate are the criteria provided for the UG3 Phase to determine the successful completion of milestones? How appropriate are the milestones for the UG3 Phase to allow future project expansion? 

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 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

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

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients 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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and 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.”

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, 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's 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have the following primary responsibilities:

• 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 Committees. This plan will clearly spell out interactive requirements that all CIP-Net 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.
• Meeting yearly milestones as defined by PI(s) and NCI Project Scientists at the time of award;
• Participating in NCI-coordinated evaluation of CIP-Net.

In addition to the standard annual Research Performance Progress Report (RPPR) submissions, Principal Investigators may be expected to supply additional progress-related information.

Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to the Government's rights of access consistent with current DHHS, PHS, and NIH policies. PI(s) are also encouraged to organize and participate in collaborative activities and scientific or programmatic working groups.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  Designated Program Director(s) from NCI and other NIH Institutes supporting this initiative will have substantial involvement as Project Scientists. Activities of substantially involved staff members from NIH involved will include, but will not be limited to:

• 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 those within the NCI ITCR program and 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, a Program Director from NCI (or another appropriate NIH Institute), 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. 

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: 

• The NCI Project Scientists will collectively have one vote for NCI; and
• One representative from each new UG3/UH3 (a PI or their designee) 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:

• Conducting monthly teleconferences or virtual meetings;
• Establishing the CIP-Net policies, procedures, and guidelines;
• Establishing CIP-Net policies and procedures for collaborative projects and protocols;
• Developing guidelines for the collection and distribution of specimen reference sets for collaborative research;
• Identifying impediments to success and developing strategies to overcome them;
• Serving as a nucleus for a broader outreach to the entire extramural immunoprevention research community;
• Organizing agendas for annual Steering Committee meetings;
• CIP-Net’s all major scientific and policy decisions will be determined by voting policies as established by the SC; 
• Developing shared tools for disseminating information about the CIP-Net; and
• The SC may decide to establish sub-committees for specific purposes and NCI Project Scientists will serve on such sub-committees, as they deem appropriate.

Dispute Resolution: Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual 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 DHHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

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. 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

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 45 CFR Part 75 and 2 CFR Part 200.