RFA-CA-25-032-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)

Funding Opportunity Title

Cancer Intervention and Surveillance Modeling Network (CISNET) (U01 Clinical Trial Not Allowed)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

RFA-CA-19-054

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

RFA-CA-25-032

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.399, 93.393, 93.394, 93.395, 93.396

Funding Opportunity Purpose

The purpose of this Notice of Funding Opportunity (NOFO) is to request applications for the Cancer Intervention and Surveillance Modeling Network (CISNET) (https://cisnet.cancer.gov). This NOFO invites multiple PD/PI applications for collaborative research projects using simulation and other modeling techniques for specific cancer types (see below). The proposed research is expected to generate sophisticated, evidence-based tools capable of informing decisions on the most efficient utilization of existing and emerging technologies and strategies for the control of cancer.

Funding Opportunity Goal(s)

The overall goals of this NOFO are to reduce cancer risk, incidence, morbidity, and mortality and enhance quality of life in cancer survivors through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results through dissemination and diffusion strategies.

Key Dates

Posted Date

Open Date (Earliest Submission Date)

January 11, 2026

February 11, 2026

Not Applicable

Not Applicable

December 2026

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).

Due Dates for E.O. 12372

Not Applicable

Expiration Date

February 12, 2026

Required Application Instructions

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 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.

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 This Notice of Funding Opportunity (NOFO) invites applications for the reissuance of the Cancer Intervention and Surveillance Modeling Network (CISNET) (U01 Clinical Trial Not Allowed). The CISNET consortium uses simulation modeling to extend evidence provided by trial, epidemiologic, and surveillance data to guide public health research and priorities across the cancer continuum. The purpose of the NOFO is to expand and extend the work of CISNET systematically in specific priority areas where modeling can help optimize the translation of cancer research into practice.

The NOFO invites multiple-PI applications for collaborative research projects using simulation and other modeling techniques for specific cancer types. Each proposal should focus on one of the following ten cancer types: bladder, breast, cervix, colon/rectum, esophagus, gastric, multiple myeloma, lung, prostate and uterine. It is expected that a cancer-type specific proposal will be comprised of 2-6 independent modeling teams and one coordinating center. All applicants must have established models for the cancer type with a demonstrated history of comparative modeling among the modeling teams for the selected cancer type.

The NOFO is open to all qualified investigators as described below. Prior involvement in CISNET, while welcomed, is not required. Accordingly, proposed research is expected to reflect new projects and directions even for the current CISNET awardees.

Key Terms in this NOFO Modeling: Modeling is defined as the use of simulation and mathematical techniques within a logical framework to integrate and synthesize known biological, epidemiological, clinical, behavioral, genetic, and/or economic information. De novo models are defined as ones which are developed from scratch, while modified models are ones that already have a history of development and are being extended, refined, merged with another existing modeling or reformulated using a more robust statistical and/or mathematical framework.

Modeling Group: A modeling group is defined as a team of researchers using a single model or a suite of interrelated model components for a single cancer type that is applicable to cancer control. A modeling group may include investigators from multiple institutions.

Cancer Type: Cancers of specific organs or systems on which the proposed application is focused.

Background There is a formidable gap between the rapid pace of biomedical innovation and our ability to harness it to improve population health. Today, that gap is particularly notable with respect to advances in the molecular and biological understanding of cancer, emerging technologies for cancer detection, novel treatments, and the challenges and opportunities they present. While biomedical advances have enabled the collection of health-related data, enormous challenges remain to integrate the information into optimal decision making tools for guiding cancer research and public health priorities. CISNET closes this gap by providing a suite of rigorously tested models to respond to emerging cancer control questions. CISNET research informs clinical practice and guidelines by synthesizing existing knowledge in a modeling framework under clearly specified assumptions. Modeling helps extend trial results beyond the limited regimens or eligibility criteria in any one study; estimate longer-term results from short-term studies and clarify the impact of interventions over the entire life course; estimate important but unobservable quantities (e.g., overdiagnosis); and disentangle conflicting trial results. Results like these are usually not directly observable, as they involve the preclinical “natural history” of disease, and many studies exclude key subgroups (e.g., the elderly) and rarely have enough follow-up time to reflect the full life course of individuals. CISNET models translate evidence from trials and epidemiological studies to the population setting by extrapolating beyond study protocols to the general population, accounting for patterns of care in less controlled settings.

For more information on the current CISNET consortium, including its history, see: https://cisnet.cancer.gov/.

Specific Objectives, Research Scope, and Requirements for this NOFO General Requirements and Expectations This NOFO encourages projects aligned with NCI priorities that translate cancer research into practice across the cancer control continuum. Applications should advance the practice of simulation modeling with the overarching goal of informing pressing decisions about cancer prevention and control.

Overall Characteristics of the CISNET Approach to Modeling: CISNET conducts comparative analyses using population-based models to answer critical questions informing patient care and use of technologies and services for cancer control. Distinguishing features of CISNET’s modeling capabilities and perspective include:

For more information on these important characteristics of CISNET, please see: https://cisnet.cancer.gov/modeling/ Required attributes and areas of focus: The main attributes of CISNET projects include the following:

Models: Proposed modeling efforts must adhere to the approaches and characteristics of CISNET models described above. Most models should include a "natural history" component, modeling the initiation, growth, and metastatic spread of the tumor, relevant precursor lesions, and relevant biomarkers. Models without a natural history component can be included; however, the application must provide justification for their inclusion, including how they complement the suite of other models proposed. Investigators may propose the use, extension, refinement and/or merging of existing models, including extension or incorporation of a multi-scale model if well justified. If well justified, an existing model can be reformulated using a more robust statistical/mathematical framework. However, de novo model development will not be supported.

Cancer Types of Focus: Each proposed project must be limited to one of ten cancer types: bladder, breast, cervix, colon/rectum, esophagus, gastric, multiple myeloma, lung, prostate and uterine. Applications focused on other cancer types will be viewed as non-responsive and will not be reviewed. Applicants should also be aware that NCI's general intent is to fund one project per each "eligible" cancer type. Although individual applications must focus on a single cancer type, cross-cancer site work along certain themes (e.g., prevention, biomarkers, targeted therapy) or methods (e.g., model calibration, enablement of high-performance computing, clinical trial design and value of information) could be proposed. It is noted that cross-cancer site collaborations would be dependent on the other cancer types that are funded and their interests. Cross-cancer collaborations across different CISNET cancer site awardees are encouraged for pilot projects (using rapid response funds as noted below) although to be responsive to this NOFO, the vast majority of the proposed work must focus on a single cancer type.

Applicability to Public Health Issues and Comprehensive Coverage: The emphasis of the proposed research must be on the applied use of modeling approaches to important public health issues. Applicants for this NOFO are expected to propose collaborative, interactive projects involving groups of researchers that put forward a program of comparative modeling with coverage across the important cancer control issues and relevant specific focus areas for the selected cancer type.

External Collaborations and Outreach: To fully achieve CISNET's goals, proposed activities should emphasize not only the extension of models and their use but also the communication and translation of modeling results to users who may utilize the results for decision making. Accordingly, one of CISNET's core values is to make the cancer community aware of the modeling capacity and encourage collaborations. Applicants are strongly encouraged to establish scientific collaborations and partnerships and develop mechanisms for inviting new ones during the award period. Examples include:

Targeted Priority Areas: There are nine specific priority research areas encompassing pressing evidence gaps across the cancer control continuum, from prevention through survivorship targeted by this NOFO. Each application should propose projects in as many of these areas as feasible and as relevant for the cancer type of interest. Applicants are not expected to address all priority areas but should select and justify those most pertinent.

Area 1) Modeling to assist understanding of contributions of cancer control efforts to achieve goals and milestones such as those in the National Cancer Plan and Healthy People 2030. CISNET models provide rich and rigorous laboratories for asking and answering questions about the past and present to inform future cancer control efforts and evidence-based cancer control approaches. CISNET modeling differs from other forecasting methods, as these methods explicitly incorporate observable secular trends in cancer risk, natural history and interventions across the cancer spectrum. By changing assumptions, models can be used to make future predictions about whether and how future goals could be achieved under a range of options—from questions about prevention, screening, diagnosis, treatment, and surveillance to end-of-life care and what the population impact might be.

Area 2) Understanding past trends with a special emphasis on risk factors and downstream implications of the increasing incidence of early onset cancer. Modifiable risk factors like smoking, obesity, alcohol use, and HPV may contribute to up to 40% of all new cancers. Further, such factors have been suggested as potential drivers of recent increases in cancer incidence prior to age 50. Because they capture the underlying cancer natural history including the often long latency periods, CISNET models can be used to investigate hypotheses about trends, which helps focus biologic and epidemiologic research. Often underpinning this type of CISNET research are detailed “risk factor generators” developed by the investigators. Such generators, like the existing generators for smoking history and obesity, capture detailed birth cohort-specific lifetime trajectories of risk factors in individuals that together aggregate to replicate U.S. or other area population-level trends. These risk factor generators are used as common inputs into the cancer models. With new data and evidence, work to develop new generators for other risk factors like alcohol use or emerging trends like e-cigarettes, adding other dimensions to existing generators and modeling multiple risk factors together should be considered. Similar generators have also been developed to model the dissemination of new screening modalities and treatments in the population. There have been efforts to release these generators to the research community at large, and similar efforts to disseminate generators are encouraged.

Area 3) Evaluating the potential for emerging technologies in Artificial Intelligence (AI), liquid-biopsy, and biomarkers, or other technologies to improve precision prevention, screening and/or surveillance. Given the rapid dissemination of new technologies into practice, often prior to solid evidence about performance and effectiveness, understanding their potential impact early is critical for decision making about use. Modeling can evaluate the potential of technologies with established operating characteristics and ask also “what-if” questions about the necessary characteristics, costs, or other factors that a new technology, like an AI tool for cancer detection in radiologic imaging, would need to achieve to be incorporated into clinical practice. For example, blood-based tests may be more acceptable and thus increase uptake compared with traditional screening tests like colonoscopy. “What if” questions about operating characteristics should be well justified and bounded based on what is currently known about the technology. Analyses that proposed unconstrained explorations of the feasible parameter space are discouraged. Novel technologies for self-sampling or self-testing may have lower accuracy yet improve access and in turn, cancer outcomes. Modeling is uniquely suited to understanding the benefits and harms of such testing options and how they may compare with or complement current age and/or risk-based screening practices. Models can quantify the impact of compliance, estimate overdiagnosis, and project diagnostic burden and long-term mortality outcomes.

Area 4) Opportunities for precision treatment and survivorship care. With new linkages between electronic health data and population-based cancer registry data, opportunities exist for more detailed modeling of cancer progression—including local and metastatic recurrence as well as cancer treatments, side effects and toxicities, downstream consequences, and the population-level impact. For example, modeling can help inform the design of multi-modal treatment strategies involving use of radiation, surgery, chemotherapies in neoadjuvant, adjuvant and metastatic settings by quantifying trade-offs in dimensions such as quality and length of life. Examining trade-offs from de-escalation of treatment is also of interest. Cost and economic considerations are other dimensions for decision making that modeling can incorporate. CISNET modeling can also inform trial design and conduct Value of Information (VOI) analyses that aid in prioritizing research needs. Further, given the estimated 18 million cancer survivors in the U.S. currently, modeling can be useful for assessing future care needs (including end-of-life). Survivors face lifelong health risks, such as treatment side effects and cancer recurrence, affecting both quality and quantity of life. Opportunities exist for modeling to inform other decisions such as workforce needs to care for survivors, assessment of overall cancer control progress accounting for quality of life and side effects as well as length of life, and evaluating surveillance strategies to monitor disease progression including imaging, liquid-biopsy and other biomarkers.

Area 5) Informing decisions about implementation and de-implementation of cancer control interventions and strategies in real-world settings across the cancer spectrum. Real-world effectiveness is often attenuated from efficacy observed in idealized study settings. Modeling informed by real-world data which accounts for local factors affecting both under- and overuse of appropriate care can help elucidate whether and how to adopt and/or scale a new intervention in different geographic areas, communities and care settings. Similarly, it can be used to understand the value of an existing intervention and whether de-implementation is merited. Examples of modeling analyses include how changing care delivery (e.g., adding nurse navigators) could facilitate adherence, improve follow-up, reduce delays and impact cost; how breakdowns in care processes could reduce effectiveness and increase cost; or how new screening or surveillance modalities could improve outcomes. Careful consideration of how models could be customized to model outcomes for different geographic settings or demographic subgroups is needed, as often the data needed to inform such work are sparse. Modelers must consider what parameters can and should be customized for each area, how the models can be validated.

Area 6) Designing strategies to improve outcomes in populations at risk across the cancer control continuum. CISNET models offer powerful platforms for exploring sources of differences in outcomes and designing cancer prevention, screening, treatment and survivorship strategies to efficiently and effectively improve them. Incorporating area-level context including geography and rurality into the models is encouraged.

Area 7) Modeling as the information backbone for individual and population-level decision-making tools. Decision support tools can help inform patients and physicians about the potential harms and benefits of screening and treatment options and facilitate decision making based on individual values and preferences. Such tools tailored to an individual’s risk or clinical factors have been shown to be more effective than generic tools. CISNET modelers can partner with experts in shared decision making to embed models, model components or model results into tools for use by the public and/or health care professionals. CISNET model results can also be used to inform population-level tools that generate outcomes across relevant dimensions for evaluating cancer control programs considering specific care delivery settings, locations, and resource availability.

Area 8) Methods for complex model calibration, reporting of comparative modeling results, and other modeling methodology. CISNET modelers have been at the forefront in developing rigorous and reproducible modeling and calibration methods, yet challenges remain especially for improving computational algorithms and efficiency. For example, one complex step in model development and extension is the calibration of unobservable model parameters such that models can replicate observable phenomenon over time. Improvement of computational efficiency for CISNET models, their calibrations, and the analyses via use of high-performance computing platforms and related algorithms is also of interest. In addition, methodologic opportunities exist to enhance the synthesis and interpretation of comparative modeling results for decision makers, especially when reporting model or parameter uncertainty and differences in results across models. Applicants should keep in mind that CISNET is primarily focused on informing issues in cancer control, and all proposed methodology development should explicitly relate to this primary goal. Therefore, methods can be developed if directly motivated and justified by important issues in proposed modeling analyses and projects.

Area 9) Cancer-Type Specific Opportunities. Opportunities may exist for cancer-type specific modeling that are critical for that cancer type but may not fit into the eight areas above.

Organizational Structure and Coordination of Proposed CISNET Applications Each proposal must have the following functional elements:

Other Expectations

CISNET Governance and Advisory Committees CISNET will be governed by a Consortium Steering Committee. For details, see Section VI.2. Cooperative Agreement Terms and Conditions of Award.

Cancer-type specific external advisory committees are suggested to consult on evolving areas of focus.

Non-Responsive Applications Applicants are strongly encouraged to consult with scientific contacts to assure responsiveness to the NOFO prior to submission. The following types of research activities are outside the scope of this NOFO and will be considered non-responsive. Non-responsive applications will not be reviewed.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The NCI intends to commit $9.438M (total cost) in FY 2026 to fund up to eight awards.

Award Budget

Applicants may request budgets of up to $1.24M in direct costs per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the maximum allowable budget will be requested only in case of particularly comprehensive approaches and applications proposing six or more modeling groups.

Award Project Period

The maximum project period is five years.

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

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

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

Applications Involving the NIH Intramural Research Program The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. Intellectual property will be managed in accord with established policy of NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Foreign Organizations/International Collaborations

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

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

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 the 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 registrations; 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

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

For this NOFO, applicants are required to designate multiple PDs/PIs including at least one who is responsible for the Coordinating Center. Other PDs/PIs are expected to lead individual modeling groups. Alternative arrangements may be proposed if justified. For example, the Coordinating Center PD/PI does not have to be modeling group PD/PI, and additional PDs/PIs can be added for specialized aims.

It is suggested that the contact PD/PI be the Coordinating Center PD/PI and that the Coordinating Center be located at the institution submitting the application in response to this NOFO.

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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.

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

For this NOFO, the Research Strategy section is limited to 30 pages.

Instructions for Application Submission

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.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

The following additional materials must be included. Each attachment should be uploaded as a separate PDF using the indicated filenames. The Other Attachments files combined must not exceed 10 pages and are not counted against the 30-page limit for the Research Strategy section.

Attachment 1: Model Characteristics (use filename "Models"). Provide a table summarizing differences and similarities across the models. Table should use columns for models and rows for model characteristics such as key assumptions, structure, components, data used to parameterize/calibrate/validate, etc.

Attachment 2: Prior Modeling Analyses (use filename "Analyses"). Provide a table summarizing the prior modeling analyses. The table should use rows for prior model analyses and columns to describe important attributes such as model groups participating, key findings and related publications/products. Analyses can be clustered area of coverage in the cancer control continuum (e.g., prevention, screening, diagnosis, treatment, surveillance, end-of-life) as applicable.

Attachment 3: Proposed Modeling Projects (use filename "Projects"). Provide a table summarizing the modeling projects that are being proposed in applications responding to this funding announcement using rows for projects. Columns should indicate items such as the specific aim to be addressed, area of coverage (e.g., prevention, screening, diagnosis, treatment, surveillance, end-of-life) and/or priority area represented, modeling groups included, timeline, coordinator/project leaders, outside collaborators or key additional data resources as appropriate, etc.

SF424(R&R) Senior/Key Person Profile

R&R or Modular Budget

It is anticipated/expected that requested budgets will vary, depending on the scale of work and the number of modeling groups proposed. The budget request (direct costs) for the entire application per year must not exceed $570K, $750K, $950K, $1.15M and $1.24M for 2, 3, 4, 5, and 6 (or more) modeling groups, respectively.

The PI level of effort must comply with requirements described in NOT-CA-21-096.

Budget Justification Section. In the budget justification section, applicants should break out the time commitment and responsibilities of each individual (in particular, for the PDs/PIs) involved with respect to modeling and Coordinating Center activities.

The budget justification section should include the approximate direct costs for:

Coordinating Center. The budget allocation for the Coordinating Center should generally not exceed $110K direct costs per year.

Modeling Groups. Budget allocations for individual modeling groups should generally not exceed $180K direct costs per year and collectively the sum must not exceed the direct cost caps noted above based on the number of modeling groups to be included. For applications with 6 or more modeling groups, the budget allocations for the modeling groups will need to be adjusted to meet the overall direct cost cap. Further, for all applications, it is expected that budget allocations for the modeling groups with specialized focus and/or limited participation in aims including leadership roles should be substantially smaller. In exceptional situations, budget allocations for a particularly complex modeling group could be slightly larger if well justified. For example, this extra amount would include specialized expertise needed to address some of the priority areas (e.g., decision aid development, implementation science), and junior modelers. Persons with specialized expertise in one modeling group would generally be expected to be shared across the groups as needed. To be included, a modeling group must have demonstrated evidence of prior collaborative modeling with the other groups included in the application.

"Rapid Response" Funds. Applicants must budget for special funds that will be used for support of post-award projects/activities developed to address emerging opportunities. The amount allocated to these "rapid response" funds should be based on the number of modeling groups per application and generally should not exceed $100K, $120K, and $140K direct costs per year for 3 or fewer, 4, and 5 or more modeling groups, respectively. Further, it is expected that approximately $30K, $35K, and $40K of this amount for applications with 3 or fewer, 4, and 5 or more modeling groups, respectively, will be designated for projects providing professional enhancement activities for junior investigators within the cancer site and across the consortium. These funds should be presented in the Other Direct Costs category under the heading “Rapid Response Funds”. Funds will be activated following discussion and approval of proposed projects by the respective Cancer-Type Leadership Group.

Travel. Applicants must budget travel funds for up to three persons per modeling group to participate in two consortium meetings per year, including: (1) an annual meeting and (2) a mid-year meeting. The structure of both includes approximately 2 days for a cancer-type specific meeting and a full day for a cross-cancer plenary session. The mid-year meeting is at one of the modeling groups' home institutions, selected on a rotating basis, and that group is expected to host the meeting, providing administrative support and information about on-campus meeting rooms and other local details. Since the mid-year meetings are generally held at a common location to facilitate modelers who are part of more than one cancer type, each application should budget for additional administrative support to host one meeting during the five-year award period.

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: Describe the specific objectives and aims of the proposal (generally 4-6 aims are expected). Indicate how the proposed aims correspond to the priority areas.

Research Strategy: Research Strategy must consist of the following sub-sections:

Sub-section A. Overall Objectives and Significance.

Sub-section B. Project Leadership and Coordination, Rapid Response and Professional Enhancement, and Advisory Committee.

Sub-section C. Modeling Groups, Their Models, and Previous Modeling Projects.

Sub-section D. Proposed Model Extensions, Analyses and Comparative Modeling Activities.

See detailed instructions below for the content of these sub-sections.

Sub-section A. Overall Objectives and Significance:

Describe the background leading to the proposed specific aims, critically evaluating existing knowledge, and specifically identifying the gaps in evidence and knowledge that the project overall and the aims specifically are intended to fill. In addition, this sub-section should include the following:

Sub-Section B. Project Leadership and Coordination, Rapid Response and Professional Enhancement, and Advisory Committee:

This section should describe how the activities across the modeling groups within the cancer site and across CISNET will be integrated and coordinated.

B.1 Project Leadership and Coordination. Each application must include a Coordinating Center and a Coordinating Center PD/PI. The Cancer Site Leadership Team may be comprised of all the PDs/PIs and/or model group or topic leads depending on organizational structure. Applicants must describe their plan for the following activities:

Although the Coordinating Center will provide oversight, it is expected that certain coordination activities will be distributed across the leadership team and modeling groups. For example, if there is a collaborative modeling activity among a subset of modeling groups, coordination of that work might be done by one modeling group rather than through the Coordinating Center. If a meeting is held at a particular investigator's institution, they would be responsible for making local arrangements. Local specialized expertise included in one group (e.g., specific clinical, methodological or topical expertise) might be shared across the group. Even though there is one Coordinating Center, it is expected that decision making will be conducted through consensus across the leadership team that includes the modeling groups.

B2. Rapid Response and Professional Enhancement. Outline plans and processes for projects that will use the rapid response funds, listing examples of anticipated activities (e.g., plans for professional enhancement activities for junior investigators, collaboration with external researchers regarding…